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(o) establish a Development Manufacturing Plan and review and approve any amendments thereto, in accordance with Section 3.6.1; |
(p) establish a Global Commercialization Plan for the Commercialization of each Licensed Product and review and approve any amendments thereto, in accordance with Section 4.1.1; |
(q) oversee at a high level all Commercialization activities in the Territory with respect to the Licensed Products; |
(r) coordinate, where appropriate, communications regarding product positioning, brand planning, and other material aspects of Commercializing the Licensed Products in the Parties' Applicable Territories; |
(s) develop the Publication Policy and oversee the publication of abstracts, manuscripts and presentations that disclose results of the Development of any Licensed Compound or Licensed Product; |
(t) form such other joint committees or Working Groups under the JSC as may be necessary or desirable to facilitate the activities under this Agreement as the Parties may agree and oversee the activities of any such other committees or working groups (each, a "Subcommittee", and collectively with the JSC, "Joint Commit... |
(u) 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. |
2.1.3. Disbandment. In the event of a Change in Control of Richter, AbbVie shall have the right at any time and for any reason, effective upon written notice, to disband the JSC and any Subcommittees pursuant to Section 13.2.1(b). |
2.2 General Provisions of the JSC. |
2.2.1. Meetings and Minutes. The JSC shall meet quarterly or as otherwise agreed to by the Parties, with the location of such meetings alternating between locations designated by Richter and locations designated by AbbVie. The chairperson of the JSC shall be responsible for calling meetings on no less than fifteen (15)... |
2.2.2. Procedural Rules. Each Joint Committee shall have the right to adopt such standing rules as shall be necessary for its work, to the extent that such rules are not inconsistent with this Agreement. A quorum of the Joint Committee shall exist whenever there is present at a meeting at least one (1) representative a... |
2.2.3. Dispute Resolution. If a Joint Committee (other than the JSC) cannot, or does not, reach consensus on an issue at a meeting or within a period of ten (10) Business Days thereafter or such other period as the Parties may agree, then the dispute shall be referred to the JSC for resolution and a special meeting of ... |
(a) Subject to Section 2.2.3(c), Richter shall have final decision-making authority with respect to any matter relating to (i) the day-to-day conduct of Discovery Program Activities and IND-Enabling Activities in accordance with the applicable Discovery Program Plan or IND-Enabling Studies Plan and Budget, (ii) the Ric... |
(b) AbbVie shall have final decision-making authority with respect to any matter relating to (i) any amendments to the IND-Enabling Studies Plan and Budget, (ii) the Clinical Development Plans (excluding amendments to include any New Indications proposed by AbbVie pursuant to Section 3.3.3(c)), the conduct of the Clini... |
(c) AbbVie shall have final decision-making authority with respect to any matter for which each Party believes in good faith that exercise by the other Party of its final decision-making authority could reasonably be expected to materially negatively impact the Development, receipt or maintenance of any Regulatory Appr... |
(d) Except as specified in Section 2.2.3(a), Section 2.2.3(b) and Section 2.2.3(c), neither Party will have final decision-making authority with respect to any matter if the Senior Officers are not able to agree on a resolution, including, for clarity, with respect to amendments to the Discovery Program Plan, the selec... |
(e) Disputes arising between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith, and that are outside of the jurisdiction of the JSC, shall be resolved pursuant to Section 13.7. |
2.2.4. Limitations on Authority. Each Party shall retain the rights, powers, and discretion granted to it under this Agreement and no such rights, powers, or discretion shall be delegated to or vested in a Joint Committee unless such delegation or vesting of rights is expressly provided for in this Agreement or the Par... |
2.2.5. Alliance Manager. Each Party shall appoint a person(s) who shall oversee contact between the Parties for all matters between meetings of each Joint Committee and shall have such other responsibilities as the Parties may agree in writing after the Effective Date (each, an "Alliance Manager"). Each Party may repla... |
2.3 Discontinuation of Participation on a Committee. Subject to Section 2.1.3 and Section 13.2.1(b), each Joint Committee (other than the JSC) shall continue to exist until the Parties mutually agree to disband the Joint Committee. Once the Parties mutually agree to disband a Joint Committee, such Joint Committee shall... |
