CONFIDENTIAL
EXECUTION VERSION
Exhibit 10.25
COLLABORATION
AND
LICENSE AGREEMENT
by and between
CYTOMX THERAPEUTICS, inc.
and
MODERNATX, INC.
Dated as of December 30, 2022
CONFIDENTIAL
EXECUTION VERSION
COLLABORATION AND LICENSE AGREEMENT
This Collaboration and License Agreement (“Agreement”) is entered into as of December 30, 2022 (the “Effective Date”) by and between CytomX Therapeutics, Inc., organized and existing under the laws of Delaware with its principal place of business at 151 Oyster Point Blvd., Suite 400, South San Francisco, California 94080, U.S.A. (“CytomX”) and ModernaTX, Inc., a corporation organized and existing under the laws of Delaware with its principal place of business at 200 Technology Square, Cambridge, Massachusetts 02139 (“Moderna”). CytomX and Moderna are each hereafter referred to individually as a “Party” and together as the “Parties”.
WHEREAS, Moderna has developed expertise and technology useful for the research, development, manufacture, and commercialization of mRNA-based pharmaceutical products delivered via lipid nanoparticles;
WHEREAS, CytomX has technology and expertise relating to the discovery and development of conditionally activated therapeutic molecules;
WHEREAS, CytomX and Moderna desire to collaborate in the performance of preclinical and clinical development programs for the discovery and development of certain mRNA sequences encoding conditionally activated therapeutic molecules for delivery in lipid nanoparticles, subject to the terms and conditions of this Agreement.
NOW, THEREFORE, in consideration of the mutual covenants contained herein, and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Parties hereby agree as follows:
All references to particular Exhibits, Articles or Sections mean the Exhibits to, and Articles and Sections of, this Agreement, unless otherwise specified. For the purposes of this Agreement and the Exhibits and Appendices hereto, the following words and phrases have the following meanings:
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2.1.1 Moderna and CytomX are entering into a research collaboration to identify and Develop Licensed Products under Collaboration Programs. As of the Effective Date, the Parties have agreed to conduct [***] Collaboration Programs: [***]. The Parties shall enter into Work Plans for the conduct of Preclinical Research activities on a Collaboration Program-by-Collaboration Program basis.
2.1.2 As of the Effective Date, the Parties have entered into Work Plans in respect of the [***] Collaboration Programs directed to the Initial Molecules. The Parties have agreed that the [***] Collaboration Programs are the Initial Collaboration Programs.
2.1.3 The Parties shall commence activities in respect [***], no sooner than [***] from the Effective Date after identification of the [***]. Prior to commencement of any activities in respect of [***], the Parties shall enter into [***] for such [***] that, unless otherwise mutually agreed, shall be generally consistent with the Work Plans for the Initial Collaboration Programs (e.g., the necessary resources (including FTEs), allocation of the activities and responsibilities between the Parties, and the Preclinical Research Budget for such [***]shall be calculated using the same calculation principles that were applied in determining such matters for the Initial Collaboration Programs).
2.2.1 Overview. Within [***] after the Effective Date, the Parties shall establish a cross-functional, joint steering committee (the “Joint Steering Committee” or the “JSC”), which shall manage the collaboration between the Parties.
2.2.2 Alliance Managers. Each of Moderna and CytomX shall appoint [***] representative who possesses a general understanding of Development, regulatory, Manufacturing and Commercialization matters to act as its respective alliance manager(s) for this relationship (each, an “Alliance Manager”). Each Party may replace its respective Alliance Manager at any time upon written notice to the other in accordance with this Agreement. Any Alliance Manager may designate a substitute to temporarily perform the functions of that Alliance Manager. Each Alliance Manager shall be charged with creating and maintaining a collaborative work environment within the JSC. Consistent with the Work Plan(s), each Alliance Manager will also be responsible for:
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The Alliance Managers shall have the right to attend all JSC and subcommittee meetings as non-voting observers. In accordance with Section 2.2.3(c) (Meetings), each Alliance Manager may bring any matter to the attention of the JSC that such Alliance Manager reasonably believes requires the attention of the JSC. Within [***] after the Effective Date, each Party shall appoint and notify the other Party in writing of the identity of such Party’s representative to act as Alliance Manager under this Agreement.
2.2.3 Joint Steering Committee.
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2.2.4 Cooperation. Each Party shall provide the JSC such information as required under this Agreement or as otherwise reasonably requested by the other Party and reasonably available to such Party to enable the other Party to perform its obligations under this Agreement, in each case relating to the progress against the goals or performance of activities under each Work Plan.
2.2.5 Decisions. The JSC shall serve as [***]. The JSC shall take action by consensus of the representatives present at a meeting, with each Party having [***], or by a written resolution signed by at least [***] appointed by each Party. If a dispute arises that cannot be resolved by a subcommittee of the JSC, such dispute shall be referred to the JSC for resolution. If the JSC cannot reach consensus or a dispute arises that cannot be resolved within the JSC (whether the matter originated at the JSC or within a subcommittee), such dispute shall be [***]; provided that [***] shall not be entitled to use its final decision-making authority with respect to any [***], and, in such event, any such decision by [***]shall be deemed to have no force or effect. Without limiting the foregoing, in no event (unless separately agreed by the Parties in writing) shall [***].
2.2.6 Exceptions. [***].
2.2.7 Authority. The JSC and any subcommittee shall have only the powers assigned expressly to it in this Section 2.2 (Management) and elsewhere in this Agreement, and shall not have any power to amend, modify or waive compliance with this Agreement. In furtherance thereof, each Party shall retain the rights, powers and discretion granted to it under this Agreement and no such rights, powers or discretion shall be delegated or vested in the JSC or subcommittee unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writing. For the avoidance of doubt, JSC and subcommittee rights to discuss, comment, review or monitor (and other similar activities) shall not require any Party or designee thereof to act or be bound in any respect by such discussion, comment, review, or monitoring.
2.2.8 Discontinuation of JSC. [***].
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2.5.1 [***].
2.5.2 [***].
3.1.1 The Parties have agreed upon the Initial Molecules for the Initial Collaboration Programs. At any time on or before [***] from [***], [***] shall nominate a [***] for [***] pursuant to Section 3.1.3 (Selection of Molecules). After nomination and selection of the [***], [***] shall have a right to nominate [***] in accordance with Section 3.1.2 and Section 3.1.3 (Selection of Molecules), [***].
3.1.2 [***] shall have the right to [***] if [***] occurs with respect to [***]; provided that [***]may exercise this right up to [***] under this Agreement; and further provided that [***] must occur no later than [***] after the date on which [***]notifies [***] that [***] has [***]. If [***]desires to exercise [***], [***]shall inform [***] through the JSC of [***] basis (and providing supporting information) for wanting [***].
3.1.3 To exercise the right to [***] pursuant to Section 3.1.1 (Selection of Molecules) or to [***] pursuant to Section 3.1.2 (Selection of Molecules), [***] shall submit written notice to the
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Gatekeeper on a confidential basis of its intention to determine whether a Proposed Molecule is Available within the time period specified. On receipt of such notice, the Gatekeeper shall assess Availability of the Proposed Molecule and provide written notice to [***] as to whether such Proposed Molecule is Available.
3.1.4 After the Gatekeeper notifies [***] that a Proposed Molecule is Available, [***] shall submit written notice to [***] of [***] nomination of such Proposed Molecule (the “Molecule Notice”). Upon [***] receipt of the Molecule Notice, the [***] comprising the Proposed Molecule shall be deemed a Collaboration Protein and the Parties will have all rights and obligations hereunder in connection with such Collaboration Protein. For clarity, the identity of each Proposed Molecule, and the corresponding [***], shall not be disclosed to [***] until such time such Proposed Molecule is deemed to be Available. Upon such date as the Gatekeeper notifies [***]that a Proposed Molecule is Available for [***], the [***]for which such [***], and the relevant Collaboration Protein in the [***].
