Item 1.01 Entry into a Material Definitive Agreement.
On
For a period of three years following the Effective Date (the "Development
Term"), the parties will conduct certain research and development activities
under mutually agreed development plans and associated budgets for the
Collaboration Programs. Subject to certain exceptions, the parties will
exclusively collaborate with respect to (a) all Vir Influenza mAbs that the
parties agree to develop (with respect to VIR-2482, only if GSK exercises the
Option as described below) until such time as there are no Vir Influenza mAbs
being developed or commercialized by the lead party under the Influenza Program
or by a
If the Company in its discretion elects to proceed with development of VIR-2482, an intramuscularly administered investigational mAb designed as a universal prophylactic for influenza A that has completed a Phase 1 clinical trial, through completion of a Phase 2 clinical trial, then after the Company completes and reports the Phase 2 clinical trial outcomes for VIR-2482, GSK will have the exclusive option to obtain exclusive rights to co-develop and commercialize VIR-2482 (the "Option"). If the Company elects to proceed with development of VIR-2482, the Company will be responsible for development and clinical manufacturing activities for VIR-2482 through completion of Phase 2 clinical trials. If GSK exercises the Option, VIR-2482 will be included in the Influenza Program and the parties will collaborate on the further development, manufacturing and commercialization of VIR-2482. If GSK does not exercise the Option for VIR-2482, then in general, the Company has the right to continue the development and/or commercialization of VIR-2482 by itself or with a third party.
GSK will be the lead party for development, clinical and commercial manufacturing and commercialization activities for products under the Influenza Program (other than VIR-2482 unless and until GSK exercises the Option). The parties will mutually agree upon the allocation of responsibility for development of products under the Expanded Functional Genomics Program and the Additional Pathogen Program and upon the allocation of responsibility for pre-Phase 3 clinical trial manufacturing of products under the Additional Pathogen Program (in each case, subject to GSK's final decision making authority if the parties cannot agree), and GSK will be the lead party for commercial manufacturing and commercialization activities for products under the Functional Genomics Program and Additional Pathogen Program.
The parties will share 50% of all development costs in accordance with the
budget for each Collaboration Program, with each party having the right (on
a target-by-target basis with respect to the Expanded Functional Genomics
Program, or a collaboration product-by-collaboration product basis with respect
to the Influenza Program and the Additional Pathogen Programs) to opt-out of
its co-funding obligations at specified points in development. Following the
exercise of an opt-out right by a party, the other party (the "
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Of the
With respect to the Influenza Program and each Additional Pathogen Program,
unless earlier terminated, the Agreement will remain in effect for as long as
there is a product from such Collaboration Program being developed or
commercialized by the lead party in the Collaboration Program or by the
The foregoing description of the material terms of the Agreement is qualified in
its entirety by reference to the full text of the Agreement, a copy of which
will be filed as an exhibit to a subsequent filing with the
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. Words such as
"may," "will," "expect," "plan," "anticipate," "estimate," "intend," "potential"
and similar expressions (as well as other words or expressions referencing
future events, conditions or circumstances) are intended to identify
forward-looking statements. These forward-looking statements are based on the
Company's expectations and assumptions as of the date of this Current Report.
Each of these forward-looking statements involves risks and uncertainties.
Actual results may differ materially from these forward-looking statements.
Forward-looking statements contained in this Current Report include statements
regarding the potential benefits of the collaboration with GSK, the potential
benefits of VIR-2482 and the Company's ability to address influenza, respiratory
diseases, diseases caused by non-influenza target pathogens, and future
outbreaks of any such diseases. Many factors may cause differences between
current expectations and actual results, including unexpected safety or efficacy
data observed during preclinical or clinical studies, challenges in the
treatment of hospitalized patients, difficulties in collaborating with other
companies or government agencies, challenges in accessing manufacturing
capacity, successful development and/or commercialization of alternative product
candidates by our competitors, changes in expected or existing competition,
delays in or disruptions to our business or clinical trials due to
the COVID-19 pandemic, geopolitical changes or other external factors, and
unexpected litigation or other disputes. Other factors that may cause actual
results to differ from those expressed or implied in the forward-looking
statements in this Current Report are discussed in the Company's filings with
the
Item 5.07 Submission of Matters to a Vote of Security Holders.
On
Proposal 1. Election of Directors
The Company's stockholders elected the three persons listed below as Class II Directors, each to serve until the Company's 2024 Annual Meeting of Stockholders and until their respective successors are duly elected and qualified. The final voting results are as follows:
Votes Broker Votes For Withheld Non-Votes Robert Nelsen 82,484,773 14,341,277 9,704,618 Robert Perez 95,066,921 1,759,129 9,704,618
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Proposal 2. Approval, on an Advisory Basis, on the Frequency of Solicitation of Advisory Stockholder Approval of Executive Compensation
The Company's stockholders approved, on an advisory basis, the frequency of every one year as the frequency preferred by stockholders for the solicitation of advisory stockholder approval of the compensation paid to the Company's named executive officers. The final voting results are as follows:
Votes For Votes For Votes For Broker
1 Year 2 Years 3 Years Abstentions Non-Votes 96,639,117 117,118 33,838 35,977 9,704,618
In light of this result, the Company determined to hold future advisory votes on executive compensation every year until the next required advisory vote on the frequency of such stockholder votes.
Proposal 3. Ratification of the Selection of Independent Registered Public Accounting Firm
The Company's stockholders ratified the selection by the Audit Committee of the
Company's Board of Directors of
Broker Votes For Votes Against Abstentions Non-Votes 106,472,305 29,528 28,835 0
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