Exhibit 10.2
Certain information has been excluded from this agreement (indicated by “[***]”) because such information is both not material and the type that the registrant treats as private or confidential.
CONFIDENTIAL
LICENSE AGREEMENT
This License Agreement (this “Agreement”) is made effective as of June 3, 2021 (the “Effective Date”) by and between Cyclerion Therapeutics, Inc., a Massachusetts corporation (“Cyclerion”) and Akebia Therapeutics, Inc., a Delaware corporation (“Akebia”) (each of Cyclerion and Akebia being a “Party”, and collectively, the “Parties”).
WHEREAS, Cyclerion controls certain intellectual property rights with respect to the Licensed Compounds (as defined herein) and Products (as defined herein) in the Territory (as defined herein); and
WHEREAS, Cyclerion wishes to grant to Akebia, and Akebia wishes to be granted, an exclusive license under such intellectual property rights to Exploit (as defined herein) Licensed Compounds and Products in the Territory, in each case, in accordance with the terms and conditions set forth below.
NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:
The following terms, whether used in the singular or the plural, shall have the meanings designated to them under this Article unless otherwise specifically indicated.
1.3 | “Agreement” has the meaning set forth in the preamble hereto. |
1.4 | “Akebia” has the meaning set forth in the preamble hereto. |
1.5 | “Akebia Indemnitees” has the meaning set forth in Section 12.1. |
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1.7 | “Akebia Primary Patents” has the meaning set forth in Section 9.2(b)(i). |
1.9 | “Business Day” means any day except (a) Saturday, (b) Sunday, (c) any day that is a federal legal holiday in the U.S., or (d) any day on which banking institutions in the Commonwealth of Massachusetts are authorized or required by law or other governmental action to close. |
1.10 | “Calendar Quarter” means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date, and the last Calendar Quarter shall end on the last day of the Term. |
1.12 | “Centralized Approval Procedure” means the procedure through which a MAA filed with the EMA results in a single marketing authorization valid throughout the European Union. |
1.14 | “Combination Product” means a Product that is comprised of or contains a Licensed Compound as an active ingredient together with one or more other active ingredients and is sold either as a fixed dose or as separate doses but in any event for a single price. |
1.16 | “Commercial Sublicense Income” means any consideration received by Akebia or any of its Affiliates solely on the basis of sales of the Products by any Significant Sublicensee in any of the Major Countries (and sales by such Significant Sublicensee in any other countries or other jurisdictions in the Territory to the extent included in the grant of such a sublicense for any Major Country), including [***]. Notwithstanding any provision to the contrary set forth in this Agreement, Commercial Sublicense Income shall exclude [***]. To the extent that Akebia or its Affiliates receives any amounts not solely related to the sale of the Products, then the “Commercial Sublicense Income” attributable to the Products will be apportioned between [***]. |
1.17 | “Commercially Reasonable Efforts” means, with respect to the efforts to be expended by a Party with respect to any objective or activity, [***]. |
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1.20 | “Control Transferring Patent” has the meaning set forth in Section 9.2(a)(i). |
1.21 | “Convicted Entity” has the meaning set forth in Section 11.3(d). |
1.22 | “Convicted Individual” has the meaning set forth in Section 11.3(d). |
1.24 | “Cyclerion” has the meaning set forth in the preamble hereto. |
1.25 | “Cyclerion Competing Product” means any pharmaceutical product that contains [***]. |
1.26 | “Cyclerion Indemnitee” has the meaning set forth in Section 12.2. |
1.28 | “Cyclerion Intellectual Property” means the Cyclerion Patents and Cyclerion Know-How and Cyclerion’s interest in the Joint Intellectual Property Rights. |
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1.30 | “Cyclerion Patent” means any Patent, other than a Joint Patent, Controlled by Cyclerion or its Affiliates as of the Effective Date or [***]. |
1.31 | “Debarred Entity” has the meaning set forth in Section 11.3(b). |
1.32 | “Debarred Individual” has the meaning set forth in Section 11.3(a). |
1.34 | “Development Materials” has the meaning set forth in Section 5.4. |
1.35 | “Development Plan” has the meaning set forth in Section 3.1. |
1.36 | “Dollars” means U.S. dollars. |
1.37 | “Drug Product” means that certain finished Product manufactured [***]. |
