Relay Pipeline Combination definition
Examples of Relay Pipeline Combination in a sentence
In accordance with Sections 5.6.1, the Parties will establish a JPT with respect to Relay Pipeline Combinations at least [***] prior to the date of the anticipated submission of the first NDA for a Relay Pipeline Combination.
Licensee will provide Relay with copies of Regulatory Materials related to any Relay Pipeline Combination Eligible Licensed Products that are reasonably requested by Relay for use by or on behalf of Relay, its Affiliates or Relay Sublicensees in connection with Developing, Manufacturing or Commercializing any Relay Pipeline Combination as permitted hereunder.
Except as set forth in Section 7.2.3, in no event will Relay owe Licensee any milestones, royalties or other payments with respect to the retained rights under the Relay IP or license under Licensee IP to Develop and co-promote, in accordance with this Agreement and any applicable Coordinated Promotion Agreement, the Relay Pipeline Combination Eligible Licensed Products for Combination Use in Relay Pipeline Combinations.
If after submission of the Proposed Relay Pipeline Combination Development Plan to the JDT, Relay proposes to make any changes to the Proposed Relay Pipeline Combination Development Plan that could reasonably be expected to materially conflict with or negatively impact Licensee’s Development activities with respect to Licensed Products and Licensed Candidates, Relay will submit such changes to the JDT and this Section 3.7.2 will apply to such proposed changes (mutatis mutandis).
Relay will be responsible for [***] for each Relay Pipeline Combination except that Licensee will provide the Relay Pipeline Combination Eligible Licensed Product therefor to Relay [***], Licensee will [***] for such Relay Pipeline Combinations in accordance with either (a) or (b) below (with such [***] being determined in the same manner as [***] pursuant to Section [***], mutatis mutandis: [***].
The JPT will coordinate the activities of the Parties with respect to the promotion of the Relay Pipeline Combination Eligible Licensed Products that are contained in Relay Pipeline Combinations and will serve as a forum for the coordination of such promotion activities to the extent expressly and as more specifically provided in Section 10.3.2. Each Party agrees to keep the JPT informed of its progress and activities with respect to coordinated promotion of such Relay Pipeline Combinations.
Notwithstanding anything herein to the contrary, the Regulatory Lead responsibilities with respect to Relay and Relay Pipeline Combinations apply only to the Relay Pipeline Products contained in a Relay Pipeline Combinations and the Relay Pipeline Combination taken as a whole but not with respect to the Relay Pipeline Combination Eligible Licensed Product contained therein on its own.
The Parties will establish a joint development team (“JDT”) to oversee the Development of Licensed Candidates and Licensed Products in the Field in the Territory and, a joint promotion team (“JPT”) to oversee the activities of the Parties with respect to the promotion of the Relay Pipeline Combination Eligible Licensed Product included in a Relay Pipeline Combination.
If a Party becomes aware of any actual or potential claim that the Development, Manufacture or Commercialization of any Licensed Candidate or Licensed Product (including any Licensee Combination or Relay Pipeline Combination) under this Agreement infringes the intellectual property rights of any Third Party (a “Third Party Action”), such Party will promptly notify the other Party.
Upon the request of a Party, the Parties will negotiate in good faith and enter into a separate pharmacovigilance agreement at least [***] prior to filing the IND for the first Relay Pipeline Compound in a Relay Pipeline Combination (the “Pharmacovigilance Agreement”), which will govern the exchange of safety data information, adverse events reporting and Licensed Product complaints to ensure timely communication to Regulatory Authorities and compliance with Applicable Law.