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continued-pretraining

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1.146 "Non-Vraylar Indication" means (a) with respect to milestone payments triggered by events in the United States, an Indication for which cariprazine does not have Regulatory Approval for in the United States at the time the applicable regulatory milestone event is achieved pursuant to Section 6.2 and (b) with respect to the milestone payment for the First Commercial Sale in Japan, an Indication for which cariprazine does not have Regulatory Approval for in Japan at the time the applicable regulatory milestone event is achieved pursuant to Section 6.2.
1.147 "Owned Patents" has the meaning set forth in Section 10.2.3.
1.148 "PAC Study" or "Post Authorization Commitment Study" means any non-human study, human clinical trial, or other commitment with respect to a Licensed Compound or Licensed Product initiated after completion of a Phase III Study (including after receipt of Regulatory Approval) for such Licensed Product in a country or territory, the completion of which is recommended or required by the Regulatory Authority to obtain further information on such Licensed Product's safety or to measure the effectiveness of risk-management measures, including drug-drug interaction studies.
1.149 "Party" and "Parties" has the meaning set forth in the preamble hereto.
1.150 "Party Development Activities" means Development activities to be conducted by or on behalf of a Party pursuant to a Discovery Program Plan, IND-Enabling Study Plan and Budget, or Clinical Development Plan.
1.151 "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, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications, (c) any and all patents that have issued or in the future issue from the foregoing patent applications ((a) and (b)), including utility models, petty patents and design patents and certificates of invention, (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications ((a), (b), and (c)), and (e) any similar rights, including so-called pipeline protection or any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions to any of such foregoing patent applications and patents.
1.152 "Payment" has the meaning set forth in Section 6.8.
1.153 "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 political subdivision, department or agency of a government.
1.154 "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 Privacy Laws.
1.155 "Phase 0 Study" means an exploratory, first-in-human 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 very early on whether the agent behaves in human subjects as was anticipated from pre-clinical studies.
1.156 "Phase I Study" means a human clinical trial of a Licensed Compound 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, including the trials referred to in 21 C.F.R. §312.21(a), as amended.
1.157 "Phase II Study" 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 similar clinical study prescribed by the Regulatory Authorities, from time to time, pursuant to Applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(b), as amended.
1.158 "Phase IIa Study" means a human clinical trial of a Licensed Compound or Licensed Product, as described in 21 CFR 312.21(b) (as hereafter modified or amended), whose primary objective is to explore safety and tolerability, pharmacokinetic and/or pharmacodynamics effects in selected populations of patients (including an equivalent clinical trial conducted in any country other than the United States). For clarity, a "Phase IIa Study" would include the Phase IIa Study portion of a Phase I/II human clinical trial involving a Licensed Compound or Licensed Product in which the Phase IIa portion of such clinical trial is continued to be conducted in patients with the disease being studied after the point in time at which more than a specified minimum number of human subjects (as described in the clinical trial protocol for such clinical trial) have been dosed in the portion of such clinical trial that constitutes a Phase I Study.
1.159 "Phase IIb Study" means a human clinical trial that utilizes the pharmacokinetic and/or pharmacodynamics information obtained from one or more previously conducted human clinical trial(s) and which is designed to provide a preliminary determination of efficacy of such Licensed Compound or Licensed Product in a target patient population over a range of doses or dose regimens, as further described in 21 CFR 312.21(b) (as hereafter modified or amended) (including an equivalent clinical trial conducted in any country other than the United States).
1.160 "Phase III Study" 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 relationship, warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support marketing approval of such Licensed Compound or Licensed Product, including all tests and studies that are required by the FDA from time to time, pursuant to Applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(c), as amended.
1.161 "Phase IV Study" means any non-human study, human clinical trial, or other commitment with respect to a Licensed Compound or a Licensed Product with respect to any indication that is commenced after the receipt of Regulatory Approval for such indication or for a use that is the subject of an investigator-initiated study program, including the trials referred to in 21 C.F.R. § 312.85, as amended, but excluding any PAC Studies.
1.162 "PMDA" means Japan's Pharmaceuticals and Medical Devices Agency and any successor agency(ies) or authority having substantially the same function.
