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. PUBLIC HEALTH SERVICE Amendment This Agreement is based...
Exhibit 10.3
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.
PUBLIC HEALTH SERVICE
Amendment
This Agreement is based on the model Amendment Agreement adopted by the U.S. Public Health Service ("PHS") Technology Transfer Policy Board for use by components of the National Institutes of Health ("NIH"), the Centers for Disease Control and Prevention ("CDC"), and the Food and Drug Administration ("FDA"), which are agencies of the PHS within the Department of Health and Human Services ("HHS").
This Cover Page identifies the Parties to this Agreement:
The U.S. Department of Health and Human Services, as represented by National Institute of Allergy and Infectious Diseases
an Institute or Center (hereinafter referred to as the "NIAID") of the
NIH
and
hereinafter referred to as the "Licensee",
having offices at 0000 Xxxxx Xxx., Xxxxx 0000, Xxxxxxx, XX 00000, created and operating under the laws of Delaware.
Tax ID No.: [***]
THIRD AMENDMENT TO [***]
Third Amendment of [***] Model 10-2015
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[Final]
[Icosavax, Inc.]
[May 2023]
This is the Third amendment ("Third Amendment") of the agreement by and between the NIAID and Licensee having an effective date of June 28, 2018 and having NIAID Reference Number [***], as amended by the First amendment dated September 10, 2018 and having NIAID Reference Number [***] (the "First Amendment") and the Second amendment dated September 9, 2020 and having NIAID Reference Number [***] (the "Second Amendment") ( the "Agreement"). This Third Amendment, having NIAID Reference Number [***] includes, in addition to the amendments made below, a Signature Page.
WHEREAS, the NIAID and the Licensee desire that the Agreement be amended a third time as set forth below.
NOW, THEREFORE, in consideration of the mutual covenants and promises contained herein, the NIAID and the
Licensee, intending to be bound, hereby mutually agree to the following (all additions are shown in underline and
deletions are shown in strike out):
Icosavax, Inc., hereinafter referred to as the "Licensee" having offices at 0000 Xxxxxxxx Xxxxxx Xxxx, Xxxxx 000, Xxxxxxx Xxxxxxxxxx, 00000 0000 Xxxxx Xxx., Xxxxx 0000, Xxxxxxx, XX 00000, created and operating under the laws of Delaware.
2.16. "Licensed Products" means tangible materials, which in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights in the country in which such processes are practiced that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction. [***]
2.19. "Net Sales" means, with respect to a Licensed Product or Licensed Process, the total gross receipts for sales of such Licensed Product(s) or practice of such Licensed Process(es) by or on behalf of the Licensee or of its Affiliates or sublicensees to third parties, and from leasing, renting or otherwise making Licensed Products available to third parties without sale or other dispositions, whether invoiced or not, less the following items: (a) returns, allowances, and credits given or made for rejection or return of previously sold Licensed Products or Licensed Processes or for retroactive price reductions that are actually allowed and granted in the specific reporting period, (b) packing costs, insurance costs, freight out and other transportation charges, (c) taxes or excise duties or other governmental charges imposed on the transaction (if separately invoiced), (d) rebates and chargeback payments granted to managed health care organizations, pharmacy benefit managers (or equivalents thereof), and government agencies, and (e) wholesaler and cash and quantity discounts in amounts customary in the trade to the extent actually granted. No deductions shall be made for [***].
Notwithstanding the foregoing, transfers of Licensed Product or practice of the Licensed Process internally among Licensee, its Affiliate(s), or their respective sublicensees shall be exempt from the calculation of Net Sales, unless the recipient is an end user of the Licensed Product or Licensed Process. The supply of Licensed Product or practice of Licensed Process as samples for charitable, or non-commercial purposes, for use in non-clinical or clinical trials, or any test or other studies reasonably necessary to comply with any applicable laws shall not be included in the calculation of Net Sales.
Third Amendment of [***] Model 10-2015
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[Final]
[Icosavax, Inc.]
[May 2023]
The Licensee agrees to pay the NIAID Benchmark royalties within [***] of Licensee's a Licensed Product achieving each of the following Benchmarks, payable one (1) time only for a given Licensed Product regardless of the number of indications against which such Licensed Product is directed:
The Benchmark royalties shall be payable only once upon the initial achievement of such Benchmark by a Licensed Product exercised in performance of in the Licensed Field of Use and no amounts shall be due hereunder for subsequent or repeated achievement of such Benchmark by such Licensed Product.
The Licensee agrees to the following Benchmarks for its performance under this Agreement and, within thirty (30) days of achieving a Benchmark, shall notify the NIAID that the Benchmark has been achieved.
[***]
Benchmarks for elderly RSV vaccination indication (either in combination with hMPV or alone) indication
Benchmarks for maternal RSV vaccination for prophylaxis in newborns indication (either in combination with
Third Amendment of [***] Model 10-2015
[***]
[Final]
[Icosavax, Inc.]
[May 2023]
hMPV or alone) indication
Regulatory Authority: Third (3rd) Quarter [***]
SIGNATURES BEGIN ON NEXT PAGE
Third Amendment of [***] Model 10-2015
[***]
[Final]
[Icosavax, Inc.]
[May 2023]
THIRD AMENDMENT TO [***]
SIGNATURE PAGE
In Witness Whereof, the parties have executed this Third Amendment on the dates set forth below. Any communication or notice to be given shall be forwarded to the respective addresses listed below.
For the NIAID:
/s/ Xxxxxxx X. Xxxxxx, Ph.D. 2023.05.23
Xxxxxxx X. Xxxxxx, Ph.D. Date
Director
Technology Transfer and Intellectual Property Office
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Mailing Address or E-mail Address for Agreement notices and reports:
License Compliance and Administration Monitoring & Enforcement
Office of Technology Transfer National Institutes of Health
0000 Xxxxxxxxx Xxxxxxxxx, Xxxxx 000 Xxxxxxxxx, Xxxxxxxx 00000-3804 U.S.A.
E-maiI: XxxxxxxXxxxxxx_Xxxxxxx@xxxx.xxx.xxx
For the Licensee (Upon information and belief, the undersigned expressly certifies or affirms that the contents of any statements of the Licensee made or referred to in this document are truthful and accurate.):
/s/ Xxxxxx Xxxxxxx 24-May-2023
Signature of Authorized Official Date
Name:
Title:
Chief Business Officer Icosavax, Inc.
0000 Xxxxx Xxxxxx, Xxxxx 0000
Seattle, WA 98101
Phone: [***]
E-mail: [***]
Accounts Payable c/o Xxxxxx Xxxxxxx
Chief Business Officer Icosavax, Inc.
Third Amendment of [***] Model 10-2015
[***]
[Final]
[Icosavax, Inc.]
[May 2023]
0000 Xxxxx Xxxxxx, Xxxxx 0000
Seattle, WA 98101
[***]
[***]
Any false or misleading statements made, presented, or submitted to the Government, including any relevant omissions, under this Agreement and during the course of negotiation of this Agreement are subject to all applicable civil and criminal statutes including Federal statutes 31 U.S.C. §§3801-3812 (civil liability) and
18 U.S.C. §1001 (criminal liability including fine(s) or imprisonment).
Third Amendment of [***] Model 10-2015
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[Final]
[Icosavax, Inc.]
[May 2023]
ATTACHMENT 1 - ROYALTY PAYMENT INFORMATION
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Third Amendment of [***] Model 10-2015
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[Final]
[Icosavax, Inc.]
[May 2023]