AMENDMENT NO. 2 TO THE COLLABORATION AND LICENSE AGREEMENT
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Exhibit 10.20
AMENDMENT NO. 2 TO THE
COLLABORATION AND LICENSE AGREEMENT
This Amendment No. 2 to the Collaboration Agreement (this “Amendment”) is effective as of the 27th day of October, 2021 (the “Amendment Effective Date”) by and between Amgen Inc., a Delaware corporation having an address at Xxx Xxxxx Xxxxxx Xxxxx, Xxxxxxxx Xxxx, Xxxxxxxxxx 00000 (“Amgen”) and CytomX Therapeutics, Inc., a Delaware corporation having an address at 000 Xxxxxx Xxxxx Xxxx., Xxxxx 000, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000 (“CytomX”). Amgen and CytomX are each hereafter referred to individually as a “Party” and together as the “Parties”.
WHEREAS, Amgen and XxxxxX entered into that certain Collaboration and License Agreement, dated as of September 29, 2017, as amended (the “Agreement”); and
WHEREAS, Amgen and CytomX wish to amend certain additional terms of the Agreement as further provided herein; and
NOW, THEREFORE, in consideration of the mutual promises and covenants hereinafter set forth, the Parties agree to amend the Agreement as follows. Capitalized terms used in this Amendment and not otherwise defined herein shall have the meanings ascribed to such terms in the Agreement.
PART 1 - AMENDMENTS TO CERTAIN TERMS
“(i) [***]shall decide matters with respect to [***] through the [***], other than [***], which shall be decided by [***]; provided that, notwithstanding anything to the contrary herein:
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to decide any [***]with respect to the conduct of the [***] to be conducted for [***], provided that if such decision would result in [***]incurring costs beyond [***] of the costs set forth in the budget for such study set forth in the [***] approved by the JSC on [***], then [***] shall only have the right to decide such matter if [***]agrees to bear the excess costs; and”
“4.4.1 Amgen shall have the right to elect to select (a) one (1) additional Target (the “First Additional Amgen Target”) by nominating such additional Target at any time prior to [***] (the “First Additional Amgen Target Selection Date”) for inclusion under this Agreement, subject to Section 4.4.2 and
(b) a second (2nd) additional Target (the “Second Additional Amgen Target” and, together with the First Additional Amgen Target, the “Additional Amgen Targets”) by nominating such additional Target at any time prior to [***] (the “Second Additional Amgen Target Selection Date” and, together with the First Additional Amgen Target Selection Date, the “Selection Dates”) for inclusion under this Agreement, subject to Section 4.4.2 (collectively, the “Amgen Expansion Option”).”
Section 6.1.3 is hereby deleted and replaced in its entirety as follows:
“6.1.3 EGFR Products. Following the Effective Date and at all times during the Term (except with respect to Preclinical Development and clinical activities conducted by each Party pursuant to the Preclinical Development Plan and EGFR Initial Development Plan, and except as set forth in clauses (a) and (b) below), Amgen shall be responsible for, and shall bear all costs associated with, the development, manufacture and commercialization of EGFR Products, including development, distribution, marketing and sales activities. For clarity, after completion of the Preclinical Development Plan and [***], and notwithstanding any other activities conducted by CytomX pursuant to the EGFR Initial Development Plan, if [***], Amgen shall continue to have the right to conduct preclinical and clinical development with respect to all EGFR Products. Subject to the terms of this Agreement, [***]. After completion of CytomX’s activities as set forth in the Preclinical Development Plan and EGFR Initial Development Plan and [***] , CytomX will promptly transfer to Amgen all CytomX Licensed Know-How as is reasonably necessary or useful for Amgen to develop and seek Marketing Approval for the EGFR Products, including all materials for supporting regulatory filings consistent with Amgen’s obligations under Article 5. Notwithstanding the foregoing:”
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Section 6.1.3(a) is hereby deleted and replaced in its entirety as follows:
“(a) CytomX shall be responsible for conducting any EGFR Dose Escalation Study and any EGFR Cohort Expansion Study pursuant to the EGFR Initial Development Plan, with costs borne by [***]. With respect to the first EGFR Dose Escalation Study included in the EGFR Initial Development Plan approved by the [***]:
7.3.2 (Certain CytomX EGFR Costs) is hereby deleted and replaced in its entirety as follows:
“7.3.2 Certain CytomX EGFR Costs. CytomX shall be responsible for [***] with respect to the first EGFR Dose Escalation Study and the first EGFR Cohort Expansion Study; provided, however, that Amgen shall reasonably assist CytomX upon CytomX’s request [***], which shall include reviewing [***].”
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under this Section 7.4 is Four Hundred Fifty-Five Million Dollars ($455,000,000).” is hereby deleted and replaced in its entirety as follows:
“For EGFR Products, the maximum amount payable under this Section 7.4 is Four Hundred Sixty Million Dollars ($460,000,000).”