1.38 | “Effective Date” has the meaning set forth in the preamble hereto. |
1.39 | “EMA” means the European Medicine Agency or any successor agency thereto or authority having substantially the same function. |
1.40 | “E.U. Regulatory Approval” means (a) receipt of Regulatory Approval by the EMA through the Centralized Approval Procedure or (b) receipt of Regulatory Approval from the applicable Regulatory Authorities in [***] Major European Countries. |
1.41 | “European Union” or “E.U.” means the economic, scientific, and political organization of member states known as the European Union, as its membership may be altered from time to time, and any successor thereto; provided that for the purposes of this Agreement, the European Union shall be deemed to include the United Kingdom. |
1.42 | “Excluded Entity” has the meaning set forth in Section 11.3(c). |
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1.43 | “Excluded Individual” has the meaning set forth in Section 11.3(c). |
1.45 | “Executive Officer” means, with respect to Cyclerion, its Chief Executive Officer and, with respect to Akebia, its Chief Executive Officer. |
1.46 | “Existing Drug Substance” means the existing inventory of praliciguat drug substance that Cyclerion has on hand as of the Effective Date, [***]. |
1.47 | “Exploit” means to Develop, Manufacture, perform Medical Affairs with respect to, Commercialize, and otherwise make, use, sell, offer for sale, or import. |
1.48 | “FDA” means the U.S. Food and Drug Administration or any successor agency thereto or authority having substantially the same function. |
1.49 | “FDA’s Disqualified/Restricted List” has the meaning set forth in Section 11.3(d). |
1.51 | “Field” means the treatment, prevention, or diagnosis of any diseases or conditions in humans. |
1.52 | “First Commercial Sale” means, with respect to a Product and a country or other jurisdiction in the Territory, the first bona fide, arm’s length sale of such Product in such country after Regulatory Approval has been obtained for such Product in such country or other jurisdiction. First Commercial Sale excludes any sale or other distribution of a Product for Clinical Trial or other Development purposes, early access programs (such as to provide patients with such Product prior to Regulatory Approval pursuant to treatment INDs or protocols, named patient programs or compassionate use programs) or any similar use. |
1.53 | “GAAP” means U.S. generally accepted accounting principles (or such accounting principles adopted by Akebia for the calculation of Net Sales, as applicable), consistently applied. |
1.54 | “Generic Product” means, with respect to a Product and a particular country, any pharmaceutical product that (a) is sold in such country by a Third Party that is not a Sublicensee of Akebia or its Affiliates, or any of their Sublicensees, under a Regulatory Approval granted by the applicable Regulatory Authority to a Third Party, (b) contains as an active ingredient the same active ingredient as such Product, and (c) is approved in part in reliance on the prior approval (or on safety or efficacy data submitted in support of the prior approval) of such Product (i) in the U.S., pursuant to Section 505(b)(2) or Section 505(j) of the FFDCA (21 U.S.C. 355(b)(2) and 21 U.S.C. 355(j), respectively), or (ii) in any other country or jurisdiction in the Territory, pursuant to all equivalents of any of the foregoing. Notwithstanding the foregoing, [***]. |
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entitled “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance,” and including related regulatory requirements imposed by the FDA or EMA, as applicable. |
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1.69 | “Knowledge” means the actual knowledge, as of the Effective Date, of the individuals of Cyclerion [***]. |
1.77 | “Manufacturing Process Patents” means any Patents Controlled by Akebia that Cover any Manufacturing Process Improvements. |
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1.94 | “Patent Transfer Date” means the earlier of [***], and (b) such date that the Parties may agree, following request by Akebia or Cyclerion. |
1.95 | “Person” means any individual, corporation, partnership, limited liability company, trust, governmental entity, or other legal entity of any nature whatsoever. |
1.98 | “PMDA” means the Pharmaceuticals and Medical Devices Agency of Japan or any successor agency thereto or authority having substantially the same function. |
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Countries and Sublicensee has the right to record such Product sales in its financial statements in accordance with U.S. GAAP or similar accounting standards in countries outside of the U.S.. |
