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1.128 "Licensed Product" means any product containing a Licensed Antibody, alone or in combination with one (1) or more New Technologies, in any and all forms, presentations, delivery systems, dosages, and formulations. |
1.129 "Licensed Trem2 Antibody" means any Antibody that (a) specifically binds Trem2 and a principal therapeutic mechanism of action of which is mediated as a result of such binding and (b) claimed in the Existing Patents or Licensor Program Patents or made by or on behalf of Licensor or its Affiliates under this Agree... |
1.130 "Licensor" has the meaning set forth in the preamble hereto. |
1.131 "Licensor Background Know-How" means all Information that is (a) Controlled by Licensor or any of its Affiliates on the Execution Date or at any time during the Term, (b) not generally known, (c) developed or invented outside the scope of this Agreement, and (d) reasonably necessary or useful for the Development,... |
1.132 "Licensor Background Patents" means all Patents that are (a) Controlled by Licensor or any of its Affiliates on the Execution Date or at any time during the Term, (b) developed or invented outside the scope of this Agreement, and (c) reasonably necessary or useful for the Development, Manufacture, or Commercializ... |
1.133 "Licensor Commercialization Opt Out" has the meaning set forth in Section 6.3.1. |
1.134 "Licensor Competing Product" has the meaning set forth in Section 5.10.1(a). |
1.135 "Licensor Continued Funding Notice" has the meaning set forth in Section 6.5.2(b)(ii). |
1.136 "Licensor Development Opt Out" has the meaning set forth in Section 3.7.2. |
1.137 "Licensor Indemnitees" has the meaning set forth in Section 11.1. |
1.138 "Licensor Funded AbbVie Program Patents" means AbbVie Program Patents claiming one or more invention(s) that were invented prior to Licensor's exercise of a Licensor Opt Out with respect to the Collaboration Program in connection with which such inventions were made. |
1.139 "Licensor Opt Out" means a Licensor Development Opt Out or Licensor Commercialization Opt Out, as applicable. |
1.140 "Licensor Opt Out Date" means the effective date of a Licensor Development Opt Out or Licensor Commercialization Opt Out, as applicable, taking into account the required advance notice period. |
1.141 "Licensor Patent" has the meaning set forth in Section 13.2.1(a). |
1.142 "Licensor Program Know-How" means all Information and inventions that are, as between the Parties, conceived, discovered, developed, or otherwise made solely by or on behalf of Licensor or its Affiliates or sublicensees or subcontractors as a result of performance of this Agreement. Licensor Program Know-How expr... |
1.143 "Licensor Program Patents" mean all Patents that claim inventions that, as between the Parties, are conceived, discovered, developed, or otherwise made solely by or on behalf of Licensor or its Affiliates or sublicensees or subcontractors as a result of performance of this Agreement. Licensor Program Patents expr... |
1.144 "Licensor's Proportionate Share" has the meaning set forth in Section 3.7.1(e)(iii). |
1.145 "Losses" has the meaning set forth in Section 11.1. |
1.146 "MAA" has the meaning set forth in the definition of Drug Approval Application. |
1.147 "Major Markets" means the United States, France, Germany, Italy, Spain and the United Kingdom. |
1.148 "Major Regulatory Filings" has the meaning set forth in Section 3.8.2(c). |
1.149 "Manufacture" and "Manufacturing" means all activities related to the synthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, labeling, shipping, and holding of the Licensed Antibody, any Licensed Product, or any intermediate thereof, including process development, proces... |
1.150 "Manufacturing Cost" with respect to the Licensed Antibody or a Licensed Product has the meaning set forth on Schedule 1.150. |
1.151 "Manufacturing Process" has the meaning set forth in Section 3.5.3. |
1.152 "Manufacturing Technology Transfer" has the meaning set forth in Section 3.5.3. |
1.153 "Markings" has the meaning set forth in Section 4.7. |
1.154 "Material Amendment" has the meaning set forth in Section 2.4.3(a)(i). |
1.155 "Medical Affairs Activities" means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Antibodies or Licensed Products, including activities of medical scientific liaisons and the... |