“CytomX will have the first right, [***], but not the obligation, to assume responsibility for preparing, filing, prosecuting (including, but not limited to provisional, reissue, reexamination, continuing, divisional, continuation, continuation-in-part, and substitute applications and any foreign counterparts thereof), and maintaining [***] (a) [***] (i) [***] and (ii) [***], (b) [***], (c) [***] or
(d) subject to the rest of this Section 8.2.3, [***], and in each case, conducting any interferences and oppositions or similar proceedings relating to such Patent Rights. [***]. Amgen will have the first right, but not the obligation, [***], for preparing, filing, prosecuting (including, but not limited to provisional, reissue, reexamination, continuing, divisional, continuation, continuation-in-part, and substitute applications and any foreign counterparts thereof), and maintaining [***], and in each case, conducting any interferences and oppositions or similar proceedings relating to such Patent Rights. [***]. For clarity, following [***], if Amgen has not [***], and [***] has not occurred, prior to [***], Amgen shall [***].”
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“Either Party, subject to the other Party’s written consent, not to be unreasonably withheld, delayed or conditioned, may make disclosures relating to the development or commercialization of an EGFR Product, including the results of research and any clinical trial conducted by the Parties or any health or safety matter related to an EGFR Product, except that [***], [***], provided that at least [***] days in advance of any such disclosure, [***]shall provide [***]with a copy of and timing of such disclosure and [***]shall consider in good faith any comments on such disclosure provided by [***]; provided, however, that from and after the EGFR Cohort Expansion Study Completion Date, [***]shall be entitled to direct the disclosure strategy with respect to EGFR Products and may make any such disclosure prior to disclosure by [***].”
“CytomX will have the sole right to publish and make scientific presentations with respect to CytomX Platform Technology, CytomX Products and [***], any results of the first EGFR Dose Escalation Study, and to issue press releases (except with respect to the terms of this Agreement, which is governed by Section 12.2) or make other public disclosures regarding any such CytomX Platform Technology, CytomX Products and [***], any results of the first EGFR Dose Escalation Study, and Amgen will not do so without CytomX’s prior written consent, except as required by Law; provided, however, that any publication or presentation to be made by CytomX that names Amgen will require the prior written consent of Amgen. Amgen will have the sole right to publish and make scientific presentations with respect to Amgen Products or EGFR Products other than the results of the first EGFR Dose Escalation Study prior to [***], and to issue press releases (except with respect to the terms of this Agreement, which is governed by Section 12.2) or make other public disclosures regarding any such Amgen Products or such EGFR Products, and CytomX will not do so without Amgen’s prior written consent, except as required by Law or in connection with any research or clinical trial conducted by CytomX prior to the EGFR Cohort Expansion Study Completion Date; provided, however, that any publication or presentation to be made by Amgen that names CytomX will require the prior written consent of CytomX and vice versa.”
13.3.2 (Discretionary Termination):
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“Notwithstanding the foregoing, if Amgen provides notice of termination of this Agreement with respect to the EGFR Target and EGFR Products and the rights and obligations thereunder during [***], then (a) such termination shall be effective [***]and (b) notwithstanding Section 13.6 or achievement of the Initiation of first EGFR Cohort Expansion Study Milestone Event, Amgen shall not be obligated to [***].”
The third sentence of Section 13.5(e) is hereby deleted and replaced in its entirety as follows:
“To the extent the foregoing license is [***], [***] shall [***] to [***]on [***]at [***]: (i) if [***], (ii) if [***] or (iii) if [***].”
The following Section 13.5(i) is hereby added to Section 13.5:
“(i) If [***], or [***], at [***] request, (A) [***]shall assign (or, if applicable, cause its Affiliate to assign) to [***]all of [***] (and such Affiliates’) right, title and interest in and to any [***], at [***] expense, and (B) with respect to all other [***] or its Affiliates that [***], if [***], then (1) [***]shall provide [***]with reasonable notice of such decision (which notice shall in any event be given no later than [***] days prior to the next deadline for any action that may be taken with respect to such [***] with the U.S. Patent & Trademark Office or any foreign patent office), (2) [***]shall have the right to elect, by written notice to [***], to [***], and (3) [***]shall, at [***] reasonable request and expense, assist and cooperate in [***].”
PART 2 – REFERENCE TO AND EFFECT ON THE AGREEMENT
PART 3 – MISCELLANEOUS
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[Signature page follows]
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IN WITNESS THEREOF, duly authorized representatives of the Parties hereto have executed this Amendment No. 2 as of the date first set forth above.
AMGEN INC.
DocuSign Envelope ID: BC0B85A8-4C4E-49BF-9DC2-0D8965BBCF25
By:
DocuSign Envelope ID: BC0B85A8-4C4E-49BF-9DC2-0D8965BBCF25
DocuSign Envelope ID: BC0B85A8-4C4E-49BF-9DC2-0D8965BBCF25
Name: [***]
Title: [***]
By:
Name: [***]
Title: [***]
Appendix A
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Appendix A