3.5.1 Moderna shall be responsible for all of the Preclinical Research Costs incurred by either Party and its Affiliates in connection with Preclinical Research under this Agreement that are set forth in the approved Preclinical Research Budget. CytomX shall have the right to invoice Moderna for its Preclinical Research Costs [***], and Moderna shall pay [***] within [***] after receipt of such invoice. CytomX shall cooperate with any reasonable request of Moderna to confirm the information in any such invoice(s) in accordance with Section 7.9 (Reports; Records and Audits).
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4.1.1 Preclinical Research License.
4.1.2 License Grant to Moderna. Subject to the terms and conditions of this Agreement and commencing on the expiration of the applicable Preclinical Research Term on a Collaboration Product-by-Collaboration Product basis, CytomX hereby grants to Moderna [***] license under the CytomX IP that is necessary or reasonably useful to Exploit Licensed Products in the Licensed Field in the Territory during the Term. For clarity, the license granted pursuant to this Section 4.1.2 (License Grant to Moderna) would not include a grant to any compound that is proprietary to CytomX and that is not a Collaboration Product. Notwithstanding the foregoing, [***].
4.1.3 Data License Grant.
4.1.4 Limitation. Moderna shall not [***].
4.1.5 [***].
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6.5.1 Generally. Moderna shall have the [***] right to Commercialize Licensed Products under this Agreement.
6.5.2 Commercialization Reports. During the Term, for each Licensed Product, Moderna shall report on the Commercialization status of Moderna’s and its Affiliates’, subcontractors and Sublicensees’ Commercialization activities under this Agreement with respect to such Licensed Product in accordance with the procedures established by the JSC and no less frequently than [***] every [***].
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7.4.1 As partial consideration for the rights granted by CytomX to Moderna pursuant to the terms of this Agreement, for access to the CytomX Platform Technology and CytomX undertaking its responsibilities under this Agreement, on a Licensed Product-by-Licensed Product basis, Moderna shall pay to CytomX one-time milestone payments (“Milestone Payments”) following the first occurrence of the corresponding milestone events (“Milestone Events”) with respect to each Licensed Product within a particular Collaboration Program for which such Milestone Event is achieved by or on behalf of Moderna, as set forth in the following tables:
Development Milestone Events
[***]
Approval and First Sale Milestone Events
[***]
Commercial Milestone Events
[***]
7.4.2 If a Milestone Event set forth in the table titled “Development Milestone Events” in Section 7.4.1 (Milestone Payments) is achieved prior to the achievement of the preceding Milestone Event for the same Licensed Product, as applicable, set forth in the relevant chart (i.e., if a lower-listed Milestone Event is achieved before a Milestone Event that is listed higher up in the relevant chart), then upon achievement of the relevant Milestone Event, all preceding Milestone Events for such Licensed Product set forth in the relevant chart shall become due and payable if not previously paid for that Licensed Product. The maximum amount payable under this Section 7.4 (Milestone Payments) is [***] for each Licensed Product. Moderna shall report to CytomX its achievement of each Milestone Event for which payment to CytomX is due no later than [***] after the end of the [***]; provided that Moderna shall use good faith efforts to inform CytomX of any Development or regulatory Milestone Event within [***] following achievement, and Moderna shall pay to CytomX such Milestone Payment (a) with respect to Development or regulatory Milestone Events, within [***] after receipt of an invoice from CytomX in respect of any payment required as a result of such achievement, and (b) with respect to all other Milestone Events, within [***] after the end of the Calendar Quarter during which such Milestone Event is achieved.
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7.5.1 Royalties Payable. As partial consideration for the rights granted by CytomX to Moderna pursuant to the terms of this Agreement, for access to the CytomX Platform Technology and CytomX undertaking its responsibilities under this Agreement, subject to the provisions of this Section 7.5 (Royalties), Moderna shall pay to CytomX, on a Licensed Product-by-Licensed Product and country-by-country basis, royalties on quarterly Net Sales of Licensed Products during the applicable Royalty Term, calculated as set forth in Section 7.5.3 (Royalty Rates). Royalties will be payable on a Calendar Quarter-by-Calendar Quarter basis and any such payments shall be made within [***] after the end of the Calendar Quarter during which the applicable Net Sales of Licensed Products occurred.
7.5.2 Royalty Term. Moderna’s obligation to pay royalties with respect to a Licensed Product in a particular country shall commence upon the First Commercial Sale of such Licensed Product in such country and shall expire on a country-by-country and Licensed Product-by-Licensed Product basis on the latest of [***] (the “Royalty Term”).
7.5.3 Royalty Rates. The royalty rates payable under Section 7.5.1 (Royalties Payable) shall be calculated as follows:
[***]
7.5.4 Royalty Reductions.
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7.5.5 Mutual Convenience of the Parties. The royalty and other payment obligations set forth hereunder have been agreed to by the Parties for the purpose of reflecting and advancing their mutual convenience, including the ease of calculating and paying royalties and other amounts required hereunder.
If Moderna is the paying Party:
ModernaTX, Inc.
200 Technology Square
Cambridge, MA 02139
Attention: [***]
[***]
If CytomX is the paying Party:
CytomX Therapeutics, Inc.
151 Oyster Point Blvd, Suite 400
South San Francisco, CA 94080
Attention: [***]
[***]
All invoices shall be sent in portable document format (pdf) and will reference this Agreement.
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7.9.1 Reports. After the First Commercial Sale of the first Licensed Product by Moderna and until expiration or termination of this Agreement, Moderna shall prepare and (within [***] after the end of each Calendar Quarter) deliver to CytomX reports of the sale of Licensed Products by Moderna or its Affiliates, and their respective Sublicensees [***] together with the corresponding royalty payment or other consideration to be paid to CytomX, specifying [***].
7.9.2 Moderna Records. Moderna will keep complete and accurate records of royalty, milestone and other payments required under this Agreement, for a period of [***] after the end of the Calendar Year in which such were incurred or such payment was due. Moderna shall require its Affiliates, and its and their respective Sublicensees to retain and provide to Moderna all records of payments that Moderna would be required to keep as if sales of Licensed Product by such Affiliates or Sublicensees were sales of Licensed Product by Moderna, to enable CytomX to audit such records pursuant to this Section 7.9 (Reports; Records and Audits).
7.9.3 CytomX Records. CytomX will keep complete and accurate records of its Preclinical Research Costs with respect to each Licensed Product for a period of [***] after the end of the Calendar Year in which such Preclinical Research Costs were incurred. Without limiting the foregoing, CytomX shall calculate and maintain records of FTE hours incurred by it in the same manner as used for other products developed by CytomX.
7.9.4 Audits. Each of CytomX and Moderna (the “Auditing Party”) will have the right, not more than [***] at its own expense, to have a nationally recognized, independent, certified public accounting firm, selected by it and subject to the other Party’s prior written consent (which shall not be unreasonably withheld, conditioned or delayed), review any such records of the other Party and its Affiliates (the “Non-Auditing Party”) in the location(s) where such records are maintained upon reasonable written notice (which shall be no less than [***] prior written notice) and during regular business hours and under obligations of strict confidence, for the sole purpose of verifying the basis and accuracy of payments made under this Agreement within the [***] period preceding the date of the request for review. Upon either Party’s written request, the other Party shall use good faith efforts to conduct audits of its subcontractors and Sublicensees (at the requesting Party’s cost), and the requesting Party shall have the right to receive and retain a copy of the applicable audit report. No Calendar Year will be subject to audit under this Section 7.9.4 (Audits) more than [***] without the consent of the Non-Auditing Party. The Non-Auditing Party will receive a copy of each such report within [***] following receipt by the Auditing Party, and such accounting firm shall report to the Parties only whether or not such calculations are correct and the amount of any discrepancy. No other information shall be shared. The Auditing Party shall treat the results of any such review of the Non-Auditing Party’s records under this Section 7.9.4 (Audits) as Confidential Information of the Non-Auditing Party and subject to the terms of Article 12 (Confidentiality). Should such inspection lead to the discovery of a discrepancy to the Auditing Party’s detriment, the Non-Auditing Party will, within [***] after receipt of such report from the accounting firm, pay any undisputed amount of the discrepancy together with interest at the rate set forth in Section 7.10 (Late Payments). The Auditing Party will pay the full cost of the review unless the underpayment of amounts due to the Auditing Party with respect to audited royalty or sales milestone, is more than [***], of the amount due for the entire period being examined, in which case, the Non-Auditing Party will pay the cost charged by such accounting firm for such review; provided that reimbursement for accounting firm fees shall (a) be no more than would have been paid by the Auditing Party had such reimbursement
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not been required and (b) not include any contingency fee charged by the auditor (or any other increased fee resulting from the auditor discovering discrepancies). Should the audit lead to the discovery of a discrepancy to the Non-Auditing Party’s detriment, the Non-Auditing Party may credit the amount of the discrepancy, [***], against future payments payable to the Auditing Party under this Agreement or, if there are no such payments payable, then the Auditing Party shall pay to the Non-Auditing Party the amount of the discrepancy, [***], within [***] of the Auditing Party’s receipt of the report.
