Development Transition Plan Clause Samples
Development Transition Plan. Promptly following the Merck Participation Election Date for a given Program, Moderna will prepare and provide to Merck a draft plan for the transition of any Development activities then being conducted by or on behalf of Moderna or its Affiliates from Moderna to Merck for such Program (including with respect to the PCV Program, Clinical Studies for Collaboration PCV Products) (a “Development Transition Plan”), which Development Transition Plan will be reviewed by the JDC and subject to the approval of the JSC. If and to the extent applicable, the Development Transition Plan will require Moderna to perform the following activities (provided that, for clarity, the Development Transition Plan shall not include any obligations for Moderna to provide to Merck any information or materials previously provided to Merck or to re-perform any activities that have already been transitioned to Merck), on the timeline set forth in the Development Transition Plan:
(i) transfer and assign to Merck or its designee [***];
(ii) transfer to Merck [***];
(iii) deliver to Merck copies of all [***];
(iv) (A) with respect to the PCV Program, to the extent it is determined pursuant to [***] that [***] should be [***], at Merck’s request, reasonably assist Merck in [***] and (B) with respect to each Joint SAV Program, to the extent it is determined pursuant to [***] that [***] should be [***], at Merck’s request, reasonably assist Merck in [***]; and
(v) deliver to Merck, in an electronic format (the form of which shall be agreed upon by the Parties), [***]. Each Party will use Commercially Reasonable Efforts to perform the obligations assigned to it under the Development Transition Plan in accordance with the timelines set forth therein. All costs and expenses incurred by or on behalf of the Parties (or their Affiliates) in connection with the conduct of the Development Transition Plan shall be considered Allowable Development Costs.
Development Transition Plan. During the period from the Restated Effective Date until the completion of the transfer of Development activities from ARIAD to MERCK, ARIAD and MERCK shall each exercise Commercially Reasonable Efforts to expeditiously perform all activities set forth in the Development Transition Plan attached hereto as Schedule 4 within [***] ([***]) days after the Restated Effective Date. The Development Transition Plan may not be modified or amended without the written agreement of representatives of both Parties with responsibility for implementation of the Development Transition Plan, or the relevant portion thereof. Without limitation of the foregoing, ARIAD shall (A) as soon as reasonably practical following the Restated Effective Date or as otherwise set forth in the Development Transition Plan, transfer to MERCK all of its right, title and interest in all Regulatory Filings, Drug Approval Applications, Regulatory Approvals and DMFs then in its name applicable to Products in the Territory, if any; and all data bases and Confidential Information Controlled by ARIAD relating to such Regulatory Filings, Drug Approval Applications, Regulatory Approvals and DMFs; (B) as soon as reasonably practical following the Restated Effective Date or as otherwise set forth in the Development Transition Plan, notify the applicable Regulatory Authorities in the Territory and take any other action reasonably necessary to effect such transfer; (C) as soon as reasonably practical following the Restated Effective Date or as otherwise set forth in the Development Transition Plan, provide MERCK with copies of all correspondence between ARIAD and such Regulatory Authorities relating to such Regulatory Filings, Drug Approval Applications, Regulatory Approvals and DMFs; (D) unless expressly prohibited by any Regulatory Authority, as soon as reasonably practical following the Restated Effective Date or as otherwise set forth in the Development Transition Plan transfer control to MERCK of all Clinical Trials of such Product being conducted by or on behalf of ARIAD as of the Restated Effective Date and continue to conduct such trials, at MERCK’s sole discretion and expense to enable such transfer to be completed without interruption of any such trial; (E) as soon as reasonably practical following the Restated Effective Date, or as otherwise set forth in the Development Transition Plan, and subject to the remaining provisions of this Section 3.3.1, assign (or cause its Affiliates to assign) to ...