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13.3. Assignment ......................................................................................................... 104 |
13.4. Severability ......................................................................................................... 106 |
13.5. Dispute Resolution.............................................................................................. 106 |
13.6. Governing Law ................................................................................................... 107 |
13.7. Notices ................................................................................................................ 107 |
13.8. Entire Agreement; Amendments......................................................................... 108 |
13.9. English Language................................................................................................ 108 |
13.10. Equitable Relief .................................................................................................. 108 |
13.11. Waiver and Non-Exclusion of Remedies............................................................ 109 |
13.12. No Benefit to Third Parties ................................................................................. 109 |
13.13. Further Assurance ............................................................................................... 109 |
13.14. Relationship of the Parties .................................................................................. 109 |
13.15. References........................................................................................................... 110 |
13.16. Construction........................................................................................................ 110 |
13.17. Performance by Affiliates ................................................................................... 110 |
13.18. Change in Control of Cugene ............................................................................. 110 |
13.19. Counterparts........................................................................................................ 111 |
Schedules |
Schedule 1.54 Corporate Names |
Schedule 1.94 Existing Patents Schedule |
Schedule 1.116 In-License Schedule |
Schedule 1.123 Indications |
Schedule 1.126 Initial Development Plan and Budget |
Schedule 2.3.4 Permitted Entities |
Schedule 7.5 Sample Royalty Calculation |
Schedule 9.6 Form of Joint Press Release |
Schedule 10.2.1(c) Cugene Patents |
Schedule 13.5.3 ADR Procedures |
COLLABORATION AND LICENSE OPTION AGREEMENT |
This Collaboration and License Option Agreement (this "Agreement") is made and entered into as of May 6, 2022 (the "Effective Date") by and between Cugene, Inc., a Delaware corporation ("Cugene"), and AbbVie Global Enterprises Ltd., a Bermudian limited company ("AbbVie"). Cugene and AbbVie are sometimes referred to her... |
RECITALS |
WHEREAS, Cugene owns and controls certain intellectual property rights with respect to certain IL-2 (as defined below) muteins in the Territory (as defined below); and |
WHEREAS, the Parties wish for Cugene to perform certain Development (as defined below) activities with respect to such muteins; and |
WHEREAS, Cugene wishes to grant to AbbVie, and AbbVie wishes to obtain, an option to take an exclusive license under such intellectual property rights to Exploit (as defined below) Licensed Therapeutics (as defined below) and Licensed Products (as defined below) in the Field (as defined below) in the Territory, in acco... |
NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions set forth herein 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: |
ARTICLE 1 DEFINITIONS |
Unless otherwise specifically provided herein, the following terms shall have the following meanings: |
1.1. "418 Patent" means any Cugene Patent related to the Excluded Compound, including WO/2020/252418. |
1.2. "AbbVie" has the meaning set forth in the preamble hereto. |
1.3. "AbbVie Grantback Agreement Know-How" means all Information Controlled by AbbVie or its Affiliates during the Term or as of the effective date of the applicable termination of this Agreement that was conceived, discovered, developed or otherwise made by or on behalf of AbbVie (or its Affiliates or its or their Sub... |
1.4. "AbbVie Grantback Agreement Patent" means any Patent Controlled by AbbVie or its Affiliates during the Term or as of the effective date of the applicable termination of this Agreement that was conceived, discovered, developed or otherwise made by or on behalf of AbbVie (or its Affiliates or its or their Sublicense... |
1.5. "AbbVie Grantback Background Know-How" means all Information Controlled by AbbVie or its Affiliates as of the effective date of the applicable termination of this Agreement, other than AbbVie Grantback Agreement Know-How, that is not generally known and is necessary for the Exploitation of any Reversion Product as... |