1.156 "Medical Affairs Costs" means those FTE Costs (charged in accordance with Section 6.4.4) incurred and the Out-of-Pocket Costs, including costs for independent contractors engaged as permitted under this Agreement, incurred by or on behalf of AbbVie in accordance with Accounting Standards after the Effective Date ... |
1.157 "Mono Product" has the meaning set forth in the definition of "Net Sales." |
1.158 "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 Sublicensees in the Territory to Third Parties (including Third Party wholesalers or Distributors), in bona fide arm's length... |
(a) trade, cash and quantity discounts; |
(b) price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid to governmental authorities or other payees; |
(c) 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; |
(d) 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; |
(e) 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; |
(f) any consideration actually paid or payable for any Delivery System related to a billed or invoiced sale of such Licensed Product, where for purposes of this Net Sales definition, a "Delivery System" means any delivery system comprising equipment, instrumentation, one (1) or more devices, or other mechanical compone... |
(g) any invoiced amounts from a prior period which are not collected and are written off by AbbVie or its Affiliates, including bad debts; |
(h) 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 of the Licensed Products; |
(i) 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 |
(j) any other similar and customary deductions that are consistent with Accounting Standards, but which may not be duplicative of the deductions specified in (a) – (i) above. |
Net Sales shall not include transfers or dispositions without charge or for a price less than Manufacturing Cost 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 Affiliate... |
Subject to the above, Net Sales shall be calculated in accordance with the standard internal policies and procedures of AbbVie, its Affiliates, or Sublicensees, which must be in accordance with Accounting Standards. |
For purposes of calculating Net Sales, all Net Sales shall be converted into Dollars in accordance with Section 6.7. |
In the event a Licensed Product is sold as part of a Bundle, the Net Sales for such Bundle shall be calculated as follows: |
(i) If AbbVie, its Affiliate, or Sublicensee separately sells in substantial volumes in such country or other jurisdiction in the same reporting period, (A) the Licensed Product contained in such Bundle (the "Mono Product") and (B) the Other Product contained in such Bundle, the Net Sales attributable to such Bundle sh... |
(ii) If AbbVie, its Affiliates, and Sublicensees do not separately sell in such country or other jurisdiction as described above substantial volumes of one (or both) of the Mono Product and the Other Product in such Bundle in the same reporting period, the Net Sales attributable to such Bundle shall be determined by th... |
1.159 "Neutral" has the meaning set forth on Schedule 13.7.3. |
1.160 "New Technology" means any technology that could be added to or otherwise used to modify an Antibody in order to alter the pharmacological activity or other direct therapeutic effect of such Antibody (including technologies that increase blood brain barrier access, provide for tissue or cell targeting, or provide... |
1.161 "Non-Breaching Party" has the meaning set forth in Section 12.2. |
1.162 "Non-Controlling Party" has the meaning set forth in Section 7.2.2. |
1.163 "Non-Material License(s)" has the meaning set forth in Section 10.2.7. |
1.164 "Notice of Approval" has the meaning set forth in Section 6.5.2(b)(i). |
1.165 "Open Label Extension Study" means, with respect to each Collaboration Program, the open label extension trial for such Collaboration Program described in the Pre Exercise Development Plan and Budget. |
1.166 "Option" has the meaning set forth in Section 5.1.1. |
1.167 "Option Exercise Date" has the meaning set forth in Section 5.1.1. |
1.168 "Option Exercise Notice" has the meaning set forth in Section 5.1.1. |
1.169 "Option Period" has the meaning set forth in Section 5.1.1. |
1.170 "Other Antitrust Laws" has the meaning set forth in Section 12.1.1. |
1.171 "Other Income" means any payment or income (other than Net Sales) received by AbbVie or its Affiliate from a Third Party that is reasonably attributable to a Licensed Antibody or Licensed Product, including any such payment received in connection with the grant of a Sublicense or other right or activity with resp... |
