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As confidentially submitted to the Securities and Exchange Commission on June 22, 2020.

This draft registration statement has not been publicly filed with the Securities and Exchange Commission and all information herein remains strictly confidential.

Registration No. 333-                

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

 

 

Vir Biotechnology, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   2836   81-2730369

(State or other jurisdiction of

incorporation or organization)

 

(Primary Standard Industrial

Classification Code Number)

 

(I.R.S. Employer

Identification Number)

(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)

 

 

George Scangos, Ph.D.

President and Chief Executive Officer

Vir Biotechnology, Inc.

499 Illinois Street, Suite 500

San Francisco, California 94158

(415) 906-4324

(Name, address, including zip code, and telephone number, including area code, of agent for service)

 

 

Copies to:

Laura A. Berezin

Charles S. Kim

Kristin VanderPas

Cooley LLP

3175 Hanover Street

Palo Alto, California 94304

(650) 843-5000

 

Brian J. Cuneo

B. Shayne Kennedy

Drew Capurro

Latham & Watkins LLP

140 Scott Drive

Menlo Park, California 94025

(650) 328-4600

 

 

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this Registration Statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended, check the following box.  ☐

If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

If this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer      Accelerated filer  
Non-accelerated filer      Smaller reporting company  
Emerging growth company       

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act.  ☐

 

 

CALCULATION OF REGISTRATION FEE

 

 

Title of each class of
securities to be registered
 

Amount

to be
registered(1)

 

Proposed

maximum

offering price

per share

 

Proposed

maximum

aggregate

offering price(1)(2)

  Amount of
registration fee (2)

Common Stock, $0.0001 par value per share

               

 

 

(1)

Includes            shares that the underwriters have the option to purchase.

(2)

Estimated solely for the purpose of computing the amount of the registration fee pursuant to Rule 457(c) under the Securities Act of 1933, as amended, on the basis of the average high and low sales price of the Registrant’s common stock as reported by The Nasdaq Global Select Market on            , 2020

 

 

The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the Registration Statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

 

 

 


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The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

 

SUBJECT TO COMPLETION, DATED                 , 2020

PRELIMINARY PROSPECTUS

            Shares

 

 

LOGO

Common Stock

 

 

We are offering             shares of our common stock.

Our common stock is listed on The Nasdaq Global Select Market under the trading symbol “VIR.” The last reported sale price of our common stock on The Nasdaq Global Select Market on             , 2020 was $            per share.

We are an “emerging growth company” as defined under the federal securities laws and, as such, have elected to comply with certain reduced public company reporting requirements.

 

 

Investing in our common stock involves a high degree of risk. See the section titled “Risk Factors” beginning on page 17.

 

     Per
Share
     Total  

Public offering price

   $                    $                

Underwriting discounts and commissions(1)

   $                $            

Proceeds to us before expenses

   $                $            

 

(1)

See the section titled “Underwriting” for additional information regarding compensation payable to the underwriters.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities, or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.

We have granted the underwriters an option for a period of 30 days to purchase up to             additional shares of common stock at the public offering price, less the underwriting discounts and commissions.

The underwriters expect to deliver the shares against payment in New York, New York on             , 2020.

 

 

Goldman Sachs & Co. LLC

Prospectus dated                 , 2020


Table of Contents

TABLE OF CONTENTS

 

     Page  

Prospectus Summary

     1  

Risk Factors

     17  

Special Note Regarding Forward-Looking Statements

     19  

Market and Industry Data

     20  

Use of Proceeds

     21  

Dividend Policy

     23  

Capitalization

     24  

Dilution

     26  

Certain Relationships and Related Party Transactions

     28  

Description of Capital Stock

     32  

Material U.S. Federal Income Tax Consequences to Non-U.S. Holders

     37  

Underwriting

     41  

Legal Matters

     47  

Experts

     47  

Where You Can Find Additional Information

     47  

Incorporation of Certain Information by Reference

     48  

 

 

Neither we nor the underwriters have authorized anyone to provide any information or to make any representations other than those contained or incorporated by reference in this prospectus or in any free writing prospectuses prepared by or on behalf of us or to which we have referred you. We take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This prospectus is an offer to sell only the shares offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so. The information contained or incorporated by reference in this prospectus or in any applicable free writing prospectus is current only as of its date, regardless of its time of delivery or any sale of shares of our common stock. Our business, financial condition, results of operations and prospects may have changed since that date.

For investors outside the United States: Neither we nor the underwriters have done anything that would permit this offering or possession or distribution of this prospectus or any free writing prospectus we may provide to you in connection with this offering in any jurisdiction where action for that purpose is required, other than in the United States. You are required to inform yourselves about and to observe any restrictions relating to this offering and the distribution of this prospectus and any such free writing prospectus outside the United States.

Unless the context otherwise requires, the terms “Vir,” “the company,” “we,” “us,” “our” and similar references in this prospectus refer to Vir Biotechnology, Inc. and its consolidated subsidiaries.

 

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PROSPECTUS SUMMARY

This summary highlights selected information contained elsewhere in this prospectus or incorporated by reference herein. Before investing in our common stock, you should carefully read this entire prospectus, including the information incorporated by reference herein, especially the matters discussed in the information set forth under the sections titled “Risk Factors” in this prospectus and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, and the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2019 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, each of which are incorporated by reference herein.

Business Summary

Our mission is to create a world without infectious disease

We are a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Infectious diseases are one of the leading causes of death worldwide and can cause trillions of dollars of direct and indirect economic burden each year – as evidenced by the current coronavirus disease 2019, or COVID-19, pandemic. We believe that now is the time to apply the recent and remarkable advances in immunology to combat infectious diseases. Our approach begins with identifying the limitations of the immune system in combating a particular pathogen, the vulnerabilities of that pathogen and the reasons why previous approaches have failed. We then bring to bear powerful technologies that we believe, individually or in combination, will lead to effective therapies.

We have assembled four technology platforms, focused on antibodies, T cells, innate immunity and small interfering ribonucleic acid, or siRNA, through internal development, collaborations and acquisitions. Our current development pipeline consists of product candidates targeting severe acute respiratory syndrome coronavirus 2, or SARS-CoV-2, the virus that causes COVID-19, hepatitis B virus, or HBV, influenza A, human immunodeficiency virus, or HIV, and tuberculosis, or TB. For SARS-CoV-2, VIR-7831, a SARS-CoV-2- neutralizing monoclonal antibody, or mAb, is planned to start a Phase 2/3 clinical trial program this summer and we anticipate initial clinical data to be available before the end of the year. VIR-7832, a vaccinal SARS-CoV-2-neutralizing mAb, is planned to initiate a Phase 2 clinical trial later this year. VIR-2703, a SARS-CoV-2-targeting siRNA, is in preclinical studies. For HBV, VIR-2218, an HBV-targeting siRNA, is currently in an ongoing Phase 2 clinical trial. Initial Phase 2 data have demonstrated substantial, durable, and dose dependent reduction of hepatitis B virus surface antigen, or HBsAg, and VIR-2218 has been generally well-tolerated. We plan to initiate a Phase 2 clinical trial to combine VIR-2218 with pegylated interferon-alpha, or PEG-IFN-α, an approved immune modulatory agent in the second half of this year. In addition, we recently initiated a Phase 1 clinical trial for VIR-3434, an HBV-neutralizing mAb. For influenza A, VIR-2482, a mAb designed for the prevention of influenza A, is currently in a Phase 1/2 clinical trial and has been generally well-tolerated. For HIV, VIR-1111, an HIV T cell vaccine based on HCMV, is planned to initiate a Phase 1 trial in the second half of this year. We have built an industry-leading team that has deep experience in immunology, infectious diseases and product development. Given the global impact of infectious diseases, we are committed to developing cost-effective treatments that can be delivered at scale.

Our Technology Platforms

Our four current technology platforms are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. We are using our platforms to advance our current product candidates and generate additional product candidates for multiple indications.



 

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Antibody Platform: We have established a robust method for capitalizing on unusually successful immune responses naturally occurring in people who are protected from, or have recovered from, infectious diseases. We identify rare antibodies from survivors that have the potential to treat and prevent rapidly evolving and/or previously untreatable pathogens via direct pathogen neutralization and immune system stimulation. The fully-human antibodies that we discover may also be modified to enhance their therapeutic potential.

T Cell Platform: We are exploiting the unique immunology of human cytomegalovirus, or HCMV, a commonly occurring virus in humans, as a vaccine vector to potentially treat and prevent infection by pathogens refractory to current vaccine technologies. This approach is based on fundamental observations made in non-human primates, or NHPs, with rhesus cytomegalovirus, or RhCMV. We believe that this platform may also have applicability beyond infectious diseases, to areas such as cancer.

Innate Immunity Platform: Moving beyond more traditional approaches that are used to evoke adaptive immunity or that directly target pathogens, where the development of resistance can occur, we plan to target host proteins as a means of creating host-directed therapies with high barriers to resistance. We believe that by leveraging the power of innate immunity, we can create medicines that break the “one-drug-for-one-bug” paradigm to produce “one-drug-for-multiple-bugs.”

siRNA Platform: We are harnessing the power of siRNA to inhibit pathogen replication, eliminate key host factors necessary for pathogen survival and remove microbial immune countermeasures. Our collaboration with Alnylam Pharmaceuticals, Inc., or Alnylam, includes VIR-2218 for HBV, VIR-2703 for SARS-CoV-2 and seven additional programs for infectious diseases.

Our Development Pipeline

Our current product candidates are summarized in the chart below:

LOGO

 

*

VIR-1111 is a vaccine designed to establish proof of concept in Phase (Ph) 1 clinical trial to determine whether unique immune response observed in NHPs can be replicated in humans; ultimately, any candidates we advance as a potential HIV vaccine will require modifications to VIR-1111 before further clinical development.

 

    

IND: Investigational New Drug Application.



 

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SARS-CoV-2: The substantial impact of viral outbreaks and the need for global preparedness have been highlighted by the current COVID-19 pandemic. As of June 19, 2020, the virus had spread to 188 countries, there were over 8.5 million recorded infections and over 450,000 recorded deaths. We have moved rapidly to address this global health challenge. Our focus is on treating and preventing SARS-CoV-2, as well as potential future coronavirus outbreaks. To do so, we are taking multiple approaches: antibodies (VIR-7831 and VIR-7832), siRNA (VIR-2703), applying our innate immunity platform to identify cellular host genes necessary for virus replication, and vaccines. We anticipate that the initial registration populations for our product candidates will include those at high risk of contracting COVID-19 and those in need of treatment for COVID-19.

VIR-7831 and VIR-7832 are SARS-CoV-2-neutralizing mAbs. For VIR-7831, we plan to submit an IND and thereafter commence a Phase 2/3 clinical trial program this summer. VIR-7832 is planned to initiate a Phase 2 clinical trial later this year. Both VIR-7831 and VIR-7832 are based on a parent antibody, S309, which was derived from samples previously gathered for research on pan-coronavirus-neutralizing mAbs. S309 has demonstrated high affinity and avidity for the SARS-CoV-2 spike protein and the ability to neutralize SARS-CoV-2 in multiple live-virus cellular assays. S309 binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also commonly known as ‘SARS’), indicating that the epitope is highly conserved. We believe the conservation of this epitope will make it more difficult for escape mutants to develop. S309 also exhibits potent effector function in vitro, potentially allowing the engagement and recruitment of immune cells to kill off already infected cells. VIR-7831 and VIR-7832 have both been engineered with “LS” mutations within the Fc region of the mAbs, for the purpose of increasing lung tissue bioavailability and extending their half-life. VIR-7832 has been further engineered with “XX2” mutations in the Fc region of the mAb to potentially allow it to function as a T cell vaccine. We anticipate initial clinical data from our Phase 2/3 trial of VIR-7831 to be available before the end of the year.

To accelerate the progress of VIR-7831 and VIR-7832, we have signed a number of collaboration agreements to aid in their manufacture and potential commercialization. Specifically, we are collaborating on clinical manufacturing with WuXi Biologics (Hong Kong) Limited, or WuXi, and Biogen Inc., or Biogen; on commercial manufacturing with WuXi and Samsung Biologics Co., Ltd., or Samsung; and on potential commercialization with WuXi for greater China and GlaxoSmithKline plc, or GSK, for all other countries. See the section titled “Recent SARS-CoV-2 Activities” for a description of these and other collaborations.

VIR-2703 is an inhaled SARS-CoV-2-targeting siRNA for which we are conducting preclinical studies that are expected to be completed by the end of 2020. In vitro, VIR-2703 has demonstrated the ability to significantly reduce SARS-CoV-2 live virus replication. It is designed to degrade the viral genome, leading to inhibition of viral protein synthesis and blocking the production of infectious virus. It targets a nucleic acid sequence in the SARS-CoV-2 genome that is highly conserved amongst currently available viral sequences and is also conserved in SARS-CoV-1. VIR-2703 leverages Alnylam’s latest advances in lung delivery of siRNAs and is the first development candidate selected in our expanded collaboration with Alnylam for SARS-CoV-2 and other coronaviruses.

HBV: Approximately 290 million people globally are chronically infected with HBV and approximately 900,000 of them die from HBV-associated complications each year. There is a significant unmet medical need for more effective therapies that lead to life-long control of the virus after a finite duration of therapy, which is the definition of a functional cure. For a registrational trial to demonstrate a functional cure, the formal endpoint accepted by the U.S. Food and Drug Administration, or the FDA, is undetectable HBsAg, defined as less than 0.05 international units per milliliter, or IU/ml, as well as HBV DNA less than the lower limit of quantification, in the blood six months after the end of therapy.

We are developing VIR-2218 and VIR-3434 for the functional cure of HBV. Each of these product candidates has the potential to stimulate an effective immune response and also has direct antiviral activity



 

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against HBV. We believe that a functional cure for HBV will require an effective immune response, in addition to antiviral activity, based on the observation that severe immunosuppression can reactivate HBV disease. While monotherapy with VIR-2218 and VIR-3434 may provide a functional cure in some patients, we believe combination therapy will be necessary for a functional cure in many patients. We are planning trials that combine VIR-2218 and VIR-3434, which we believe have the potential to act in concert by removing potentially tolerogenic HBV proteins and stimulating new HBV specific T cells. We are also initiating trials that combine VIR-2218 with PEG-IFN-α and are evaluating additional combinations with other immunotherapy agents and direct acting antiviral agents. We anticipate that the initial registration population for these product candidates will be patients chronically infected with HBV.

VIR-2218 is a subcutaneously administered HBV-targeting siRNA that is currently in a Phase 2 clinical trial. By targeting a conserved region of the HBV genome, it is designed to inhibit the production of all HBV proteins: X, polymerase, S, and core. Suppression of HBV proteins, particularly HBsAg, is hypothesized to remove the inhibition of T cell and B cell activity directed against HBV, allowing VIR-2218 to potentially result in a functional cure. VIR-2218 was the first siRNA in the clinic to include Alnylam’s ESC+ technology, which has the potential to enhance the therapeutic index. In total, 37 healthy volunteers have received VIR-2218 and 12 healthy volunteers have received placebo. In addition, 24 patients with chronic HBV on nucleotide/nucleoside reverse transcriptase inhibitors, or NRTIs, have received VIR-2218, and eight patients with chronic HBV on NRTIs have received placebo. The data suggest that VIR-2218 is generally well-tolerated in healthy volunteers given as a single dose up to 900 mg and in patients given as two doses of 20 mg, 50 mg, 100 mg or 200 mg each dose. The data also demonstrate substantial, dose dependent reductions in HBsAg in patients at doses ranging from 20 mg to 200 mg, which are durable at the higher doses for at least six months. We anticipate initiating a Phase 2 combination trial of VIR-2218 and PEG-IFN-α in the second half of 2020.

VIR-3434 is a subcutaneously administered HBV-neutralizing mAb currently in a Phase 1 clinical trial. By targeting a conserved region of HBsAg, it is designed to block entry of all 10 genotypes of HBV into liver cells called hepatocytes and reduce the level of virions and subviral particles in the blood. We have also engineered VIR-3434 to have an extended half-life and to potentially function as a therapeutic T cell vaccine for chronic HBV infection. These modifications are intended to enhance its potential to result in an HBV functional cure. We anticipate clinical data from our Phase 1 trial will enable us to initiate a Phase 2 clinical trial of VIR-3434 in combination with VIR-2218 in 2021.

Influenza: On average, each year the influenza virus infects 5% to 10% of the world’s population and results in an estimated 500,000 deaths. In the 2017-2018 flu season, it is now estimated that 61,000 people died from influenza in the United States alone. Influenza vaccines have historically had limited success, with an average efficacy of 40%. This limited efficacy results from incomplete coverage against seasonal strains and the lack of an effective immune response in many individuals after receiving the vaccine. We are developing VIR-2482 as a universal prophylactic for influenza A and have designed it to overcome both limitations of flu vaccines, which we believe will lead to meaningfully higher levels of protection. We anticipate that the initial registration population for VIR-2482 will be individuals at high risk of influenza A complications, such as the elderly with chronic lung disease or congestive heart failure.

VIR-2482 is an intramuscularly administered influenza A-neutralizing mAb currently in a Phase 1/2 clinical trial. In vitro, VIR-2482 has been shown to cover all major strains of influenza A that have arisen since the 1918 Spanish flu pandemic. We believe that VIR-2482 has the potential to provide superior protection to flu vaccines and be able to be used year after year because it has broad strain coverage as opposed to the limited strain coverage generated by vaccines. We also believe that it provides passive immunity rather than relying on a person to generate active immunity via a functional immune response, an ability that is known to decline with age. VIR-2482 has been engineered to increase lung tissue bioavailability and to extend its half-life so that a single intramuscular dose has the potential to last the entire flu season, which is typically five to six months long.



 

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VIR-2482 has been generally well-tolerated in the approximately 100 healthy volunteers dosed in the Phase 1 portion of the clinical trial. We anticipate initiating the Phase 2 portion of the clinical trial in the northern hemisphere in the fourth quarter of 2020. Data from an interim analysis of the first flu season (northern hemisphere) of the Phase 2 clinical trial are anticipated to be available in the first half of 2021.

HIV: Each year there are approximately 1.8 million new cases of HIV and approximately 1.0 million HIV-related deaths globally. Current prevention approaches such as behavioral modification and pharmacological intervention have had only a modest effect on HIV transmission globally, leaving a high unmet medical need for a safe and effective vaccine for the billions of individuals who are or may become sexually active. VIR-1111 is a proof of concept HIV vaccine designed to elicit a type of immune response that is different from other vaccines. We anticipate the initial registration population for our eventual HIV vaccine will be individuals at high risk of contracting HIV.

VIR-1111 is a subcutaneously administered HIV T cell vaccine based on HCMV for which we plan to submit an IND in the second half of 2020 and thereafter commence a Phase 1 clinical trial. VIR-1111 has been designed to elicit T cells that recognize HIV epitopes that are different from those recognized by prior HIV vaccines and to stimulate a different and specific type of T cell immune response to HIV, known as an HLA-E restricted immune response. An HLA-E restricted immune response has been shown to be associated with protection of NHPs from simian immunodeficiency virus, or SIV, the NHP equivalent of HIV. VIR-1111 is a vaccine designed solely to establish proof of concept in a Phase 1 clinical trial to determine whether the unique immune response observed in NHPs can be replicated in humans.

TB: Globally, nearly two billion people are latently infected with TB, and each year there are approximately 10 million new active cases of TB and approximately 1.6 million TB-related deaths. There is a high unmet medical need for a safe and effective vaccine that prevents active pulmonary TB in adolescents and adults, as they represent the key sources of TB transmission and are the primary contributors to overall disease burden. VIR-2020 is a vaccine designed to provide a type of immune response that is different from other vaccines and lead to meaningful levels of protection from active TB. We anticipate that the initial registration population for VIR-2020 will be people at high risk of developing active TB, such as those who have latent TB infection.

VIR-2020 is a subcutaneously administered TB T cell vaccine based on HCMV for which we plan to submit an IND in 2023 and thereafter commence a Phase 1 clinical trial. VIR-2020 is designed to stimulate T cells that reside in the lung and to recognize TB epitopes that are different from those recognized by prior TB vaccines. In preclinical studies, a T cell vaccine based on RhCMV has been shown to provide protection of NHPs from TB.

Recent SARS-CoV-2 Activities

Since February 2020, we have entered into a number of collaboration agreements to accelerate the development, manufacture, and potential commercialization of therapies to treat and prevent SARS-CoV-2 and other coronaviruses. We have also made substantial efforts to protect our intellectual property in this area, as evidenced by our recent expansion of our patent portfolio.

Development and Commercialization

GSK Collaboration Agreement

In June 2020, we entered into a definitive collaboration agreement with Glaxo Wellcome UK Limited and Beecham S.A. of GSK (and collectively referred to as GSK), pursuant to which we agreed to collaborate to research, develop and commercialize products for the prevention, treatment and prophylaxis of diseases caused by SARS-CoV-2 and potentially other coronaviruses. The collaboration is focused on the development and commercialization of three types of collaboration products under three programs: (1) antibodies targeting



 

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SARS-CoV-2, and potentially other coronaviruses, or the Antibody Program; (2) vaccines targeting SARS-CoV-2, and potentially other coronaviruses, or the Vaccine Program, and (3) products based on genome-wide CRISPR screening of host targets expressed in connection with exposure to SARS-CoV-2, or the Functional Genomics Program. The initial antibodies under the Antibody Program will be VIR-7831 and VIR-7832, which have demonstrated high affinity for the SARS-CoV-2 spike protein and are highly potent in neutralizing SARS-CoV-2 in live-virus cellular assays.

We are primarily responsible for the development and clinical manufacturing activities for the Antibody Program, and for conducting the initial development activities directed to a vaccine in the Vaccine Program. GSK will be primarily responsible for the commercialization activities for the Antibody Program (except in connection with sales of antibody products licensed to WuXi in greater China), the later-stage development, manufacturing and commercialization activities for the Vaccine Program and the development, manufacturing and commercialization activities for the Functional Genomics Program. We and GSK are required to use commercially reasonable efforts to conduct the activities assigned to each party under each development plan and to seek and obtain regulatory approval for collaboration products that arise from such activities in the United States and specified major markets. Subject to an opt-out mechanism, we and GSK will share all development costs, manufacturing costs and costs and expenses for the commercialization of the collaboration products, with us bearing 72.5% of such costs for the antibody products, 27.5% of such costs for the vaccine products, and we and GSK sharing equally all such costs for the functional genomics products, and all profits will be shared in the same ratios. If we and GSK elect to conduct a technology transfer of manufacturing technology under our agreements with WuXi (as further described below) and Biogen, we will bear 72.5% of the costs related to such manufacturing technology transfer and for commercial manufacturing of the antibody products under such agreements with WuXi and Biogen, and GSK will bear 27.5% of such costs. The parties will also share the committed costs for the reservation of manufacturing capacity for the drug substance for antibody products in the foregoing ratio under our agreement with Samsung as well as such costs relating to committed manufacturing capacity for antibody products as are approved by the joint steering committee from time to time.

On an antibody product-by-antibody product basis, we have a co-promotion right with respect to such antibody product in the United States, pursuant to which we will have the right to perform up to 20% of details in connection with such antibody product. GSK will lead commercialization and book all sales and is required to use commercially reasonable efforts to commercialize each collaboration product following regulatory approval in the United States and specified major markets. This definitive agreement superseded and replaced the April 2020 preliminary agreement with GSK. In connection with the GSK collaboration, we also entered into a stock purchase agreement in April 2020, pursuant to which we issued 6,626,027 shares of our common stock to an affiliate of GSK at a price per share of $37.73, for an aggregate purchase price of approximately $250.0 million.

Expansion of Alnylam Collaboration and License Agreement

In March and April 2020, we entered into two further amendments to our collaboration and license agreement with Alnylam, dated October 16, 2017, to expand our existing collaboration to include the development and commercialization of RNAi therapeutics targeting up to four additional RNAi therapeutics for infectious diseases, including one targeting SARS-CoV-2 and potentially other coronaviruses, and up to three targeting human host factors for SARS-CoV-2 and potentially other coronaviruses, bringing the total number of infectious disease targets in our collaboration with Alnylam to nine.

Pursuant to both recent amendments, we and Alnylam will each be responsible for pre-clinical development costs incurred by such party in performing its allocated responsibilities under an agreed-upon initial pre-clinical development plan for each of the four new targets. We and Alnylam will equally share costs incurred in connection with the manufacture of non-GMP drug product required for pre-clinical development prior to filing of an IND. Following the completion of initial pre-clinical development activities, if we exercise our option to



 

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progress one or more candidates arising from the coronavirus program into further development, we will be responsible for conducting all development, manufacturing and commercialization activities at our sole expense, subject to Alnylam’s right to opt-in, during a specified period, to share equally with us the profits and losses in connection with development and commercialization of a coronavirus product.

Manufacturing

Consistent with our corporate manufacturing strategy of building internal capabilities in chemistry, manufacturing and control, or CMC, and working with contract development and manufacturing organizations, or CDMOs, to supply clinical and commercial batches of our product candidates, we have entered into the following agreements to date in support of our SARS-CoV-2 program:

WuXi Manufacturing Agreements

In February 2020, we entered into a development and manufacturing collaboration agreement with WuXi, for the clinical development, manufacturing, and commercialization of our proprietary antibodies developed for SARS-CoV-2. Under the agreement, WuXi will conduct cell-line development, process and formulation development, and initial manufacturing for clinical development. WuXi will have the right to commercialize products incorporating such antibodies in greater China pursuant to an exclusive license granted for the selected antibodies that have been developed. We will have the right to commercialize such products in all other markets worldwide.

WuXi will perform mutually agreed development and manufacturing activities, under individual statements of work. In addition, the parties agreed that WuXi will pay us tiered royalties at percentages ranging from the high single-digits to mid-teens on annual net sales of all products sold by WuXi in greater China.

On June 15, 2020, we entered into a binding letter of intent with WuXi, pursuant to which WuXi will perform certain development and manufacturing services for our SARS-CoV-2 antibody program. Under the terms of the letter of intent, we have committed to purchase a firm and binding capacity reservation for the manufacture of a specified number of batches of drug substance of our SARS-CoV-2 antibody in 2020 and 2021. In addition, we have the right to order an additional specified number of batches of drug substance, provided we make such election by a specified date in the fourth calendar quarter in 2020. WuXi is obligated to reserve such manufacturing slots on a non-cancellable basis, and will manufacture the agreed number of batches of drug substance in accordance with an agreed manufacturing schedule. We are obligated to pay a total of approximately $130.0 million for such capacity reservation, if all batches are manufactured, inclusive of estimated raw material costs, with between 70% and 80% of the batch production fees owed to WuXi on a take-or-pay basis regardless of whether we utilize such manufacturing slots. The amounts will be payable during 2020 and 2021 and invoiced on a per-batch basis. The SARS-CoV-2 antibody drug substance contemplated to be manufactured in accordance with the terms of the letter of intent will be utilized in connection with progressing the development and commercialization of the SARS-CoV-2 antibody product under our collaboration with GSK.

We and WuXi will continue to negotiate additional terms in a definitive commercial manufacturing and supply agreement and will use commercially reasonable efforts to execute such definitive agreement before July 30, 2020.

We will bear 72.5% of the costs under the development and manufacturing collaboration agreement and letter of intent with WuXi and GSK will bear 27.5% of such costs pursuant to our collaboration agreement with GSK, subject to certain conditions and exceptions.



 

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Biogen Clinical Development and Manufacturing Agreement

In May 2020, we entered into a clinical development and manufacturing agreement with Biogen pursuant to which Biogen will perform process development activities and specified manufacturing services under agreed statements of work for certain pre-commercial and clinical supply of our SARS-CoV-2 mAbs. We also agreed to collaborate with Biogen to develop highly productive clonal cell lines and clinical and commercial manufacturing processes for our SARS-CoV-2 mAbs. These processes are designed to be transferrable to global biomanufacturing facilities designed for advanced biologics production. Under the agreement, Biogen will conduct cGMP clinical manufacturing in the United States and provide technical support to facilitate process transfer to Samsung, and potentially other large-scale biomanufacturing facilities in the United States and other regions of the world to enable us to obtain reliable supply of a potential commercial product.

Under the terms of the Biogen agreement, we have agreed to pay fees for Biogen’s performance of services as provided in each applicable statement of work, including costs to third parties on a pass-through basis. We entered into three statements of work with Biogen for the process development and certain clinical manufacturing services simultaneously with the execution of the agreement, with the cost of activities under such agreed statements of work totaling approximately $13.8 million.

The Biogen agreement provides us the right to request a technology transfer of all manufacturing technology and processes developed under the agreement to us or any third party designated by us to conduct manufacturing of a SARS-CoV-2 antibody using such technology, including applicable licenses to us under Biogen’s relevant intellectual property rights. In connection with any such technology transfer, we have also agreed to pay an “access fee” to Biogen for each successful batch of SARS-CoV-2 antibody drug substance manufactured using certain improvements relating to increases in batch yield developed under the agreement, whether such manufacturing is performed by us, our affiliates, or third parties. If we successfully manufacture all batches of SARS-CoV-2 antibody drug substance for which we are currently committed under the Samsung letter agreement, based on our current working assumptions of manufacturing yield per batch, the access fee payable to Biogen in connection with the Samsung manufacturing will total approximately $100.0 million.

We will bear 72.5% of the costs under the Biogen agreement and GSK will bear 27.5% of such costs pursuant to our collaboration agreement with GSK, subject to certain conditions and exceptions.

Samsung Manufacturing Agreement

In April 2020, we entered into a binding letter agreement with Samsung pursuant to which Samsung will perform development and manufacturing services for our SARS-CoV-2 mAbs. Under the terms of the letter agreement, we have committed to purchase a firm and binding capacity reservation for a specified number of drug substance manufacturing slots in 2021 and 2022. Samsung will reserve such manufacturing slots on a non-cancellable, non-adjustable basis and will not offer such manufacturing slots under our capacity reservation to third parties. We are obligated to pay a total of approximately $362.0 million for such capacity reservation on a take-or-pay basis regardless of whether such manufacturing slots are utilized by us. The amounts will be payable during 2021 and 2022 and invoiced on a per-batch basis, with shortfalls invoiced at the end of the year in which such shortfall occurs. Samsung began performing services for us upon execution of the letter agreement, and we agreed to pay fees and out-of-pocket costs for the services performed thereunder. Samsung is expected to commence manufacturing on our behalf as early as October 2020 with the first engineering run.

We will bear 72.5% of the costs under the Samsung letter agreement and GSK will bear 27.5% of such costs pursuant to our collaboration agreement with GSK, subject to certain conditions and exceptions.

We continue to negotiate a definitive agreement with Samsung, to expand upon the letter agreement, and agreed to use best efforts to execute such definitive agreement before July 31, 2020.



 

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Intellectual Property

VIR-7831

Our VIR-7831 intellectual property portfolio includes multiple United States provisional patent applications. These applications include composition of matter claims, pharmaceutical composition claims, and method of treatment claims. The 20-year term of any patents issuing from these provisional patent applications is presently estimated to expire in 2041, absent any available patent term adjustments or extensions.

Licensed Patents

Our VIR-7831 intellectual property portfolio also includes patents and patent applications that we have non- exclusively licensed from Xencor, Inc., or Xencor. As of February 15, 2020, these patents and applications include seven issued patents in the United States directed to composition of matter claims, methods of extending antibody serum half-life claims, pharmaceutical composition claims and process (methods of producing) claims. The 20-year term of these patents is presently estimated to expire between 2021 and 2025, absent any available patent term adjustments or extensions. Additionally, as of February 15, 2020, these patents and applications include 70 issued patents in Australia, Austria, Belgium, Canada, China, Croatia, Czech Republic, Estonia, Finland, France, Germany, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, South Korea, Lithuania, Luxembourg, Malta, Monaco, Netherlands, Poland, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom directed to composition of matter claims, pharmaceutical composition claims, method of treatment claims, composition for use in treatment claims and process (methods of producing) claims. The 20-year term of these patents is presently estimated to expire between 2021 and 2028, absent any available patent term adjustments or extensions.

The patents and applications we have non-exclusively licensed from Xencor also include, as of February 15, 2020, a pending patent application in the United States and five patent applications pending in Brazil, Canada, China, Europe and Russia directed to composition of matter claims, pharmaceutical composition claims, composition for use in treatment claims, and process (methods of producing) claims. The 20-year term of any patents issuing from these patent applications is presently estimated to expire between 2021 and 2028, absent any available patent term adjustments or extensions.

VIR-7832

Our VIR-7832 intellectual property portfolio includes multiple United States provisional patent applications. These applications include composition of matter claims, pharmaceutical composition claims, and method of treatment claims. The 20-year term of any patents issuing from these provisional patent applications is presently estimated to expire in 2041, absent any available patent term adjustments or extensions.

Licensed Patents

Our VIR-7832 intellectual property portfolio includes a patent family that we have exclusively licensed from Rockefeller, which includes, as of February 15, 2020, one pending patent application in the United States, one pending PCT patent application and one pending patent application in Europe. The applications in this family include composition of matter claims, pharmaceutical composition claims, method of treatment claims, composition for use in treatment claims and process (methods of producing) claims. The 20-year term of any patents issuing from the application in this family is presently estimated to expire in 2038, absent any available patent term adjustments or extensions.

Our VIR-7832 intellectual property portfolio also includes patents and patent applications that we have non- exclusively licensed from Xencor. As of February 15, 2020, these patents and applications include seven issued



 

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patents in the United States directed to composition of matter claims, methods of extending antibody serum half-life claims, pharmaceutical composition claims and process (methods of producing) claims. The 20-year term of these patents is presently estimated to expire between 2021 and 2025, absent any available patent term adjustments or extensions. Additionally, as of February 15, 2020, these patents and applications include 70 issued patents in Australia, Austria, Belgium, Canada, China, Croatia, Czech Republic, Estonia, Finland, France, Germany, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, South Korea, Lithuania, Luxembourg, Malta, Monaco, Netherlands, Poland, Russia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom directed to composition of matter claims, pharmaceutical composition claims, method of treatment claims, composition for use in treatment claims and process (methods of producing) claims. The 20-year term of these patents is presently estimated to expire between 2021 and 2028, absent any available patent term adjustments or extensions.

The patents and applications we have non-exclusively licensed from Xencor also include, as of February 15, 2020, a pending patent application in the United States and five patent applications pending in Brazil, Canada, China, Europe and Russia directed to composition of matter claims, pharmaceutical composition claims, composition for use in treatment claims, and process (methods of producing) claims. The 20-year term of any patents issuing from these patent applications is presently estimated to expire between 2021 and 2028, absent any available patent term adjustments or extensions.

VIR-2703

Licensed Patents

Our VIR-2703 intellectual property portfolio includes multiple United States provisional patent applications that we have exclusively licensed from Alnylam. These applications include composition of matter claims, pharmaceutical composition claims, and method of treatment claims. The 20-year term of any patents issuing from these provisional patent applications is presently estimated to expire in 2041, absent any available patent term adjustments or extensions.

Risks Associated with Our Business

Our business is subject to a number of risks of which you should be aware before making a decision to invest in our common stock. These risks are more fully described in the section titled “Risk Factors” immediately following this prospectus summary. These risks include, among others, the following:

 

   

We have incurred significant net losses since inception and anticipate that we will continue to incur substantial net losses for the foreseeable future and may never achieve or maintain profitability.

 

   

Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.

 

   

Even after this offering, we will require substantial additional funding to finance our operations. If we are unable to raise capital when needed, we could be forced to delay, reduce or terminate certain of our development programs or other operations.

 

   

Our pursuit of a potential therapy for COVID-19, the disease caused by the virus SARS-CoV-2, is at an early stage.

 

   

Our future success is substantially dependent on the successful clinical development, regulatory approval and commercialization of our product candidates in a timely manner. If we are not able to obtain required regulatory approvals, we will not be able to commercialize our product candidates and our ability to generate product revenue will be adversely affected.



 

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Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials and we cannot assure you that any ongoing, planned or future clinical trials will lead to results sufficient for the necessary regulatory approvals.

 

   

Clinical product development involves a lengthy and expensive process. We may incur additional costs and encounter substantial delays or difficulties in our clinical trials.

 

   

Our business could be materially adversely affected by the effects of health pandemics or epidemics, including the current COVID-19 pandemic and future outbreaks of the disease.

 

   

We intend to rely on third parties to produce clinical and commercial supplies of our product candidates.

 

   

We are a party to strategic collaboration and license agreements pursuant to which we are obligated to make substantial payments upon achievement of milestone events and, in certain cases, have relinquished important rights over the development and commercialization of certain current and future product candidates. We also intend to explore additional strategic collaborations, which may never materialize or may require that we relinquish rights to and control over the development and commercialization of our product candidates.

 

   

Our pursuit of a potential therapy for COVID-19, the disease caused by the virus SARS-CoV-2, is at an early stage, and we are committing financial resources and personnel, and making capital commitments with third parties in furtherance thereof.

 

   

If we are unable to obtain and maintain patent protection for our product candidates and technology, or if the scope of the patent protection obtained is not sufficiently broad or robust, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our product candidates and technology may be adversely affected.

 

   

We are highly dependent on our key personnel, and if we are not able to retain these members of our management team or recruit and retain additional management, clinical and scientific personnel, our business will be harmed.

Our Corporate Information

We were incorporated under the laws of the State of Delaware on April 7, 2016. Our principal executive offices are located at 499 Illinois Street, Suite 500, San Francisco, California 94158, and our telephone number is (415) 906-4324. Our corporate website address is www.vir.bio. Information contained on or accessible through our website is not a part of this prospectus or the registration statement of which it forms a part, and the inclusion of our website address in this prospectus is an inactive textual reference only.

“Vir Biotechnology,” “Vir Bio,” “Vir.Bio,” the Vir logo and other trademarks, trade names or service marks of Vir Biotechnology, Inc. appearing in this prospectus or the documents incorporated by reference herein are the property of Vir Biotechnology, Inc. All other trademarks, trade names and service marks appearing in this prospectus or incorporated by reference herein are the property of their respective owners. Solely for convenience, the trademarks and trade names in this prospectus or the documents incorporated by reference herein may be referred to without the ® and symbols, but such references should not be construed as any indicator that their respective owners will not assert their rights thereto.

Implications of Being an Emerging Growth Company

We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act, or the JOBS Act, enacted in April 2012. For so long as we remain an emerging growth company, we are permitted and intend to rely on certain exemptions from various public company reporting requirements, including not being required



 

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to have our internal control over financial reporting audited by our independent registered public accounting firm pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and any golden parachute payments not previously approved. In particular, in this prospectus, we have provided only two years of audited consolidated financial statements and have not included all of the executive compensation-related information that would be required if we were not an emerging growth company. Accordingly, the information contained herein may be different than the information you receive from other public companies in which you hold stock.

We would cease to be an “emerging growth company” upon the earliest to occur of: (i) December 31, 2024; (ii) the last day of the fiscal year in which we have $1.07 billion or more in annual revenue; (ii) the date on which we first qualify as a large accelerated filer under the rules of the U.S. Securities and Exchange Commission, or the SEC; and (iii) the date on which we have, in any three-year period, issued more than $1.0 billion in non-convertible debt securities. We may choose to take advantage of some but not all of these reduced reporting burdens.

In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an emerging growth company to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of this exemption from new or revised accounting standards, and therefore we will not be subject to the same requirements to adopt new or revised accounting standards as other public companies that are not emerging growth companies.



 

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The Offering

 

Common stock to be offered by us

                shares

 

Underwriters’ option to purchase additional shares

                shares

 

Common stock to be outstanding immediately after this offering

                shares (or approximately                shares if the underwriters exercise in full their option to purchase additional shares of common stock)

 

Use of proceeds

We estimate that the net proceeds from this offering will be approximately $            million (or approximately $            million if the underwriters exercise in full their option to purchase up to              additional shares of common stock), based on the assumed public offering price of $            per share, which was the last reported sale price of our common stock on The Nasdaq Global Select Market on            , 2020, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

 

  We currently intend to use the net proceeds from this offering, together with our existing cash, cash equivalents and short-term investments, to fund the research and development of our product candidates and development programs, including VIR-7831, VIR-7832, VIR-2703, VIR-2218, VIR-3434 and VIR-2482, and the remainder for commercial manufacturing and launch preparation for our SARS-CoV-2 antibodies, our other clinical trials and preclinical programs, including our planned Phase 2 clinical trial combining VIR-2218 with PEG-IFN-α for HBV, as well as for working capital and other general corporate purposes.

 

  The intended uses set forth above include any related milestone payments that may be due from us under the applicable license and collaboration agreements. In addition, we expect that the current grants from the Bill & Melinda Gates Foundation will fund the manufacture and early clinical development of VIR-1111 and VIR-2020.

See the section titled “Use of Proceeds” for additional information.

 

Risk factors

You should read the section titled “Risk Factors” for a discussion of factors to consider carefully, together with all the other information included in this prospectus and incorporated by reference herein, before deciding to invest in our common stock.

 

Nasdaq Global Select Market symbol

“VIR”


 

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The number of shares of our common stock to be outstanding after this offering is based on 116,299,280 shares of common stock (excluding 1,457,432 shares of unvested restricted common stock) outstanding as of March 31, 2020 on a pro forma basis, and after giving effect to the subsequent issuances after March 31, 2020 of an aggregate of 7,948,912 shares of our common stock as described below, and excludes:

 

   

7,959,416 shares of our common stock issuable upon the exercise of outstanding stock options as of March 31, 2020, with a weighted-average exercise price of $7.30 per share;

 

   

1,884,693 shares of our common stock issuable upon the exercise of outstanding stock options granted subsequent to March 31, 2020, with a weighted-average exercise price of $30.36 per share;

 

   

7,611,513 shares of our common stock reserved for future issuance under our 2019 Equity Incentive Plan, or the 2019 Plan, as of March 31, 2020; and

 

   

2,377,244 shares of our common stock reserved for future issuance under our 2019 Employee Stock Purchase Plan, or ESPP, as of March 31, 2020.

Unless otherwise indicated, all information contained in this prospectus, including the number of shares of common stock that will be outstanding after this offering, assumes or gives effect to:

 

   

the issuance of 6,626,027 shares of our common stock to Glaxo Group Limited, or GGL, on April 29, 2020 at a purchase price per share of $37.73, or approximately $250.0 million;

 

   

the issuance of 1,111,111 shares of our common stock to Alnylam on May 6, 2020 upon the achievement of a development milestone pursuant to a collaboration and license agreement;

 

   

the issuance of 211,774 shares of common stock to Takeda Ventures, Inc., or Takeda, on May 26, 2020 upon the cashless exercise of a warrant to purchase 244,444 shares;

 

   

no exercise of the outstanding options after March 31, 2020; and

 

   

no exercise by the underwriters of their option to purchase up to                additional shares of our common stock.



 

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Summary Consolidated Financial Data

The following tables summarize our consolidated financial data for the periods and as of the dates set forth below. You should read the following summary consolidated financial data together with the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and the related notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2019 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, each of which are incorporated by reference herein. We have derived the summary consolidated statements of operations data for the years ended December 31, 2018 and 2019 from our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2019, which are incorporated by reference herein. We derived the summary consolidated statements of operations data for the three months ended March 31, 2019 and 2020, and the summary consolidated balance sheet data as of March 31, 2020, from our unaudited interim condensed consolidated financial statements included in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, which are incorporated by reference herein. Our unaudited consolidated interim financial statements were prepared on a basis consistent with our audited consolidated financial statements and include, in management’s opinion, all adjustments, consisting of normal recurring adjustments, that we consider necessary for a fair presentation of the financial information set forth in those financial statements. Our historical results are not necessarily indicative of the results that may be expected in the future and our results for the three months ended March 31, 2020 are not necessarily indicative of results to be expected for the full fiscal year or any other period.