1.116 | “Third Party” means any person or entity other than Cyclerion, Akebia, and their respective Affiliates. |
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3.6 | Records. Akebia shall maintain records in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, and in compliance with applicable law, which shall reflect all work done and results achieved in the performance of its Development activities for the Products in the Field in the Territory. Such records shall be retained by Akebia for at least [***] |
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years after the termination of this Agreement, or for such longer period as may be required by applicable law. |
Article 4
REGULATORY MATTERS
Article 5
MANUFACTURE AND SUPPLY OF PRODUCT AND PRE-CLINICAL MATERIALS
5.2 | Compliance; Warranties. The Supply Agreement will contain terms and conditions regarding compliance with applicable law and specifications for the Existing Drug Substance and Drug Product, delivery, acceptance, recalls, indemnification, and limitations of liability. |
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5.7 | Transfer of Responsibility for Manufacturing. Upon request by Akebia (but no later than the date of delivery of the Initial Supply to Akebia or its designee, as the case may be), on a |
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manufacturer-by-manufacturer and material-by-material basis, the Parties shall collaborate to [***], each a “Manufacturing Transfer Plan”). For the avoidance of doubt, Akebia may request the [***]. |
Article 6
MEDICAL AFFAIRS AND COMMERCIALIZATION
6.1 | Medical Affairs and Commercialization. Subject to the terms of this Agreement, Akebia shall have sole control over and decision-making authority with respect to the performance of Medical Affairs and Commercialization of the Products in the Field in the Territory, including the establishment and implementation of its commercial strategy. Akebia shall be solely responsible for all costs and expenses associated with its performance of Medical Affairs and Commercialization of the Products in the Field in the Territory. |
6.3 | Statements and Compliance with Applicable Law. Akebia shall, and shall cause its Affiliates to, comply with all applicable law with respect to the Commercialization of Products. |
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set forth in Table 7.2 within [***] after the first achievement of each of the following milestones by Akebia or its Affiliates for the first Product: |
Table 7.2 – Development and Regulatory Milestones | |
U.S. | Development and Regulatory Milestone Payment |
Initiation of a Phase 2 Clinical Trial in the U.S. for a Product for the first Indication | [***] |
Initiation of a Phase 3 Clinical Trial in the U.S. for a Product for the first Indication | [***] |
Initiation of a Phase 3 Clinical Trial in the U.S. for a Product for the second Indication | [***] |
Receipt of Regulatory Approval by the FDA for a Product for the first Indication | [***] |
Receipt of Regulatory Approval by the FDA for a Product for the second Indication | [***] |
[***] | [***] |
[***] | Development and Regulatory Milestone Payment |
Receipt of [***] Regulatory Approval for a Product for the first Indication | [***] |
Receipt of [***] Regulatory Approval for a Product for the second Indication | [***] |
[***] | [***] |
[***] | Development and Regulatory Milestone Payment |
Receipt of Regulatory Approval by [***] for a Product for the first Indication | [***] |
Receipt of Regulatory Approval by [***] for a Product for the second Indication | [***] |
[***] | [***] |
Each milestone payment in this Section 7.2 shall be payable one time only upon the first achievement of such milestone by the first Product.
If Akebia or its Affiliates achieves any milestone set forth in this Section 7.2 for a particular Product in a particular Indication before an earlier listed milestone for the same Product in the same Indication, then the earlier listed milestone shall become payable at the same time as the achieved milestone for the same Product in such Indication. No milestone payments in this Section 7.2 shall be due based on the achievement of any of the foregoing milestone events by any Significant Sublicensee.
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Table 7.4 – Sales Milestones | |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
For the avoidance of doubt, each sales milestone payment in this Section 7.4(a) shall be payable one time only upon the first achievement of such sales milestone event [***]. For the avoidance of doubt, (i) the maximum aggregate amount payable by Akebia pursuant to this Section 7.4(a) [***], and (ii) the maximum aggregate amount payable by Akebia pursuant to this Section 7.4(a) worldwide is [***].