2.4 Interactions Between a Joint Committee and Internal Teams. The Parties recognize that each Party possesses an internal structure (including various committees, teams and review boards) that will be involved in administering such Party's activities under this Agreement. Nothing contained in this Article 2 shall prev... |
2.5 Working Groups. From time to time, a Joint Committee may establish and delegate duties to sub-committees or directed teams (each, a "Working Group") on an "as-needed" basis to oversee particular projects or activities (for example, joint project team, joint finance group, and/or joint intellectual property group). ... |
2.6 Expenses. Each Party shall be responsible for all travel and related costs and expenses for its members and other representatives to attend meetings of, and otherwise participate on, a Joint Committee or other Working Group. |
ARTICLE 3 DEVELOPMENT AND REGULATORY |
3.1 Discovery Programs. |
3.1.1. Discovery Program Activities. |
(a) Generally; Diligence. Richter shall perform the Discovery Program Activities, and shall do so in material compliance with the applicable Discovery Program Plan by allocating the time, effort, equipment, skilled personnel, and other resources that are required to complete such Discovery Program Activities successful... |
(b) Results of Discovery Programs; Disclosure of Licensed Compounds. Richter will provide all material data and results generated by or on behalf of Richter or its Affiliates in the course of any Discovery Program Activities as soon as reasonably practicable following generation of such data and results. In addition, a... |
(c) Lead Compound Nomination; Backup Compounds. The JSC will determine on a Licensed Compound-by-Licensed Compound and Discovery Program-by-Discovery Program basis if any Licensed Compound has met the Lead Compound Criteria for such Discovery Program or should otherwise advance or not advance, regardless of whether suc... |
3.1.2. Discovery Program Plan Amendments. The JSC shall review each Discovery Program Plan covering Discovery Program Activities at least once every Calendar Quarter for the purpose of considering appropriate amendments thereto. In addition, either Party, through its representatives on the JSC, may propose amendments t... |
3.1.3. Discovery Program Term. Each Discovery Program shall be performed during the period commencing on the Effective Date and expiring with respect to each Discovery Program upon the earlier of (a) the date on which at least one (1) Lead Compound and at least one (1) Backup Compound have been identified for such Disc... |
3.2 IND-Enabling Studies. |
3.2.1. IND-Enabling Activities. |
(a) IND-Enabling Studies Plan and Budget. Within thirty (30) days of designating any Licensed Compound as a Lead Compound, the JSC shall develop the initial IND-Enabling Studies Plan and Budget for the performance by the Parties of Development with respect to such Lead Compound (such activities, "IND-Enabling Activitie... |
(b) Results of IND-Enabling Studies. Richter will provide all material data and results generated by or on behalf or Richter or its Affiliates in the course of any IND-Enabling Activities as soon as reasonably practicable following generation of such data and results. In addition, at least once every Calendar Quarter, ... |
3.2.2. Completion of IND-Enabling Studies; Backup Compounds. The JSC will determine on a Lead Compound-by-Lead Compound basis whether the IND-Enabling Activities have been successfully completed in accordance with the applicable IND-Enabling Studies Criteria in the applicable IND-Enabling Studies Plan and Budget. If th... |
3.2.3. Updates; Amendments. The JSC shall review each IND-Enabling Studies Plan and Budget covering all IND-Enabling Activities at least once every Calendar Quarter for the purpose of considering appropriate amendments thereto. In addition, either Party, through its representatives on the JSC, may propose amendments to... |
3.3 Clinical Development Activities. |
3.3.1. Clinical Development Plan. Prior to completion of the IND-Enabling Activities with respect to any Lead Compound, the JSC shall jointly develop an initial Clinical Development Plan for the performance of Clinical Studies and other Development activities not covered under the applicable Discovery Program Plan or t... |
3.3.2. Results of Clinical Studies. AbbVie will provide all material data and results generated by or on behalf of AbbVie or its Affiliates or its Sublicensees in the course of any Clinical Development Activities as soon as reasonably practicable following generation of such data and results. In addition, at least once... |
3.3.3. Updates; Amendments. |
(a) Generally. The JSC shall review each Clinical Development Plan covering all Clinical Development Activities at least annually for the purpose of considering appropriate amendments thereto. In addition, either Party, through its representatives on the JSC, may propose amendments to any Clinical Development Plan for ... |