 

    Year Ended
December 31,
    Three Months Ended
March 31,
 
    2018     2019     2019     2020  
   

(in thousands, except share and per share data)

 

Consolidated Statements of Operations Data:

       

Revenue:

       

Grant revenue

  $ 9,800     $ 7,380     $ 3,644     $ 5,231  

Contract revenue

    868       711       17       487  
 

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

    10,668       8,091       3,661       5,718  

Operating expenses:

       

Research and development

    100,229       148,472       25,872       64,979  

General and administrative

    29,131       37,598       8,559       12,649  
 

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

    129,360       186,070       34,431       77,628  
 

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

    (118,692     (177,979     (30,770     (71,910

Other income (expense):

       

Interest income

    2,540       8,511       2,245       1,755  

Other income (expense), net

    (212     (5,061     (145     (7,069
 

 

 

   

 

 

   

 

 

   

 

 

 

Total other income (expense)

    2,328       3,450       2,100       (5,314
 

 

 

   

 

 

   

 

 

   

 

 

 

Loss before benefit from (provision for) income taxes

    (116,364     (174,529     (28,670     (77,224

Benefit from (provision for) income taxes

    480       (154     —         (16
 

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

  $ (115,884   $ (174,683   $ (28,670   $ (77,240)  
 

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share, basic and diluted(1)

  $ (15.12)     $ (5.76)     $ (3.19)     $ (0.71)  
 

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average shares outstanding, basic and diluted(1)

    7,666,463       30,349,920       9,001,158       108,387,913  
 

 

 

   

 

 

   

 

 

   

 

 

 

 

(1)

See Notes 2 and 13 to our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2019 and Note 12 to our unaudited condensed consolidated financial statements included in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, each of which are incorporated by reference herein, for explanations of the



 

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  calculations of our basic and diluted net loss per share and the weighted-average number of shares outstanding used in the computation of the per share amounts.

 

     As of March 31, 2020  
     Actual      Pro  Forma(1)      Pro Forma
As Adjusted(2)(3)
 
     (in thousands)  

Consolidated Balance Sheet Data:

  

Cash, cash equivalents and short-term investments

   $ 355,611      $ 605,611      $                    

Working capital(4)

     321,145        571,145     

Total assets

     477,114        727,114     

Accumulated deficit

     (445,759      (445,759   

Total stockholders’ equity

     380,333        630,333     

 

(1)

The pro forma column reflects: (i) the issuance of 6,626,027 shares of our common stock to GGL on April 29, 2020 at a purchase price per share of $37.73, or approximately $250.0 million; (ii) the issuance of 1,111,111 shares of our common stock to Alnylam on May 6, 2020 upon the achievement of a development milestone pursuant to a collaboration and license agreement; and (iii) the issuance of 211,774 shares of common stock to Takeda on May 26, 2020 upon the cashless exercise of a warrant to purchase 244,444 shares.

(2)

The pro forma as adjusted column reflects (i) the pro forma adjustments set forth in footnote (1) above and (ii) the sale of                shares of our common stock in this offering at the assumed public offering price of $                per share, which was the last reported sale price of our common stock on The Nasdaq Global Select Market on                , 2020, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

(3)

The pro forma as adjusted information discussed above is illustrative only and will depend on the actual public offering price and other terms of this offering determined at pricing. Each $1.00 increase or decrease in the assumed public offering price of $                per share, which was the last reported sale price of our common stock on The Nasdaq Global Select Market on                , 2020, would increase or decrease, as applicable, each of our pro forma as adjusted cash, cash equivalents and short-term investments, working capital, total assets and total stockholders’ equity by approximately $                million, assuming the number of shares of common stock offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase or decrease of 1.0 million shares of common stock offered by us would increase or decrease, as applicable, each of our pro forma as adjusted cash, cash equivalents and short-term investments, working capital, total assets and total stockholders’ equity by approximately $            million, assuming the assumed public offering price of $                per share remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

(4)

We define working capital as current assets less current liabilities. See our unaudited condensed consolidated financial statements and the related notes included in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, which is incorporated by reference herein, for further details regarding our current assets and current liabilities.



 

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RISK FACTORS

Investing in our common stock involves a high degree of risk. You should consider carefully the risks and uncertainties described below, as well as the risks and uncertainties set forth under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, which is incorporated by reference herein, and all of the other information in this prospectus and the documents incorporated by reference herein before deciding whether to purchase shares of our common stock. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are unaware of, or that we currently believe are not material, may also become important factors that affect us. If any of the following risks are realized, our business, financial condition, results of operations and prospects could be materially and adversely affected. In that event, the price of our common stock could decline, and you could lose part or all of your investment.

Risks Related to This Offering

We have broad discretion in the use of our cash, cash equivalents and short-term investments, including the net proceeds from this offering, and may use them ineffectively, in ways with which you do not agree or in ways that do not increase the value of your investment.

Our management will have broad discretion in the application of our cash, cash equivalents and short-term investments, including the net proceeds from this offering, and could spend the proceeds in ways that do not improve our results of operations or enhance the value of our common stock. The failure by our management to apply these funds effectively could result in additional operating losses that could have a negative impact on our business, cause the price of our common stock to decline and delay the development of our product candidates. Pending their use, we may invest our cash, cash equivalents and short-term investments, including the net proceeds from this offering, in a manner that does not produce income or that loses value. See the section titled “Use of Proceeds” for additional information.

If you purchase shares of common stock in this offering, you will suffer immediate dilution of your investment.

The public offering price of our common stock will be substantially higher than the pro forma, as adjusted net tangible book value per share of our common stock as of March 31, 2020. Therefore, if you purchase shares of our common stock in this offering, you will pay a price per share that substantially exceeds our pro forma, as adjusted net tangible book value per share immediately after this offering. Based on the assumed public offering price of $                 per share, which was the last reported sale price of our common stock on The Nasdaq Global Select Market on                  , 2020, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, you will experience immediate dilution of $                 per share, representing the difference between our pro forma, as adjusted net tangible book value per share after this offering and the public offering price per share. After this offering, we will also have outstanding options to purchase common stock. To the extent these outstanding options are exercised, there will be further dilution to investors in this offering. See the section titled “Dilution” for additional information.

Future sales and issuances of our capital stock or rights to purchase capital stock could result in additional dilution of the percentage ownership of our stockholders and could cause the price of our common stock to decline.

We may issue additional securities following the closing of this offering. Future sales and issuances of our capital stock or rights to purchase our capital stock could result in substantial dilution to our existing stockholders. We may sell common stock, convertible securities, and other equity securities in one or more transactions at prices and in a manner as we may determine from time to time. If we sell any such securities in subsequent transactions, investors may be materially diluted. New investors in such subsequent transactions could gain rights, preferences, and privileges senior to those of holders of our common stock.

 

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Future sales of our common stock in the public market could cause the market price of our common stock to decline.

Sales of a substantial number of shares of our common stock in the public market, or the perception that these sales might occur, could depress the market price of our common stock and could impair our ability to raise capital through the sale of additional equity securities. We are unable to predict the effect that such sales may have on the prevailing market price of our common stock.

As of March 31, 2020, we had outstanding a total of 108,350,368 shares of common stock (without giving effect to any of the share issuances that occurred after March 31, 2020). All of our outstanding shares as of such date were eligible for sale in the public market, other than shares and options held by directors, executive officers, and other affiliates that are subject to volume limitations under Rule 144 of the Securities Act of 1933, as amended, or the Securities Act, and various vesting agreements.

Future sales also could cause the trading price of our common stock to decline and make it more difficult for investors to sell shares of our common stock.

 

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus and the documents we have filed with the SEC that are incorporated by reference herein contain “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. These statements relate to future events or to our future operating or financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. All statements other than statements of historical facts contained in this prospectus or in the documents incorporated by reference herein, including statements regarding our strategy, future financial condition, future operations, research and development, planned clinical trials and preclinical studies, technology platforms, the timing and likelihood of regulatory filings and approvals for our product candidates, our ability to commercialize our product candidates, the potential benefits of collaborations, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology.

We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. These forward-looking statements are subject to a number of known and unknown risks, uncertainties and assumptions described in the section titled “Risk Factors” and in the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section in our Annual Report on Form 10-K for the year ended December 31, 2019 and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, which are incorporated by reference herein, and elsewhere in this prospectus and the documents incorporated by reference herein. Other sections of this prospectus and the documents incorporated by reference herein may include additional factors that could harm our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements.

In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each forward-looking statement contained in this prospectus or the documents incorporated by reference herein, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur at all. You should refer to the section titled “Risk Factors” for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. The Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act do not protect any forward-looking statements that we make in connection with this offering.

You should read this prospectus and the documents that we incorporate by reference in this prospectus and the documents that we have filed as exhibits to the registration statement, of which this prospectus is a part, completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of the forward-looking statements in this prospectus and in the documents incorporated by reference herein by these cautionary statements.

 

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MARKET AND INDUSTRY DATA

Certain market, industry and competitive data contained or incorporated by reference in this prospectus were obtained from our own internal estimates and research, as well as from publicly available information, reports of governmental agencies and industry publications and surveys. In some cases, we do not expressly refer to the sources from which this data is derived. All of the market and industry data used in this prospectus is inherently subject to uncertainties and involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such information. The industry in which we operate is subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the section titled “Risk Factors” in this prospectus. These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by us.

 

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USE OF PROCEEDS

We estimate that the net proceeds to us from this offering will be approximately $                million (or approximately $                million if the underwriters exercise in full their option to purchase up to                additional shares of common stock), based on the assumed public offering price of $                per share, which was the last reported sale price of our common stock on The Nasdaq Global Select Market on                , 2020, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

Each $1.00 increase or decrease in the assumed public offering price of $                per share would increase or decrease, as applicable, the net proceeds to us from this offering by approximately $                million, assuming that the number of shares of common stock offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase or decrease of 1.0 million shares of common stock offered by us, would increase or decrease, as applicable, the net proceeds to us by approximately $                million, assuming the assumed public offering price of $                per share remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

We currently intend to use the net proceeds from this offering, together with our existing cash, cash equivalents and short-term investments, as follows:

 

   

to fund the following clinical trials through completion:

 

   

VIR-7831 – our planned IND for SARS-CoV-2 and assuming regulatory clearance, subsequent Phase 2/3 clinical trial,

 

   

VIR-7832 – our planned IND or equivalent submission for SARS-CoV-2 and assuming regulatory clearance, subsequent Phase 2 clinical trial,

 

   

VIR-2703 – our ongoing preclinical studies for SARS-CoV-2,

 

   

VIR-2218 – our ongoing Phase 2 clinical trial for HBV,

 

   

VIR-3434 – our ongoing Phase 1 clinical trial for HBV, and

 

   

VIR-2482 – our ongoing Phase 1/2 clinical trial for influenza A; and

 

   

the remainder for commercial manufacturing and launch preparation for our SARS-CoV-2 antibodies, our other clinical trials and preclinical programs, including our planned Phase 2 clinical trial combining VIR-2218 with PEG-IFN-α for HBV, as well as for working capital and other general corporate purposes.

The intended uses set forth above include any related milestone payments that may be due from us under the applicable license and collaboration agreements. In addition, we expect that the current grants from the Bill & Melinda Gates Foundation will fund the manufacture and early clinical development of VIR-1111 and VIR-2020.

Based on our current operating plan, we expect our operating expenses to increase in future periods relative to our historical spend, and we believe that the net proceeds from this offering, together with our existing cash, cash equivalents and short-term investments, will fund our operations through at least                 .

This expected use of the net proceeds from this offering represents our intentions based on our current plans and business conditions, which could change in the future as our plans and business conditions evolve. Further, due to the uncertainties inherent in the drug development process, it is difficult to estimate with certainty the amounts of the net proceeds from this offering that may be used for the above purposes.

 

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Our management will have broad discretion over the use of the net proceeds from this offering, and our investors will be relying on the judgment of our management regarding the application of the net proceeds of this offering. The amounts and timing of our expenditures will depend upon numerous factors including the results of our research and development efforts, the timing and success of preclinical studies and any ongoing clinical trials or clinical trials we may commence in the future, the timing of regulatory submissions and the amount of cash obtained through current and any future collaborations.

The expected net proceeds from this offering, together with our cash, cash equivalents and short-term investments, will not be sufficient for us to fund any of our product candidates through regulatory approval, and we will need to raise additional capital to complete the development and commercialization of our product candidates. We expect to finance our cash needs through a combination of equity offerings, debt financings and potential collaborations, and license and development agreements. We have based these estimates on assumptions that may prove to be incorrect, and we could expend our available capital resources at a rate greater than we currently expect.

Pending the use of the net proceeds from this offering as described above, we intend to invest the net proceeds in a variety of capital preservation instruments, including short-term, interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the U.S. government.

 

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DIVIDEND POLICY

We have never declared or paid cash dividends on our capital stock, and we do not currently intend to pay any cash dividends on our capital stock in the foreseeable future. We currently intend to retain all available funds and any future earnings, if any, to fund the development and expansion of our business. Any future determination related to dividend policy will be made at the discretion of our board of directors, subject to applicable laws, and will depend upon, among other factors, our results of operations, financial condition, contractual restrictions and capital requirements. In addition, our ability to pay cash dividends on our capital stock in the future may be limited by the terms of any future debt or preferred securities we issue or any credit facilities we enter into.

 

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CAPITALIZATION

The following table sets forth our cash, cash equivalents and short-term investments, and our capitalization as of March 31, 2020 on:

 

   

an actual basis;

 

   

a pro forma basis to reflect: (i) the issuance of 6,626,027 shares of our common stock to GGL on April 29, 2020 at a purchase price per share of $37.73, or approximately $250.0 million, (ii) the issuance of 1,111,111 shares of our common stock to Alnylam on May 6, 2020 upon the achievement of a development milestone pursuant to a collaboration and license agreement, and (iii) the issuance of 211,774 shares of common stock to Takeda on May 26, 2020 upon the cashless exercise of a warrant to purchase 244,444 shares; and

 

   

a pro forma as adjusted basis giving effect to the pro forma adjustments discussed above, and giving further effect to the sale of                shares of our common stock in this offering at the assumed public offering price of $                 per share, which was the last reported sale price of our common stock on The Nasdaq Global Select Market on                 , 2020, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

You should read this table together with the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” our consolidated financial statements and the related notes included in our condensed consolidated financial statements in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, which are incorporated by reference herein.

 

     As of March 31, 2020  
     Actual     Pro Forma     Pro Forma
As Adjusted(1)
 
    

(in thousands, except share

and per share amounts)

 

Cash, cash equivalents and short-term investments

   $ 355,611     $ 605,611     $                    
  

 

 

   

 

 

   

 

 

 

Stockholders’ equity:

      

Preferred stock, $0.0001 par value per share; 10,000,000 shares authorized as of March 31, 2020; no shares issued or outstanding, actual, pro forma, or pro forma as adjusted

     —         —      

Common stock, $0.0001 par value per shares; 300,000,000 shares authorized as of March 31, 2020; 108,350,368 shares issued and outstanding as of March 31, 2020, actual; 116,299,280 shares issued and outstanding, pro forma, and              shares issued and outstanding, pro forma as adjusted

     11       12    

Additional paid-in capital

     825,833       1,075,832    

Accumulated other comprehensive income

     248       248    

Accumulated deficit

     (445,759     (445,759  
  

 

 

   

 

 

   

 

 

 

Total stockholders’ equity

     380,333       630,333    
  

 

 

   

 

 

   

 

 

 

Total capitalization

   $ 380,333     $ 630,333     $    
  

 

 

   

 

 

   

 

 

 

 

(1)

The pro forma as adjusted information discussed above is illustrative only and will depend on the actual public offering price and other terms of this offering determined at pricing. Each $1.00 increase or decrease in the assumed public offering price of $                per share, which was the last reported sale price of our common stock on The Nasdaq Global Select Market on                , 2020, would increase or decrease, as applicable, each of our pro forma as adjusted cash, cash equivalents and short-term investments, additional paid-in capital, total stockholders’ equity and total capitalization by approximately $                million, assuming that the number of shares of common stock offered by us, as set forth on the cover page of this prospectus, remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase or decrease of 1.0 million shares of common stock offered by us would increase or decrease, as applicable, each of our pro forma as adjusted cash, cash equivalents and

 

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  short-term investments, additional paid-in capital, total stockholders’ equity and total capitalization by approximately $                million, assuming that the assumed public offering price of $                per share remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

The number of shares of our common stock to be outstanding after this offering is based on 116,299,280 shares of common stock (excluding 1,457,432 shares of unvested restricted common stock) outstanding as of March 31, 2020 on a pro forma basis, and after giving effect to the subsequent issuances after March 31, 2020 of an aggregate of 7,948,912 shares of our common stock as described above, and excludes:

 

   

7,959,416 shares of our common stock issuable upon the exercise of outstanding stock options as of March 31, 2020, with a weighted-average exercise price of $7.30 per share;

 

   

1,884,693 shares of our common stock issuable upon the exercise of outstanding stock options granted subsequent to March 31, 2020, with a weighted-average exercise price of $30.36 per share;

 

   

7,611,513 shares of our common stock reserved for future issuance under the 2019 Plan as of March 31, 2020; and

 

   

2,377,244 shares of our common stock reserved for future issuance under the ESPP as of March 31, 2020.

 

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DILUTION

If you invest in our common stock in this offering, your ownership interest will be diluted to the extent of the difference between the public offering price per share of our common stock and the pro forma as adjusted net tangible book value per share of our common stock after this offering.

Our historical net tangible book value as of March 31, 2020 was $328.0 million, or $3.03 per share of our common stock. Our historical net tangible book value represents our total tangible assets less total liabilities. Historical net tangible book value per share is our historical net tangible book value divided by the number of shares of our common stock (excluding 1,457,432 shares of unvested restricted common stock) outstanding as of March 31, 2020.

Our pro forma net tangible book value as of March 31, 2020 was $578.0 million, or $4.97 per share of our common stock, based on the total number of shares of our common stock outstanding as of March 31, 2020 on a pro forma basis to reflect issuances of our common stock after March 31, 2020 as described below. Pro forma net tangible book value per share represents our total tangible assets less our total liabilities, divided by the number of shares of our common stock (excluding 1,457,432 shares of unvested restricted common stock) outstanding as of March 31, 2020 after giving effect to:

 

   

the issuance of 6,626,027 shares of our common stock to GGL on April 29, 2020 at a purchase price per share of $37.73, or approximately $250.0 million;

 

   

the issuance of 1,111,111 shares of our common stock to Alnylam on May 6, 2020 upon the achievement of a development milestone pursuant to a collaboration and license agreement; and

 

   

the issuance of 211,774 shares of common stock to Takeda on May 26, 2020 upon the cashless exercise of a warrant to purchase 244,444 shares.

After giving effect to the sale of                 shares of common stock in this offering at the assumed public offering price of $                 per share, which was the last reported sale price of our common stock on The Nasdaq Global Select Market on                  , 2020, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, our pro forma as adjusted net tangible book value as of March 31, 2020 would have been $                 million, or $                per share. This represents an immediate increase in pro forma as adjusted net tangible book value of $                per share to our existing stockholders and an immediate dilution of $                per share to new investors participating in this offering.

The following table illustrates this dilution on a per share basis:

 

Assumed public offering price per share

      $        

Historical net tangible book value per share as of March 31, 2020

   $ 3.03     

Pro forma increase in net tangible book value per share as of March 31, 2020 attributable to the pro forma transactions described above

     1.94     
  

 

 

    

Pro forma net tangible book value per share as of March 31, 2020

     4.97     

Increase in pro forma net tangible book value per share attributable to new investors participating in this offering

     
  

 

 

    

Pro forma as adjusted net tangible book value per share after this offering

     
     

 

 

 

Dilution per share to new investors participating in this offering

      $                
     

 

 

 

The pro forma as adjusted information discussed above is illustrative only and will depend on the actual public offering price and other terms of this offering determined at pricing. Each $1.00 increase or decrease in the assumed public offering price of $                per share, which was the last reported sale price of our common stock on The Nasdaq Global Select Market on                , 2020, would increase or decrease, as applicable, our pro

 

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forma as adjusted net tangible book value per share after this offering by $                per share and the dilution per share to new investors participating in this offering by $                per share, assuming that the number of shares of common stock offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, an increase of 1.0 million in the number of shares of common stock offered by us would increase the pro forma as adjusted net tangible book value after this offering by $                per share and decrease the dilution per share to new investors participating in this offering by $                per share, and a decrease of 1.0 million shares of common stock offered by us would decrease the pro forma as adjusted net tangible book value by $                per share, and increase the dilution per share to new investors in this offering by $                per share, assuming that the assumed public offering price of $                per share remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

If the underwriters exercise in full their option to purchase up to                additional shares of common stock from us, the pro forma as adjusted net tangible book value per share after giving effect to this offering would be $                per share, representing an immediate increase to existing stockholders of $                per share, and dilution to new investors participating in this offering of $                per share.

The foregoing discussion and tables above are based on 116,299,280 shares of common stock (excluding 1,457,432 shares of unvested restricted common stock) outstanding as of March 31, 2020 on a pro forma basis, and after giving effect to the subsequent issuances after March 31, 2020 of an aggregate of 7,948,912 shares of our common stock as described above, and excludes:

 

   

7,959,416 shares of our common stock issuable upon the exercise of outstanding stock options as of March 31, 2020, with a weighted-average exercise price of $7.30 per share;

 

   

1,884,693 shares of our common stock issuable upon the exercise of outstanding stock options granted subsequent to March 31, 2020, with a weighted-average exercise price of $30.36 per share;

 

   

7,611,513 shares of our common stock reserved for future issuance under the 2019 Plan as of March 31, 2020; and

 

   

2,377,244 shares of our common stock reserved for future issuance under the ESPP as of March 31, 2020.

To the extent that any outstanding options are exercised, new options or other equity awards are issued under our equity incentive plans, or we issue additional equity or convertible debt securities in the future, there will be further dilution to new investors participating in this offering.

 

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CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS

The following includes a summary of transactions since January 1, 2017 and any currently proposed transactions, to which we were or are to be a participant, in which (i) the amount involved exceeded or will exceed $120,000 and (ii) any of our directors, executive officers or holders of more than 5% of our capital stock, or any affiliate or member of the immediate family of the foregoing persons, had or will have a direct or indirect material interest, other than compensation and other arrangements that are described under the sections titled “Executive Compensation” and “Director Compensation” included in our Definitive Proxy Statement on Schedule 14A for our 2020 Annual Meeting of Stockholders, which is incorporated by reference herein.

We believe the terms obtained or consideration that we paid or received, as applicable, in connection with the transactions described below were comparable to terms available or the amounts that we would pay or receive, as applicable, in arm’s-length transactions.

Convertible Preferred Stock Financings

Series A-1 Convertible Preferred Stock Financing

In September 2016, we entered into a Series A-1 preferred stock purchase agreement with various investors, pursuant to which we issued shares of our Series A-1 convertible preferred stock at a price per share of $4.50. We held a second closing in March 2017, at which time we issued an additional 3,333,333 shares of our Series A-1 convertible preferred stock for gross cash proceeds of $15.0 million. Two additional closings occurred in June 2017, at which time we issued an aggregate of 24,571,107 shares of our Series A-1 convertible preferred stock for gross cash proceeds of $110.6 million. The fifth closing occurred in July 2017, at which time we issued an additional 6,641,111 shares of our Series A-1 convertible preferred stock for gross cash proceeds of $29.9 million.

In August 2017, the Series A-1/B Purchase Agreement was amended and restated, or the A&R Purchase Agreement, pursuant to which we issued an aggregate of 25,843,330 shares of Series A-1 convertible preferred stock at $4.50 per share for gross proceeds of $116.3 million in five closings. The first two closings occurred in August 2017, at which time we issued an aggregate of 21,111,110 shares of our Series A-1 convertible preferred stock for gross cash proceeds of $95.0 million. Two additional closings occurred in September 2017, at which time we issued an aggregate of 3,968,270 shares of our Series A-1 convertible preferred stock for gross cash proceeds of $17.9 million. The fifth closing occurred in October 2017, at which time we issued an aggregate of 763,950 shares of our Series A-1 convertible preferred stock for gross cash proceeds of $3.4 million. In June 2018, the A&R Purchase Agreement was amended, or the Amended A&R Purchase Agreement, pursuant to which we issued an aggregate of 3,222,220 shares of Series A-1 convertible preferred stock at $4.50 per share for gross proceeds of $14.5 million in two closings. The first closing occurred in June 2018, at which time we issued an additional 2,777,776 shares of our Series A-1 convertible preferred stock for gross cash proceeds of $12.5 million. The second closing occurred in July 2018, at which time we issued an additional 444,444 shares of our Series A-1 convertible preferred stock for gross cash proceeds of $2.0 million.

The table below sets forth the number of shares of our Series A-1 convertible preferred stock purchased by our executive officers, directors, holders of more than 5% of our capital stock and their affiliated entities or immediate family members. Each share of Series A-1 convertible preferred stock in the table below converted into one share of our common stock in October 2019 upon the closing of our initial public offering.

 

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Name    Series A-1
Convertible
Preferred
Stock
(#)
     Aggregate
Cash
Purchase Price
($)
 

Entities affiliated with ARCH Venture Partners(1)

     24,444,442        110,000,000  

SVF Endurance (Cayman) Limited(2)

     15,555,555        70,000,000  

Alta Partners NextGen Fund I, L.P.(3)

     1,666,666        7,500,000  

 

(1)

Kristina Burow and Robert Nelsen, members of our Board of Directors, were designated to our Board in 2016 by ARCH Venture Fund IX, L.P., or ARCH IX, which is an affiliate of ARCH Venture Fund IX Overage, L.P., or ARCH Overage, and their affiliated funds. ARCH Venture Partners IX, L.P., or ARCH IX LP, is the sole general partner of ARCH IX, and ARCH IX Overage LP is the sole general partner of ARCH Overage. Mr. Nelsen is a managing director of ARCH Venture Partners IX, LLC, or ARCH IX LLC, the sole general partner of ARCH IX LP and ARCH IX Overage LP. Ms. Burow holds an interest in each of ARCH IX LP and ARCH IX Overage LP. Dr. Daniel, a former member of our Board of Directors, is a venture partner of ARCH, which is an affiliate of ARCH IX and ARCH Overage, and their affiliated funds. Dr. Parrish, our Chief Business Officer, is a venture partner of ARCH, which is an affiliate of ARCH IX and ARCH Overage, and their affiliated funds.

(2)

SVF Endurance (Cayman) Limited is a wholly owned subsidiary of SoftBank Vision Fund (AIV M1) L.P., SVF. Dipchand Nishar, a member of our Board of Directors, was designated to our Board in 2017 by SVF. Mr. Nishar is Senior Managing Partner at SoftBank Investment Advisers, an affiliate of SVF.

(3)

Robert More, a member of our board of directors, is a managing director of Alta Partners NextGen Fund I Management, LLC, or APNG I Management. APNG I Management is the general partner of Alta Partners NextGen Fund I, L.P., or APNG I.

Series B Convertible Preferred Stock Financing

In January 2019, we issued an aggregate of 18,202,213 shares of Series B convertible preferred stock at $18.00 per share for gross proceeds of $327.6 million in two closings pursuant to an Amended and Restated Series A-1 and Series B Preferred Stock Purchase Agreement. Both closings occurred in January 2019.

The table below sets forth the number of shares of our Series B convertible preferred stock purchased by our executive officers, directors, holders of more than 5% of our capital stock and their affiliated entities or immediate family members. Each share of Series B convertible preferred stock in the table below converted into one share of our common stock upon the completion of our initial public offering.

 

Name

   Series B
Convertible
Preferred
Stock
(#)
     Aggregate
Cash
Purchase
Price

($)
 

Entities affiliated with ARCH Venture Partners(1)

     2,777,777        50,000,000  

SVF Endurance (Cayman) Limited(2)

     6,111,111        110,000,000  

Alta Partners NextGen Fund I, L.P.(3)

     277,777        5,000,000  

 

(1)

Ms. Burow and Mr. Nelsen, members of our Board of Directors, were designated to our Board in 2016 by ARCH IX, which is an affiliate of ARCH Overage, and their affiliated funds. ARCH IX LP, is the sole general partner of ARCH IX, and ARCH IX Overage LP is the sole general partner of ARCH Overage. Mr. Nelsen is a managing director of ARCH IX LLC, the sole general partner of ARCH IX LP and ARCH IX Overage LP. Ms. Burow holds an interest in each of ARCH IX LP and ARCH IX Overage LP. Dr. Daniel, a former member of our Board of Directors, is a venture partner of ARCH, which is an affiliate of ARCH IX and ARCH Overage, and their affiliated funds. Dr. Parrish, our Chief Business Officer, is a venture partner of ARCH, which is an affiliate of ARCH IX and ARCH Overage, and their affiliated funds.

(2)

SVF Endurance (Cayman) Limited is a wholly owned subsidiary of SVF. Mr. Nishar, a member of our Board of Directors, was designated to our Board in 2017 by SVF. Mr. Nishar is Senior Managing Partner at SoftBank Investment Advisers, an affiliate of SVF.

(3)

Mr. More, a member of our Board of Directors, is a managing director of APNG I Management. APNG I Management is the general partner of APNG I.

 

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Relationships with Klaus Frueh

In June 2016, we entered into a consulting agreement with Klaus Frueh, Ph.D., a former member of our Board of Directors and a stockholder, pursuant to which Dr. Frueh agreed to provide certain consulting, advisory and related services within the field of immune programming on an exclusive basis, in exchange for a consulting fee of $150,000 per year. Unless we terminate the agreement earlier, the consulting agreement will terminate in September 2021. We paid Dr. Frueh an aggregate of $150,000 pursuant to the consulting agreement during 2019.

Investors’ Rights, Management Rights, Voting and Co-Sale Agreements

In connection with our convertible preferred stock financings, we entered into investors’ rights, management rights, voting and right of first refusal and co-sale agreements containing registration rights, information rights, rights of first offer, voting rights and rights of first refusal, among other things, with certain holders of our capital stock. The holders of more than 5% of our capital stock that are party to these agreements are entities affiliated with ARCH Venture Partners and SVF. In connection with our acquisition of TomegaVax, former stockholders of TomegaVax became parties to the investors’ rights, voting and right of first refusal and co-sale agreements. Our directors who are parties to these agreements are Dr. Frueh, who resigned from our Board in October 2019, and Mr. More.

These stockholder agreements terminated upon the closing of our initial public offering in October 2019, except for the registration rights granted under our investors’ rights agreement, which will terminate upon the earliest of (i) the closing of a deemed liquidation event, as defined in our amended and restated certificate of incorporation as currently in effect; (ii) with respect to each stockholder, the date when such stockholder can sell all of its registrable shares without limitation during a three-month period without registration pursuant to Rule 144 of the Securities Act, or Rule 144, or another similar exemption under the Securities Act; and (iii) five years after the completion of our initial public offering.

Certain Loan Transactions

In January 2017, we issued two promissory notes to Dr. Scangos, our President, Chief Executive Officer and a member of our Board of Directors, and Vicki Sato, Ph.D., Chairman of our Board of Directors, for principal amounts of $2.9 million and $0.2 million, respectively, with an interest rate of 1.97% per annum, to allow Dr. Scangos and Dr. Sato to purchase 3,338,222 shares and 286,133 shares of our restricted stock, respectively, pursuant to their respective restricted stock purchase agreements. The principal and accrued interest outstanding on each of these promissory notes was approximately $3.0 million and $0.3 million for Dr. Scangos and Dr. Sato, respectively, as of July 31, 2019. These loans were repaid in full in August 2019.

Employment of an Immediate Family Member

Jennifer Scangos, the daughter of Dr. Scangos, our President, Chief Executive Officer and a member of our board of directors, is employed by us as a legal counsel. For the years ended December 31, 2017 and 2018, Ms. Scangos earned $9,394 and $153,282, respectively, in base salary and bonus which was in line with similar roles at the Company. For the year ended December 31, 2019, Ms. Scangos earned $139,000 and $24,325, respectively, in base salary and bonus, which was in line with compensation we pay to employees in similar roles. Ms. Scangos has received and continues to be eligible to receive equity awards and benefits on the same general terms and conditions as applicable to unrelated employees in similar positions.

Collaboration with Brii Biosciences

In May 2018, we entered into an option and license agreement with Brii Bio Parent and Brii Bio, pursuant to which we granted, and were granted, an exclusive option with respect to up to four collaboration programs for the development and commercialization of therapeutic products for infectious diseases. Dr. Scangos, our

 

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President, Chief Executive Officer and a member of our Board of Directors, and Mr. Nelsen, a member of our Board of Directors, served at the time and currently serve as directors of Brii Bio Parent and Brii Bio. We agreed to pay Brii Bio an option exercise fee for each licensed Brii Bio program up to $50.0 million, and milestone payments and royalties for net sales of licensed products in the United States arising from the selected collaboration programs. Brii Bio agreed to pay us an option exercise fee for each licensed Vir program up to $20.0 million, and milestone payments and royalties for net sales of licensed products in greater China arising from the selected collaboration programs. On June 12, 2020, following our achievement of proof of concept for VIR-2218, Brii Bio notified us of the exercise of its option to obtain exclusive rights to develop and commercialize compounds and products arising from VIR-2218 in greater China. Brii Bio paid us a $20.0 million option exercise fee in connection with the option exercise, half of which we will pay to Alnylam in connection with our collaboration and license agreement with Alnylam.

Other Transactions

We have entered into offer letter agreements with our executive officers that, among other things, provide for certain compensatory and change in control benefits, as well as severance benefits. For a description of these agreements with our named executive officers, see the sections titled “Executive Compensation” and “Director Compensation” included in our Definitive Proxy Statement on Schedule 14A for our 2020 Annual Meeting of Stockholders, which is incorporated by reference herein.

We have also granted stock options and restricted stock to our executive officers and certain of our directors. For a description of these equity awards, see the sections titled “Executive Compensation” and “Director Compensation” included in our Definitive Proxy Statement on Schedule 14A for our 2020 Annual Meeting of Stockholders, which is incorporated by reference herein.

Indemnification Agreements

We have entered into indemnification agreements with each of our current directors and executive officers. Our amended and restated certificate of incorporation and our amended and restated bylaws provide that we will indemnify our directors and officers to the fullest extent permitted by applicable law.

Other than as described above under this section “Certain Relationships and Related Party Transactions” and in the documents incorporated by reference herein, since January 1, 2017, we have not entered into any transactions, nor are there any currently proposed transactions, between us and a related person where the amount involved exceeds, or would exceed, $120,000, and in which any related person had or will have a direct or indirect material interest. We believe the terms of the transactions described above were comparable to terms we could have obtained in arm’s length dealings with unrelated third parties.

 

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DESCRIPTION OF CAPITAL STOCK

The following description of our capital stock is based upon our amended and restated certificate of incorporation and our amended and restated bylaws. This summary does not purport to be complete and is subject to, and is qualified in its entirety by express reference to, the applicable provisions of our amended and restated certificate of incorporation and our amended and restated bylaws, which are filed as exhibits to the registration statement of which this prospectus is part. We encourage you to read our amended and restated certificate of incorporation, our amended and restated bylaws and the applicable provisions of the Delaware General Corporation Law, or the DGCL for more information.

General

Our amended and restated certificate of incorporation states that our authorized capital stock consists of 300,000,000 shares of common stock, par value $0.0001 per share, and 10,000,000 shares of preferred stock, par value $0.0001 per share.

Common Stock

Voting Rights

Each holder of common stock is entitled to one vote for each share on all matters submitted to a vote of the stockholders. The affirmative vote of holders of at least 66 2/3% of the voting power of all of the then-outstanding shares of capital stock, voting as a single class, is required to amend certain provisions of our amended and restated certificate of incorporation, including provisions relating to amending our amended and restated bylaws, the classified structure of our board of directors, the size of our board of directors, removal of directors, director liability, vacancies on our board of directors, special meetings, stockholder notices, actions by written consent and exclusive jurisdiction.

Dividends

The holders of our common stock are entitled to receive ratably any dividends that our board of directors may declare out of funds legally available for that purpose on a non-cumulative basis.

Liquidation

In the event of our liquidation, dissolution or winding up, holders of our common stock will be entitled to share ratably in the net assets legally available for distribution to stockholders after the payment of all of our debts and other liabilities.

Rights and Preferences

Holders of our common stock have no preemptive, conversion or subscription rights, and there are no redemption or sinking fund provisions applicable to our common stock.

Preferred Stock

Under our amended and restated certificate of incorporation, our board of directors has the authority, without further action by the stockholders, to issue up to 10,000,000 shares of preferred stock in one or more series, to establish from time to time the number of shares to be included in each such series, to fix the rights, preferences and privileges of the shares of each wholly unissued series and any qualifications, limitations or restrictions thereon and to increase or decrease the number of shares of any such series, but not below the number of shares of such series then outstanding. Our board of directors may authorize the issuance of preferred stock with voting or conversion rights that could adversely affect the voting power or other rights of the holders of the common stock. The issuance of preferred stock, while providing flexibility in connection with possible

 

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acquisitions and other corporate purposes, could, among other things, have the effect of delaying, deferring or preventing a change in our control that may otherwise benefit holders of our common stock and may adversely affect the market price of the common stock and the voting and other rights of the holders of common stock.

Registration Rights Under Amended and Restated Investors’ Rights Agreement

Certain holders of shares of our common stock issued upon conversion of previously outstanding convertible preferred stock are entitled to certain rights with respect to registration of such shares under the Securities Act. These shares are referred to as registrable securities. The holders of these registrable securities possess registration rights pursuant to the terms of our amended and restated investors’ rights agreement and are described in additional detail below. The registration of shares of our common stock pursuant to the exercise of the registration rights described below would enable the holders to trade these shares without restriction under the Securities Act when the applicable registration statement is declared effective. We will pay the registration expenses, other than underwriting discounts, selling commissions and stock transfer taxes, of the shares registered pursuant to the piggyback and Form S-3 registrations described below.

Generally, in an underwritten offering, the managing underwriter, if any, has the right, subject to specified conditions and limitations, to limit the number of shares the holders may include. The demand, piggyback and Form S-3 registration rights described below will expire no later than five years after the completion of our initial public offering, or with respect to any particular holder, at such time that such holder can sell its shares under Rule 144 of the Securities Act during any three-month period.

Demand Registration Rights

Certain holders of our common stock issued upon conversion of previously outstanding convertible preferred stock are entitled to certain demand registration rights. Certain major investors holding, collectively, a majority of registrable securities may, on not more than two occasions, request that we register all or a portion of their shares, subject to certain specified exceptions.

Piggyback Registration Rights

Certain holders of our common stock issued upon conversion of previously outstanding convertible preferred stock are entitled to their rights to notice of this offering and to include their shares of registrable securities in this offering. The requisite percentage of these stockholders have waived all such stockholders’ rights to notice of this offering and to include their shares of registrable securities in this offering. In the event that we propose to register any of our securities under the Securities Act in another offering, either for our own account or for the account of other security holders, the holders of registrable securities will be entitled to certain “piggyback” registration rights allowing them to include their shares in such registration, subject to specified conditions and limitations.

S-3 Registration Rights

Certain holders of our common stock issued upon conversion of previously outstanding convertible preferred stock will be entitled to certain Form S-3 registration rights. Certain major investors holding at least 10% of registrable securities may, on not more than two registrations on Form S-3 within any 12-month period, request that we register all or a portion of their shares on Form S-3 if we are qualified to file a registration statement on Form S-3, subject to specified exceptions. Such request for registration on Form S-3 must cover securities with an aggregate offering price which equals or exceeds $5.0 million, net of selling expenses. The right to have such shares registered on Form S-3 is further subject to other specified conditions and limitations.

Stock Purchase Agreement with Glaxo Group Limited

On April 5, 2020, concurrently with the execution of the Preliminary Collaboration Agreement, we entered into a stock purchase agreement, or the Stock Purchase Agreement, with GGL, an affiliate of GSK, pursuant to

 

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which GGL purchased 6,626,027 shares of our common stock on April 29, 2020, or the GGL Shares, at a purchase price of $37.73 per share, or approximately $250.0 million.

Pursuant to the terms of the Stock Purchase Agreement, GGL has agreed not to, without our prior written consent and subject to certain conditions and exceptions, among other things, directly or indirectly acquire additional shares of our common stock, seek or propose a tender or exchange offer, merger or other business combination involving us, solicit proxies or consents with respect to any matter, or undertake other specified actions related to the potential acquisition of additional equity interests in us. Such restrictions will expire on the one-year anniversary of the effective date of the Stock Purchase Agreement.

The Stock Purchase Agreement also provides that until the first anniversary of the effective date of such agreement, GGL will hold and not sell any of the GGL Shares, subject to certain exceptions. We agreed to register the GGL Shares for resale following expiration of the one-year lock-up period if Rule 144 under the Securities Act is not available for such resale without any volume or manner of sale restrictions.

Anti-Takeover Provisions of Delaware Law and Our Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws

Section 203 of the Delaware General Corporation Law

We are subject to Section 203 of the DGCL, which prohibits a Delaware corporation from engaging in any business combination with any interested stockholder for a period of three years after the date that such stockholder became an interested stockholder, with the following exceptions:

 

   

before such date, the board of directors of the corporation approved either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder;

 

   

upon completion of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction began, excluding for purposes of determining the voting stock outstanding (but not the outstanding voting stock owned by the interested stockholder) those shares owned (i) by persons who are directors and also officers and (ii) employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or

 

   

on or after such date, the business combination is approved by the board of directors and authorized at an annual or special meeting of the stockholders, and not by written consent, by the affirmative vote of at least 66 2/3% of the outstanding voting stock that is not owned by the interested stockholder.

Section 203 defines a “business combination” to include the following:

 

   

any merger or consolidation involving the corporation and the interested stockholder;

 

   

any sale, transfer, pledge or other disposition of 10% or more of the assets of the corporation involving the interested stockholder;

 

   

subject to certain exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation to the interested stockholder;

 

   

any transaction involving the corporation that has the effect of increasing the proportionate share of the stock or any class or series of the corporation beneficially owned by the interested stockholder; and

 

   

the receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits by or through the corporation.

 

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In general, Section 203 defines an “interested stockholder” as an entity or person who, together with the person’s affiliates and associates, beneficially owns, or within three years prior to the time of determination of interested stockholder status did own, 15% or more of the outstanding voting stock of the corporation.

The statute could prohibit or delay mergers or other takeover or change in control attempts and, accordingly, may discourage attempts to acquire us even though such a transaction may offer our stockholders the opportunity to sell their stock at a price above the prevailing market price.

Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws

Among other things, our amended and restated certificate of incorporation and amended and restated bylaws will:

 

   

permit our board of directors to issue up to 10,000,000 shares of preferred stock, with any rights, preferences and privileges as they may designate, including the right to approve an acquisition or other change in control;

 

   

provide that the authorized number of directors may be changed only by resolution of our board of directors;

 

   

provide that our board of directors will be classified into three classes of directors;

 

   

provide that, subject to the rights of any series of preferred stock to elect directors, directors may only be removed for cause, which removal may be effected, subject to any limitation imposed by law, by the holders of at least 66 2/3% of the voting power of all of our then-outstanding shares of the capital stock entitled to vote generally at an election of directors;

 

   

provide that all vacancies, including newly created directorships, may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum;

 

   

require that any action to be taken by our stockholders must be effected at a duly called annual or special meeting of stockholders and not be taken by written consent or electronic transmission;

 

   

provide that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide advance notice in writing, and also specify requirements as to the form and content of a stockholder’s notice;

 

   

provide that special meetings of our stockholders may be called only by the chairman of our board of directors, our chief executive officer or president or by our board of directors pursuant to a resolution adopted by a majority of the total number of authorized directors, and not by our stockholders; and

 

   

not provide for cumulative voting rights, therefore allowing the holders of a majority of the shares of common stock entitled to vote in any election of directors to elect all of the directors standing for election, if they should so choose.

The amendment of any of these provisions would require approval by the holders of at least 66 2/3% of the voting power of all of our then-outstanding common stock entitled to vote generally in the election of directors, voting together as a single class.

