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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. |
1.59. "Cugene Existing P19/126 Oncology Compound" means any compound that is or comprises an IL-2 Mutein with an internal Cugene reference ID number P-1247 or P-1248. |
1.60. "Cugene Indemnitees" has the meaning set forth in Section 11.1. |
1.61. "Cugene IP" means the Cugene Know-How, Cugene Patents and Cugene Trademarks. |
1.62. "Cugene Know-How" means all Information Controlled by Cugene or any of its Affiliates as of the Effective Date or at any time during the Term that is not generally known and is necessary or reasonably useful to Exploit a Licensed Therapeutic or Licensed Product in the Field in the Territory, but excluding any (a)... |
1.63. "Cugene Patent" means all Patents Controlled by Cugene or any of its Affiliates as of the Effective Date or at any time during the Term that are necessary or reasonably useful (or, with respect to patent applications, would be necessary or reasonably useful if such patent applications were to issue as patents) to... |
1.64. "Cugene Trademarks" means any Trademarks Controlled by Cugene or any of its Affiliates that are used in connection with any Licensed Therapeutic or Licensed Product as of the License Option Effective Date, excluding Cugene's Corporate Names. |
1.65. "Data Breach" has the meaning set forth in Section 10.3.4. |
1.66. "Data Package" means an Early Exercise Data Package, Preliminary Final Data Package or the Final Data Package. |
1.67. "Data Protection Laws" means all Applicable Law relating to the privacy, Processing and security of Personal Data. |
1.68. "Debarred Entity" has the meaning set forth in Section 10.2.1(u)(2). |
1.69. "Debarred Individual" has the meaning set forth in Section 10.2.1(u)(1). |
1.70. "Defense Proceeding" has the meaning set forth in Section 8.2.1(a). |
1.71. "Development" means all activities related to research, pre-clinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, CMC Activities, Clinical Studie... |
1.72. "Development Milestone Event" has the meaning set forth in Section 7.3. |
1.73. "Development Milestone Payment" has the meaning set forth in Section 7.3. |
1.74. "Different Licensed Product" has the meaning set forth in Section 7.3. |
1.75. "Disclosing Party" has the meaning set forth in Section 9.1.1. |
1.76. "Dispute" has the meaning set forth in Section 13.5. |
1.77. "Distributor" means any Person appointed by AbbVie or any of its Affiliates or its or their Sublicensees to distribute, market and sell Licensed Product with or without packaging rights, in one or more countries or other jurisdictions in the Territory, in circumstances where such Person purchases its requirements... |
1.78. "DOJ" means the United States Department of Justice. |
1.79. "Dollars" or "$" means United States Dollars. |
1.80. "DRC" means, with respect any Clinical Study conducted under the Initial Development Plan and Budget, the data review committee or data monitoring committee established in accordance with the Initial Development Plan and Budget and Applicable Law. |
1.81. "Drug Approval Application" means a Biologics License Application as defined in the FFDCA (a "BLA") or any corresponding foreign application in the Territory, including, with respect to the European Union, a marketing authorization application filed with the EMA pursuant to the centralized approval procedure or w... |
1.82. "Early Exercise Data Package" has the meaning set forth in Section 2.5.1. |
1.83. "Early Exercise Request" has the meaning set forth in Section 2.5.1. |
1.84. "EEA" means the European Economic Area. |
1.85. "Effective Date" has the meaning set forth in the preamble hereto. |
1.86. "EMA" means the European Medicines Agency and any successor agency(ies) or authority having substantially the same function. |
1.87. "European Union" 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. |
1.88. "Excluded Compound" means any mutein, antibody, compound, molecule or other therapeutic that is or comprises an IL-2 Mutein for which an Fc-fusion protein that comprises such IL-2 Mutein has significantly less agonist activity to IL-2Rαβγ (expressed on CD4+Treg) compared with an Fc-fusion protein that comprises W... |
Bioassay Criteria EC50 fold change for pSTAT5 comparing with Fc-fusion protein comprising Wild-Type IL-2 in the Assay |
CD4+Treg/CD8+T CD4+Treg CD8+T |
Low/High >200-fold reduction Greater than or comparable to WT IL2Fc and ranging to ≤10-fold reduction |
Low/Medium >200-fold reduction >10-fold to ≤100-fold reduction |
Medium/High >20-fold to ≤200-fold reduction Greater than or comparable to WT IL2Fc and ranging to ≤10-fold reduction |
Medium/Medium >20-fold to ≤200-fold reduction >10-fold to ≤100-fold reduction |
1.89. "Excluded Entity" has the meaning set forth in Section 10.2.1(u)(3). |
1.90. "Excluded Individual" has the meaning set forth in Section 10.2.1(u)(3). |
1.91. "Exercise Notice" has the meaning set forth in Section 3.2.1. |
1.92. "Existing Know-How" means, as of the Effective Date, or each Bring Down Date, as applicable, all Cugene Know-How existing as of such date. |
1.93. "Existing Patents" means, as of the Effective Date, or each Bring Down Date, as applicable, all Cugene Patents existing as of such date. |
1.94. "Existing Patents Schedule" means Schedule 1.94, as such schedule may be updated in connection with the delivery of any Updated Disclosure Schedules. |
1.95. "Existing Regulatory Documentation" means, as of the Effective Date or each Bring Down Date, as applicable, all Regulatory Documentation Controlled by Cugene or any of its Affiliates as of such date. |
1.96. "Exploit" means to make, have made, import, export, use, have used, sell, have sold, or offer for sale, including to Develop, Commercialize, register, modify, enhance, improve, Manufacture, have Manufactured, hold or keep (whether for disposal or otherwise), formulate, optimize, transport, distribute, promote, ma... |
1.97. "FDA" means the United States Food and Drug Administration and any successor agency(ies) or authority having substantially the same function. |
1.98. "FDA's Disqualified/Restricted List" has the meaning set forth in Section 10.2.1(u)(5). |
1.99. "FFDCA" means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time, together with any rules, regulations, and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto). |
1.100. "Field" means all human and non-human diagnostic, prophylactic and therapeutic uses. |
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