Table 7.5 – Akebia Royalties [***] | |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
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| by Akebia or its Affiliates or Sublicensees (other than a Significant Sublicensee) of all Products [***] in a [***]. |
| (d) | Royalty Term. Akebia shall have no obligation to pay any royalty pursuant to this Section 7.5 with respect to sales of any Product in any country or other jurisdiction after the Royalty Term for such Product in such country or other jurisdiction has expired. |
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| (a) | Akebia shall pay to Cyclerion an amount equal to [***]. |
| (b) | Akebia shall pay to Cyclerion an amount equal to [***]. |
| (d) | Akebia shall pay Cyclerion its portion of all [***]. |
7.9 | Taxes. |
| (a) | [***]. |
| (b) | [***]. |
| (b) | Access to Records. At the request of Cyclerion, Akebia shall, and shall cause its Affiliates and Sublicensees to, permit an independent auditor designated by Cyclerion and reasonably acceptable to Akebia, at reasonable times and upon at least [***] advance notice, to audit the books and records maintained pursuant to Section 7.11(a) to ensure the accuracy of all reports and payments made hereunder relating to Net Sales, royalties, Non-Commercial |
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| Sublicense Income, and Commercial Sublicense Income. Except as provided below, the cost of this audit shall be borne by Cyclerion, unless the audit reveals a variance of more than [***] from the reported amounts, in which case Akebia shall bear the cost of the audit. If such audit concludes that (i) additional amounts were owed by Akebia, then Akebia shall pay the additional amounts, with interest from the date originally due as provided in Section 7.10, or (ii) excess payments were made by Akebia, then Cyclerion shall reimburse such excess payments, in either case ((i) or (ii)), within [***] after the date on which such audit is completed by Cyclerion. |
Article 8
LICENSE RIGHTS AND LIMITATIONS
8.5 | Survival of Sublicenses. Upon [***] not then in breach of its sublicense agreement or the terms of this Agreement applicable to such Sublicensee, Cyclerion will enter into a direct license from |
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Article 9
INTELLECTUAL PROPERTY
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|
All Manufacturing Process Improvements shall be the Confidential Information of Akebia and Akebia shall be under no obligation to disclose the technical details or other information required to enable Cyclerion to practice any Manufacturing Process Improvements, except pursuant to the terms of a license agreement negotiated between the Parties as provided herein. [***].
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| Schedule 9.2(a) (the “Control Transferring Patents”), at its sole cost and expense and by Cyclerion’s counsel as of the Effective Date, provided that: |
(1)If Cyclerion chooses to use counsel other than its counsel as of the Effective Date, then such counsel shall be reasonably acceptable to Akebia;
(2)Cyclerion shall consult with Akebia on all prosecution strategies, including what subject matter to pursue in an application, strategies for responding to substantive communications from a patent office, and divisional filing strategies with respect to the Control Transferring Patents;
(3)Cyclerion shall provide Akebia copies of all correspondence received from the relevant patent office regarding the Control Transferring Patents;
(4)Cyclerion shall provide Akebia copies of all documents relevant to such filing and prosecution at least [***] prior to submission of such documents to the applicable patent office;
(5)Cyclerion shall incorporate all reasonable comments with respect to any Control Transferring Patent provided by Akebia no later than [***] prior to the next deadline for the applicable action that must be taken with respect to such Control Transferring Patent, except that the foregoing obligation will not be construed to require Cyclerion to take any course of action that would negatively impact patent protection for Cyclerion’s proprietary compound, olinciguat, unless such course of action may be necessary to maintain patent protection for praliciguat;
(6)Cyclerion shall not, without the prior written consent of Akebia, file a divisional application for any Control Transferring Patent; provided, however, that, no such consent shall be required to file any divisional application that contains claims solely Covering Cyclerion’s proprietary compound, olinciguat, unless such divisional filing could negatively impact any issued patent or pending application Covering praliciguat, in which case, prior written consent of Akebia is required;
(7)Cyclerion shall not, without the prior written consent of Akebia, abandon or cease prosecution or maintenance of any Control Transferring Patent;
(8)Cyclerion shall use reasonable efforts to prepare, file, prosecute, and maintain the Control Transferring Patents so as to maximize the protection offered by such Control Transferring Patents for the Licensed Compounds and Products;
(9)the Control Transferring Patents shall be deemed the Confidential Information of both Parties;
