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3.5. Termination of License Option. Without limiting each Party's rights to terminate this Agreement in its entirety in accordance with Section 12.2, if (a) AbbVie has not delivered an Exercise Notice prior to the expiration of the License Option Period, or (b) prior to the expiration of the License Option Period AbbVi... |
ARTICLE 4 GRANT OF RIGHTS; EXCLUSIVITY |
4.1. Grants to AbbVie. Subject to Section 4.3 and Section 4.4, Cugene (on behalf of itself and its Affiliates) hereby grants to AbbVie and its Affiliates, effective upon the License Option Effective Date, (a) an exclusive (even as to Cugene and its Affiliates) license (or sublicense), with the right to grant sublicense... |
4.2. Grants to Cugene. AbbVie (on behalf of itself and its Affiliates) hereby grants to Cugene and its Affiliates, during the performance of Cugene's Development activities under the Initial Development Plan and Budget (including, for clarity, the Unfinished Initial Development Activities, if any, pursuant to Section 3... |
4.3. Sublicenses. Subject to the terms and conditions of this Agreement, including the rest of this Section 4.3, AbbVie shall have the right to grant sublicenses, through multiple tiers of sublicenses, under the licenses granted in Section 4.1, to its Affiliates and Third Parties; provided that any such sublicenses sha... |
4.4. No Implied Licenses. Except as expressly provided herein, Cugene grants no other right or license, including any rights or licenses to the Cugene IP, Cugene's interests in the Joint IP, if any, Cugene's Corporate Names or any other Patent or intellectual property rights not otherwise expressly granted herein. Cuge... |
4.5. Confirmatory Patent License. Cugene shall, and shall cause its Affiliates to, if requested to do so by AbbVie, immediately enter into confirmatory license agreements in such form as may be reasonably requested by AbbVie and reasonably acceptable to Cugene for purposes of recording the licenses granted under Sectio... |
4.6. Exclusivity. |
4.6.1. Cugene's Exclusivity Obligations. During the Term, Cugene shall not, and shall cause its Affiliates not to (a) Exploit or (b) license, authorize, appoint, or otherwise assist or enable any Third Party to, Exploit, in either case ((a) or (b)), any Competing Product in the Field in the Territory; provided that the... |
4.6.2. Exceptions. Subject to Section 4.1 and Section 4.2 and the remainder of this Section 4.6.2, if during the Term, Cugene or any of its Affiliates merges or consolidates with, or is acquired by, a Third Party through a Change in Control and such Third Party or any of its Affiliates prior to such transaction (collec... |
(a) no employees of the Pre-Existing Entity who work on or have worked on Exploiting any Competing Product shall have access to the Confidential Information of AbbVie, Product Information, Product Patents, Joint Patents or Joint Know-How; |
(b) no employees of Cugene who have or have had access to, the Confidential Information of AbbVie, Product Information, Product Patents, Joint Patents or Joint Know-How work for such Pre-Existing Entity in Exploiting such Competing Product(s); |
(c) all such Pre-Existing Entity's manufacturing, research, development, and commercialization activities (and the personnel conducting such activities) for such Competing Product(s) are kept separate from the Manufacturing, research, Development, and Commercialization activities for Licensed Products under this Agreem... |
(d) Cugene shall, and shall cause such Pre-Existing Entity to, establish, maintain and enforce internal safeguards reasonably designed to ensure that the foregoing requirements are satisfied. |
4.6.3. Acknowledgement. Cugene acknowledges and agrees that (a) this Section 4.6 has been negotiated by the Parties, (b) the geographical and time limitations on activities set forth in this Section 4.6 are reasonable, valid and necessary in light of the Parties' circumstances and necessary for the adequate protection ... |
ARTICLE 5 DEVELOPMENT AND COMMERCIALIZATION BY ABBVIE |
5.1. In General. After the License Option Effective Date, AbbVie (itself or through its Affiliates or its or their Sublicensees), at its sole cost and expense, shall, as between the Parties, have the sole right to further Develop, Manufacture, Commercialize and otherwise Exploit the Licensed Therapeutics and the Licens... |
