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1.68 "Development Costs" means the FTE Costs (charged in accordance with Section 3.9) incurred, and the direct 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 Execution Date and during the Term that are specifically identifiable or reasonably allocable to Discovery Program Activities, IND-Enabling Activities, or Clinical Development Activities, as the case may be, in accordance with the applicable Discovery Program Plan, IND-Enabling Studies Plan and Budget, or Clinical Development Plan, excluding any Manufacturing Costs. Except in the case of Development Costs incurred in accordance with clause (d) below, Development Costs shall be limited to Discovery Program Activities, IND-Enabling Activities, or Clinical Development Activities, as the case may be, that are specifically identified in the applicable Discovery Program Plan, IND-Enabling Studies Plan and Budget, or Clinical Development Plan; provided, that with respect to costs incurred with respect to IND-Enabling Activities, such costs shall be included in "Development Costs" only to the extent less than or equal to the amounts set forth in the applicable IND-Enabling Studies Plan and Budget for such IND-Enabling Activities (subject to permitted overruns pursuant to Section 3.9.2). Subject to the foregoing, Development Costs shall include such costs in connection with the following activities, as applicable: |
(a) pre-clinical and non-clinical activities such as toxicology and formulation development, test method development, stability testing, quality assurance, quality control development and statistical analysis; |
(b) Clinical Studies for a Licensed Compound or Licensed Product, including (i) the preparation for and Conduct of such clinical trials; (ii) data collection and analysis and report writing; (iii) clinical laboratory work; (iv) regulatory activities in connection with such clinical trials, including adverse event recordation and reporting; and (v) advisory meetings in connection with a Licensed Compound or Licensed Product; |
(c) all activities necessary to obtain any Regulatory Approval for a Licensed Product in the AbbVie Territory and filing fees in connection with the filing of applications for any Regulatory Approval in the AbbVie Territory; |
(d) Losses incurred in connection with Third Party Claims described in Section 11.3 to the extent such Losses are to be included in Development Costs in accordance with Section 11.3; and |
(e) any other activities set forth in the Discovery Program Plan, IND-Enabling Studies Plan and Budget, or Clinical Development Plan. |
1.69 "Development Manufacturing Activities" has the meaning set forth in Section 3.6.1. |
1.70 "Development Manufacturing Plan" has the meaning set forth in Section 3.6.1. |
1.71 "Discovery Program Activities" means the Party Development Activities set forth in the D3 Receptor Discovery Program Plan and Pro-metabolite Discovery Program Plan to be performed by Richter (or, pursuant to Section 3.1.1, AbbVie) in order to attempt to identify at least one (1) Lead Compound and (1) Backup Compound with respect to each Discovery Program. |
1.72 "Discovery Program Cap" has the meaning set forth in Section 3.9.3(b). |
1.73 "Discovery Program Plan" means the D3 Receptor Discovery Program Plan and the Pro-metabolite Discovery Program Plan. |
1.74 "Discovery Program Term" has the meaning set forth in Section 3.1.3. |
1.75 "Discovery Programs" means the D3 Receptor Discovery Program and the Pro-metabolite Discovery Program. |
1.76 "Dispute" has the meaning set forth in Section 13.7. |
1.77 "Distributor" has the meaning set forth in Section 5.3.2. |
1.78 "Divestiture" means, with respect to a Competing Product, the sale, exclusive license or other transfer by Richter and its Affiliates of all of their development and commercialization rights with respect to such Competing Product to a Third Party without the retention or reservation of any development or commercialization obligation, interest or participation rights (other than solely an economic interest or the right to enforce customary terms and conditions contained in the relevant agreements effectuating such transaction). When used as a verb, "Divest" means to engage in a Divestiture. |
1.79 "Dollars" or "$" means United States Dollars. |
1.80 "Drug Approval Application" means a New Drug Application as defined in the FFDCA, or any corresponding foreign application in the Territory. |
1.81 "Effective Date" has the meaning set forth in Section 12.2. |
1.82 "Employee Invention" has the meaning set forth in Section 7.1.5. |
1.83 "European Union" or "EU" 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. |
1.84 "Excluded Entity" has the meaning set forth in Section 10.2.21(c). |
1.85 "Excluded Individual" has the meaning set forth in Section 10.2.21(c). |
1.86 "Execution Date" means the date of execution of this Agreement as set forth in the preamble hereto. |
1.87 "Existing Collaboration Agreement" means that certain (a) License and Cooperation Agreement between Gedeon Richter Plc, Gedeon Richter USA, Inc. and Forest Laboratories Ireland Limited dated November 22, 2004, as amended on February 26, 2009, November 12, 2010, April 28, 2017, June 3, 2019 and June 1, 2021; (b) Letter Agreement, dated October 20, 2006; (c) Letter of Confirmation dated March 17, 2010; (d) Letter Agreement dated June 3, 2010, (e) Letter Agreement dated June 29, 2010, and (f) Letter Agreement dated April 4, 2011. |