The combination of these provisions will make it more difficult for our existing stockholders to replace our board of directors as well as for another party to obtain control of us by replacing our board of directors. Because our board of directors has the power to retain and discharge our officers, these provisions could also make it more difficult for existing stockholders or another party to effect a change in management. In addition, the authorization of undesignated preferred stock makes it possible for our board of directors to issue preferred stock with voting or other rights or preferences that could impede the success of any attempt to change our control.

 

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These provisions are intended to enhance the likelihood of continued stability in the composition of our board of directors and its policies and to discourage coercive takeover practices and inadequate takeover bids. These provisions are also designed to reduce our vulnerability to hostile takeovers and to discourage certain tactics that may be used in proxy fights. However, such provisions could have the effect of discouraging others from making tender offers for our shares and may have the effect of delaying changes in our control or management. As a consequence, these provisions may also inhibit fluctuations in the market price of our stock that could result from actual or rumored takeover attempts. We believe that the benefits of these provisions, including increased protection of our potential ability to negotiate with the proponent of an unfriendly or unsolicited proposal to acquire or restructure our company, outweigh the disadvantages of discouraging takeover proposals, because negotiation of takeover proposals could result in an improvement of their terms.

Choice of Forum

Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware (or, if and only if the Court of Chancery of the State of Delaware lacks subject matter jurisdiction, any state court located within the State of Delaware or, if and only if all such state courts lack subject matter jurisdiction, the federal district court for the District of Delaware) is the sole and exclusive forum for the following types of actions or proceedings under Delaware statutory or common law: (i) any derivative action or proceeding brought on our behalf; (ii) any action or proceeding asserting a claim of breach of a fiduciary duty owed by any of our current or former directors, officers or other employees to us or our stockholders; (iii) any action or proceeding asserting a claim against us or any of our current or former directors, officers or other employees, arising out of or pursuant to any provision of the Delaware General Corporation Law, our certificate of incorporation or our bylaws; (iv) any action or proceeding to interpret, apply, enforce or determine the validity of our certificate of incorporation or our bylaws; and (v) any action asserting a claim against us or any of our directors, officers or other employees governed by the internal affairs doctrine. This provision would not apply to suits brought to enforce a duty or liability created by the Exchange Act or any other claim for which the U.S. federal courts have exclusive jurisdiction. Nothing in our amended and restated certificate of incorporation precludes stockholders that assert claims under the Securities Act from bringing such claims in state or federal court, subject to applicable law. Our amended and restated certificate of incorporation further provides that the federal district courts of the United States is the exclusive forum for resolving any complaint asserting a cause of action under the Securities Act, unless we consent in writing to the selection of an alternative forum.

Listing

Our common stock is listed on The Nasdaq Global Select Market under the trading symbol “VIR.”

Transfer Agent and Registrar

The transfer agent and registrar for our common stock is Computershare Trust Company, N.A. The transfer agent’s address is 250 Royall Street, Canton, Massachusetts 02021.

 

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MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS

The following is a general discussion of the material U.S. federal income tax consequences applicable to non-U.S. holders (as defined herein) with respect to their purchase, ownership and disposition of shares of our common stock issued pursuant to this offering. All prospective non-U.S. holders of our common stock should consult their own tax advisors with respect to the U.S. federal, state, local and non-U.S. tax consequences of the purchase, ownership and disposition of our common stock. In general, a non-U.S. holder means a beneficial owner of our common stock (other than a partnership or an entity or arrangement treated as a partnership for U.S. federal income tax purposes) that is not, for U.S. federal income tax purposes:

 

   

an individual who is a citizen or resident of the United States;

 

   

a corporation, or an entity treated as a corporation for U.S. federal income tax purposes, created or organized in the United States or under the laws of the United States or of any state thereof or the District of Columbia;

 

   

an estate, the income of which is subject to U.S. federal income tax regardless of its source; or

 

   

a trust if (i) a U.S. court can exercise primary supervision over the trust’s administration and one or more U.S. persons have the authority to control all of the trust’s substantial decisions or (ii) the trust has a valid election in effect under applicable U.S. Treasury Regulations to be treated as a U.S. person.

We assume in this discussion that a non-U.S. holder holds shares of our common stock as a capital asset within the meaning of Section 1221 of the Code (generally, property held for investment). This discussion does not address all aspects of U.S. federal income taxation that may be relevant to a particular non-U.S. holder in light of that non-U.S. holder’s individual circumstances, nor does it address any estate or gift tax consequences, or any aspects of U.S. state, local or non-U.S. taxes. This discussion also does not consider any specific facts or circumstances that may apply to a non-U.S. holder and does not address the special tax rules applicable to particular non-U.S. holders, such as holders that own, or are deemed to own, more than 5% of our capital stock (except to the extent specifically set forth below), corporations that accumulate earnings to avoid U.S. federal income tax, tax-exempt or governmental organizations, banks, financial institutions, insurance companies, brokers, dealers or traders in securities, commodities or currencies, tax-qualified retirement plans, holders subject to the alternative minimum tax or the Medicare contribution tax on net investment income, holders holding our common stock as part of a hedge, straddle or other risk reduction strategy, conversion transaction, synthetic security or other integrated investment, holders deemed to sell our common stock under the constructive sale provisions of the Code, controlled foreign corporations, passive foreign investment companies, accrual method taxpayers subject to special tax accounting rules under Section 451(b) of the Code, and U.S. expatriates and certain former U.S. citizens or long-term residents.

In addition, this discussion does not address the tax treatment of partnerships (or entities or arrangements that are treated as partnerships for U.S. federal income tax purposes) or persons that hold their common stock through such partnerships. If a partnership, including any entity or arrangement treated as a partnership for U.S. federal income tax purposes, holds shares of our common stock, the U.S. federal income tax treatment of a partner in such partnership will generally depend upon the status of the partner, the activities of the partnership and certain determinations made at the partner level. Such partners and partnerships should consult their own tax advisors regarding the tax consequences of the purchase, ownership and disposition of our common stock.

There can be no assurance that a court or the Internal Revenue Service, or the IRS, will not challenge one or more of the tax consequences described herein, and we have not obtained, nor do we intend to obtain, a ruling with respect to the U.S. federal income tax consequences to a non-U.S. holder of the purchase, ownership or disposition of our common stock.

Distributions on Our Common Stock

As described in the section titled “Dividend Policy,” we do not currently intend to pay any cash dividends on our capital stock in the foreseeable future. If we do make distributions of cash or property on our common

 

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stock, such distributions generally will constitute dividends for U.S. federal income tax purposes to the extent paid from our current or accumulated earnings and profits, as determined under U.S. federal income tax principles. If a distribution exceeds our current and accumulated earnings and profits, the excess will be treated as a tax-free return of the non-U.S. holder’s investment, up to such holder’s adjusted tax basis in the common stock. Any remaining excess will be treated as capital gain from the sale or exchange of such common stock subject to the tax treatment described below in “Gain on Sale, Exchange or Other Disposition of Our Common Stock.” Any distributions will also be subject to the discussion below under the heading “Foreign Accounts.”

Dividends paid to a non-U.S. holder will generally be subject to withholding of U.S. federal income tax at a 30% rate or such lower rate as may be specified by an applicable income tax treaty between the United States and such holder’s country of residence.

Dividends that are treated as effectively connected with a trade or business conducted by a non-U.S. holder within the United States and, if an applicable income tax treaty so provides, that are attributable to a permanent establishment or a fixed base maintained by the non-U.S. holder within the United States, are generally exempt from the 30% withholding tax if the non-U.S. holder satisfies applicable certification and disclosure requirements. However, such U.S. effectively connected income, net of specified deductions and credits, is taxed at the U.S. federal income tax rates applicable to “United States persons” (as defined in the Code). Any U.S. effectively connected income received by a non-U.S. holder that is a corporation may also, under certain circumstances, be subject to an additional “branch profits tax” at a 30% rate or such lower rate as may be specified by an applicable income tax treaty between the United States and such holder’s country of residence.

To claim a reduction or exemption from withholding, a non-U.S. holder of our common stock generally will be required to provide (i) a properly executed IRS Form W-8BEN (in the case of individuals) or IRS Form W-8BEN-E (in the case of entities), or successor form, and satisfy applicable certification and other requirements to claim the benefit of an applicable income tax treaty between the United States and such holder’s country of residence, or (ii) a properly executed IRS Form W-8ECI stating that dividends are not subject to withholding because they are effectively connected with such non-U.S. holder’s conduct of a trade or business within the United States. The tax forms referred to above must be provided to us or our paying agent prior to the payment of dividends and must be updated periodically. In the case of a non-U.S. holder that is an entity, Treasury Regulations and any relevant tax treaty provide rules to determine whether, for purposes of determining the applicability of a tax treaty, dividends will be treated as paid to the entity or to those holding an interest in that entity. If a non-U.S. Holder holds stock through a financial institution or other agent acting on the holder’s behalf, the holder will be required to provide appropriate documentation to such agent. The holder’s agent will then be required to provide certification to us or our paying agent, either directly or through other intermediaries. Non-U.S. holders are urged to consult their tax advisors regarding their entitlement to benefits under a relevant income tax treaty.

A non-U.S. holder that is eligible for a reduced rate of U.S. withholding tax under an income tax treaty may obtain a refund or credit of any excess amounts withheld by timely filing an appropriate claim for refund with the IRS.

Gain on Sale, Exchange or Other Disposition of Our Common Stock

Subject to the discussion below regarding backup withholding, in general, a non-U.S. holder will not be subject to any U.S. federal income or withholding tax on any gain realized upon such holder’s sale, exchange or other disposition of shares of our common stock unless:

 

   

the gain is effectively connected with a U.S. trade or business of the non-U.S. holder and, if an applicable income tax treaty so provides, is attributable to a permanent establishment or a fixed base maintained in the United States by such non-U.S. holder, in which case the non-U.S. holder generally will be taxed at the U.S. federal income tax rates applicable to “United States persons” (as defined in the Code) and, if the non-U.S. holder is a foreign corporation, the branch profits tax described above in “Distributions on Our Common Stock” may also apply;

 

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the non-U.S. holder is a nonresident alien individual who is present in the United States for 183 days or more in the taxable year of the disposition and certain other conditions are met, in which case the non-U.S. holder will be subject to a 30% tax (or such lower rate as may be specified by an applicable income tax treaty) on the net gain derived from the disposition, which may be offset by U.S. source capital losses of the non-U.S. holder, if any (even though the individual is not considered a resident of the United States), provided the non-U.S. holder has timely filed U.S. federal income tax returns with respect to such losses; or

 

   

our common stock constitutes a U.S. real property interest because we are, or have been, at any time during the five-year period preceding such disposition (or the non-U.S. holder’s holding period, if shorter) a U.S. real property holding corporation. Generally, a corporation is a U.S. real property holding corporation only if the fair market value of its U.S. real property interests equals or exceeds 50% of the sum of the fair market value of its worldwide real property interests plus the fair market value of its other assets used or held for use in a trade or business. We do not believe that we are, or have been, a U.S. real property holding corporation, or that we are likely to become one in the future. However, because the determination of whether we are a U.S. real property holding corporation depends on the fair market value of our U.S. real property relative to the fair market value of our other business assets, there can be no assurance that we will not become a U.S. real property holding corporation in the future. Even if we are or become a U.S. real property holding corporation, provided that our common stock is “regularly traded” (as defined by applicable Treasury Regulations), on an established securities market, our common stock will be treated as a U.S. real property interest only with respect to a non-U.S. holder that holds more than 5% of our outstanding common stock, actually or constructively, during the shorter of the five-year period ending on the date of the disposition or the period that the non-U.S. holder held our common stock. In such case, such non-U.S. holder generally will be taxed on its net gain derived from the disposition at the U.S. federal income tax rates applicable to “United States persons” (as defined in the Code). No assurance can be provided that our common stock will continue to be regularly traded on an established securities market for purposes of the rules described above.

Backup Withholding and Information Reporting

We must report annually to the IRS and to each non-U.S. holder the gross amount of the distributions on our common stock paid to such holder and the tax withheld, if any, with respect to such distributions. Non-U.S. holders will have to comply with specific certification procedures to establish that the holder is not a “United States person” (as defined in the Code) in order to avoid backup withholding at the applicable rate with respect to dividends on our common stock. A non-U.S. holder generally will not be subject to U.S. backup withholding with respect to payments of dividends on our common stock if it certifies its non-U.S. status by providing a valid IRS Form W-8BEN (in the case of individuals), IRS Form W-8BEN-E (in the case of entities) or IRS Form W-8ECI, or successor form, or otherwise establishes an exemption; provided the applicable withholding agent does not have actual knowledge or reason to know such non-U.S. holder is a “United States person,” as defined in the Code.

Information reporting and backup withholding will generally apply to the proceeds of a disposition of our common stock by a non-U.S. holder effected by or through the U.S. office of any broker, U.S. or foreign, unless the holder certifies its status as a non-U.S. holder and satisfies certain other requirements, or otherwise establishes an exemption. Generally, information reporting and backup withholding will not apply to a payment of disposition proceeds to a non-U.S. holder where the transaction is effected outside the United States through a non-U.S. office of a broker. However, for information reporting purposes, dispositions effected through a non-U.S. office of a broker with substantial U.S. ownership or operations generally will be treated in a manner similar to dispositions effected through a U.S. office of a broker. Information reporting and backup withholding requirements may, however, apply to a payment of disposition proceeds if the broker has actual knowledge, or reason to know, that the holder is, in fact, a U.S. person. Non-U.S. holders should consult their own tax advisors regarding the application of the information reporting and backup withholding rules to them.

 

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Copies of information returns that are filed with the IRS may be made available under the provisions of a specific treaty or agreement to the tax authorities of the country in which the non-U.S. holder resides or is incorporated.

Backup withholding is not an additional tax. Any amounts withheld under the backup withholding rules from a payment to a non-U.S. holder may be allowed as a credit against the non-U.S. holder’s U.S. federal income tax liability, if any, and may entitle such holder to a refund, provided that the required information is timely furnished to the IRS.

Foreign Accounts

Withholding taxes may be imposed under Sections 1471 to 1474 of the Code (such Sections commonly referred to as the Foreign Account Tax Compliance Act, or FATCA) on certain types of payments made to non-U.S. financial institutions and certain other non-U.S. entities. Specifically, a 30% withholding tax may be imposed on dividends on our common stock paid to a “foreign financial institution” (as specifically defined for this purpose), unless such institution enters into an agreement with the U.S. government to, among other things, withhold on certain payments and to collect and provide to the U.S. tax authorities substantial information regarding U.S. account holders of such institution (which includes certain equity and debt holders of such institution, as well as certain account holders that are foreign entities with U.S. owners) or otherwise qualifies for an exemption from these rules. A U.S. federal withholding tax of 30% also applies to dividends on our common stock paid to a “non-financial foreign entity” (as defined in the Code), unless such entity provides the withholding agent with either a certification that it does not have any substantial direct or indirect U.S. owners or provides information regarding substantial direct and indirect U.S. owners of the entity, or otherwise qualifies for an exemption from these rules. The withholding provisions described above currently apply to dividends paid on our common stock. Under the applicable Treasury Regulations and administrative guidance, withholding under FATCA would have applied to payments of gross proceeds from the sale or other disposition of stock on or after January 1, 2019, although under proposed Treasury Regulations (the preamble to which specifies that taxpayers are permitted to rely on such proposed Treasury Regulations pending finalization), no withholding applies with respect to payments of gross proceeds. Under certain circumstances, a non-U.S. holder might be eligible for refunds or credits of such taxes. An intergovernmental agreement between the United States and an applicable foreign country may modify the requirements described in this paragraph.

EACH PROSPECTIVE INVESTOR SHOULD CONSULT ITS TAX ADVISOR REGARDING THE PARTICULAR U.S. FEDERAL, STATE AND LOCAL AND NON-U.S. TAX CONSEQUENCES OF PURCHASING, HOLDING AND DISPOSING OF OUR COMMON STOCK, INCLUDING THE CONSEQUENCES OF ANY RECENT AND PROPOSED CHANGE IN APPLICABLE LAWS.

 

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UNDERWRITING

We and the underwriters named below have entered into an underwriting agreement with respect to the shares being offered. Subject to certain conditions, each underwriter has severally agreed to purchase the number of shares indicated in the following table. Goldman Sachs & Co. LLC is the sole representative of the underwriters.

 

Underwriters    Number of
Shares
 

Goldman Sachs & Co. LLC

                   
  

 

 

 

Total

  
  

 

 

 

The underwriters are committed to take and pay for all of the shares being offered, if any are taken, other than the shares covered by the option described below unless and until this option is exercised.

The underwriters have an option to buy up to an additional                shares from us to cover sales by the underwriters of a greater number of shares than the total number set forth in the table above. They may exercise that option for 30 days. If any shares are purchased pursuant to this option, the underwriters will severally purchase shares in approximately the same proportion as set forth in the table above.

The following table shows the per share and total underwriting discounts and commissions to be paid to the underwriters by us. Such amounts are shown assuming both no exercise and full exercise of the underwriters’ option to purchase additional shares.

 

Paid by Us    No Exercise      Full Exercise  

Per Share

   $                    $                

Total

   $        $    

Shares sold by the underwriters to the public will initially be offered at the initial public offering price set forth on the cover of this prospectus. Any shares sold by the underwriters to securities dealers may be sold at a discount of up to $                per share from the initial public offering price. After the initial offering of the shares, the representative may change the offering price and the other selling terms. The offering of the shares by the underwriters is subject to receipt and acceptance and subject to the underwriters’ right to reject any order in whole or in part.

We and our directors, our executive officers and certain affiliated stockholders have agreed with the underwriters, subject to certain limited exceptions, not to dispose of or hedge any of their common stock or securities convertible into or exchangeable for shares of common stock during the period from the date of this prospectus continuing through the date 90 days after the date of this prospectus, except with the prior written consent of Goldman Sachs & Co. LLC. This agreement does not apply to any existing employee benefit plans.

Our common stock is listed on The Nasdaq Global Select Market under the trading symbol “VIR.”

In connection with the offering, the underwriters may purchase and sell shares of common stock in the open market. These transactions may include short sales, stabilizing transactions and purchases to cover positions created by short sales. Short sales involve the sale by the underwriters of a greater number of shares than they are required to purchase in the offering, and a short position represents the amount of such sales that have not been covered by subsequent purchases. A “covered short position” is a short position that is not greater than the amount of additional shares for which the underwriters’ option described above may be exercised. The underwriters may cover any covered short position by either exercising their option to purchase additional shares or purchasing shares in the open market. In determining the source of shares to cover the covered short position, the underwriters will consider, among other things, the price of shares available for purchase in the open market as compared to the price at which they may purchase additional shares pursuant to the option described above.

 

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“Naked” short sales are any short sales that create a short position greater than the amount of additional shares for which the option described above may be exercised. The underwriters must cover any such naked short position by purchasing shares in the open market. A naked short position is more likely to be created if the underwriters are concerned that there may be downward pressure on the price of the common stock in the open market after pricing that could adversely affect investors who purchase in the offering. Stabilizing transactions consist of various bids for or purchases of common stock made by the underwriters in the open market prior to the completion of the offering.

The underwriters may also impose a penalty bid. This occurs when a particular underwriter repays to the underwriters a portion of the underwriting discount received by it because the representative has repurchased shares sold by or for the account of such underwriter in stabilizing or short covering transactions.

Purchases to cover a short position and stabilizing transactions, as well as other purchases by the underwriters for their own accounts, may have the effect of preventing or retarding a decline in the market price of our common stock, and together with the imposition of the penalty bid, may stabilize, maintain or otherwise affect the market price of the common stock. As a result, the price of the common stock may be higher than the price that otherwise might exist in the open market. The underwriters are not required to engage in these activities and may end any of these activities at any time. These transactions may be effected on the New York Stock Exchange, The Nasdaq Global Select Market or relevant exchange, in the over-the-counter market or otherwise.

We estimate that our share of the total expenses of the offering, excluding underwriting discounts and commissions, will be approximately $                . We will reimburse the underwriters for certain of their expenses incurred in connection with this offering in an amount up to $                .

We have agreed to indemnify the several underwriters against certain liabilities, including liabilities under the Securities Act.

The underwriters and their respective affiliates are full service financial institutions engaged in various activities, which may include sales and trading, commercial and investment banking, advisory, investment management, investment research, principal investment, hedging, market making, brokerage and other financial and non-financial activities and services. Certain of the underwriters and their respective affiliates have provided, and may in the future provide, a variety of these services to the issuer and to persons and entities with relationships with the issuer, for which they received or will receive customary fees and expenses.

In the ordinary course of their various business activities, the underwriters and their respective affiliates, officers, directors and employees may purchase, sell or hold a broad array of investments and actively trade securities, derivatives, loans, commodities, currencies, credit default swaps and other financial instruments for their own account and for the accounts of their customers, and such investment and trading activities may involve or relate to assets, securities and/or instruments of the issuer (directly, as collateral securing other obligations or otherwise) and/or persons and entities with relationships with the issuer. The underwriters and their respective affiliates may also communicate independent investment recommendations, market color or trading ideas and/or publish or express independent research views in respect of such assets, securities or instruments and may at any time hold, or recommend to clients that they should acquire, long and/or short positions in such assets, securities and instruments.

Selling Restrictions

European Economic Area and United Kingdom

In relation to each Member State of the European Economic Area and the United Kingdom (each a “Relevant State”), no shares have been offered or will be offered pursuant to this offering to the public in that Relevant State prior to the publication of a prospectus in relation to the shares which has been approved by the competent authority in that Relevant State or, where appropriate, approved in another Relevant State and notified

 

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to the competent authority in that Relevant State, all in accordance with the Prospectus Regulation, except that offers of shares may be made to the public in that Relevant State at any time under the following exemptions under the Prospectus Regulation:

 

   

to any legal entity which is a qualified investor as defined in the Prospectus Regulation;

 

   

to fewer than 150 natural or legal persons (other than qualified investors as defined under the Prospectus Regulation), subject to obtaining the prior consent of the representative for any such offer; or

 

   

in any other circumstances falling within Article 1(4) of the Prospectus Regulation, provided that no such offer of shares shall require us or any underwriter to publish a prospectus pursuant to Article 3 of the Prospectus Regulation or supplement a prospectus pursuant to Article 23 of the Prospectus Regulation and each person who initially acquires any shares or to whom any offer is made will be deemed to have represented, acknowledged and agreed to and with each of the underwriters and the company that it is a “qualified investor” within the meaning of Article 2(e) of the Prospectus Regulation. In the case of any shares being offered to a financial intermediary as that term is used in the Prospectus Regulation, each such financial intermediary will be deemed to have represented, acknowledged and agreed that the shares acquired by it in the offer have not been acquired on a non-discretionary basis on behalf of, nor have they been acquired with a view to their offer or resale to, persons in circumstances which may give rise to an offer of any shares to the public other than their offer or resale in a Relevant State to qualified investors as so defined or in circumstances in which the prior consent of the underwriters have been obtained to each such proposed offer or resale.

For the purposes of this provision, the expression an “offer to the public” in relation to shares in any Relevant State means the communication in any form and by any means of sufficient information on the terms of the offer and any shares to be offered so as to enable an investor to decide to purchase or subscribe for any shares, and the expression “Prospectus Regulation” means Regulation (EU) 2017/1129.

This European Economic Area selling restriction is in addition to any other selling restrictions set out below.

United Kingdom

In the United Kingdom, this prospectus is only addressed to and directed as qualified investors who are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the Order); or (ii) high net worth entities and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). Any investment or investment activity to which this prospectus relates is available only to relevant persons and will only be engaged with relevant persons. Any person who is not a relevant person should not act or relay on this prospectus or any of its contents.

Canada

The securities may be sold in Canada only to purchasers purchasing, or deemed to be purchasing, as principal that are accredited investors, as defined in National Instrument 45-106 Prospectus Exemptions or subsection 73.3(1) of the Securities Act (Ontario), and are permitted clients, as defined in National Instrument 31-103 Registration Requirements, Exemptions, and Ongoing Registrant Obligations. Any resale of the securities must be made in accordance with an exemption form, or in a transaction not subject to, the prospectus requirements of applicable securities laws.

Securities legislation in certain provinces or territories of Canada may provide a purchaser with remedies for rescission or damages if this offering memorandum (including any amendment thereto) contains a misrepresentation, provided that the remedies for rescission or damages are exercised by the purchaser within the

 

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time limit prescribed by the securities legislation of the purchaser’s province or territory. The purchaser should refer to any applicable provisions of the securities legislation of the purchaser’s province or territory of these rights or consult with a legal advisor.

Pursuant to section 3A.3 of National Instrument 33-105 Underwriting Conflicts (NI 33-105), the underwriters are not required to comply with the disclosure requirements of NI 33-105 regarding underwriter conflicts of interest in connection with this offering.

Hong Kong

The shares may not be offered or sold in Hong Kong by means of any document other than (i) in circumstances which do not constitute an offer to the public within the meaning of the Companies (Winding Up and Miscellaneous Provisions) Ordinance (Cap. 32 of the Laws of Hong Kong) (“Companies (Winding Up and Miscellaneous Provisions) Ordinance”) or which do not constitute an invitation to the public within the meaning of the Securities and Futures Ordinance (Cap. 571 of the Laws of Hong Kong) (“Securities and Futures Ordinance”), or (ii) to “professional investors” as defined in the Securities and Futures Ordinance and any rules made thereunder, or (iii) in other circumstances which do not result in the document being a “prospectus” as defined in the Companies (Winding Up and Miscellaneous Provisions) Ordinance, and no advertisement, invitation or document relating to the shares may be issued or may be in the possession of any person for the purpose of issue (in each case whether in Hong Kong or elsewhere), which is directed at, or the contents of which are likely to be accessed or read by, the public in Hong Kong (except if permitted to do so under the securities laws of Hong Kong) other than with respect to shares which are or are intended to be disposed of only to persons outside Hong Kong or only to “professional investors” in Hong Kong as defined in the Securities and Futures Ordinance and any rules made thereunder.

Singapore

This prospectus has not been registered as a prospectus with the Monetary Authority of Singapore. Accordingly, this prospectus and any other document or material in connection with the offer or sale, or invitation for subscription or purchase, of the shares may not be circulated or distributed, nor may the shares be offered or sold, or be made the subject of an invitation for subscription or purchase, whether directly or indirectly, to persons in Singapore other than (i) to an institutional investor (as defined under Section 4A of the Securities and Futures Act, Chapter 289 of Singapore, or the SFA) under Section 274 of the SFA, (ii) to a relevant person (as defined in Section 275(2) of the SFA) pursuant to Section 275(1) of the SFA, or any person pursuant to Section 275(1A) of the SFA, and in accordance with the conditions specified in Section 275 of the SFA, or (iii) otherwise pursuant to, and in accordance with the conditions of, any other applicable provision of the SFA, in each case subject to conditions set forth in the SFA.

Where the shares are subscribed or purchased under Section 275 of the SFA by a relevant person which is a corporation (which is not an accredited investor (as defined in Section 4A of the SFA)) the sole business of which is to hold investments and the entire share capital of which is owned by one or more individuals, each of whom is an accredited investor, the securities (as defined in Section 239(1) of the SFA) of that corporation shall not be transferable for six months after that corporation has acquired the shares under Section 275 of the SFA except: (i) to an institutional investor under Section 274 of the SFA or to a relevant person (as defined in Section 275(2) of the SFA), (ii) where such transfer arises from an offer in that corporation’s securities pursuant to Section 275(1A) of the SFA, (iii) where no consideration is or will be given for the transfer, (iv) where the transfer is by operation of law, (v) as specified in Section 276(7) of the SFA, or (vi) as specified in Regulation 32 of the Securities and Futures (Offers of Investments) (Shares and Debentures) Regulations 2005 of Singapore (“Regulation 32”).

 

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Where the shares are subscribed or purchased under Section 275 of the SFA by a relevant person which is a trust (where the trustee is not an accredited investor (as defined in Section 4A of the SFA)) whose sole purpose is to hold investments and each beneficiary of the trust is an accredited investor, the beneficiaries’ rights and interest (howsoever described) in that trust shall not be transferable for six months after that trust has acquired the shares under Section 275 of the SFA except: (i) to an institutional investor under Section 274 of the SFA or to a relevant person (as defined in Section 275(2) of the SFA), (ii) where such transfer arises from an offer that is made on terms that such rights or interest are acquired at a consideration of not less than S$200,000 (or its equivalent in a foreign currency) for each transaction (whether such amount is to be paid for in cash or by exchange of securities or other assets), (iii) where no consideration is or will be given for the transfer, (iv) where the transfer is by operation of law, (v) as specified in Section 276(7) of the SFA, or (vi) as specified in Regulation 32.

Singapore Securities and Futures Act Product Classification—Solely for the purposes of its obligations pursuant to Sections 309B(1)(a) and 309B(1)(c) of the SFA, we have determined, and hereby notify all relevant persons (as defined in Section 309A of the SFA) that the common shares are “prescribed capital markets products” (as defined in the Securities and Futures (Capital Markets Products) Regulations 2018) and Excluded Investment Products (as defined in MAS Notice SFA 04-N12: Notice on the Sale of Investment Products and MAS Notice FAA-N16: Notice on Recommendations on Investment Products).

Japan

The securities have not been and will not be registered under the Financial Instruments and Exchange Act of Japan (Act No. 25 of 1948, as amended), or the FIEA. The securities may not be offered or sold, directly or indirectly, in Japan or to or for the benefit of any resident of Japan (including any person resident in Japan or any corporation or other entity organized under the laws of Japan) or to others for reoffering or resale, directly or indirectly, in Japan or to or for the benefit of any resident of Japan, except pursuant to an exemption from the registration requirements of the FIEA and otherwise in compliance with any relevant laws and regulations of Japan.

Israel

In the State of Israel this prospectus shall not be regarded as an offer to the public to purchase shares of common stock under the Israeli Securities Law, 5728 – 1968, which requires a prospectus to be published and authorized by the Israel Securities Authority, if it complies with certain provisions of Section 15 of the Israeli Securities Law, 5728–1968, including, inter alia, if: (i) the offer is made, distributed or directed to not more than 35 investors, subject to certain conditions (“Addressed Investors”); or (ii) the offer is made, distributed or directed to certain qualified investors defined in the First Addendum of the Israeli Securities Law, 5728 – 1968, subject to certain conditions (“Qualified Investors”). The Qualified Investors shall not be taken into account in the count of the Addressed Investors and may be offered to purchase securities in addition to the 35 Addressed Investors. The company has not and will not take any action that would require it to publish a prospectus in accordance with and subject to the Israeli Securities Law, 5728 – 1968. We have not and will not distribute this prospectus or make, distribute or direct an offer to subscribe for our common stock to any person within the State of Israel, other than to Qualified Investors and up to 35 Addressed Investors.

Qualified Investors may have to submit written evidence that they meet the definitions set out in of the First Addendum to the Israeli Securities Law, 5728 – 1968. In particular, we may request, as a condition to be offered common stock, that Qualified Investors will each represent, warrant and certify to us and/or to anyone acting on our behalf: (i) that it is an investor falling within one of the categories listed in the First Addendum to the Israeli Securities Law, 5728 – 1968; (ii) which of the categories listed in the First Addendum to the Israeli Securities Law, 5728 – 1968 regarding Qualified Investors is applicable to it; (iii) that it will abide by all provisions set forth in the Israeli Securities Law, 5728 – 1968 and the regulations promulgated thereunder in connection with the offer to be issued common stock; (iv) that the shares of common stock that it will be issued are, subject to exemptions available under the Israeli Securities Law, 5728 – 1968: (1) for its own account; (2) for investment purposes only; and (3) not issued with a view to resale within the State of Israel, other than in accordance with

 

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the provisions of the Israeli Securities Law, 5728 – 1968; and (v) that it is willing to provide further evidence of its Qualified Investor status. Addressed Investors may have to submit written evidence in respect of their identity and may have to sign and submit a declaration containing, inter alia, the Addressed Investor’s name, address and passport number or Israeli identification number.

Switzerland

The securities will not be offered, directly or indirectly, to the public in Switzerland and this prospectus does not constitute a public offering prospectus as that term is understood pursuant to article 652a or 1156 of the Swiss Federal Code of Obligations.

 

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LEGAL MATTERS

The validity of the issuance of our common stock offered in this prospectus will be passed upon for us by Cooley LLP, Palo Alto, California. Certain legal matters in connection with this offering will be passed upon for the underwriters by Latham & Watkins LLP, Menlo Park, California.

EXPERTS

Ernst & Young LLP, independent registered public accounting firm, has audited our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2019, as set forth in their report, which is incorporated by reference in this prospectus and elsewhere in the registration statement. Our financial statements are incorporated by reference in reliance on Ernst & Young LLP’s report, given on their authority as experts in accounting and auditing.

WHERE YOU CAN FIND ADDITIONAL INFORMATION

We have filed with the SEC a registration statement on Form S-1, including exhibits and schedules, under the Securities Act, with respect to the shares of common stock being offered by this prospectus. This prospectus, which constitutes part of the registration statement, does not contain all of the information in the registration statement and its exhibits. For further information with respect to us and the common stock offered by this prospectus, we refer you to the registration statement and its exhibits. Statements contained in this prospectus as to the contents of any contract or any other document referred to are not necessarily complete, and in each instance, we refer you to the copy of the contract or other document filed as an exhibit to the registration statement. Each of these statements is qualified in all respects by this reference.

You may read our SEC filings, including this registration statement, over the Internet at the SEC’s website at www.sec.gov. We are subject to the information reporting requirements of the Exchange Act and have filed reports, proxy statements and other information with the SEC. These reports, proxy statements and other information will be available for review on the web site of the SEC referred to above. We also maintain a website at www.vir.bio, at which you may access these materials free of charge as soon as reasonably practicable after they are electronically filed with, or furnished to, the SEC. Information contained on or accessible through our website is not a part of this prospectus or the registration statement of which it forms a part, and the inclusion of our website address in this prospectus is an inactive textual reference only.

 

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INCORPORATION OF CERTAIN INFORMATION BY REFERENCE

The SEC allows us to “incorporate by reference” information from other documents that we file with it, which means that we can disclose important information to you by referring you to those documents. The information incorporated by reference is considered to be part of this prospectus. Information in this prospectus supersedes information incorporated by reference that we filed with the SEC prior to the date of this prospectus. We incorporate by reference into this prospectus and the registration statement of which this prospectus is a part the information or documents listed below that we have filed with the SEC (File No. 001-39083):

 

   

our Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on March 26, 2020;

 

   

the portions of our Definitive Proxy Statement on Schedule 14A for our 2020 Annual Meeting of Stockholders specifically incorporated by reference into our Annual Report on Form 10-K for the year ended December  31, 2019, filed with the SEC on April  6, 2020 and as supplemented on May 8, 2020;

 

   

our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, filed with the SEC on May 12, 2020;

 

   

our Current Reports on Form 8-K (File No. 001-39083) filed with the SEC on January  23, 2020, January 30, 2020, February  12, 2020, March 9, 2020, April  6, 2020, April 7, 2020, April  10, 2020, April 30, 2020, May  22, 2020, May 29, 2020, June  15, 2020 and June 19, 2020; and

 

   

the description of the Common Stock contained in our Registration Statement on Form 8-A filed with the SEC on October 9, 2019, including any amendments or reports filed for the purpose of updating such description.

Notwithstanding the statements in the preceding paragraphs, no document, report or exhibit (or portion of any of the foregoing) or any other information that we have “furnished” to the SEC pursuant to the Exchange Act shall be incorporated by reference into this prospectus.

We will furnish without charge to you, on written or oral request, a copy of any or all of the documents incorporated by reference in this prospectus, including exhibits to these documents. You should direct any requests for documents to Vir Biotechnology, Inc., Attn: Investor Relations, 499 Illinois Street, Suite 500, San Francisco, California 94158.

You also may access these filings on our website at www.vir.bio. Information contained on or accessible through our website is not a part of this prospectus or the registration statement of which it forms a part, and the inclusion of our website address in this prospectus is an inactive textual reference only.

Any statement contained in a document incorporated or deemed to be incorporated by reference in this prospectus will be deemed modified, superseded or replaced for purposes of this prospectus to the extent that a statement contained in this prospectus modifies, supersedes or replaces such statement.

 

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            Shares

LOGO

Common Stock

 

 

PRELIMINARY PROSPECTUS

 

 

Goldman Sachs & Co. LLC

 

 

            , 2020

 

 

 


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PART II

INFORMATION NOT REQUIRED IN PROSPECTUS

Item 13. Other Expenses of Issuance and Distribution.

The following table sets forth the costs and expenses, other than the underwriting discounts and commissions, payable by Vir Biotechnology, Inc., or the Registrant, in connection with the sale of our common stock being registered. All amounts are estimates except for the Securities and Exchange Commission, or SEC, registration fee, and the Financial Industry Regulatory Authority, or FINRA, filing fee.

 

Item    Amount
Paid or to Be
Paid
 

SEC registration fee

   $          

FINRA filing fee

                 *  

Printing expenses

                 *  

Legal fees and expenses

                 *  

Accounting fees and expenses

                 *  

Transfer agent fees and expenses

                 *  

Miscellaneous expenses

                 *  
  

 

 

 

Total

   $  
  

 

 

 

 

*

To be filed by amendment.

Item 14. Indemnification of Directors and Officers.

As permitted by Section 102 of the Delaware General Corporation Law, we have adopted provisions in our amended and restated certificate of incorporation and amended and restated bylaws that limit or eliminate the personal liability of our directors for a breach of their fiduciary duty of care as a director. The duty of care generally requires that, when acting on behalf of the corporation, directors exercise an informed business judgment based on all material information reasonably available to them. Consequently, a director will not be personally liable to us or our stockholders for monetary damages for breach of fiduciary duty as a director, except for liability for:

 

   

any breach of the director’s duty of loyalty to us or our stockholders;

 

   

any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law;

 

   

any act related to unlawful stock repurchases, redemptions or other distributions or payment of dividends; or

 

   

any transaction from which the director derived an improper personal benefit.

These limitations of liability do not affect the availability of equitable remedies such as injunctive relief or rescission. Our amended and restated certificate of incorporation also authorizes us to indemnify our officers, directors and other agents to the fullest extent permitted under Delaware law.

As permitted by Section 145 of the Delaware General Corporation Law, our amended and restated bylaws provide that:

 

   

we may indemnify our directors, officers and employees to the fullest extent permitted by the Delaware General Corporation Law, subject to limited exceptions;

 

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we may advance expenses to our directors, officers and employees in connection with a legal proceeding to the fullest extent permitted by the Delaware General Corporation Law, subject to limited exceptions; and

 

   

the rights provided in our bylaws are not exclusive.

Our amended and restated certificate of incorporation and our amended and restated bylaws provide for the indemnification provisions described above and elsewhere herein. We have entered or will enter into, and intend to continue to enter into, separate indemnification agreements with our directors and officers that may be broader than the specific indemnification provisions contained in the Delaware General Corporation Law. These indemnification agreements generally require us, among other things, to indemnify our officers and directors against certain liabilities that may arise by reason of their status or service as directors or officers, other than liabilities arising from willful misconduct. These indemnification agreements also generally require us to advance any expenses incurred by the directors or officers as a result of any proceeding against them as to which they could be indemnified. These indemnification provisions and the indemnification agreements may be sufficiently broad to permit indemnification of our officers and directors for liabilities, including reimbursement of expenses incurred, arising under the Securities Act of 1933, as amended, or the Securities Act.

The Registrant has purchased and currently intends to maintain insurance on behalf of each and every person who is or was a director or officer of the Registrant against any loss arising from any claim asserted against him or her and incurred by him or her in any such capacity, subject to certain exclusions.

The form of underwriting agreement for this public offering provides for indemnification by the underwriters of us and our officers and directors who sign this registration statement for specified liabilities, including matters arising under the Securities Act.

Item 15. Recent Sales of Unregistered Securities.

Since May 31, 2017, we have made the following sales of unregistered securities:

Equity Plan-Related Issuances

 

1.

Since May 31, 2017, we have granted to certain of our directors, employees and consultants options to purchase 7,714,906 shares of our common stock with per share exercise prices ranging from $1.49 to $10.40 under our 2016 Equity Incentive Plan, as amended or 2016 Plan.

 

2.

Since May 31, 2017, we have issued to certain of our directors, employees and consultants an aggregate of 1,902,016 shares of our common stock at per share purchase prices ranging from $0.86 to $10.40 pursuant to exercises of options under the 2016 Plan for an aggregate purchase price of $3.7 million.

 

3.

In October 2019, we granted to certain of our directors and employees options to purchase 306,441 shares of our common stock with a per share exercise price of $20.00 under our 2019 Equity Incentive Plan.

Sale of Common Stock

 

4.

In October 2017, we issued 1,111,111 shares of our common stock to one accredited investor as partial consideration for entry into a collaboration and license agreement and the investor granting us certain license rights.

 

5.

In August 2019, we issued 38,888 shares of our common stock to one accredited investor as partial consideration for entry into a license agreement and the investor granting us certain license rights.

 

6.

In April 2020, we issued and sold 6,626,027 shares of our common stock to one accredited investor pursuant to a stock purchase agreement at a cash purchase price per share of $37.73, or approximately $250.0 million.

 

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7.

In May 2020, we issued 1,111,111 shares of our common stock to one accredited investor as consideration for achieving a specified development milestone under a collaboration and license agreement.

 

8.

In May 2020, we issued 211,774 shares of our common stock to one accredited investor upon the exercise of an outstanding warrant to acquire 244,444 shares pursuant to the cashless exercise provisions contained therein.

Sale of Preferred Stock

 

9.

Between May 2017 and July 2018, we issued and sold an aggregate of 60,277,749 shares of Series A-1 convertible preferred stock to 13 accredited investors at a purchase price per share of $4.50 for an aggregate purchase price of $271.3 million.

 

10.

In January 2019, we issued and sold an aggregate of 18,202,213 shares of Series B convertible preferred stock to 20 accredited investors at a purchase price per share of $18.00 for an aggregate purchase price of $327.6 million.

Acquisitions

 

11.

In August 2017, we issued to 23 accredited investors, including certain of our employees and consultants, 1,666,656 shares of our common stock in connection with our acquisition of a company.

 

12.

In January 2018, we issued to 35 accredited investors, including certain of our consultants, an aggregate of 555,537 shares of Series A-2 convertible preferred stock in connection with our acquisition of a company.

 

13.

In February 2018, we issued to two accredited investors an aggregate of 188,333 shares of Series A-2 convertible preferred stock in connection with our acquisition of a company.

The offers, sales and issuances of the securities described in paragraphs (1) through (3) were deemed to be exempt from registration under Rule 701 promulgated under the Securities Act as transactions under compensatory benefit plans and contracts relating to compensation, or under Section 4(a)(2) of the Securities Act as a transaction by an issuer not involving a public offering. The recipients of such securities were our directors, employees or bona fide consultants and received the securities under our equity incentive plans. Appropriate legends were affixed to the securities issued in these transactions. Each of the recipients of securities in these transactions had adequate access, through employment, business or other relationships, to information about us.

The offers, sales and issuances of the securities described in paragraphs (4) through (13) were deemed to be exempt under Section 4(a)(2) of the Securities Act or Rule 506 of Regulation D under the Securities Act as a transaction by an issuer not involving a public offering. The recipients of securities in each of these transactions acquired the securities for investment only and not with a view to or for sale in connection with any distribution thereof and appropriate legends were affixed to the securities issued in these transactions. Each of the recipients of securities in these transactions was an accredited investor within the meaning of Rule 501 of Regulation D under the Securities Act and had adequate access, through employment, business or other relationships, to information about us. No underwriters were involved in these transactions.

 

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Item 16. Exhibits and Financial Statement Schedules.

(a) Exhibits.

The exhibits listed below are filed as part of this registration statement.