5.2. Diligence. After the License Option Effective Date, AbbVie shall use Commercially Reasonable Efforts to Develop, seek Regulatory Approval and Commercialize one Licensed Product in the United States and three of the Major European Markets for one Indication in compliance with all Applicable Law. |
5.3. Manufacturing Technology Transfer. Upon AbbVie's request at any time after the License Option Effective Date and from time to time, Cugene shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Cugene Know-How and Joint Know-How relating to ... |
5.3.1. Cugene shall provide, and shall cause its Affiliates to provide, and shall use commercially reasonable efforts to cause Third Party manufacturers to provide (including by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entere... |
(a) Cugene shall make available, and shall cause its Affiliates to make available, and shall use commercially reasonable efforts to cause Third Party manufacturers to make available, to AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) from time to time as AbbVie may request, all Cugene Kn... |
(b) Cugene shall assign to AbbVie all of its right, title and interest in and to, and shall deliver to AbbVie, the cell banks and reference standards (and such other materials as the Parties may agree in writing) used by Cugene or any of its Affiliates or Third Party manufacturers in the Manufacturing Process; |
(c) Cugene shall cause all appropriate employees and representatives of Cugene and its Affiliates, and shall use commercially reasonable efforts to cause all appropriate employees and representatives of its Third Party manufacturers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Th... |
(d) Without limiting the generality of Section 5.3.1(c), Cugene shall cause all appropriate analytical and quality control laboratory employees and representatives of Cugene and its Affiliates, and shall use commercially reasonable efforts to cause all appropriate analytical and quality control laboratory employees and... |
(e) Cugene shall, and shall cause its Affiliates to, take such steps, and shall use commercially reasonable efforts to cause its Third Party manufacturers to take such steps, as are reasonably necessary or useful to assist AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) in obtaining any ... |
(f) Cugene shall provide, and shall cause its Affiliates and shall use commercially reasonable efforts to cause its Third Party manufacturers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) may reasonably request to enable AbbVie (or its Affiliate or ... |
5.3.2. Cugene shall reasonably promptly disclose to AbbVie (a) all modifications, enhancements and improvements, if any, to the Manufacturing Process transferred to AbbVie pursuant to this Section 5.3 and (b) any other Manufacturing process, in each case ((a) and (b)) conceived, discovered, developed or otherwise made ... |
5.4. Subcontracting; Distributors. AbbVie shall have the right to subcontract any of its Development, Manufacturing or Commercialization activities to a Third Party (including by appointing one or more contract sales forces, co-promotion partners or Distributors); provided that no such permitted subcontracting shall re... |
5.5. Records; Development and Commercialization Reports. |
5.5.1. AbbVie shall, and shall cause its Affiliates and Sublicensees to, maintain, in good scientific manner, complete and accurate books and records pertaining to its activities under this Agreement conducted after the License Option Effective Date, which books and records shall (a) be appropriate for Patent and regul... |
5.5.2. No later than 30 days after the License Option Effective Date, AbbVie will provide Cugene with a Development plan, including anticipated Development activities to be conducted during the next 24-month period. After the License Option Effective Date, no later than 30 days after the end of each Calendar Year, AbbV... |
5.6. Regulatory Activities. |
5.6.1. After the License Option Effective Date, AbbVie shall, as between the Parties, have the sole right to prepare, obtain and maintain Drug Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals and other submissions and to conduct communications with th... |
5.6.2. After the License Option Effective Date, all Regulatory Documentation (including all Regulatory Approvals) in the Territory relating to the Licensed Products shall be owned by, and shall be the sole property and held in the name of, AbbVie or its designated Affiliate, Sublicensee or designee. |
5.7. Adverse Event and Safety Information Agreement. Within 90 days after the License Option Effective Date, the Parties shall enter into an agreement (the "Adverse Event and Safety Information Agreement") to initiate a process for the exchange of adverse event safety data in a mutually agreed format in order to monito... |
