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Exhibit 10.2
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
AMENDED AND RESTATED EXCLUSIVE LICENSE AGREEMENT
BETWEEN
Icosavax, Inc.
AND
UNIVERSITY OF WASHINGTON FOR
Computationally Designed Nanoparticles and Vaccines Based Upon Such Designs
uw comotion agreement ref. [***]
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TABLE OF CONTENTS
Page
Exhibit A 26
Exhibit B 38
Exhibit C 39
Exhibit D 40
-i-
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AMENDED AND RESTATED EXCLUSIVE LICENSE AGREEMENT [***]
This Amended and Restated Exclusive License Agreement [***] (this “Agreement”), effective as of the date of last signature (the “Effective Date”), is made and entered into between the University of Washington, a public institution of higher education and an agency of the state of Washington, (“University”), and Icosavax, Inc., a for profit corporation under the laws of Delaware (“Company”).
BACKGROUND
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AGREEMENT
The Parties agree as follows:
“Acquisition” means (a) the sale by Company of all, or substantially all of, its assets in a transaction to a Third Party at arm’s length, (b) the sale, transfer, or exchange by the shareholders, partners, or equity owners of Company of a majority interest in Company’s outstanding stock in an arm’s length transaction to a Third Party, or (c) the merger of Company with a Third Party at arm’s length; provided, however, that in no event will (y) any bona fide equity financing for the primary purpose of raising capital for corporate purposes, or (z) any license, or any option to obtain a license, relating to all or substantially all of Company’s rights (whether such rights pertain to this Agreement or to Company’s rights more generally) that is granted to a Third Party (whether or not collaborative or partnership activities also will be conducted), be considered an Acquisition under this Agreement. For the avoidance of doubt, the Parties agree that any license or option to obtain a license, as stipulated in (z) above, shall be considered a Sublicense if such license or option to obtain a license includes sublicensed rights under this Agreement.
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“Acquisition Consideration” means all consideration for an Acquisition (including, as an example only, any payment made to exercise an option to effect an Acquisition) for the first Acquisition to occur after the Effective Date (but does not include any consideration received for any subsequent Acquisition). Any Acquisition Consideration is expressly excluded from Sublicense Consideration.
“Combination Product” means a product sold in a form containing a Licensed Product and at least one other product, component, or ingredient which could be sold separate and apart from the Licensed Product and which is not required for the function of the Licensed Product.
“Confidential Information” means any information or materials of a Party not generally known to the public, including any information comprised of those materials and Company’s business plans or reports. Confidential Information does not include any information that: (a) is, or becomes, part of the public domain through no fault of receiving Party; (b) is known to receiving Party prior to the disclosure by the disclosing Party, as evidenced by documentation; (c) is publicly released as authorized under this Agreement by University, its employees or agents; (d) is subsequently obtained on a non-confidential basis by receiving Party from a Third Party who is authorized to have and disclose such information; or (e) is independently developed by receiving Party without reliance on any portion of the Confidential Information received from the disclosing Party and without any breach of this Agreement as evidenced by documentation.
“Developing Countries” means the list of countries set forth on Exhibit C.
“Distributor” means a distributor, reseller or OEM to which a Licensed Party sells a Licensed Product for resale of Licensed Product by the Distributor, and where Distributor has no other rights with respect to the Licensed Rights other than to resell or otherwise distribute Licensed Products (including but not limited to integrated or bundled with other products or services), and for which resale or distribution such Licensed Party receives no further consideration (including but not limited to royalties and/or commissions) beyond the price for the initial sale of Licensed Product to the Distributor.
“Event of Force Majeure” means an unforeseeable act that prevents or delays a Party from performing one or more of its duties under this Agreement and that is outside of the reasonable control of the affected Party. An Event of Force Majeure includes acts of war or of nature, insurrection and riot, and labor strikes. An Event of Force Majeure does not include a Party’s inability to obtain a Third Party’s consent to any act or omission, unless the inability was caused by a separate Event of Force Majeure.
“Fair Market Value” means the average price at which the stock in question is publicly trading for twenty
(20) days prior to the announcement of its purchase by the Sublicensee(s), or, if the stock is not publicly traded, the value of such stock as determined in good faith by the board of directors of Company or Sublicensee.