 

Exhibit

Number

  

Description

  1.1#    Form of Underwriting Agreement.
  3.1    Amended and Restated Certificate of Incorporation of the Company (incorporated herein by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K (File No. 001-39083), filed with the SEC on October 16, 2019).
  3.2    Amended and Restated Bylaws of the Company (incorporated herein by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K (File No. 001-39083), filed with the SEC on October 16, 2019).
  4.1    Form of Common Stock Certificate of the Company (incorporated herein by reference to Exhibit 4.1 to the Company’s Registration Statement on Form S-1 (File No. 333-233604), filed with the SEC on September 30, 2019).
  4.2    Amended and Restated Investors’ Rights Agreement, by and among the Company and certain of its stockholders, dated November  29, 2017 (incorporated herein by reference to Exhibit 4.2 to the Company’s Registration Statement on Form S-1 (File No.  333-233604), filed with the SEC on September 3, 2019).
  5.1#    Opinion of Cooley LLP.
10.1+    Form of Indemnity Agreement by and between the Company and its directors and executive officers (incorporated herein by reference to Exhibit 10.1 to the Company’s Registration Statement on Form S-1 (File No. 333-233604), filed with the SEC on September 3, 2019).
10.2+    Vir Biotechnology, Inc. 2019 Equity Incentive Plan, (incorporated herein by reference to Exhibit 4.8 to the Company’s Form S-8 (File No. 333-234212), filed with the SEC on October 15, 2019).
10.3+    2019 Employee Stock Purchase Plan (incorporated herein by reference to Exhibit 4.11 to the Company’s Form S-8 (File No. 33-234212), filed with the SEC on October 15, 2019).
10.4+    Forms of Option Grant Notice and Option Agreement under Vir Biotechnology, Inc. 2019 Equity Incentive Plan, (incorporated herein by reference to Exhibit 10.3 to the Company’s Registration Statement on Form S-1 (File No. 333-233604), filed with the SEC on September 3, 2019).
10.5+    Form of Restricted Stock Unit Grant Notice and Unit Award Agreement under Vir Biotechnology, Inc. 2019 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.4 to the Company’s Registration Statement on Form S-1 (File No. 333-233604), filed with the SEC on September 3, 2019).
10.6+    Vir Biotechnology, Inc. 2016 Equity Incentive Plan, as amended (incorporated herein by reference to Exhibit 10.5 to the Company’s Registration Statement on Form S-1 (File No. 333-233604), filed with the SEC on September 3, 2019).
10.7+    Forms of Incentive Stock Option Notice and Agreement, Non-Qualified Stock Option Notice and Agreement, Restricted Stock Agreement, Restricted Stock Agreement and Restricted Stock Purchase Agreement under the Vir Biotechnology, Inc. 2016 Equity Incentive Plan, as amended (incorporated herein by reference to Exhibit 10.6 to the Company’s Registration Statement on Form S-1 (File No. 333-233604), filed with the SEC on September 3, 2019).
10.8+    Non-Employee Director Compensation Policy (incorporated herein by reference to Exhibit 10.8 to the Company’s Registration Statement on Form S-1 (File No. 333-233604), filed with the SEC on September 30, 2019).

 

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Exhibit

Number

  

Description

10.9+    Amended and Restated Employment Letter Agreement between the Company and George Scangos, dated August  27, 2019 (incorporated herein by reference to Exhibit 10.9 to the Company’s Registration Statement on Form S-1 (File No.  333-233604), filed with the SEC on September 3, 2019).
10.10+    Amended and Restated Employment Letter Agreement between the Company and Howard Horn, dated August  27, 2019 (incorporated herein by reference to Exhibit 10.10 to the Company’s Registration Statement on Form S-1 (File No.  333-233604), filed with the SEC on September 3, 2019).
10.11+    Amended and Restated Employment Letter Agreement between the Company and Michael Kamarck, dated August  28, 2019 (incorporated herein by reference to Exhibit 10.11 to the Company’s Registration Statement on Form S-1 (File No.  333-233604), filed with the SEC on September 3, 2019).
10.12+    First Amendment to Amended and Restated Employment Letter Agreement between the Company and Michael Kamarck, dated March  13, 2020 (incorporated herein by reference to Exhibit 10.12 to the Company’s Form 10-K (File No. 001-39083), filed with the SEC on March  26, 2020).
10.13+    Amended and Restated Employment Letter Agreement between the Company and Phil Pang, dated August  27, 2019 (incorporated herein by reference to Exhibit 10.12 to the Company’s Registration Statement on Form S-1 (File No.  333-233604), filed with the SEC on September 3, 2019).
10.14+    Amended and Restated Employment Letter Agreement between the Company and Jay Parrish, dated August  27, 2019 (incorporated herein by reference to Exhibit 10.13 to the Company’s Registration Statement on Form S-1 (File No.  333-233604), filed with the SEC on September 3, 2019).
10.15+    Amended and Restated Employment Letter Agreement between the Company and Herbert Virgin, dated September  3, 2019 (incorporated herein by reference to Exhibit 10.14 to the Company’s Registration Statement on Form S-1 (File No.  333-233604), filed with the SEC on September 3, 2019).
10.16+    Vir Biotechnology, Inc. Change in Control and Severance Benefit Plan (incorporated herein by reference to Exhibit 10.15 to the Company’s Registration Statement on Form S-1 (File No. 333-233604), filed with the SEC on September 3, 2019).
10.17†    Collaboration, Option, and License Agreement between the Company and Brii Biosciences Limited (previously named BiiG Therapeutics Limited), dated May 23, 2018 (incorporated herein by reference to Exhibit 10.16 to the Company’s Registration Statement on Form S-1 (File No. 333-233604), filed with the SEC on September 3, 2019).
10.18†    Collaboration and License Agreement between the Company and Alnylam Pharmaceuticals, Inc., dated October  16, 2017 (incorporated herein by reference to Exhibit 10.17 to the Company’s Registration Statement on Form S-1 (File No.  333-233604), filed with the SEC on September 3, 2019).
10.19†    Amendment No.  1 to the Collaboration and License Agreement between the Company and Alnylam Pharmaceuticals, Inc., dated December 17, 2019 (incorporated herein by reference to Exhibit 10.19 to the Company’s Annual Report on Form 10-K (File No. 001-39083), filed with the SEC on March 26, 2020).
10.20†    Amendment No. 2 to the Collaboration and License Agreement between the Company and Alnylam Pharmaceuticals, Inc., dated March  3, 2020 (incorporated herein by reference to Exhibit 10.20 to the Company’s Annual Report on Form 10-K (File No. 001-39083), filed with the SEC on March  26, 2020).

 

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Exhibit

Number

  

Description

10.21†    Amendment No. 3 to the Collaboration and License Agreement between the Company and Alnylam Pharmaceuticals, Inc., dated April 1, 2020.
10.22†    Common Stock Issuance Agreement between the Company and Alnylam Pharmaceuticals, Inc., dated October  16, 2017 (incorporated herein by reference to Exhibit 10.18 to the Company’s Registration Statement on Form S-1 (File No.  333-233604), filed with the SEC on September 3, 2019).
10.23†    Amendment No. 1 to the Common Stock Issuance Agreement between the Company and Alnylam Pharmaceuticals, Inc., dated December  17, 2019 (incorporated herein by reference to Exhibit 10.22 to the Company’s Annual Report on Form 10-K (File No. 001-39083), filed with the SEC on March  26, 2020).
10.24†    Letter Agreement between the Company and Alnylam Pharmaceuticals, Inc., dated November  13, 2018 (incorporated herein by reference to Exhibit 10.19 to the Company’s Registration Statement on Form S-1 (File No.  333-233604), filed with the SEC on September 3, 2019).
10.25†    License Agreement between the Company and MedImmune, LLC, dated September  7, 2018 (incorporated herein by reference to Exhibit 10.20 to the Company’s Registration Statement on Form S-1 (File No.  333-233604), filed with the SEC on September 3, 2019).
10.26†    Second Revised and Restated Master License Agreement between the Company and Oregon Health  & Science University, dated August 27, 2019 (incorporated herein by reference to Exhibit 10.21 to the Company’s Registration Statement on Form S-1 (File No.  333-233604), filed with the SEC on September 3, 2019).
10.27†    Letter Agreement between the Company and the stockholders of TomegaVax, Inc. set forth therein, dated September  12, 2016 (incorporated herein by reference to Exhibit 10.22 to the Company’s Registration Statement on Form S-1 (File No.  333-233604), filed with the SEC on September 3, 2019).
10.28†    Agreement and Plan of Merger between the Company, Vir Merger Sub, Inc., Agenovir Corporation, and Dr. Stephen  R. Quake, dated January 2, 2018 (incorporated herein by reference to Exhibit 10.23 to the Company’s Registration Statement on Form S-1 (File No.  333-233604), filed with the SEC on September 3, 2019).
10.29†    Securities Purchase Agreement between the Company, Humabs BioMed SA, the shareholders of Humabs set forth therein, the option-holders of Humabs set forth therein and Fortis Advisors LLC and certain Securityholders, dated August 22, 2017 (incorporated herein by reference to Exhibit 10.24 to the Company’s Registration Statement on Form S-1 (File No. 333-233604), filed with the SEC on September 3, 2019).
10.30†    Letter Agreement between the Company and the Bill & Melinda Gates Foundation, dated December  23, 2016 (incorporated herein by reference to Exhibit 10.25 to the Company’s Registration Statement on Form S-1 (File No.  333-233604), filed with the SEC on September 3, 2019).
10.31†    Grant Agreement between the Company and the Bill & Melinda Gates Foundation, dated January  26, 2018 (incorporated herein by reference to Exhibit 10.26 to the Company’s Registration Statement on Form S-1 (File No.  333-233604), filed with the SEC on September 3, 2019).
10.32†    Amendment No. 1 to the Grant Agreement between the Company and the Bill & Melinda Gates Foundation, dated April  18, 2019 (incorporated herein by reference to Exhibit 10.31 to the Company’s Form 10-K (File No. 001-39083), filed with the SEC on March 26, 2020.
10.33†    Amendment No. 2 to the Grant Agreement between the Company and the Bill & Melinda Gates Foundation, dated February  24, 2020 (incorporated herein by reference to Exhibit 10.32 to the Company’s Form 10-K (File No. 001-39083), filed with the SEC on March 26, 2020).

 

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Exhibit

Number

  

Description

10.34†    Grant Agreement between the Company and the Bill & Melinda Gates Foundation, dated March  16, 2018 (incorporated herein by reference to Exhibit 10.27 to the Company’s Registration Statement on Form S-1 (File No.  333-233604), filed with the SEC on September 3, 2019).
10.35†    Amendment No. 1 to the Grant Agreement between the Company and the Bill & Melinda Gates Foundation, dated April  22, 2019 (incorporated herein by reference to Exhibit 10.34 to the Company’s Form 10-K (File No. 001-39083), filed with the SEC on March 26, 2020).
10.36†    Amendment No. 2 to the Grant Agreement between the Company and the Bill & Melinda Gates Foundation, dated October  28, 2019 (incorporated herein by reference to Exhibit 10.35 to the Company’s Form 10-K (File No. 001-39083), filed with the SEC on March 26, 2020).
10.37†    Amended and Restated Exclusive License Agreement between the Company (as successor in interest to Humabs BioMed SA (f/k/a Humabs Holding GmbH)) and the Institute for Research in Biomedicine, dated December 16, 2011 (incorporated herein by reference to Exhibit 10.28 to the Company’s Registration Statement on Form S-1 (File No. 333-233604), filed with the SEC on September 3, 2019).
10.38†    Amendment to Amended and Restated Exclusive License Agreement between the Company (as successor in interest to Humabs BioMed SA (f/k/a Humabs Holding GmbH)) and the Institute for Research in Biomedicine, dated February 10, 2012 (incorporated herein by reference to Exhibit 10.29 to the Company’s Registration Statement on Form S-1 (File No. 333-233604), filed with the SEC on September 3, 2019).
10.39†    Exclusive License Agreement between the Company (as successor in interest to Humabs BioMed SA) and the Institute for Research in Biomedicine, dated December 16, 2011 (incorporated herein by reference to Exhibit 10.30 to the Company’s Registration Statement on Form S-1 (File No. 333-233604), filed with the SEC on September 3, 2019).
10.40    Amendment to License Agreement between the Company (as successor in interest to Humabs BioMed SA) and the Institute for Research in Biomedicine, dated February 10, 2012 (incorporated herein by reference to Exhibit 10.31 to the Company’s Registration Statement on Form S-1 (File No. 333-233604), filed with the SEC on September 3, 2019).
10.41†    Amendment Agreement between the Company (as successor in interest to Humabs BioMed SA) and the Institute for Research in Biomedicine, dated January 29, 2018 (incorporated herein by reference to Exhibit 10.32 to the Company’s Registration Statement on Form S-1 (File No. 333-233604), filed with the SEC on September 3, 2019).
10.42†    Exclusive License Agreement between the Company and The Rockefeller University, dated July  31, 2018 (incorporated herein by reference to Exhibit 10.33 to the Company’s Registration Statement on Form S-1 (File No.  333-233604), filed with the SEC on September 3, 2019).
10.43†    Amendment to Exclusive License Agreement between the Company and The Rockefeller University, dated May  17, 2019 (incorporated herein by reference to Exhibit 10.34 to the Company’s Registration Statement on Form S-1 (File No.  333-233604), filed with the SEC on September 3, 2019).
10.44†    Sub-License and Collaboration Agreement between the Company (as successor in interest to Humabs BioMed SA) and MedImmune, LLC, dated March 20, 2012 (incorporated herein by reference to Exhibit 10.35 to the Company’s Registration Statement on Form S-1 (File No. 333-233604), filed with the SEC on September 3, 2019).

 

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Exhibit

Number

  

Description

10.45†    Amendment 1 to Sub-License and Collaboration Agreement, dated April  19, 2013, between the Company (as successor in interest to Humabs BioMed SA) and MedImmune, LLC, dated March 20, 2012 (incorporated herein by reference to Exhibit 10.36 to the Company’s Registration Statement on Form S-1 (File No. 333-233604), filed with the SEC on September 3, 2019).
10.46†    Amendment 2 to Sub-License and Collaboration Agreement, dated April  27, 2015, between the Company (as successor in interest to Humabs BioMed SA) and MedImmune, LLC, dated March 20, 2012 (incorporated herein by reference to Exhibit 10.37 to the Company’s Registration Statement on Form S-1 (File No. 333-233604), filed with the SEC on September 3, 2019).
10.47†    Amendment 3 to Sub-License and Collaboration Agreement, dated December  31, 2015, between the Company (as successor in interest to Humabs BioMed SA) and MedImmune, LLC, dated March 20, 2012 (incorporated herein by reference to Exhibit 10.38 to the Company’s Registration Statement on Form S-1 (File No. 333-233604), filed with the SEC on September 3, 2019).
10.48†    Amendment 4 to Sub-License and Collaboration Agreement, dated August  29, 2016, between the Company (as successor in interest to Humabs BioMed SA) and MedImmune, LLC, dated March 20, 2012 (incorporated herein by reference to Exhibit 10.39 to the Company’s Registration Statement on Form S-1 (File No. 333-233604), filed with the SEC on September 3, 2019).
10.49†    Amendment 5 to Sub-License and Collaboration Agreement, dated July  15, 2017, between the Company (as successor in interest to Humabs BioMed SA) and MedImmune, LLC, dated March 20, 2012 (incorporated herein by reference to Exhibit 10.40 to the Company’s Registration Statement on Form S-1 (File No. 333-233604), filed with the SEC on September 3, 2019).
10.50†    Amendment 6 to Sub-License and Collaboration Agreement, dated September  7, 2018, between the Company (as successor in interest to Humabs BioMed SA) and MedImmune, LLC, dated March 20, 2012 (incorporated herein by reference to Exhibit 10.41 to the Company’s Registration Statement on Form S-1 (File No. 333-233604), filed with the SEC on September 3, 2019).
10.51†    Patent License Agreement between the Company and Xencor, Inc., dated August  15, 2019 (incorporated herein by reference to Exhibit 10.44 to the Company’s Registration Statement on Form S-1 (File No.  333-233604), filed with the SEC on September 3, 2019).
10.52†    Patent License Agreement between the Company and Xencor, Inc., dated March 25, 2020 (incorporated herein by reference to Exhibit  99.1 to the Company’s Current Report on Form 8-K (File No. 001-39083), filed with the SEC on June 19, 2020).
10.53†    Preliminary Collaboration Agreement between the Company, GlaxoSmithKline Intellectual Property Development Limited and GlaxoSmithKline Biologicals SA, dated April 5, 2020.
10.54†    Definitive Collaboration Agreement between the Company and Glaxo Wellcome UK Limited and Beecham S.A., dated June 9, 2020.
10.55    Stock Purchase Agreement between the Company and Glaxo Group Limited, dated April 5, 2020.
10.56†    Clinical Development and Manufacturing Agreement between the Company and Biogen Inc., dated May 22, 2020.
10.57†    Binding Letter Agreement between the Company and Samsung Biologics Co., Ltd., dated April 9, 2020.
10.58†    Development and Manufacturing Collaboration Agreement between the Company and Wuxi Biologics (Hong Kong) Limited, dated February 25, 2020.
10.59†    Letter of Intent between the Company and Wuxi Biologics (Hong Kong) Limited, dated June 15, 2020.

 

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Exhibit

Number

  

Description

10.60    Lease Agreement between the Company and ARE-SAN FRANCISCO NO. 43, LLC, dated March  30, 2017 (incorporated herein by reference to Exhibit 10.42 to the Company’s Registration Statement on Form S-1 (File No.  333-233604), filed with the SEC on September 3, 2019).
10.61    First Amendment to Lease between the Company and ARE-SAN FRANCISCO NO. 43, LLC, dated April 10, 2019 (incorporated herein by reference to Exhibit 10.43 to the Company’s Registration Statement on Form S-1 (File No. 333-233604), filed with the SEC on September 3, 2019).
21.1    List of subsidiaries of the Company (incorporated herein by reference to Exhibit 21.1 to the Company’s Registration Statement on Form S-1 (File No. 333-233604), filed with the SEC on September 3, 2019).
23.1#    Consent of Independent Registered Public Accounting Firm.
23.2#    Consent of Cooley LLP (included in Exhibit 5.1).
24.1#    Power of Attorney (included on the signature page to this registration statement).

 

+

Indicates a management contract or compensatory plan.

Certain portions of this exhibit (indicated by “[***]”) have been omitted pursuant to confidential treatment.

#

To be filed by amendment.

(b) Financial Statement Schedules.

Schedules not listed above have been omitted because the information required to be set forth therein is not applicable or is shown in the consolidated financial statements or notes thereto, which are incorporated herein by reference.

Item 17. Undertakings.

The undersigned Registrant hereby undertakes to provide to the underwriters at the closing specified in the underwriting agreement certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser.

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Registrant pursuant to the foregoing provisions, or otherwise, the Registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act, and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the Registrant of expenses incurred or paid by a director, officer or controlling person of the Registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question of whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

The undersigned Registrant hereby undertakes that:

1. For purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this Registration Statement in reliance upon Rule 430A and contained in a form of prospectus filed by the Registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this Registration Statement as of the time it was declared effective.

2. For the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

 

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SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, as amended, the registrant has duly caused this registration statement on Form S-1 to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of San Francisco, State of California on                , 2020.

 

VIR BIOTECHNOLOGY, INC.
By:    
  George Scangos, Ph.D.
  President and Chief Executive Officer

POWER OF ATTORNEY

KNOW ALL BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints George Scangos, Ph.D., and Howard Horn, and each of them, as his or her true and lawful attorneys-in-fact and agents, each with the full power of substitution, for him or her and in his or her name, place or stead, in any and all capacities, to sign any and all amendments to this registration statement (including post-effective amendments), and to sign any registration statement for the same offering covered by this registration statement that is to be effective upon filing pursuant to Rule 462(b) promulgated under the Securities Act, and all post-effective amendments thereto, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or their, his or her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Act of 1933, as amended, this registration statement on Form S-1 has been signed by the following persons in the capacities and on the dates indicated.

 

Signature

  

Title

 

Date

     

George Scangos, Ph.D.

   President, Chief Executive Officer and Director (Principal Executive Officer)           , 2020

     

Howard Horn

  

Chief Financial Officer and Secretary

(Principal Financial and Accounting Officer)

          , 2020

     

Vicki Sato, Ph.D.

   Chairman of the Board of Directors           , 2020

     

Kristina Burow

   Director           , 2020

     

Robert More

   Director           , 2020

     

Robert Nelsen

   Director           , 2020

 

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Signature

  

Title

 

Date

     

Dipchand Nishar

   Director           , 2020

     

Robert Perez

   Director           , 2020

     

Saira Ramasastry

   Director           , 2020

     

Phillip Sharp, Ph.D.

   Director           , 2020

 

II-11

EX-10.21

Exhibit 10.21

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

 

CONFIDENTIAL    EXECUTION VERSION

AMENDMENT NO. 3 TO THE COLLABORATION AND LICENSE AGREEMENT

THIS AMENDMENT NO. 3 TO THE COLLABORATION AND LICENSE AGREEMENT (“Amendment”) is made and entered into, effective as of April 1, 2020 (“Amendment No. 3 Effective Date”), by and between Vir Biotechnology, Inc., a Delaware corporation with offices at with an office at 499 Illinois Street, San Francisco, California 94158 (“Vir”), and Alnylam Pharmaceuticals, Inc., a Delaware corporation located at 675 West Kendall Street – Henri A. Termeer Square, Cambridge, Massachusetts 02142 (“Alnylam”). Each of Vir and Alnylam are referred to in this Amendment as a “Party” and together, the “Parties”.

BACKGROUND

WHEREAS, the Parties have entered into that certain Collaboration and License Agreement effective as of October 16, 2017 (as amended by Letter Agreement dated November 13, 2018 and by Amendment No. 1 to the Collaboration and License Agreement effective December 17, 2019 and Amendment No. 2 to the Collaboration and License Agreement effective March 3, 2020, the “Collaboration Agreement”) pursuant to which the Parties entered into a collaboration to develop and commercialize certain compounds and products based on Alnylam’s RNAi technology, in connection with Hepatitis B and other infectious diseases;

WHEREAS, pursuant to Section 3.1(b) and 3.1(c) of the Collaboration Agreement Vir has selected five (5) ID Collaboration Targets;

WHEREAS, the Parties desire to add three additional ID Collaboration Targets to the Collaboration, bringing the total number of ID Collaboration Targets to eight (8) on the terms and conditions described in this Amendment; and

WHEREAS, Section 14.4 of the Collaboration Agreement provides that the Collaboration Agreement may only be modified by a written instrument duly executed by an authorized representative of each Party.

NOW, THEREFORE, the Parties desire, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, to amend the Collaboration Agreement as set forth in this Amendment.

ARTICLE 1

DEFINITIONS

1.1 Capitalized Terms. Capitalized terms used in this Amendment shall have the meanings set forth in the Collaboration Agreement unless otherwise defined and set forth in this Amendment. Except as expressly modified by this Amendment, the remainder of the Collaboration Agreement shall remain in force in accordance with its terms and without any modification.

ARTICLE 2

AMENDMENTS

2.1 Addition of New Section 1.1.54B: Article 1 of the Collaboration Agreement is hereby amended by adding a new Section 1.1.54B immediately after Section 1.1.54A as follows:

1.1.54B “Coronaviruses” shall mean any coronavirus, or isolate or isoform thereof, that causes severe acute respiratory syndrome in humans, including SARS-CoV-2, SARS-CoV and MERS-CoV.

 

1


2.2 Amendment to Section 1.1.77: Section 1.1.77 of the Collaboration Agreement is hereby amended in its entirety as follows:

1.1.77 “Field” shall mean (a) for all Collaboration Targets other than the Host Factor Targets, all uses and purposes, including the treatment, palliation, diagnosis or prevention of any human disease, disorder or condition, and (b) for the Host Factor Targets, the treatment, palliation, diagnosis or prevention of Coronaviruses, but in each case ((a)-(b)) excluding applications in agriculture, horticulture, forestry, aquaculture, and/or residential markets relating to plants, fish, arthropods and/or pests and pathogens thereof (e.g., home, lawn and/or garden).

2.3 Addition of New Section 1.1.90A: Article 1 of the Collaboration Agreement is hereby amended by adding a new Section 1.1.90A immediately after Section 1.1.90 as follows:

1.1.90A “Host Factor” shall mean a human trait that affects susceptibility to disease.

2.4 Addition of New Section 1.1.90B: Article 1 of the Collaboration Agreement is hereby amended by adding a new Section 1.1.90B immediately after Section 1.1.90A as follows:

90B “Host Factor Targets” shall mean (a) the two Initial Host Factor Targets, (b) an additional Host Factor selected by the Parties in accordance with Section 3.1(d)(i), and (iii) a replacement Host Factor selected by the Parties in accordance with Section 3.1(d)(i).

2.5 Amendment to Section 1.1.92: Section 1.1.92 of the Collaboration Agreement is hereby amended in its entirety as follows:

1.1.92 “ID Collaboration Target” shall mean an ID Target that is designated for an ID Program pursuant to Section 3.1(b), 3.1(c) or 3.1(d).

2.6 Amendment to Section 1.1.97: Section 1.1.97 of the Collaboration Agreement is hereby amended in its entirety as follows:

1.1.97 “ID Target” shall mean (a) for all Targets other than the Host Factor Targets, a Target primarily for intervention in the treatment, palliation, diagnosis or prevention of Infectious Disease in humans or animals, and (b) for the Host Factor Targets, a Target for intervention in the treatment, palliation, diagnosis or prevention of Coronaviruses in humans or animals.

2.7 Addition of Section 1.1.99A: Article 1 of the Collaboration Agreement is hereby amended by adding a new Section 1.1.99A immediately after Section 1.1.99 as follows:

1.1.99A “Initial Host Factor Targets” shall mean (a) angiotensin converting enzyme 2 (ACE2) and (b) transmembrane serine protease 2 (TMPRSS2).

2.8 Amendment to Section 1.1.182: Section 1.1.182 of the Collaboration Agreement is hereby amended in its entirety as follows:

1.1.182 “Vir Improvements” means any patented improvement, discovery or Know-How that (a) is first conceived or reduced to practice, or with respect to inventions and discoveries other than patentable inventions, otherwise identified, discovered, made or developed, solely by individuals who are employees, agents or consultants of Vir or its Affiliates in the course of conducting Development, Manufacturing or Commercialization activities with respect to Licensed Products under this Agreement, (b) is Controlled by Vir or its Affiliates, and (c) constitutes an improvement that would otherwise be dominated by Alnylam Core Technology Patent Rights, including, as applicable, formulation technology. Vir Improvements excludes [***].

 

2


2.9 Amendment of Section 3.1: Section 3.1(d) of the Collaboration Agreement is hereby amended to add the following Section 3.1(d):

(a) Host Factor Targets.

(i) Host Factor Targets. Notwithstanding the provisions of Section 3.1(b) or 3.1(c) above, the Parties agree to collaborate in a program to Develop RNAi Products Directed to the Host Factor Targets for use in the Field, which program may include the use of [***], until Development Candidate selection pursuant to Section 3.3 below. The program shall be directed to the Initial Host Factor Targets, and the Parties may mutually agree to the selection of up to one (1) additional Host Factor as an ID Collaboration Target. Once mutually agreed by the Parties, the new Host Factor Target shall be added to the list of ID Collaboration Targets listed on Schedule D. The Host Factor Targets shall be ID Collaboration Targets and shall be in addition to, and not in lieu of, the five (5) ID Collaboration Targets described in Sections 3.1(b) and 3.1(c). Notwithstanding any provision of Section 3.3(b) to the contrary, if Alnylam has not commenced work pursuant to a DC Workplan for a given Host Factor Target, Vir shall have the right to propose to replace such Host Factor Target with a replacement Host Factor pursuant to this Section 3.1(d), provided that such proposed replacement Host Factor is discussed and mutually agreed upon by the Parties (which discussions may occur via the JSC). If the Parties mutually agree to designate the proposed replacement Host Factor as a Host Factor Target, then Schedule D shall be updated to include such new Host Factor Target as an ID Collaboration Target, and the Parties shall develop an ID Development Plan for such new ID Collaboration Target in accordance with Section 3.2(a). The Host Factor Target that is replaced shall be classified as an “Abandoned ID Target” and shall cease to be an ID Collaboration Target under this Agreement, Vir’s Program Option and other rights with respect to such Abandoned ID Target and any RNAi Products Directed to such Abandoned ID Target shall terminate and the provisions of Section 4.1(b) shall apply to the Abandoned ID Target and the ID Program for such Abandoned IT Target. Unless otherwise mutually agreed by the Parties, the Parties shall not replace more than one (1) Host Factor Target and, for clarity, at no time during the Term shall there be more than three (3) Host Factor Targets.

(ii) ID Development Plan. The initial ID Development Plan for the Host Factor Targets developed by the JSC pursuant to Section 3.2(a) shall include the following responsibilities of the Parties and unless otherwise agreed by the Parties, Alnylam’s DC Workplan for the Host Factor Targets shall be limited to the following responsibilities of Alnylam:

 

Host Factor Target ID Development Plan Activities
Prior to Development Candidate Selection

  

Responsible
Party(ies)

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

2.10 Amendment of Section 3.4(b). Section 3.4(b) of the Collaboration Agreement is hereby amended in its entirety as follows:

(b) ID Programs. Subject to the exercise by Alnylam of its Profit-Sharing Option pursuant to Section 4.2, with respect to an ID Licensed Product, Vir shall bear 100% of the Program Costs incurred by the Parties during the Collaboration Term for each ID Program in conducting each ID Program pursuant to the Development Plan for such ID Program, including ID Licensed Product supplied by Alnylam pursuant to Section 5.1(a)(ii); provided, however, that Alnylam shall bear the Program Costs incurred by Alnylam [***]

 

3


under the DC Workplan for the COV Target ID Program and the Host Factor Target ID Programs. In addition, (i) [***], and (ii) the Parties shall each bear fifty percent (50%) of all Program Costs in connection with the Manufacture of non-GMP Drug Product required for nonclinical use prior to filing of an IND for the first Licensed Product in each of the COV Target ID Program and the Host Factor Target ID Programs. In no event shall any of the Host Factor Target ID Programs be conducted outside of the Field.

2.11 Amendment of Section 3.5(c). Section 3.5(c) of the Collaboration Agreement is hereby amended in its entirety as follows:

(c) ID Programs. After exercise of its Program Option with respect to an ID Program, Vir shall use Commercially Reasonable Efforts to Develop, obtain Regulatory Approval and following Regulatory Approval Commercialize [***] ID Licensed Product Directed to the ID Collaboration Target in such ID Program in the Field in [***] Major Markets, provided that solely with respect to the COV Target ID Program and the Host Factor Target Programs, [***], Vir may [***]; provided, however, that [***] with respect to the COV Target ID Program or such Host Factor Target ID Program (as applicable).

2.12 Amendment of Section 4.1(a). Section 4.1(a) of the Collaboration Agreement is hereby amended in its entirety, as follows:

(a) With respect to each ID Program, Alnylam hereby grants Vir an exclusive option (“Program Option”) to obtain a Program License for such ID Program. Vir may exercise its Program Option with respect to an ID Program by written notice to Alnylam (“Program Option Notice”) at any time prior to the date that is [***] after the earlier of (i) [***] and (ii) the date that is [***] after [***] (“Program Option Period”). Upon Vir’s giving a Program Option Notice to Alnylam, Vir shall pay Alnylam (x) the Program Option Exercise Fee, which is payable within [***] after Vir’s exercise of such Program Option for such ID Program, and (y) any outstanding undisputed Program Costs due to Alnylam for such ID Program, within [***] after receipt by Vir of any invoice therefor. Upon payment in full of the Program Option Exercise Fee and any outstanding undisputed Program Costs as set forth above, (i) Alnylam shall and hereby does grant to Vir the Program License with respect to such ID Program as set forth in Section 6.1(b)(ii), and (ii) subject to the exercise by Alnylam of its Profit-Sharing Option pursuant to Section 4.2 with respect to an ID Licensed Product and Alnylam’s responsibilities for ID Licensed Product Manufacturing [***] pursuant to Section 5.1(a), [***], for the further Development, Manufacture and Commercialization of the ID Licensed Products in such ID Program. Notwithstanding anything herein to the contrary, no Program Option Exercise Fee shall be payable with respect to the COV Target ID Program or the Host Factor Target ID Programs, and the licenses granted to Vir in Sections 6.1(b)(i) and (ii) shall become effective for the COV Target ID Program and a given Host Factor Target ID Program automatically upon Vir’s delivery to Alnylam of a Program Option Notice for such COV Target ID Program or such Host Factor Target ID Program (as applicable) and payment of all undisputed Program Costs reimbursable to Alnylam for such COV Target ID Program or such Host Factor Target ID Program (as applicable).

2.13 Amendment of Section 6.1(d). Section 6.1(d) of the Collaboration Agreement is hereby amended in its entirety, as follows:

(d) Retained Rights. Notwithstanding the license grants in Sections 6.1(a) and 6.1(b), Alnylam retains the rights under Alnylam Intellectual Property (a) to Develop and Manufacture Licensed Products in the Field in the Territory solely for the purpose and only to the extent necessary for the performance of its obligations under this Agreements, and (b) subject to Alnylam’s obligations under Section 10.5(a), for [***]. Notwithstanding anything herein to the contrary, (i) with respect to the COV Target and each Host Factor Target, neither Vir nor its Affiliates, directly or indirectly (alone or with an affiliate or Third Party), shall have any right or license under this Agreement to any Licensed Product for the COV Target or such Host Factor Target to [***].

 

4


2.14 Amendment of Section 7.3(a)(ii). Section 7.3(a)(ii) of the Collaboration Agreement is hereby amended in its entirety as follows:

(ii) ID Licensed Products other than ID Licensed Products Directed to the COV Target or the Host Factor Targets, with respect to which Vir has exercised its Program Option:

 

Milestone Event

  

Milestone Payment

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

[***]

   [***]

2.15 Amendment of Section 7.3(a). Section 7.3(a) of the Collaboration Agreement is hereby amended to add the following Section 7.3(a)(iv) to the end of such Section:

(iv) ID Licensed Products Directed to each Host Factor Target with respect to which Vir has exercised its Program Option:

 

Milestone Event

  

Milestone Payment

[***]

   [***]

[***]

   [***]

2.16 Amendment of Section 7.5(b). Section 7.5(b) of the Collaboration Agreement is hereby amended by inserting the following at the end of such Section:

; provided, however, that solely with respect to an ID Licensed Product Directed to the COV Target or a Host Factor Target, if (i) Vir or its Related Parties sell such ID Licensed Product to a Biodefense Authority in a country, (ii) such sale is for the purposes of [***], and (iii) the aggregate amount of such Net Sales of such ID Licensed Product to such Biodefense Authority during such Calendar Year is [***] of such ID Licensed Product on which such Net Sales are based, then (1) Vir shall pay Alnylam a [***] royalty on such Net Sales [***] by Alnylam or its Affiliates to Third Parties under any applicable Alnylam In-License with respect to such ID Licensed Product sales, (2) such royalty shall [***], and (3) such Net Sales shall not be [***] Net Sales of such ID Licensed Product.

2.17 Amendment of Section 10.5(d). Section 10.5(d) of the Collaboration Agreement is hereby amended in its entirety as follows:

(d) [***].

2.18 Amendment of Section 10.5. Section 10.5 of the Collaboration Agreement is hereby amended to add the following Section 10.5(e) to the end of such Section:

(e) for each Host Factor Target, neither Vir nor its Affiliates shall: (i) alone or with or for any Third Party, research, develop, manufacture or commercialize any Licensed Product Directed to such Host Factor Target outside of the Field; (ii) grant a license, sublicense or other rights to any Third Party to conduct any of the activities in the foregoing clause (i) with respect to any Licensed Product Directed to such Host Factor Target outside of the Field; or (iii) transfer, assign, convey or otherwise sell any Licensed Product Directed to such Host Factor Target outside of the Field.

2.19 Amendment of Schedule A (Existing Alnylam Third Party Agreements). Schedule A (Existing Alnylam Third Party Agreements) of the Collaboration Agreement is hereby amended as follows. [***]:

[***]

 

5


2.20 Amendment of Schedule D (ID Targets, Reserved Targets and ID Collaboration Targets). Schedule D (ID Targets, Reserved Targets and ID Collaboration Targets) of the Collaboration Agreement is hereby amended by adding the [***].

ARTICLE 3

MISCELLANEOUS

3.1 No Waiver. Nothing in this Amendment is intended to operate as a waiver of any claims either Party may have against the other Party arising prior to the date of this Amendment, including any claims arising prior to the date of this Amendment with respect to the performance of the Parties under the Collaboration Agreement. Any delay in enforcing a party’s rights under this Amendment or the Collaboration Agreement, or any waiver as to a particular default or other matter, will not constitute a waiver of such party’s rights to the future enforcement of its rights under this Amendment or the Collaboration Agreement, except with respect to an express written waiver relating to a particular matter for a particular period of time signed by an authorized representative of the waiving Party, as applicable.

3.2 Miscellaneous. This Amendment shall be governed by and interpreted in accordance with the law of the State of New York, U.S.A., without reference to any principles of conflicts of laws to the contrary. The United Nations Convention on Contracts for the International Sale of Goods shall not apply to the transactions contemplated by this Amendment. Except as specifically amended by this Amendment, the terms and conditions of the Collaboration Agreement shall remain in full force and effect. This Amendment may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Signatures transmitted by PDF shall be treated as original signatures. Except to the extent expressly provided herein, the Collaboration Agreement, as amended by this Amendment, together with the Commitment Letter between the Parties entered into on the Commitment Letter Date and the Stock Purchase Agreement, including all appendices, exhibits and schedules to each of the foregoing, constitute the entire agreement between the Parties relating to the subject matter of the Collaboration Agreement and supersedes all previous oral and written communications, including all previous agreements, between the Parties.

 

6


IN WITNESS WHEREOF, on the Amendment No. 3 Effective Date Vir and Alnylam have caused this Amendment to be duly executed by their authorized representatives.

 

Vir Biotechnology, Inc.

Name:

 

/s/ George Scangos

Title:

 

George Scangos

Date:

 

Chief Executive Officer

 

Alnylam Pharmaceuticals, Inc.

Name:

 

/s/ Yvonne Greenstreet

Title:

 

Yvonne Greenstreet

Date:

 

Chief Operating Officer

 

7

EX-10.53

Exhibit 10.53

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

EXECUTION VERSION

CONFIDENTIAL

Preliminary Collaboration Agreement

This Preliminary Collaboration Agreement (“Preliminary Collaboration Agreement”) is entered into as of April 5, 2020 (the “Execution Date”), by and between GlaxoSmithKline Intellectual Property Development Limited, a limited liability company incorporated under the laws of England having an office at 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK, and GlaxoSmithKline Biologicals SA, a limited liability company incorporated under the laws of Belgium having its registered place of business at rue de l’Institut 89, 1330 Rixensart, Belgium, registered with the Legal Entity Register (RPM Nivelles) under number 0440.72.918 (together, “GSK”), and Vir Biotechnology, Inc., a Delaware corporation having an office at 499 Illinois Street, Suite 500, San Francisco, CA 94158 (“Vir”) (each GSK and Vir, a “Party” and together, the “Parties”). The capitalized terms used herein and not otherwise defined have the meanings given to them in the Stock Purchase Agreement.

 

1. Binding Nature of this Preliminary Collaboration Agreement   

The Parties hereby enter into this Preliminary Collaboration Agreement, which constitutes a binding obligation of both Parties. This Section 1 and Sections 2, 15, 16, 17, 18, 19(a), 20, 21, 22, 23, 24 and 25 of this Preliminary Collaboration Agreement (together with the appendices referenced in such sections) shall be effective as of the Execution Date; all other terms shall be automatically effective as of the Closing (as defined in the Stock Purchase Agreement) without any further action on the part of any person. The terms of this Preliminary Collaboration Agreement shall remain in effect until the earlier of (a) valid termination of the Stock Purchase Agreement or (b) the effectiveness of the Definitive Collaboration Agreement. The Parties shall execute an agreement containing a more detailed set of terms governing the collaboration established under this Preliminary Collaboration Agreement (which agreement shall be consistent with the terms of this Preliminary Collaboration Agreement) (such expanded version of such terms, the “Definitive Collaboration Agreement”), subject to Section 17 of this Preliminary Collaboration Agreement. If the Stock Purchase Agreement is validly terminated in accordance with Section 10 thereof such that the Closing does not occur, this Preliminary Collaboration Agreement and if entered into, the Definitive Collaboration Agreement, shall terminate, both effective as of the termination date of the Stock Purchase Agreement. [***], Vir shall [***]. Following the date hereof, the capitalized terms used in the appendices hereto and not otherwise defined therein have the meanings given to them in this Preliminary Collaboration Agreement.

 

Collaboration Products” means (a) the 309 Antibody and any Antibodies developed against any coronavirus under the Antibody Program (“Antibody Products”), (b) Vaccines that


  

are developed under the Vaccine Program (“Vaccine Products”), and (c) such products that the JRC agrees to include in the Functional Genomics Program based on the results of the genomic screens conducted under the Functional Genomics Program (which may be any modality) (“Functional Genomics Products”).

 

[***].

 

Development Plan” means a detailed plan and budget mutually agreed to govern the conduct of the applicable Program. The agreed Development Plan for clinical elements of the Development activities for the Antibody Program directed to the 309 Antibody and a high level version of the budget therefor (the “309 Antibody Program”) is attached hereto as Appendix A.

 

Collaboration” means (a) research activities conducted under the Development Plans, and (b) the Development, Manufacture and Commercialization activities with respect to the Collaboration Products during the Term pursuant to and in accordance with the terms of this Preliminary Collaboration Agreement or the Definitive Collaboration Agreement. For the avoidance of doubt, neither Party’s assets (targets or compounds), including those discovered, licensed or acquired by such Party outside of the Collaboration, shall be included at any time as part of the Collaboration unless otherwise agreed by such Party in the applicable Development Plan; provided that, for clarity, [***].

 

Field” means the prevention, treatment and prophylaxis of diseases caused by coronaviruses, (including SARS-COV-2 [***]) in humans, including the disease known as CoVID-19, [***].

 

The Collaboration will be directed to three programs (each a “Collaboration Program”) for the Development and Commercialization of separate types of Collaboration Products as set forth below, in each case pursuant to mutually agreed Development and Commercialization plans, including budgets:

 

(a)    Antibodies, including the 309 Antibody, as further described below (the “Antibody Program”).

 

(b)    Vaccines, which may include the development of Vaccines directed against SARS-COV-2 and other specific coronaviruses (the “Vaccine Program”).

 

(c)    Genome-wide CRISPR screening activities and other functional genomic screens as are mutually agreed, including [***] (“Functional Genomics Program”). If the Parties mutually agree, they may include in the Functional Genomics Program, drug discovery, development and commercialization of Functional Genomics Products. [***].

 

2


   Vir’s existing collaboration with Alnylam Pharmaceuticals in connection with development, manufacture and commercialization of RNAi products in the Field is excluded from the Collaboration.
2. Certain Definitions   

Antibody” means any monoclonal antibodies that bind to coronaviruses and [***]. For clarity, Antibodies shall not include any Vaccine. [***].

 

Commercialization” (and corresponding terms) means any and all activities directed to the preparation for sale of (but excluding Commercial Manufacture), offering for sale of, or sale of a Collaboration Product, including activities related to marketing, promoting, selling, distributing, importing and exporting such Collaboration Product, and interacting with regulatory authorities regarding any of the foregoing.

 

Commercial Manufacture” means Manufacture for commercial sale, including use of contract manufacturers for such commercial sale, and the following activities, whenever required during the Term for a given Collaboration Product (a) selection of the facility(ies) for commercial Manufacturing of Collaboration Product (including for pivotal trials) (“Commercial Facilities”); (b) subject to the terms of any existing Third Party agreements, technology transfer of the Manufacturing process for Collaboration Product to Commercial Facilities; (c) conduct of process performance qualification (“PPQ”) batches and other process qualification and validation activities required for Regulatory Approval for commercial Manufacturing of Collaboration Product at the Commercial Facility(ies); and (d) obtaining pre-approval inspection and required licenses and permits for Commercial Facilities.

