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1.138 "Licensed Technology" means Heptares Know-How and Heptares Patents. |
1.139 "Losses" has the meaning set forth in Section 11.1. |
1.140 "MAA" has the meaning set forth in the definition of Drug Approval Application. |
1.141 "Major European Market" means each of the United Kingdom, Germany, France, Italy and Spain. |
1.142 "Manufacture" and "Manufacturing" means all activities related to the synthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, labeling, shipping, and holding of a Compound, any Product, or any intermediate thereof, including process Development, process qualification and ... |
1.143 "Manufacturing Process" has the meaning set forth in Section 3.14. |
1.144 "Manufacturing Technology Transfer" has the meaning set forth in Section 3.14. |
1.145 "Material Research Plan Amendment" means any amendment to a Research Plan that materially changes the course, scope, budget, timing, or personnel and resource requirements of the Development activities set forth therein. |
1.146 "Mono Product" has the meaning set forth in Section 1.147. |
1.147 "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 wholesalers or Distributors), in bona fide arm's length transaction... |
(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 the purposes of this Net Sales definition, a "Delivery System" means any delivery system designed to assist in the administration of such Licensed Product; |
(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 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 the Licensed Product, wheth... |
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 7.10. |
In the event a Licensed Product is a Combination Product, the Net Sales for such Combination Product shall be calculated as follows: |
If AbbVie, its Affiliate, or Sublicensee separately sells in such country or other jurisdiction, (A) a product containing as its sole active ingredient a Licensed Compound contained in such Combination Product (the "Mono Product") and (B) products containing as their sole active ingredients the other active ingredients... |
If AbbVie, its Affiliate, or Sublicensee separately sells in such country or other jurisdiction the Mono Product but does not separately sell in such country or other jurisdiction products containing as their sole active ingredients the other active in such Combination Product, the Net Sales attributable to such Combin... |
If AbbVie, its Affiliates, and Sublicensees do not separately sell in such country or other jurisdiction the Mono Product but do separately sell products containing as their sole active ingredients the other active ingredients contained in such Combination Product, the Net Sales attributable to such Combination Product... |
If AbbVie, its Affiliates, and Sublicensees do not separately sell in such country or other jurisdiction both the Mono Product and the other active ingredient or ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be determined by the Parties in good faith based on the ... |
1.148 "Neutral" has the meaning set forth in Schedule 13.7.3. |
1.149 "Non-Breaching Party" has the meaning set forth in Section 12.2.1. |
1.150 "Option Compounds" means (i) the therapeutic agents specifically directed to the applicable Option Target in the Designated Pharmacology Developed by Heptares or its Affiliates or by AbbVie or AbbVie's Affiliates under a Research Plan, and (ii) any other therapeutic agents specifically directed to the applicable ... |
1.151 "Option Data Package" means, with respect to each Option Program, (i) the complete results of all Development activities carried out by Heptares with respect to such Option Program, and (ii) the Information set forth in the applicable Research Plan, and (iii) an Updated Disclosure Schedule that Heptares is obliga... |
1.152 "Option Period" means, for (i) the GPR65 Program, the period commencing on the Effective Date, (ii) a Reserved Option Program, the period commencing on AbbVie's delivery of a Reserved Option Program Activation Notice, and (iii) for the Additional Option Program, the period commencing on AbbVie's receipt of Heptar... |
1.153 "Option Product" means any product comprising or containing an Option Compound, alone or in combination with one or more other active ingredients, in all forms, in current and future formulations, dosage forms and strengths, and delivery modes, including any improvements to any of the foregoing forms, formulation... |
1.154 "Option Program" means (i) the GPR65 Program, as of the Effective Date, (ii) the GPR132 Program and/or the FPR2 Program, upon delivery of an applicable Reserved Option Program Activation Notice pursuant to Section 3.5, (iii) the Additional Option Program, following AbbVie's receipt of Heptares' confirmation that ... |
1.155 "Option Target" means GPR65, and, to the extent that AbbVie selects other Option Programs pursuant to its rights set forth in Sections 3.5, 3.6.1, 3.7.1, or 3.8, GPR132, FPR2, the Additional Option Target and any Substitute Option Target, as applicable. For clarity, Option Targets (i) for which the applicable Opt... |
1.156 "Out-of-Pocket Costs" means direct expenses paid by Heptares or its Affiliates to Third Parties incurred to conduct the Development and Manufacturing activities in the applicable Research Plan and this Agreement, including payments to subcontractors. For clarity, Out-Of-Pocket Costs shall not include Third Party ... |