ARTICLE 6 COLLABORATION MANAGEMENT |
6.1. Joint Governance Committee. |
6.1.1. Formation. Within 15 days after the Effective Date, the Parties shall establish a joint governance committee (the "Joint Governance Committee" or "JGC") to serve as the oversight and decision-making body for the activities to be conducted by the Parties pursuant to this Agreement during the License Option Period... |
6.1.2. Responsibilities. During the License Option Period, the JGC shall perform the following functions, subject to the final decision-making authority of the respective Parties as set forth in Section 6.2.4: |
(a) oversee the Development of, and regulatory activities for, Licensed Therapeutics and Licensed Products in the Field in the Territory pursuant to the Initial Development Plan and Budget; |
(b) periodically (no less often than once per Calendar Quarter) review and serve as a forum for discussing the Initial Development Plan and Budget, and review and approve amendments thereto, including any Material Amendment; |
(c) serve as a forum for discussing, reviewing and approving any submissions to Governmental Authorities (or decisions to decline to do so) with respect to the preparation, filing, prosecution and maintenance by Cugene of Product Patents pursuant to Section 8.2.1(b); |
(d) coordinate the Parties' activities under this Agreement; |
(e) serve as a forum for providing advice and assistance on the conduct of the Phase Ib Clinical Trial for a Licensed Product in accordance with the Initial Development Plan and Budget, including advising Cugene on matters related to site selection, initiation and recruitment strategies; |
(f) review and discuss all real-time data and information received by either Party from activities conducted by contract research organizations, clinical sites and investigators under the Initial Development Plan and Budget; |
(g) review and discuss all material safety and efficacy data and information received by either Party under the Initial Development Plan and Budget, including any material toxicology or pharmacokinetics issue; |
(h) serve as a consultation forum for discussing any clinical hold placed on a Licensed Product and for discussing, reviewing and approving any Clinical Study that Cugene, after consultation with the DRC (if any), proposes to terminate due to a Safety Event; |
(i) serve as a forum for discussing and reviewing any amendment to IND, study protocol or other regulatory submission for a Licensed Product to be filed by Cugene, or any communication or interaction with a Regulatory Authority, excluding any administrative or scheduling communications or interactions, pursuant to Sect... |
(j) serve as a forum for discussing, reviewing and approving the study protocol for the GLP toxicology study (the "GLP Toxicology Protocol") to be performed under the Initial Development Plan and Budget; |
(k) serve as an initial forum for discussion of, and attempt to resolve, any issues or Disputes that may arise between the Parties or otherwise under this Agreement; and |
(l) 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. |
For clarity, the JGC shall not have any authority beyond the specific matters set forth in this Section 6.1.2, and in particular shall not have any power to amend or modify the terms of this Agreement or waive a Party's compliance with this Agreement or to decide or resolve any issues other than those specifically subj... |
6.2. General Provisions Applicable to the JGC. |
6.2.1. Composition. The JGC shall consist of three representatives from each Party, each with the requisite experience and seniority to enable such representative to make decisions on behalf of the applicable Party with respect to the issues falling within the jurisdiction of the JGC. From time to time, each Party may ... |
6.2.2. Meetings and Minutes. The JGC shall meet monthly or as otherwise agreed to by the Parties until the initiation of the first Phase Ib Clinical Trial for a Licensed Product conducted in accordance with the Initial Development Plan and Budget. Thereafter, the JGC shall meet quarterly or as otherwise agreed to by th... |
6.2.3. Procedural Rules. The JGC shall have the right to adopt such standing rules as shall be necessary for its work, which shall be consistent with this Agreement. A quorum of the JGC shall exist whenever there is present at a meeting at least one representative appointed by each Party. Representatives of the Parties... |