1.172 "Other Product" means any standalone pharmaceutical product, which pharmaceutical product is not covered by a Valid Claim of the Licensor Background Patents, Licensor Program Patents, Joint Program Patents or Licensor Funded AbbVie Program Patents. For purposes of clarity, it is understood that New Technologies s... |
1.173 "Out-of-Pocket Costs" means amounts paid to Third Party vendors or contractors, under arm's length arrangements for services or materials provided by them directly in the performance of activities under the Post Exercise Development Plan and Budget or the Commercialization Plan and Budget, to the extent such serv... |
1.174 "Party" and "Parties" has the meaning set forth in the preamble hereto. |
1.175 "Party Development Activities" means Development activities conducted in support of obtaining or maintaining Regulatory Approval of a Licensed Product in a country or other jurisdiction in the Territory. |
1.176 "Patent Costs" means those FTE Costs of in-house legal counsel and related personnel (charged in accordance with Section 6.4.4) incurred and the Out-of-Pocket Costs (including the reasonable fees and expenses paid to outside counsel and other Third Parties, and filing and maintenance fees paid to governmental aut... |
1.177 "Patent Term Extension" has the meaning set forth in Section 7.2.5. |
1.178 "Patents" means (a) all national, regional and international patents and patent applications, including provisional patent applications, (b) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, includ... |
1.179 "Person" means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or polit... |
1.180 "Phase 0" means an exploratory, trial conducted in accordance with the FDA 2006 Guidance on Exploratory Investigational New Drug Studies (or the equivalent in any country or other jurisdiction outside of the United States) and designed to expedite the development of therapeutic or imaging agents by establishing v... |
1.181 "Phase I" means a clinical trial of a Licensed Antibody or Licensed Product, the principal purpose of which is a preliminary determination of safety, tolerability, pharmacological activity or pharmacokinetics in healthy individuals or patients or similar clinical study prescribed by the Regulatory Authorities, in... |
1.182 "Phase II" means a clinical trial of a Licensed Antibody or Licensed Product, the principal purpose of which is to explore safety and efficacy in the target patient population, which is designed to generate sufficient data that may permit commencement of pivotal clinical trials, or a similar clinical study recomm... |
1.183 "Phase III" means a human clinical trial of a Licensed Antibody or Licensed Product on a sufficient number of subjects in an indicated patient population that is designed to establish that a Licensed Antibody or Licensed Product is safe and efficacious for its intended use and to determine the benefit/risk relati... |
1.184 "Phase IV Costs" means those FTE Costs (charged in accordance with Section 6.4.4) and the Out-of-Pocket Costs recorded as an expense in accordance with Accounting Standards by or on behalf of a Party or any of its Affiliates after the Effective Date, during the Term of and pursuant to this Agreement, that are spe... |
1.185 "Phase IV Study" means: (a) a post-approval clinical study for a Licensed Product with respect to any Indication for which Regulatory Approval has been received or that is required or agreed to be conducted as a condition of receiving Regulatory Approval in a country; as well as (b) any marketing study, epidemiol... |
1.186 "PHSA" means the United States Public Health Service Act, as amended from time to time. |
1.187 "PMDA" means Japan's Pharmaceuticals and Medical Devices Agency and any successor agency(ies) or authority having substantially the same function. |
1.188 "PoC Trial" means the proof of concept (PoC) clinical study meeting the parameters described in Schedule 1.188. |
1.189 "PoC Trial Report" has the meaning set forth in Section 3.1.3. |
1.190 "Post Exercise Development Activities" has the meaning set forth in Section 3.2.1. |
1.191 "Post Exercise Development Plan and Budget" has the meaning set forth in Section 3.2.1. |
