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(d) If Calibr, its Affiliate and (sub)licensees do not separately sell in such country or other jurisdiction both the Mono CD19 Product and the other Active Agents in such Combination Product, the Net Sales attributable to such Combination Product shall be determined by the Parties in good faith based on the relative f... |
1.63 "Calibr Sole Inventions" has the meaning set forth in Section 8.1.1. |
1.64 "Calibr Sole Patents" has the meaning set forth in Section 8.1.1. |
1.65 "Category 1 Target" means each of PRLR, LIV1 and BMPR1 (in each case, unless and until it becomes a Failed Target). |
1.66 "Category 2 Target" means any Research Target that is not a Category 1 Target. |
1.67 "CD19" means B-lymphocyte antigen Cluster of Differentiation 19. Entrez Gene ID:930. HGNC ID: HGNC:1633. |
1.68 "CD19 Autoimmune Data Package" means a data package prepared by Calibr in a form reasonable under the circumstances setting forth the Development activities conducted by or on behalf of Calibr or its Affiliates under the CD19 Autoimmune Subplan and the Information generated in connection with the same, including: ... |
1.69 "CD19 Autoimmune Option" means the option to amend the CD19 Plan to include the Initial CD19 Autoimmune Subplan. |
1.70 "CD19 Autoimmune Option Fee" has the meaning set forth in Section 7.3. |
1.71 "CD19 Autoimmune Program" means all Development activities pursuant to the CD19 Autoimmune Subplan. |
1.72 "CD19 Autoimmune Subplan" means the portion of the CD19 Plan with respect the Development of CD19 Products for an autoimmune disease designated by AbbVie, including (a) preclinical activities with respect to the use of CD19 Products in additional autoimmune indications and settings and (b) a Phase I Clinical Trial... |
1.73 "CD19 Data Package" means a data package prepared by Calibr in a form reasonable under the circumstances setting forth the Development activities conducted by or on behalf of Calibr or its Affiliates under the CD19 Plan (excluding the CD19 Autoimmune Subplan, if applicable) and the Information generated in connect... |
1.74 "CD19-JDC" or "CD19 Platform Proof-of-Principle Joint Development Committee" has the meaning set forth in Section 6.2. |
1.75 "CD19 License Option" has the meaning set forth in Section 3.1.1. |
1.76 "CD19 License Option Fee" means (a) if AbbVie exercises the CD19 License Option before the CD19 Autoimmune Data Package Acceptance Date, Fifteen Million Dollars ($15,000,000) and (b) if AbbVie exercises the CD19 License Option after the CD19 Autoimmune Data Package Acceptance Date, Twenty Million Dollars ($20,000,... |
1.77 "CD19 License Option Period" means, subject to Section 2.10.5, the time period commencing on the Original Execution Date and ending (a) if AbbVie does not exercise the CD19 Autoimmune Option before the first (1st) anniversary of the A&R Effective Date, ninety (90) days after the Acceptance Date for the CD19 Data P... |
1.78 "CD19 Licensed Product" has the meaning set forth in the definition of Licensed Product. |
1.79 "CD19 Option Bringdown Date" has the meaning set forth in Section 10.2.2. |
1.80 "CD19 Plan" means the Development plan with respect to CD19 attached hereto as Schedule 1.80, as the same may be amended from time to time in accordance with the terms hereof. For clarity, (a) unless and until AbbVie exercises the CD19 Autoimmune Option, the CD19 Plan does not include any (i) preclinical activitie... |
1.81 "CD19 Product" means any biopharmaceutical product comprised of (a) a sCAR-T or vector encoding the chimeric proteins expressed by a sCAR-T that is Directed to CD19 and (b) one (1) or more Switches Directed to CD19. |
1.82 "CD19 Program" means all Development activities pursuant to the CD19 Plan. |
1.83 "CD19 Technology Transfer Product" has the meaning set forth in the definition of Technology Transfer Product. |
1.84 "Change of Control", with respect to a Party, shall be deemed to have occurred if any of the following occurs after the Original Execution Date: |
1.84.1 any "person" or "group" (as such terms are defined below) (a) is or becomes the "beneficial owner" (as defined below, except that a "person" or "group" shall be deemed to have "beneficial ownership" of all shares of capital stock or other equity interests if such person or group has the right to acquire, whether... |
1.84.2 such Party (or, if applicable, a parent of such Party) enters into a merger, consolidation or similar transaction with another Person (whether or not such Party (or, if applicable, a parent of such Party) is the surviving entity) and as a result of such merger, consolidation or similar transaction (a) the member... |
1.84.3 such Party (or, if applicable, a parent of such Party) sells or transfers to any Third Party, in one (1) or more related transactions, properties or assets representing all or substantially all of such Party's (or, if applicable, a parent of such Party) consolidated total assets; |