7.11.1 Withholding. Subject to Section 7.11.3 (German Exemption Certificate), in the event that any Law requires a Party making any payment pursuant to this Agreement (the “Paying Party”) to withhold taxes with respect to any such payment, the Paying Party (a) will notify the non-Paying Party of such withholding requirement prior to making the payment to the non-Paying Party (such notice, which shall include the authority, basis and method of calculation for the proposed deduction or withholding, shall be given at least a reasonable period of time before such deduction or withholding is required, in order for the non-Paying Party to obtain reduction of or relief from such deduction or withholding), and (b) provide such assistance to the non-Paying Party, including the provision of such standard documentation as may be required by a tax authority, as may be reasonably necessary in the non-Paying Party’s efforts to claim an exemption from or reduction of such taxes. The Paying Party will, in accordance with such Law, withhold taxes from such payment, remit such taxes to the appropriate tax authority, and furnish the non-Paying Party with proof of payment of such taxes within [***] following the payment. If taxes are so withheld and paid to a tax authority, the Paying Party shall provide reasonable assistance to the non-Paying Party to obtain a refund of taxes withheld, or obtain a credit with respect to taxes paid. The non-Paying Party shall provide the Paying Party any tax forms (including Internal Revenue Service Forms W-9 or applicable W-8) that may be reasonably necessary in order for the Paying Party to determine whether to withhold tax on any such payments or to withhold tax on such payments at a reduced rate under applicable Law, including any applicable bilateral income tax treaty. [***].
7.11.2 Indirect Taxes. All payments due to the non-Paying Party from the Paying Party pursuant to this Agreement shall be paid exclusive of any value-added tax, sales tax, consumption taxes and other similar taxes (“Indirect Taxes”) (which, if applicable, shall be payable by the Paying Party upon receipt of a valid Indirect Tax invoice). If the non-Paying Party determines that it is required to report any such tax, the Paying Party shall promptly provide the non-Paying Party with applicable receipts and other documentation necessary or appropriate for such report. For clarity, this Section 7.11.2 (Indirect Taxes) is not intended to limit the Paying Party’s right to deduct value-added taxes in determining Net Sales.
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7.11.3 German Exemption Certificate. Notwithstanding Section 7.11.1 (Withholding) and 7.11.2 (Indirect Taxes), if at any time the CytomX IP includes intellectual property that is registered in a German public book or register, CytomX shall obtain and provide Moderna with a valid certificate issued by the applicable German authorities establishing CytomX’s exemption from German withholding tax (a “German Exemption Certificate”), provided, however, that a German Exemption Certificate shall not be required if current German law changes and/or if obtaining and providing a German Exemption Certificate is no longer required, in each case, to exempt such payment from German withholding tax. Intellectual property shall be considered registered as soon as an application is filed (even if it is not yet granted) and intellectual property shall be considered registered in Germany if it has been filed with or validated (e.g., under the Patent Cooperation Treaty) in Germany or in a German E.U. office or non-German E.U. office (in the case of Patent Rights, the German Patent and Trademark Office (Deutsches Patent- and Markenamt) or European Patent and Trademark Office under the European Patent Convention), if filing or validating such intellectual property in such German EU office or non-German EU office would be considered filing or validating such intellectual property in Germany under German law. Notwithstanding Section 7.11.1 (Withholding) and 7.11.2 (Indirect Taxes), if any payments are due to CytomX hereunder with respect to such CytomX IP and, at the time such payment is to be made, Moderna is not in possession of a valid and effective German Exemption Certificate, Moderna shall inform CytomX and CytomX may elect to either have (i) Moderna delay making such payment until such time as CytomX receives such a German Exemption Certificate or (ii) Moderna withhold such amounts from such payment as determined by Moderna, in which case no tax gross up amount shall be payable to CytomX. If Moderna withholds any amount under (ii) above, Moderna shall remit such withheld amount to the applicable German tax authorities and provide CytomX with reasonable evidence of such payment in a form and with such details as reasonably requested by CytomX. Notwithstanding anything to the contrary in this Agreement, Moderna shall not withhold taxes on the Upfront Payment due and payable to CytomX under Section 7.1 (Upfront Payment). As applicable, CytomX will file for the German Exemption Certificate within [***] of the Effective Date and provide reasonable evidence of such filing to Moderna. Moderna authorizes CytomX to share this Agreement with the applicable German Tax authorities and CytomX tax counsel for the sole purpose of applying for the German Exemption Certificate, notwithstanding anything to the contrary in Article 12 (Confidentiality). In the event it is determined that CytomX is not eligible for the German Exemption Certificate and is definitively denied by the German Tax Authorities or CytomX fails to apply for the German Exemption Certificate within [***] of the Effective Date, CytomX shall work in good faith to compensate Moderna for the applicable withholding related to the payment in Section 7.1 (Upfront Payment) and taxes in this Section 7.11.3 (German Exemption Certificate).
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8.1.1 Background IP. Each Party will own all right, title and interest in its Background IP.
8.1.2 Collaboration IP. [***].
8.1.3 CytomX Platform Improvements IP. [***].
8.1.4 Moderna Platform Improvements IP. [***].
8.1.5 Product-Specific Collaboration IP. [***].
8.1.6 Jointly Owned Collaboration IP. [***].
8.1.7 Data Ownership. [***].
8.1.8 Disclosure; Further Assurances. Each Party shall promptly disclose to the other Party in writing, and shall cause its Affiliates, and Sublicensees to so disclose, the conception of any Collaboration IP, and, in the case of Moderna or its Affiliates, licensees and Sublicensees, CytomX Platform Improvements IP, and, in the case of CytomX or its Affiliates, licensees and Sublicensees, Moderna Platform Improvements IP. Each Party shall cause its Sublicensees and Affiliates, and their respective employees, consultants, agents, or independent contractors to so assign to such Party, such person’s or entity’s right, title and interest in and to the foregoing, and all intellectual property rights therein, as is necessary to enable such Party to fully effect the ownership of the foregoing, and intellectual property rights therein, as provided in this Agreement. Each Party shall also include provisions in its relevant agreements with Third Parties performing activities on its behalf pursuant to this Agreement, that effect the intent of this Article 8 (Intellectual Property). Each Party hereby appoints the other Party as attorney-in-fact of such Party to execute and deliver all documents reasonably required to evidence or record any assignment pursuant to this Agreement if such Party is unable, after making reasonable inquiry, to obtain assistance of such other Party with respect to any such document. Each Party shall, and shall cause its Sublicensees and Affiliates, and their respective employees, consultants, agents, or independent contractors to, cooperate with the other Party and take all reasonable additional actions and execute such agreements, instruments and documents as may be reasonably required to perfect such other Party’s right, title and interest in and to Inventions, and intellectual property rights therein, as set forth in this Section 8.1 (Intellectual Property (“IP”) Ownership).