1.88 "Existing Confidentiality Agreement" means that certain Confidential Disclosure Agreement between the Parties or their respective Affiliates dated August 27, 2020. |
1.89 "Existing Patents" has the meaning set forth in Section 10.2.1. |
1.90 "Existing Regulatory Documentation" means the Regulatory Documentation Controlled by Richter or any of its Affiliates as of the Effective Date. |
1.91 "Exploit" or "Exploitation" 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), or otherwise dispose of. |
1.92 "FDA" means the United States Food and Drug Administration and any successor agency(ies) or authority having substantially the same function. |
1.93 "FDA's Disqualified/Restricted List" has the meaning set forth in Section 10.2.21(e). |
1.94 "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). |
1.95 "Field" means all human and non-human diagnostic, prophylactic, and therapeutic uses. |
1.96 "First Commercial Sale" means, with respect to a Licensed Product and a country, the first sale for monetary value for use or consumption by the end user of such Licensed Product in such country after all Regulatory Approval for such Licensed Product has been obtained in such country. Sales prior to receipt of all Regulatory Approval for such Licensed Product, such as so-called "treatment IND sales," "named patient sales," and "compassionate use sales," shall not be construed as a First Commercial Sale. |
1.97 "FTE" means the equivalent of the work of one (1) employee full time for one (1) Calendar Year (consisting of at least a total of eighteen hundred (1800) hours per Calendar Year) of work performing Development or Manufacturing activities for a Licensed Compound or Licensed Product. No additional payment shall be made with respect to any person who works more than eighteen hundred (1800) hours per Calendar Year and any person who devotes less than eighteen hundred (1800) hours per Calendar Year (or such other number as may be agreed by the JSC) shall be treated as an FTE on a pro rata basis based upon the actual number of hours worked divided by eighteen hundred (1800). |
1.98 "FTE Costs" means, with respect to a Party for any period, the applicable FTE Rate multiplied by the applicable number of FTEs of such Party performing Development or Manufacturing activities during such period in accordance with the applicable Discovery Program Plan, IND-Enabling Studies Plan and Budget, or Clinical Development Plan. |
1.99 "FTE Rate" means the applicable FTE rate set forth on Schedule 3.9.5 as adjusted pursuant to Section 3.9.5. |
1.100 "Generic Product" means, with respect to a Licensed Product, any product that (a) is sold by a Third Party under a Drug Approval Application granted by a Regulatory Authority to a Third Party; (b) contains a Licensed Compound as an active ingredient; and (c) is approved in reliance, in whole or in part, on the prior approval (or on safety or efficacy data submitted in support of the prior approval) of such Licensed Product as determined by the applicable Regulatory Authority, including any product authorized for sale (i) in the U.S. pursuant to Section 505(b)(2) or Section 505(j) of the FFDCA (21 U.S.C. 355(b)(2) and 21 U.S.C. 355(j), respectively), or (ii) in any other country or jurisdiction pursuant to all equivalents of such provisions, including any amendments and successor statutes with respect to the subsections (i) through (ii) thereto. A Licensed Product licensed or produced by AbbVie or any of its Affiliates under the same Drug Approval Application owned by AbbVie or any of its Affiliates (i.e., an authorized generic product) will not constitute a Generic Product. |
1.101 "Global Commercialization Plan" has the meaning set forth in Section 4.1.1. |
1.102 "Good Manufacturing Practice" or "GMP" means all Applicable Laws to the Manufacture of Product, including the current good manufacturing practices as specified in (a) the U.S. Code of Federal Regulations and FDA's guidance documents, and all successor applicable regulations and guidance documents thereto, (b) the EUDRALEX Vol. 4 "Medicinals for Human and Veterinary Use: Good Manufacturing Practice", in particular Part II "Basic Requirements for Active Substances used as Starting Materials" (03 October 2005), and applicable Annexes to Vol.4, and (c) the ICH (International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use) guidelines, including without limitation, ICH Q7A "ICH Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients". |
1.103 "Governmental Authority" means any multi-national, federal, national, state, provincial, local, municipal or other government authority of any nature (including any governmental division, subdivision, commission, department, bureau, prefecture, agency, branch, office, governmental arbitrator or arbitral body, council, court or other tribunal entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power). |
1.104 "HSR Act" means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. |
1.105 "HSR Filing" has the meaning set forth in Section 12.1. |
1.106 "Identified Indications" means, with respect to a Licensed Product, the Indications set forth on Schedule 1.106. |
1.107 "IND" means an application filed with a Regulatory Authority for authorization to commence Clinical Studies, including (a) an Investigational New Drug Application as defined in the FFDCA or any successor application or procedure filed with the FDA, (b) any equivalent of a United States IND in other countries or regulatory jurisdictions, (i.e., clinical trial application (CTA)) and (c) all supplements, amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing. |