(10)Cyclerion shall not, without the prior written consent of Akebia, (A) grant any Third Party control over the preparation, filing, prosecution, or maintenance of any Control Transferring Patent or (B) any right to comment on Cyclerion’s preparation, filing, prosecution, or maintenance of any Control Transferring Patent that either (I) would permit such Third Party to provide comments directly to Akebia after the Patent Transfer Date, or (II) exceeds or is otherwise incompatible with Cyclerion’s right to provide comments after the Patent Transfer Date as provided under Section 9.2(b)(i); and
(11)Cyclerion shall not, without the prior written consent of Akebia, take or fail to take any action (whether alone or in conjunction with other actions) in the course of
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preparation, filing, prosecution, and maintenance of any Control Transferring Patent that could materially diminish or limit the scope of such Control Transferring Patent’s protection of one or more Licensed Compounds or Products (if such Control Transferring Patent were to issue in its then-current form) in favor of increasing the protection of any other compound or product, including for the avoidance of doubt, Cyclerion’s proprietary compound, olinciguat. If at any time any course of action taken by Cyclerion may negatively impact patent protection for the Licensed Compounds or Products, then upon Akebia’s request Cyclerion shall cease such action.
| (b) | Prosecution of Control Transferring Patents After Patent Transfer Date and Joint Patents. |
| (ii) | In the event that Akebia desires to abandon or cease prosecution or maintenance of any Akebia Primary Patent, Akebia shall provide reasonable prior written notice to Cyclerion of such intention to abandon (which notice shall, to the extent possible, be given no later than [***] prior to the next deadline for any action that must be taken with respect to any such Akebia Primary Patent in the relevant patent office). In such case, upon Cyclerion’s written election provided no later than [***] after such notice from Akebia, Cyclerion shall have the right to assume the prosecution and maintenance of such Akebia Primary Patent at Cyclerion’s expense. |
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| reasonable comments with respect thereto provided by Akebia no later than [***] prior to the next deadline for the applicable action that must be taken with respect to any such Non-Control Transferring Patent. Cyclerion shall not take any action that could jeopardize the validity or enforceability of the Akebia Primary Patents or any action may negatively impact the Akebia Primary Patents. |
| (ii) | In the event that Cyclerion desires to abandon or cease prosecution or maintenance of any Non-Control Transferring Patent, Cyclerion shall provide reasonable prior written notice to Akebia of such intention to abandon (which notice shall, to the extent possible, be given no later than [***] prior to the next deadline for any action that must be taken with respect to any such Non-Control Transferring Patent in the relevant patent office). In such case, upon Akebia’s written election provided no later than [***] after such notice from Cyclerion, Akebia shall have the right to assume the prosecution and maintenance of such Non-Control Transferring Patent at Akebia’s expense. If Akebia does not provide such election within [***] after such notice from Cyclerion, Cyclerion may, in its sole discretion, continue or discontinue prosecution and maintenance of such Non-Control Transferring Patent. |
| (d) | Update to Schedule 1.30 upon Patent Transfer. [***] after the Patent Transfer Date, but in any event within [***], Cyclerion shall provide Akebia an updated Schedule 1.30 setting forth all Cyclerion Patents existing as of the Patent Transfer Date. |
| (e) | Cooperation. Each Party shall provide the other Party all reasonable assistance and cooperation, at the other Party’s request and expense, in the patent prosecution efforts provided above in this Section 9.2, including providing any necessary powers of attorney, executing any other required documents or instruments for such prosecution, and making its personnel with appropriate scientific expertise available to assist in such efforts. |
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| 9.4 in a manner that, or knowingly take any other action in the course thereof that, materially adversely affects the other Party’s interest in the Non-Control Transferring Patent or Akebia Primary Patents, without the written consent of such other Party, such consent not to be unreasonably withheld, conditioned or delayed. |
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| (b) | has been in the receiving Party’s possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information; |
| (c) | is subsequently received by the receiving Party from a Third Party without restriction and without breach of any agreement between such Third Party and the disclosing Party; or |
| (d) | has been independently developed by or for the receiving Party without reference to, or use or disclosure of the disclosing Party’s Confidential Information. |
Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the receiving Party unless the combination and its principles are in the public domain or in the possession of the receiving Party.