1.192 "Pre Exercise Development Activities" means the Party Development Activities set forth in each Pre Exercise Development Plan and Budget to be performed by Licensor (or, pursuant to Section 3.1.2, AbbVie) prior to expiration of the Option Exercise Period. |
1.193 "Pre Exercise Development Plan and Budget" means the Development Plan and Budget covering the Pre Exercise Development Activities for the CD33 Collaboration Program attached hereto as Schedule 1.193 Part 1 and the Development Plan and Budget covering the Pre Exercise Development Activities for the Trem2 Collabora... |
1.194 "Product Information" has the meaning set forth in Section 9.1. |
1.195 "Product Infringement" has the meaning set forth in Section 7.3.1. |
1.196 "Product Labeling" means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, (a) the Regulatory Authority-approved full prescribing information for such Licensed Product for such country or other jurisdiction, including any required patient information, and (b) all labels and ... |
1.197 "Product Trademarks" means the product specific Trademark(s) to be used by AbbVie or its Affiliates or its or their respective Sublicensees for the Development or Commercialization of Licensed Products in the Territory and any registrations thereof or any pending applications relating thereto in the Territory (ex... |
1.198 "Program Costs" has the meaning set forth in Section 6.5.2(a). |
1.199 "Prosecuted Infringements" has the meaning set forth in Section 7.3.1. |
1.200 "Regulatory Approval" means, with respect to a country or other jurisdiction in the Territory, all approvals (including Drug Approval Applications), licenses, registrations, or authorizations of any Regulatory Authority necessary to Commercialize a Licensed Antibody or Licensed Product in such country or other ju... |
1.201 "Regulatory Authority" means any applicable supra-national, federal, national, regional, state, provincial, or local governmental or regulatory authority, agency, department, bureau, commission, council, or other entities (e.g., the FDA, EMA and PMDA) regulating or otherwise exercising authority with respect to a... |
1.202 "Regulatory Data" has the meaning set forth in Section 3.8.3(a). |
1.203 "Regulatory Documentation" means all (a) applications (including all INDs and Drug Approval Applications and other Major Regulatory Filings), registrations, licenses, authorizations, and approvals (including Regulatory Approvals), (b) correspondence, materials and reports submitted to or received from Regulatory ... |
1.204 "Regulatory Exclusivity" means, with respect to any country or other jurisdiction in the Territory, an additional market protection, other than Patent protection, granted by a Regulatory Authority in such country or other jurisdiction which confers an exclusive Commercialization period during which AbbVie or its ... |
1.205 "Regulatory Expenses" means those FTE Costs (charged in accordance with Section 6.4.4) incurred and the Out-of-Pocket Costs (including filing, user, maintenance and other fees paid to Regulatory Authorities) recorded as an expense in accordance with Accounting Standards by or on behalf of AbbVie or any of its Aff... |
1.206 "Repayment Amount" has the meaning set forth in Section 3.7.1(b). |
1.207 "Reverse Royalty Term" means, with respect to each Licensed Product for which a royalty is due under Section 12.8, and each country or other jurisdiction in a Terminated Program, the period beginning on the date of the First Commercial Sale of such Licensed Product in such country or other jurisdiction after term... |
1.208 "ROW" means all regions, countries and territories other than the United States. |
1.209 "ROW Profit" means, with respect to the Licensed Products, the Net Sales of the Licensed Products in the ROW by AbbVie and its Affiliates (but excluding Net Sales of a Sublicensee) plus Other Income received in connection with the Licensed Products in the ROW less the following allocable to such Net Sales: (a) Ma... |
1.210 "ROW Profit Threshold" has the meaning set forth in Section 6.3.2(b). |
1.211 "Royalty Term" means, with respect to each Licensed Product and each country or other jurisdiction in the Territory, the period beginning on the date of the First Commercial Sale of such Licensed Product in such country or other jurisdiction, and ending on the later to occur of (a) the expiration, invalidation or... |
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