1.157 "Owned Patents" has the meaning set forth in Section 10.2.6. |
1.158 "Party" and "Parties" has the meaning set forth in the preamble hereto. |
1.159 "Patents" means (a) all national, regional and international patents and patent applications, including provisional patent applications and rights to claim priority from any such patents or applications, (b) all patent applications filed either from such patents, patent applications or provisional applications or... |
1.160 "Payment" has the meaning set forth in Section 7.11. |
1.161 "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... |
1.162 "Personal Data" means (a) all information identifying, or in combination with other information, identifiable to an individual, including pseudonymized (key-coded) clinical data containing such information; and (b) any other information that is governed, regulated or protected by one or more Data Security and Pri... |
1.163 "Pharmacology" means an (a) agonist or positive allosteric modulator, (b) antagonist, inverse agonist or negative allosteric modulator, or (c) another action mode, as the case may be. |
1.164 "Phase II" means a human clinical trial of a Licensed Compound or Licensed Product, the principal purpose of which is a determination of safety and efficacy in the target patient population, which is prospectively designed to generate sufficient data that may permit commencement of pivotal clinical trials, or a s... |
1.165 "Phase III" means a human clinical trial of a Licensed Compound or Licensed Product on a sufficient number of subjects in an indicated patient population that is designed to establish that a Licensed Compound or Licensed Product is safe and efficacious for its intended use and to determine the benefit/risk relati... |
1.166 "PMDA" means Japan's Pharmaceuticals and Medical Devices Agency and any successor agency(ies) or authority having substantially the same function |
1.167 "Pre-IND Meeting" has the meaning set forth in Section 3.15.1. |
1.168 "Pricing and Reimbursement Approval" means such approval, agreement, determination or decision establishing prices for a Licensed Product that can be charged to consumers or will be reimbursed by Governmental Authorities in a country in the Territory where Governmental Authorities of such country approve or deter... |
1.169 "Processing" (or its conjugates) means any operation or set of operations that is performed upon Personal Data, whether or not by automatic means, such as collection, recording, organization, storage, adaptation or alternation, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise m... |
1.170 "Product" means an Option Product or Licensed Product, as applicable. |
1.171 "Product Information" has the meaning set forth in Section 9.1. |
1.172 "Product Infringement" has the meaning set forth in Section 8.3.1. |
1.173 "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 ... |
1.174 "Product Trademarks" means the Trademark(s) to be used by AbbVie or its Affiliates or its or their respective Sublicensees for the Exploitation of Licensed Products in the Territory and any registrations thereof or any pending applications relating thereto in the Territory (excluding, in any event, any trademarks... |
1.175 "Program" means an Option Program or Licensed Program, as applicable |
1.176 "Regulatory Approval" means, with respect to a country or other jurisdiction in the Territory, the approvals (including Drug Approval Applications), licenses, registrations, or authorizations of any Regulatory Authority necessary to Commercialize a Licensed Compound or Licensed Product in such country or other ju... |
1.177 "Regulatory Authority" means any applicable supra-national, federal, national, regional, state, provincial, or local Governmental Authority or regulatory authority, agency, department, bureau, commission, council, or other entities (e.g., the FDA, EMA and PMDA) regulating or otherwise exercising authority with re... |
1.178 "Regulatory Documentation" means all (a) applications (including all INDs and Drug Approval Applications), registrations, licenses, authorizations, and approvals (including Regulatory Approvals) made to or given by a Regulatory Authority, (b) correspondence and reports submitted to or received from Regulatory Aut... |
1.179 "Regulatory Exclusivity" means, with respect to any country or other jurisdiction in the Territory, (i) any period of regulatory data protection or equivalent (including orphan drug protection) that prevents a Third Party during such period from relying on the data submitted in support of an application for Regul... |
1.180 "Research Plan" means, for each Option Program, the research plan that sets forth (i) Development activities to be performed by AbbVie and Heptares with respect to such Option Program, and (ii) all Information that is required to be in the Option Data Package. The Research Plan for the GPR65 Program and the Reser... |
1.181 "Research Plan Activities" means the Development activities set forth in a Research Plan. |
1.182 "Reserved Compound" means any therapeutic agents specifically directed to a Target of a Reserved Option Program in the Designated Pharmacology. |
1.183 "Reserved Option Program Activation Fee" has the meaning set forth in Section 7.1.2. |
1.184 "Reserved Option Program Activation Notice" has the meaning set forth in Section 3.5.1. |
1.185 "Reserved Option Program Confirmation Notice" has the meaning set forth in Section 3.5.1. |