6.2.4. Decision-Making. If the JGC cannot, or does not, reach consensus on an issue at a meeting or within a period of ten Business Days thereafter, or such other period as the Parties may agree, including any dispute arising in a Working Group, then the dispute shall first be referred to the Senior Officers of the Par... |
(a) Cugene shall have final decision-making authority with respect to conduct of activities performed pursuant to the Initial Development Plan and Budget, including termination of a Clinical Study due to a Safety Event; provided that (i) any conduct that would materially adversely affect the information AbbVie would re... |
(b) neither Party shall have final decision-making authority with respect to (i) approval of any amendment to IND, study protocol or other regulatory submission (excluding any administrative or scheduling communications or interactions) to be filed by Cugene pursuant to Section 2.3.2, (ii) approval of the GLP Toxicolog... |
(c) all such decisions must be consistent with the terms of this Agreement and Applicable Law; and |
(d) 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 JGC or described in Section 6.1.2(k), shall be resolved pursuant to Section 13.5. For clarity, with respect to the mat... |
6.2.5. 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 the JGC unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expre... |
6.2.6. Discontinuation; Disbandment. The JGC shall continue to exist until the first to occur of: (a) the Parties mutually agreeing to disband the JGC, (b) the License Option Effective Date (provided that, if Cugene is required to perform any Unfinished Initial Development Activities after the License Option Effective ... |
6.3. Working Groups. From time to time, the JGC may establish and delegate duties to other committees or directed teams (each, a "Working Group") on an "as-needed" basis to oversee particular projects or activities. Each such Working Group shall be constituted and shall operate as the JGC determines; provided that each... |
6.4. Alliance Managers. Each Party shall appoint an individual who shall oversee contact between the Parties for all matters between meetings of the JGC, shall be the primary contacts between the Parties after disbandment of the JGC, and shall have such other responsibilities as the Parties may agree in writing after t... |
ARTICLE 7 PAYMENTS AND RECORDS |
7.1. Upfront Payment. Subject to the terms and conditions of this Agreement, no later than 30 days after the Effective Date, AbbVie shall pay Cugene a non-refundable, non-creditable upfront amount equal to $48,500,000. |
7.2. License Option Exercise Payment. If AbbVie delivers Cugene an Exercise Notice pursuant to Section 3.2.1, AbbVie shall pay to Cugene a one-time non-refundable, non-creditable payment of $40,000,000 (the "License Option Exercise Payment") within 30 days after the License Option Effective Date. |
7.3. Development Milestone Events. Subject to the terms and conditions of this Agreement, with respect to each milestone event set forth in the table immediately below (each, a "Development Milestone Event"), AbbVie shall pay Cugene the corresponding non-refundable, non-creditable milestone payment set forth in such ta... |
Development Milestone Event |
1. Initiation of the first Phase Ib Clinical Trial for a Licensed Product containing CUG252, as set forth the Initial Development Plan and Budget for such Licensed Product following Successful Completion of the Phase Ia Clinical Trial |
1.1. Initiation of the first Phase II Clinical Trial sponsored by AbbVie or any of its Affiliates or Sublicensees for a Different Licensed Product |
2. Initiation of the first Registrational Trial sponsored by AbbVie or any of its Affiliates or Sublicensees for a Licensed Product |
3. Initiation of the first Registrational Trial sponsored by AbbVie or any of its Affiliates or Sublicensees for a Licensed Product for an Indication other than the Indication for the Registrational Trial that achieved Development Milestone Event #2 |
4. Acceptance of a BLA for a Licensed Product by the FDA |
5. First Commercial Sale of a Licensed Product in the United States |
6. First Commercial Sale of a Licensed Product in any Major European Market |
Except as follows, each Development Milestone Event in this Section 7.3 shall be payable once. If, after the First Commercial Sale of a Licensed Product that contains CUG252 in the United States, any Development Milestone Event (other than the Development Milestone Events #1 and #1.1) is achieved for the second time by... |