10.2 | Permitted Disclosures. Each Party may disclose Confidential Information to the extent that such disclosure is: |
| (b) | made by or on behalf of the receiving Party to the Regulatory Authorities as required in connection with any Regulatory Submission or in connection with any inspection or audit by any Regulatory Authority; |
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| Compounds or the Products, or otherwise in connection with the performance of its obligations or exercise of its rights as contemplated by this Agreement; provided, however, that such Persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information no less stringent than the obligations of confidentiality and non-use of the receiving Party pursuant to this Article 10; |
| (d) | subject to Section 9.4, made by or on behalf of the receiving Party to a patent authority as may be reasonably [***] for purposes of filing, prosecuting, maintaining, enforcing, or defending a Patent as permitted under this Agreement; or |
10.6 | Return of Confidential Information. Upon the effective date of the termination of this Agreement for any reason, either Party may request in writing, and the other Party shall either, with |
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respect to Confidential Information to which such first Party does not retain rights under the surviving provisions of this Agreement: (a) promptly destroy all copies of such Confidential Information in the possession of the other Party and confirm such destruction in writing to the requesting Party; or (b) promptly deliver to the requesting Party, at the other Party’s expense, all copies of such Confidential Information in the possession of the other Party; provided, however, the other Party shall be permitted to retain copies of such Confidential Information for the sole purpose of performing any continuing obligations hereunder or for archival purposes. Notwithstanding the foregoing, such other Party also shall be permitted to retain such additional copies of or any computer records or files containing such Confidential Information that have been created solely by such Party’s automatic archiving and back-up procedures, to the extent created and retained in a manner consistent with such other Party’s standard archiving and back-up procedures, but not for any other use or purpose. |
Article 11
REPRESENTATIONS AND WARRANTIES
11.1 | Representations and Warranties by Cyclerion. Cyclerion hereby represents and warrants to Akebia as of the Effective Date as follows: |
| (a) | the execution, delivery, and performance of this Agreement have been duly authorized by all necessary corporate actions; |
| (b) | this Agreement constitutes a valid obligation of Cyclerion and is binding and enforceable against Cyclerion in accordance with the terms hereof; |
| (c) | Cyclerion and, to Cyclerion’s Knowledge, its contractors and consultants, have complied in all material respects with all applicable law in the Development and Manufacture of the Licensed Compound and Product prior to the Effective Date; |
| (d) | Cyclerion has the corporate power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder, and there is no contractual restriction or other legal obligation binding on Cyclerion that would be contravened by execution and delivery of this Agreement or by the performance or observance of its terms; |
| (e) | Cyclerion has not granted, and will not grant during the Term, a license or sublicense to any Affiliate or Third Party under the Cyclerion Intellectual Property that would conflict with the rights granted to Akebia hereunder; |
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| (i) | to Cyclerion’s Knowledge, the Cyclerion Patents set forth on Schedule 1.30 have been diligently prosecuted with the respective patent offices where such Cyclerion Patents have been filed in the Territory in accordance with applicable law, and all applicable fees necessary to maintain the Cyclerion Patents set forth on Schedule 1.30 have been paid on or before the due date for such payment; |
| (j) | each individual who is an inventor of or otherwise has or has had any rights in or to any Cyclerion Patents identified as being owned by Cyclerion on Schedule 1.30 has assigned to Cyclerion all of his or her interest therein; |
| (k) | Cyclerion is entitled to grant the licenses specified herein; |
| (l) | the conception, development, and reduction to practice of any of the Cyclerion Intellectual Property have not constituted or involved the misappropriation of trade secrets or other intellectual property rights of any Third Party; |
| (m) | the process used by Cyclerion to Manufacture the Licensed Compounds or Products (as applicable) as of the Effective Date does not require the use of any Third Party intellectual property right; |
