Early Development Plan Clause Samples
Early Development Plan. Each Early Development Program will be carried out by Regulus pursuant to an Early Development Plan, subject to JSC approval and/or amendment as set forth in Section 2.1.6. The Early Development Plan shall be updated by Regulus as needed, but at least once Annually and submitted to the JSC for its review and comment and may be further amended, at any time and from time to time, by Regulus, to reflect material events or changes under the current Early Development Plan, subject to JSC approval and GSK final decision-making authority on the PoC Criteria and the PoC Trial design. It is expected that the level of detail required for activities with respect to each Development Candidate will vary depending on the state of progression of Regulus’ efforts with regard to such Development Candidate.
Early Development Plan. The EDP includes the following budget and timeline as well as the performance of the studies as outlined in the attached protocols. [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. [*] [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Transfer from Principia to Sanofi of Principia Know-How existing as of Signing Date or thereafter (but prior to the completion of the transfer), including the contents of the data room provided to Sanofi during due diligence, information shared with Sanofi on-site and the following: [*] [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Early Development Plan. 3.2.1 On a Collaboration Target-by-Collaboration Target basis, during the Research Term, Kymera will conduct its Development activities under Section 3.1 for the Collaboration Candidates and Licensed Products Directed Against each Collaboration Target in the Field in accordance with a written plan (the “Early Development Plan”) that includes [***]. A copy of the current Early Development Plan as of the Restatement Execution Date is attached hereto as Schedule 3.2.1. Any amendments to the Early Development Plan will be subject to Section 3.2.2 and Section 9.2.2(b). In the event of any inconsistency between the Early Development Plan and this Agreement, the terms of this Agreement will prevail.
3.2.2 Kymera may propose amendments to the Early Development Plan at any time to reflect any material developments or adjustments to the applicable Development activities, provided that (a) any such amended Early Development Plan will at all times meet the requirements set forth in Section 3.2.1, and (b) in no event will Sanofi conduct any activities under the Early Development Plan except as provided in Section 3.1, Section 3.2.3, Section 3.4 or as otherwise mutually agreed by the Parties. Kymera will promptly provide any such proposed amendment to the Early Development Plan to the JRDC for review and discussion. No update or material amendment to the Early Development Plan will be effective unless and until approved by the JRDC in accordance with Section 9.2.2(b).
3.2.3 Sanofi may propose amendments to the Early Development Plan at any time to include [***] to be conducted by or on behalf of Sanofi [***]. Sanofi will promptly provide any such proposed amendment to the Early Development Plan to the JRDC for review and discussion. No update or material amendment to the Early Development Plan will be effective unless and until approved by the JRDC in accordance with Section 9.2.2(b); provided that, Sanofi shall have final decision-making authority in the event that such [***].
Early Development Plan. 3.2.1 On a Collaboration Target-by-Collaboration Target basis, during the Research Term, Kymera will conduct its Development activities under Section 3.1 for the Collaboration Candidates and Licensed Products Directed Against each Collaboration Target in the Field in accordance with a written plan (the “Early Development Plan”) that includes [***]. A copy of the initial Early Development Plan is attached hereto as Schedule 3.2.1. Any amendments to the Early Development Plan will be subject to Section 3.2.2 and Section 9.2.2
Early Development Plan. Notwithstanding the foregoing, the Early Development Plan in this Appendix 3, including without limitation details of the task and timeline, will be changeable without both Party’s signature if PLs of both Parties agree on the changes. Any delay in meeting the timeline set forth in this Appendix 3 shall not be construed as a breach of the Agreement if the delaying Party made commercially reasonable efforts with prior notice to the other Parity.