1.163 "Pro-Metabolite Competing Product" means any product that is or contains a compound, molecule or other therapeutic that generates desmethyl cariprazine or di-desmethyl cariprazine and related analogs including isotopic modifications, other than cariprazine as exploited pursuant to the Existing Collaboration Agreement.
1.164 "Pro-metabolite Compound" means (a) the compounds set forth on Schedule 1.164 together with any other compound capable of generating desmethyl cariprazine or di-desmethyl cariprazine that is Controlled by Richter or any of its Affiliates as of the Effective Date or at any time during the Discovery Program Term, and (b) any compounds identified by Richter during the Discovery Program Term under the Pro-metabolite Discovery Program that meet the Pro-metabolite Compound Criteria set forth in the Pro-metabolite Discovery Program Plan, and any metabolite, salt, ester, hydrate, solvate, isomer, enantiomer, free acid form, free base form, crystalline form, co-crystalline form, amorphous form, pro-drug (including ester pro-drug) form, racemate, polymorph, chelate, stereoisomer, tautomer, or optically active form of any of the foregoing.
1.165 "Pro-metabolite Compound Criteria" means the criteria agreed upon by the Parties for the compound, molecule or other therapeutic identified during the conduct of the Pro-metabolite Discovery Program, as set forth in the Pro-metabolite Discovery Program Plan.
1.166 "Pro-metabolite Discovery Program" means the program of discovery and pre-clinical activities for Pro-metabolites of desmethyl or di-desmethyl cariprazine undertaken as set forth in Section 3.1 and the Pro-metabolite Discovery Program Plan.
1.167 "Pro-metabolite Discovery Program Plan" means the written summary attached hereto as Schedule 1.167, including any amendments thereto, of the specific research activities to be conducted by Richter under the Pro-metabolite Discovery Program, the timelines for completion of such activities, and the corresponding Pro-metabolite Compound Criteria.
1.168 "Pro-metabolite Product" any product containing a Pro-metabolite Compound, alone or in combination with one (1) or more other active ingredients, in any and all forms, presentations, delivery systems, dosages, and formulations.
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 making available, alignment or combination, blocking, erasure or destruction.
1.170 "Product Information" has the meaning set forth in Section 9.1.
1.171 "Product Infringement" has the meaning set forth in Section 7.3.1(a).
1.172 "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 other written, printed, or graphic matter upon a container, wrapper, or any package insert, instructions, websites, and other promotional materials utilized with or for such Licensed Product in such country or other jurisdiction.
1.173 "Proposed Future In-Licensed Rights" has the meaning set forth in Section 5.9.2(b).
1.174 "Proposed Sublicense" has the meaning set forth in Section 5.3.1.
1.175 "Publication Policies" has the meaning set forth in Section 9.6.
1.176 "Quarterly Royalty Report" has the meaning set forth in Section 6.5(a).
1.177 "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 jurisdiction, including, where applicable, (a) pricing or reimbursement approval in such country or other jurisdiction, (b) pre- and post-approval marketing authorizations (including any prerequisite Manufacturing approval or authorization related thereto), and (c) approval of Product Labeling.
1.178 "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 and PMDA) regulating or otherwise exercising authority with respect to activities contemplated in this Agreement, including the Exploitation of the Licensed Compounds or Licensed Products in the Territory.
1.179 "Regulatory Data" has the meaning set forth in Section 3.10.6.
1.180 "Regulatory Documentation" means all (a) applications (including all INDs and Drug Approval Applications and other regulatory filings), registrations, licenses, authorizations, and approvals (including Regulatory Approvals), (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all regulatory drug lists, advertising and promotion documents, adverse event files, and complaint files, and (c) Clinical Data and data contained or relied upon in any of the foregoing, in each case ((a), (b), and (c)) relating to a Licensed Compound or Licensed Product.
1.181 "Regulatory Exclusivity" means, with respect to any country or other jurisdiction in the Territory, an additional market protection, other than Patent-related protection, granted by a Regulatory Authority in such country or other jurisdiction which confers an exclusive Commercialization period during which AbbVie or its Affiliates or Sublicensees have the exclusive right to market and sell (such that any Third Party is prevented from marketing and selling) a Licensed Compound or Licensed Product in such country or other jurisdiction through a regulatory exclusivity right.