 

Control” means, with respect to any material, information, or intellectual property, the possession (whether by ownership or license, other than the licenses granted hereunder) of the ability to grant a license or sublicense or other right to exploit, as provided herein, without violating the terms of any agreement or other arrangement with any Third Party, or any applicable law.

 

Development” means all activities related to research, pre- clinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, process development, quality assurance/quality control, clinical trials, including manufacturing in support thereof, statistical analysis and report writing, the preparation and submission of applications for marketing approval, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a regulatory authority as a condition or in support of obtaining or maintaining a regulatory approval. When used as a verb, “Develop” means to engage in Development.

 

3


  

 

Development Costs” has the meaning set forth on Appendix C.

 

GSK Licensed Technology” means, on a Collaboration Program-by-Collaboration Program basis, all patents and know-how that are both (a) [***], and (b) [***], provided that GSK Licensed Technology shall not include (i) any GSK Program Technology or (ii) [***]. If GSK includes any patents or know-how in the GSK Licensed Technology, such inclusion shall be subject to any Third Party agreements and any limitations on use imposed by GSK at the time of the inclusion. For clarity, [***].

 

GSK Program Technology” means, on a Collaboration Program-by-Collaboration Program basis, GSK’s right and interest in any patent and know-how generated under such Collaboration Program.

 

Manufacture” (and corresponding terms) means all activities related to the synthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, labeling, shipping, and holding of any Collaboration Product, or any component or intermediate thereof, including process development, process qualification and validation, scale-up, qualification, validation, pre-clinical, clinical and commercial production and analytic development, product characterization, stability testing, quality assurance, and quality control.

 

Program Antibodies” means (a) any Antibody [***] that is directed against any coronaviruses, including the Antibody known as the 309 Antibody [***] (the “309 Antibody”); (b) any Antibody created, discovered, conceived or reduced to practice by either Party or both Parties jointly during the conduct of activities under an Antibody Development Plan during the Initial Development Term, and (c) any Antibody Controlled by either Party that the Parties agree during the Initial Development Term, through the JRC, to include as the subject of Development activities under an Antibody Development Plan.

 

Third Party” means a person or entity other than (a) Vir and its Affiliates, and (b) GSK and its Affiliates.

 

U.S. Territory” means the United States and its territories and possessions.

 

Vaccine” means any biological product, including nucleic acid(s), protein(s), peptide(s), polysaccharide(s), conjugated polysaccharide(s), live, live-attenuated or inactivated microorganism(s) including replication-competent and replication defective virus(es), bacteriophages(s) and bacteria, in each case comprising or encoding an antigen derived from

 

4


  

the pathogen or the disease to be prevented or treated, optionally in combination with one or more biological or non-biological product(s) and that when administered to an subject induces, increases, decreases or qualitatively modifies, an immune response intended to prevent or treat the target disease or condition.

 

Vir Licensed Technology” means, on a Collaboration Program-by-Collaboration Program basis, all patents and know-how that are (i) (a) [***], and (b) [***], and (ii) [***]; provided that Vir Licensed Technology shall not include any Vir Program Technology.

 

Vir Licensed Technology” shall [***]. If Vir includes any patents or know-how in the Vir Licensed Technology for the Vaccine Program or the Functional Genomics Program, such inclusion shall be subject to any Third Party agreements and any limitations on use imposed by Vir at the time of the inclusion. For clarity, any technology that Vir includes within Vir Licensed Technology for a given Collaboration Program shall not be deemed included in Vir Licensed Technology for any other Collaboration Program, unless Vir expressly agrees to such inclusion in the applicable Development Plan for such other Collaboration Program, and specifically, [***].

 

Vir Program Technology” means, on a Collaboration Program-by-Collaboration Program basis, Vir’s right and interest in any patent and know-how generated under such Collaboration Program.

 

WuXi Agreement” means the Development and Manufacturing Collaboration Agreement by and between WuXi Biologics (Hong Kong) Limited and Vir dated 25 February, 2020.

 

WuXi Territory” means solely with respect to Collaboration Programs and Collaboration Products that are subject to the WuXi Agreement, (as of the date hereof) the People’s Republic of China, Hong Kong and Macau and Taiwan, for so long as such Collaboration Programs and Collaboration Products is subject to the WuXi Agreement. [***].

3. Exclusivity    During the Initial Development Term, neither Vir nor its Affiliates (either internally or through enabling a Third Party) will (a) create or generate Antibodies for the purpose of developing or commercializing any Antibody directed to SARS-COV-2 or any other coronaviruses; or (b) conduct functional genomics screens (including genome-wide screens using CRISPR) for SARS-COV-2 or any other coronaviruses to discover novel targets or progress such targets into drug discovery and development, in each case ((a) and (b)), except pursuant to the Collaboration.

 

5


  

During the Initial Development Term, neither GSK nor its Affiliates (either internally or through enabling a Third Party ) will (a) create or generate Antibodies for the purpose of developing or commercializing any antibody product directed to SARS-COV-2 or any other coronaviruses; or (b) conduct functional genomics screens (including genome-wide screens using CRISPR) for SARS-COV-2 or any other coronaviruses to discover novel targets or progress such targets into drug discovery and development, in each case ((a) and (b)), except pursuant to the Collaboration; provided, however, [***].

 

For the avoidance of doubt, the foregoing exclusivity obligation shall not apply to, with respect to GSK, [***].

 

Notwithstanding the foregoing, if during the Initial Development Term, either Party or its Affiliates wishes to pursue a new program that falls within the exclusivity obligations above (whether alone or with a Third Party), then such Party shall first offer to include any such program under the Collaboration. If the other Party declines to include such program under the Collaboration, then the offering Party or its Affiliates shall have the right to pursue such program outside of the Collaboration, regardless of its obligations under this Section 3.

 

Each Party will be free to pursue by itself or through the grant of rights to or from a Third Party, other therapeutic or prophylactic approaches to the prevention, treatment and prophylaxis of diseases caused by coronaviruses that do not fall within the exclusivity obligations above, including with respect to Vir, RNAi products with Alnylam.

4. Collaboration Programs; Lead Party   

For a period of four (4) years from the Closing (the “Initial Development Term”), the Parties will collaborate, under mutually agreed upon research and development plans (and associated budgets) for each of the (a) Antibody Program, (b) Vaccine Program, and (c) Functional Genomics Program (each a “Development Plan”), to generate and evaluate potential clinical candidates under each Collaboration Program. Each Development Plan will set out the allocation of responsibilities, as between the Parties, for Development (including related CMC activities) under the applicable Collaboration Program. The Parties agree that, any activities under a Development Plan to be conducted by or with WuXi or any additional counterparty in China shall be expressly agreed and set forth in such Development Plan and that [***].

 

With respect to each Collaboration Program (and any Collaboration Product generated therefrom), the Party that is designated as the lead party in accordance with a Development Plan or specified in this Preliminary Collaboration Agreement or the Definitive Collaboration Agreement (the “Lead Party”) shall be primarily responsible for Development (including

 

6


  

research), regulatory, or Manufacturing in accordance with the Development Plan, unless expressly provided otherwise herein or in the Definitive Collaboration Agreement.

 

The Lead Party for each Collaboration Program shall have the final decision-making right with respect to Development or clinical Manufacturing of the Collaboration Products under the applicable Collaboration Program. With respect to each Antibody Product under the Antibody Program, Vir shall be the Lead Party for such Program Antibody until the first filing for Regulatory Approval for such Antibody Product; provided that [***]. GSK shall become the Lead Party for such Antibody Product upon the first filing for Regulatory Approval.

 

The Parties will be responsible for activities under each Collaboration Program as follows:

 

1.  Antibody Program.

 

•   The Antibody Program will be the first Collaboration Program to be progressed by the Parties, and will build on Vir’s ongoing activities in the Field, including under Vir’s collaboration with WuXi and Biogen. For clarity, Vir will be permitted to continue to perform activities under (a) the WuXi Agreement (in accordance with its terms), and (b) the agreement currently under negotiation between Vir and Biogen Inc. in connection with the manufacture (including the development of manufacturing processes) of Antibodies for use in the Field (the “Biogen Draft Agreement”), in each case ((a) and (b)) solely in connection with manufacturing for clinical supply of Antibodies for use in the Field, as further set forth in Section 9 below.

 

•   In connection with the negotiation of the Definitive Collaboration Agreement, the Parties will agree upon the clinical Development Plan (including the budget therefor) for the Antibody Program (which shall include the 309 Development Plan) (the “Antibody Development Plan”), which will be included as an exhibit to the Definitive Collaboration Agreement.

 

•   Vir will be primarily responsible for and shall be the Lead Party for Development and clinical Manufacturing activities for the Antibody Program, under the oversight of the JSC and any other governance committees as further described in Section 8 below.

 

•   GSK will be primarily responsible for Commercialization and, where applicable, Commercial Manufacturing activities for such Antibody Product, under the oversight of the JSC and any other governance committees as further described in Section 8 below.

 

•   Subject to the opt-out provisions and any other provisions expressly set forth in this Preliminary Collaboration Agreement, the Parties will share all Development Costs associated with

 

7


  

activities under the Antibody Development Plan, in accordance with the budget therefor, with Vir bearing 72.5% and GSK bearing 27.5% of such Development Costs. Any Development Costs incurred in excess of the agreed upon budget (including any pre-agreed overage percentage) in the Antibody Development Plan will be subject to the terms set forth in Section 5 below.

 

•   The Definitive Collaboration Agreement will set forth the operational terms for reconciliation of Development Costs as between the Parties in accordance with the above cost-sharing ratios.

 

2.  Vaccine Program

 

•   The Vaccine Program will commence promptly following adoption of the Development Plan for the Vaccine Program and will include such proprietary technology of Vir and GSK, in case as contributed by the applicable Party in [***] and set forth in the Development Plan. The Development Plan will set forth the expected timing for the commencement of activities under the Vaccine Program.

 

•   In connection with the negotiation of the Definitive Collaboration Agreement, the Parties will negotiate in good faith an initial draft of the Development Plan (including the budget therefor) for the Vaccine Program (the “Vaccine Development Plan”); provided that if the Development Plan is not attached to the Definitive Collaboration Agreement then, the Parties will continue such negotiation.

 

•   GSK will be the Lead Party and the LCP and it is anticipated that the research work will be conducted predominantly by Vir. [***]. If the research is successful, then the Parties may take forward the project in accordance with the terms of this Preliminary Collaboration Agreement or, once executed, the Definitive Collaboration Agreement. In the event that GSK does not elect to take the applicable Vaccine Product forward (i.e., exercises its Opt-Out Rights), then Vir may take the project forward, subject to the terms and conditions of this Preliminary Collaboration Agreement and Definitive Collaboration Agreement, once executed; [***].

 

•   If GSK determines that a development candidate from such program was not successful or otherwise wished to opt out from further Development, Manufacturing or Commercialization, GSK shall have the right to do so. [***].

 

•   The Parties will share all Development Costs associated with activities under the Vaccine Development Plan, in accordance with the budget therefor, with GSK bearing 72.5% and Vir bearing 27.5% of such Development Costs. Any Development Costs incurred in excess of the agreed upon budget (including any pre-agreed overage percentage) in the Vaccine Development Plan will be subject to the terms set forth in Section 5 below.

 

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•   The Definitive Collaboration Agreement will set forth the operational terms for reconciliation of Development Costs as between the Parties in accordance with the above cost-sharing ratios, which shall be [***] except as otherwise agreed in the Definitive Collaboration Agreement.

 

3.  Functional Genomics Program

 

•   The Functional Genomics Program will commence promptly following the adoption of the Development Plan for the Functional Genomics Program, or if later, the date specified in the Development Plan for the commencement of the Functional Genomics Program. Any databases and data mining technologies [***] shall be included solely as specified in the Functional Genomics Program Development Plan, and in each case subject to any applicable Third Party agreements.

 

•   The Parties will mutually agree upon the timing for drafting and negotiating a Development Plan (including the budget therefor) for the Functional Genomics Program (the “Functional Genomics Development Plan”), which Development Plan shall specify the date on which the Functional Genomics Program shall commence.

 

•   GSK will be primarily responsible for and shall be the Lead Party for Development and Manufacturing activities for the Functional Genomics Program, under the oversight of the JSC and any other governance committees as further described in Section 8 below.

 

•   The Parties will share equally all Development Costs associated with activities under the Functional Genomics Development Plan, in accordance with the budget therefor, with each of GSK and Vir bearing 50% of such Development Costs. Any Development Costs incurred in excess of the agreed upon budget (including any pre-agreed overage percentage) in the Genomics Development Plan would be subject to the terms set forth in Section 5 below.

 

•   The Definitive Collaboration Agreement will set forth the operational terms for reconciliation of Development Costs as between the Parties in accordance with the above cost-sharing ratios, which reconciliation shall be [***] except as otherwise agreed by the Parties.

 

Diligence

 

Each Party will use commercially reasonable efforts to conduct the activities assigned to it under each Development Plan and to enable GSK to seek and obtain regulatory approval for any Collaboration Product progressed thereunder in the United States, the European Union, and the United Kingdom. The Parties further agree that, with respect to a Collaboration Product, the Parties will discuss and agree on [***].

 

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Regulatory Matters

 

In general, the Lead Party for a given Collaboration Program shall have the right to prepare and file for, in its own name, and will own all regulatory applications and approvals for any Collaboration Product under such Collaboration Program. The Parties will discuss and seek to agree upon the appropriate regulatory strategy for each Collaboration Product, taking into account any accelerated pathways to regulatory approval that may be available in connection with CoVID-19 and other diseases associated with coronavirus infection, provided that the Lead Party will have the right to make a final decision in connection with regulatory activities and strategy for Collaboration Products for which it is the Lead Party.

 

Notwithstanding the foregoing, with respect to any Collaboration Product for which Vir is the Lead Party, unless GSK has exercised its Opt-Out Right, any NDA or BLA for such Collaboration Product shall be filed in the name of GSK, and [***].

5. Development Cost Overruns    Neither Party will be liable to the other for Development Costs incurred by such other Party in an amount in excess of [***] of the then-approved budget for such Collaboration Program, without approval of the JSC for so long as it remains a Collaboration Program (i.e. as long as neither Party has exercised its opt-out rights for such Collaboration Program). Any expenditure in excess of [***] of the then-approved budget for such Collaboration Program will be subject to mutual agreement through the JSC. Subject to the overage provision set forth above, if the Parties are not able to agree on a proposed increase to a Development Plan budget, then [***].
6. Third Party Technologies    The Parties, through the JSC, would discuss and mutually agree upon any third party technologies (other than the Vir Licensed Technology and the GSK Licensed Technology) they feel are appropriate to include within a Collaboration Program, as well as the terms associated therewith. To the extent applicable to the activities under a given Collaboration Program, any costs associated with obtaining and use of technology under Third Party licenses (including costs under any such licenses existing as of the effective date of the Preliminary Collaboration Agreement) would be borne as a Development Cost under the applicable Collaboration Program and subject to the Opt-Out provisions, allocated between the Parties in accordance with the cost-sharing ratios applicable thereto.

 

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7. Collaboration Governance   

The Parties would establish, [***], a Joint Steering Committee (the “JSC”) consisting of an equal number of representatives of each Party. The JSC will, among other things:

 

•   oversee and guide the strategic direction of the Collaboration;

 

•   facilitate communication between the Parties regarding the identification and evaluation of Collaboration Products;

 

•   establish, as appropriate, sub-committees or working groups responsible for managing specific aspects of the Collaboration, which shall include a joint research committee (the “JRC”), a joint development committee, and/or a joint manufacturing committee and such other committees as mutually agreed by the Parties;

 

•   delegate its decision making authority to the applicable subcommittees, provided that any material dispute shall be elevated to the JSC;

 

•   serve as a forum for each Party to communicate at certain points in time its decisions regarding continuation of its participation in the development of each Collaboration Product;

 

•   resolve issues elevated to it by any other subcommittee or working group the JSC may establish; and

 

•   Perform such other functions as the Parties may mutually agree in writing.

 

Meetings of the JSC would be held [***] initially, with at least [***] per year, and the JSC would have the right to change such frequency as it determines appropriate. Meetings would alternative between each party’s facilities, to the extent conducted in person. All decisions of the JSC would be made by consensus of the Parties. In the event of dispute within the JSC’s jurisdiction, [***], will attempt to resolve such dispute within [***]. If senior management cannot resolve the dispute, then, such dispute shall be resolved as follows:

 

(a)     With respect to research activities:

 

•   Any such unresolved disputes shall [***].

 

(b)     With respect to each Collaboration Product prior to the first filing for Regulatory Approval of such Collaboration Product:

 

•   With regard to [***], the Lead Party shall have the final decision making authority, except for budget increases and assignment of activities to the other Party, in which case consent of the other Party shall be required.

 

•   Thereafter, GSK will have final decision-making except for assignment of activities to Vir, in which case consent of Vir shall be required.

 

•   In addition, GSK will have final decision-making with regard to any matter relating to [***].

 

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(c) With respect to each Collaboration Product, after the first filing for regulatory approval of such Collaboration Product:

 

•   GSK shall have the final decision-making authority.

 

Notwithstanding the foregoing, (i) neither Party may exercise its final decision-making authority to impose additional obligations upon the other Party without such Party’s consent, and (ii) if a Party elects its Opt-Out Right at any time in a Collaboration Program, then thereafter, to the extent such opt-out Party would have the final decision-making authority pursuant to (a)-(c) above, then, such opt-out Party shall no longer have such decision-making authority, and dispute that would be subject to such opt-out Party’s final decision-making authority shall then be subject to the non opt-out Party’s final decision-making authority. Matters explicitly reserved to the consent, approval or other decision-making authority of one or both Parties, as expressly provided in this Preliminary Collaboration Agreement, are outside the jurisdiction and authority of the JSC, including amendment, modification or waiver of compliance with the Preliminary Collaboration Agreement or the Definitive Collaboration Agreement.

 

Matters explicitly reserved to the consent, approval or other decision-making authority of one or both Parties, as expressly provided in this Agreement, are outside the jurisdiction and authority of the JSC, including amendment, modification or waiver of compliance with the Preliminary Collaboration Agreement or the Definitive Collaboration Agreement.

 

[***], each Party shall designate an individual to serve as the main point of contact for each Party for the Antibody Program and upon agreement on a Development Plan for the Vaccine Program and Functional Genomics Program, respectively each such Collaboration Program to exchange information, facilitate communication and coordinate the Parties’ activities under the Definitive Collaboration Agreement (each, an “Alliance Manager”).

 

The Alliance Managers shall attend JSC meetings (or designate an appropriate representative to attend JSC meetings on the Alliance Manager’s behalf).

8. Collaboration Programs –Right to Opt-Out   

For each Collaboration Program, all Development Costs will be shared by the Parties in the cost-sharing ratios set forth in Section 4 above unless and until a Party opts-out of co-funding (as provided below).

 

Opt-Out Right

 

On a Collaboration Product-by-Collaboration Product basis, either Party would have the right, at each of the specified milestones set forth below (each, an “Opt-Out Point”), to elect to “opt out” of its co-funding obligation (the “Opt-Out Right”):

 

•   [***]

 

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If a Party elects to opt-out of its participation at any of the indicated points for a Collaboration Product, it would communicate in writing to the other Party that it desires to cease all further funding for such Collaboration Product, provided that such opting-out Party shall continue to be liable for its allocation of costs [***]. For clarity, if a Party does not elect to exercise its Opt-Out Right at one of the above specified points in time, it will be obligated to continue to co-fund all Development Costs until such time as the next Opt-Out Right event occurs, if any; provided, that [***].

 

Upon receipt of any opt-out notice from a Party the other Party will have the right to elect either to:

 

•   pursue such program unilaterally, in which case the opting-out Party’s rights to share in future net profits shall cease and instead it shall be entitled to royalties and as to be further set forth in the Definitive Collaboration Agreement, and a certain percentage of Sublicense Revenue [***] from the other Party on Net Sales [***] of the applicable Collaboration Product(s).

 

•   also cease the conduct and funding of such Collaboration Product and if so, the Parties may agree to out-license or otherwise divest such Collaboration Product, in which case the [***] shall take the lead in negotiations, and the reasonable and properly incurred costs associated with such negotiations and entry into any agreements with a Third Party, and any revenue arising from such outlicensing or divestment shall be shared in accordance with the cost-sharing ratios.

9. Manufacture and Supply   

For each Collaboration Program the Parties will jointly through a Joint Manufacturing Committee or the JSC (and subject to each Party’s applicable final decision-making authority) determine a, Manufacturing strategy with respect to the Manufacture and supply of Collaboration Product drug substance or drug product, which may as appropriate include manufacturing capabilities of both Parties, or contract manufacturer.

 

During the [***], Vir will remain the Lead Party for all Manufacturing activities for the Antibody Program, provided that [***].

 

In consultation with GSK, following the execution date hereof, Vir will [***].

 

Vir shall be the Lead Party and responsible for Manufacturing for clinical supply, and GSK shall be the Lead Party and responsible for the Commercial Manufacture of Antibody Product, including any scale-up activities for Commercial Manufacture.

 

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If the Parties agree to seek a contract manufacturer, the Lead Party for such Collaboration Program will be the lead contracting party for the applicable drug substance or drug product. To the extent one Party supplies the other with drug substance or drug product for such Collaboration Program the costs to supply such drug substance or drug product shall be deemed part of the overall Development Costs, or commercial costs, as the case may be, as they are incurred.

 

Any supply agreement for commercial supply during the Term shall include [***].

 

With respect to [***].

10. Commercialization of Collaboration Products   

Unless a Party has opted-out prior to such time, the Parties will share in all profits and losses arising from any Collaboration Product in the same ratios in which the Parties bore Development Costs for such Collaboration Program.

 

In general, except for the Antibody Program, as set forth below, the Lead Party for Development will continue to act as the “Lead Commercialization Party” or “LCP” for such Collaboration Program. The LCP will conduct its activities in accordance with an agreed upon commercialization plan (the “Commercial Plan”) and budget (“Commercial Budget”) (with a [***] overage provision) for such countries.

 

For each Antibody Product, following the filing for Regulatory Approval (i.e. an NDA or MAA, as applicable), GSK will assume the role of LCP for the Commercialization of each such Antibody Product, and will be responsible for booking all sales of such Antibody Product.

 

GSK will be responsible for all Commercialization activities worldwide with respect to each Collaboration Product, except (a) for detailing conducted by Vir in the US Territory under the Co-Promotion Agreement, if agreed by the Parties, for so long as the Co-Promotion Agreement is in effect, and (b) in connection with sales in the WuXi Territory for Antibody Products arising or licensed to WuXi under the WuXi Agreement and directed to SARs-COV-2. GSK will be required to use commercially reasonable efforts to Commercialize each Collaboration Product in the US following regulatory approval in the US, in [***] following regulatory approval in the European Union, and the United Kingdom, following regulatory approval in the United Kingdom.

 

Except in the case of an Opt-Out, for each Collaboration Product, Vir and GSK will share net profits and net losses, to be defined in the Definitive Collaboration Agreement from commercialization of any Collaboration Product worldwide.

 

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11. Vir Co-Promotion Right for Antibody Products   

On an Antibody Product-by-Antibody Product basis, Vir shall have the right to opt in to co-detail such Antibody Product in the United States subject to [***] and an agreed Co-Promotion Agreement (the “Co-Promotion Option”), which will include provisions around [***]. Vir’s detail percentage shall not exceed twenty percent (20%), and subject to [***], and as otherwise may be reasonably agreed by the Parties in the Co-Promotion Agreement.

 

The Definitive Collaboration Agreement shall set forth (which may be in an appendix or separate form of co-promotion or similar agreement) the timing of Vir’s right to exercise the Co- Promotion Option, and the nature of Vir’s rights and responsibilities in connection with the Commercialization of the applicable Antibody Product.

12. Economic Terms

a. Collaboration Programs

  

The Definitive Collaboration Agreement will include a financial terms exhibit or appendix setting forth the financial terms, including definitions, consistent with any financial terms and definitions set forth herein: (a) such more detailed definitions [***], (b) the rules for calculating net profits and net losses, and (c) the operational provisions governing payment/reimbursement as between the Parties of net profits and net losses. Without limiting the foregoing, the Parties agree that the following specific costs will be included as either Development Costs or in the net profits and net losses calculation (subject to the applicable budget and overage provisions) as well as other customary cost categories:

 

•   Costs of Third Party licenses necessary for the Development, Manufacture or Commercialization of any Collaboration Product.

 

•   Costs of Manufacturing technology transfer to either Party or to a designated contract manufacturer in connection with activities to be conducted under the WuXi Agreement or any agreement between Vir and Biogen relating to the development of manufacturing processes for Antibody Products in the Field.

 

•   For the Antibody Program, costs incurred by Vir in connection with the Development and Manufacture of Antibody Products under the WuXi Agreement, provided that [***].

b. Programs subject to Opt-Out Right    For each Collaboration Product as to which a Party exercises its Opt-Out Right as described herein, the commercializing Party will pay to the opting out Party royalties on Net Sales (to be defined in the Definitive Collaboration Agreement) of the applicable Collaboration Product at commercially reasonable rates to be agreed in good faith in the Definitive Collaboration

 

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Agreement, taking into account, among other relevant commercial factors (a) the development stage of the Collaboration Product at the time of the exercise of the Opt-Out Right, (b) [***], and (c) whether the Party exercising the Opt-Out Right is the Lead Party or Non-Lead Party.

 

If, following the Opt-Out by one Party, the other Party does not continue the further Development of the applicable Collaboration Product, then the non Opt-Out Party shall have the right to take the lead on sublicensing or otherwise divesting rights to the applicable Collaboration Product (consistent with the terms of this Preliminary Collaboration Agreement or Definitive Collaboration Agreement and subject to any applicable limitations applicable to sublicensing); provided, however, that in such case the non Opt-Out Party shall pay to the original Opt-Out Party a portion of Sublicense Revenue at rates to be agreed in the Definitive Collaboration Agreement. For clarity, [***].

 

The term of any royalties and Sublicense Revenue due to the Opt-Out Party shall be paid on Net Sales and Sublicense Revenue received prior to the end of the Term for the applicable Collaboration Product.

 

[***]:

 

In the event that [***] with respect to a Collaboration Product:

 

(a)    if neither Party has exercised Opt-Out Right with respect to such Collaboration Product, then [***];

 

(b)    if one Party has exercised Opt-Out Right, then [***].

13. Change of Control of Vir    The Definitive Collaboration Agreement will include provisions setting forth the consequences for any ongoing Collaboration Program as a result of a change of control of Vir, which consequences shall [***].
14. Intellectual Property   

Except as otherwise set forth in the Definitive Collaboration Agreement, ownership of inventions arising in the conduct of activities under the Collaboration will follow inventorship in accordance with United States patent laws.

 

On a Collaboration Program-by-Collaboration Program basis, and subject to the terms and conditions of this Preliminary Collaboration Agreement (or the Definitive Collaboration Agreement once executed), including the profit-sharing terms thereof:

 

(a)   Vir hereby grants to GSK effective as of the Closing:

 

(i) a co-exclusive (with Vir), worldwide (excluding the WuXi Territory to the extent such rights have been granted to WuXi for so long as the Wuxi Agreement is in effect), sublicenseable license under the Vir Licensed Technology and Vir Program Technology to Develop and Manufacture Collaboration Products arising from such Collaboration Program;

 

16


  

(ii)  an exclusive, worldwide (excluding the WuXi Territory for so long as the Wuxi Agreement is in effect), sublicenseable license under the Vir Licensed Technology and Vir Program Technology to Commercialize Collaboration Products arising from such Collaboration Program, provided that for clarity, where Vir exercises the Co-Promotion Option, under the Co-Promotion Agreement, GSK will grant back to Vir such licenses under the Vir Licensed Technology and Vir Program Technology as are necessary for Vir to perform its activities under the “Co-Promotion Agreement” to be entered into by the Parties; and

 

(iii)  [***].

 

(b)   GSK will grant to Vir:

 

(i) a non-exclusive, worldwide, sublicenseable [***] license under the GSK Licensed Technology to Develop and Manufacture Collaboration Products in accordance to the applicable Development Plan and to Manufacture in accordance with this Preliminary Collaboration Agreement (or the Definitive Collaboration Agreement, once executed), subject to any obligations to Third Parties with respect to the applicable GSK Licensed Technology;

 

(ii)  a co-exclusive, worldwide, sublicenseable [***] license under the GSK Program Technology to Develop, Manufacture Collaboration Products arising from such Collaboration Program, and, solely with respect to any Antibody Product for which Vir has exercised the Co- Promotion Option, Commercialize such Antibody Product solely in accordance with Vir’s rights under the Preliminary Collaboration Agreement (or the Definitive Collaboration Agreement, once executed) in connection with the exercise of such Co-Promotion Option; and

 

(iii)  [***].

 

All licenses granted by a Party to the other Party hereunder shall be subject to the licensing restrictions set forth in the existing agreements between such Party and any Third Party existing as of the signing date.

 

Provisions relating to patent prosecution, maintenance, enforcement, and defense rights for the Collaboration will be set forth in the Definitive Collaboration Agreement.

15. Indemnification; Limitation of Liability    Each Party shall indemnify, defend and hold harmless the other Party and its Affiliates and their respective directors, officers,

 

17


  

employees and agents, and the respective successors and assigns (any of the foregoing “Indemnitees”), from and against any and all suits, claims, actions, demands, losses, damages, liabilities, settlements, penalties, fines, costs and expenses (including reasonable attorneys’ fees and other expenses of litigation) (collectively, “Losses”) asserted by a Third Party arising from [***].

 

The Definitive Collaboration Agreement shall include the indemnities set forth above and other customary indemnities to be agreed by the Parties.

 

NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS PRELIMINARY COLLABORATION AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 15 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY SET FORTH ABOVE, OR DAMAGES AVAILABLE FOR A PARTY’S BREACH OF ITS OBLIGATIONS HEREUNDER RELATING TO CONFIDENTIALITY. THE DEFINITIVE COLLABORATION AGREEMENT WILL INCLUDE ANALOGOUS LANGUAGE.

16. Term and Termination   

This Preliminary Collaboration Agreement shall terminate upon execution of the Definitive Collaboration Agreement. For clarity, the Definitive Collaboration Agreement will supersede the Preliminary Collaboration Agreement and will remain in effect in perpetuity, unless earlier terminated as set forth below (including on a Collaboration Program or Collaboration Product basis, as the case may be) (the term of this Preliminary Collaboration Agreement and the Definitive Collaboration Agreement, collectively, the “Term”).

 

This Preliminary Collaboration Agreement shall terminate in the event of a valid termination of the Stock Purchase Agreement pursuant to Section 10 thereof.

 

Additionally, either Party shall have the right to terminate this Preliminary Collaboration Agreement or the Definitive Collaboration Agreement, (a) in the case of the insolvency of the other Party (as termination for insolvency is customarily defined), (b) in the case of a material breach with respect to the Preliminary Collaboration Agreement or the Definitive Collaboration Agreement as a whole by the other Party with respect to the applicable Collaboration Program or Collaboration Product, subject to a reasonable cure period, and (c) in the case of the Definitive Collaboration Agreement, in the case of such other events that both Parties agree shall be included in the Definitive Collaboration Agreement.

 

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In the case of a termination of this Preliminary Collaboration Agreement or the Definitive Collaboration Agreement (including in the case of an opt-out), the terminated Party shall reasonably support the transition to the continuing Party of all Development and Commercialization activities related to the applicable Collaboration Product, including the reasonable grant of licenses to any Vir Licensed Technology or GSK Licensed Technology, as the case may be, that is [***] at the time of termination, including Commercialization of the applicable Collaboration Products, subject to the agreement upon reasonable license terms (including any financial terms for such licenses) and any rights granted to a Third Party. In addition, [***].

 

In the case of a termination for material breach with respect to the Agreement as a whole or insolvency by a Party, [***].

17. Governing Law; Dispute Resolution   

This Preliminary Collaboration Agreement and the Definitive Collaboration Agreement are and will be governed by and construed under the laws of the State of Delaware, without reference to conflicts of law principles.

 

If the Parties are unable to reach agreement on the final terms of the Preliminary Collaboration Agreement within 45 days of the execution of the Preliminary Collaboration Agreement (a “Definitive Agreement Terms Dispute”), the Parties agree that any dispute regarding the final terms of the Preliminary Collaboration Agreement shall be finally resolved by “baseball- style” arbitration pursuant to the provisions set forth on Appendix E. The Parties further agree that during the pendency of a Definitive Agreement Terms Dispute, any dispute regarding the interpretation of any term of the Preliminary Collaboration Agreement and its implementation in the Definitive Collaboration Agreement shall also be finally resolved in accordance with Appendix E and shall be consolidated into any pending arbitration.

 

The Parties further agree that it is intended that the “baseball- style” arbitration pursuant to the provisions set forth on Appendix E controls all disputes among the Parties related to resolving gaps or indefinite terms in the Preliminary Collaboration Agreement and each Party agrees not to bring such claims pursuant to the arbitration procedures set forth in Appendix F, but, rather, to resolve such claims through the “baseball-style” arbitration pursuant to the provisions set forth on Appendix E even if such claims arise prior to the commencement of a Definitive Agreement Terms Dispute.

 

Except for a Definitive Agreement Terms Dispute or any dispute contemplated by the preceding paragraph, which arises prior to the commencement of a Definitive Agreement Terms

 

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   Dispute, any dispute arising out of or relating to this Preliminary Collaboration Agreement or Definitive Collaboration Agreement, or the breach, termination or validity thereof (a “Dispute”), shall be finally resolved pursuant to the provisions set forth on Appendix F.
18. Assignment of the Agreement   

The Preliminary Collaboration Agreement (or the Definitive Collaboration Agreement if executed) shall not be assignable by either Party in whole or in part to any Third Party without the prior written consent of the other Party hereto.

 

Notwithstanding the foregoing, [***].

19. (a) Representations and Warranties; Pre-Closing Covenants    Vir hereby makes, and in the Definitive Collaboration Agreement shall make, the representations and warranties and agrees to the pre-closing covenants in each case, as set forth in Appendix D. The Definitive Collaboration Agreement will contain required representations and warranties relating to human rights, anti-bribery and corruption, human tissue samples, and animal welfare that are adequate to meet both Parties’ corporate standards.
19. (b) Additional Covenant    [***].
20. Confidentiality    The confidentiality provisions set forth on Appendix G shall apply with respect to this Preliminary Collaboration Agreement.
21. Counterparts; Electronic Signatures    This Preliminary Collaboration Agreement may be executed and delivered (including by facsimile transmission or PDF or any other electronically transmitted signatures) in two counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
22. Severability   

If any provision of this Preliminary Collaboration Agreement should be held invalid, illegal or unenforceable in any jurisdiction, the Parties will negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the Parties and all other provisions hereof will remain in full force and effect in such jurisdiction and will be liberally construed in order to carry out the intentions of the Parties as nearly as may be possible.

 

Such invalidity, illegality or unenforceability will not affect the validity, legality or enforceability of such provision in any other jurisdiction.

23. Entire Agreement; Amendments    This Preliminary Collaboration Agreement, the Stock Purchase Agreement and, once entered into, the Definitive Collaboration Agreement (including any schedules, appendices and exhibits hereto or thereto and any certificates delivered hereunder or thereunder) constitute the entire agreement between the Parties with respect to the subject matter hereof and thereof. There are no restrictions, promises, warranties or undertakings, other than those set forth or referred to herein or therein. This Preliminary Collaboration Agreement supersedes all prior agreements and

 

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   understandings between the Parties with respect to the subject matter hereof. No provision of this Preliminary Collaboration Agreement may be waived or amended other than by an instrument in writing signed by the Party to be charged with enforcement. Any amendment or waiver effected in accordance with this Section 23 will be binding upon GSK and Vir.
24. Third Party Beneficiaries    This Preliminary Collaboration Agreement is intended for the benefit of the Parties, their respective permitted successors and assigns, and is not for the benefit of, nor may any provision hereof be enforced by, any other Person.
25. Miscellaneous    The Definitive Collaboration Agreement will include other reasonable and customary terms and conditions for an agreement of its type, including with respect to Termination, Indemnification, Insurance, Representations and Warranties, and Confidentiality (including Press Release). Section 11.5 (Rules of Construction) of the Stock Purchase Agreement shall apply, mutandis mutatis, to this Preliminary Collaboration Agreement (including the appendices hereto) and the Definitive Collaboration Agreement.

SIGNATURES FOLLOW

 

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IN WITNESS WHEREOF, GSK and Vir have caused this Preliminary Collaboration Agreement to be duly executed as of the date first above written.

 

GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LIMITED
By:  

/s/ Victoria Whyte

  for and on behalf of Glaxo Group Ltd.
Its:   Corporate Director
GLAXOSMITHKLINE BIOLOGICALS SA
By:  

/s/ Antoon Loomans

Name:   Antoon Loomans
Its:   SVP GC, Director
VIR BIOTECHNOLOGY, INC.
By:  

/s/ George Scangos

Name:   George Scangos
Its:   President and Chief Executive Officer

[Signature page to Preliminary Collaboration Agreement]


Appendix A

309 Antibody Program Development Plan

[***]


Appendix B

Listed Program Antibodies

Vir mAb-S309 [***]

[***]


Appendix C

Development Costs

Development Costs” means the following costs incurred by the Parties following the Effective Date in conducting Development under the applicable Collaboration Programs, in each case to the extent incurred in accordance with this Preliminary Collaboration Agreement or the Definitive Collaboration Agreement and the applicable Development Plan, and without any additional mark-up: [***].


Appendix D

REPRESENTATIONS AND WARRANTIES

1.1.    Mutual Representations and Warranties. Each Party hereby represents and warrants to the other Party as of the Execution Date and the Effective Date as follows:

(a)    such Party is duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation and has full corporate power and authority and legal right to enter into this Preliminary Collaboration Agreement and to carry out the provisions hereof;

(b)    such Party has the right to grant the licenses to the other Party purported to be granted pursuant to this Preliminary Collaboration Agreement;

(c)    such Party has taken all necessary action on its part required to authorize the execution and delivery of this Preliminary Collaboration Agreement and the performance of its obligations hereunder;

(d)    such Party has received all necessary laboratory licenses and certificates with respect to facilities within such Party’s ownership or control sufficient to allow such Party to conduct the activities assigned to such Party under this Preliminary Collaboration Agreement, and such Party is in compliance with the requirements of such licenses and certificates;

(e)    this Preliminary Collaboration Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid and binding obligation of such Party that is enforceable against it in accordance with the terms and conditions hereof, subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance and general principles of equity (whether enforceability is considered a proceeding at law or equity);

(f)    the execution, delivery and performance of this Preliminary Collaboration Agreement by such Party (i) will not constitute a default under, or conflict with, any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound; (ii) violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party; and (iii) is not prohibited or limited by, and shall not result in the breach of or a default under, any provision of the certificate or articles of incorporation or bylaws of such Party;

(g)    Except for any filings that may be required to comply with the HSR Act , no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality , domestic or foreign, under any applicable laws, rules or regulations currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Preliminary Collaboration Agreement or any other agreement or instrument executed in connection herewith, or for the performance by it of its obligations under this Preliminary Collaboration Agreement and such other agreements;

(h)    such Party and its Affiliates have not employed (and, to its knowledge, has not used a (sub)contractor or consultant that has employed) and, during the Term, will not knowingly employ (or, to its knowledge, use any (sub)contractor or consultant that employs, provided that such Party may reasonably rely on a representation made by such (sub)contractor or consultant) any Person debarred by the FDA (or subject to a similar sanction of EMA or foreign equivalent), or any Person which is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMA or foreign equivalent); and


(i)    Each Party and its Affiliates performing activities under the Collaboration has in place or will have in place prior to its conduct of its activities under the Collaboration a written agreement with its employees and other personnel it appoints to perform such activities hereunder sufficient to ensure that such Party has sufficient ownership or license rights to any Program Technology developed or created by such Party to grant the rights to the other Party as required to be granted under the Preliminary Collaboration Agreement;

1.2.    Representations and Warranties of Vir. Vir hereby represents and warrants to GSK, as of the Execution Date and the Effective Date as follows:

(a)    Vir or one of its Affiliates solely owns or exclusively licenses and Controls the Existing Antibodies and Vir Licensed Technology;

(b)    neither Vir nor any of its Affiliates has entered into any agreement (other than agreements with subcontractors) granting any right, interest or claim in or to, any Existing Antibodies or Vir Licensed Technology that would conflict with the rights and licenses to GSK as required to be granted in the Preliminary Collaboration Agreement;

(c)    neither Vir nor any of its Affiliates has previously entered into any agreement, whether written or oral, to assign, transfer, license, convey or otherwise encumber its right, title or interest in or to any Patent or other know-how that is necessary for the Development, Manufacture, or Commercialization of Antibody Products, in each case, where such Patent or other know-how would be Vir Licensed Technology but for such assignment, transfer, license, conveyance or encumbrance;;

(d)    [***];

(e)    Vir has not, and will not, after the Execution Date and during the Term, grant any right to any Third Party that would conflict with the rights granted to GSK hereunder;

(f)    [***];

(g)    all Patents that are included in the Vir Licensed Technology (“Vir Licensed Patents”) are subsisting and all Vir Licensed Patents for which Vir controls prosecution and maintenance activities are being diligently prosecuted in the patent offices in accordance with applicable law and, to Vir’s Knowledge, are not invalid or unenforceable in whole or in part;

(h)    to Vir’s Knowledge, no Person is infringing or threatening to infringe or misappropriating or threatening to misappropriate any Vir Licensed Technology and there are no activities by Third Parties that would constitute infringement or misappropriation of the Vir Licensed Technology;

(i)    no claim or litigation has been brought or threatened in writing by any Person against Vir or any of its Affiliates alleging, and Vir has no Knowledge of any reasonable basis for any such claim or allegation, whether or not asserted, that (A) any Vir Licensed Patents are invalid or unenforceable, or (B) the use or practice of any Vir Licensed Technology, or the disclosing, copying, making, assigning or licensing of any Vir Licensed Technology, or the exploitation of the Existing Antibodies, does or will violate, infringe, misappropriate or otherwise conflict or interfere with, any Patent or other intellectual property or proprietary right of any Third Party;

(j)    [***];

(k)    Vir has provided or made available to GSK all material adverse information with respect to the safety and efficacy of the Existing Antibodies of which Vir is aware and is or could be reportable to the Applicable Regulatory Authorities;


(l)    [***];

(m)    [***];

(n)    [***];

(o)    Vir or one of its Affiliates has obtained the right (including under any Patents and other intellectual property rights) to use all information and all other materials (including any formulations and manufacturing processes and procedures) developed or delivered by any Third Party under any agreements between Vir or one of its Affiliates and any such Third Party with respect to any Existing Antibodies to the extent necessary to provide GSK with the rights granted to it hereunder, and Vir or one of its Affiliates has the rights to grant GSK the right to use such information or other materials in the Development or Commercialization of the Program Antibodies (e.g., 309 Antibody) as contemplated in the Preliminary Collaboration Agreement;

(p)    Vir is in material compliance with (i) all applicable laws relating to data privacy and data security, including with respect to the collection, use, storage, sharing, transfer, disposition, protection and processing of personally identifiable information (PII); (ii) all privacy policies and other related policies, programs and other notices of Vir relating to the privacy, protection and security of PII; and (iii) all contractual and other legal requirements to which Vir is subject with respect to the privacy, protection, and security of PII; and has in place reasonable safeguards to protect the confidentiality and security of PII, including from unauthorized access or misuse, based on applicable law;

(q)    [***];

(r)    [***];

(s)    [***]; and

(t)    [***].

1.3.    Disclaimer of Warranty. EXCEPT AS EXPRESSLY SET FORTH IN THIS PRELIMINARY COLLABORATION AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY OF ANY KIND, AND BOTH PARTIES EXPRESSLY DISCLAIM ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT.