“Field of Use” means prophylactic and/or therapeutic treatments in a defined “Indication Category”, specifically: for (i) respiratory syncytial virus (“RSV”) (the “First Indication Category”), (ii) human metapneumovirus (the “Second Indication Category”), (iii) [***] (the “Third Indication Category”), (iv) [***] (the “Fourth Indication Category”), (v) [***] (the “Fifth Indication Category”), (vi) [***] (the “Sixth Indication Category”), (vii) [***] (the “Seventh Indication Category”), (viii) [***] (the “Eighth Indication Category”), and (ix) [***] (the “Ninth Indication Category”). These viruses, bacteria and pathogens listed within each Indication Category represent a preliminary indication of Company’s priorities and targeted indications within the broad category of commercially attractive vaccines. Accordingly, University grants Company the right, from time to time, to re-order the priority of, and/or substitute a new replacement virus, bacteria and/or pathogen for any of the Indication Categories above by written notice to University (“Updated Indication Designation”) designating the new order of Indication Category(ies) and/or potential substitution (i.e., deletion of current and replacement with new) virus, bacteria and/or pathogen, subject to then-current availability (i.e., not exclusively licensed to a Third Party) of the replacement virus, bacteria and/or pathogen (as applicable) and University’s willingness to license such rights. The Parties agree that such Updated Indication Designation(s) shall be captured in a written amendment per Section 13.1 “Amendment and Waiver”.
“Improvements” means patentable inventions that (a) are owned by University after the Effective Date and not encumbered by Third-Party rights that would prevent delivery to Company, (b) would require a license under the exclusively Licensed Rights to practice, (c) were developed in the laboratory of the Principal Investigator, and identified to UW CoMotion as Improvements falling under this license, and (d) do not include an HHMI employee as an inventor under the applicable patent law.
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“IND” means an Investigational New Drug Application.
“Investigational New Drug Application” means a request from a clinical study sponsor to obtain authorization from the Food and Drug Administration to administer an investigational drug or biological product to humans in compliance with the requirements set forth in 21 CFR 312 (or its successor regulation), or its foreign equivalent.
“Licensed Know-How” means University knowledge or intangible work that: (a) was developed in the laboratory of Principal Investigator, (b) exists as of the Amendment No. 3 Effective Date, (c) is relevant to utilizing any of the Licensed Patents, (d) is unpublished, (e) is not subject to patent or copyright protection, and (f) is not covered by Third-Party rights that would prevent delivery to Company.
“Licensed Party” means Company or any of its Sublicensees.
“Licensed Patents” means (a) the patents and patent applications listed in Exhibit A1.1 “Licensed Patents”, all (b) divisions, continuations, and claims in continuations-in-part that are entitled to claim priority to, or that share a common priority claim with, and are directed to subject matter specifically described in, any item listed on Exhibit A1.1 “Licensed Patents”; (c) claims of extensions, renewals, substitutes, reexaminations and re-issues of any of the items in (a) or (b) that are directed to subject matter specifically described in any items listed on Exhibit A1.1; and (d) claims of foreign counterparts of any of the items in (a), (b), or (c) that are directed to subject matter specifically described in any items listed on Exhibit A1.1, wherever and whenever filed.
“Licensed Product” means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.
“Licensed Rights” means all rights granted to Company under Article 2 “License Grant” of this Agreement.
“Net Sales” means the gross amount received by a Licensed Party from Distributors, customers, end users and other Third Parties for sales, leases, and other dispositions of Licensed Products, less [***]. On sales of Licensed Products by made in other than an arm’s length transaction, the value of the Net Sales attributed to such transaction will be equal to the Net Sales that would have been received in an arm’s length transaction, based on sales of like quantity and quality of Licensed Products sold on or about the time of the transaction. Net Sales does not include sale, lease, disposition or other transfer of Licensed Products among or between Company, Subsidiaries and Sublicensees for the purpose of subsequent resale to a Third Party, but does include subsequent resale to such Third Party. For avoidance of doubt Net Sales are calculated on sales by a Licensed Party to Distributor, and not on the subsequent sale by Distributor.
Net Sales of Combination Products will be calculated by multiplying actual Net Sales of such Combination Products by the fraction A/(A+B), where “A” is the Net Sales price of the Licensed Product if sold or performed separately, and “B” is the Net Sales price of the other product, component or ingredient in the Combination Product if sold separately. If, on a country-by-country basis, the other product, component or ingredient in the Combination Product is not sold separately in said country, Net Sales for the purpose of determining running royalties of the Combination Product shall be calculated by multiplying actual Net Sales of the Combination Product by the fraction A/C where “A” is the Net Sales price of the Licensed Product, if sold separately, and “C” is the Net Sales price of the Combination Product. If, on a country-by-country basis, neither the Licensed Product, nor the other product, component or ingredient in the Combination Product, is sold separately in said country, Net Sales for the purpose of determining running royalties of the Combination Product shall be determined in good faith by the Parties. A Combination Product may include a Licensed Product and any separate product, component or ingredient or service developed by or in- licensed by a Licensed Party from a Third Party provided it is a Combination Product as defined in this Agreement.
“New Patent Applications” means patents and patent applications which claim Improvements and that the Company elects under Section 2.4 “Improvements” to include in the Licensed Patents.