8.2.1 CytomX Patents. CytomX shall be solely responsible, [***], for preparing, filing, prosecuting (including provisional, reissue, reexamination, continuing, divisional, continuation, continuation-in-part, and substitute applications and any foreign counterparts thereof), and maintaining all CytomX Patents, and conducting any interferences and oppositions or similar proceedings relating to any CytomX Patents. CytomX will [***].
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8.2.2 Moderna Patents. Moderna shall be solely responsible, [***], for preparing, filing, prosecuting (including provisional, reissue, reexamination, continuing, divisional, continuation, continuation-in-part, and substitute applications and any foreign counterparts thereof), and maintaining all Moderna Patents, and conducting any interferences and oppositions or similar proceedings relating thereto. CytomX acknowledges and agrees that [***].
8.2.3 Collaboration Patents.
8.2.4 Inventor’s Remuneration. Each Party shall be solely responsible for any remuneration that may be due to such Party’s inventors under any applicable inventor remuneration Laws.
8.3.1 The Parties will cooperate with each other in gaining Patent Right term extension (including supplementary protection certificates for Collaboration Patents to the extent applicable to Licensed Products); provided that, in the case of any disagreement, [***].
8.3.2 Moderna shall have the sole right to make all filings with Regulatory Authorities in the Territory with respect to Moderna Patents [***] as required or allowed (a) in the United States, and (b) outside the United States, under the national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or other international equivalents. [***].
8.3.3 [***] will [***] regarding filings with Regulatory Authorities in the Territory with respect to CytomX Patents as required or allowed (a) in the United States, and (b) outside the United States, under the national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or other international equivalents, but in all cases, CytomX shall retain full discretion with respect thereto.
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8.5.1 If a Third Party asserts, as a defense or as a counterclaim in any infringement action under Section 8.7 (Enforcement) that any CytomX Patent, Collaboration Patent or Moderna Patent is invalid or unenforceable, then the Party defending such infringement action shall promptly give written notice to the other Party. Each Party shall reasonably cooperate with the other Party in any such action.
8.5.2 With respect to the [***], [***] shall respond to such defense and use Commercially Reasonable Efforts to defend against such counterclaim (as applicable) and, if [***] is pursuing the applicable infringement action under Section 8.7 (Enforcement), [***] shall allow [***] to control such response or defense (as applicable). [***] with respect to such response or defense against such counterclaim [***].
8.5.3 With respect to the [***], [***] shall have the [***] right, but not the obligation, to defend against such counterclaim (as applicable) and, if [***] is pursuing the applicable infringement action under Section 8.7 (Enforcement), [***] shall allow [***] to control such response or defense (as applicable). [***] with respect to such response or defense against such counterclaim [***]. Notwithstanding the foregoing, if [***] fails to assume such defense in respect to any [***], [***] shall have the right to defend against such action or claim, unless [***].
8.6.1 If a Third Party asserts, in a declaratory judgment action or similar action or claim filed by such Third Party, that any Moderna Patent, Collaboration Patent or CytomX Patent is invalid or unenforceable, then the Party first becoming aware of such action or claim shall promptly give written notice to the other Party. Each Party shall reasonably cooperate with the other Party in any such action.
8.6.2 [***] shall have the [***] right, but not the obligation, to defend against such action or claim against an [***]. [***] shall use Commercially Reasonable Efforts to defend against such action or claim against a [***]. Any costs and expenses with respect to such defense with respect to such Patent Rights shall be borne by the Party defending such action. Notwithstanding the foregoing, if [***] fails to assume such defense with respect to any [***], [***] shall have the right to defend against such action or claim, unless [***]. For clarity, [***] shall not have any such right to defend under this Section 8.6.2 (Third Party Declaratory Judgment or Similar Action) with respect to any [***].
8.7.1 Notice of Infringement. The Parties shall inform each other promptly of any infringement or colorable cause of action for infringement of any Patent Right within the Collaboration Patents, CytomX Patents or Moderna Patents that claim the composition of matter of, methods of making, or methods of using any Licensed Product (“Competitive Infringement”) and shall provide such other Party with available evidence of such Competitive Infringement.
8.7.2 CytomX Enforcement. CytomX shall have the sole right to enforce the CytomX Patents. CytomX shall at all times keep Moderna informed as to the status of such enforcement pursuant to this Section 8.7.2 (CytomX Enforcement). CytomX may, at its own expense, institute suit against any infringer or alleged infringer and control and defend such suit in a manner consistent with the terms and provisions hereof and recover any damages, awards or settlements resulting therefrom, subject to Section
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8.7.5 (Allocation of Recoveries). Moderna shall reasonably cooperate in any such litigation at CytomX’s expense. CytomX shall not enter into any settlement of any claim described in this Section 8.7.2 (CytomX Enforcement) that admits to [***].
8.7.3 Moderna Enforcement. Moderna shall have the sole right, but not the obligation, to institute, prosecute, and control any action or proceeding with respect to any Competitive Infringement of any Patent Right within the [***] by counsel of its own choice, in Moderna’s own name and under Moderna’s direction and control. The foregoing right of Moderna shall include the right [***]. Moderna shall at all times keep CytomX informed as to the status of any enforcement pursuant to this Section 8.7.3 (Moderna Enforcement). Moderna may, at its own expense, institute suit against any infringer or alleged infringer and control and defend such suit in a manner consistent with the terms and provisions hereof and recover any damages, awards or settlements resulting therefrom, subject to Section 8.7.5 (Allocation of Recoveries). CytomX shall reasonably cooperate in any such litigation at Moderna’s expense. Moderna shall not enter into any settlement of any claim described in this Section 8.7.3 (Moderna Enforcement) that admits to [***]. CytomX shall not enter into any settlement of any claim described in this Section 8.7.3 (Moderna Enforcement) that admits to [***].
8.7.4 Progress Reporting. The Party initiating or defending any enforcement action under this Section 8.7 (Enforcement) (the “Enforcing Party”) shall keep the other Party reasonably informed of the progress of any such enforcement action, and such other Party shall have the individual right to participate with counsel of its own choice [***].
8.7.5 Allocation of Recoveries. Except as otherwise expressly provided herein, the costs and expenses of the Party bringing suit under this Section 8.7 (Enforcement) [***], and any damages, settlements or other monetary awards recovered shall be shared as follows: [***].
8.8.1 [***] will designate, to the extent permitted by applicable Law, or otherwise [***] will designate in accordance with [***] instructions, the outside counsel and in-house counsel who will receive confidential access to the Biosimilar Application, information regarding the process or processes
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used to manufacture the product that is the subject of the Biosimilar Application, and any related confidential information pursuant to 42 U.S.C. §262(l)(1)(B)(ii).
8.8.2 In each case, after consulting with [***] and considering [***] comments in good faith, [***] will have the right to (a) list any [***] as required pursuant to 42 U.S.C. §262(l)(3)(A) or 42 U.S.C. §262(l)(7), (b) respond to any communications with respect to such lists from the filer of the Biosimilar Application, (c) negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange other than that specified in 42 U.S.C. §262(l)(1), and (d) as to the [***] that will be subject to the litigation procedure as described in 42 U.S.C. §262(l)(4), decide which [***] will be selected for litigation under 42 U.S.C. §262(l)(5)(B)(i)(II), and commence such litigation under 42 U.S.C. §262(l)(6). If [***] is required pursuant to applicable Law to execute any of these tasks it will do so in accordance with [***] instructions.
8.8.3 [***] will cooperate with [***] reasonable requests in connection with the foregoing activities to the extent required or permitted by applicable Laws. [***] will consult with [***] prior to [***] as contemplated by this Section 8.8 (Biosimilars). [***] will consider in good faith advice and suggestions with respect thereto received from [***], and notify [***] of any such lists or communications promptly after they are made.
8.8.4 Each Party will within [***] after receiving any notice of commercial marketing provided by the filer of a Biosimilar Application to [***] pursuant to 42 U.S.C. §262(l)(8)(A), notify the other Party. To the extent permitted by applicable Law, [***] will have the first right, but not the obligation, to seek an injunction against such commercial marketing as permitted pursuant to 42 U.S.C. §262(l)(8)(B) and to file an action for infringement. If required pursuant to applicable Law, upon [***] request, [***] will assist in seeking such injunction or filing such infringement action after consulting with [***]. Except as otherwise provided in this Section 8.8 (Biosimilars), any such action will be subject to the other terms and conditions of Section 8.6 (Third Party Declaratory Judgment or Similar Action) or Section 8.7 (Enforcement) as applicable.