1.182 "Required Richter Territory Development Activities" has the meaning set forth in Section 3.4.1.
1.183 "Reverse Royalty Term" means, with respect to each Licensed Product and each country or other jurisdiction in the Terminated Territory, the period beginning on the date of the first sale of such Licensed Product by Richter, its Affiliates or Sublicensees in such country or other jurisdiction after the effective date of the applicable termination (in whole or in part) of this Agreement with respect to such country or other jurisdiction and ending on the later to occur of (a) the expiration, invalidation or abandonment date of the last-to-expire AbbVie Patent or Joint Patent included in the AbbVie Grantback Technology that includes a Valid Claim that claims such Licensed Product in such country or other jurisdiction, (b) the expiration of Regulatory Exclusivity in such country or other jurisdiction for such Licensed Product and (c) the tenth (10th) anniversary of the first sale of such Licensed Product in such country or other jurisdiction after the effective date of the applicable termination (in whole or in part) of this Agreement with respect to such country or other jurisdiction. Solely for purposes of this Section 1.183, each reference in the definitions of "Regulatory Exclusivity" and "Sublicensee" to AbbVie shall be deemed to be a reference to Richter.
1.184 "Reverted Country" has the meaning set forth in Section 12.3.4.
1.185 "Richter" has the meaning set forth in the preamble hereto.
1.186 "Richter Acquiree" has the meaning set forth in Section 5.8.4.
1.187 "Richter Acquirer" has the meaning set forth in Section 5.8.3.
1.188 "Richter Indemnitees" has the meaning set forth in Section 11.1.
1.189 "Richter Know-How" means all Information that is (a) Controlled or Developed by Richter or any of its Affiliates as of the Effective Date or at any time during the Term, (b) not generally known and (c) reasonably necessary or useful for the Development, Manufacture, or Commercialization of a Licensed Compound or Licensed Product, but excluding any Joint Know-How or any Information disclosed in published Richter Patents or Joint Patents.
1.190 "Richter Manufacturing Process" has the meaning set forth in Section 4.9.3(a).
1.191 "Richter Manufacturing Technology Transfer" has the meaning set forth in Section 4.9.3(a).
1.192 "Richter Patents" means all of the Patents that are (a) Controlled or Developed by Richter or any of its Affiliates as of the Effective Date or at any time during the Term and (b) reasonably necessary or useful (or, with respect to patent applications, would be reasonably necessary or useful if such patent applications were to issue as patents) for the Development, Manufacture, or Commercialization of a Licensed Compound or Licensed Product, but excluding any Joint Patents. The Richter Patents include the Existing Patents.
1.193 "Richter Product Trademarks" means (a) the Trademark(s) to be owned and used by Richter or its Affiliates for the Development or Commercialization of Licensed Products in the Richter Territory and (b) any registrations thereof or any pending applications relating thereto in the Richter Territory (excluding, in any event, any trademarks, service marks, names or logos that include any corporate name or logo of the Parties or their Affiliates).
1.194 "Richter Proprietary Manufacturing Information" has the meaning set forth in Section 4.9.3(c).
1.195 "Richter Prosecuted Infringements" has the meaning set forth in Section 7.3.1(c).
1.196 "Richter Supply Agreement" has the meaning set forth in Section 4.9.1.
1.197 "Richter Territory" means the countries listed in Schedule 1.197.
1.198 "Richter Territory Development Plan" has the meaning set forth in Section 3.4.1.
1.199 "ROFN Exercise Notice" has the meaning set forth in Section 5.3.1.
1.200 "Royalty Dispute" has the meaning set forth in Schedule 12.9.1.
1.201 "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 abandonment date of the last Richter Patent or Joint Patent that includes one or more Valid Claims that (i) claim a Licensed Compound contained in such Licensed Product in such country or other jurisdiction or (ii) claim all Indications for which Regulatory Approval has been received for such Licensed Products in such country or other jurisdiction; (b) the expiration of Regulatory Exclusivity in such country or other jurisdiction for such Licensed Product; and (c) the tenth (10th) anniversary of the First Commercial Sale of such Licensed Product in such country or other jurisdiction.