“Parties” means University and Company and “Party” means either University or Company.
“Patent Expenses” means all reasonable costs (including attorneys’ and application fees) incurred by University in accordance with this Agreement to apply for, prosecute and maintain Licensed Patents, including but not limited to the costs of interferences, oppositions, inter partes review and re-examinations. Costs for interferences,
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oppositions, inter partes review, re-examinations and other complex and expensive patent-related proceedings will be incurred in consultation with Company, pursuant to the processes of Article 4 “Applications and Patents”. Patent Expenses also include reimbursement for in-house costs to apply for, prosecute and maintain Licensed Patents; provided they are for activities that would otherwise have been performed by outside counsel at an equal or greater expense.
“Performance Milestone” means any of the milestones described in Section A2 “Performance Milestones” of attached Exhibit A “License Schedule”.
“Performance Milestone Date” means the date by which a Performance Milestone is to be achieved as set forth in Section A2 “Performance Milestones” of attached Exhibit A “License Schedule”, as such date may be extended pursuant to Section 5.1 “Performance Milestones” or as otherwise agreed upon by the Parties.
“Permitted Sublicense” means any arm’s length agreement with a Third-Party manufacturer, contract research organization or contract researcher/developer with whom a Licensed Party contracts for manufacture, research or development of Licensed Products on Licensed Party’s behalf, and where such Third Party has no other rights with respect to the Licensed Rights other than to manufacture, research or develop on behalf of Licensed Party.
“Permitted Sublicensee” means a Third Party holding a Permitted Sublicense.
“Phase 2 Trial” means a human clinical trial that would satisfy the requirements for a Phase 2 study as defined in 21 C.F.R. §312.21(b) (or its successor regulation), or its foreign equivalent.
“Phase 3 Trial” means a human clinical trial that would satisfy the requirements for a Phase 3 study as defined in 21 C.F.R. §312.21(c) (or its successor regulation), or its foreign equivalent.
“Sales Report” means a report in substantially the form set forth in Exhibit B “Royalty Report Form”. “Shares” means shares of the Company’s common stock.
“Sublicense” means the grant by a Licensed Party to a Third Party of any license, option, first right to negotiate, or other right granted under the Licensed Rights, in whole or in part. The grant of the right to resell to a Distributor and the grant of a license or other right to use a Licensed Product to an end-user, where the end user has no other rights with respect to the Licensed Rights other than to be an end user of the Licensed Product, will not be a Sublicense and will be treated solely under Net Sales.
“Sublicensee” means a Third Party holding a Sublicense under the Licensed Rights.
“Sublicense Consideration” means all consideration, including but not limited to [***]; but excluding [***]. For avoidance of doubt, consideration paid to Company by Sublicensees for the following shall not be deemed Sublicense Consideration: [***]. For clarity, University acknowledges and agrees that, if Company should enter into an agreement with a Third Party that includes a Sublicense as part, but not all, of the subject matter of such agreement, then the total non-royalty consideration paid to Company under such Third-Party agreement will not be deemed Sublicense Consideration merely because a Sublicense is granted (since only a portion of the consideration received is for the grant of the Sublicense).
Furthermore, to the extent that: (1) this Agreement has not been assigned by Company prior to the date Sublicense Consideration is received by Company; and (2) Company has not raised more than [***] in equity financing prior to the date Sublicense Consideration is received by Company, amounts received by Company from a Third Party for [***], shall be excluded from Sublicense Consideration, as stipulated in the paragraph above in (a)(ii). Company will provide to University a copy of the [***] together with a copy of the executed Sublicense as required by Section 2.3 “Sublicense Rights”.
“Territory” means worldwide.
“Third Party” means an individual or entity other than University and Company. “Third-Party” (with the hyphen) is used in the Agreement when used as a modifier.
“Valid Claim” means (a) a claim in an issued, unexpired United States or granted foreign patent included in the Licensed Patents that: (i) has not been held invalid, unpatentable, or unenforceable by a decision of a court or other
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governmental agency of competent jurisdiction and not subject to appeal (ii) has not been admitted to be invalid or unenforceable through reissue, inter partes review, disclaimer, or otherwise, (iii) has not been lost through an interference, reexamination, or reissue proceeding; or (b) a pending claim of a pending patent application included in the Licensed Patents.
Additional Definitions. The following terms have the meanings set forth in the corresponding sections of this Agreement, as described below.