1.108 "IND-Enabling Activities" has the meaning set forth in Section 3.2.1(a). |
1.109 "IND-Enabling Studies" means all activities for a compound following designation by the JSC as a Lead Compound or Backup Compound pursuant to Section 3.2.2 that are required to select a Licensed Compound or Licensed Product to advance to Clinical Studies, including GLP toxicology studies, API characterization, communications with Regulatory Authorities regarding an IND filing and other activities necessary to support the filing of an IND. |
1.110 "IND-Enabling Studies Criteria" means the criteria agreed upon by the Parties for determining whether a Lead Compound should progress beyond IND-Enabling Activities to Clinical Studies, as set forth in the IND-Enabling Studies Plan and Budget. |
1.111 "IND-Enabling Studies Plan and Budget" means a development plan setting forth in reasonable detail specific IND-Enabling Studies to be performed by Richter with respect to the applicable Lead Compound and the budget for such Development activities. |
1.112 "Indemnification Claim Notice" has the meaning set forth in Section 11.4. |
1.113 "Indemnified Party" has the meaning set forth in Section 11.4. |
1.114 "Indication" means, with respect to a Licensed Product, the intended use of such Licensed Product (a) for the treatment, control, mitigation, prevention or cure of a distinct recognized human disease or condition, or of a manifestation of a recognized human disease or condition, or (b) for the relief of symptoms associated with a recognized human disease or condition, and which, in each case ((a) and (b)), if approved in the U.S., would be reflected in the "Indications and Usage" section of labeling pursuant to 21 C.F.R. §201.57(c)(2) or, to the extent applicable, any comparable labeling section outside the U.S. Notwithstanding the foregoing, each of the following will be treated as the same Indication and not a distinct Indication: (a) the treatment of a disease, disorder or condition in a particular patient population and the treatment of the same disease, disorder or condition in another population (e.g., adult population and pediatric population), (b) different subtypes or lines of therapy for the same disease, disorder or condition, and (c) label expansions or label changes (including dose, dosing schedule, use in the same Indication in combination with various other agents, etc.) for a given Indication. |
1.115 "Indication Cap" has the meaning set forth in Section 3.9.2(b). |
1.116 "Indirect Taxes" has the meaning set forth in Section 6.9. |
1.117 "Information" means all knowledge of a technical, scientific, business and other nature, including know-how, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results, documents and other material, Regulatory Data, and other biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and information, including study designs and protocols, reagents (e.g., plasmids, proteins, cell lines, assays and compounds) and biological methodology; in each case (whether or not confidential, proprietary, patented or patentable, of commercial advantage or not) in written, electronic or any other form now known or hereafter developed. |
1.118 "Initiation" or "Initiate" means, with respect to a Clinical Study, the first dosing of the first human subject in such Clinical Study. |
1.119 "In-License Agreement" means any agreement between Richter and a Third Party under which Richter has in-licensed or otherwise obtained rights in or to any of the Intellectual Property licensed to AbbVie under this Agreement, including such agreements under which AbbVie is granted a sublicense or other right as provided in Section 5.9.2. |
1.120 "In-Licensed Patents" has the meaning set forth in Section 10.2.3. |
1.121 "Intellectual Property" has the meaning set forth in Section 12.6.1. |
1.122 "Joint Committees" has the meaning set forth in Section 2.1.2(t). |
1.123 "Joint Intellectual Property Rights" has the meaning set forth in Section 7.1.2. |
1.124 "Joint Know-How" has the meaning set forth in Section 7.1.2. |
1.125 "Joint Patents" has the meaning set forth in Section 7.1.2. |
1.126 "Joint Steering Committee" has the meaning set forth in Section 2.1.1. |
1.127 "Knowledge" means the good faith understanding of the facts and information after reasonable investigation with respect to the relevant facts and information of the Research Director, Director of Regulatory Science Affairs, and Head of Intellectual Property or any personnel holding positions equivalent to such job titles (but only to the extent such positions exist at such Party). |
1.128 "Lead Compound" means has the meaning set forth in Section 3.1.1(c). |
1.129 "Lead Compound Criteria" means, with respect to each Discovery Program, the criteria agreed upon by the Parties for the designation of a Licensed Compound as the lead compound, as set forth in the applicable Discovery Program Plan. |
1.130 "Licensed Compound" means any D3 Receptor Compound or Pro-metabolite Compound that is Developed or Commercialized under this Agreement. |
1.131 "Licensed Product" means any D3 Receptor Product or Pro-metabolite Product that is Developed or Commercialized under this Agreement. |
1.132 "Losses" has the meaning set forth in Section 11.1. |
