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1.153 "United States" or "U.S." means the United States of America and its territories and possessions (including the District of Columbia and Puerto Rico). |
1.154 "Updated Disclosure Schedule" has the meaning set forth in Section 10.2.30. |
1.155 "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, dedication to the public, or disclaimer; or (b) a holding, finding, or decision of invalidity, unenforcea... |
1.156 "Voting Stock" has the meaning set forth in the definition of "Change in Control." |
1.157 "Withholding Amount" has the meaning set forth in Section 6.11. |
1.158 "Withholding Party" has the meaning set forth in Section 6.11. |
1.159 "Working Group" has the meaning set forth in Section 2.2.6. |
ARTICLE 2 TRANSITION GOVERNANCE |
2.1 Transition Governance Committee. |
2.1.1 Formation. As soon as practical after the Effective Date, no later than thirty (30) days after the Effective Date, the Parties shall establish a joint governance committee for the Transition Term (the "JGC") to serve as the oversight and decision-making body for the Transition Activities to be conducted by OSE pu... |
2.1.2 Responsibilities. The JGC shall perform the following functions, subject to the final decision-making authority of the respective Parties as set forth in Section 2.2.4: |
(a) monitor the transfer of Development responsibility from OSE to AbbVie and any other Transition Activities; |
(b) oversee and discuss the performance of OSE in completing the Transition Activities; |
(c) review, discuss and approve any material updates or amendments to the Transition Development Plan proposed by AbbVie, including in the event that OSE or its subcontractors experience technical difficulties, provided that no such update or amendment would result in (i) materially amending its objectives, including t... |
(d) serve as an initial forum for discussion of, and attempt to resolve, any issues or Disputes that may arise during the Transition Term; |
(e) coordinate the Parties' activities under the Transition Development Plan; and |
(f) 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 2.1.2, 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... |
2.2 General Provisions Applicable to the JGC. |
2.2.1 Composition. The JGC 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 JGC. From time to time, each Party may subst... |
2.2.2 Meetings and Minutes. The JGC shall meet quarterly or as otherwise agreed to by the Parties, with the location of any in-person meetings alternating between locations designated by OSE and locations designated by AbbVie. Alternatively, the JGC may meet by means of teleconference, videoconference or other similar ... |
2.2.3 Procedural Rules. The JGC 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 JGC shall exist whenever there is present at a meeting at least one (1) representative appointed by each Party. Re... |
2.2.4 Dispute Resolution. If the JGC cannot, or does not, reach consensus on an issue, including any dispute, then the dispute shall be finally and definitively resolved by the Senior Officer of AbbVie. Disputes arising between the Parties in connection with or relating to this Agreement or any document or instrument d... |
2.2.5 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 expres... |
2.2.6 Working Groups. From time to time, the JGC may establish and delegate duties to other committees or directed teams (each, a "Working Group") on a monthly or an "as-needed" basis to oversee particular projects or activities. Each such Working Group shall be constituted and shall meet on a monthly basis and operate... |
2.2.7 JGC Discontinuation; Disbandment. The JGC shall be terminated and shall have no further rights or obligations under this Agreement upon completion of the Transition Term. |
2.2.8 Alliance Manager. Promptly following the Effective Date, each Party shall appoint an employee(s) who shall oversee contact for all matters and communication between the Parties in respect of the collaboration, including facilitating review of press releases and the provision by AbbVie of annual reports concerning... |
2.3 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 the JGC. |
ARTICLE 3 DEVELOPMENT AND REGULATORY |
3.1 Transition and Development Activities. |
3.1.1 Transition. |
(a) Promptly following the Effective Date, OSE shall, subject to Section 3.1.2(b), transition to AbbVie (or cause to be transitioned to AbbVie, as applicable) or its designee all materials and supporting data packages (including complete toxicology packages and reports by OSE) related to the Transition Activities in ac... |
(b) transfer to AbbVie of any and all regulatory filings, it being understood that there are no regulatory filings as of the Execution Date; |
(c) delivery to AbbVie of all preclinical and IND-enabling data, reports and materials to support regulatory submissions; |
(d) cause and facilitate the technology transfer to AbbVie or its designee of manufacturing and supply capabilities detailed in and in accordance with Section 3.4.1; and |
(e) conduct (and cause to be conducted, as applicable) any remaining Transition Activities in accordance with the Transition Development Plan. |
3.1.2 Development Activities. |
(a) OSE shall perform or cause to be performed, if applicable, the Transition Activities, in good scientific manner and in compliance with all Applicable Law. |
(b) The Parties acknowledge and agree that the Development activities pursuant to the Transition Development Plan are experimental by nature and OSE does not guarantee that it will be able to generate results achieving the objectives of the Parties. Failure to achieve those objectives shall not be a breach of this Agre... |
