Common use of Performance of Development Plan Clause in Contracts

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 Lxxxx 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 Lxxxx 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 Lxxxx’x prior written approval, which shall not be unreasonably withheld, provided that (i) Lxxxx may waive such requirement of Lxxxx’x 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 Lxxxx does not approve or reject a proposed submission within [**] of Telix’s written request therefor, Lxxxx shall be deemed to have waived the requirement of Lxxxx’x 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).

Appears in 4 contracts

Samples: License Agreement (Telix Pharmaceuticals LTD), License Agreement (Telix Pharmaceuticals LTD), License Agreement (Telix Pharmaceuticals LTD)

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