8.9.1 Ownership and Prosecution of Product Trademarks. Moderna shall own all right, title, and interest to trademarks, branding and logos associated specifically with each Licensed Product (collectively, “Product Trademarks”) in the Territory, and shall be responsible for the registration, prosecution, and maintenance thereof. Moderna also shall have the sole right, but not the obligation, to conduct the selection, registration, prosecution, and maintenance of any international nonproprietary name (“INN”) or other name, identifier or regulatory nomenclature for each Licensed Product. All costs and expenses of registering, prosecuting, and maintaining the Product Trademarks shall be borne solely by Moderna. CytomX shall provide, at Moderna’s sole cost and expense, assistance and documents reasonably requested by Moderna in support of its prosecution, registration, and maintenance of the Product Trademarks.
8.9.2 Enforcement of Product Trademarks. Moderna shall have the sole right and responsibility for taking such action as Moderna deems necessary against a Third Party based on any alleged, threatened, or actual infringement, dilution, misappropriation, or other violation of, or unfair trade practices or any other like offense relating to, the Product Trademarks by a Third Party in the Territory. Moderna shall bear the costs and expenses relating to any enforcement action commenced pursuant to this Section 8.9.2 (Enforcement of Product Trademarks) and any settlements and judgments with respect thereto, and shall retain any damages or other amounts collected in connection therewith.
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8.9.3 Third Party Claims. Moderna shall have the sole right and responsibility for defending against any alleged, threatened, or actual claim by a Third Party that the use or registration of the Product Trademarks in the Territory infringes, dilutes, misappropriates, or otherwise violates any trademark or other right of that Third Party or constitutes unfair trade practices or any other like offense, or any other claims as may be brought by a Third Party against a Party in connection with the use of the Product Trademarks with respect to a Licensed Product in the Territory. Moderna shall bear the costs and expenses relating to any defense commenced pursuant to this Section 8.9.3 (Third Party Claims) and any settlements and judgments with respect thereto, and shall retain any damages or other amounts collected in connection therewith.
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10.1.1 By CytomX. CytomX agrees to defend Moderna, its Affiliates, and each of their respective directors, officers, employees and agents (the “Moderna Indemnified Parties”), at CytomX’s cost and expense, and will indemnify and hold Moderna and the other Moderna Indemnified Parties harmless from and against any claims, losses, costs, damages, fees or expenses (including reasonable legal fees and expenses) (collectively, “Losses”) in connection with any claims, actions, demands, suits or proceedings [***]; except, in each case, to the extent such Losses result from clause (a), (b) or (c) of Section 10.1.2 (Indemnity—By Moderna).
10.1.2 By Moderna. Moderna agrees to defend CytomX, its Affiliates and their respective directors, officers, employees and agents (the “CytomX Indemnified Parties”), at Moderna’s cost and expense, and will indemnify and hold CytomX and the other CytomX Indemnified Parties harmless from and against any Losses in connection with any Third Party Claims to the extent arising out of or resulting from [***]; except, in each case, to the extent such Losses result from clause (a), (b) or (c) of Section 10.1.1 (Indemnity—By CytomX).
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10.2.1 Notice. The indemnified Party (“Indemnitee”) will promptly notify the indemnifying Party (“Indemnitor”) in writing of the assertion or the commencement of the relevant Third Party Claim; provided, however, that any failure or delay to notify shall not excuse any obligation of the Indemnitor, except to the extent the Indemnitor is actually prejudiced thereby. Such notice must contain a description of the claim and the nature and amount of any Losses (to the extent that the nature and the amount of such Losses is known at such time). The Indemnitee shall furnish promptly to the Indemnitor copies of all papers and official documents received in respect of any Losses and Third Party Claims.
10.2.2 Control of Defense. The Indemnitee hereby grants the Indemnitor the right to assert sole management and control, at the Indemnitor’s sole expense, of the defense of such Third Party Claim and its settlement; provided, however, that the Indemnitor shall not settle any such Third Party Claim without the prior written consent of the Indemnitee if such settlement does not include a complete release from liability or if such settlement would involve the Indemnitee undertaking an obligation (including the payment of money by the Indemnitee), would bind or impair the Indemnitee, or includes any admission of wrongdoing by the Indemnitee or that any intellectual property or proprietary right of Indemnitee or this Agreement is invalid, narrowed in scope or unenforceable. The assertion of the defense of a Third Party Claim by the Indemnitor shall not be construed as an acknowledgment that the Indemnitor is liable to indemnify the Indemnitee in respect of the Third Party Claim, nor shall it constitute a waiver by the Indemnitor of any defenses it may assert against the Indemnitee’s claim for indemnification. Upon assuming the defense of a Third Party Claim, the Indemnitor may appoint as lead counsel in the defense of the Third Party Claim any legal counsel selected by the Indemnitor, which shall be reasonably acceptable to the Indemnitee. In the event the Indemnitor assumes the defense of a Third Party Claim, except as provided in this Section 10.2.2 (Control of Defense), the Indemnitor shall not be liable to the Indemnitee for any legal expenses subsequently incurred by such Indemnitee in connection with the analysis, defense or settlement of the Third Party Claim unless specifically requested in writing by the Indemnitor. In the event that it is ultimately determined that the Indemnitor is not obligated to indemnify, defend or hold harmless the Indemnitee from and against the Third Party Claim, the Indemnitee shall reimburse the Indemnitor for any Losses incurred by the Indemnitor in defense of the Third Party Claim. The Indemnitee shall have the right (at its own expense) to be present in person or through counsel at all legal proceedings giving rise to the right of indemnification. Notwithstanding the foregoing, the Indemnitee will have the right to employ separate counsel at the Indemnitor’s expense and to control its own defense of the applicable Third Party Claim if: (a) the employment thereof, and the assumption by the Indemnitor of such expense, has been specifically authorized by the Indemnitor in writing, (b) the Indemnitor has failed to assume the defense and employ counsel in accordance with this Section 10.2.2 (Control of Defense) (in which case, the Indemnitee shall control the defense), (c) there are or may be legal defenses available to the Indemnitee that are different from or additional to those available to the Indemnitor, or (d) in the reasonable opinion of counsel to the Indemnitee, a conflict or potential conflict exists between the Indemnitee and the Indemnitor that would make such separate representation advisable; provided that in no event will the Indemnitor be required to pay fees and expenses under this sentence for more than one firm of attorneys in any jurisdiction in any one legal action or group of related legal actions. In such event, the Indemnitee shall not settle or compromise such Third Party claim without the prior written consent of the Indemnitor, such consent not to be unreasonably withheld, conditioned or delayed. The Indemnitor shall not be liable for any settlement, compromise or other voluntary disposition of a Loss by an Indemnitee that is reached without the written consent of the Indemnitor.
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10.2.3 Cooperation. Regardless of whether the Indemnitor chooses to defend or prosecute any Third Party Claim, Indemnitee shall, and shall cause each other indemnitee to, cooperate in the defense or prosecution thereof and shall furnish such records, proceedings, hearings, trials and appeals as may be reasonably requested in connection therewith. Such cooperation shall include access during normal business hours afforded to the Indemnitor to, and reasonable retention by the Indemnitee of, records and information that are reasonably relevant to such Third Party Claim, and making Indemnitees and other employees and agents available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder, and the Indemnitor shall reimburse the Indemnitee for all of its reasonable out-of-pocket expenses in connection therewith as set forth in Section 10.2.4 (Expenses).