(b) PAC Studies. |
(i) In the event a Regulatory Authority in the AbbVie Territory, but not in the Richter Territory, requires the Conduct of one or more PAC Studies for a Licensed Product, unless otherwise agreed by the Parties, AbbVie shall have sole control over and decision-making authority with respect to the completion of such PAC ... |
(ii) In the event a Regulatory Authority in the Richter Territory, but not in the AbbVie Territory, requires the Conduct of one or more PAC Studies for a Licensed Product, Richter may conduct and shall have sole control over and decision-making authority with respect to the completion of such PAC Studies; provided that... |
(iii) In the event that a Regulatory Authority in the AbbVie Territory and a Regulatory Authority in the Richter Territory each require the Conduct of one or more PAC Studies for a Licensed Product in their Applicable Territories, then AbbVie shall have sole control over and decision-making authority with respect to th... |
(c) Additional Indications. If either Party wishes to Conduct Clinical Studies to support Regulatory Approval of an existing Licensed Product in a New Indication, then the Party wishing to Conduct Clinical Studies shall propose such Indication expansion and a plan for such Clinical Studies to the JSC. If the JSC agrees... |
3.4 Required Richter Territory Development Activities. |
3.4.1. All Clinical Development Activities shall be designed and implemented so as to support the filing of Drug Approval Applications and the obtaining of all Regulatory Approvals for the Licensed Product in the AbbVie Territory. The Parties will also aim to include the Development activities required to support the f... |
3.4.2. Richter may not conduct any Development activity under the Richter Territory Development Plan that could reasonably be expected to materially negatively impact the Development, receipt or maintenance of any Regulatory Approval, or Commercialization of the Licensed Compounds or Licensed Products in the AbbVie Ter... |
3.5 Development and Regulatory Diligence. On a Discovery Program-by-Discovery Program basis, following the successful completion by Richter of the IND-Enabling Activities for such Discovery Program, AbbVie shall use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval for one (1) Licensed Product f... |
3.6 Pre-Clinical and Clinical Supply of Licensed Compounds or Licensed Products; Subcontracting. |
3.6.1. Development Manufacturing Plan. Within one hundred twenty (120) days after the Effective Date, the JSC shall finalize a plan setting forth in reasonable detail the specific Manufacturing activities to be performed by each Party to support the Development of the Licensed Compounds and Licensed Products based on a... |
3.6.2. Supply by Richter. Richter shall, as and to the extent required under the Development Manufacturing Plan, supply pre-clinical and clinical requirements (including for formulation Development activities) of the Licensed Compounds for use by Richter and AbbVie in the Development of Licensed Compounds or Licensed P... |
3.6.3. Supply by AbbVie. AbbVie shall, as and to the extent required under the Development Manufacturing Plan, be responsible for supplying the pre-clinical and clinical requirements of the Licensed Products (the Licensed Compound contained therein having been provided by Richter pursuant to Section 3.6.2) for use by R... |
3.6.4. Formulation Activities. If Richter wishes to conduct any formulation Development activities for the Licensed Product for use in the Richter Territory (such activities, "Richter Formulation Activities"), then Richter shall propose an amendment to the Development Manufacturing Plan that includes such Richter Formu... |
3.7 Subcontracting. AbbVie shall have the right to subcontract any of its Party Development Activities and its Development Manufacturing Activities to a Third Party (a "Third Party Provider"); provided, that AbbVie furnishes Richter with advanced written notice thereof and an opportunity to consult regarding such subco... |
3.8 Supply of Technology for Development Purposes. |
(a) Richter shall, and shall cause its Affiliates to, without additional compensation, disclose and make available to AbbVie, in whatever form AbbVie may reasonably request, Regulatory Documentation, Richter Know-How, Joint Know-How, and any other Information described in any Richter Patent or Joint Patent or otherwise... |
(b) If Richter is conducting any Richter Formulation Activities under the Development Manufacturing Plan in accordance with Section 3.6.4, then, upon reasonable request by Richter, AbbVie shall, and shall cause its Affiliates to, without additional compensation, disclose and make available to Richter, in whatever form ... |