| (o) | no Third Party has challenged the ownership, scope, duration, validity, enforceability, priority, or right to use any Cyclerion Patent (including, by way of example, through the institution of or written threat of institution of interference, inter partes review, reexamination, protest, opposition, nullity, or similar invalidity proceeding before the United States Patent and Trademark Office or any foreign patent authority or court); |
| (p) | Cyclerion has not previously assigned, transferred, conveyed, or granted any license or other rights under the Cyclerion Intellectual Property, except in each case where such assignment, transfer, conveyance, or grant is not inconsistent with the rights and licenses granted to Akebia under this Agreement; |
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| inventions is not permitted by applicable law, will be) assigned in writing to Cyclerion pursuant to a written agreement to assign such inventions and discoveries to Cyclerion; |
| (t) | all INDs owned or Controlled by Cyclerion that cover any Licensed Compound are listed on Schedule 4.1; |
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11.2 | Representations and Warranties by Akebia. Akebia hereby represents and warrants to Cyclerion as of the Effective Date as follows: |
| (a) | The execution, delivery, and performance of this Agreement have been duly authorized by all necessary corporate actions; |
| (b) | This Agreement constitutes a valid obligation of Akebia and is binding and enforceable against Akebia in accordance with the terms hereof; and |
| (c) | Akebia has the corporate power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder, and there is no contractual restriction or obligation binding on Akebia that would be contravened by execution and delivery of this Agreement or by the performance or observance of its terms. |
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| or is otherwise ineligible to participate in federal procurement and non-procurement programs, including those produced by the U.S. General Services Administration (GSA). |
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Article 13
TERM AND TERMINATION
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| to be agreed by the Parties in order to permit the breaching Party a reasonable period of time to cure such breach (but in no event will such additional time period be more than [***]. Any notice provided pursuant to this Section 13.2(b) shall identify with particularity the alleged breach and state the non-breaching Party’s intent to terminate this Agreement if such breach is not cured. If the material breach described in the notice of such material breach solely pertains to one or more specific Major Countries, then the other Party may terminate this Agreement solely with respect to those Major Countries to which such breach pertains. |
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| any of its Affiliates or licensees; (ii) any Patent Challenge to the extent commenced by a Third Party that after the Effective Date acquires or is acquired by Akebia or any of its Affiliates or its of their business or assets, whether by stock purchase, merger, asset purchase or otherwise; provided that such proceeding commenced prior to the closing of such acquisition; or (iii) any Patent Challenge that is commenced by a Sublicensee; provided that Akebia demands that such Sublicensee withdraw such Patent Challenge promptly after Akebia becomes aware of such Patent Challenge and terminates the sublicense agreement with the applicable Sublicensee if such Sublicensee does not withdraw such Patent Challenge [***] after receipt of notice from Akebia. |
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| performance by Akebia will release Cyclerion from liability resulting from rejection of the license or the failure to perform such obligations; and |
13.3 | Consequences of Termination. In the event of a termination of this Agreement in its entirety for any reason, the following will apply: |
| (a) | all rights and licenses granted by Cyclerion hereunder shall immediately terminate; |
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| all applicable laws and regulations or (B) transfer such on-going Clinical Trials in the Territory to Cyclerion; |
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If to Akebia, to:
Akebia Therapeutics, Inc.
245 First Street
14th Floor
Cambridge, MA 02142
Attention: [***]
Email: [***]
with a copy (which shall not constitute notice) to:
Akebia Therapeutics, Inc.
245 First Street
Cambridge, MA 02142
Attention: [***]
Email: [***]
And
Ropes & Gray LLP
Prudential Tower, 800 Boylston Street
Boston, MA 02199-3600
Attention: [***]
Email: [***]
If to Cyclerion, to:
Cyclerion Therapeutics, Inc.
245 First Street
Riverview II, 18th Floor
Cambridge, MA 02142
40
CONFIDENTIAL
Attention: [***]
with a copy (which shall not constitute notice) to:
Cyclerion Therapeutics, Inc.