3.2 Development Activities and Costs. Following the Effective Date, AbbVie shall control the Development of all Licensed Antibodies and Licensed Products. Subject to OSE completing, at its cost (subject to Section 3.1.2(b) and Section 3.4), the Transition Activities, AbbVie shall be responsible for all Development and ... |
3.3 Subcontracting. Except as specifically set forth in the Transition Development Plan, OSE shall not subcontract any of its Transition Activities to a Third Party (a "Third Party Provider") without AbbVie's prior written consent. AbbVie's consent, to be granted at AbbVie's discretion, shall be conditioned on the foll... |
3.4 Supply, Manufacture and Cost of Licensed Antibodies or Licensed Products. Following the Effective Date, AbbVie shall have the right, at its expense, to Manufacture (or have Manufactured) and supply the Licensed Antibodies and Licensed Products for Development and Commercialization by AbbVie and its Affiliates and S... |
3.4.1 Manufacturing Technology Transfer. Upon the Effective Date, OSE shall initiate the facilitation of full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer, and which Third Party manufacturer may be a backup manufacturer or a second manufacturer of Licensed Antibod... |
(a) OSE shall make available, and shall use commercially reasonable efforts to cause its 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: (i) all Manufacturing-related Know-How, Information, and mater... |
(b) OSE shall cause all appropriate employees and representatives of OSE and its Affiliates to meet with, 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 design... |
(c) Without limiting the generality of Section 3.4.1(b), OSE shall cause all appropriate analytical and quality control laboratory employees and representatives of OSE and its Affiliates to meet with, and shall use commercially reasonable efforts to cause all appropriate analytical and quality control employees and rep... |
(d) OSE shall take such steps, and OSE shall use commercially reasonable efforts to cause its Third Party manufacturers to take such steps, as are reasonably necessary or useful to assist in reasonable respects AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) in obtaining any necessary li... |
(e) OSE shall provide, 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 designated Third Party manufacture... |
In this Section 3.4.1, wherever OSE is required to use commercially reasonable efforts to cause its Third Party manufacturers to take an action or otherwise assist, such obligation shall include using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under ... |
3.5 Records. |
3.5.1 OSE shall and shall ensure that its Third Party Providers, if applicable, maintain records in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, and in compliance with Applicable Law, which shall be complete and accurate and shall properly reflect all work done and res... |
3.5.2 AbbVie shall have the right, during normal business hours and upon reasonable notice, to inspect and copy all records of OSE or its Third Party Provider maintained pursuant to Section 3.5. AbbVie shall maintain such records and the information disclosed therein in confidence in accordance with Article 9. |
3.6 Regulatory Matters. |
3.6.1 Regulatory Activities. |
(a) AbbVie shall have the sole right to prepare, obtain, and maintain the IND and 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 Regulatory Authorities, for Licensed Antibodies o... |
(b) All Regulatory Documentation (including all IND, Regulatory Approvals and Product Labeling) relating to the Licensed Antibodies or Licensed Products with respect to the Territory shall be owned by, and shall be the sole property and held in the name of, AbbVie or its designated Affiliate, Sublicensee or designee. O... |
3.7 AbbVie Diligence Obligations. |
3.7.1 AbbVie shall use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval for a Licensed Product for any Indication in the United States and three countries in the European Major Market; provided that such obligation is expressly conditioned upon continuing absence of any adverse condition as det... |
3.7.2 Progress Reporting. At least sixty (60) days prior to the start of each Calendar Year until receipt of the first two Regulatory Approvals for which milestone payments are due pursuant to Section 6.3, AbbVie shall provide to OSE a written summary of ongoing and planned material Development activities for any Licen... |
ARTICLE 4 COMMERCIALIZATION |
4.1 In General. AbbVie (itself or through its Affiliates or Sublicensees) shall have the sole right to Commercialize Licensed Antibodies and Licensed Products in the Field in the Territory at its own cost and expense (except as otherwise expressly set forth herein). |
4.2 Statements and Compliance with Applicable Law. AbbVie shall, and shall cause its Affiliates to, comply in all material respects with all Applicable Law with respect to the Commercialization of Licensed Products. |
4.3 Booking of Sales; Distribution. AbbVie (or its designee(s)) shall have the sole right to invoice and book sales, establish all terms of sale (including pricing and discounts) and warehousing, and distribute the Licensed Products in the Territory and to perform or cause to be performed all related services. AbbVie s... |
ARTICLE 5 GRANT OF RIGHTS |
5.1 Grants to AbbVie. OSE (on behalf of itself and its Affiliates) hereby grants to AbbVie an exclusive (including with regard to OSE and its Affiliates) license, with the right to grant sublicenses through multiple tiers of sublicensees to its Affiliates and other Persons (subject to Section 5.2), under the Licensed I... |
5.2 Sublicenses. AbbVie shall have the right to grant sublicenses through multiple tiers of sublicensees, under the license granted to AbbVie in Section 5.1, to its Affiliates and other Persons, provided that any sublicenses shall be consistent with the terms and conditions of this Agreement. Promptly after execution o... |