(c) Each Party, at its sole cost and expense, shall provide the other Party with all reasonable assistance required in order to transfer (but, for clarity, not assign) to the other Party the Regulatory Documentation, the Richter Know-How or the AbbVie Know-How (as applicable), the Joint Know-How, and any other Informat... |
3.9 Development Costs. |
3.9.1. Development Costs Relating to Discovery Program Activities. Richter shall be solely responsible for and shall bear all Development Costs (a) incurred by it and its Affiliates in connection with the performance of the Discovery Program Activities, and (b) incurred by AbbVie and its Affiliates in connection with D... |
3.9.2. Development Costs Relating to IND-Enabling Activities. |
(a) Each Party shall bear fifty percent (50%) of all aggregate Development Costs incurred in connection with the performance of IND-Enabling Activities in accordance with the applicable IND-Enabling Studies Plan and Budget, unless otherwise agreed by the Parties and set forth in the applicable IND-Enabling Studies Plan... |
(b) Richter shall promptly inform AbbVie upon Richter determining that it is likely to overspend or underspend by more than ten percent (10%) its respective aggregate budgeted costs and expenses for IND-Enabling Activities, as the case may be, set forth in each applicable IND-Enabling Studies Plan and Budget. The porti... |
(c) If Richter exceeds its aggregate budgeted costs and expenses by more than ten percent (10%), Richter shall provide to the JSC a full explanation for exceeding such aggregate budgeted costs under the applicable IND-Enabling Studies Plan and Budget. If and to the extent that any such overspend is in excess of ten per... |
(d) To the extent that any overspend is not included in Development Costs as provided in Section 3.9.2(b) or Section 3.9.2(c) above, Richter shall be solely responsible for the overspend. |
3.9.3. Development Costs Relating to Clinical Development Activities. |
(a) Phase I Studies and Phase II Studies. Each Party shall bear fifty percent (50%) of all Development Costs incurred in connection with the Conduct of Phase I Studies and Phase II Studies and related Clinical Development Activities in accordance with the applicable Clinical Development Plan (including, for clarity, an... |
(b) Phase III Studies. Each Party shall bear Development Costs incurred in connection with the Conduct of Phase III Studies and related Clinical Development Activities in accordance with the applicable Clinical Development Plan (including, for clarity, any Phase III Studies added to the Clinical Development Plan in acc... |
(i) Each Party shall bear fifty percent (50%) of the aggregate Development Costs incurred with respect to such Licensed Product and such Indication less than or equal to Fifty Million Dollars ($50,000,000); |
(ii) Richter shall bear forty percent (40%) and AbbVie shall bear sixty percent (60%) of the aggregate Development Costs incurred with respect to such Licensed Product and such Indication in excess Fifty Million Dollars ($50,000,000) and less than or equal to One Hundred Million Dollars ($100,000,000); |
(iii) Richter shall bear thirty percent (30%) and AbbVie shall bear seventy percent (70%) of the aggregate Development Costs incurred with respect to such Licensed Product and such Indication in excess of One Hundred Million Dollars ($100,000,000) and less than or equal to Two Hundred Million Dollars ($200,000,000); an... |
(iv) AbbVie shall bear one hundred percent (100%) of the aggregate Development Costs incurred with respect to such Licensed Product and such Indication in excess of Two Hundred Million Dollars ($200,000,000). |
Notwithstanding the foregoing but subject to any adjustments pursuant to Section 3.9.3(d), Richter's obligations to bear Development Costs in accordance with this Section 3.9.3(b) shall not exceed (a) Seventy Five Million Dollars ($75,000,000) with respect to any single Indication for any Licensed Product (the "Indicat... |
(c) PAC Studies. |
(i) In Both Territories. |
(1) If a PAC Study is required by a Regulatory Authority in the AbbVie Territory as a condition to Regulatory Approval and in the Richter Territory as a condition to Regulatory Approval, then each Party shall bear fifty percent (50%) of the Development Costs incurred with respect to the Conduct of such PAC Study, subje... |
(2) If a PAC Study is required by a Regulatory Authority in the Richter Territory but not as a condition to Regulatory Approval and by a Regulatory Authority in the AbbVie Territory but not as a condition to Regulatory Approval, then each Party shall bear fifty percent (50%) of the Development Costs incurred with respe... |
(ii) Only in the AbbVie Territory. |
(1) If a PAC Study is required only by a Regulatory Authority in the AbbVie Territory and such PAC Study is required as a condition to Regulatory Approval, then each Party shall bear fifty percent (50%) of the Development Costs incurred with respect to the Conduct of such PAC Study, subject to the Indication Cap and Di... |