10.2.4 Expenses. The reasonable and verifiable costs and expenses, including costs, expenses, fees and disbursements of counsel, incurred by the Indemnitee pursuant to Section 10.2.3 (Cooperation) shall be reimbursed on a monthly basis in arrears by the Indemnitor, without prejudice to the Indemnitor’s right to contest the Indemnitee’s right to indemnification and subject to refund in the event the Indemnitor is ultimately held not to be obligated to indemnify the Indemnitee.
12.1.1 Confidential Information. Each Party (the “Receiving Party”) may receive during the course and conduct of activities under this Agreement, certain proprietary or confidential information of the other Party (the “Disclosing Party”) as furnished to the Receiving Party by or on behalf of the Disclosing Party. The term “Confidential Information” means all ideas and information of any kind, whether in written, oral, graphical, machine-readable or other form, whether or not marked as confidential or proprietary, which are transferred, disclosed or made available by Disclosing Party or at the request of Receiving Party, including any of the foregoing of Affiliates or Third Parties. Notwithstanding anything to the contrary in the foregoing, (a) any information that includes [***] shall be Confidential Information of [***], and [***] shall be deemed the Disclosing Party thereof for purposes of this Article 12 (Confidentiality), (b) any information that includes [***] shall be Confidential Information of [***], and [***] shall be deemed the Disclosing Party thereof for purposes of this Article 12 (Confidentiality), (c) [***] shall be deemed to be the Confidential Information of [***], and [***] shall
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be deemed to be the Disclosing Party and the Receiving Party with respect thereto for purposes of this Article 12 (Confidentiality), and (d) any information generated by a Party in the performance of any Preclinical Research, Development, or Commercialization activities pursuant to this Agreement that solely relates to a Collaboration Product or a Licensed Product that is the subject of such activities (excluding, for clarity, any information that includes CytomX Platform Technology or CytomX Platform Improvements IP) shall be deemed to be Confidential Information of [***], and [***] shall be deemed the Disclosing Party thereof for purposes of this Article 12 (Confidentiality).
12.1.2 Restrictions. During the Term and for [***] thereafter (or, for any trade secret, for so long as the Disclosing Party maintains such trade secret as a trade secret), Receiving Party will keep all Disclosing Party’s Confidential Information in confidence with the same degree of care with which Receiving Party holds its own confidential information (but in no event less than a commercially reasonable degree of care). Receiving Party will not use Disclosing Party’s Confidential Information except in connection with the performance of its obligations and exercise of its rights under this Agreement. Receiving Party has the right to disclose Disclosing Party’s Confidential Information without Disclosing Party’s prior written consent to Receiving Party’s Affiliates and their employees, subcontractors, consultants or agents who have a need to know such Confidential Information in order to perform its obligations and exercise its rights under this Agreement and who are bound by restrictions on use and disclosure consistent with this Section 12.1.2 (Confidentiality—Restrictions). Receiving Party will use diligent efforts to cause those entities and persons to comply with the restrictions on use and disclosure in this Section 12.1.2 (Confidentiality—Restrictions). Receiving Party assumes responsibility for those entities and persons maintaining Disclosing Party’s Confidential Information in confidence and using same only for the purposes described herein.
12.1.3 Exceptions. Receiving Party’s obligation of nondisclosure and the limitations upon the right to use the Disclosing Party’s Confidential Information will not apply to the extent that Receiving Party can demonstrate that the Disclosing Party’s Confidential Information: (a) was known to Receiving Party or any of its Affiliates prior to the time of disclosure without any obligation of confidentiality with respect to such information (provided that subsection (a) shall not apply to Moderna’s obligation of nondisclosure and the limitations upon the right to use any information that includes CytomX Platform Technology that is first disclosed by Moderna to CytomX); (b) is or becomes public knowledge through no wrongful act, fault or omission of Receiving Party or any of its Affiliates; (c) is subsequently obtained by Receiving Party or any of its Affiliates from a Third Party not known by the Receiving Party after due inquiry to be under an obligation of confidentiality; (d) has been independently discovered or developed by employees, subcontractors, consultants or agents of Receiving Party or any of its Affiliates without the aid, application or use of Disclosing Party’s Confidential Information, as evidenced by contemporaneous written records; or (e) was released from the restrictions set forth in this Agreement by express prior written consent of the Disclosing Party.
12.1.4 Permitted Disclosures. Receiving Party may disclose Disclosing Party’s Confidential Information to the extent (and only to the extent) such disclosure is reasonably necessary in the following instances:
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provided, however, that (1) with respect to Sections 12.1.4(a) or 12.1.4(b) (Permitted Disclosures), where reasonably possible, Receiving Party will notify Disclosing Party of Receiving Party’s intent to make any disclosure pursuant thereto sufficiently prior to making such disclosure so as to allow Disclosing Party adequate time to take whatever action it may deem appropriate to protect the confidentiality of the information to be disclosed and, in the event that no protective order or other remedy is obtained, or the Disclosing Party waives compliance with the terms of this Agreement, the Receiving Party shall furnish only that portion of Confidential Information that the Receiving Party is advised by counsel is legally required to be disclosed; and (2) with respect to Section 12.1.4(c) (Permitted Disclosures), (A) each of those named people and entities are bound by restrictions on use and disclosure consistent with Section 12.1.2 (Restrictions) (other than advisors, investment bankers, investors and lenders, which must be bound prior to disclosure by commercially reasonable obligations of confidentiality) and (B) all information not relevant to the potential acquirer or investor, including all Work Plans and the financial terms, shall not be disclosed to any such potential acquirer or investor if it has a competing product to any Licensed Product.
12.1.5 Use of Name. Except as expressly provided herein, neither Party shall mention or otherwise use the name, logo or trademark of the other Party or any of its Affiliates (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material, or other form of publicity without the prior written approval of such other Party in each instance. The restrictions imposed by this Section 12.1.5 (Use of Name) shall not prohibit either Party from making any disclosure identifying the other Party that, in the opinion of the Disclosing Party’s counsel, is required by applicable Law (including any securities law or regulation or the rules of a securities exchange or as a requirement in filing for an INN or the like) or with a legal or administrative proceeding, or in connection with prosecuting or defending litigation; provided that such Party shall submit the proposed disclosure identifying the other Party in writing to the other Party as far in advance as reasonably practicable so as to provide a reasonable opportunity to comment thereon.
12.2.1 The Parties agree that the terms of this Agreement will be treated as Confidential Information of both Parties, and thus may be disclosed only as permitted by this Agreement. Except as required by Law or as permitted under Section 12.1.4 (Permitted Disclosures), each Party agrees not to
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issue any press release or public statement disclosing information relating to this Agreement or the transactions contemplated hereby or the terms hereof without the prior written consent of the other Party, not to be unreasonably withheld, conditioned or delayed. Notwithstanding the foregoing, a joint press release substantially in the form attached hereto as Schedule 12.2 shall be issued by the Parties on or as promptly as practicable after the Effective Date. Without limiting Section 12.1.4 (Permitted Disclosures), the Parties agrees to seek reasonable and customary redactions in any filing of this Agreement with the SEC.
12.2.2 The Parties agree that each Party may issue future announcements concerning the advancement of a Licensed Product; provided that, except as permitted under Section 12.1.4 (Permitted Disclosures), any such announcement by CytomX has been mutually agreed upon by the Parties (such agreement not to be unreasonably withheld, conditioned, or delayed) or contains only information that has been previously publicly announced. [***].
12.3.1 Subject to the requirements of this Article 12 (Confidentiality), Moderna will have the sole right to publish and make scientific presentations, issue press releases (except with respect to the terms of this Agreement, which is governed by Section 12.2 (Terms of this Agreement; Public Announcements)) or make other public disclosures with respect to [***] consistent with Moderna’s publication policy. CytomX will not issue any such publications without Moderna’s prior written consent, except as required by applicable Law or as otherwise permitted under this Agreement. Notwithstanding the foregoing, any such publication or presentation to be made by Moderna that names CytomX will require the prior written consent of CytomX.