1.84.4 the holders of capital stock, voting members or governing board, as applicable, of such Party (or, if applicable, a parent of such Party) approve a plan or proposal for the liquidation or dissolution of such Party (or, if applicable, a parent of such Party); or |
1.84.5 with respect to Calibr, if Calibr (a) ceases to be subject to the laws governing nonprofit entities in the jurisdiction where Calibr is incorporated or (b) ceases to qualify as an organization described in Section 501(c)(3) of the Internal Revenue Code of 1986, as amended. |
For the purpose of this definition of Change of Control: (i) "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, codified at 15 U.S.C. § 78a et seq. (the "Act") as may be amended from time to time, and the term "group" includes any ... |
1.85 "Combination Product" means a product that contains both (a) one (1) or more Calibr Components, as well as (b) one (1) or more Active Agents, in any and all forms, presentations, Delivery Systems, dosages, formulations and administrations, whether as a fixed dose, co-formulated or co-packaged combination or other ... |
1.86 "Commercial Milestones" means, as applicable to a given Licensed Product, each of the following milestones for such Licensed Product: (a) Milestone Event 5 in Section 7.5.1 (First Commercial Sale in the United States of a Licensed Product), (b) Milestone Event 6 in Section 7.5.1 (First Commercial Sale in a Major E... |
1.87 "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 and importing such Licensed Product, and interacting with Regulatory Authorities regarding any of the fore... |
1.88 "Commercially Reasonable Efforts" means (a) with respect to the efforts and resources to be expended, or considerations to be undertaken, by AbbVie with respect to any objective, activity or decision to be undertaken with respect to the Development, Manufacture or Commercialization of a Licensed Product, the use o... |
1.89 "Committee" has the meaning set forth in Section 6.3.1. |
1.90 "Confidential Information" has the meaning set forth in Section 9.1.1. |
1.91 "Control" means, subject to Section 13.3.2, with respect to any item of Information, Regulatory Documentation, material, Patent, sCAR-T, Switch or other intellectual property right, possession of the right, whether directly or indirectly and whether by ownership, license or otherwise (other than by operation of th... |
1.92 "Conversion Date" has the meaning set forth in the definition of "Converted Trial". |
1.93 "Converted Trial" means an Adaptive Trial that is modified to meet and otherwise satisfies the criteria for a Registration Study based on pre-specified analyses following an analysis of interim data from subjects in such Adaptive Trial. For clarity, an Adaptive Trial shall only constitute a Converted Trial if, fro... |
1.94 "Corporate Names" means the Trademarks and logos identified on Schedule 1.94 and such other names and logos as Calibr may designate in writing from time to time. |
1.95 "Cost-Share Product" has the meaning set forth in Section 3.3.3. |
1.96 "Cost-Sharing Option" has the meaning set forth in Section 3.3.1. |
1.97 "Cost-Sharing Option Period" means (a) with respect to a Licensed Product that is not a CD19 Licensed Product or Directed to an Included Existing Target, the time period commencing on the Acceptance Date for the Data Package for the Research Target to which such Licensed Product is Directed and ending ninety (90) ... |
1.98 "CPI" means (a) with respect to FTEs in the United States the Consumer Price Index – All Urban Consumers, 1982-84=100, by the United States Department of Labor, Bureau of Statistics (or its successor equivalent index) or (b) an equivalent index in a foreign country applicable to FTEs in such country, accounting if... |
1.99 "CPI Adjustment" means the percentage increase or decrease, if any, in the CPI applicable to such personnel for the twelve (12) months ending June 30 of the Calendar Year prior to the Calendar Year for which the adjustment is being made. |
1.100 "Data Package" means with respect to each Research Target, Existing Target or Additional Gene, as applicable, a data package prepared by Calibr in a form reasonable under the circumstances setting forth the Development activities conducted by or on behalf of Calibr or its Affiliates in respect of such Target or A... |
1.101 "Data Protection Laws" means any law, statute, declaration, decree, directive, legislative enactment, order, ordinance, regulation, rule or other binding restriction (as amended, consolidated or re-enacted from time to time) which relates to the protection of individuals with regards to the Processing of Personal... |
1.102 "Deadlocked Dispute" has the meaning set forth in Section 6.4.1. |