CERTAIN COVENANTS

1.1    Mutual Covenants.

(a) Immediately following the Execution Date, Vir and GSK shall commence negotiations with the intent to enter into the Definitive Collaboration Agreement. Vir and GSK shall use their respective best efforts to negotiate diligently and agree upon final terms for the Definitive Collaboration Agreement as promptly as practicable following the Execution Date and in no event later than the later of (x) the Antitrust Clearance Date (as defined in the Stock Purchase Agreement) and (y) forty-five (45) days following the Execution Date (or such longer period as Vir and GSK may mutually agree in writing) (the “Negotiation Period”). For the avoidance of doubt, entry into the Definitive Collaboration Agreement is not a condition to the effectiveness of this Preliminary Collaboration Agreement. If the Definitive Collaboration Agreement has not been finalized and executed, but the Closing (as defined in the Stock Purchase Agreement) occurs in accordance with the terms thereof, then this Preliminary Collaboration Agreement, which is binding and governs the Parties’ collaboration relationship, shall continue in full force and effect and Vir and GSK shall continue to negotiate or otherwise finalize the Definitive Collaboration Agreement in accordance with Appendix E of this Preliminary Collaboration Agreement.

(b) Each of Vir and GSK shall duly execute and deliver the Definitive Collaboration Agreement, on final terms as are (a) mutually agreed by Vir and GSK within the Negotiation Period, or (b) in the absence of such mutual agreement, determined in accordance with Appendix E of this Preliminary Collaboration Agreement.

(c) Upon execution by the Parties, this Preliminary Collaboration Agreement shall be a fully integrated and binding agreement and in full force and effect, subject only to the satisfaction of the conditions set forth therein. Neither Party, nor any of their respective Affiliates shall seek to assert that this Preliminary Collaboration Agreement or any term thereof is unenforceable for vagueness, or for not having sufficiently clear or defined terms, for failure of consideration or because it lacks any essential term for enforcement and each of Vir and GSK, on behalf of themselves and their Affiliates, hereby waive any right to make such an assertion. To the extent that any material term has not been included in this Preliminary Collaboration Agreement, Vir and GSK agree that such term (or terms) will be provided through the process set forth in Appendix E of this Preliminary Collaboration Agreement and will be binding and enforceable as if it had been included in this Preliminary Collaboration Agreement.

1.2    Pre-Closing Negative Covenants of Vir. During the period beginning on the Execution Date and ending on the Effective Date, Vir shall not, and shall cause its Affiliates not to, without the prior written consent of GSK (such consent not to be unreasonably withheld, conditioned or delayed):

(a)    enter into any agreement with any Third Party, whether written or oral, with respect to, or otherwise assign, transfer, license or convey its right, title or interest in or to, the Vir Licensed Technology relating to the Antibody Program in connection with the 309 Antibody (the “309 Antibody Program”) or any Program Antibodies Controlled by Vir as of the Execution Date (“Existing Antibodies”), in each case, in a manner that creates a material conflict with the rights granted or purported to be granted by Vir to GSK under this Preliminary Collaboration Agreement;

(b) (i)    sell, out-license or otherwise dispose of any assets or rights relating to the 309 Antibody Program or any Existing Antibodies, in each case, in a manner that creates a material conflict with the rights granted or purported to be granted by Vir to GSK under this Preliminary Collaboration Agreement, (ii) amend any agreements, licenses or other rights of Vir or any of its Affiliates relating to the 309 Antibody Program or any Existing Antibodies, in each case, in a manner that creates a material conflict with the rights granted or purported to be granted by Vir to GSK under this Preliminary Collaboration Agreement, or (iii) grant any security interest or otherwise encumber material assets and properties (including Vir Licensed Technology), relating to the 309 Antibody Program or any Existing Antibodies;


(c) (i)     compromise, settle or agree to settle any litigation, dispute, action or other proceeding or institute any such litigation, dispute, action or other proceeding, in each case, concerning any Vir Licensed Technology that is material to the 309 Antibody Program or any Existing Antibodies, or (ii) fail to take any action necessary or advisable to protect or maintain any Vir Licensed Technology that is material to the 309 Antibody Program or any Existing Antibodies; provided that none of the foregoing shall be interpreted as requiring Vir or any of its Affiliates to commence any such litigation, dispute, action or other proceeding;

(d) (i)    enter into any material agreement relating to the 309 Antibody Program or any Existing Antibodies or (ii) enter into any agreement pertaining to a merger, sale, acquisition, licensing, development, manufacturing, distribution, co-development, marketing or co-marketing arrangement, or any contract containing exclusivity provisions or restrictive covenants relating to the 309 Antibody Program or any other Existing Antibodies, in each case ((i) and (ii)), that creates a conflict with the rights granted or purported to be granted by Vir under this Preliminary Collaboration Agreement; or

(e)    enter into any agreement with any Third Party, whether written or oral, with respect to contract manufacturing arrangements related to the Antibody Program if the costs of supply thereunder would be shared by the Parties pursuant to the Collaboration.

1.3    Pre-Closing Affirmative Covenants of Vir. During the period beginning on the Execution Date and ending on the Effective Date, Vir covenants that:

(a)    [***];

(b)    Vir shall, and shall cause its Affiliates and its and their respective contractors, licensees and consultants to, conduct the 309 Antibody Program and all other activities relating to the Existing Antibodies undertaken pursuant to this Preliminary Collaboration Agreement in accordance with Applicable Law;

(c)    with respect to all intellectual property that it purports to license to GSK under this Preliminary Collaboration Agreement that is, may be or becomes subject to the Bayh-Dole Act, Vir shall, and shall cause its Affiliates and the relevant research partners to, continue to comply with the applicable provisions of the Bayh-Dole Act, in a manner that protects and preserves Vir’s right, title and interest in the subject intellectual property to the maximum extent permitted by Applicable Law; and

(d)    Vir shall [***] notify GSK of the occurrence of a Key Product Event, and in no event more than [***] after such occurrence. “Key Product Event” means any event with respect to the 309 Antibody Program or Existing Antibodies, that: (a) is determined by an independent safety review committee overseeing the safety of the relevant clinical trial to be directly related to the 309 Antibody or any other Existing Antibody in such program and (i) to have resulted in death, (ii) been life-threatening, (iii) required inpatient hospitalization or a significant prolongation of existing hospitalization, (iv) resulted in persistent or significant disability or incapacity, (v) resulted in a congenital anomaly or birth defect or (vi) required significant intervention to prevent permanent impairment or damage; and (b) results in any Applicable Regulatory Authority (as defined in the Stock Purchase Agreement) placing a clinical hold on such program.

1.4    Nothing contained in this Preliminary Collaboration Agreement shall be deemed to give GSK, directly or indirectly, the right to control or direct the business of Vir prior to the Closing. Prior to


the Closing, Vir and its subsidiaries shall exercise, consistent with the terms and conditions of this Preliminary Collaboration Agreement and the Stock Purchase Agreement, complete control over their businesses and operations.


Appendix E

Arbitration for Failure to Agree on Final Collaboration Terms

If the Parties cannot reach agreement and enter into the Definitive Collaboration Agreement within 45 days following the execution date of the Preliminary Collaboration Agreement, then the Parties will communicate their respective positions to the [***], in the case of GSK, and [***], in the case of Vir (or their respective designee with power and authority to resolve such dispute) (“Senior Officials”), who will use good faith efforts to resolve the matter within [***] following the date of such referral. If the Senior Officials are not able to agree upon any unresolved terms to be included in the Definitive Collaboration Agreements referred to them [***] from the date of the Preliminary Collaboration Agreement, then the final terms and conditions of the Definitive Collaboration Agreement will be determined through the mediation and binding arbitration procedures set forth below:

[***]


Appendix F

Dispute Resolution

Any dispute arising out of or relating to the Agreement, or the breach, termination or validity thereof (a “Dispute”), shall be finally resolved pursuant to the following provision:

In the event a Dispute arises, the parties agree that they shall attempt in good faith to resolve the Dispute by negotiation between GSK’s [***] and Vir’s [***] (or their respective designee with power and authority to resolve such dispute). Either party may refer a Dispute to the applicable officers in the preceding sentence by serving notice that Dispute has arisen and demand that negotiations commence. If the parties are unable for any reason to resolve a Dispute within [***] of service of the notice, either party shall have the right to refer the Dispute for mediation as set forth in below.

[***].


Appendix G

Confidentiality Provisions

Confidentiality Obligations. The Definitive Collaboration Agreement will provide for confidentiality and use restrictions in respect of information disclosed by each Party to the other Party that are customary for arrangements such as the Collaboration and similar to the terms set forth herein.

In general, during the term of the Collaboration and for a period of [***] following termination or expiration thereof each Party will be obligated to keep confidential and not publish or otherwise disclose to a third party, and not to use, directly or indirectly, for any purpose other than the Collaboration, any Confidential Information furnished or otherwise made known to it, directly or indirectly, by the other Party, except to the extent such disclosure or use is expressly permitted by the terms of this Preliminary Collaboration Agreement or is reasonably necessary or useful for the performance of, or the exercise of such Party’s rights under, the Preliminary Collaboration Agreement. “Confidential Information” will be defined to mean any technical, business, or other information provided by or on behalf of one Party to the other Party in connection with the Preliminary Collaboration Agreement or the Collaboration, whether prior to, on, or after the effective date of the Preliminary Collaboration Agreement, including information relating to the GSK Licensed Technology, where GSK is the disclosing Party, and information relating to the Vir Licensed Technology, where Vir is the disclosing Party, any inventions, know-how or other information developed in connection with the Collaboration with respect thereto by or on behalf of the disclosing Party (including GSK Program Technology, where GSK is the disclosing Party, and Vir Program Technology, where Vir is the disclosing Party), or the scientific, regulatory or business affairs or other activities of the disclosing Party. The confidentiality and non-use obligations with respect to either Party’s Confidential Information will not include any information that:

(a)    is or becomes part of the public domain through no wrongful act, fault or negligence on the part of the receiving Party;

(b)    can be demonstrated by competent proof to have been in the receiving Party’s possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information;

(c)    is subsequently received by the receiving Party from a third party who is not bound by any obligation of confidentiality with respect to such information;

(d)    has been published by a third party or otherwise enters the public domain through no fault of the receiving Party in breach of its contractual obligations to the disclosing Party; or

(e)    can be demonstrated by competent proof to have been independently developed by or for the receiving Party without reference to the disclosing Party’s Confidential Information.

Permitted Disclosures. The receiving Party may disclose Confidential Information of the disclosing Party to the extent that such disclosure is:

(a)    made in response to a valid order of a court or other governmental authority or, if in the reasonable opinion of the receiving Party’s legal counsel, such disclosure is otherwise required by law, including by reason of filing with securities regulators; provided, however, that the receiving Party shall first have given notice to the disclosing


Party and given the disclosing Party a reasonable opportunity to quash such order or to obtain a protective order or confidential treatment; and provided further that the Confidential Information disclosed in response to such court or governmental order shall be limited to that information which is legally required to be disclosed in response to such court or governmental order;

(b)    made by or on behalf of the receiving Party to regulatory authorities as required in connection with any filing, application or request for marketing or other regulatory approval; provided, however, that reasonable measures shall be taken to assure confidential treatment of such information to the extent practicable and consistent with applicable law;

(c)    made by or on behalf of the receiving Party to a patent authority as may be reasonably necessary or useful for purposes of obtaining or enforcing a patent; provided, however, that reasonable measures shall be taken to assure confidential treatment of such information, to the extent such protection is available; or

(d)    made by the receiving Party to its attorneys, auditors, advisors, consultants, contractors, existing or prospective collaboration partners, licensees, sublicensees, existing or prospective investors, prospective acquirers, or other third parties as may be necessary or useful in connection with exploitation of Collaboration Products as contemplated by the Collaboration or otherwise in connection with the performance of its obligations or exercise of its rights as contemplated by the Preliminary Collaboration Agreement; provided, however, that such persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party set forth herein.

Publication. The Collaboration will be subject to, and the Preliminary Collaboration Agreement will reflect, provisions for publication of papers regarding results of, and other information regarding, activities under the Collaboration in a form customary for arrangements like the Collaboration. In general, the Parties will maintain the confidentiality of any Confidential Information included in any invention disclosure or draft patent application until such patent application has been filed. Each Party will accordingly have the right to review and approve any paper or other presentation proposed for publication or disclosure by a Party that contains clinical data or clinical results in respect of Collaboration activities or that includes Confidential Information of the other Party. The publishing or presenting Party will comply with the other Party’s request to delete references to such other Party’s Confidential Information in any such paper or presentation and will withhold publication of any such paper or presentation for a reasonable period (at least [***]) in order to permit the Parties to obtain patent protection. Any publication or presentation by a Party will recognize the contributions of the other Party according to standard practice for assigning scientific credit.

Return of Confidential Information. Upon the termination of the Collaboration, either Party may request the return or destruction by the other Party of the requesting Party’s Confidential Information. Except for retention of an appropriate archival copy of any such Confidential Information, the Party requested to effect such return or destruction shall promptly comply.

EX-10.54

Exhibit 10.54

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED.

 

CONFIDENTIAL    EXECUTION VERSION

DEFINITIVE COLLABORATION AGREEMENT

By and Among

GLAXO WELLCOME UK LIMITED;

BEECHAM S.A.;

And

VIR BIOTECHNOLOGY, INC.


TABLE OF CONTENTS

 

         Page  

ARTICLE 1

  DEFINITIONS      1  

ARTICLE 2

  EFFECTIVENESS; OVERVIEW; EXCLUSIVITY      22  

2.1

  Effectiveness of the Agreement      22  

2.2

  Overview      22  

2.3

  Exclusivity      23  

ARTICLE 3

  MANAGEMENT OF THE COLLABORATION      25  

3.1

  Joint Steering Committee      25  

3.2

  Joint Research and Development Committee      26  

3.3

  Joint Commercialization Committee      27  

3.4

  Joint Patent Committee      28  

3.5

  Joint Manufacturing Committee      29  

3.6

  Financial Working Group      30  

3.7

  Other Subcommittees      30  

3.8

  Membership, Meetings and Meeting Minutes      30  

3.9

  Decision-Making      32  

3.10

  Alliance Managers      33  

3.11

  Most Conservative Approach and Internal Policies      34  

ARTICLE 4

  COLLABORATION PROGRAMS      34  

4.1

  Collaboration Program Leads      34  

4.2

  Antibody Program      35  

4.3

  Vaccine Program      35  

4.4

  Functional Genomics Program      35  

4.5

  Compassionate Use Programs.      36  

4.6

  Parties’ Assets; Products      36  

4.7

  Compliance with Applicable Law      36  

ARTICLE 5

  DEVELOPMENT      36  

5.1

  Development Plans      36  

5.2

  Development Efforts      38  

5.3

  Development Records; Exchange of Information      38  

5.4

  Performance by Affiliates; Subcontracting      39  

5.5

  Clinical Studies      39  

5.6

  Rights to Opt-Out      40  

ARTICLE 6

  REGULATORY ACTIVITIES      43  

6.1

  Generally      43  

6.2

  Meetings and Communications      43  

 

- i -


TABLE OF CONTENTS

(continued)

 

         Page  

6.3

  Regulatory Submissions      44  

6.4

  Exchange of Development Data      44  

6.5

  Lead Party Opt-Out      45  

ARTICLE 7

  COMMERCIALIZATION      45  

7.1

  General      45  

7.2

  Commercialization Plan      45  

7.3

  Commercialization Efforts      46  

7.4

  Co-Promotion Option of Vir      46  

7.5

  Right to Subcontract Commercialization Activities; Distribution      47  

7.6

  Commercialization Reports      47  

7.7

  GSK Opt-Out      47  

ARTICLE 8

  PHARMACOVIGILANCE AND MEDICAL AFFAIRS      48  

8.1

  Pharmacovigilance Technical Agreement      48  

8.2

  Costs      48  

8.3

  Medical Inquiries      48  

ARTICLE 9

  FINANCIAL PROVISIONS      48  

9.1

  Development Costs      48  

9.2

  Profit/Loss Sharing      49  

9.3

  Adjustment of Actual Profits      49  

9.4

  Reconciliation Procedures      49  

9.5

  Opt-Out Royalties and Payments      51  

9.6

  Third Party Technologies and Government Funding      52  

9.7

  Audits      54  

9.8

  Tax Matters      54  

9.9

  General Payment Terms      56  

9.10

  Blocked Payments      56  

9.11

  Reporting; Financial Records      56  

9.12

  Cooperation on Inter-Party Structure      56  

9.13

  Resolution of Financial Disputes      56  

9.14

  Specific Finance Disputes      57  

ARTICLE 10

  LICENSES      57  

10.1

  Collaboration Programs      57  

10.2

  Following Opt-Out Option      58  

10.3

  Rejected Collaboration Product License      58  

 

- ii -


TABLE OF CONTENTS

(continued)

 

         Page  

10.4

  Sublicenses      59  

10.5

  Licensing Program Technology      59  

10.6

  No Implied Licenses      59  

10.7

  Retained Rights      59  

10.8

  Rights in Bankruptcy      60  

10.9

  Existing Third Party Agreements      60  

ARTICLE 11

  MANUFACTURING AND SUPPLY      61  

11.1

  General      61  

11.2

  Manufacturing Party      61  

11.3

  Antibody Program      61  

11.4

  Other Collaboration Programs      62  

11.5

  Transition of Manufacturing and Supply      63  

ARTICLE 12

  SCIENTIFIC PUBLICATIONS AND PRESENTATIONS      63  

12.1

  Research and Pre-Clinical Publications      63  

12.2

  Clinical Development Publications      63  

12.3

  Review by the Parties      64  

12.4

  Third Parties      64  

12.5

  Lead Party Publication      64  

12.6

  Publication after Opt-Out      65  

ARTICLE 13

  MATERIALS TRANSFER; INTELLECTUAL PROPERTY; INFORMATION TECHNOLOGY      65  

13.1

  Materials Transfer      65  

13.2

  Ownership of Intellectual Property      67  

13.3

  Prosecution, Maintenance and Defense      68  

13.4

  Enforcement Rights      69  

13.5

  Joint Patent Committee      71  

13.6

  Third Party Technologies      71  

13.7

  Infringement Claims by Third Parties      72  

13.8

  Product Marks      72  

13.9

  Information Technology Requirements      73  

ARTICLE 14

  TERM AND TERMINATION      74  

14.1

  Term      74  

14.2

  Mutual Termination      74  

14.3

  Termination for Cause      74  

14.4

  Termination for Insolvency      75  

 

- iii -


TABLE OF CONTENTS

(continued)

 

         Page  

ARTICLE 15

  EFFECTS OF EXPIRATION OR TERMINATION      75  

15.1

  Accrued Obligations      75  

15.2

  Effects of Termination by Mutual Agreement      75  

15.3

  Effects of Termination for Material Breach or Insolvency      76  

15.4

  Other Termination Consequences      76  

15.5

  Survival      77  

15.6

  Termination Not Sole Remedy      77  

ARTICLE 16

  CONFIDENTIALITY      78  

16.1

  Confidentiality      78  

16.2

  Authorized Disclosure      78  

16.3

  Injunctive Relief      79  

16.4

  Return of Confidential Information      79  

16.5

  Press Releases and Other Public Statements      79  

ARTICLE 17

  REPRESENTATIONS AND WARRANTIES AND COVENANTS      80  

17.1

  Mutual Representations and Warranties      80  

17.2

  Representations and Warranties of Vir      82  

17.3

  Post-Closing Covenants of Vir      84  

17.4

  Disclaimer of Warranty      85  

ARTICLE 18

  INDEMNIFICATION      85  

18.1

  Indemnification      85  

18.2

  Insurance      86  

18.3

  LIMITATION OF CONSEQUENTIAL DAMAGES      86  

ARTICLE 19

  ANTI-BRIBERY AND ANTI-CORRUPTION      87  

ARTICLE 20

  MISCELLANEOUS      87  

20.1

  Dispute Resolution      87  

20.2

  Equitable Relief      87  

20.3

  Governing Law      87  

20.4

  Assignment      88  

20.5

  Change of Control of Vir      88  

20.6

  Force Majeure      89  

20.7

  Notices      89  

 

- iv -


TABLE OF CONTENTS

(continued)

 

         Page  

20.8

  Export Clause      90  

20.9

  Waiver      90  

20.10

  Severability      90  

20.11

  Entire Agreement      90  

20.12

  Independent Contractors      91  

20.13

  Headings      91  

20.14

  Further Actions      91  

20.15

  Books and Records      91  

20.16

  Construction of Agreement      91  

20.17

  Supremacy      91  

20.18

  Counterparts      91  

20.19

  No Third Party Beneficiaries      91  

 

- v -


TABLE OF CONTENTS

(continued)

 

SCHEDULES   
Schedule 1.1    309 Antibody [***]
Schedule 1.100    Financial Schedule
Schedule 1.122    GSK Specified Internal Policies
Schedule 1.250    Vir Functional Genomics Targets
Schedule 2.3.1    Existing Vir Third Party Agreements
Schedule 4.2.2    Existing Antibody Development Plan
Schedule 5.6.5    Animal Welfare
Schedule 8.1    Key Terms for Pharmacovigilance Technical Agreement
Schedule 9.5.2    Royalties following Opt-Out
Schedule 9.5.3    [***]
Schedule 10.9    Existing Third Party IP Agreements
Schedule 13.1.1    Form of Material Transfer Record
Schedule 20.1    Arbitration

 

- vi -


DEFINITIVE COLLABORATION AGREEMENT

This Definitive Collaboration Agreement (“Agreement”) is made and entered into as of June 9, 2020 (“Execution Date”) and is effective as of the Effective Date (as defined below), by and among Glaxo Wellcome UK Limited, a private company limited by shares organized under the laws of England having an office at [***]; and Beecham S.A., a private company limited by shares organized under the laws of Belgium having its registered place of business at [***] (together, “GSK”), and Vir Biotechnology, Inc., a Delaware corporation having an office at 499 Illinois Street, Suite 500, San Francisco, CA 94158 (“Vir”). GSK and Vir are sometimes referred to herein, individually, as a “Party” and, collectively, as the “Parties.”

BACKGROUND

WHEREAS, GSK, among other things, conducts programs to discover, develop, manufacture and commercialize innovative pharmaceutical medicines, vaccines and consumer healthcare products;

WHEREAS, Vir, among other things, conducts programs to develop and commercialize therapeutic products for the treatment and prevention of serious infectious diseases;

WHEREAS, an Affiliate (as defined below) of GSK and Vir have entered into a Stock Purchase Agreement, dated April 5, 2020 (the “SPA”), pursuant to which it has purchased certain voting shares of Vir;

WHEREAS, in connection with the SPA, Affiliates of GSK and Vir entered into a binding Preliminary Collaboration Agreement, dated April 5, 2020 (the “Preliminary Collaboration Agreement”), outlining the transactions contemplated therein to discover, develop and commercialize preventatives and treatment products for diseases caused by SARS-COV-2 (as defined below) and other Coronaviruses (as defined below);

WHEREAS, as contemplated under the SPA and the Preliminary Collaboration Agreement, GSK and Vir desire to enter into this Agreement containing a more detailed set of terms governing the collaboration established under the Preliminary Collaboration Agreement, consistent with the terms and conditions set forth therein.

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:

ARTICLE 1

DEFINITIONS

Capitalized terms used in this Agreement, whether used in the singular or plural, shall have the meanings set forth below, unless otherwise specifically indicated herein.

1.1    “309 Antibody” means the Antibody having the amino acids sequence listed on Schedule 1.1, and [***].

1.2    “309 Antibody Product” has the meaning set forth in Section 5.6.1.


1.3    “Accounting Standards means, with respect to GSK, IFRS, and with respect to Vir, GAAP, in each case as consistently applied by the applicable Party and its Affiliates, as the same may be changed from time to time by the Parties; provided that each Party shall promptly notify the other Party in the event that such Party changes its Accounting Standards pursuant to which such Party’s records are maintained, and it being understood that each Party may only use internationally recognized accounting principles (e.g., IFRS, GAAP).

1.4    “[***]” has the meaning set forth in [***].

1.5    “[***]” has the meaning set forth in [***].

1.6    “[***]” has the meaning set forth in [***].

1.7    “Adverse Event” means any untoward medical occurrence in a patient or subject who is administered a product, whether or not considered related to such product, including any undesirable sign (including abnormal laboratory findings of clinical concern), symptom or disease temporally associated with the use of such product.

1.8    “Affiliate” means, with respect to a given Party or Third Party, any corporation, firm, limited liability company, partnership or other entity which directly or indirectly controls, or is controlled by, or is under common control with such Party or such Third Party, respectively. For the purposes of this Section 1.8, “control” means ownership, directly or indirectly through one or more Affiliates, of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or fifty percent (50%) or more of the equity interests in the case of any other type of legal entity, or status as a general partner in the case of any partnership, or any other arrangement whereby a corporation or other entity controls or has the right to control the Board of Directors or equivalent governing body or management of another corporation or other entity.

1.9    “Agreement” has the meaning set forth in the preamble.

1.10    “Alliance Manager” has the meaning set forth in Section 3.10.

1.11    “Allowable Expenses” has the meaning set forth in the Financial Schedule.

1.12    “[***]” has the meaning set forth in [***].

1.13    “Alnylam Agreement” means the Collaboration and License Agreement between Vir and Alnylam Pharmaceuticals, Inc. (“Alnylam”), dated October 16, 2017 and amended December 17, 2019, March 3, 2020 and April 1, 2020.

1.14    “Antibody” means any monoclonal antibody that binds to a Coronavirus and [***]. For clarity, Antibodies shall not include any Vaccine. [***].

1.15    “Antibody Development Plan” has the meaning set forth in Section 4.2.2.

1.16    “Antibody Product” has the meaning set forth in Section 2.2.

 

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1.17    “Antibody Program” means the Collaboration Program for Antibodies, including the 309 Antibody and other Program Antibodies, as further described in Section 4.2.

1.18    “Applicable Internal Policies” means those Internal Policies of either Party applicable to a Party by virtue of application of Section 3.11.

1.19    “Bankruptcy Code” means Title 11 of the United States Code.

1.20    “Balancing Payment” has the meaning set forth in Section 9.4.3(b).

1.21    “Biogen Agreement” means that certain Clinical Development and Manufacturing Agreement between Vir and Biogen, Inc. (“Biogen”), dated May 22, 2020.

1.22    “Biologic” means any composition of matter comprising proteins, nucleic acids, carbohydrates, or any combination of these substances, including antibodies (derivatives or fragments thereof), other binding proteins, peptide molecules, RNA molecules, DNA molecules, viruses, gene therapy vectors, genetically engineered cells, and chemically modified cells.

1.23    “Biosimilar” means, with respect to a Collaboration Product or Sole Development Product, any product containing a Biologic sold in a country by a Third Party that receives Regulatory Approval (including via Emergency Use Authorization) and is claimed to be biosimilar to, or interchangeable with, such Collaboration Product or Sole Development Product (including a product that is the subject of an application submitted under Section 351(k) of the Public Health Service Act in the United States or under Article 10(4) of Directive 2001/83/EC in the European Union or any member state thereof, in each case citing such Collaboration Product or Sole Development Product as the reference product) or for which the BLA otherwise references or relies on such Collaboration Product or Sole Development Product, including any product containing an active substance with the same core nonproprietary name as the active substance in the Collaboration Product or Sole Development Product.

1.24    “BLA” means a Biologics License Application (as defined in 21 C.F.R. 600 et. seq.) or an equivalent application for marketing authorization with respect to a Collaboration Product or Sole Development Product in any jurisdiction in the world.

1.25    “Blocking Third Party IP Agreement” has the meaning set forth in Section 9.6.1.

1.26    “Blocking Third Party IP Costs” has the meaning set forth in the Financial Schedule.

1.27    “BPCIA” has the meaning set forth in Section 13.4.1.

1.28    “Business Day” means a day, other than (a) Saturday or Sunday, or any other day on which banking institutions in New York, New York, London, England and Brussels, Belgium are not open for business, (b) [***], or (c) [***], provided that in the case of (b) and (c), [***].

1.29    “[***]” has the meaning set forth in [***].

 

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1.30    “Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.

1.31    “Calendar Year” means each successive period of twelve (12) months commencing on January 1 and ending on December 31.

1.32    “Change of Control” means, with respect to either Party, an event or transaction or series of events or transactions by which: (a) any Third Party (or group of Third Parties acting in concert) becomes the beneficial owner, directly or indirectly, of more than fifty percent (50%) of the outstanding securities of such Party or the total voting power of such securities normally entitled to vote in elections of directors; (b) (i) such Party reorganizes, consolidates or comes under common control with, or merges into another entity, or (ii) any entity reorganizes, consolidates or comes under common control with, or merges into such Party, in either event of the foregoing ((i) or (ii)) where more than fifty percent (50%) of the total voting power of the securities outstanding of the surviving entity normally entitled to vote in elections of directors is not held by the parties holding at least fifty percent (50%) of the outstanding shares of such Party immediately preceding such consolidation or merger; (c) such Party conveys, transfers or leases to a Third Party (A) all or substantially all of its assets or the control thereof, or (B) all or substantially all of its assets or business relating to this Agreement or the control thereof; or (d) any other arrangement whereby a Third Party (or group of Third Parties acting in concert) obtains control or the right to control the board of directors or equivalent governing body that has the ability to cause the direction of the management, policies or affairs of such Party.

1.33    “Change of Control Group” means, with respect to a Party, the Person, or group of Persons, that is the acquirer of, or successor to, such Party in connection with a Change of Control of such Party, together with all of the Affiliates of such Persons, in each case that are not Affiliates of such Party immediately prior to the closing of such Change of Control of such Party.

1.34    “China” means mainland China, Hong Kong and Macau.

1.35    “Clinical Development Publication Strategy” has the meaning set forth in Section 12.2.

1.36    “Clinical Study” means any human clinical study, including any Phase I Clinical Study, Phase I/IIa Clinical Study, Phase II Clinical Study, Phase II/III Clinical Study, Phase III Clinical Study, Pivotal Clinical Study, or Phase IV Clinical Study.

1.37    “Closing Date” means the closing of the transactions with respect to stock purchase outlined in the Stock Purchase Agreement, which occurred on April 29, 2020.

1.38    “CMO” has the meaning set forth in Section 11.2.

1.39    “[***]” has the meaning set forth in [***].

1.40     “[***]” has the meaning set forth in [***].

1.41    “[***]” has the meaning set forth in [***].

 

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1.42    “[***]” [***].

1.43    “[***]” has the meaning set forth in [***].

1.44    “[***]” has the meaning set forth in [***].

1.45    “[***]” has the meaning set forth in [***].

1.46    “Co-Chair” has the meaning set forth in Section 3.8.1.

1.47    “Collaboration” means (a) any Research activities conducted under the Development Plans, and (b) the Development, Manufacture and Commercialization activities with respect to the Collaboration Products during the Term pursuant to and in accordance with the terms of this Agreement and the Development Plans and Commercialization Plans.

1.48    “Collaboration Product” means (a) an Antibody Product, (b) a Vaccine Product, or (c) a Functional Genomics Product, in each case ((a) - (c)), for which a Party has not exercised its Opt-Out Option. For clarity, (i) [***]; and (ii) a Collaboration Product shall not include a Sole Development Product.

1.49    “Collaboration Program” means a Development, Manufacturing and Commercialization program with respect to a separate type of Collaboration Products, in each case pursuant to mutually agreed Development and Commercialization plans, including budgets as further specified herein. The Collaboration Programs include: (a) Antibody Program; (b) Vaccine Program; and (c) Functional Genomics Program.

1.50    “Commercialization” means any and all activities directed to the preparation for sale of (but excluding Development, Commercial Manufacture or other Manufacture), offering for sale of, or sale of a Collaboration Product, including activities related to obtaining pricing and reimbursement approvals, as applicable, marketing, promoting, selling, distributing, importing and exporting such Collaboration Product, and interacting with Regulatory Authorities regarding any of the foregoing. “Commercialize” and “Commercializing” shall have their correlative meanings.

1.51    “Commercialization Budget means the annual budget for conducting Commercialization pursuant to a Collaboration Program for a given Collaboration Product as prepared by the LCP and reviewed by the JCC pursuant to Section 3.3.2(a) and approved by the JSC in accordance with Section 3.1.2(j), and as updated on a Calendar Year basis by the LCP concurrently with the Commercialization Plan in accordance with Sections 3.3.2(a), 3.1.2(j), and 7.2. Each annual Commercialization Budget shall include (a) a budget, [***], for the estimated FTE Costs and out-of-pocket external costs and expenses expected to be incurred by each Party in the given Calendar Year with respect to such Commercialization Plan, including [***], and (b) a good faith non-binding forecasted budget, [***], for the [***] period following the Calendar Year covered by the budget in (a), of the estimated FTE Costs and out-of-pocket external costs and expenses expected to be incurred by each Party in connection with activities under the applicable Commercialization Plan during such [***] period.

1.52    “Commercialization Plan” has the meaning set forth in Section 7.2.

 

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1.53    “Commercially Reasonable Efforts” means, such efforts that are consistent with the efforts and resources normally used by GSK (in the case of GSK) or a biopharmaceutical company (in the case of Vir) in the exercise of its reasonable business discretion relating to a research program, pharmaceutical product or target owned by it or to which it has exclusive rights, with similar product characteristics, which is of similar market potential at a similar stage in its development or product life as the Collaboration Program, Collaboration Product, Target, or, where applicable, Sole Development Product, taking into account issues of [***].

1.54    “Commercial Facility” means a facility for Commercial Manufacture of any Collaboration Product.

1.55    “Commercial Manufacture” means Manufacture for commercial sale, including (a) reservation of Manufacturing capacity for use in Manufacture for commercial sale; (b) selection and use of contract manufacturers; (c) selection of the Commercial Facilities; (d) subject to the terms of any existing Third Party agreements, technology transfer of the Manufacturing process for Collaboration Product to Commercial Facilities; (e) conduct of process performance qualification batches and other process qualification and validation activities required for Regulatory Approval for Commercial Manufacture of Collaboration Product at the Commercial Facility(ies); and (f) obtaining pre-approval inspection and required licenses and permits for Commercial Facilities.

1.56    “[***]” has the meaning set forth in [***].

1.57    “Committee” means, individually, the JSC, JRDC, JMC, JCC, JPC, the Financial Working Group and the Program Team or any other Subcommittee established as set forth in Section 3.7.

1.58    “Committee Deadlock” has the meaning set forth in Section 3.9.1.

1.59    “Companion Diagnostic” means a product designed for use in a diagnostic biomarker assay tailored or optimized for use with a Collaboration Product or a Sole Development Product, for predicting or monitoring the suitability of such Collaboration Product for prophylactic or therapeutic use in human patients or defined subpopulations thereof. A Companion Diagnostic shall be intended for use (a) as a means to select or monitor the patient population for the conduct of Clinical Studies of such Collaboration Product or Sole Development Product, (b) to predict predisposition to treatment in clinical use with such Collaboration Product or Sole Development Product, or (c) to predict or monitor potential safety considerations in clinical use with such Collaboration Product or Sole Development Product. Use of a Companion Diagnostic to guide use of the Collaboration Product will be contingent on appropriate Regulatory Approvals for such uses as deemed necessary by the FDA or other similar Regulatory Authority with appropriate jurisdiction.

1.60    “[***]” has the meaning set forth in [***].

1.61    “Confidential Information” means any technical, business, or other information provided by or on behalf of one Party of any of its Affiliates (the “Disclosing Party”) to the other Party or any of its Affiliates (the “Receiving Party”) in connection with this

 

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Agreement or the Collaboration, whether prior to, on, or after the Effective Date of this Agreement, including information relating to the GSK Licensed Technology, where GSK is the Disclosing Party, and information relating to the Vir Licensed Technology, where Vir is the Disclosing Party, any inventions, Know-How or other information developed in connection with the Collaboration with respect thereto by or on behalf of the Disclosing Party (including GSK Program Technology, where GSK is the Disclosing Party, Vir Program Technology, where Vir is the Disclosing Party, and Joint Program Technology, where both Parties will be deemed to be both Disclosing Party and Receiving Party), or the scientific, regulatory or business affairs or other activities of the Disclosing Party. For clarity, Confidential Information regarding any Collaboration Product shall be Confidential Information of both Parties.

1.62    “Control” (including variations such as “Controlled,” “Controlling” and the like) means, with respect to any material, information, or intellectual property, the possession (whether by ownership or license, other than the licenses granted hereunder) of the ability to grant a license or sublicense or other right to exploit, as provided herein, without violating the terms of any agreement or other arrangement with any Third Party, or any applicable Law.

1.63    “Controlling Party” has the meaning set forth in Section 13.4.3.

1.64    “Co-Promote Exercise Date” has the meaning set forth in Section 7.4.2.

1.65    “Co-Promotion Agreement” has the meaning set forth in Section 7.4.2.

1.66    “Co-Promotion Option” has the meaning set forth in Section 7.4.1.

1.67    “Co-Promotion Product” has the meaning set forth in Section 7.4.1.

1.68    “Coronavirus” means any spherical or pleomorphic enveloped virus of the family Coronaviridae containing single-stranded (positive-sense) RNA associated with a nucleoprotein within a capsid comprised of matrix protein, including SARS-COV-2.

1.69    “CoVID-19” means the Coronavirus disease-2019 caused by SARS-COV-2.

1.70    “CRISPR” means the gene editing and engineering technology known as “clustered regularly interspaced short palindromic repeats.”

1.71    “CRO” has the meaning set forth in Section 5.4.2.

1.72    “Currency Gains and Losses” means the gain or loss resulting from changes in exchange rates between the functional currency and the foreign currency in which the transaction is denominated, to the extent specifically identifiable to a Collaboration Product and shall only include the currency gains and losses realized between the end of a Calendar Quarter and the date of invoice payment for that Calendar Quarter.

1.73    “Data” means preclinical data (including computational validation, genetic data (including genotype, phenotype and genetic sequencing data), in vitro and in vivo data), clinical data (including broad data sets, study and investigator reports, both preliminary and final,

 

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statistical analyses, expert opinions and reports, safety and other electronic databases), and regulatory, Manufacturing, marketing, pricing, biological, chemical, pharmacological, toxicological, pharmaceutical, physical, analytical, safety and quality control data, information and documentation, whether in written or electronic form.

1.74    “[***]” has the meaning set forth in [***].

1.75    “Defending Party” means any Party participating in the defense of a Third Party Infringement Claim.

1.76    “[***]” means, [***].

1.77    “Development” means any and all Research and development activities conducted to develop or seek, obtain or maintain Regulatory Approvals for the Collaboration Products, which include Non-Clinical GLP Studies, Clinical Studies, quality of life assessments, pharmacoeconomics, regulatory affairs, and such other activities related to the Collaboration Products as are set forth in the applicable Development Plan approved by the JSC. “Develop” and “Developing” shall have their correlative meanings.

1.78    “Development Budget” means on a Collaboration Program-by-Collaboration Program basis, the budget of Development Costs for conducting activities under such Collaboration Program pursuant to the applicable Development Plan during a given Calendar Year, as prepared by the applicable Lead Party, with input from the other Party with respect to Development Costs to be borne by the other Party, and reviewed by the JRDC in accordance with Section 3.2.2(c) and approved by the JSC in accordance with Section 3.1.2(i), which budget shall be updated and amended (if necessary) on a Calendar Year basis concurrently with the Development Plan in accordance with Sections 3.2.2(c) and 3.1.2(i), and at any other time in accordance with Section 5.1.3(a). Each Development Budget shall include (a) a budget, [***], for the estimated Development FTE Costs and out-of-pocket external costs and expenses expected to be incurred by each Party in the given Calendar Year with respect to such Development Plan, and (b) a nonbinding good faith forecasted budget, [***], of the estimated Development Costs to be incurred in connection with activities under the applicable Development Plan, (i) with respect to [***], for the [***], and (ii) with respect to [***], for the time period [***].

1.79    “Development Candidate” means, (a) with respect to an Antibody Program or a Vaccine Program, an Antibody Product or Vaccine Product selected by the JRDC as suitable to progress into further Development, including in Non-Clinical GLP Studies, and (b) with respect to the Functional Genomics Program, a construct, molecule or compound directed to such Target selected by the JRDC as suitable to progress into further Development as a Functional Genomics Product.

1.80    “Development Costs” has the meaning set forth in the Financial Schedule.

1.81    “[***]” has the meaning set forth in the Financial Schedule.

1.82    “[***]” has the meaning set forth in the Financial Schedule.

 

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1.83    “Development Plan” means a detailed plan and budget mutually agreed to govern the conduct of Development activities for the applicable Collaboration Program. For clarity, the Parties intend that there will be one Development Plan for all Collaboration Products in a given Collaboration Program, for a total of three Development Plans, but there may be sub-plans for individual Collaboration Products.

1.84    “Development Summary” has the meaning set forth in Section 5.6.2.

1.85    “Disclosing Party” has the meaning set forth in the definition of “Confidential Information.”

1.86    “Drug Approval Application” means a BLA, NDA or any corresponding application in the applicable country or jurisdiction outside of the United States, including, with respect to the European Union, an application for marketing authorization approval (“MAA”) filed with the EMA pursuant to the centralized approval procedure, or with the applicable national Regulatory Authority of a country in the European Union with respect to the mutual recognition procedure, decentralized procedure or any other national approval.

1.87    “[***]” has the meaning set forth in [***].

1.88    “Effective Date” shall have the meaning set forth in Section 2.1.

1.89    “EMA” means the European Medicines Agency, or any successor entity thereto performing similar functions.

1.90    “Entity” has the meaning set forth in Section 9.8.4.

1.91    “European Union” means the economic, scientific and political organization of member states in Europe, as it may be constituted from time to time.

1.92    “Excess Costs” has the meaning set forth in Section 9.4.2(c)(i).

1.93    “Execution Date” has the meaning set forth in the preamble.

1.94    “Existing Program Antibodies” means the 309 Antibody and [***].

1.95    “Existing Third Party IP Agreement” has the meaning set forth in the Financial Schedule.

1.96    “[***]” has the meaning set forth in [***].

1.97    “FDA” means the U.S. Food and Drug Administration, or any successor entity thereto performing similar functions.

1.98    “Field” means the prevention, treatment and prophylaxis of diseases caused by Coronaviruses, (including SARS-COV-2) in humans, including the disease known as CoVID-19, [***]. [***].

1.99    “Financial Report” has the meaning set forth in Section 9.4.1(a).

 

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1.100    “Financial Schedule” means the schedule set forth in Schedule 1.100 attached hereto, as the same may be amended from time to time by the written agreement of the Parties.

1.101    “Financial Working Group” has the meaning set forth in Section 3.6.

1.102    “First Commercial Sale” means, with respect to a given product in a country, the first commercial sale for use or consumption by the general public in an arms-length transaction of such product by or on behalf of a Party, its Affiliate or its licensee or Sublicensee in such country following receipt of all applicable Regulatory Approvals of such product in such country; provided that the following shall not constitute a First Commercial Sale: (a) any sale or inter-company transfers to an Affiliate or sublicensee unless the Affiliate or sublicensee is the last entity in the distribution chain of such product, (b) any use of such product in Clinical Studies, preclinical activities or other research or Development activities, or (c) disposal or transfer of such products for a bona fide charitable purpose, compassionate use, so called “treatment IND sales” and “named patient sales” or use under the Temporary Authorisation for Use system in France or other equivalent systems.

1.103    “Force Majeure” means any event beyond the reasonable control of the affected Party including: embargoes; war or acts of war, including terrorism; insurrections, riots, or civil unrest; strikes, lockouts or other labor disturbances; epidemics (including pandemics), fire, floods, earthquakes or other acts of nature; unavailability of drug substance, receipt of warning letters, or loss, infection or failure of cell banks (in each case due to reasons other than the affected Party’s negligence or willful misconduct or any other cause within the reasonable control of the affected Party); or acts, omissions or delays in acting by any Governmental Authority (including the refusal of any Regulatory Authority to issue required Regulatory Approvals due to reasons other than the affected Party’s negligence or willful misconduct or any other cause within the reasonable control of the affected Party), and failure of plant or machinery (provided that such failure could not have been prevented by the exercise of skill, diligence, and prudence that would be reasonably and ordinarily expected from a skilled and experienced person engaged in the same type of undertaking under the same or similar circumstances).

