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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... |
1.156 "IND" means (a) an investigational new drug application filed with the FDA for authorization to commence clinical studies and its equivalent in other countries or regulatory jurisdictions and (b) all supplements and amendments that may be filed with respect to the foregoing. |
1.157 "IND Enabling Activities" means, with respect to a Research Target Product, all Development activities required (including the compilation of data resulting therefrom in a form suitable for filing with FDA) to support the filing of an effective IND with FDA (e.g., that would not be subject to a clinical hold with... |
1.158 "IND Enabling Study" means, with respect to a Research Target, any study with respect to a Research Target Product that includes a Switch Directed to such Research Target that is designed to obtain results, in compliance with current good laboratory practices, for inclusion in an IND for such Research Target Prod... |
1.159 "Indemnification Claim Notice" has the meaning set forth in Section 11.3.1. |
1.160 "Indemnified Party" has the meaning set forth in Section 11.3.1. |
1.161 "Indemnifying Party" has the meaning set forth in Section 11.3.1. |
1.162 "Indirect Taxes" has the meaning set forth in Section 7.13.2. |
1.163 "Inflation Reduction Act" means P.L. 117-169 (Aug. 16, 2022), as codified at 42 U.S.C. § 1320f, 42 U.S.C. § 1395w-3a and 42 U.S.C. § 1395w-114a (inter alia), and as it may be amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplemen... |
1.164 "Information" means all technical, scientific and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs,... |
1.165 "Infringement" has the meaning set forth in Section 8.4.1. |
1.166 "Initial Disclosure Schedules" has the meaning set forth in Section 10.2.1. |
1.167 "Initial CD19 Autoimmune Subplan" has the meaning set forth in the definition of CD19 Autoimmune Subplan. |
1.168 "Initiation" means, with respect to a clinical trial, the first dosing of the first human subject in such clinical trial. When used as a verb, "Initiated" has a corresponding meaning. |
1.169 "Joint IP" has the meaning set forth in Section 8.1.2. |
1.170 "Joint Know-How" has the meaning set forth in Section 8.1.2. |
1.171 "Joint Patents" has the meaning set forth in Section 8.1.2. |
1.172 "Key Personnel" has the meaning set forth in Section 2.6.3. |
1.173 "Knowledge" means, with respect to Calibr and the representations and warranties of Calibr hereunder, the actual knowledge of the Chief Executive Officer, Chief Operating Officer, Director of Protein Sciences, Vice President of Program Management, internal counsel or any personnel holding positions equivalent to ... |
1.174 "Licensed Product" means either (a) a product that (i) contains one (1) or more Calibr Components, in any and all forms, presentations, Delivery Systems, dosages, formulations and administrations and (ii) does not contain any other Active Agent (a "Single Agent Product"), or (b) a Combination Product, in any and ... |
1.175 "LIV1" means solute carrier family 39. |
1.176 "Losses" has the meaning set forth in Section 11.1. |
1.177 "Major European Market" means each of the United Kingdom, France, Germany, Italy and Spain. |
1.178 "Manufacture", "Manufactured" and "Manufacturing" means all activities related to the production, manufacture, processing, filling, finishing, packaging, labeling, shipping and holding of any Licensed Product, including any Calibr Component or any intermediate thereof, including process development, process quali... |
1.179 "Manufacturing Process" has the meaning set forth in Section 5.3.1. |
1.180 "Manufacturing Technology Transfer" has the meaning set forth in Section 5.3.1. |
1.181 "Merck" means Merck Sharp & Dohme Corp. |
1.182 "Merck Agreement" means that certain Drug Discovery Collaboration and License Option Agreement, dated January 1, 2012 between Merck and Calibr. |
1.183 "Milestone Events" has the meaning set forth in Section 7.5. |
1.184 "Milestone Payments" has the meaning set forth in Section 7.5. |
1.185 "Mixed Patent" means, subject to Section 8.3.2(a), any Calibr Patent that includes (a) at least one (1) claim that claims a Licensed Product or Exploitation thereof and (b) at least one (1) claim that generally claims (i) a Calibr Component or the sCAR-T Platform or the Exploitation thereof (i.e., the claim does ... |
1.186 "Mono CD19 Product" has the meaning set forth in the definition of Calibr Sales. |
1.187 "mRNA Data Package" means a data package prepared by Calibr in a form reasonable under the circumstances setting forth the research activities conducted by or on behalf of Calibr or its Affiliates under the mRNA Work Plan and the Information generated in connection with the same, including: (a) a written report s... |
1.188 "mRNA Work Plan" has the meaning set forth in Section 2.3.2. |
1.189 "Net Sales" means, with respect to a Licensed Product for any period, the total amount billed or invoiced on sales of such Licensed Product during such period by AbbVie, its Affiliates, or, subject to Section 7.7, Sublicensees in the Territory to Third Parties (including wholesalers or Distributors), in bona fide... |
1.189.1 trade, cash and quantity discounts; |
1.189.2 price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid to Governmental Authorities or other payees; |
1.189.3 taxes on sales (such as sales, value added, or use taxes) to the extent added to the sale price and set forth separately as such in the total amount invoiced; |
1.189.4 amounts repaid or credited by reason of rejections, defects, return goods allowance, recalls or returns, or because of retroactive price reductions, including rebates or wholesaler charge backs; |
1.189.5 the portion of administrative fees paid during the relevant time period to group purchasing organizations, pharmaceutical benefit managers or Medicare Prescription Drug Plans relating to such Licensed Product; |
1.189.6 any consideration actually paid or payable for any Delivery System related to a billed or invoiced sale of such Licensed Product; provided, that for clarity, any consideration actually paid or payable for any Delivery System related to a billed or invoiced sale of a Licensed Product shall only be deducted once ... |
1.189.7 any invoiced amounts from a prior period that are not collected and are written off by AbbVie, its Affiliates or Sublicensees, including bad debts; |
1.189.8 that portion of the annual fee on prescription drug manufacturers imposed by the Patient Protection and Affordable Care Act, Pub. L. No. 111-148 (as amended) and reasonably allocable to sales such Licensed Product; |
1.189.9 freight, insurance, import/export, and other transportation charges to the extent added to the sale price and set forth separately as such in the total amount invoiced, as well as any fees for services provided by wholesalers and warehousing chains related to the distribution of such Licensed Product; and |
1.189.10 any other similar and customary deductions that are consistent with the Accounting Standards, but which may not be duplicative of the deductions specified in Section 1.189.1 through Section 1.189.9. |
Net Sales shall not include transfers or dispositions for charitable, promotional, pre-clinical, clinical, regulatory, or governmental purposes. Net Sales shall include the amount or fair market value of all other consideration received by AbbVie, its Affiliates or Sublicensees in respect of such Licensed Product, whet... |
Subject to the above, Net Sales shall be calculated in accordance with the standard internal policies and procedures of AbbVie, its Affiliates or its or their Sublicensees, which must be in accordance with the Accounting Standards. |
For purposes of calculating Net Sales, all Net Sales shall be converted into Dollars in accordance with Section 7.12. |
In the event a Licensed Product is a Combination Product, the Net Sales for such Combination Product shall be calculated as follows: |
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