Defined Term | Section |
“Accountants” | 6.5.1 |
“Act” | 13.3.3 |
“Additional BMGF Agreements” | Background |
“Agreement” | Preamble |
“Amendment No. 1 Effective Date” | Background |
“Amendment No. 3 Effective Date” | Background |
“BMGF” | Background |
“BMGF Agreements” | Background |
“BMGF Humanitarian License” | Background |
“BMGF Reservation of Rights” | Background |
“Claim” | 10.2.1 |
“[***] PCT Application” | 4.4 |
“[***] Provisional Application” | 4.4 |
“Company” | Preamble |
“Dispute Notice” | 13.4 |
“Effective Date” | Preamble |
“Eighth Indication Category” | Definition of Field of Use |
“Financial Milestone” | A3.4 |
“Fifth Indication Category” | Definition of Field of Use |
“First Indication Category” | Definition of Field of Use |
“Flu NA License” | A3.2.2 |
“Flu Non-Exclusive License” | A3.2.2 |
“Fourth Indication Category” | Definition of Field of Use |
“HHMI” | Background |
“HHMI Claims” | 10.2.2 |
“HHMI Indemnitees” | 10.2.2 |
“HHMI License” | 2.8 |
“Humanitarian License” | 3.4 |
Defined Term | Section |
“Indemnitee” | 10.2.1 |
“Indication Category” | Definition of Field of Use |
“Initial Notice Period” | 9.8 |
“IRB” | Background |
“Ninth Indication Category” | Definition of Field of Use |
“[***]” | Definition of [***] |
“[***]” | Definition of [***] |
“Option” | 13.21 |
“Original License Agreement” | Background |
“Other License Agreements” | A3.2.2 |
“Principal Investigator” | Background |
“Restated [***] Provisional Application” | 4.4 |
“SARS-CoV-2 License” | A3.2.2 |
“Second Indication Category” | Definition of Field of Use |
“Sell-Off Period” | 9.6 |
“Seventh Indication Category” | Definition of Field of Use |
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“Sixth Indication Category” | Definition of Field of Use |
“Subsidiaries” | 2.7 |
“Third Indication Category” | Definition of Field of Use |
“University” | Preamble |
“Utah” | Background |
and insurance. Each Sublicense agreement must also contain obligations, terms and conditions in favor of HHMI or the HHMI Indemnitees, as applicable, that are substantially similar to those undertaken by Company in favor of HHMI or the HHMI Indemnitees, as applicable, under this Agreement and intended for the protection of the HHMI Indemnitees, including, without limitation, the obligations, terms and conditions regarding indemnification, insurance and HHMI’s Third-Party beneficiary status. Company will provide University with a copy of the executed Sublicense, excluding any Permitted Sublicense agreement, within thirty (30) days after its execution. Company will not enter into any Sublicense agreement if the terms of such agreement are inconsistent in any material respect with the material terms of this Agreement. Any Sublicense made in violation of this Section 2.3 “Sublicense Rights” will be void and will constitute an event of default that requires remedy under Section 9.2 “Termination by University”.
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(a) Company is responsible for all acts of such Subsidiaries as if they were acts of the Company, (b) such Subsidiary is bound in writing to perform all obligations to University and HHMI of this Agreement other than making payments pursuant to Article 6 “Payments, Reimbursements, Reports, and Records”, as if such Subsidiary were Company, and (c) Company reports to University pursuant to Section 13.10 “Notices” that such Subsidiary will be exercising rights under this Agreement prior to such Subsidiary exercising any such rights under this Agreement. For avoidance of doubt, Company may perform any obligation of Subsidiary on Subsidiary’s behalf.
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Subject to applicable laws and for the purpose of achieving Global Access, You grant the Foundation a nonexclusive, perpetual, irrevocable, worldwide, royalty-free, fully paid up, sublicensable license to make, use, sell, offer to sell, import, distribute, copy, create derivative works, publicly perform, and display Funded Developments and Essential Background Technology. “Essential Background Technology” means Background Technology that is: (a) owned, controlled, or developed by You, or in-licensed with the right to sublicense; and (b) either incorporated into a Funded Development or reasonably required to exercise the license to a Funded Development. If You demonstrate to the satisfaction of the Foundation that Global Access can best be achieved without this license, the Foundation and You will make good faith efforts to modify or terminate this license, as appropriate.
Notwithstanding anything to the contrary, BMGF and University agreed in the Additional BMGF Agreements that the original Indication Categories listed in the definition of the Field of Use in the Original License Agreement as originally executed, i.e., the Indication Categories listed prior to the Amendment No. 1 Effective Date, are not subject to the Humanitarian License. The Indication Categories that remain in the Field of Use as of the Effective Date and that are not subject to the BMGF Humanitarian License are RSV, [***] and [***].
