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) and Clause 5.7, the JDC may amend in writing the Co-Development Plan for each Party’s Initial Candidate and Joint Selected Candidate from time to time and will regularly update the Parties’ Co-Development Plans as each phase of the plan progresses. It is envisioned that after […***…]. Exhibit 6 outlines the anticipated responsibilities of each Party for any Co-Development Plan but may be amended for any particular Co-Development Plan. 5.1.5 The JDC shall also agree upon the criteria for any Initial Candidate to proceed through each Co-Development Phase and in particular the criteria for designation of an Initial Candidate as a Joint Selected Candidate for progression into preclinical development and onwards into Clinical Trials. Initial criteria are set out in Exhibit 7 and these will be amended and reviewed by the JDC as appropriate. Only one Joint Selected Candidate shall proceed to pre-clinical development for any Co-Development Plan at any one time, and an alternative Candidate will only be selected for pre-clinical development where such initial Joint Selected Candidate fails to achieve the agreed criteria for completion of pre-clinical development (such alternative Candidate will be deemed the Joint Selected Candidate upon replacement of the original Joint Selected Candidate). […***…].
Appears in 1 contract
Sources: Co Development and Co Commercialisation Agreement (Bellicum Pharmaceuticals, Inc)
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) and Clause 5.7, the JDC may amend in writing the Co-Development Plan for each Party’s Initial Candidate and Joint Selected Candidate from time to time and will regularly update the Parties’ Co-Development Plans as each phase of the plan progresses. It is envisioned that after […***…]* . Exhibit 6 outlines the anticipated responsibilities of each Party for any Co-Development Plan but may be amended for any particular Co-Development Plan.
5.1.5 The JDC shall also agree upon the criteria for any Initial Candidate to proceed *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. through each Co-Development Phase and in particular the criteria for designation of an Initial Candidate as a Joint Selected Candidate for progression into preclinical development and onwards into Clinical Trials. Initial criteria are set out in Exhibit 7 and these will be amended and reviewed by the JDC as appropriate. Only one Joint Selected Candidate shall proceed to pre-clinical development for any Co-Development Plan at any one time, and an alternative Candidate will only be selected for pre-clinical development where such initial Joint Selected Candidate fails to achieve the agreed criteria for completion of pre-clinical development (such alternative Candidate will be deemed the Joint Selected Candidate upon replacement of the original Joint Selected Candidate). […***…]* .
Appears in 1 contract
Sources: Co Development and Co Commercialisation Agreement (Adaptimmune Therapeutics PLC)