Performance of Development Plan Sample Clauses
Performance of Development Plan. Telix shall use Commercially Reasonable Efforts to perform the activities set forth in the Development Plan, including but not limited to the POC Study, in accordance with the timelines and other requirements set forth therein, provided that, if Telix (i) has used Commercially Reasonable Efforts to complete the POC Study within the timeline set forth therefor on the Development Plan, (ii) has been unable to complete the POC Study within such timeline despite such efforts, and (iii) provides L▇▇▇▇ written notice of Telix’s need to extend such timeline for the performance of the POC Study at least [**] prior to the Development Plan’s target date for such completion, Telix shall be entitled to extend such date by up to [**] as necessary to provide for such completion. Neither Telix nor any Affiliate thereof shall use any Third Party contractors to perform any portion of the POC Study or use or handle any Transferred Materials except to the extent such Third Party is listed on Exhibit G attached hereto or is approved by L▇▇▇▇ in writing and in advance, which approval will not be unreasonably withheld. Further, notwithstanding anything to the contrary, neither Telix, any Affiliate thereof, any Sublicensee, nor any Third Party acting on behalf of any of the foregoing shall submit any material documentation (e.g., study protocol or investigator’s brochure) related to the POC Study for review or approval by any institutional review board, ethics committee, Governmental Authority, or body similar to any of the foregoing without L▇▇▇▇’▇ prior written approval, which shall not be unreasonably withheld, provided that (i) L▇▇▇▇ may waive such requirement of L▇▇▇▇’▇ approval with respect to any particular proposed submission by written notice to Telix (and, upon such waiver, Telix shall be entitled to make such proposed submission without breach of this sentence) and (ii) if L▇▇▇▇ does not approve or reject a proposed submission within [**] of Telix’s written request therefor, L▇▇▇▇ shall be deemed to have waived the requirement of L▇▇▇▇’▇ approval for such proposed submission (and Telix shall, upon the expiration of such [**] period, be entitled to make such proposed submission without breach of this sentence).
Performance of Development Plan. Each of Licensor and BioLine shall perform its respective obligations under the Development Plan in accordance with the terms thereof and cooperate with the other party in order to satisfy the requirements of the Development Plan. In connection with the foregoing, Licensor shall cooperate with BioLine in uploading all data, information, documents and agreements regarding the Drug and the Contemplated Clinical Trials to BioLine’s data management system. In addition, Licensor shall provide BioLine’s project manager with prompt and regular updates concerning the progress of the Contemplated Clinical Trials, as requested by BioLine, including without limitation all data, documentation and results relating to or produced by such trials. BioLine shall designate a project manager who will work with the Licensor’s team in the performance of the Development Plan. Licensor’s team shall provide prompt and regular updates to BioLine’s project manager regarding the progress of the Development Plan, as reasonably requested. The failure of one of the Contemplated Clinical Trials to hew to the schedule set forth in the Development Plan shall not be deemed a breach of this Agreement so long as the applicable party is making reasonable commercial efforts to perform its obligations thereunder.
Performance of Development Plan. During the term of any Development Plan, the Parties will work together in a mutually beneficial and cooperative fashion in order to meet the objectives of the Development Plan. In connection therewith, each Party agrees to use commercially reasonable efforts to perform its responsibilities and to allocate sufficient resources to complete the Program in accordance with the relevant specifications and development schedule, if any, set forth in such Development Plan. For clarity, the failure of a Party to achieve any scientific or technical result contemplated under the Development Plan, including failure of Genomatica to reach any milestone, shall not be a breach of the foregoing so long as such Party uses commercially reasonable efforts to achieve such result, but Genomatica’s failure to devote the time and efforts of 10 FTEs (as defined and described in Section 6.1 below) to the Program and the Development Plan shall be considered a breach of this Agreement unless otherwise approved in writing by WMOG. To the extent specified in the Development Plan and otherwise permitted under its existing legal and contractual obligations, each Party will use and disclose its Background Technology directly relevant to the Program to the other Party.
Performance of Development Plan. Subject to the terms and conditions of this Agreement, Ipsen hereby grants to Lexicon and its Affiliates a non-exclusive, non-royalty bearing license in the Licensed Territory, without the right to grant sublicenses except as contemplated by the Development Plan or as otherwise authorized in writing by Ipsen, under the Ipsen Technology and Ipsen Patent Rights, including ▇▇▇▇▇’▇ rights to Joint Technology and Joint Patent Rights, for the sole purpose of performing Lexicon’s obligations under this Agreement, including conducting the activities assigned to Lexicon under the Development Plan or Commercialization Plan.
Performance of Development Plan. Each Party shall use Commercially Reasonable Efforts to perform the Development tasks assigned to it under the Development Plan in accordance with the Development Plan, including the timelines and Development
Performance of Development Plan. Athenex shall perform its obligations under the Development Plan according to the time-lines set out in the Development Plan, in a professional manner, and otherwise in compliance in all material respects with the Development Plan and the requirements of applicable Laws and all applicable GCP, GLP, and cGMP. Almirall shall, as reasonably requested by Athenex, provide reasonable assistance and expertise with respect to the Development Plan or performance thereof.
Performance of Development Plan. BDSI shall use Commercially Reasonable Efforts to conduct its tasks pursuant to the Development Plan and to attempt to achieve the objectives of the Development Plan, ***. BDSI shall perform such obligations under the Development Plan in a professional manner, and in compliance in all material respects with the Development Plan and the requirements of applicable laws and regulations and all applicable good clinical and manufacturing practices. Changes in the scope or direction of the development work under this Agreement that would require a material deviation from the Development Plan must be approved by the JDC as set forth in Section 2.3.
Performance of Development Plan. (a) As set forth in greater detail in the applicable Development Plan, MedImmune will develop the Lead Product Process. MedImmune will use the manufacturing process transferred to it by Micromet pursuant to Section 3.1 as the basis for the Lead Product Process. MedImmune will bear all costs and expenses associated with the development of the Lead Product Process.
(b) Micromet will assist MedImmune in the development of each Commercial Process being developed by MedImmune through Micromet’s participation in the JPT and by providing any other assistance reasonably requested by MedImmune. MedImmune will reimburse Micromet for any reasonable and documented out-of-pocket expenses and, based *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. on the FTE Rate, for any FTEs performing Development Activities relating to a Commercial Process, but only to the extent requested by MedImmune. MedImmune will make any such payments to Micromet quarterly in arrears based on an invoice and supporting documentation submitted by Micromet.