1.202 "Senior Officer" means, with respect to Richter, its Chief Executive Officer or his/her designee, and with respect to AbbVie, its Chief Scientific Officer or his/her designee, with respect to Development matters and its Chief Commercial Officer or his/her designee, with respect to Commercialization matters.
1.203 "SOFR" means the Secured Overnight Financing Rate for a thirty (30)-day term published by US Federal Reserve Bank of New York, as adjusted from time to time on the first New York business day of each month.
1.204 "Subcommittee" has the meaning set forth in Section 2.1.2(r).
1.205 "Sublicensee" means a Person, other than an Affiliate or a Distributor, that is (a) with respect to AbbVie, granted a sublicense by AbbVie under the grants in Section 5.1 as provided in Section 5.3.1, excluding any Person to which AbbVie has granted such sublicense as a result of a settlement of a dispute involving any Richter Patents and (b) with respect to Richter, granted a sublicense by Richter under the grants in Section 5.2 as provided in Section 5.3.2.
1.206 "Term" has the meaning set forth in Section 12.2.
1.207 "Terminated Discovery Program" means each Discovery Program with respect to which this Agreement is terminated by AbbVie pursuant to Section 12.4.1. If this Agreement is terminated in its entirety, then both Discovery Programs will be considered Terminated Discovery Programs.
1.208 "Terminated Product" means each Licensed Product with respect to which this Agreement is terminated by Richter pursuant to Section 12.3.2 and each Licensed Product with respect to which this Agreement is terminated by AbbVie pursuant to Section 12.4.1. If this Agreement is terminated with respect to a Discovery Program, then all Licensed Products that are subject to such Discovery Program will be considered Terminated Products and if this Agreement is terminated in its entirety, then all Licensed Products will be considered Terminated Products.
1.209 "Terminated Territory" means (a) each country or jurisdiction with respect to which this Agreement is terminated by Richter pursuant to Section 12.3.2, (b) each country or jurisdiction with respect to which this Agreement is terminated by AbbVie pursuant to Section 12.4.1 and (c) each Reverted Country that is included in the Non-Breaching Party's territory pursuant to Section 12.3.4. If this Agreement is terminated in its entirety, then the entire Territory will be considered the Terminated Territory.
1.210 "Territory" means the entire world.
1.211 "Third Party" means any Person other than Richter, AbbVie and their respective Affiliates.
1.212 "Third Party Claims" has the meaning set forth in Section 11.1.
1.213 "Third Party Payments" has the meaning set forth in Section 6.4.2(b).
1.214 "Third Party Provider" has the meaning set forth in Section 3.7.
1.215 "Trademark" means any word, name, symbol, color, designation or device or any combination thereof that functions as a source identifier, including any trademark, trade dress, brand mark, service mark, trade name, brand name, logo, business symbol or domain names, whether or not registered.
1.216 "Transferee Party" has the meaning set forth in Section 4.9.3(c).
1.217 "Transferor Party" has the meaning set forth in Section 4.9.3(c).
1.218 "Transition Agreement" has the meaning set forth in Section 12.10.1.
1.219 "United States" or "U.S." means the United States of America and its territories and possessions (including the District of Columbia and Puerto Rico).
1.220 "Valid Claim" means a claim of any issued and unexpired Patent whose validity, enforceability, or patentability has not been affected by any of the following: (a) irretrievable lapse, abandonment, revocation, cancellation, dedication to the public, or disclaimer; or (b) a holding, finding, or decision of invalidity, unenforceability, or non-patentability by a court, governmental agency, national or regional patent office, or other appropriate body that has competent jurisdiction, such holding, finding, or decision being final and unappealable or unappealed within the time allowed for appeal. For clarity, a holding, finding or decision that is final and unappealable or unappealed means a holding, finding or decision from which no appeal (other than a petition to the United States Supreme Court for a writ of certiorari or a similar appeal the consideration of which is subject to the discretion of the higher court) can be or has been taken.