1.104    “FTE” means, with respect to a Person who is an employee or an individual who is an independent contractor of a Party or its Affiliates, the equivalent of the work of one (1) such Person directly engaged in performing Development, Commercialization or Manufacturing activities under this Agreement full time for one (1) year (consisting of a total of [***] hours per year, or such other number as may be agreed to by the Parties). [***].

1.105    “FTE Costs” has the meaning set forth in the Financial Schedule.

1.106    “Functional Genomics Development Plan” has the meaning set forth in Section 4.4.1.

1.107    “Functional Genomics Product” has the meaning set forth in Section 2.2.

1.108    “Functional Genomics Program” means the Collaboration Program for genome-wide CRISPR screening activities and other functional genomic screens as are mutually agreed, as further described in Section 4.4, including [***].

 

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1.109    “GAAP” means United States generally accepted accounting principles applied on a consistent basis.

1.110    “GCP” means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, including, as applicable, (a) FDA regulations and guidelines for good clinical practice, as promulgated by the FDA under 21 CFR Parts 50, 54, 56, 312 and 812, (b) as set forth in European Commission Directive 2001/20/EC relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, and brought into law by European Commission Directive 2005/28/EC laying down the principles and detailed guidelines for good clinical practice for investigational medicinal products, (c) the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the EU, (d) the Declaration of Helsinki (2008), and (e) any further amendments or clarifications with respect to any of the foregoing and any equivalents thereto in the country in which pre-clinical or clinical studies of a product are conducted.

1.111    “General Principles” means the General Principles set forth in Section 1 of the Financial Schedule.

1.112    “Generic Product” means, with respect to a Collaboration Product or Sole Development Product in a country in the Territory, any product sold by a Third Party (not licensed, supplied or otherwise authorized by a Party or its Affiliates or Sublicensees) that (a) contains the same active ingredient as such Collaboration Product or Sole Development Product, (b) is sold under a Regulatory Approval that (i) is based upon or relies upon the Regulatory Approval granted to a Party or any of its Affiliates or Sublicensees for such Collaboration Product or Sole Development Product or (ii) is otherwise granted by a Regulatory Authority pursuant to an expedited or abbreviated approval process, and (c) is categorized by the applicable Regulatory Authority in such country to be therapeutically equivalent to, or interchangeable with such Collaboration Product or Sole Development Product.

1.113    “GLP” means all applicable Good Laboratory Practice standards, including, as applicable: (a) FDA regulations and guidelines for good laboratory practice, as promulgated by the FDA under 21 CFR Part 58; (b) European Commission Directive 2004/10/EC relating to the application of the principles of good laboratory practices, as may be amended from time to time as well as any Rules Governing Medicinal Products in the European Community Vol. III, ISBN 92.825 9619-2 (ex - OECD principles of GLP); and (c) any further amendments or clarifications with respect to any of the foregoing and any equivalents thereto in the country in which pre-clinical or clinical studies of a product are conducted.

1.114    “GMP” means all applicable Good Manufacturing Practices, including: (a) the applicable part of quality assurance to ensure that products are consistently produced and controlled in accordance with the quality standards appropriate for their intended use, as defined in European Commission Directive 2003/94/EC laying down the principals and guidelines of good manufacturing practice; (b) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Sections 210, 211, 601, 610 and 820; (c) the Rules Governing Medicinal

 

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Products in the European Community, Volume IV Good Manufacturing Practice for Medicinal Products; (d) the principles detailed in the ICH Q7A guidelines; and (e) the equivalent Laws in any relevant country, each as may be amended and applicable from time to time.

1.115    “Governmental Authority” means any federal, state, provincial, local, municipal, foreign or other governmental or quasi-governmental authority, including any arbitrator and applicable securities exchanges, or any department, minister, agency, commission, commissioner, board, subdivision, bureau, agency, instrumentality, court or other tribunal of any of the foregoing.

1.116    “[***]” has the meaning set forth in [***].

1.117    “GSK Indemnitees” has the meaning set forth in Section 18.1.1.

1.118    “[***]” means [***].

1.119    “GSK Licensed Patent” has the meaning set forth in Section 13.3.2(b).

1.120    “GSK Licensed Technology” means, on a Collaboration Program-by-Collaboration Program basis, all Patents and Know-How that are both (a) Controlled by GSK or its Affiliates as of the Effective Date or during the Term, and (b) [***] provided that GSK Licensed Technology shall not include (i) any GSK Program Technology, (ii) [***], or (iii) [***]. For clarity, any technology that GSK includes within GSK Licensed Technology for a given Collaboration Program shall not be deemed included in GSK Licensed Technology for any other Collaboration Program, unless GSK expressly agrees to such inclusion in the applicable Development Plan for such other Collaboration Program.

1.121    “GSK Program Technology” means, on a Collaboration Program-by-Collaboration Program basis, GSK’s right and interest in any Program Technology generated under such Collaboration Program.

1.122    “GSK Specified Internal Policies” means the Internal Policies set forth in Schedule 1.122 herein, and such other Relevant Internal Policies of GSK as are provided to Vir during the Term.

1.123    “Hatch-Waxman Act” has the meaning set forth in Section 13.4.1.

1.124    “IFRS” means the International Financial Reporting Standards, the set of accounting standards and interpretations and the framework in force on the Effective Date and adopted by the European Union or the United Kingdom, as applicable, as issued by the International Accounting Standards Board (IASB) and the International Financial Reporting Interpretations Committee (IFRS IC), and as adopted by the European Union or the United Kingdom, as applicable, as such accounting standards may be amended from time to time.

1.125    “[***]” has the meaning set forth in [***].

1.126    “IND” means an Investigational New Drug Application (including any amendments thereto) filed with the FDA pursuant to 21 CFR Part 312 before the Initiation of Clinical Studies of a product, or any equivalent filing with any relevant Regulatory Authority in any jurisdiction.

 

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1.127    “[***]” has the meaning set forth in [***].

1.128    “Indemnifying Party” has the meaning set forth in Section 18.1.3.

1.129    “Indemnitee” has the meaning set forth in Section 18.1.3.

1.130    “Infringement” has the meaning set forth in Section 13.4.1.

1.131    “Infringement Notice” has the meaning set forth in Section 13.4.1.

1.132    “[***]” has the meaning set forth in [***].

1.133    “Initial Development Term” means the period from the Effective Date through the fourth (4th) anniversary thereof.

1.134    “Initiation” means, with respect to a Clinical Study, the first dosing of the first human subject in such Clinical Study. “Initiating” means the act of Initiating a Clinical Study.

1.135    “Institutional Review Board” means an institutional review board (“IRB”) or independent ethics committee (“IEC”) that reviews the methods proposed for research and development activities to ensure such methods satisfy ethical requirements.

1.136    “Intellectual Property Rights” means Patents, design rights, copyrights, trademarks, services marks, trade secret rights, or other rights in Know-How, database rights, and all other intellectual property rights or similar proprietary rights of whatever nature, whether registered or not, and including applications to register or rights to apply for registration or renewals or extensions of, and rights to claim priority from, which may now or in the future subsist anywhere in the world.

1.137    “Internal Policies” means, with respect to a Party, such Party’s health care compliance, ethical, reputational, anti-bribery and corruption and other policies applicable to such Party’s activities under this Agreement, and any standard operating procedures implementing such policies, including the codes of conduct of any self-regulatory body of which that Party is a member. Internal Policies includes the Vir Specified Internal Policies and the GSK Specified Internal Policies.

1.138    “[***]” means [***].

1.139    “Joint Commercialization Committee” or “JCC” has the meaning set forth in Section 3.3.1.

1.140    “Joint Manufacturing Committee” or “JMC” has the meaning set forth in Section 3.5.

 

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1.141    “Joint Patent Committee” or “JPC” has the meaning set forth in Section 3.4.1.

1.142    Joint Research and Development Committee” or JRDC” has the meaning set forth in Section 3.2.1.

1.143    “Joint Steering Committee” or “JSC” has the meaning set forth in Section 3.1.1.

1.144    “Joint Technology” means any and all Program Technology that is jointly owned by the Parties pursuant to Section 13.2.2.

1.145    “Key Product Event” means any event with respect to the Collaboration Program or any Collaboration Product, that: (a) is determined by an independent safety review committee overseeing the safety of the relevant clinical trial to be directly related to the Collaboration Product, and (i) to have resulted in death, (ii) been life-threatening, (iii) required inpatient hospitalization or a significant prolongation of existing hospitalization, (iv) resulted in persistent or significant disability or incapacity, (v) resulted in a congenital anomaly or birth defect or (vi) required significant intervention to prevent permanent impairment or damage; and (b) results in a clinical hold being imposed on such program by the FDA or any comparable state, foreign or other Regulatory Authority to which the Collaboration Program or Collaboration Products are subject.

1.146    “Know-How” means proprietary and confidential trade secrets, models, discoveries, ideas, Data and other types of data, databases, results, assays, instructions, processes, techniques, formulas, algorithms, Materials, inventions, computational models, human-relevant disease models, computer software (including source code), predictive model implementations, data analytic tools, biotechnology hardware and associated algorithms and methodologies, methods of use, expert knowledge and information.

1.147    “Knowledge” means, with respect to a particular fact or matter and a Party, the knowledge [***].

1.148    “Law” means, individually and collectively, any and all laws, ordinances, rules, directives and regulations of any kind whatsoever of any governmental or regulatory authority within the applicable jurisdiction.

1.149    “LCP” has the meaning set forth in Section 4.1.1.

1.150    “Lead Party” means (a) with respect to any Antibody Product under the Antibody Program, (i) prior to the first filing of the Drug Approval Application for such Antibody Product, Vir, and (ii) following the first filing of the Drug Approval Application for such Antibody Product, GSK; and (b) with respect to a Vaccine Program or a Functional Genomics Program, GSK.

1.151    “Legal Requirement” has the meaning set forth in Section 16.5.

 

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1.152    “Licensed Technology” means (a) GSK Licensed Technology or (b) Vir Licensed Technology, as applicable.

1.153    “Losses” has the meaning set forth in Section 18.1.1.

1.154    “Major Market” has the meaning set forth in Section 7.3.

1.155    “Malwares” has the meaning set forth in Section 13.9.

1.156    “Manufacturing” means all activities related to the synthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, labeling, shipping, and holding of any Collaboration Product, or any component or intermediate thereof, and all activities performed in support of the CMC (chemistry, manufacturing and controls, or equivalent) section of an IND, NDA or BLA and other Regulatory Filing, including process and formulation development, process qualification and validation, scale-up, qualification, validation, pre-clinical, clinical and commercial production and analytic development, product characterization, stability testing, quality assurance, and quality control. “Manufacture” shall have a correlative meaning.

1.157    “Manufacturing Party” has the meaning set forth in Section 11.2.

1.158    “Material Receiving Party” means the Party receiving Materials from the other Party as contemplated in Section 13.1.

1.159    “Materials” means any chemical or biological substances, including any biological or chemical compounds, drug products, human samples, or other materials, regardless of the route of transfer, which are supplied by a Party or its nominee to the other Party or its nominee for use in the conduct of activities under this Agreement, including any applicable Development Plan. For clarity, clinical supplies delivered pursuant to a Supply Agreement shall not constitute “Materials” for purposes of this Agreement.

1.160    “Materials Transferring Party” has the meaning set forth in Section 13.1.1.

1.161    “Medical Affairs Activities” means activities directed to interacting with physicians and other healthcare professionals who utilize or conduct research related to a drug or biological product, including [***]. For the avoidance of doubt, Medical Affairs Activities do not include any activities involving the marketing, promotion or sale of any Collaboration Product.

1.162    “[***]” has the meaning set forth in [***].

1.163    “Most Conservative Approach” means the approach or position offered by a Party in its Internal Policies, which approach or position, in the aggregate, is [***].

1.164    “MTR” or “Material Transfer Record” has the meaning set forth in Section 13.1.

 

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1.165    “NDA” means a New Drug Application (as more fully defined in 21 C.F.R. 314.5 et seq. or its successor regulation) and all amendments and supplements thereto filed with the FDA.

1.166    “Net Sales” has the meaning set forth in the Financial Schedule.

1.167    “Non-Clinical GLP Studies” means those studies conducted under GLP to produce data intended for inclusion in an IND, including IND-enabling toxicology studies.

1.168    “Non-Lead Party” means, with respect to a given Collaboration Program, the Party that is not the Lead Party.

1.169    “Non Opt-Out Notice” has the meaning set forth in Section 5.6.4(a).

1.170    “Non Opt-Out Party” has the meaning set forth in Section 5.6.4(a).

1.171    “Opt-Out Effective Date” has the meaning set forth in Section 5.6.3(a).

1.172    “Opt-Out Notice” has the meaning set forth in Section 5.6.1.

1.173    “Opt-Out Option” has the meaning set forth in Section 5.6.1.

1.174    “Opt-Out Party” has the meaning set forth in Section 5.6.1.

1.175    “Opt-Out Point” has the meaning set forth in Section 5.6.1.

1.176    “Orange Book” means the FDA publication titled “Approved Drug Products with Therapeutic Equivalence Evaluations.”

1.177    “[***]” has the meaning set forth in [***].

1.178    “[***]” has the meaning set forth in [***].

1.179    “[***]” has the meaning set forth in [***].

1.180    “[***]” has the meaning set forth in the [***].

1.181    “Patents” means all patents and pending patent applications (including inventor’s certificates and utility models) and any patents issuing therefrom, in any country in the Territory, including any and all provisionals, non-provisionals, substitutions, continuations, continuations-in-part, divisional and other continuing applications, supplementary protection certificates, renewals, and any and all reissues, extensions, registrations, reexaminations, extensions, confirmations, registrations and patents of addition on any of the foregoing.

1.182    “Payee” has the meaning set forth in Section 9.8.2.

1.183    “Payor” has the meaning set forth in Section 9.8.2.

1.184    “PCA Execution Date” means April 5, 2020.

 

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1.185    “Permitted Overage” has the meaning set forth in Section 9.4.2(b).

1.186    “Person” means any natural person, corporation, firm, business trust, joint venture, association, organization, company, partnership or other business entity, or any government, or any agency or political subdivisions thereof.

1.187    “Personally Identifiable Information” or “PII” means information that can be used to distinguish or trace an individual’s identity, either alone or when combined with other personal or identifying information that is linked or linkable to a specific individual, including: (a) a first and last name; (b) a home or other physical address, including street name and name of city or town; (c) an email address or other online contact information, such as an instant messaging user identifier or a screen name that reveals an individual’s email address; (d) a telephone number; (e) a social security number; (f) a bank, loan, or credit card account number; or (g) a persistent identifier, such as a customer number held in a “cookie” or processor serial number, that is combined with other available data that identifies an individual consumer.

1.188    “Pharmacovigilance Technical Agreement” has the meaning set forth in Section 8.1.

1.189    “Phase I Clinical Study” means, with respect to a given product, any clinical study administering such product to humans, whether healthy volunteers or patients, for the first time as a single or repeated dose for a given indication.

1.190    “[***]” has the meaning set forth in [***].

1.191    “Phase I/IIa Clinical Study” means, with respect to a given product, any clinical study of such product, for the purpose of studying pharmacology/pharmacodynamics effects or mechanism of action when administered to humans, whether healthy volunteers or patients, preliminarily determining dose or a range of doses or evaluating preliminary safety and which is not a Phase I Clinical Study.

1.192    “Phase II Clinical Study” means, with respect to a given product, any clinical study of such product, which provides for the trial of such product on a limited number of patients for the purpose of determining dose or a range of doses and evaluating safety and preliminary efficacy in the proposed therapeutic indication.

1.193    “[***]” has the meaning set forth in [***].

1.194    “Phase II/III Clinical Study” means, with respect to a given product, any clinical study of such product, for the purpose of determining a dose or dose ranges of such product and evaluating safety and effectiveness of dose ranges of such product in patients with the disease or condition being studied for the purposes of filing for Regulatory Approval with the FDA or other applicable Regulatory Authority.

1.195    “Phase III Clinical Study” means, with respect to a given product, any Pivotal Clinical Study of such product for the purpose of establishing to establish safety and efficacy of such product in patients with the disease or condition being studied for purposes of filing for Regulatory Approval with the FDA or other applicable Regulatory Authority, as described under 21 C.F.R. §312.21(c) with respect to the United States, or, with respect to a jurisdiction other than the United States, a similar clinical study.

 

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1.196    “Phase IV Clinical Study” means of such product for the purpose of establishing any clinical study conducted for such product after such product has received Regulatory Approval for marketing in a particular jurisdiction, including trials the principal purpose of which is to (a) continue testing such product to collect information about (i) its safety or efficacy to provide comprehensive data confirming the benefit-risk balance is positive to convert to a standard Regulatory Approval for marketing in broader or various populations, (ii) its long term safety and side effects associated with long term use, or (iii) its use in additional diseases or conditions other than those for which Regulatory Approval was previously granted where the product is likely to be used “off label” in the disease or condition as a result of a similar mechanism of action, (b) obtain or widen reimbursement coverage, (c) improve the product’s competitive position, or (d) improve the standard of care. For clarity, Phase IV Clinical Studies do not include investigator-initiated trials.

1.197    “Pivotal Clinical Study” means, with respect to a product, a Clinical Study for the purpose of establishing any randomized, well-controlled, appropriately powered study of product as described in 21 C.F.R. §312.21(c) that is either a Phase II Clinical Study (including any Phase II Clinical Study as described in 21 C.F.R. §312.84(b)), Phase II/III Clinical Study or any Phase III Clinical Study, the results of which, if the pre-defined primary endpoint(s) is met or where the weight of evidence or totality of data provide sufficient data on safety and effectiveness to support a marketing approval (including any conditional approval) of the relevant product in the Territory.

1.198    “Plan” means any Development Plan or Commercialization Plan.

1.199    “[***]” has the meaning set forth in Section [***].

1.200    “Pre-Tax Profit or Loss” has the meaning set forth in the Financial Schedule.

1.201    “Product Mark Controlling Party” has the meaning set forth in Section 13.8.1.

1.202    “Product Mark Non-Controlling Party” has the meaning set forth in Section 13.8.1.

1.203    “Product Marks” means the trademarks for use in connection with the Commercialization of any Collaboration Product or Sole Development Product, including trademarks, generic names, international nonproprietary names, trade dress, style of packaging and Internet domain names used in connection with the Commercialization of such Collaboration Product or Sole Development Product.

1.204    “Program Antibody” means (a) any Antibody [***] that is directed against any Coronaviruses, including the 309 Antibody; (b) any Antibody created, discovered, conceived or reduced to practice by either Party or both Parties jointly during the conduct of activities under the Antibody Development Plan during the Initial Development Term; and (c) to the extent not

 

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included in the foregoing subclause (a) or (b), any Antibody Controlled by either Party that the Parties agree during the Initial Development Term, through the JDC, to include as the subject of Development activities under an Antibody Development Plan.

1.205    “Program Technology” means, on a Collaboration Program-by-Collaboration Program basis, all Patents and Know-How generated under such Collaboration Program.

1.206    “Program Teams” has the meaning set forth in Section 3.2.2(n).

1.207    “Public Statement” has the meaning set forth in Section 16.5.

1.208    “Receiving Party” has the meaning set forth in the definition of “Confidential Information.”

1.209     “Regulatory Approval” means, with respect to a country or jurisdiction in the Territory, all approvals, licenses, registrations or authorizations of any Regulatory Authority (including approvals of Drug Approval Applications), necessary for the Manufacturing, use, storage, import, export, transport, marketing and sale of a product, as applicable, in such country or jurisdiction.

1.210    “Regulatory Authority” means the FDA, the EMA or any regulatory body with similar regulatory authority in any other jurisdiction anywhere in the world.

1.211    “[***]” has the meaning set forth in the [***].

1.212    “Regulatory Filing” means any filing or regulatory application or submission related to a product with the FDA or any other Regulatory Authority within or outside the United States, including authorizations, approvals or clearances arising from the foregoing, and all correspondence with a Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with such Regulatory Authority in each case with respect to such product.

1.213    “Relevant Internal Policies” has the meaning set forth in Section 3.11.

1.214    “Research” means non-clinical and pre-clinical research activities, excluding any Clinical Studies or other clinical Development activities.

1.215    “Research and Pre-Clinical Publication Strategy” has the meaning set forth in Section 12.1.

1.216    “[***]” means [***].

1.217    “[***]” means, [***].

1.218    “[***]” has the meaning set forth in [***].

1.219    “[***]” has the meaning set forth in [***].

 

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1.220    “Samsung DS Letter Agreement” means the binding letter agreement dated April 9, 2020 by and between Vir and Samsung BioLogics Co., Ltd. (“Samsung”).

1.221     “SARS-COV-2” means the severe acute respiratory syndrome Coronavirus 2.

1.222    “Senior Managers” has the meaning set forth in Section 20.1.1.

1.223    “[***]” means, [***].

1.224    “[***]” has the meaning set forth in [***].

1.225    “[***]” has the meaning set forth in the [***].

1.226    “Sole Development Product” means (a) an Antibody Product, (b) a Vaccine Product, or (c) a Functional Genomics Product, in each case ((a) - (c)), upon which one Party has exercised its Opt-Out Option and the Non Opt-Out Party has elected to pursue such product unilaterally pursuant to Section 5.6.4(b). In the event GSK has exercised its Opt-Out Option and Vir has elected to pursue such product unilaterally, such product thereafter becomes a “Vir Sole Development Product” and ceases to be a Collaboration Product. Similarly, in the event Vir has exercised its Opt-Out Option and GSK has elected to pursue such product unilaterally, such Collaboration Product becomes a “GSK Sole Development Product” and ceases to be a Collaboration Product.

1.227    “Subcommittee” has the meaning set forth in Section 3.7.

1.228    “Subcommittee Deadlock” has the meaning set forth in Section 3.9.1.

1.229    “Sublicensee” has the meaning set forth in Section 10.4.

1.230    “Target” means a biological or chemical molecule, including a protein, having a biological or chemical activity or function that may be modulated by one or more active compounds (including small molecules, monoclonal antibodies, oligonucleotides, gene therapies, or other biomolecules or modalities) or by exposure to pathogens such as viruses. A Target may reside on or may be otherwise expressed in or associated with either the applicable virus or a host cell.

1.231    “Tax” or “Taxes” means any present or future taxes, levies, imposts, duties, charges, assessments or fees of any nature (including interest, penalties and additions thereto), but not including any taxes, levies, imposts, duties, charges, assessments or fees taken into account in the determination of Pre-Tax Profit or Loss pursuant to the Financial Schedule.

1.232    “Term” has the meaning set forth in Section 14.1.

1.233    “Terminated Collaboration Product(s)” has the meaning set forth in Section 15.3.1.

1.234    “Terminated Party has the meaning set forth in Section 15.3.1.

 

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1.235    “Terminating Party” has the meaning set forth in Section 15.3.1.

1.236    “Territory” means all countries and territories in the world.

1.237    “Third Party” means a person or entity other than (a) Vir and its Affiliates, and (b) GSK and its Affiliates.

1.238    “Third Party Infringement Claim” has the meaning set forth in Section 13.7.1.

1.239    “Third Party Patent Rights” means any Patents owned or controlled by a Third Party.

1.240    “United States” or “U.S.” means the United States and its territories and possessions.

1.241    “USD”, “United States Dollar” or “$” means the official currency of the United States of America.

1.242    “Vaccine” means any biological product, including nucleic acid(s), protein(s), peptide(s), polysaccharide(s), conjugated polysaccharide(s), live, live-attenuated or inactivated microorganism(s) including replication-competent and replication defective virus(es), bacteriophages(s) and bacteria, in each case comprising or encoding an antigen derived from the pathogen or the disease to be prevented or treated, optionally in combination with one or more biological or non-biological product(s) and that when administered to an subject induces, increases, decreases or qualitatively modifies, an immune response intended to prevent or treat the target disease or condition.

1.243    “Vaccine Development Plan” has the meaning set forth in Section 4.3.1.

1.244    “Vaccine Product” has the meaning set forth in Section 2.2.

1.245    “Vaccine Program” means the Collaboration Program for Vaccines as further described in Section 4.3, including, the Development of Vaccines Products directed against SARS-COV-2 and other specific Coronaviruses, in each case that is expressly set out in and is the subject of a Vaccine Development Plan.

1.246    “[***]” has the meaning set forth in [***].

1.247    “[***]” has the meaning set forth in [***].

1.248    “[***]” means, [***].

1.249    “[***]” has the meaning set forth in [***].

1.250    “Vir Functional Genomics Target” means (a) any Target Controlled by Vir or its Affiliates that (i) [***], or (ii) [***], and (b) any other Target the Parties agree to include in a Functional Genomics Program Development Plan.

 

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1.251    “Vir Indemnitees” has the meaning set forth in Section 18.1.2.

1.252    “Vir License Agreements” means all license and other agreements regarding [***], as amended, as of the applicable date.

1.253    “Vir Licensed Technology” means, on a Collaboration Program-by-Collaboration Program basis, all Patents and Know-how that are (a) [***], (b) [***], and (c) [***]; provided that in each case ((a) through (c)), Vir Licensed Technology shall not include any Vir Program Technology. For clarity, any technology that Vir includes within Vir Licensed Technology for a given Collaboration Program shall not be deemed included in Vir Licensed Technology for any other Collaboration Program, unless Vir expressly agrees to such inclusion in the applicable Development Plan for such other Collaboration Program, and specifically, [***].

1.254    “[***]” has the meaning set forth in [***].

1.255    “[***]” means [***].

1.256    “Vir Program Technology” means, on a Collaboration Program-by-Collaboration Program basis, Vir’s right and interest in any Patent and Know-How generated under such Collaboration Program.

1.257    “[***]” has the meaning set forth in [***].

1.258    “Vir Specified Internal Policies” means Relevant Internal Policies of Vir as are provided by Vir to GSK during the Term.

1.259    “WuXi Agreement” means that certain Development and Manufacturing Collaboration Agreement by and between WuXi Biologics (Hong Kong) Limited (“WuXi”) and Vir, dated February 25, 2020, which incorporates by reference the amendment dated February 25, 2020 to the Cell Line License Agreement between WuXi and Vir dated February 3, 2019 to address license terms relating to products directed to the Specified Virus (as defined therein).

1.260    “WuXi LOI” has the meaning set forth in Section 11.3.1(b).

1.261    “WuXi Territory” means solely with respect to Collaboration Programs and Collaboration Products that are subject to the WuXi Agreement (as of the PCA Execution Date) the People’s Republic of China, Hong Kong and Macau and Taiwan, for so long as such Collaboration Programs and Collaboration Products are subject to the WuXi Agreement.

ARTICLE 2

EFFECTIVENESS; OVERVIEW; EXCLUSIVITY

2.1    Effectiveness of the Agreement. This Agreement is effective as of the Closing Date (the “Effective Date”).

2.2    Overview. Generally, the Parties shall collaborate to Develop pharmaceutical or biological products or Vaccines for the prevention, treatment and prophylaxis of diseases caused by SARS-COV-2 and potentially other Coronaviruses, each, in accordance with

 

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an applicable Development Plan and shall collaborate to further Manufacture and Commercialize such Collaboration Products under the terms set forth herein and in accordance with an applicable Commercialization Plan. The Collaboration is comprised of the following three Collaboration Programs for the Development, Manufacture and Commercialization of three types of products: (a) an Antibody Program for the Development, Manufacture and Commercialization of products containing Antibodies targeted against SARS-COV-2 and, where applicable, other Coronaviruses, including any Program Antibodies (each, an “Antibody Product”), provided that, for clarity, (i) if an Antibody arises from the Functional Genomics Program rather than the Antibody Program, such Antibody shall not be considered an Antibody Product and shall be considered as Functional Genomics Product, and (ii) [***]; (b) a Vaccine Program for the Development, Manufacture and Commercialization of products containing any Vaccine mutually agreed by the Parties that targets against SARS-COV-2 and, where applicable, other Coronaviruses(each, a “Vaccine Product”); provided that, for clarity, [***]; and (c) a Functional Genomics Program for the Development, Manufacture and Commercialization of other products in any modality, as mutually agreed by the Parties, based on genome-wide CRISPR screening of host Targets expressed in connection with exposure to SARS-COV-2, and, where applicable, other Coronaviruses (each a “Functional Genomics Product”). During the Initial Development Term, the Parties will collaborate, under mutually agreed Development Plan(s) for each Collaboration Program, to generate and evaluate Development Candidates under such Collaboration Program. With respect to each Collaboration Product under an applicable Collaboration Program, the Parties will conduct Development, Manufacturing, and regulatory activities in accordance with a Development Plan and Commercialization activities in accordance with a Commercialization Plan.

2.3    Exclusivity.

2.3.1    Exclusivity Obligations of Vir. During the Initial Development Term, neither Vir nor its Affiliates (either internally or through intentionally enabling a Third Party) shall (a) create or generate Antibodies for the purpose of Developing or Commercializing any Antibody directed to SARS-COV-2 or any other Coronavirus(es); or (b) conduct genome-wide screens using CRISPR or gene editing screens for SARS-COV-2 or any other Coronavirus(es) to discover Targets or progress such Targets into drug discovery and development, in each case ((a) and (b)), except pursuant to the Collaboration under this Agreement, provided that, the exclusivity obligations under this Section 2.3.1 shall not apply to (i) Vir’s continued conduct of activities (A) under its agreements with Third Parties existing as of the PCA Execution Date and set forth on Schedule 2.3.1 (“Existing Vir Third Party Agreements”), or (B) [***]; or (ii) subject to Section 11.3.1(c), Vir’s activities under (A) the WuXi Agreement (in accordance with its terms), (B) the Biogen Agreement, (C) [***], and (D) the Samsung DS Letter Agreement, in each case ((A) through (D)) solely in connection with (x) the negotiation of the terms of definitive agreements with Biogen and Samsung, or (y) Development and Manufacturing for clinical and commercial supply of Antibodies. [***].

2.3.2    Exclusivity Obligations of GSK. During the Initial Development Term, neither GSK nor its Affiliates (either internally or through intentionally enabling a Third Party) shall (a) create or generate Antibodies for the purpose of Developing or Commercializing any Antibody directed to SARS-COV-2 or any other Coronavirus(es); or (b) conduct genome-wide screens using CRISPR or gene editing screens for SARS-COV-2 or any other Coronaviruses to discover Targets or progress such Targets into drug discovery and development, in each case

 

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((a) and (b)), except pursuant to the Collaboration under this Agreement; provided that, the exclusivity obligations under this Section 2.3.2 shall not apply to any activities or enablement (including funding) conducted by GSK or its Affiliates pursuant to a written agreement with a Third Party entered into prior to the PCA Execution Date, either (x) for the purpose of discovering any Antibody directed to SARS-COV-2 or other Coronaviruses, or conducting genome-wide screens using CRISPR or gene editing screens for SARS-COV-2 or any other Coronaviruses, or (y) that are not for the purposes described in subclause (x) but [***] (each, an “Existing GSK Third Party Agreement”), provided further, for clarity, that the foregoing exception shall not include any amendment of an Existing GSK Third Party Agreement that expands the scope thereof with respect to any Antibody directed to, or conducting genome-wide screens using CRISPR or gene editing screens for, SARS-COV-2 or other Coronaviruses; or (ii) [***].

2.3.3    Activities Outside Collaboration. For the avoidance of doubt, during the Initial Development Term, each Party shall have the right to pursue by itself or through the grant of rights to or from a Third Party, other therapeutic or prophylactic approaches to the prevention, treatment and prophylaxis of diseases caused by Coronaviruses that do not fall within the exclusivity obligations under Section 2.3.1 or Section 2.3.2 including with respect to Vir, any RNAi products generated from its collaboration with Alnylam under the Alnylam Agreement.

2.3.4    Inclusion of Competing Programs. Notwithstanding Section 2.3.1 and Section 2.3.2, if during the Initial Development Term, either Party or its Affiliates wishes to conduct any activities under a program, including generating or advancing a new Antibody, that would constitute a breach by such Party of its exclusivity obligations under Section 2.3.1 or Section 2.3.2, as applicable (whether alone or with a Third Party), then such Party shall, prior to initiation of such program, first notify the other Party in writing, and offer to include any such program under the Collaboration (an “Inclusion Notice”), [***]. The other Party shall have [***] from the date on which it receives the Inclusion Notice to determine whether or not it will accept such offer to include such program in the Collaboration and to notify the offering Party of its decision. If such other Party notifies the offering Party in writing within such [***] period, then such program shall be included in the Collaboration, the scope of which will be included in the Antibody Development Plan or the Functional Genomics Development Plan, as applicable, and shall constitute part of the Antibody Program or the Functional Genomics Program, as the case may be and the terms and conditions of this Agreement shall apply. If such other Party declines, or fails to notify the offering Party in writing within such [***] period that it wishes to include such program in the Collaboration, then the offering Party or its Affiliates shall have the right to exploit such program outside of the Collaboration, and such exploitation shall not constitute a breach of Section 2.3.1 or Section 2.3.2 by such offering Party. Notwithstanding the foregoing, during the Initial Development Term, neither Party nor its Affiliates (either internally or through enabling a Third Party) shall Develop or Commercialize any Program Antibody [***] outside of this Agreement without the other Party’s prior written consent.

 

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ARTICLE 3

MANAGEMENT OF THE COLLABORATION

3.1    Joint Steering Committee.

3.1.1    Establishment of JSC. Prior to the Execution Date, the Parties established a Joint Steering Committee (“Joint Steering Committee” or “JSC”), which is constituted in accordance with Section 3.8. The JSC shall operate in accordance with the provisions of Section 3.8 and Section 3.9. At its meetings, the JSC shall discuss the matters described below and such other matters as are reasonably requested by either Party’s Alliance Managers.

3.1.2    Responsibilities of the JSC. The JSC shall perform the following functions:

(a)    oversee, guide and approve the overall strategic direction of the Collaboration (but without modifying or limiting the rights or obligations of either Party as otherwise set forth herein);

(b)    facilitate communications between the Parties regarding the identification and evaluation of Collaboration Products;

(c)    establish, as appropriate, additional sub-committees or working groups responsible for managing specific aspects of the Collaboration as contemplated herein;

(d)    delegate decision-making authority with respect to specified issues to the applicable subcommittees, provided that any such delegated decision-making shall remain subject to Section 3.9;

(e)    oversee and supervise the subcommittees and resolve issues or Dispute elevated to it by any subcommittee, Program Team or working group the JSC may establish;

(f)    serve as a forum for each Party to communicate regarding each Party’s interest in participation in further Development of each Collaboration Product, including approval of proposals from the JRDC for the inclusion of, and terms for, Third Party assets or Intellectual Property Rights within a given Collaboration Program;

(g)    serve as a forum for the Parties to discuss any proposal from either Party for a competing program in accordance with Section 2.3.4;

(h)    [***];

(i)    for each Collaboration Product, review and approve the initial Development Plan (and the Development Budget therein) in accordance with Section 5.1.2 and any material updates or amendments thereto in accordance with Section 5.1.3;

 

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(j)    for each Collaboration Product [***] the initial Commercialization Plan (including the associated Commercialization Budget) and proposed material updates and amendments thereto (including any updates to the Commercialization Budget [***];

(k)    [***];

(l)    [***]; and

(m)    perform such other functions as are assigned to the JSC in this Agreement, or otherwise agreed by the Parties in writing.

3.2    Joint Research and Development Committee.

3.2.1    Establishment of JRDC. The Parties shall, [***], establish a joint research and development committee (“Joint Research and Development Committee” or “JRDC”) to oversee Development of Collaboration Products and to coordinate Development activities of both Parties with respect to such Collaboration Products.

3.2.2    Responsibilities of the JRDC. The JRDC shall perform the following functions:

(a)    oversee, review and coordinate the conduct, implementation and progress of the Development (including any Research) activities of each Collaboration Product with respect thereto under this Agreement, as described in the applicable Development Plan;

(b)    discuss and develop the Development (including Research) strategy for the Collaboration, including any next-generation Collaboration Products;

(c)    review and approve the applicable initial Development Plan and proposed updates and amendments thereto, in each case, as prepared by the Lead Party in conjunction with the Program Teams with respect to clinical Development of any Collaboration Product, including the applicable Development Budget and the allocation of responsibilities between the Parties, from time to time, and submit such Development Plan, updates, and other amendments to the JSC for review and approval in accordance with Section 5.1.2 or Section 5.1.3, as applicable;

(d)    review and evaluate any results or reports delivered to the JRDC with respect to the Research activities, including validation and designation of each Development Candidate;

(e)    review and evaluate any results or reports delivered to the JRDC with respect to further Development activities in addition to Research activities under the Development Plans, including the protocol concepts for Clinical Studies of the Collaboration Products and any revision of such protocols with respect to issues that are referred to the JRDC, in each case pursuant and subject to Section 5.5.3;

 

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(f)    address issues escalated from Program Teams, including [***], and oversee risk mitigation plans proposed by Program Teams;

(g)    [***];

(h)    approve CROs and other subcontractors in accordance with Section 5.4.2, excluding manufacturing subcontractors, which shall be approved by the JMC;

(i)    [***];

(j)    for each Collaboration Program, discuss each Party’s interest in participation in further Development activities in connection with the applicable Opt-Out Points;

(k)    review and approve any Research and Pre-Clinical Publication Strategy or Clinical Development Publication Strategy proposed by the Lead Party of a Collaboration Program, pursuant to Section 12.1 or Section 12.2;

(l)    [***];

(m)    provide periodic updates to the JSC and otherwise supporting the JSC’s decision-making;

(n)    establish a working functional teams for each Collaboration Program (each, a “Program Team”) to oversee the Development activities under each Collaboration Program, and delegate one or more of its functions under this Section 3.2.2 to such Program Team, with the supervision of the JRDC; and

(o)    perform such other functions as are specifically designated to the JRDC in this Agreement, or as the Parties otherwise agree in writing are appropriate to further the purposes of this Agreement.

3.3    Joint Commercialization Committee.

3.3.1    Establishment of JCC. The Parties shall establish a joint commercialization committee (“Joint Commercialization Committee” or “JCC”), [***], to oversee and review progress of Commercialization activities with respect to such Collaboration Products.

3.3.2    Responsibilities of the JCC. The JCC shall perform the following functions:

(a)    [***] the initial Commercialization Plan, including the associated Commercialization Budget, and proposed material updates thereto proposed by either Party (including any updates to the Commercialization Budget), in each case, [***], with respect to Commercialization of each Collaboration Product, and, [***], [***] of the then-existing approved Commercialization Budget) to the JSC for review and approval in accordance with Section 7.2;

 

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(b)    provide a forum for discussing the need for significant updates to Commercialization Plan [***], as applicable;

(c)    review and discuss the [***] forecast for the Commercialization Budget, in conjunction with the Finance Working Group;

(d)    following exercise of the Co-Promotion Option by Vir, oversee and review Vir’s proposed sales force and sales force activities, and provide a forum for the exchange of information in relation thereto;

(e)    review reports delivered to the JCC with respect to [***] and, [***];

(f)    following Vir’s exercise of the Co-Promotion Option, (i) set direction for sales training, compliance procedures, use of GSK promotional materials, and other relevant matters in connection with the Parties’ negotiation and entry into the Co-Promotion Agreement, and (ii) oversee, review and coordinate the conduct and progress of the Commercialization activities with respect to each Antibody Product for which Vir has exercised its Co-Promotion Option, including activities under the Co-Promotion Agreement;

(g)    to the extent not addressed by a Program Team, [***]; and

(h)     perform such other functions as are specifically designated to the JCC in this Agreement or the Co-Promotion Agreement, as applicable, or as the Parties otherwise agree in writing are appropriate to further the purposes of this Agreement or the Co-Promotion Agreement, as applicable.

3.4    Joint Patent Committee.

3.4.1    Establishment of JPC. [***], the Parties shall establish a joint patent committee (“Joint Patent Committee” or “JPC”) to oversee patent matters relating to the Collaboration, as more specifically described below.

3.4.2    Responsibilities of the JPC. The JPC shall perform the following functions.

(a)    serve as a forum for the discussion of the overall intellectual property strategies for the Collaboration, including the prosecution, maintenance, defense and enforcement of Program Patents, GSK Licensed Patents and Vir Licensed Patents, and submission of patent information to the FDA for listing in the Orange Book, “Purple Book” (or Orange Book-equivalent framework document for Biologics) or any foreign equivalents thereof;

(b)    [***];

(c)    [***];

(d)    review proposed publication by the Parties for any Patent-related issues;

 

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(e)    [***]; and

(f)    perform such other functions regarding Patents included in the Program Patents, GSK Licensed Patents and Vir Licensed Patents, that are specifically designated to the JPC in this Agreement, or as the Parties otherwise agree in writing are appropriate to further the purposes of this Agreement.

3.4.3    Decision-Making of the JPC. For matters relating to prosecution, maintenance or defense of a Patent, the Party [***] with Section 13.3. For matters relating to submission of patent information for listing in the Orange Book or any foreign equivalents thereof, [***] shall have the final decision-making authority pursuant to Section 6.3. For matters relating to whether to enter into a Blocking Third Party IP Agreement (and the agreement on the material terms thereof), any dispute shall be resolved in accordance with Section 9.6.1. For matters relating to whether to include any Third Party Intellectual Property Rights under a Third Party IP Agreement, any dispute shall be resolved in accordance with Section 10.9.2. [***]. For all other matters under the JPC authority, if the JPC cannot resolve a dispute with respect to such matter, the JPC shall be submitted such dispute to the JSC for resolution in accordance with Section 3.9.

3.5    Joint Manufacturing Committee.

3.5.1    Establishment of the JMC. [***], the Parties shall establish a joint Manufacturing committee (“Joint Manufacturing Committee” or “JMC”) to oversee matters relating to Manufacturing (including Commercial Manufacturing and technology transfer) of any Collaboration Product under the Collaboration. The JMC shall be chaired by [***].

3.5.2    Responsibilities of the JMC. The JMC shall perform the following functions:

(a)    serve as a forum for the discussion of the overall Manufacturing strategies and plans for the Collaboration, including [***];

(b)    review and approve the Manufacturing plans included in a Development Plan or Commercialization Plan, including with respect to Manufacturing process, physical product, Manufacturing and technology transfer, supply chain for launch and commercial supply and solutions for technical issues;

(c)    assist the JRDC, and where applicable, the JCC and JSC, in review and approval of the Development Budget or Commercialization Budget to the extent relating to Manufacturing activities;

(d)    provide recommendations to JSC for the selection of CMOs for Commercial Manufacturing and the terms and conditions of the proposed CMO agreement; and

(e)    perform such other functions as are specifically designated to the JMC in this Agreement, or as the Parties otherwise agree in writing are appropriate to further the purposes of this Agreement.

 

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3.5.3    Decision-Making of the JMC. The JMC shall operate in accordance with Section 3.8, and the JMC shall make decisions generally in accordance with Section 3.9. If the JMC is unable, despite the good faith efforts of all members, to resolve any dispute relating to matters within the JMC’s authority within [***] after a disputed issue has been referred to the JMC by either Party, the disputed issue shall be referred to the JRDC, and shall be resolved in accordance with Section 3.9.

3.6    Financial Working Group. Within thirty (30) days following the Effective Date, the JSC will establish a financial working group subcommittee (“Financial Working Group”) that will be responsible for initially reviewing all budgets included as part of the Development Plans and Commercialization Plans, and for overseeing the operational aspects of all co-funding and payment activities under this Agreement. The JSC shall determine the appropriate number of representatives of each Party that will constitute the Financial Working Group. Promptly following the Effective Date, each Party shall designate their respective initial representatives to the Financial Working Group to allow such Financial Working Group to begin organizing information for the initial meetings of each of the JRDC and JSC. Unless otherwise specified by the JSC, the Financial Working Group shall operate generally in accordance with the provisions of Section 3.8, and shall have no authority to alter or amend the terms and conditions of this Agreement. Both Parties’ representatives on the Financial Working Group shall make decisions and act in accordance with the General Principles.