1.133 "Manufacture" and "Manufacturing" means all activities related to the synthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, labeling, shipping, and holding of any Licensed Compound, any Licensed Product, or any intermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial production and analytic development, product characterization, stability testing, quality assurance, and quality control. |
1.134 "Manufacturing Cost" with respect to a Licensed Compound or Licensed Product has the meaning set forth on Schedule 1.134. |
1.135 "Manufacturing Process" means, as applicable, the AbbVie Formulation Manufacturing Process or the Richter Manufacturing Process. |
1.136 "Manufacturing Technology Transfer" means, as applicable, the AbbVie Formulation Manufacturing Technology Transfer or the Richter Manufacturing Technology Transfer. |
1.137 "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 Compounds or Licensed Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Licensed Product. |
1.138 "Minimum Safety Stock" has the meaning set forth in Section 4.9.1(b). |
1.139 "Mono Product" has the meaning set forth in the definition of "Net Sales." |
1.140 "Necessary Third Party IP" has the meaning set forth in Section 5.9.1. |
1.141 "Necessary Third Party License" has the meaning set forth in Section 5.9.1. |
1.142 "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 AbbVie Territory to Third Parties (including wholesalers or Distributors), in bona fide arm's length transactions, less the following deductions, in each case related specifically to the Licensed Product and actually allowed and taken by such Third Parties and not otherwise recovered by or reimbursed to AbbVie, its Affiliates, or Sublicensees: |
(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 invoiced amounts from a prior period which are not collected and are written off by AbbVie or its Affiliates, including bad debts; provided that if such amounts are subsequently collected by AbbVie or its Affiliates then such collected amounts will be subsequently included in Net Sales; |
(g) 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; |
(h) 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 |
(i) any other similar and customary deductions that are consistent with Accounting Standards, but which may not be duplicative of the deductions specified in (a) – (h) above. |
Net Sales shall not include transfers or dispositions for charitable, compassionate, promotional, pre-clinical, clinical, or regulatory 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, whether such consideration is in cash, payment in kind, exchange or other form. Net Sales shall not include sales between or among AbbVie, its Affiliates, or Sublicensees. |
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 6.6. |
In the event a Licensed Product is a Combination Product, the Net Sales for such Combination Product shall be calculated as follows: |
(i) 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 in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product by the fraction A/(A+B) where: "A" is AbbVie's (or its Affiliate's or Sublicensee's, as applicable) average Net Sales price during the period to which the Net Sales calculation applies for the Mono Product in such country or other jurisdiction and "B" is AbbVie's (or its Affiliate's or Sublicensee's, as applicable) average Net Sales price during the period to which the Net Sales calculation applies in such country or other jurisdiction, for products that contain as their sole active ingredients the other active ingredients in such Combination Product. |
(ii) 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 ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying the Net Sales of such Combination Product by the fraction A/C where: "A" is AbbVie's (or its Affiliate's or Sublicensee's, as applicable) average Net Sales price during the period to which the Net Sales calculation applies for the Mono Product in such country or other jurisdiction, and "C" is AbbVie's (or its Affiliate's or Sublicensee's, as applicable) average Net Sales price in such country or other jurisdiction during the period to which the Net Sales calculation applies for such Combination Product. |
(iii) 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 shall be calculated by multiplying the Net Sales of such Combination Product by the fraction (D-E)/D where: "D" is the average Net Sales price during the period to which the Net Sales calculation applies for such Combination Product in such country or other jurisdiction and "E" is the average Net Sales price during the period to which the Net Sales calculation applies for products that contain as their sole active ingredients the other active ingredients in such Combination Product. |
(iv) 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 calculated by multiplying the Net Sales of such Combination Product by the fraction 1/(1+F) where: "F" is the number of other active ingredients (other than a Licensed Compound) in such Combination Product. If the Parties cannot agree on such relative value, the Dispute shall be resolved pursuant to Section 13.7. |
1.143 "Neutral" has the meaning set forth in Schedule 13.7.3. |
1.144 "New Indication" means, with respect to a Licensed Product, an Indication that is not an Identified Indication for such Licensed Product. |
1.145 "Non-Breaching Party" has the meaning set forth in Section 12.3.1. |
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