1.221 "Valuation Expert" has the meaning set forth in Schedule 12.9.1.
1.222 "Valuation Notice" has the meaning set forth in Schedule 12.9.1.
1.223 "Voting Stock" has the meaning set forth in the definition of "Change in Control."
1.224 "Vraylar Indication" means (a) with respect to milestone payments triggered by events in the United States, an Indication for which cariprazine has Regulatory Approval for in the United States at the time the applicable regulatory milestone event is achieved pursuant to Section 6.2 and (b) with respect to the milestone payment for the First Commercial Sale in Japan, an Indication for which cariprazine has Regulatory Approval for in Japan at the time the applicable regulatory milestone event is achieved pursuant to Section 6.2.
1.225 "Withholding Amount" has the meaning set forth in Section 6.8.
1.226 "Withholding Party" has the meaning set forth in Section 6.8.
1.227 "Working Group" has the meaning set forth in Section 2.5.
ARTICLE 2 COLLABORATION MANAGEMENT
2.1 Joint Steering Committee.
2.1.1. Formation. As soon as practical after the Effective Date, but no later than thirty (30) days, the Parties shall establish a joint steering committee (the "Joint Steering Committee" or "JSC"), which shall (a) oversee the Development, Manufacturing, Commercialization, and other Exploitation of the Licensed Compounds or Licensed Product in the Territory, (b) resolve Disputes that may arise in any Subcommittee, (c) coordinate the Parties' activities under this Agreement, including oversight of the Subcommittees, and (d) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement. The JSC shall consist of three (3) representatives from each of the Parties, each with the requisite experience and seniority to enable such person to make decisions on behalf of the Parties with respect to the issues falling within the jurisdiction of the JSC. From time to time, each Party may substitute one (1) or more of its representatives to the JSC on written notice to the other Party. AbbVie shall select from its representatives the chairperson for the JSC. From time to time, AbbVie may change the representative who will serve as chairperson on written notice to Richter.
2.1.2. Specific Responsibilities. The JSC shall develop the strategies for and oversee the Development, Manufacturing and Commercialization of the Licensed Compounds and Licensed Products in the Territory, and shall serve as a forum for the coordination of Development, Manufacturing and Commercialization activities for the Licensed Compounds and Licensed Products for the Territory. In particular, the JSC shall:
(a) serve as a forum for discussing proposed Discovery Program Activities;
(b) periodically (no less often than once each Calendar Quarter) review and serve as a forum for discussing each Discovery Program Plan, and review and approve amendments thereto in accordance with Section 3.1.2;
(c) serve as a forum for discussing proposed IND-Enabling Activities;
(d) periodically (no less often than once each Calendar Quarter) review and serve as a forum for discussing each IND-Enabling Studies Plan and Budget, and review and approve amendments thereto in accordance with Section 3.2.3;
(e) serve as a forum for discussing proposed Clinical Development Activities;
(f) periodically (no less often than annually) review each Clinical Development Plan for Clinical Development Activities, and review and approve amendments thereto in accordance with Section 3.3.3;
(g) oversee the conduct of Discovery Program Activities;
(h) determine whether any Licensed Compound meets the Lead Compound Criteria for the applicable Discovery Program or will otherwise be designated as a Lead Compound and advanced to IND-Enabling Activities;
(i) oversee the conduct of the IND-Enabling Activities;
(j) determine whether the IND-Enabling Activities have been successfully completed in accordance with the applicable IND-Enabling Studies Plan and Budget with respect to a Lead Compound and, if applicable, the selection of a Backup Compound;
(k) oversee the conduct of Clinical Development Activities;
(l) review and approve any Richter Territory Development Plans (including any amendments thereto) in accordance with Section 3.4.1;
(m) serve as a forum for discussing and coordinating strategies for obtaining all Regulatory Approvals for the Licensed Products in the Territory;
(n) establish secure access methods (such as secure databases) for each Party to transfer any Confidential Information as contemplated under this Agreement or access Regulatory Documentation and other JSC related Information as contemplated under this Agreement;