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All wire or electronic fund transfers must be confirmed via email referencing the above agreement number to: ipfin@uw.edu
Wire transfers: Electronic Fund Transfer (ACH):
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Except as set forth in Subsection 9.8.5 “Time Limitations”, University may, at its sole discretion, waive any of the
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requirements in Subsections 9.8.1 through 9.8.4. If all of the conditions set forth in this Section 9.8 “Sublicenses After Termination” are met, then Sublicensee will be granted such direct license by University. If any condition set forth in this Section 9.8 “Sublicenses After Termination” is not met, then after expiration of any time period granted to Sublicensee with respect to meeting such condition (for example and to the extent applicable, the Initial Notice Period and/or the periods described in Subsections 9.8.4 “Sublicensee Certification that Conditions are Satisfied” and 9.8.5 “Time Limitations”), Sublicensee will not practice Licensed Rights except as provided for in Section 9.6 “Effect of Termination” and University will be free to license or not license Licensed Rights to such Sublicensee according to University’s sole discretion.
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(ii) in the interinstitutional agreement between University and Utah, Utah represents that its inventors are obligated to assign to Utah all of the inventors’ rights in the Licensed Patents, and that Utah will use diligent efforts to cause its inventors to sign any additional papers as may be necessary to evidence such assignment.
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(iii) to employees and trustees of HHMI who have a need to know. In no event will receiving Party incorporate or otherwise use disclosing Party’s Confidential Information in connection with any patent application filed by or on behalf of receiving Party. Receiving Party will restrict the use of disclosing Party’s Confidential Information to uses exclusively in accordance with the terms of this Agreement. Receiving Party will use reasonable procedures to safeguard disclosing Party’s Confidential Information. In the case where Company is the receiving Party, Company’s confidentiality obligations will also apply equally to Sublicensees.
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(iii) Company disputes in good faith any amounts that are owed to University under this Agreement, and a late fee for such disputed amount has been charged to Company under Section 6.3 “Late Payments”, then Company may provide University with a written dispute notice (“Dispute Notice”). In the case of (i) and (ii) above such Dispute Notice must be received by University prior to expiration of the 60-day cure period referenced in Section 9.2 “Termination by University”, stating the basis of Company’s disagreement with respect to such default or cure. In the case of (iii) above such Dispute Notice must be received by University within thirty (30) days of being charged a late fee for such disputed amount. If Company disputes that a default has occurred as contemplated in Section 9.3 “Events of Default”, then Company may provide University with a Dispute Notice within thirty (30) days of University sending the notice of termination referenced in Section 9.3 “Events of Default”. Upon receipt of a Dispute Notice, University’s right to terminate this Agreement or demand payment of late fees will be suspended and all rights under this Agreement will continue unaffected provided the dispute resolution process in this Section 13.4 “Escalation; Dispute Resolution” is being exercised. Any dispute will first be escalated to Company’s Chief Executive Officer or to a representative from Company’s Board of Directors, and to University’s Vice President for Innovation Strategy, representatives of which will be instructed to work in good faith to attempt to reach a mutually acceptable resolution of the dispute that would avoid termination of this Agreement. If the representatives are unable to reach such resolution of the dispute within thirty (30) days of delivery of the Dispute Notice, an independent, neutral mediator acceptable to both Parties (acting reasonably) will be appointed. The Parties will submit their dispute to mediation according to such parameters as they may mutually agree in writing. The Parties agree to discuss their differences in good faith and to attempt in good faith, with facilitation by the mediator, to reach an amicable resolution of the dispute within thirty (30) days after the mediator’s appointment. If the Parties are not able to agree on resolution of the dispute within such period, or within ninety (90) days of the Dispute Notice, whichever is earlier, including agreeing on a new Performance Milestone pursuant to Section 5.2 “Renegotiation of Performance Milestones” if that is the subject of the dispute, then the dispute resolution process of this Section 13.4 “Escalation; Dispute Resolution” will be complete and either Party may pursue any other action that is legally available to it. Notwithstanding the foregoing, no dispute affecting the rights or property of HHMI shall be subject to the dispute resolutions provisions set forth above.
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If to University: UW CoMotion
ATTN: Director, Innovation Development 4545 Roosevelt Way NE, Suite 400
Seattle, WA 98105-4721
Facsimile No.: 206-685-4767
If to Company: Icosavax, Inc.
ATTN: Adam Simpson
1930 Boren Ave, Suite 1000
Seattle, WA 98101
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IN WITNESS WHEREOF, the Parties have caused this Agreement to be duly executed by their respective authorized representatives.