1.6. "AbbVie Grantback Background Patent" means any Patent Controlled by AbbVie or its Affiliates as of the effective date of the applicable termination of this Agreement, other than AbbVie Grantback Agreement Patents, that is necessary for the Exploitation of any Reversion Product as of such effective date of terminat... |
1.7. "AbbVie Grantback Know-How" means the AbbVie Grantback Agreement Know-How and AbbVie Grantback Background Know-How. |
1.8. "AbbVie Grantback Patents" means the AbbVie Grantback Agreement Patents and AbbVie Grantback Background Patents. |
1.9. "AbbVie Indemnitees" has the meaning set forth in Section 11.2. |
1.10. "AbbVie Liquid Formulation" means any formulation Developed by or on behalf of AbbVie during the Term specifically for a Licensed Product that is liquid above 0°C. For clarity, AbbVie Liquid Formulation does not include the liquid formulation for the Licensed Product described in the Initial Development Plan and ... |
1.11. "AbbVie Patents" means all Patents owned or Controlled, that are conceived, discovered, developed or otherwise made, by or on behalf of AbbVie under this Agreement (other than the Joint Patents). For clarity, AbbVie Patents shall not include Cugene Patents. |
1.12. "Acceptance" means, with respect to a BLA, receipt of written notice from the FDA indicating that such BLA has been accepted for filing and further FDA review. |
1.13. "Accounting Standards" means, with respect to a Party or its Affiliates or its or their (sub)licensees, United States generally accepted accounting principles, consistently applied. |
1.14. "Acquirer IP" has the meaning set forth in Section 13.3.2. |
1.15. "Acquiring Entities" has the meaning set forth in Section 13.3.2. |
1.16. "Acquisition" means, with respect to a Party, a merger, acquisition (whether of all of the stock or all or substantially all of the assets of a Person or any operating or business division of a Person) or similar transaction by or with the Party (or any controlling Affiliate), other than a Change in Control of th... |
1.17. "Acquisition Party" has the meaning set forth in Section 13.3.2. |
1.18. "Acquisition Transaction" has the meaning set forth in Section 13.3.2. |
1.19. "ADR" has the meaning set forth in Section 13.5.1. |
1.20. "Adverse Event and Safety Information Agreement" has the meaning set forth in Section 5.7. |
1.21. "Affiliate" means, with respect to a Party, any Person that, directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with such Party. For purposes of this definition, "control" and, with correlative meanings, the terms "controlled by" and "under common con... |
1.22. "Agreement" has the meaning set forth in the preamble hereto. |
1.23. "Alliance Managers" has the meaning set forth in Section 6.4. |
1.24. "Applicable Law" means applicable laws, rules and regulations, including any rules, regulations, regulatory guidelines or other requirements of Regulatory Authorities, that may be in effect from time to time. |
1.25. "Assay" means the in vitro pSTAT5 human PBMC assay, the protocol of which is set forth in the Side Letter. |
1.26. "Auditor" has the meaning set forth in Section 7.12.2. |
1.27. "Biosimilar Application" has the meaning set forth in Section 8.3.7. |
1.28. "Biosimilar Product" means, with respect to a Licensed Product in a country or other jurisdiction, a biological product that (a) is highly similar to such Licensed Product (as the reference product with respect thereto) notwithstanding minor differences in clinically inactive components; (b) has no clinically mea... |
1.29. "Bispecific Patent" means any Cugene Patent related to bifunctional or multi-functional fusion molecules comprising an IL-2 variant, including WO/2020/252421. |
1.30. "BLA" has the meaning set forth in the definition of "Drug Approval Application". |
1.31. "Board of Directors" has the meaning set forth in the definition of "Change in Control". |
1.32. "Breaching Party" has the meaning set forth in Section 12.2.1(a). |
1.33. "Bring Down Date" has the meaning set forth in Section 10.2.2(c). |
1.34. "Bring Down Request" has the meaning set forth in Section 10.2.2(a). |
1.35. "Bring Down Request Date" has the meaning set forth in Section 10.2.2(a). |
1.36. "Business Day" means a day other than a Saturday or Sunday on which banking institutions in Chicago, Illinois, and Boston, Massachusetts, are open for business. |
1.37. "Calendar Quarter" means each successive period of three calendar months commencing on January 1, April 1, July 1 or 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 and Octob... |
1.38. "Calendar Year" means each successive period of 12 calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term sh... |
1.39. "CD4" means the CD4 membrane glycoprotein of T lymphocytes, encoded by the gene with NCBI gene ID: 920. |
1.40. "CD4+Treg" means CD4+CD25+FOXP3+ T cells. |
1.41. "CD8" means the CD8 membrane glycoprotein on cytotoxic T lymphocytes, encoded by the gene with NCBI gene ID: 925. |
1.42. "Change in Control" means, with respect to a Party, that any of the following occurs after the Effective Date: |