3.7    Other Subcommittees. From time to time, the JSC and the JRDC may establish other subcommittees to oversee particular projects or activities under this Agreement, and such subcommittees shall be constituted and have such responsibility as the JSC or JRDC approves (such subcommittees, along with the other subcommittees established hereunder, each referred to herein as a “Subcommittee”). The Subcommittees shall operate in accordance with the provisions of Section 3.8, and shall have no authority to alter or amend the terms and conditions of this Agreement.

3.8    Membership, Meetings and Meeting Minutes.

3.8.1    Membership. Except as otherwise stated herein, each Committee shall be composed of at least [***] representatives ([***]) in each case from each of Vir and GSK, or such other equal number of representatives as the Parties may agree. As of the Effective Date, the Parties anticipate that the JSC will be composed of [***] of each Party, and the JRDC will be composed of [***] of each Party. Either Party may replace its respective Committee representatives at any time with prior written notice to the other Party, provided that such replacement is of comparable authority and scope of functional responsibility within that Party’s organization as the person he or she is replacing. Each Party’s representatives to each Committee shall be individuals suitable in seniority and experience and amongst such representatives shall be [***] from each Party with relevant decision-making authority to make decisions within the scope of the applicable Committee’s responsibilities, provided that it is understood that [***]. For each Committee, or where applicable, Subcommittees, each Party shall designate one of its representatives on such Committee to co-chair the meetings for such Committee (each, a “Co-Chair”). The Co-Chairs shall, with and through the assistance of the Alliance Managers, coordinate and prepare the agenda for, and ensure the orderly conduct of, the meetings of such Committee. The Co-Chairs shall, with and through the assistance of the Alliance Managers, solicit

 

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agenda items from Committee members and provide an agenda, along with appropriate information for such agenda, reasonably in advance of any meeting, including [***]. Such agenda shall include all items requested by either Co-Chair for inclusion therein. In the event the Co-Chairs or another Committee member from either Party is unable to attend or participate in a meeting of such Committee, the Party whose Co-Chair or member is unable to attend may designate a substitute co-chair or other representative for the meeting. For clarity, while the Alliance Managers may attend meetings of all Committees, the Alliance Managers shall not: (a) serve as a voting member of any such Committee; nor (b) be counted towards either Party’s representation on any such Committee.

3.8.2    Meetings. The JSC shall meet at least [***] per year, or at a frequency determined by the JSC, for so long as the Parties are engaging in Development activities as part of the Collaboration or a Collaboration Product is in Development or being Commercialized, in each case, for clarity, not as a Sole Development Product, and JSC meetings can be called at other times to resolve Committee Deadlocks in accordance with Section 3.9.1. At least [***] per year will be in-person, unless the JSC members agree to meet by an alternative mechanism (e.g., telephone or videoconference). The JRDC and the JCC, once formed, shall meet at least [***], and thereafter at least [***], or in each case at a frequency determined by the JRDC or JCC, as applicable. The Financial Working Group, Program Teams and other Subcommittees, if any, shall each meet at least [***] after the Subcommittee is formed, or as more or less often as otherwise agreed by the applicable Subcommittee; provided that the Financial Working Group will meet as and when necessary to carry out its responsibilities set forth in Section 9.3. [***]. Committee meetings may be conducted by telephone, videoconference or in person. Any in-person Committee meetings shall be held on an alternating basis between Vir’s and GSK’s facilities, unless otherwise agreed by the Parties. Each Party shall be responsible for its own expenses in attending such meetings. As appropriate, the Committee may [***]. Each Party may also call for special meetings of a Committee to discuss particular matters requested by such Party. The Alliance Managers shall provide the members of each Committee with no less than [***] notice of each regularly scheduled meeting and, to the extent reasonably practicable under the circumstances, no less than [***] notice of any special meetings called by either Party.

3.8.3    Meeting Minutes. Minutes will be kept of all Committee meetings by one of the Alliance Managers (or his or her designees), or by one of the Co-Chairs (if an Alliance Manager is not present) on a rotating basis (commencing with GSK’s representative) and sent to all members of the Committee by facsimile or e-mail for review and approval within [***] after each meeting. If a Party’s Alliance Manager (or his or her designee) is not present at a Committee meeting and that Party is responsible for keeping minutes, such Party shall designate one of its Committee members to keep minutes. Minutes shall record all action items and decisions of the applicable Committee. The Committee shall formally accept the minutes of the previous Committee meeting [***]. Minutes will be deemed approved unless any member of the Committee objects to the accuracy of such minutes by [***]. Minutes shall list action items and shall designate any issues that need to be resolved by the JSC or applicable dispute resolution process. In the event of any such objection to the minutes that is not resolved by mutual agreement of the Parties, such minutes will be amended to reflect such unresolved dispute.

 

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3.9    Decision-Making.

3.9.1    Committee Decision Making. Decisions of each Committee shall be made by unanimous vote, with each Party having one vote. To the extent a Party has voted in favor of a particular action, after commencement of the implementation of such action it shall not be permitted to reverse such vote absent changed facts and circumstances that were not present at the time of the initial vote. [***]. Representatives of each Party under each Committee shall use reasonable efforts to resolve any dispute within the authority of such Committee in good faith. If (a) the JRDC, the JCC, the Financial Working Group, or the JPC (subject to Section 3.4.3) cannot or does not reach consensus with respect to a bona fide dispute within the authority of such Subcommittee (a “Subcommittee Deadlock”) after endeavoring for [***] to do so, such matter shall be referred to the JSC for discussion and attempted resolution, and (b) any Program Team or other Subcommittee cannot or does not reach consensus with respect to Subcommittee Deadlock after endeavoring for [***] to do so, then such Subcommittee Deadlock shall be first referred to the JRDC (in case of Program Teams and the JMC) or the applicable establishing Committee for resolution before they are submitted to the JSC pursuant to subsection (a). In the event that the JSC does not reach a decision with respect to a Subcommittee Deadlock, or if the JSC cannot or does not reach consensus with respect to any other matter within its authority, in each case, after endeavoring for [***] to do so, then such matter (a “Committee Deadlock”) shall be decided by the Parties in accordance with Section 3.9.2 below. For clarity, all commitments and other matters decided by the JSC or any other Committee between the Effective Date and the Execution Date (inclusive), to the extent that such commitments and other matters are actually approved and documented in the JSC meeting minutes, shall be deemed to be approved by and mutually agreed through the JSC and such other Committee, respectively, for purposes of this Agreement.

3.9.2    Decision Making Authority. The Committee Deadlock shall be submitted by either Party to the Senior Managers of both Parties. Then, the Senior Managers of each Party or their respective designees, shall attempt to resolve such Committee Deadlock within [***] after submission. If the Senior Managers (or their respective designees) cannot resolve the Committee Deadlock, then, such Committee Deadlock shall be resolved as follows:

(a)    if such Committee Deadlock is with respect to the Research activities for any Collaboration Program, [***];

(b)    prior to the first filing for Drug Approval Application of any Collaboration Product, if such Committee Deadlock is with respect to Development (other than Research) and regulatory matters regarding such Collaboration Product, including clinical Manufacturing and supply of clinical trial material for Clinical Studies, the Lead Party for such Collaboration Product shall have the final decision making authority, except that,

(i)    [***];

(ii)    [***]; and

(iii)    [***].

(c)    [***];

(d)    after the first filing for Drug Approval Application of any Collaboration Product, if such Committee Deadlock is with respect to Development, including

 

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regulatory matters regarding such Collaboration Product, the LCP shall have the final decision-making authority, except for assignment of any activities to the other Party, in which case consent of such other Party shall be required, provided that [***]; and

(e)    after the first filing for Drug Approval Application of any Collaboration Product, if such Committee Deadlock is with respect to matters other than those described in Section 3.9.2(d) above, then the LCP shall have the final decision-making authority, provided that [***].

3.9.3    Limits on Decision-Making Authority. Notwithstanding Section 3.9.2, (a) neither Party may exercise its final decision-making authority to (i) impose additional obligations upon the other Party without such Party’s consent, (ii) cause the other Party to violate any applicable Law, or the terms of any agreement it may have with any Third Party entered into prior to the Execution Date, or (iii) modify, violate, breach or waive compliance with this Agreement, or cause the other Party to do so, (b) a Party may only exercise its final decision-making authority with respect to a matter after giving good faith consideration to the other Party’s comments (through its JSC members or its Senior Manager, as applicable) on such matter, and (c) if a Party elects its Opt-Out Option at any time with respect to a Collaboration Product, then thereafter, to the extent such Opt-Out Party would have the final decision-making authority pursuant to Sections 3.9.2(a)-(e), then, such Opt-Out Party shall no longer have such final decision-making authority with respect to such Collaboration Product and any dispute that would be subject to such Opt-Out Party’s final decision-making authority shall then be subject to the Non Opt-Out Party’s final decision-making authority.

3.9.4    Day-to-Day Decision-Making Authority. Each Party shall have decision-making authority with respect to the day-to-day activities of such Party (and such Party’s employees, agents and subcontractors) under this Agreement in accordance with this Agreement, including applicable Development Plan or Commercialization Plan, provided that such decisions are not inconsistent with the terms and conditions of this Agreement (including any applicable Plan) or the decisions and actions of the JSC, the JRDC, the JCC, the JMC, the Financial Working Group or any other Subcommittee, as applicable. Subject to the foregoing, each Party shall keep the relevant Committees reasonably informed of material developments regarding the Collaboration Products.

3.9.5    Limitation of Powers. Each Committee will have only the powers as are specifically delegated to it under this Agreement. The JSC is not a substitute for the rights of the Parties under this Agreement and is intended to coordinate and facilitate the activities of the Parties during the Term. The JSC will not be involved with the day-to-day management of activities to be performed by a Party under this Agreement. Matters explicitly reserved to the consent, approval or other decision-making authority of one or both Parties, as expressly provided in this Agreement, are outside the jurisdiction and authority of the JSC, including amendment, modification or waiver of compliance with the Agreement, which shall be made by the Parties in accordance with Section 20.11.

3.10    Alliance Managers. [***], each Party shall designate an individual to serve as the main point of contact for each Party [***], to exchange information, facilitate communication and coordinate the Parties’ activities hereunder (each, an “Alliance Manager”).

 

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Each Party may designate an Alliance Manager for each specific Collaboration Program. The applicable Alliance Managers shall attend the JSC meetings (or designate an appropriate representative to attend JSC meetings on the Alliance Manager’s behalf). For all other Committees, the Alliance Managers may participate in meetings but are not required to participate. The Alliance Managers shall not be counted as members of any Committee (and shall not vote on matters discussed at any Committee meeting). Each Party may change its designated Alliance Manager from time to time upon written notice to the other Party.

3.11    Most Conservative Approach and Internal Policies. For all activities with respect to Collaboration Products, each Party will provide the other with copies of Internal Policies that are relevant and material to the activities being conducted by the Parties hereunder (the “Relevant Internal Policies”) [***], and will provide updates of such Relevant Internal Policies as appropriate. [***]. If there is a conflict between the Relevant Internal Policies with respect to a particular issue, the Parties shall [***], and, except as otherwise set forth in an applicable Development Plan or Co-Promotion Agreement, each Party shall [***] with respect to Development, Manufacturing and Commercialization activities hereunder.

ARTICLE 4

COLLABORATION PROGRAMS

4.1    Collaboration Program Leads.

4.1.1    Lead Party. Generally, (a) the Lead Party for a Collaboration Program shall be primarily responsible for Development activities with respect to each Collaboration Product under such Collaboration Program, and each, under the oversight of the JRDC, the JSC and other applicable Committees, and, subject to Section 3.9.2 and Section 11.3.1(d), shall have the final decision-making authority with respect to the Development and Manufacturing (other than Commercial Manufacture) activities under such Collaboration Program; and (b) the Lead Party for Commercialization and Commercial Manufacture of each Collaboration Program (the “LCP”) shall be primarily responsible for Commercialization and Commercial Manufacture activities with respect to each Collaboration Product under such Collaboration Program, each, under the oversight of the JCC, the JSC and other applicable Committees, and, subject to Section 3.9.2 and Section 11.3.1(d), shall have the final decision-making authority with respect to the Commercialization and Commercial Manufacture under such Collaboration Program.

4.1.2    Parties Roles. Subject to Section 5.6, (a) for the Vaccine Program and the Functional Genomics Program, GSK shall be the Lead Party for Development activities, and the LCP for Commercialization and Commercial Manufacture of each Collaboration Product under such Collaboration Program; and (b) for the Antibody Program, subject to Section 4.2.3, Vir shall be the Lead Party for Development activities and GSK shall be the LCP for Commercialization and Commercial Manufacture of each Antibody Product under the Antibody Program.

 

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4.2    Antibody Program.

4.2.1    General. The Antibody Program shall be the first Collaboration Program to be progressed by the Parties following the Effective Date, and is partly based upon Vir’s ongoing Development activities with respect to Antibodies in the Field, including under Vir’s collaboration with WuXi and Biogen. During the Term, the Parties shall discuss and agree, through the JRDC and the JSC, on Development Plans for Antibody Products under the Antibody Program in accordance with Section 5.1 (each, an “Antibody Development Plan”). Without limiting the foregoing, the Antibody Development Plan will set forth (a) [***]; (b) [***]; (c) [***]; and (d) [***]. As the initial Lead Party, Vir shall be primarily responsible for the Development and clinical Manufacturing activities for the Antibody Program, under the oversight of the JRDC and the JSC.

4.2.2    Existing Program Antibody. With respect to the Existing Program Antibody(ies), the initial Antibody Development Plan (including the mutually agreed initial Development Budget therefor) for such Existing Program Antibody(ies) is set forth in Schedule 4.2.2 (“Existing Antibody Development Plan”). Following the Effective Date, the Parties shall promptly start conducting Development activities assigned to it as set forth in the Existing Antibody Development Plan, in accordance with the associated Development Budget.

4.2.3    Change of Lead Party. Subject to Section 11.3.1 and [***] with respect to Manufacturing, for each Antibody Product under the Antibody Program, Vir shall be the Lead Party for such Antibody Product until the first filing of the Drug Approval Application (including BLA or MAA) for such Antibody Product; [***]. GSK shall become the Lead Party for such Antibody Product upon the first filing for Regulatory Approval of such Antibody Product.

4.3    Vaccine Program

4.3.1    General. [***], the Parties will, through the JRDC, discuss and mutually agree on the Development Plan for each Vaccine Product under the Vaccine Program in accordance with Section 5.1 (the “Vaccine Development Plan”). Without limiting the foregoing, the Vaccine Development Plan will set forth (a) [***]; (b) [***]; (c) [***]; (d) [***]; and (e) [***].

4.3.2    Lead Party. GSK shall be the Lead Party for the Vaccine Program, provided that it is anticipated that the initial Research activities will be conducted predominantly by Vir, as set forth in the Development Plan for the Vaccine Program. [***], as set forth in the Development Plan for the Vaccine Program.

4.3.3    [***]. The JRDC shall determine whether a designated Vaccine has met all the criteria for a Development Candidate, and if so, shall designate such Development Candidate for further Development as a Vaccine Product. If any Vaccine has not met the criteria for the Development Candidate, as determined by the JRDC, then, neither Party shall have the right to further Develop, Manufacture or commercialize any product containing such Vaccine under the Collaboration. [***].

4.4    Functional Genomics Program

4.4.1    General. [***], the Parties will, through the JRDC, discuss and mutually agree on the Development Plan for each Functional Genomics Product under the Functional Genomics Program in accordance with Section 5.1 (the “Functional Genomics Development Plan”). Without limiting the foregoing, the Functional Genomics Development Plan will include (a) [***], (b) [***], (c) [***]; (d) [***], and (e) [***].

 

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4.4.2     Lead Party. GSK as the Lead Party will be primarily responsible for Development and Manufacturing activities for the Functional Genomics Program, under the oversight of the JSC and any other applicable Committees.

4.4.3    Database Technology. Any databases and data mining technologies [***] shall only be included in the Functional Genomics Program to the extent specified as included within GSK Licensed Technology or Vir Licensed Technology in the applicable Functional Genomics Program Development Plan, in accordance with Section 4.4.1, and in each case shall be subject to any applicable Third Party agreements, [***] prior to inclusion in the Functional Genomics Program Development Plan. [***].

4.5    Compassionate Use Programs. With respect to each Collaboration Product, the Parties shall, through the JRDC and the JSC, discuss and agree on [***].

4.6    Parties’ Assets; Products. Unless otherwise agreed by such Party in the applicable Development Plan, neither Party’s assets (Targets, compounds or other products), including those discovered, licensed or acquired by such Party outside of the Collaboration, shall be included at any time as part of the Collaboration; provided that the foregoing shall not exclude [***].

4.7    Compliance with Applicable Law. Each Party shall, and shall cause their Affiliates, Sublicensees, permitted subcontractors and distributors to conduct its or their activities under this Agreement in compliance with applicable Law. Without limiting the foregoing, any information exchanged between the Parties under this Agreement shall be subject to, and limited to the extent permitted by any applicable Law, including any applicable competition Law.

ARTICLE 5

DEVELOPMENT

5.1    Development Plans.

5.1.1    Each Development Plan shall (a) provide a framework for the applicable Collaboration Program, and (b) set forth (i) the objectives of the Collaboration Program, (ii) the specific Development activities to be undertaken by either Party to achieve those objectives, with anticipated timelines, (iii) the Development Budget, (iv) [***], (v) Manufacturing plan in support of Development activities, and (v) any other items applicable to Development activities that the Parties may agree to include in the Development Plan. [***].

5.1.2    The JRDC, [***], shall review and approve each initial Development Plan (to the extent not approved prior to the Execution Date) within [***], and shall submit such Development Plan to the JSC for the JSC to review and approve, except that the JMC shall review and approve any Manufacturing plan (and associated budget) included in the Development Plan [***] prior to submission to the JSC for review and approval. If the JRDC or the JMC, as applicable, cannot agree on the Development Plan within such [***], then such dispute shall also be submitted to the JSC. If the JSC cannot agree on such proposed Development Plan

 

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submitted by the JRDC within [***] after being submitted by the JRDC or the JMC, whichever is later, then such dispute shall be resolved in accordance with Section 3.9.2. The proposed final Development Plan (including the initial Development Budget that is part of the Development Plan) will go into effect once approved by the JSC in accordance with Section 3.9. For clarity, the initial Vaccine Development Plan and initial Functional Genomics Development Plan or any material amendment to the Existing Antibody Development Plan as set forth on Schedule 4.2.2, shall not go into effect until finalized pursuant to the process set forth in this Section 5.1.2 and approved by the JSC. Once approved by the JSC, the Parties shall conduct Development activities under the Development Plan in accordance with this Agreement. All such Development activities shall be conducted under the supervision of the JRDC, as applicable and in accordance with the approved Development Plan. Activities of a Party’s Affiliates, licensees or Sublicensees shall be considered activities of such Party for purposes of this Agreement.

5.1.3    Following approval by the JSC of the initial Development Plan (including the associated Development Budget) for a Collaboration Program in accordance with Section 5.1.2, such Development Plan shall be updated or amended as follows:

(a)    the JRDC [***] shall review each Development Plan not less frequently than annually and the Lead Party shall prepare detailed and specific Development Plan updates, which shall include, as applicable, updates to the existing Development Budget, including to provide for the Development Budget for the next Calendar Year and the applicable non-binding budget forecast (as defined in the definition of Development Budget) following such Calendar Year for the particular Collaboration Program. The Lead Party shall submit all such updates to the JRDC ([***]) for review and approval no later than [***] of each Calendar Year and the JRDC shall submit such updated Development Plan to the JSC for review and approval. If the JSC cannot agree on such proposed updated Development Plan submitted by the JRDC within [***], then such dispute shall be resolved in accordance with Section 3.9.2. Upon the JSC’s preliminary approval, such updates shall be submitted to each Party for its internal budgeting process with a target for final approval no later than [***] of each Calendar Year, at which time any such approved updates shall be appended to the Development Plan, provided that, [***].

(b)    The Lead Party may also develop and submit to the JRDC [***]) from time to time other proposed amendments to the Development Plan, which the JRDC [***] will review and approve. The JRDC shall submit all material amendments to the Development Plan to the JSC for review and approval and, if the JRDC cannot agree with respect to any matter in any other proposed amendments to the Development Plan within [***], the JRDC shall submit such amendments to the JSC for review and approval. If the JSC cannot agree on such proposed amendments to the Development Plan referred by the JRDC within [***], then such dispute shall be resolved in accordance with Section 3.9.2. Proposed amendments to the Development Plan shall not go into effect until approved by the JRDC or, if applicable, the JSC, at which time such approved amendments shall be appended to the Development Plan.

(c)    For clarity, when providing the JRDC with information regarding the projected Development Budget anticipated to be expended under a particular Collaboration Program, the Lead Party shall provide to the JRDC the level and quality of information that the Parties have agreed through the Financial Working Group, which level and quality of information shall be agreed to by the Financial Working Group within [***].

 

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5.1.4    The Development Plan may include [***], solely if the Parties mutually agree to include such product in the applicable Development Plan or an amendment to such Development Plan (each agreed product, an “Additional Products”). For clarity, with respect to any portion of an Additional Product [***] the Development Plan for such Additional Product. [***]. The Development Plan may also include [***] the Development and Commercialization of Collaboration Products, for which the Parties will mutually agree on any Development activities associated therewith. For clarity, unless otherwise agreed by the Parties, the sharing of Development Costs applicable to [***] such Development Plan. If the Parties agree to include in the Collaboration an Additional Product that is [***].

5.2    Development Efforts. Each Party shall use its Commercially Reasonable Efforts to (a) perform the obligations assigned to it under each Development Plan, and (b) enable GSK to seek and obtain regulatory approval for any Collaboration Product progressed thereunder in the United States, the European Union, and the United Kingdom. [***]. Each Party shall conduct its Development activities in good scientific manner and in compliance with all applicable Law, including Laws regarding the environment, safety and industrial hygiene, and GMP, GLP, GCP, informed consent and Institutional Review Board regulations, current standards for pharmacovigilance practice, and all applicable requirements relating to the protection of human subjects.

5.3    Development Records; Exchange of Information.

5.3.1    Each Party shall maintain, in good scientific manner, complete and accurate books and records pertaining to its activities under each Development Plan, in sufficient detail to verify compliance with its obligations under this Agreement and which books and records shall (a) be appropriate for Patent and regulatory purposes, (b) be kept and maintained in compliance with applicable Law, (c) properly reflect all work done and results achieved in the performance of its activities hereunder and (d) record only such activities and not include or be commingled with records of activities outside the scope of this Agreement (such books and records, “Program Records”). As part of keeping the Program Records, each Party shall maintain records in sufficient detail as will properly reflect all work done, in the performance of activities arising out of, in conducting, or otherwise in connection with the Development Plan. Such Program Records shall be retained by the applicable Party for at least [***] after the expiration or termination of the applicable Collaboration Program or for such longer period as may be required by applicable Law. With respect to any Collaboration Programs for which the Opt-Out Party has not exercised its Opt-Out Option, the JRDC shall have the right, during normal business hours and upon reasonable notice, to inspect and copy all Program Records kept by a Party. Each Party shall provide the JRDC with detailed reports relating to its activities under each Collaboration Program each Calendar Quarter for the applicable Collaboration Program.

5.3.2    With respect to any Collaboration Program, within [***] of each year, each Party shall prepare and provide to the other Party a written report that summarizes the Development activities (including Manufacturing-related development activities) performed and the status of activities and progress with respect to the information included the Development Plan, and shall identify any issues or circumstances of which it is aware that may prevent or adversely affect in a material manner its future performance of activities assigned to it under the then-current Development Plan. The Parties may agree that minutes or presentations from Committee meetings

 

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may be used to satisfy this reporting requirement. Each Party shall have the right to review all reports related to any Clinical Studies for a Collaboration Product, whether such reports are generated by or on behalf of GSK, Vir or a CRO or subcontractor, provided that such Party has not exercised its Opt-Out Option.

5.4    Performance by Affiliates; Subcontracting.

5.4.1    Each Party conducting any Development activities under each Development Plan shall have the right to subcontract any of the activities assigned to it under any Development Plan to any of its Affiliates without further approval of the JRDC or the other Party; provided that no such permitted subcontracting shall relieve the subcontracting Party of any obligation hereunder and the subcontracting Party shall cause its permitted subcontractors to comply with its applicable obligations under this Agreement.

5.4.2    Subject to Section 5.4.3, each Party conducting any Development activities under each Development Plan may subcontract any of the activities assigned to it under any Development Plan to a Third Party subcontractor, including clinical research organizations (“CROs”), contract manufacturing organizations, subject to the following terms and conditions: (a) any such subcontracting to a Third Party shall be approved by the JRDC; (b) none of the rights of the other Party hereunder are diminished or otherwise adversely affected as a result of such subcontract; (c) such Third Party subcontractor shall be bound by a written agreement that is consistent with terms and conditions of this Agreement, including applicable confidentiality, publication and intellectual property ownership provisions; and (d) such Party shall remain responsible under this Agreement for ensuring, and shall be liable to the other Party for, the compliance of such Third Party subcontractor with this Agreement. Notwithstanding the foregoing, at the time of preparation of the Development Plan for a given Collaboration Product, where reasonably practicable, the Parties will discuss through the JRDC and agree upon any Third Party subcontractors that the Non-Lead Party anticipates it may wish to use to perform activities for or on behalf of such Non-Lead Party. Such pre-approved Third Party subcontractors will be listed in the Development Plan, and, no separate approval by the JRDC shall be required for the Non-Lead Party to use such Third Parties to perform activities with respect to any Collaboration Product under the same Collaboration Program. [***].

5.4.3    [***].

5.5    Clinical Studies.

5.5.1    Generally. All Clinical Studies of the Collaboration Products conducted by the applicable Party shall be conducted only pursuant to this Agreement and the applicable Development Plan. Any Clinical Studies of the Collaboration Product will be conducted in accordance with the Applicable Internal Policies and GCP standards and involve investigators of recognized competence. If agreed to by the Parties in writing or approved by the JRDC, or if a Party has a reasonable basis to believe a violation of applicable Law has occurred with respect to a given Clinical Study, each Party shall have the right, at its own expense and subject to the terms and conditions of any applicable agreements, to audit all Clinical Study sites used by the other Party, and have all other audit rights to ensure that any necessary compliance standards are upheld. Such audit shall be made at reasonable times during regular business hours

 

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and upon [***] prior notice to such other Party and the Clinical Study site. Summaries of results of all Clinical Studies conducted by either Party with respect to any Collaboration Product shall be published on GSK’s clinical trial register, unless GSK has exercised its Opt-Out Option and is not conducting or funding any activity with regard to the applicable program.

5.5.2    Investigator-Initiated Studies. The Lead Party shall determine, and the Development Plan shall set forth any sponsorship of investigator-initiated studies of the Collaboration Products. All sponsorship of such investigator-initiated studies shall be subject to approval by the JRDC or, where applicable, the JSC.

5.5.3    Clinical Study Protocol. All Clinical Studies conducted under a Development Plan will first be approved in concept by the JRDC. For any Clinical Studies that are to be conducted solely by a Party (including through an affiliated entity or a subsidiary) or its contractors, the protocol and related investigator’s brochures shall be designed by such Party in accordance with the approved Development Plan with review and input from the other Party within [***] after submission to the JRDC of the draft protocol; provided, that if the other Party identifies a material issue in the protocol, it may refer the issue to the JRDC for revision. Except as otherwise specified in the applicable Development Plan, the Lead Party will secure any required approvals from any IRBs, safety boards or the like. Notwithstanding the foregoing, the Party conducting the Clinical Study may make modifications to the protocol on an emergency basis for patient safety reasons and in such case, shall notify the JRDC and the other Party as promptly as practical.

5.6    Rights to Opt-Out

5.6.1    Opt-Out Points. On a Collaboration Product-by-Collaboration Product basis, each Party (whether the Lead Party or the Non-Lead Party, such Party, an “Opt-Out Party”) will have the one-time right to elect, pursuant to the procedures set forth in this Section 5.6 to cease funding its share of the Development Costs for such Collaboration Product in its entirety (the “Opt-Out Option”), with such right exercisable by providing the required written notice (an “Opt-Out Notice”) to the other Party, as further provided in this Section 5.6, at or prior to the following milestones (each, an “Opt-Out Point”):

(a)    [***]

(b)    [***];

(c)    [***]; and

(d)    [***].

For clarity, with respect to the Antibody Product containing the 309 Antibody under the existing Antibody Program (the “309 Antibody Product”), [***].

5.6.2    Share of Data and Materials. Within [***] for a Collaboration Product, the Lead Party (and the Non-Lead Party if applicable) conducting Development activities with respect to such Collaboration Product shall submit to the JRDC [***] conducted by such Party for such Collaboration Product from last Opt-Out Point (if any) to such Opt-Out Point (the “Development Summary”). The Development Summary shall include, where applicable, [***].

 

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Following presentation and discussion between the Parties, and within [***] after submission of the Development Summary to the JRDC, [***] shall be provided by the Party conducting the Development activities upon reasonable request by the other Party, provided that [***]. For clarity, this Section 5.6.2 shall apply even if [***].

5.6.3    Exercise of Opt-Out Option.

(a)    A Party may exercise an Opt-Out Option by delivering an Opt-Out Notice at any time prior to, and no later than [***] with respect to such Collaboration Product ([***]). The Opt-Out Option shall be deemed to be exercised upon (i) [***], or (ii) [***] (such date in (i) or (ii), the “Opt-Out Effective Date”).

(b)    If a Party exercises an Opt-Out Option in accordance with Section 5.6.3(a), then:

(i)    The Opt-Out Party shall be responsible for its allocation of all Development Costs and Manufacturing Costs for Development and Commercialization with respect to such Collaboration Product that are (A) incurred in connection with (x) Development, or (y) Manufacturing for Development or Commercialization activities up to the Opt-Out Effective Date, or (B) non-cancelable and, prior to the Opt-Out Effective Date, committed for such Collaboration Product in connection with [***] prior to the Opt-Out Effective Date, in each case, [***].

(ii)    Notwithstanding the foregoing, an Opt-Out Party [***]. For clarity, [***].

(iii)    The Opt-Out Party shall also be responsible for [***].

(c)    If a Party does not elect to exercise its Opt-Out Option at one of the above Opt-Out Points within the specified time periods in accordance with Section 5.6.3(a), it will be obligated to continue to fund all Development Costs for such Collaboration Product in accordance with Section 9.1.1, Section 9.1.2, or Section 9.1.3, as applicable, until such time as the next Opt-Out Point becomes available, if any; provided, that the share of Development Costs for which it is responsible shall not exceed the Development Costs set forth in the Development Plan and associated existing Development Budget (including Permitted Overage, or such other additional overage as the Parties have mutually agreed as of such time).

5.6.4    Parties Rights after Opt-Out.

(a)    Upon receipt of any Opt-Out Notice timely delivered by the Opt-Out Party in accordance with Section 5.6.3, the other Party (the “Non Opt-Out Party”) shall have the right, at any time after the Opt-Out Effective Date with respect to a Collaboration Product, to elect either to (i) continue with the Development and Commercialization of such Collaboration Product, at its own cost; or (ii) subject to the remainder of this Section 5.6.4, cease bearing Development Costs for future Development activities with respect to such Collaboration Product, in which case the Non Opt-Out Party may wind down the Development activities with respect to such Collaboration Product, or (iii) propose to out-license or otherwise divest such Collaboration

 

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Product, subject to the Opt-Out Party’s agreement. After the Opt-Out Party exercises its Opt-Out Option with respect to a Collaboration Product, the Non Opt-Out Party shall notify the Opt-Out Party of its decision to elect subsection (i), (ii) or (iii) in the foregoing within [***] following the Opt-Out Effective Date for such Collaboration Product (the “Non Opt-Out Notice”), provided that, [***], the election by the Non Opt-Out Party of subsections (i), (ii) or (iii) in the Non Opt-Out Notice shall not [***]. The Opt-Out Party shall, upon reasonable request by the Non Opt-Out Party, discuss with the Non Opt-Out Party in good faith, and cooperate to facilitate its decision-making, including by [***].

(b)    If, after the Opt-Out Party exercises its Opt-Out Option with respect to a Collaboration Product, the Non Opt-Out Party elects to continue with the Development and Commercialization of such Collaboration Product (which shall thereafter become a Sole Development Product and cease being a Collaboration Product), then:

(i)    the Opt-Out Party’s rights to share any Pre-Tax Profit or Loss in such Collaboration Product pursuant to Section 9.2 shall cease upon receipt of the Non Opt-Out Notice and the Opt-Out Party shall be entitled to receive royalties from the Non Opt-Out Party on Net Sales of such Sole Development Product in accordance with Section 9.5;

(ii)    the Non Opt-Out Party shall [***] perform such activities;

(iii)    the Opt-Out Party shall, subject to Section 10.2, provide reasonable assistance requested by the Non Opt-Out Party to (A) transfer or transition to the Non Opt-Out Party (or wind down, if applicable) all activities for which such Opt-Out Party was responsible prior to the exercise of the Opt-Out Option, [***]; (B) transfer to the Non Opt-Out Party relevant Data, information and materials [***], in each case ((A) or (B)), to the extent necessary for the Non Opt-Out Party’s continued conduct of Development, Manufacturing and Commercialization of such Sole Development Product, [***];

(iv)    with respect to [***], the Opt-Out Party shall, at the Non Opt-Out Party’s request [***], if the Opt-Out Party is required to [***] with respect to the Development, Manufacture and Commercialization of any Sole Development Product, then [***]; and

(v)    the JRDC, the JSC or other Committees shall no longer have authority over such Sole Development Product, and the applicable Development Plan and Development Budget will be of no further effect with respect to such Sole Development Product other than with respect to costs incurred prior to the Opt-Out Effective Date.

(c)    If, after the Opt-Out Party exercises its Opt-Out Option with respect to a Collaboration Product, the Non Opt-Out Party elects, [***] [***], to cease and wind down the Development activities with respect to such Collaboration Product, the Non Opt-Out Party shall conduct winding down activities in accordance with all applicable Law, and the Opt-Out Party shall, upon Non Opt-Out Party’s reasonable request, provide reasonable assistance with such winding down activities. [***].

 

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(d)    If, (i) after the Opt-Out Party exercises its Opt-Out Option with respect to a Collaboration Product, the Non Opt-Out Party elects, [***], or (ii) after the Opt-Out Party exercises its Opt-Out Option with respect to a Collaboration Product, [***] and the Non Opt-Out Party elects to, [***], in either case ((i) or (ii)), cease any further funding of, or Development or Commercialization activities with respect to such Collaboration Product, and out-license or otherwise divest such Collaboration Product, then (A) [***], (B) [***], and (C) [***].

(e)    If, after the Opt-Out Party exercises its Opt-Out Option with respect to a Collaboration Product, (i) the Non Opt-Out Party elects to, [***], cease any further funding of, or Development or Commercialization activities with respect to such Collaboration Product, and out-license or otherwise divest such Collaboration Product, and (ii) [***], then (A) [***], (B) [***] and (C) [***].

5.6.5    Animal Welfare. With respect to any Development activities conducted by either Party under this Agreement that involve the use of animals, including any animal studies, such Party agrees to comply with the terms of Schedule 5.6.5. For the avoidance of doubt, during the Term, neither Vir nor its Affiliates (either internally or through enabling a Third Party) shall Develop or Commercialize any Antibody Product for purposes of veterinary use.

ARTICLE 6

REGULATORY ACTIVITIES

6.1    Generally. Generally, the Parties will discuss and seek to agree upon the appropriate regulatory strategy for each Collaboration Product, taking into account any accelerated pathways to Regulatory Approval that may be available in connection with CoVID-19 and other diseases associated with Coronavirus infection.

6.2    Meetings and Communications. During the Term, each Party shall keep the other Party reasonably informed of any material communications from, or meetings with, any Regulatory Authority pertaining to such Party’s Development activities performed under this Agreement. To the extent relating to a Collaboration Product, the Party that is the regulatory sponsor or, following the release of headline data of the relevant Clinical Study, the applicant for the Drug Approval Application with respect to such Collaboration Product, shall provide the other Party with: (a) to the extent allowable by applicable Laws and the relevant Regulatory Authority and to the extent practicable, an opportunity to have one or more of its representatives attend and observe [***] in substantive discussions and meetings with the FDA or any other Regulatory Authority with respect to any Clinical Studies or other matters (e.g., CMC or non-clinical issues); (b) a copy of any material documents, reports or correspondence submitted to the FDA or any other Regulatory Authority; and (c) reasonable advanced notice (to the extent practicable) of substantive meetings, scheduled or unscheduled, with the FDA or any other Regulatory Authority. All such documents or reports described in subclause (b) above shall be provided to the JRDC at least [***] prior to their submission to the applicable Regulatory Authority (or such later date as the Parties may reasonably agree). To the extent a Party receives material written or oral communications from the FDA or any other Regulatory Authority relating to a Collaboration Product or activities under this Agreement with respect to a Collaboration Product, such Party shall notify the other Party and provide a copy of any such written communications to the other Party [***]. In addition, upon a reasonable request from the other Party, each Party shall provide copies of other documents, reports or communications from or to Regulatory Authorities relating to Collaboration Products.

 

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6.3    Regulatory Submissions.

6.3.1    Regulatory Filings.

(a)    For Collaboration Programs other than the Antibody Program, the Lead Party (and the LCP) for such Collaboration Program shall, in its own name, obtain and maintain all Regulatory Filings and Regulatory Approvals for Development, Manufacture and Commercialization of such Collaboration Products, including INDs, NDAs, BLAs, Regulatory Approvals for product labeling or promotional materials and other items filed with the FDA or other Regulatory Authorities with respect to any Collaboration Product under such Collaboration Program.

(b)    For the Antibody Program Vir, as the initial Lead Party, shall, in its own name, obtain and maintain Regulatory Filings for an Antibody Product prior to the filing of the first Drug Approval Application for such Antibody Product. [***]. After filing of the first Drug Approval Application for any Antibody Product, GSK shall be responsible for all subsequent Regulatory Filings and Regulatory Approvals for Development, Manufacture and Commercialization of such Antibody Product, in GSK’s name. The rights of GSK under this ARTICLE 6 with respect to an Antibody Product is subject to WuXi’s right with respect to Antibodies against SARS-COV-2 under the WuXi Agreement.

6.3.2    Other Filings. The Parties may discuss, through the JPC, regarding submission of patent information to the FDA as required for listing in the Orange Book (as required by 21 C.F.R. §214.53 (d)(2) and 35 U.S.C. §156 (Hatch-Waxman Act)), the “Purple Book” (or other Orange Book-equivalent database or listing for Biologics), or any foreign equivalents thereof, provided that the LCP shall have the decision-making authority and shall be responsible for such submission. Additionally, the LCP shall be responsible for all acts required of the reference product sponsor under the US Biologicals Price Competition and Innovation Act of 2009 (42 U.S.C. § 262) (“Biologics Act”), or any foreign equivalents thereof. Specifically, (a) for the Vaccine Program and the Functional Genomics Program, the LCP, and (b) for the Antibody Program, Vir (provided that Vir will reasonably consult with GSK through the JPC and shall consider in good faith GSK’s comments relating thereto), will control all of the actions, filings, and communications with any follow-on biologic applicant under the Biologics Act with respect to Collaboration Products including generating the following documents: [***].

6.4    Exchange of Development Data. Without limiting the other provisions of this Agreement, at the request of the Lead Party, or upon direction by the JSC or JRDC, the Non-Lead Party shall provide to the Lead Party [***] pertinent Data developed by or on behalf of the Non-Lead Party, as applicable, in connection with the Development of a Collaboration Product this Agreement or the performance of other activities under the Plans [***] for the Lead Party to satisfy Regulatory Approval requirements for application or maintenance of Regulatory Approvals of such Collaboration Product. The format of, and media for exchanging, such Data shall be decided by the JRDC. Each Party shall have the right, without obtaining the approval of the other

 

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Party and without additional payment to such other Party (other than payments expressly provided in this Agreement), to reference, access and use such Data, and all reports, documents and other information developed by any Party that is derived from such Data, (a) for purposes of preparing and submitting INDs, NDAs, BLAs and other Regulatory Filings for the Collaboration Products in the applicable Collaboration Program, and (b) preparing and filing patent applications, in each case ((a) and (b)) in accordance with this Agreement, and, with respect to such Data, reports, documents and other information developed by the other Party, solely to the extent permitted under this Agreement.

6.5    Lead Party Opt-Out. If the Lead Party exercises its Opt-Out Option with respect to a Collaboration Product pursuant to Section 5.6, and the Non-Lead Party elects to continue with the Development and Commercialization of such Collaboration Product as a Sole Development Product, then the Non-Lead Party shall notify the Lead Party in writing of such election, and thereafter shall be solely responsible for any Regulatory Filing or other regulatory activities with respect to such product. The Lead Party shall, upon reasonable request of the Non-Lead Party and to the extent permissible under applicable Law, transfer all regulatory documentation, including any Regulatory Filing or Regulatory Approval for such product Controlled by such Lead Party to the Non-Lead Party, and the Parties shall share the cost of such regulatory transfer in accordance with the profit-share percentages set forth in Section 9.2.1, as applicable. To the extent that such regulatory transfer is not permissible under applicable Law, the Parties shall discuss in good faith, and agree on a regulatory strategy to maintain such regulatory documentation for such Collaboration Product.

ARTICLE 7

COMMERCIALIZATION

7.1    General. Subject to the remainder of this ARTICLE 7, and any applicable Co-Promotion Agreement between the Parties, GSK shall be the LCP for each Collaboration Product, and GSK or its Affiliates shall have the sole right and responsibility for (a) Commercializing all Collaboration Products in the Territory, including [***]; and (b) all decisions for all Commercialization activities relating to each Collaboration Product, including [***]; provided that GSK’s right to Commercialize any Collaboration Product shall be subject to rights granted to WuXi in the WuXi Territory for Antibody directed to SARS-COV-2. [***].

7.2    Commercialization Plan.

7.2.1    With respect to each Collaboration Product, in connection with the determination to file the first Drug Approval Application for such Collaboration Product, the LCP shall prepare and provide to the JCC a commercialization plan (the “Commercialization Plan”) for such Collaboration Product. The LCP shall provide the initial Commercialization Plan for each Collaboration Product to the JCC [***]. Each such initial Commercialization Plan shall include, (a) [***]; (b) [***]; (c) [***]; (e) [***]; and (f) [***].

(a)    With respect to the initial Commercialization Plan (including the associated Commercialization Budget) [***], the JCC shall review and approve such Commercialization Plan and shall submit such Commercialization Plan to the JSC for the JSC to review and approve, with the exception of the portion relating to plans for Commercial

 

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Manufacture and supply for Commercialization, which shall be submitted to the JMC for review and approval prior to submission to the JSC for review and approval. If the JSC cannot agree on the Commercialization Plan submitted by the JCC within [***] after being submitted by the JCC or the JMC, whichever is later, then such dispute shall be resolved in accordance with Section 3.9.2. Each initial Commercialization Plan and associated Commercialization Budget [***] will go into effect once approved by the JSC in accordance with Section 3.9.

(b)    With respect to the initial Commercialization Plan (including the associated Commercialization Budget) [***], the JCC and the JSC shall review and discuss, and [***].

7.2.2    The LCP shall prepare and submit to the JCC for review and approval, on an annual basis, any material changes to each Commercialization Plan, including any updates to the Commercialization Budget for each Collaboration Product, no later than [***] of each Calendar Year.

(a)    With respect to the Commercialization Plan (including the associated Commercialization Budget) [***], the JCC shall review and approve such annual updates and shall submit such updates to the JSC for review and approval. If the JSC cannot agree on such updates submitted by the JCC within [***], then such dispute shall be resolved in accordance with Section 3.9.2. Upon the JSC’s preliminary approval, such updates shall be submitted to each Party for its internal budgeting process with a target for final approval no later than [***] of each Calendar Year, at which time any such approved update shall be appended to the Commercializ