University of Washington By: /s/ Dennis Hanson Name: Dennis Hanson Title: Director, UW CoMotion Date: 6/8/2023 | Icosavax, Inc. By: /s/ Cassia Cearley Name: Cassia Cearley Title: Chief Business Officer Date: 6/8/2023 |
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Exhibit A License Schedule
A1. Licensed Rights:
A1.1 Licensed Patents:[***]
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A2. Performance Milestones (Section 5.1 “Performance Milestones”): Subject to Company’s right to renegotiation or Company’s payment of a fee for extension as set forth in Article 5 “Commercialization” of the Agreement, Company will perform, or shall cause to happen or be performed, the following Performance Milestones:
| Performance Milestone and Performance Milestone Date for First Indication Category in the Field of Use |
A2.1.1 Performance Milestone 1 | [***] |
A2.1.2 Performance Milestone 2 | [***] |
A2.1.3 Performance Milestone 3 | [***] |
[***]
A2.1.4 Performance Milestone 4 | [***] |
A2.1.5 Performance Milestone 5 | [***] |
A2.1.6 Performance Milestone 6 | [***] |
A2.1.7 Performance Milestone 7 | [***] |
| Performance Milestone and Performance Milestone Date for Second Indication Category in the Field of Use |
A2.2.1 Performance Milestone 1 | [***] |
A2.2.2 Performance Milestone 2 | [***] |
A2.2.3 Performance Milestone 3 | [***]. |
A2.2.4 Performance Milestone 4 | [***] |
A2.2.5 Performance Milestone 5 | [***] |
A2.2.6 Performance Milestone 6 | [***] |
A2.2.7 Performance Milestone 7 | [***] |
| Performance Milestone and Performance Milestone Date for Third Indication Category in the Field of Use |
A2.3.1 Performance Milestone 1 | [***] |
A2.3.2 Performance Milestone 2 | [***] |
[***]
A2.3.3 Performance Milestone 3 | [***] |
A2.3.4 Performance Milestone 4 | [***] |
A2.3.5 Performance Milestone 5 | [***] |
A2.3.6 Performance Milestone 6 | [***] |
A2.3.7 Performance Milestone 7 | [***] |
| Performance Milestone and Performance Milestone Date for Fourth Indication Category in the Field of Use |
A2.4.1 Performance Milestone 1 | [***] |
A2.4.2 Performance Milestone 2 | [***] |
A2.4.3 Performance Milestone 3 | [***] |
A2.4.4 Performance Milestone 4 | [***] |
A2.4.5 Performance Milestone 5 | [***] |
A2.4.6 Performance Milestone 6 | [***] |
A2.4.7 Performance Milestone 7 | [***] |
| Performance Milestone and Performance Milestone Date for Fifth Indication Category in the Field of Use |
A2.5.1 Performance Milestone 1 | [***] |
[***]
A2.5.2 Performance Milestone 2 | [***] |
A2.5.3 Performance Milestone 3 | [***] |
A2.5.4 Performance Milestone 4 | [***] |
A2.5.5 Performance Milestone 5 | [***] |
A2.5.6 Performance Milestone 6 | [***] |
A2.5.7 Performance Milestone 7 | [***] |
| Performance Milestone and Performance Milestone Date for Sixth Indication Category in the Field of Use |
A2.6.1 Performance Milestone 1 | [***] |
A2.6.2 Performance Milestone 2 | [***] |
A2.6.3 Performance Milestone 3 | [***] |
A2.6.4 Performance Milestone 4 | [***] |
A2.6.5 Performance Milestone 5 | [***] |
A2.6.6 Performance Milestone 6 | [***] |
A2.6.7 Performance Milestone 7 | [***] |
[***]
| Performance Milestone and Performance Milestone Date for Seventh Indication Category in the Field of Use |
A2.7.1 Performance Milestone 1 | [***] |
A2.7.2 Performance Milestone 2 | [***] |
A2.7.3 Performance Milestone 3 | [***] |
A2.7.4 Performance Milestone 4 | [***] |
A2.7.5 Performance Milestone 5 | [***] |
A2.7.6 Performance Milestone 6 | [***] |
A2.7.7 Performance Milestone 7 | [***] |
| Performance Milestone and Performance Milestone Date for Eighth Indication Category in the Field of Use |
A2.8.1 Performance Milestone 1 | [***] |
A2.8.2 Performance Milestone 2 | [***] |
A2.8.3 Performance Milestone 3 | [***] |
A2.8.4 Performance Milestone 4 | [***] |
A2.8.5 Performance Milestone 5 | [***] |
[***]
A2.8.6 Performance Milestone 6 | [***] |
A2.8.7 Performance Milestone 7 | [***] |
| Performance Milestone and Performance Milestone Date for Ninth Indication Category in the Field of Use |
A2.9.1 Performance Milestone 1 | [***] |
A2.9.2 Performance Milestone 2 | [***] |
A2.9.3 Performance Milestone 3 | [***] |
A2.9.4 Performance Milestone 4 | [***] |
A2.9.5 Performance Milestone 5 | [***] |
A2.9.6 Performance Milestone 6 | [***] |
A2.9.7 Performance Milestone 7 | [***] |
A3. Payments (Section 6.1):
A3.1 Annual Maintenance Fee. Company will pay to University an annual, non-creditable, maintenance fee of [***] due on each anniversary of the effective date of the Original License Agreement, provided that no annual maintenance fee will be due in any year Company pays minimum annual royalties.