1.186 "Reserved Option Program FTO Analysis" has the meaning set forth in Section 3.5.1. |
1.187 "Reserved Option Program Pre-Option Period" has the meaning set forth in Section 3.5.1. |
1.188 "Reserved Option Programs" mean the GPR132 Program and/or the FPR2 Program, as applicable. |
1.189 "Reserved Product" means any product comprising a Reserved Compound, alone or in combination with one (1) or more other active ingredients, in any and all forms, in current and future formulations, dosage forms and strengths and delivery modes, including an improvement to any of the foregoing forms, formulations ... |
1.190 "Reverse Royalty Term" means, with respect to each Grantback Product that is the subject of a license pursuant to Section 12.7.1(d) or 12.8.2 and each country or other jurisdiction in the Terminated Territory, the period beginning on the date of the first sale by Heptares or its Affiliates or sublicensees of such... |
1.191 "Royalty Term" means, on a Licensed Product-by-Licensed Product, and country-by-country basis, the period beginning on the date of the First Commercial Sale of a Licensed Product in such country, and ending on the later to occur of (a) the expiration, invalidation, cancellation or abandonment date of the last Hep... |
1.192 "Screening Enabled Stabilized Receptor" means a Stabilized Receptor sufficient to enable compound screening in surface plasmon resonance (SPR) or thermostability assays as described in Appendix A of an applicable Research Plan. |
1.193 "Second Request" has the meaning set forth in Section 12.3.3(ii). |
1.194 "Second Toxicology Study Cost Amount" has the meaning set forth in Section 3.9.2. |
1.195 "Selected Heptares Patents" has the meaning set forth in Section 8.2.3(i). |
1.196 "Selected Pre-Option Prosecuted Infringement" has the meaning set forth in Section 8.3.2. |
1.197 "Senior Officer" means, with respect to Heptares, its Executive Vice Chairman or his/her designee, and with respect to AbbVie, its Vice President of Discovery or his/her designee. |
1.198 "Stabilized Receptor" means Heptares' proprietary G-Protein Coupled Receptor (GPCR) conformationally thermostabilised through mutagenesis, typically by at least ten (10) degrees Kelvin, and which binds ligands with pharmacology consistent with the wild type receptor in the same conformational state. |
1.199 "Sublicense Revenue" has the meaning set forth in Section 12.10. |
1.200 "Sublicensee" means a Person, other than an Affiliate or a Distributor, that is granted a sublicense by AbbVie under the grants in Section 6.1 as provided in Section 6.4, excluding any Third Party to which AbbVie or its Affiliates have granted such sublicense as a result of settlement involving a Patent Dispute. |
1.201 "Substitute Option Program" has the meaning set forth in Section 3.7.2. |
1.202 "Substitute Option Target" has the meaning set forth in Section 3.7.1. |
1.203 "Substitute Target Research Plan" has the meaning set forth in Section 3.7.1. |
1.204 "Target" means a protein, polypeptide, fragments and post-translationally modified versions thereof, or nucleic acid molecule, and all nucleic acids encoding such protein, polypeptide, or molecule. |
1.205 "Technical Failure" means, for an applicable Option Target, Heptares fails to produce a completed Screening Enabled Stabilized Receptor which corresponds to the Option Target. |
1.206 "Term" has the meaning set forth in Section 12.1. |
1.207 "Terminated Territory" means each country with respect to which this Agreement is terminated by Heptares pursuant to Section 12.2.2 and each country with respect to which this Agreement is terminated by AbbVie pursuant to Section 12.3.2, or, if this Agreement is terminated in its entirety, the entire Territory. |
1.208 "Territory" means the entire world. |
1.209 "Third Party" means any Person other than Heptares, AbbVie and their respective Affiliates. |
1.210 "Third Party Claims" has the meaning set forth in Section 11.1. |
1.211 "Third Party CMO" has the meaning set forth in Section 3.14. |
1.212 "Third Party CMO Agreement" has the meaning set forth in Section 3.14. |
1.213 "Third Party CMO Cost Cap" has the meaning set forth in Section 3.13.2. |
1.214 "Third Party CMO Enforcement Costs" has the meaning set forth in Section 3.13.2. |
1.215 "Toxicology Study" means a GLP toxicology study of a compound in species that will satisfy applicable regulatory requirements and that meets the standard necessary for submission as part of an IND filing with FDA, the initiation of which shall be determined by the dosing of the first animal in such GLP toxicology... |
1.216 "Trademark" means any trademark, trade dress, brand mark, service mark, trade name, brand name, logo, business symbol or domain name, or any word, name, symbol, color, designation or device or any combination thereof that functions as a source identifier, whether or not registered, and any registrations thereof o... |
1.217 "Transition Agreement" has the meaning set forth in Section 12.9.1(b). |
1.218 "Trial Master File" means the documents maintained at clinical research sites and by AbbVie or its Affiliates during the course of Clinical Studies for any Licensed Product, which enable the conduct of a clinical trial and the quality of the data produced to be evaluated, proving that the study was conducted by t... |
1.219 "Unfinished Research Plan Activities" has the meaning set forth in Section 3.12. |
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