12.3.2 Subject to the requirements of this Article 12 (Confidentiality), CytomX will have the sole right to publish and make scientific presentations, issue press releases (except with respect to the terms of this Agreement, which is governed by Section 12.2 (Terms of this Agreement; Public Announcements)) or make other public disclosures with respect to [***] consistent with CytomX’s publication practices. Moderna will not issue any such publications without CytomX’s prior written consent, except as required by applicable Law. Notwithstanding the foregoing, any such publication or presentation to be made by CytomX that names Moderna will require the prior written consent of Moderna.
12.3.3 The Party that is entitled under this Section 12.3 (Publication) to make a publication or presentation (the “Publishing Party”) will deliver to the other Party (the “Non-Publishing Party”) a copy of the proposed written publication or outline of presentation to be made by the Publishing Party at least [***] in advance of submission (or, where a copy of such publication or presentation is not available at such time, a draft or outline of such publication or a description of such presentation), and the Non-Publishing Party will have the right to: (a) require a delay of submission of not more than [***] to enable the filing of patent applications and information from such proposed publication or presentation in accordance with this Agreement; and (b) prohibit disclosure of any of the Non-Publishing Party’s Confidential Information in any such proposed publication or presentation. If the Non-Publishing Party has not provided any comments or otherwise exercised its rights as described in this Section 12.3.3 (Publication) within [***] of receiving a copy of such proposed written publication or outline of presentation, the Publishing Party shall be free to submit such publication or to orally disclose or publish the disclosed information in a manner consistent with this Article 12 (Confidentiality).
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13.2.1 Moderna Breach. CytomX will have the right to terminate this Agreement in the event of any material breach by Moderna of any terms and conditions of this Agreement; provided, however, that such termination will not be effective if such breach has been cured within [***] after written notice thereof is given by CytomX to Moderna specifying the nature of the alleged breach; provided further, however, if such breach (except for payment breaches) is not reasonably subject to cure within [***] after receipt of written notice thereof, then Moderna shall continue to use good faith efforts to cure such breach and shall have provided to CytomX a written plan intended to cure (and that Moderna reasonably believes will cure) such breach as soon as reasonably practicable thereafter. Notwithstanding the foregoing in this Section 13.2.1 (Moderna Breach), in the event of a good faith dispute as to whether a material breach by Moderna allowing for termination hereunder has occurred, the foregoing cure period with respect thereto will be tolled pending final resolution of such dispute in accordance with the terms of this Agreement; provided, however, if such dispute relates to payment, such tolling of the cure period will only apply with respect to payment of the disputed amounts, and not with respect to any undisputed amount.
13.2.2 Moderna Bankruptcy or Insolvency. CytomX will have the right to terminate this Agreement if, at any time, Moderna: (a) files in any court or agency pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of Moderna or of its assets, in each case that is not dismissed within [***] after the filing thereof; (b) is served with an involuntary petition against it, filed in any
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insolvency proceeding, and such petition will not be dismissed within [***] after the filing thereof; (c) passes a resolution for its winding up or proposes to be or is a party to any dissolution or liquidation; or (d) makes or will make an assignment of substantially all of its assets for the benefit of its creditors.
13.2.3 CytomX Patent Challenge. CytomX will have the right to terminate this Agreement on a Licensed Product-by-Licensed Product or Collaboration Program-by-Collaboration Program basis effective immediately upon written notice to Moderna if Moderna or any of its Sublicensees or Affiliates initiates or asserts any CytomX Patent Challenge and fails to initiate rescission of such CytomX Patent Challenge within [***] after such written notice and thereafter fails to rescind such CytomX Patent Challenge within [***] after such written notice. In the event any Sublicensee (or any Person acting on its behalf) of Moderna initiates or asserts any CytomX Patent Challenge in any forum, Moderna shall, upon written request by CytomX, immediately terminate the applicable sublicense agreement with such Sublicensee.
13.3.1 CytomX Breach. Moderna will have the right to terminate this Agreement in the event of any material breach by CytomX of any terms and conditions of this Agreement; provided, however, that such termination will not be effective if such breach has been cured within [***] after written notice thereof is given by Moderna to CytomX specifying the nature of the alleged breach; provided further, however, if such breach is not reasonably subject to cure within [***] after receipt of written notice thereof, then CytomX shall continue to use good faith efforts to cure such breach and shall have provided to Moderna a written plan intended to cure (and that CytomX reasonably believes will cure) such breach as soon as reasonably practicable thereafter. Notwithstanding the foregoing in this Section 13.3.1 (CytomX Breach), in the event of a good faith dispute as to whether a material breach by CytomX allowing for termination hereunder has occurred, the foregoing cure period with respect thereto will be tolled pending final resolution of such dispute in accordance with the terms of this Agreement; provided, however, if such dispute relates to payment, such tolling of the cure period will only apply with respect to payment of the disputed amounts, and not with respect to any undisputed amount. [***].
13.3.2 CytomX Bankruptcy or Insolvency. Moderna will have the right to terminate this Agreement if, at any time, CytomX: (a) files in any court or agency pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of CytomX or of its assets, in each case that is not dismissed within [***] after the filing thereof; (b) is served with an involuntary petition against it, filed in any insolvency proceeding, and such petition will not be dismissed within [***] after the filing thereof; (c) passes a resolution for its winding up or proposes to be or is a party to any dissolution or liquidation; or (d) makes or will make an assignment of substantially all of its assets for the benefit of its creditors.
13.3.3 Other Termination for Cause. Moderna may terminate this Agreement on a Licensed Product-by-Licensed Product or Collaboration Program-by-Collaboration Program basis effective immediately upon written notice to CytomX in the event that (a) Moderna in good faith believes it is not advisable for Moderna to continue to Develop or Commercialize any Licensed Products as a result of a perceived serious safety issue regarding the use of any Licensed Product (as determined by Moderna’s senior executive or committee responsible for Licensed Product safety), provided that Moderna and CytomX shall first discuss such safety issue and attempt to resolve such safety issue in good faith prior to Moderna providing such notice of termination, or (b) CytomX or any of its Sublicensees or Affiliates
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initiates or asserts any Moderna Patent Challenge and fails to initiate rescission of such Moderna Patent Challenge within [***] after such written notice and thereafter fails to rescind such Moderna Patent Challenge within [***] after such written notice. In the event any Sublicensee (or any Person acting on its behalf) of CytomX initiates or asserts any Moderna Patent Challenge in any forum, CytomX shall, upon written request by Moderna, immediately terminate the applicable sublicense agreement with such Sublicensee.
13.3.4 Discretionary Termination. Moderna, in its sole discretion, may terminate this Agreement in its entirety effective as of any time after [***] upon delivery of (a) at least [***] prior written notice to CytomX if [***], (b) at least [***] prior written notice to CytomX if [***], and (c) at least [***] prior written notice to CytomX if [***]. Moderna, in its sole discretion, may terminate this Agreement on a Licensed Product-by-Licensed Product or country-by-country basis at any time during the Term upon delivery of (i) at least [***] prior written notice to CytomX if [***], (ii) at least [***] prior written notice to CytomX if [***], and (iii) at least [***] prior written notice to CytomX if [***].
13.4.1 Ongoing Clinical Studies. If Moderna is conducting (or having conducted on its behalf) any on-going clinical studies for which it has responsibility hereunder in which patient dosing has commenced, Moderna shall either (a) continue to conduct such clinical studies, or (b) responsibly wind-down, in accordance with accepted biopharmaceutical industry norms and ethical practices, and in the case of (a) and (b) Moderna will be responsible for any costs associated therewith.
13.4.2 Termination of Licenses and Sublicense; Payments. Except as set forth herein, all relevant licenses and sublicenses granted under Article 4 (License Grant), as of the effective date of such termination, shall terminate automatically unless otherwise agreed by the Parties. All undisputed amounts due or payable to a Party hereunder that were accrued prior to the date of termination shall remain due and payable except as otherwise set forth in the last sentence of this Section 13.4.2 (Termination of Licenses and Sublicense; Payments). Upon the effective date of such termination Moderna will have no further diligence obligations under this Agreement.