1.42.1. any "person" or "group" (as such terms are defined below) acquires or becomes the "beneficial owner" (as defined below), directly or indirectly, of (a) shares of capital stock or other interests (including partnership interests) of such Party (or any controlling Affiliate of such Party) then outstanding and nor... |
1.42.2. such Party (or any controlling Affiliate of such Party) enters into a merger, consolidation or similar transaction with another Person (whether or not such Party (or any controlling Affiliate of such Party) is the surviving entity) and as a result of such merger, consolidation or similar transaction (a) the mem... |
1.42.3. such Party (or any controlling Affiliate of such Party) sells or transfers to any Third Party, in one or more related transactions, properties or assets representing all or substantially all of such Party's (or any such Party's controlling Affiliate's) consolidated total assets to which this Agreement relates; ... |
1.42.4. the holders of capital stock of such Party (or any controlling Affiliate of such Party) approve a plan or proposal for the liquidation or dissolution of such Party (or any controlling Affiliate of such Party). |
For the purpose of this definition of Change in Control, (a) "person" and "group" have the meanings given such terms under Section 13(d) and 14(d) of the United States Securities Exchange Act of 1934 and the term "group" includes any group acting for the purpose of acquiring, holding or disposing of securities within t... |
1.43. "Clinical Studies" means any tests and studies in human subjects that are required or permitted by Applicable Law to obtain or maintain any Regulatory Approval for, or to support the pricing, reimbursement or use of, a Licensed Product, including tests or studies that are intended to expand the Product Labeling f... |
1.44. "CMC Activities" means, with respect to a Licensed Therapeutic or Licensed Product, all Manufacturing activities (including the generation of all CMC Data) necessary to support the development or commercialization of such Licensed Therapeutic or Licensed Product, as applicable, at the applicable stage of developm... |
1.45. "CMC Data" means the chemistry, manufacturing and controls data for each Licensed Therapeutic or Licensed Product, as applicable, required by Applicable Law to be included or referenced in, or that otherwise supports, an application for Regulatory Approval. |
1.46. "Combination Product" means a Licensed Product that comprises or contains one or more Licensed Therapeutics as an active ingredient together with one or more other active ingredients (each, an "Other Active"), whether in the same or different formulations, and is sold either as a fixed dose or as separate doses a... |
1.47. "Commercialization" means any and all activities directed to the preparation for sale of, offering for sale of or sale of a Licensed Product, including activities related to marketing, promoting, distributing, importing and exporting such Licensed Product, and interacting with Regulatory Authorities regarding any... |
1.48. "Commercially Reasonable Efforts" means, with respect to the performance of Development, Commercialization or Manufacturing or other Exploitation activities with respect to a Licensed Therapeutic or Licensed Product by a Party, the carrying out of such activities using efforts and resources comparable to the effo... |
1.49. "Competing Product" means (a) any Licensed Therapeutic in the Field in the Territory or (b) any other mutein, antibody, compound, molecule or other therapeutic that satisfies the Immunology Test. Notwithstanding the foregoing, Competing Products do not include the Cugene Existing P19/126 Oncology Compounds. |
1.50. "Confidential Information" has the meaning set forth in Section 9.1. |
1.51. "Control" means, subject to Section 13.3.2, with respect to a Party and any item of Information, Regulatory Documentation, material, Patent or other intellectual property right, possession by such Party of the right, whether directly or indirectly and whether by ownership, license or otherwise (other than by oper... |
1.52. "Convicted Entity" has the meaning set forth in Section 10.2.1(u)(4). |
1.53. "Convicted Individual" has the meaning set forth in Section 10.2.1(u)(4). |
1.54. "Corporate Names" means the Trademarks and logos identified on Schedule 1.54 and such other replacement corporate names and logos as Cugene may use from time to time. |
1.55. "Cover" means, when referring to a Licensed Product or other product, (a) with respect to a Patent, that, in the absence of a license granted to a Person under an issued claim included in such Patent, the practice by such Person of a specified activity with respect to such Licensed Product or product would infrin... |
1.56. "CREATE Act" has the meaning set forth in Section 8.2.6. |
1.57. "CUG252" means an Fc-fusion protein that comprises the Licensed IL-2 Mutein, the amino acid sequence of which fusion protein is set forth in the Side Letter. |
1.58. "Cugene" has the meaning set forth in the preamble hereto. |
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