1.103 "Decision Point" means, with respect to each Research Target, each point identified in the Target Research Plan as a point at which the TD-JRC determines whether to continue the Development activities set forth in the Target Research Plan for such Research Target, as set forth in additional detail in Section 2.9.... |
1.104 "Delivery System" means any delivery system comprising equipment, instrumentation, one (1) or more devices, or other components designed to assist in the administration of a Licensed Product or CD19 Product. |
1.105 "Determined Amendment" has the meaning set forth in Section 2.1.6(c). |
1.106 "Determined Existing Target Economic Terms" has the meaning set forth in Section 2.1.6(c). |
1.107 "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, clinical studies, including Man... |
1.108 "Directed" or "Directed to" means (a) with respect to an sCAR-T, a Switch and a Target, that such Switch modulates the activities of such sCAR-T with respect to such Target by binding specifically to such sCAR-T and to such Target and (b) with respect to a Target and any product, that such product (i) binds, inhi... |
1.109 "Disclosing Party" has the meaning set forth in Section 9.1.1. |
1.110 "Disclosure Schedules" means any of the A&R Disclosure Schedules, Initial Disclosure Schedules or Updated Disclosure Schedules. |
1.111 "Dispute" has the meaning set forth in Section 13.5. |
1.112 "Distributor" means any Person appointed by AbbVie or Calibr, as applicable, or any of its Affiliates or any of its or their respective (sub)licensees to distribute, market and sell a Licensed Product or CD19 Product, as applicable, with or without finishing or packaging rights, in one (1) or more countries in th... |
1.113 "Dollars" or "$" means United States Dollars. |
1.114 "Earnout Event" has the meaning set forth in Section 7.8. |
1.115 "Earnout Payment" has the meaning set forth in Section 7.8. |
1.116 "EMA" means the European Medicines Agency and any successor agency thereto. |
1.117 "European Union" means the economic, scientific and political organization of member states as it may be constituted from time to time. |
1.118 "Exercise Notice" means (a) with respect to AbbVie, written notice by AbbVie to Calibr exercising a Target Option, the CD19 License Option, or the Platform Option, as applicable, and (b) with respect to Calibr, written notice by Calibr to AbbVie exercising a Cost-Sharing Option, in each case of clause (a) or (b),... |
1.119 "Existing Patent Schedule" means Schedule 1.119, as such schedule may be updated in connection with the delivery of any Updated Disclosure Schedules. |
1.120 "Existing Patents" means, as of the Original Execution Date, the Original Effective Date, the A&R Effective Date, each CD19 Option Bringdown Date, each Existing Target ROFN Bringdown Date or the Platform Option Bringdown Date, as applicable, all Calibr Patents existing as of such date. |
1.121 "Existing Target" means each of the Targets set forth on Schedule 1.121. |
1.122 "Existing Target Economic Terms" has the meaning set forth in Section 2.1.6(b). |
1.123 "Existing Target Products" means, with respect to any Existing Target that is not an Included Existing Target as of the Option Effective Date for the Platform Option, if applicable, any biopharmaceutical product comprised of (a) an sCAR-T or vector encoding the chimeric proteins expressed by an sCAR-T, in either ... |
1.124 "Existing Target ROFN" has the meaning set forth in Section 2.1.6(a). |
1.125 "Existing Target ROFN Bringdown Date" has the meaning set forth in Section 10.2.4. |
1.126 "Expired Existing Target" has the meaning set forth in Section 2.1.6(f). |
1.127 "Exploit" means, with respect to a compound, product or process, to make, have made, import, use, sell or offer for sale, including to research, Develop, Commercialize, register, modify, enhance, improve, Manufacture, have Manufactured, hold or keep (whether for disposal or otherwise), formulate, optimize, have u... |
1.128 "Failed Target" has the meaning set forth in Section 2.1.4(a). |
1.129 "Failed Target Criteria" means the criteria set forth on Schedule 1.129, which may be updated from time to time upon written agreement of the Parties. |
1.130 "Failed Target Notice" has the meaning set forth in Section 2.1.4(a). |
1.131 "FDA" means the United States Food and Drug Administration and any successor agency thereto. |
1.132 "Federally Funded Inventions" has the meaning set forth in Section 10.2.1(o). |
1.133 "FFDCA" means the United States Federal Food, Drug, and Cosmetic Act, as set forth at 21 U.S.C. ch. 9 §301 et seq., as may be amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions and modifications thereto). |
1.134 "Field" means all human and non-human diagnostic, prophylactic and therapeutic uses. |
1.135 "Final Offer" has the meaning set forth in Section 2.1.6(c). |