A3.2 Running Royalty Payments. Company will pay to University within sixty (60) days after the last day of each calendar quarter during the term of this Agreement an amount equal to [***] during such quarter as a running royalty payment.
A3.2.1 Stacking or Third-Party Royalty. If a Licensed Party is required to pay royalties to a Third Party based on such Licensed Party’s manufacture, use, offer for sale, sale or import of Licensed Product, subject to one or more patents of such Third Party, then the royalty Company pays to University may be reduced [***] of the royalty actually paid to the Third Party; provided that [***] of Licensed Product, and provided that the royalty amount paid to the University shall not fall below [***] of Net Sales.
[***]
A3.2.2 Only One Royalty. University and Company acknowledge that the Parties have entered into the License and Exclusive Option Agreement (University reference number [***]), such agreement effective as of July 2, 2020, as amended (as the same may be amended from time to time, the “SARS- CoV-2 License”), the Non-Exclusive License Agreement (University reference number [***]), such agreement effective as of September 16, 2021 (as the same may be amended from time to time, the “Flu Non-Exclusive License”) and the Exclusive License Agreement (University reference number [***]), such agreement effective as of December 14, 2022 (as the same may be amended from time to time, the “Flu NA License,” and together with the SARS-CoV-2 License and the Flu Non-Exclusive License, the “Other License Agreements”), pursuant to which University granted to Company licenses under certain licensed know-how and certain licensed patents in certain fields of use, such that, among other things, Company may potentially develop, manufacture, use and commercialize combinatorial Licensed Products comprising two or more antigens pursuant to this Agreement and also pursuant to either of the Other License Agreements. Such combinatorial Licensed Products will bear only one royalty, reportable and payable under this Agreement. For clarity, if Company is required to pay royalties on Net Sales of any Licensed Product under this Agreement, Company will not be required to pay duplicate royalties under any of the Other License Agreements with respect to such Licensed Product. By way of example, and without limitation, if Net Sales include sales of a product that includes a product that is subject to any of the Other License Agreements and a Licensed Product that is subject to this Agreement, then the royalty rate with respect to such combination product will be [***] of Net Sales, subject to any modifications for Third-Party royalties as set forth in Section A3.2.1 of this Agreement, Section A3.1.1 of the SARS-CoV-2 License, Section A3.3.1 of the Flu NA License and Section A3.3.1 of the Flu Non-Exclusive License.
A3.3 Minimum Annual Royalties. Company will pay minimum annual royalties for the term of this Agreement to be creditable against running royalty payments for the preceding calendar year on a non- cumulative basis and to be due in full and payable on January 31st of each year beginning on January 31st following the first full calendar year after the first commercial sale of a Licensed Product and continuing during the term of this Agreement according to the following schedule:
Calendar Year | Minimum Annual Royalty |
Year [***] after first commercial sale | [***] |
Year [***] after first commercial sale | [***] |
Year [***] after first commercial sale and each year after | [***] |
A3.3.1 If this Agreement is terminated prior to the payment of a minimum annual royalty in any given year, then the amount due for that minimum annual royalty payment will be prorated on the basis of the number of full quarters that have elapsed prior to termination since the last payment of a minimum annual royalty.
A3.4 Financial Milestone Payments. Company will pay to University the following non- cumulative, non-creditable, and non-refundable, one-time Performance Milestone achievement payments for each of First Indication Category, Second Indication Category, Third Indication Category, Fourth Indication Category, Fifth Indication Category, Sixth Indication Category, Seventh Indication Category, Eighth Indication Category, and Ninth Indication Category within thirty (30) days of achieving the corresponding Performance Milestone, whether achieved by Company or a Sublicensee (each, a “Financial Milestone”):
| Performance Milestone Achieved |
[***] | Performance Milestone 4 in A2.1.4, A2.2.4, A2.3.4, A2.4.4, A2.5.4, A2.6.4, A2.7.4, A2.8.4, or A2.9.4 |
[***] | Performance Milestone 5 in A2.1.5, A2.2.5, A2.3.5, A2.4.5, A2.5.5, A2.6.5, A2.7.5, A2.8.5, or A2.9.5 |
[***] | Performance Milestone 6 in A2.1.6, A2.2.6, A2.3.6, A2.4.6, A2.5.6, A2.6.6, A2.7.6, A2.8.6, or A2.9.6 |
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[***] | Cumulative Net Sales of [***] for First Indication Category, Second Indication Category, Third Indication Category, Fourth Indication Category, Fifth Indication Category, Sixth Indication Category, Seventh Indication Category, Eighth Indication Category, or Ninth Indication Category |
For the avoidance of doubt, total Financial Milestones for each Indication Category shall not exceed [***] and total Financial Milestones under this Agreement shall not exceed [***]. Each Financial Milestone shall be payable only once for the applicable Indication Category even if such milestone is achieved by more than one Licensed Product.