245 First Street
Riverview II, 18th Floor
Cambridge, MA 02142
Attention: [***]
14.4 | Designation of Affiliates. Each Party may discharge any obligations and exercise any rights hereunder through delegation of its obligations or rights to any of its Affiliates. Each Party hereby guarantees the performance by its Affiliates of such Party’s obligations under this Agreement and will cause its Affiliates to comply with the provisions of this Agreement in connection with such performance. |
14.5 | Further Assurance. Each of Cyclerion and Akebia agrees to duly execute and deliver, or cause to be duly executed or delivered, such further instruments and do and cause to be done such further acts, including the filing of additional assignments, agreements, documents, and instruments, as the other Party may at any time and from time to time reasonably request in connection with this |
41
CONFIDENTIAL
Agreement or to carry out more effectively the provisions and purposes of, or to better assure and confirm unto such other Party its rights and remedies under, this Agreement. |
42
CONFIDENTIAL
43
CONFIDENTIAL
| (b) | Waiver of Jury Trial. EACH PARTY HERETO HEREBY IRREVOCABLY WAIVES ALL RIGHT TO TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM (WHETHER BASED IN CONTRACT, TORT OR OTHERWISE) ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE ACTIONS OF ANY PARTY HERETO IN THE NEGOTIATION, ADMINISTRATION, PERFORMANCE AND ENFORCEMENT HEREOF. NOTWITHSTANDING THE FOREGOING, NEITHER PARTY WAIVES ANY RIGHT TO A JURY PROCEEDING FOR THE DETERMINATION OF DAMAGES ARISING FROM ANY SUCH ACTION PROCEEDING OR COUNTERCLAIM. |
| (c) | Disputes Related to Patent Rights. Notwithstanding anything in this Agreement to the contrary, any and all issues regarding the validity and enforceability of any Patent shall be determined in a court or other tribunal, as the case may be, of competent jurisdiction under the applicable Patent laws of such country, with a jury trial being however excluded. If such dispute involves such Patent matters and other matters, the arbitrators will have the right to stay the arbitration until determination of such Patent matters material to the resolution of the dispute as to the other matters is resolved. |
| (d) | Injunctive Relief. Nothing contained in the Agreement shall deny either Party the right to injunctive relief, equitable relief, interim or provisional relief including a temporary restraining order, specific performance, preliminary or permanent injunction or other interim equitable relief from a court of competent jurisdiction in the context of a breach or threatened breach of any provision of the Agreement, bona fide emergency or prospective irreparable harm, or as reasonable and necessary to protect its legitimate interests. Such an action may be filed and maintained, notwithstanding any ongoing discussions between the Parties or any ongoing arbitration proceeding concerning a dispute if necessary to protect the interests of such Party or to preserve the status quo pending the arbitration proceeding. |
[SIGNATURES PAGE FOLLOWS]
44
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed as of the Effective Date by their respective duly authorized officers.
CYCLERION PHARMACEUTICALS, INC. | ||
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By: |
| /s/ Cheryl Gault |
Name: |
| Cheryl Gault |
Title: |
| Chief Operating Officer |
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AKEBIA THERAPEUTICS, INC. | ||
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By: |
| /s/ John P. Butler |
Name: |
| John P. Butler |
Title: |
| Chief Executive Officer |
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By: |
| /s/ David A. Spellman |
Name: |
| David A. Spellman |
Title: |
| Chief Financial Officer |
[Signature Page to Akebia Cyclerion License Agreement]
Schedule 1.8
Assigned Trademarks
[***]
Schedule 1.30
Cyclerion Patents
Reference | Title | Country | Status | Application No. | Filing Date | Publication No. | Publication Date | Patent No. | Issue Date |
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Licensed Compounds
[***]
Schedule 1.81
CONFIDENTIAL
Schedule 3.3
Initial Development Plan
[***]
CONFIDENTIAL
Schedule 4.1
Existing INDs
[***]
1
CONFIDENTIAL
Schedule 5.3
Estimated Initial Supply
[***]
1
CONFIDENTIAL
Schedule 9.2(a)
Control Transferring Patents
[***]
CONFIDENTIAL
Schedule 9.2(c)
Non-Control Transferring Patent
[***]
Schedule 11.1(u)
Agreements relating to the Manufacture or supply of the Licensed Compounds and Products
Development Materials and related contracts:
[***]