1.136 "First Commercial Sale" means (a) with respect to a Licensed Product and a country, the first sale for monetary value of such Licensed Product in such country by AbbVie, its Affiliates or its or their Sublicensees to a Third Party after all Regulatory Approvals for such Licensed Product has been obtained in such ... |
1.137 "FTE" means the equivalent of the work of one (1) full time employee (i.e., one (1) fully-committed or multiple partially-committed employees aggregating to one (1) full-time employee) for one (1) Calendar Year (consisting of eighteen hundred (1800) hours per Calendar Year or such other number as may be agreed by... |
1.138 "FTE Costs" means (a) with respect to Calibr for any period, the applicable FTE Rate multiplied by the applicable number of FTEs of Calibr performing work related to the Target Research Plan, PRLR Switch Plan or SST Switch Plan, as applicable in accordance with such Target Research Plan, PRLR Switch Plan or SST S... |
1.139 "FTE Rate" means the applicable rate(s) set forth on Schedule 1.139, such rates to be adjusted annually (with the first of such adjustments to be made as of January 1, 2019 and each subsequent Calendar Year thereafter, but such adjustment determined no later than the preceding September 30) with respect to the FT... |
1.140 "Gatekeeper" has the meaning set forth in Section 2.1.7(a). |
1.141 "GLP Toxicology Study" means, with respect to a Licensed Product, an animal study conducted in accordance with current good laboratory practices and intended to support an IND or BLA for such Licensed Product. |
1.142 "Governmental Authority" means any multinational, federal, national, state, provincial, local or other entity, office, commission, bureau, agency, political subdivision, instrumentality, branch, department, authority, board, court, arbitral or other tribunal exercising executive, judicial, legislative, police, re... |
1.143 "HSR Act" means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as codified at 15 U.S.C. § 18a, as may be amended from time to time, and the rules and regulations promulgated thereunder, or foreign equivalent thereof under Applicable Law (including all additions, supplements, extensions and modification... |
1.144 "HSR Clearance" means, with respect to the CD19 License Option or the Platform Option, as applicable, the expiration or termination of all applicable waiting periods and requests for information (and any extensions thereof) under the HSR Act with respect thereto. |
1.145 "HSR Filing" means, with respect to the CD19 License Option or the Platform Option, as applicable, (a) filings by Scripps and AbbVie with the United States Federal Trade Commission and the Antitrust Division of the United States Department of Justice of a Notification and Report Form for Certain Mergers and Acqui... |
1.146 "I&P Amount" has the meaning set forth in Section 7.13.1. |
1.147 "Impacted Product(s)" has the meaning set forth in Section 12.5.1. |
1.148 "In-License Agreements" means all license and other agreements regarding any intellectual property rights licensed by Calibr to AbbVie hereunder, including the Calibr Patents and the Calibr Know-How. |
1.149 "In-License Schedule" means Schedule 1.149, as such schedule may be updated in connection with the delivery of any Updated Disclosure Schedules. |
1.150 "In-Situ Data Package" means a data package prepared by Calibr in a form reasonable under the circumstances setting forth the Development activities conducted by or on behalf of Calibr or its Affiliates under the In-Situ Work Plan and Information generated in connection with the same, including: (a) a written rep... |
1.151 "In-Situ Work Plan" has the meaning set forth in Section 2.3.2. |
1.152 "In Vivo Efficacy Results" means relevant, statistically significant results relating to (a) in vitro IC50/EC50 to the relevant Target(s), if ascertainable, (b) assessment of preclinical in vitro on and off-Target activity (including functional assay data for the pathway affected), (c) in vivo efficacy (in a dise... |
1.153 "Included Existing Target" means any Existing Target (a) with respect to which the Parties agree on an amendment to this Agreement to incorporate the Existing Target Economic Terms for such Existing Target or (b) any Existing Target for which AbbVie elects to accept the Determined Existing Target Economic Terms w... |
1.154 "Included FTE Costs and Expenses" means the sum of (a) all costs and expenses for the employee performing any Development activities hereunder, including salaries, wages, bonuses, commissions, benefits, profit sharing, stock option grants, FICA costs and other similar ex-U.S. costs, travel, meals and entertainmen... |
1.155 "Inclusion Date" means, (a) with respect to each Selected Target, the date after the Original Effective Date upon which AbbVie notifies Calibr of the identity of such Selected Target, (b) with respect to each Option Target, the Option Effective Date for the Target Option for such Option Target, (c) with respect t... |
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