Co-Development Plan Clause Samples
POPULAR SAMPLE Copied 1 times
Co-Development Plan. The Parties accept that each Co-Development Plan will change and develop as the applicable Joint Selected Candidate progresses through development, Clinical Trials and to Regulatory Approval. The JDC shall be responsible for reviewing and amending each Co-Development Plan as necessary, however it is understood that Lilly will be responsible for preparation of any amendments (including such amendments as may result from proposals initially made by Immunocore either directly to Lilly or through the JDC). Lilly will update each Co-Development Plan (including the budget set out therein) in accordance with Lilly’s standard internal budgeting procedures, but in any event to cover the anticipated costs of the next phase of Clinical Trials. Such budget will be discussed at the JDC and approved at the JDC. Both Parties will use Commercially Reasonable Efforts to progress the Co-Development Plan and to develop at least one Joint Selected Candidate in each Co-Development Plan through Clinical Trials and through to commercialization. On a Co-Development Plan by Co-Development Plan basis, at any point during the Co-Development Term, Lilly may decide in its discretion to add a new Indication to the Co-Development Plan. Prior to such introduction, Lilly will discuss with Immunocore addition of such new Indication and associated changes to the Co-Development Plan and this Agreement, if any (it being understood by the Parties that neither Party has an obligation to amend this Agreement).
Co-Development Plan. 3.1 The parties to this Agreement hereby agree to cooperate in the development and commercialization of PB. BTP will be responsible for conducting all clinical trials and the filing and prosecution of all applications with applicable USA and Canadian regulatory authorities, and all regulatory filings in the USA and Canada will be in the name of BTP. BOP will be responsible for conducting all clinical trials and the filing and prosecution of all applications with applicable regulatory authorities other than in the USA and Canada and all such filings shall be in the name of BOP.
3.2 The parties will promptly share all information generated under this co-development program pursuant to confidentiality including, without limitation, all information with respect to market analysis, competitor position, pre-clinical and clinical trials, the filing of any applications with the US Food and Drug Administration or similar Canadian authority and the manufacture and testing of different formulations and preparations of PB or any product incorporating the PB Technology.
3.3 BTP shall pay all costs and expenses of any work deemed necessary for the development of PB in the USA and Canada. BOP shall pay all costs and expenses of any work deemed necessary for the development of PB in any other countries within the Territory (other than USA or Canada).
Co-Development Plan. The initial Co-Development Plan shall be approved by the Steering Committee within sixty (60) days after the Effective Date and shall be attached hereto as Exhibit B. The Co-Development Plan shall describe the comprehensive worldwide development plan and budget for the Co-Development Product in the Field, including, without limitation, the overall plan for clinical trials, regulatory approvals and commercialization activities, and shall be consistent with Clause 2.2 below. As part of the budget, the Steering Committee shall agree on an annual budget for development and Marketing of the Co-Development Product in the CAT Territory and Dyax Territory, and, neither CAT nor Dyax shall expend Co-Development Costs for development and Marketing in excess of one hundred and ten percent (110%) of the amount budgeted, without the prior written approval of the Steering Committee.
Co-Development Plan. 5.1.1 Within […***…] after the Acceptance Date (or such longer time as mutually agreed by the Parties in writing) with respect to a given Selected Target, the JPT shall draft and agree upon a Co-Development Plan for the generation of Candidates directed to each Party’s Selected Target, which plan is intended to generate the data necessary to support an IND filing for such Party’s Joint Selected Candidate. No activities will be performed in connection with a proposed Co-Development Plan (and accordingly, no costs will be incurred under Clause 10.2) before the applicable JPT has agreed upon such Co-Development Plan. Each of the two Co-Development Plans shall:
(a) be prepared on a global basis;
(b) include the responsibilities of each of the Parties under the Co-Development Plan including as relates to any manufacture of Therapy for Clinical Trials;
(c) include a high level plan setting out an anticipated route (including Phase III Clinical Trials and other required trials) to obtain Regulatory Approval for such Therapy including estimated timelines and estimated budget; and
(d) include the basis for calculation of any budgeted costs, including relevant FTE and FTE Rate information to be applied to such budget (which FTE Rate(s) shall be used to calculate any Development Costs reimbursable in accordance with Clause 10).
5.1.2 Under each Co-Development Plan, each Party shall use Commercially Reasonable Efforts to perform any part of the Co-Development Plan assigned to it, including making resources available as and when required and supplying any product, equipment or materials as and when required and specified under the Co-Development Plan. The Parties may supplement the terms of this Agreement, as necessary, with terms relating to manufacture and supply, quality and/or any other terms deemed necessary or reasonably useful by a Party to govern the Parties’ co-development of such Party’s respective Candidate. The Parties will negotiate any such supplemental terms in good faith and on a timely basis to prevent any unreasonable delay to activities performed under the Co-Development Plan.
5.1.3 Under each Co-Development Plan, Adaptimmune shall use Commercially Reasonable Efforts to develop and validate starting TCRs (“Initial Candidates”) directed to each Party’s Selected Target within the timescales agreed for the relevant Co-Development Plan. […***…].
5.1.4 Subject to Clause 2.3.2(b), Clause 2.3.3 (which references the limitations set forth in Clause 2.2.4) an...
Co-Development Plan. All references to the “Development Plan” and “Development Plan Budget” in the Agreement, unmodified by this Exhibit A, shall apply solely with respect to the Jazz Territory. In addition, except with respect to the definitions of “Development Plan” and