(2) If a PAC Study is required only by a Regulatory Authority in the AbbVie Territory and such PAC is not a condition to Regulatory Approval, then AbbVie shall bear one hundred percent (100%) of the Development Costs incurred with respect to the Conduct of such PAC Study. |
(iii) Only in the Richter Territory. If a PAC Study is required only by a Regulatory Authority in the Richter Territory, then Richter shall bear one hundred percent (100%) of the Development Costs incurred with respect to the Conduct of such PAC Study (regardless of whether such PAC Study is required as a condition to ... |
(d) Additional Indications. Each Party shall bear Development Costs incurred in connection with the Conduct of any Clinical Studies to support Regulatory Approval of an existing Licensed Product in a New Indication as follows: |
(i) If the Parties mutually agree to the Conduct of such Clinical Studies and amend the Clinical Development Plan to include such Clinical Study in accordance with Section 3.3.3(c), then the Development Costs incurred with respect thereto will be borne by the Parties as set forth in Section 3.9.3(a) and Section 3.9.3(b... |
(ii) If the Parties do not mutually agree to the Conduct of such Clinical Studies and amend the Clinical Development Plan to include such Clinical Study in accordance with Section 3.3.3(c) and AbbVie is the interested Party, then AbbVie shall initially bear one hundred percent (100%) of Development Costs incurred by Ab... |
(iii) If the Parties do not mutually agree to the Conduct of such Clinical Studies and amend the Clinical Development Plan to include such Clinical Study in accordance with Section 3.3.3(c) and Richter is the interested Party, then if AbbVie consents to Richter Conducting such Clinical Studies in accordance with Sectio... |
3.9.4. FTE Costs. Each Party shall record and account for its FTE Costs and its out-of-pocket costs with respect to each Licensed Compound or Licensed Product to the extent that such costs are included in Development Costs that are, or may in the future, be shared under this Agreement, including costs for the Discovery... |
3.9.5. Adjustment of FTE Rates. The FTE Rates applicable to activities undertaken by either Party are subject to adjustments effective on January 1 of each Calendar Year, with the first such annual adjustment to be made as of January 1, 2023, based on the applicable employment cost index published by the United States ... |
3.9.6. Reports. During the Term, each Party shall report to the other Party in writing, within forty-five (45) days after the end of each Calendar Quarter, the Development Costs incurred by such Party during such Calendar Quarter (broken down by activity). Such report(s) shall specify in reasonable detail all amounts i... |
3.9.7. Payments. Unless otherwise specified in a Discovery Program Plan, IND-Enabling Studies Plan and Budget, or Clinical Development Plan, Development Costs initially shall be borne by the Party incurring the Development Cost and thereafter shall be subject to reimbursement by the other Party, if applicable, in accor... |
3.10 Regulatory Matters. |
3.10.1. Regulatory Activities Controlled by AbbVie. |
(a) Subject to Section 3.10.3, as between the Parties, AbbVie shall have the sole right to prepare, obtain, and maintain (i) the Drug Approval Applications (including the setting of the overall regulatory strategy therefor), all other Regulatory Approvals and other submissions, and to conduct communications with the Re... |
(b) All Regulatory Documentation (including all Regulatory Approval and Product Labeling) relating to the Licensed Compounds or Licensed Products with respect to the AbbVie Territory or, to the extent controlled by AbbVie pursuant to Section 3.10.1(a), the Richter Territory, shall be owned by and shall be the sole prop... |
3.10.2. Regulatory Activities Controlled by Richter. |
(a) Subject to Section 3.10.3, as between the Parties, Richter shall have the sole right to prepare, obtain, and maintain the Drug Approval Applications (including the setting of the overall regulatory strategy therefor), all other Regulatory Approvals and other submissions, and to conduct communications with the Regul... |
(b) All Regulatory Documentation (including all Regulatory Approval and Product Labeling) relating to the Licensed Compounds or Licensed Products with respect to the Richter Territory, to the extent controlled by Richter pursuant to Section 3.10.2(a), shall be owned by and shall be the sole property and held in the nam... |
3.10.3. Cooperation Regarding Regulatory Matters in the Territory. Each Party shall support the other Party, as may be reasonably necessary, in obtaining all Regulatory Approvals for the Licensed Products in the other Party's Applicable Territory, and in the activities in support thereof, including providing necessary ... |
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