5.3 Distributorships. AbbVie shall have the right, in its sole discretion, to appoint its Affiliates, and AbbVie and its Affiliates shall have the right, in their sole discretion, to appoint any other Persons, in the Territory or in any country or other jurisdiction of the Territory, to distribute, market, and sell the... |
5.4 No Other Rights. Except as otherwise expressly provided in this Agreement, under no circumstances shall a Party or Third Party, as a result of this Agreement, obtain any ownership interest, license right or other right in any Know-How, Patent rights or other intellectual property rights of the other Party or any of... |
5.5 OSE Proposed Future In-License Agreements. During the Term, neither OSE nor any of its Affiliates shall, without AbbVie's prior written consent, enter into any agreement with a Third Party related to OSE Patents, OSE Know-How (which includes Regulatory Documentation, if any) or other intellectual property rights di... |
ARTICLE 6 PAYMENTS AND RECORDS |
6.1 Upfront Payment. No later than fifteen (15) days following the Effective Date, AbbVie shall pay OSE an upfront amount equal to Forty-Eight Million Dollars (US $48,000,000). Such payment shall be non-creditable against any other payments due hereunder. |
6.2 Development Milestones. In partial consideration of the rights granted by OSE to AbbVie hereunder and subject to the terms and conditions set forth in this Agreement (including Section 6.5.3 and Section 12.10.1), AbbVie shall, within ten (10) Business Days after the occurrence of a Development Milestone, notify OSE... |
Milestone Event |
1. First IND filing in the United States |
2. Third patient dosed in the first Phase 2 Study that is designed to seek approval in the United States |
3. First patient dosed in the first Phase 3 Study that is designed to seek approval for the first Indication in the United States |
4. First patient dosed in the first Phase 3 Study that is designed to seek approval for a second Indication in the United States |
Each milestone payment in this Section 6.2 shall be payable only upon the first achievement of such milestone and no amounts shall be due for subsequent or repeated achievements of such milestone, whether for the same or a different Licensed Antibody or Licensed Product. The maximum aggregate amount payable by AbbVie p... |
6.3 Regulatory Milestones. In partial consideration of the rights granted by OSE to AbbVie hereunder and subject to the terms and conditions set forth in this Agreement (including Section 6.5.3 and Section 12.10.1), AbbVie shall pay to OSE a milestone payment within sixty (60) days after the achievement of each of the ... |
Milestone Event |
1. Regulatory Approval granted by the FDA (i.e., BLA approval) of a first Indication |
2. Regulatory Approval granted by the EMA of a first Indication such that AbbVie is able to launch in at least three European Major Markets |
3. Regulatory Approval granted by the FDA (i.e., BLA approval or supplemental BLA) of a second Indication |
4. Regulatory Approval granted by the EMA of a second Indication such that AbbVie is able to launch in at least three European Major Markets |
Each milestone payment in this Section 6.3 shall be payable only upon the first achievement of such milestone and no amounts shall be due for subsequent or repeated achievements of such milestone, whether for the same or a different Licensed Antibody or Licensed Product. The maximum aggregate amount payable by AbbVie p... |
6.4 Sales-Based Milestones. In partial consideration of the license rights granted by OSE to AbbVie hereunder, subject to Section 6.4.1, Section 6.5.3 and Section 12.10.1, in the event that the aggregate Net Sales by the first Licensed Product made by AbbVie or any of its Affiliates or Sublicensees in a given Calendar ... |
Annual Net Sales Milestone Threshold |
1. Greater than One Billion Dollars (US$1,000,000,000) |
2. Greater than Two Billion Dollars (US$2,000,000,000) |
3. Greater than Three Billion Dollars (US$3,000,000,000) |
4. Greater than Five Billion Dollars (US$5,000,000,000) |
6.4.1 Notwithstanding anything contained in Section 6.4, each milestone payment in this Section 6.4 shall be payable only upon the first achievement of such milestone in a Calendar Year, and no amounts shall be due for subsequent or repeated achievements of such milestone in subsequent Calendar Years. The maximum aggre... |
6.4.2 With respect to each Licensed Product in each country or other jurisdiction in the Territory, from and after the expiration of the Royalty Term for such Licensed Product in such country or other jurisdiction, Net Sales of such Licensed Product in such country or other jurisdiction shall be excluded for purposes o... |
6.5 Royalties. |
6.5.1 Royalty Rates. As further consideration for the rights granted to AbbVie hereunder, subject to Section 6.5.3, Section 6.6 and Section 6.7, commencing upon the First Commercial Sale of a Licensed Product in the Territory, on a Licensed Product-by-Licensed Product basis, AbbVie shall pay to OSE a tiered royalty on ... |
Annual Net Sales of Licensed Product |
For that portion of annual Net Sales less than One Billion Dollars (US$1,000,000,000) |
For that portion of annual Net Sales greater than or equal to One Billion Dollars (US$1,000,000,000) but less than Two Billion Dollars (US$2,000,000,000) |
For that portion of annual Net Sales greater than or equal to Two Billion Dollars (US$2,000,000,000) but less than Three Billion Dollars (US$3,000,000,000) |
For that portion of annual Net Sales greater than or equal to Three Billion Dollars (US$3,000,000,000) |
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