Development Milestone Events are determined as of the Initiation of a Clinical Study; provided that if a Clinical Study does not meet the criteria for a Phase Ib (or II, as applicable) Clinical Trial or Registrational Trial, as applicable, at the time such Clinical Study is Initiated, but is later modified based on int... |
7.4. Sales Milestone Events. Subject to the terms and conditions of this Agreement, with respect to each milestone event set forth set forth in the table immediately below (each, a "Sales Milestone Event"), AbbVie shall pay Cugene the corresponding non-refundable, non-creditable milestone payment set forth in such tabl... |
Sales Milestone Event |
1. The first Calendar Year in which aggregate Net Sales of such Licensed Product in the Territory exceed $500,000,000 |
2. The first Calendar Year in which aggregate Net Sales of such Licensed Product in the Territory exceed $1,000,000,000 |
3. The first Calendar Year in which aggregate Net Sales of such Licensed Product in the Territory exceed $2,000,000,000 |
4. The first Calendar Year in which aggregate Net Sales of such Licensed Product in the Territory exceed $3,000,000,000 |
Each Sales Milestone Payment in this Section 7.4 shall be payable only upon the first achievement of the applicable Sales Milestone Event and not for any other subsequent achievement by the same or another Licensed Product. For clarity, the Sales Milestone Payments shall be additive such that if multiple Sales Mileston... |
7.5. Royalties. |
7.5.1. Royalty Rates. Subject to Section 7.5.3 and Section 7.5.4, commencing on the beginning of the Royalty Term with respect to a Licensed Product in the Territory, on a Licensed Product-by-Licensed Product basis, AbbVie shall pay Cugene a non-refundable, non-creditable royalty on Net Sales of such Licensed Product i... |
Aggregate Net Sales of such Licensed Product in the Territory in a Calendar Year |
For that portion of aggregate Net Sales of such Licensed Product in the Territory in a Calendar Year that is less than $1,000,000,000 |
For that portion of aggregate Net Sales of such Licensed Product in the Territory in a Calendar Year that is greater than or equal to $1,000,000,000 but less than $3,000,000,000 |
For that portion of aggregate Net Sales of such Licensed Product in the Territory in a Calendar Year that is equal to or greater than $3,000,000,000 |
7.5.2. Royalty Term. AbbVie's obligation to pay Cugene royalties with respect to a Licensed Product, on a Licensed Product-by-Licensed Product and country-by-country basis (or jurisdiction-by-jurisdiction basis), shall commence on the beginning of the Royalty Term with respect to such Licensed Product in such country o... |
7.5.3. Royalty Rate Reductions. Notwithstanding Section 7.5.1, but subject to Section 7.5.2 and Section 7.5.5, if: |
(a) from and after the date on which a Licensed Product is sold in a country or other jurisdiction in the Territory and is not Covered by a Royalty Claim in such country or other jurisdiction during the Royalty Term for such Licensed Product in such country or other jurisdiction, the royalty rate for such Licensed Prod... |
(b) if in any country or other jurisdiction in the Territory during the Royalty Term in such country or other jurisdiction for a Licensed Product a Biosimilar Product with respect to such Licensed Product is launched in such country or other jurisdiction, then, for so long as the Net Sales of such Licensed Product in s... |
7.5.4. Third Party Payments. Subject to Section 7.5.5(b), if (a) AbbVie enters into an agreement with a Third Party in order to obtain a license or right under a Patent or Information owned or controlled by such Third Party that, absent a license thereunder, would be infringed by the sale, use, or Manufacture of a Lice... |
7.5.5. Mechanics of Royalty Adjustments. |
(a) Any reductions set forth in Section 7.5.3 shall be applied to the royalty rates payable to Cugene under Section 7.5.1 in the order in which the event triggering such reduction occurs. For purposes of Section 7.5.3, the portion of Net Sales of the applicable Licensed Product in each country or other jurisdiction sub... |
(b) In no event shall the royalties payable to Cugene under Section 7.5.1, as applicable, for Net Sales of a particular Licensed Product in a country or jurisdiction in a Calendar Quarter be reduced by more than 50% of what would otherwise be payable for such Licensed Product in such country or jurisdiction in such Cal... |
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