13.4.3 Destruction of Confidential Information. Each Party shall destroy or cause to be destroyed (or, at the other Party’s written request, return or cause to be returned) all Confidential
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Information of the other Party in the possession of such Party or its Affiliates or Sublicensees as of the effective date of expiration or termination (with the exception of one copy of such Confidential Information, which may be retained by the legal department of the Party that received such Confidential Information to confirm compliance with the non‑use and non‑disclosure provisions of this Agreement), and any Confidential Information of the other Party contained in its laboratory notebooks or databases; provided that each Party may retain and continue to use such Confidential Information of the other Party to the extent necessary to exercise any surviving rights, licenses or obligations under this Agreement. Notwithstanding the foregoing, a Party shall not be required to destroy any computer files created during automatic system back up that are subsequently stored securely by it and not readily accessible to its employees, consultants, or others who received Confidential Information under this Agreement. Moderna shall destroy or cause to be destroyed, or at CytomX’s option, return or cause to be returned to CytomX, all Materials of CytomX in the possession of Moderna or its Affiliates or Sublicensees as of the effective date of expiration or termination.
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14.5.1 Disputes; Resolution by Executive Officers. The Parties recognize that disputes as to certain matters may from time to time arise during the Term that relate to decisions to be made by the Parties herein or to the Parties’ respective rights and/or obligations hereunder. It is the desire of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to arbitration or litigation. To accomplish this objective, the Parties agree to follow the procedures set forth in this Section 14.5 (Dispute Resolution) if and when a dispute arises under this Agreement, subject to Section 2.2.5 (Decisions) and Section 14.5.3 (Injunctive Relief). Accordingly, any disputes, controversies or claims that may arise between the Parties out of or in relation to or in connection with this Agreement shall be promptly presented to the Alliance Managers for resolution. If the Alliance Managers are unable to resolve such dispute within [***] after a matter has been presented to them, then upon the request of either Party by written notice, the Parties agree to meet and discuss in good faith a possible resolution thereof, which good faith efforts shall include at least one in-person meeting between the Executive Officers of each Party within [***] after receipt by the other Party of such written notice. If any such matter, other than a matter within the final decision-making authority of Moderna, is not resolved within [***] following presentation to the Executive Officers, then either Party may invoke the provisions of Section 14.5.2 (Arbitration).
14.5.2 Arbitration. Any dispute that is not resolved pursuant to Section 14.5.1 (Disputes; Resolution by Executive Officers), shall be settled by binding arbitration to be conducted as set forth in this Section 14.5.2 (Arbitration).
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14.5.3 Injunctive Relief. Nothing in this Section 14.5 (Dispute Resolution) will preclude either Party from seeking equitable relief or interim or provisional relief from a court of competent jurisdiction, including a temporary restraining order, preliminary injunction or other interim equitable relief, concerning a dispute either prior to or during any arbitration if necessary to protect the interests of such Party or to preserve the status quo pending the arbitration proceeding. Each Party further acknowledges and agrees that the restrictions set forth in Section 2.5 (Exclusivity), Article 4 (License Grants), Article 8 (Intellectual Property) and Article 12 (Confidentiality) are reasonable and necessary to protect the legitimate interests of the other Party and that such other Party would not have entered into this Agreement in the absence of such restrictions, and that any breach or threatened breach of any provision of such Section or Article may result in irreparable injury to such other Party for which there
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will be no adequate remedy at law. In the event of a breach or threatened breach of any provision of such Section or Articles, the non-breaching Party shall be authorized and entitled to seek from any court of competent jurisdiction injunctive relief, whether preliminary or permanent, specific performance, and an equitable accounting of all earnings, profits, and other benefits arising from such breach, which rights shall be cumulative and in addition to any other rights or remedies to which such non-breaching Party may be entitled in law or equity. Both Parties agree to waive any requirement that the other (a) post a bond or other security as a condition for obtaining any such relief, and (b) show irreparable harm, balancing of harms, consideration of the public interest, or inadequacy of monetary damages as a remedy. For the avoidance of doubt, nothing in this Section 14.5.3 (Injunctive Relief) shall otherwise limit either Party’s opportunity to cure a material breach as permitted in accordance with Article 13 (Term & Termination).
14.5.4 Confidentiality. The arbitration proceedings shall be confidential and the arbitrator shall issue appropriate protective orders to safeguard each Party’s Confidential Information. Except as required by applicable Law, no Party shall make (or instruct the arbitrator to make) any public announcement with respect to the proceedings or decision of the arbitrator without prior written consent of the other Party. The existence of any dispute submitted to arbitration, and any award, shall be kept in confidence by the Parties and the arbitrator, except as required in connection with the enforcement of such award or as otherwise required by applicable Law. Notwithstanding the foregoing, each Party shall have the right to disclose information regarding the arbitration proceedings to the same extent as it may disclose Confidential Information of the other Party under Article 12 (Confidentiality).
14.5.5 Survival. Any duty to arbitrate under this Agreement shall remain in effect and be enforceable after termination of this Agreement for any reason.
14.5.6 Patent and Trademark Disputes. Notwithstanding Section 14.5.2 (Arbitration), and without prejudice to CytomX’s rights pursuant to Section 13.2.3 (CytomX Patent Challenge) or Moderna’s rights pursuant to Section 13.3.3(b) (Other Termination for Cause), any dispute, controversy or claim relating to the inventorship, scope, validity, enforceability or infringement of any patents Covering, or the scope, validity, enforceability or infringement of any trademark used in connection with, the manufacture, use, importation, offer for sale or sale of Licensed Products shall be submitted to a court of competent jurisdiction in the country in which such patent or trademark rights were granted or arose.
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If to CytomX: | CytomX Therapeutics, Inc. |
| 151 Oyster Point Blvd., Suite 400 |
| South San Francisco, CA 94080 USA |
| Attn: [***] |
|
|
| with copies (which shall not constitute notice) to: |
|
|
| CytomX Therapeutics, Inc. |
| 151 Oyster Point Blvd., Suite 400 |
| South San Francisco, CA 94080 USA |
| Attn: [***] |
|
|
| [***] |
| Latham & Watkins LLP |
| 140 Scott Drive |
| Menlo Park, CA 94025 USA |
|
|
|
|
If to Moderna: | Moderna TX, Inc. |
| 200 Technology Square |
| Cambridge, Massachusetts 02139 |
| Attn: [***] |
| Email: [***] |
|
|
| with copies (which shall not constitute notice) to: |
|
|
| Moderna TX, Inc. |
| 200 Technology Square |
| Cambridge, Massachusetts 02139 |
| Attn: [***] |
| Email: [***] |
|
|
| [***] |
| Freshfields Bruckhaus Deringer US LLP |
| 700 13th Street NW |
| Floor 10 |
| Washington, D.C. 20005 USA |
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Any such notice shall be deemed given on the date received, except any notice received after 5:00 p.m. (in the time zone of the receiving Party) on a Business Day or received on a non-Business Day shall be deemed to have been received on the next Business Day. A Party may add, delete, or change the Person or address to which notices should be sent at any time upon written notice delivered to the Party’s notices in accordance with this Section 14.6 (Notice).
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[Signature page follows]
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective Date.
CYTOMX THERAPEUTICS INC.
By: | /s/ Sean A. McCarthy |
Name: | Sean A. McCarthy, D. Phil. |
Title: | Chief Executive Officer & Chairman of the Board of Directors |
MODERNATX, INC.
By: | /s/ Said Francis |
Name: | Said Francis |
Title: | Senior Vice President, Business Development & Corporate Strategy |
[Signature Page to Collaboration and License Agreement]
Exhibit A
Initial Work Plans
[***]
56
Exhibit B
Form of Materials Transfer Agreement
[***]
Schedule 1.47
CytomX Patents
[***]
58
Schedule 1.117
Moderna Platform Patents
[***]
59
Schedule 1.173
Tools and Joint UC Patents
[***]
60
Schedule 2.3
Permitted Subcontractors
[***]
61
Schedule 9.2
Additional CytomX Representations and Warranties
[***]
62
Schedule 12.2
Form of Press Release
[***]
1