University and Company acknowledge that the Parties entered into the Other License Agreements, pursuant to which University granted to Company licenses under certain licensed know-how and certain licensed patents in certain fields of use, such that, among other things, Company may potentially develop, manufacture, use and commercialize combinatorial Licensed Products comprising two or more antigens pursuant to this Agreement and also pursuant to any of the Other License Agreements. In the event any such combinational Licensed Product achieves any milestone under this Agreement and any Other License Agreement with the same triggering event, Company shall only be responsible for the corresponding milestone payment under this Agreement and Company will not be required to pay the milestone payment with respect to the achievement of the same milestone event under the Flu NA License, the Flu Non- Exclusive License and/or the SARS-CoV-2 License. By way of example, and without limitation, if Company initiates a Phase 2 Trial that includes a Licensed Product that is subject to this Agreement and a product that is subject to the Flu NA License, the Flu Non-Exclusive License and/or the SARS-CoV-2 License, then Company shall be responsible only for the applicable Financial Milestone under this Agreement.
A3.5 Equity. In consideration for the rights granted to Company hereunder, in accordance with Section A3.5 (Equity) of the Original License Agreement, Company previously issued to University [***] Shares, which converted into [***] shares in the reverse stock split effected in connection with the Company’s initial public offering.
A3.5.1 Participation Rights. The Parties acknowledge that Section A3.5.1 (Participation Rights) under the Original License Agreement expired on the date Company closed its initial public offering of its common stock (i.e., August 2, 2021).
A3.6 Sublicense Consideration. Within sixty (60) days of the end of each calendar quarter during the term of this Agreement, Company will pay to University [***] any Sublicense Consideration received by Company during such calendar quarter unless reduced by achievement of Performance Milestones by Company or its Sublicensees prior to execution of the particular Sublicense in accordance with the schedule below. Determination of the relevant Performance Milestone having been achieved for the purposes of determining the Sublicense Consideration percentage shall be based on the [***] (without regard to whether [***]). For clarity, if Company also grants a Sublicensee a sublicense under any of the Other License Agreements, Company will not be required to pay to University under this Agreement and/or such Other License Agreements an aggregate amount in excess of the percentage of the Sublicense Consideration set forth in this Agreement. A further reduction of the percentage of Sublicense Consideration payable to University under this Agreement will be negotiated in good faith between the Parties where, in addition to the Sublicense of any rights granted to Company hereunder, Company or its Sublicensee also grants a Sublicensee a license or sublicense under a Third Party’s intellectual property rights that are or would be infringed by Licensed Product(s) (treating pending patent applications as if they were issued patents), but only to the extent that the total aggregate consideration for such combined license is treated as Sublicense Consideration.
| Performance Milestone of the Most Advanced Licensed Product that Has Been Achieved at the Date of Execution of the Sublicense | Sublicense Consideration Percentage |
A3.6.1 Milestone 1 | Performance Milestone 1 in any Indication Category | [***] |
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A3.6.2 Milestone 2 | Performance Milestone 2 in any Indication Category | [***] |
A 3.6.3 Milestone 3 | Performance Milestone 3 in any Indication Category | [***] |
A3.6.4 Milestone 4 | Performance Milestone 4 in any Indication Category | [***] |
A3.6.5 Milestone 5 | Performance Milestone 5 in any Indication Category | [***] |
A3.6.6 Milestone 6 | Performance Milestone 6 in any Indication Category | [***] |
A3.6.7 Milestone 7 | Performance Milestone 7 in any Indication Category | [***] |
A3.7 Patent Expense Payment. Company will pay, or reimburse University for paying, all Patent Expenses on a pro rata basis with any other licensees of the Licensed Patents, incurred before, on or after the Effective Date within thirty (30) days of its receipt of University’s invoice for such Patent Expenses. University reserves the right to request advance payments for certain Patent Expenses, at University’s discretion.
A3.7.1 Notwithstanding Sections 4.2 and 4.3 of this Agreement, if at any time Company is not fully reimbursing University for Patent Expenses, or fails to provide advance payment when requested, University shall make patent filing, prosecution, and maintenance decisions, including choosing in which countries to prosecute patents, in its sole discretion and Company shall have no rights to provide instruction or to take over patent prosecution. University shall reasonably consider input provided by Company but have no obligation to act on such input.
Exhibit B
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Exhibit C
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Exhibit D
Additional BMGF Agreements
[Exhibit D to follow]
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