Implementation; Strain Selection Clause Samples

Implementation; Strain Selection. (a) Within [**] of the completion of the activities under a given TDP, Customer will have the right to select up to (but not more than) [**] Candidate Strains under such TDP (the “Selected Strains”) by providing written notice to Ginkgo of the identity of such selected Candidate Strains, each of which Selected Strains will then be available to Customer for future designation as the Collaboration Strain for such TDP in accordance with the remainder of this Section 2.3. Completion of the activities under a given TDP will be deemed to have occurred upon the achievement of certain mutually-agreed criteria set forth in such TDP or as otherwise agreed by the Parties in writing; provided, that, in any event, completion of the activities under a given TDP shall be deemed to have occurred upon the designation by Customer, its Affiliates or Sublicensees of the Collaboration Strain under such TDP and in no event later than the filing of the first IND by Customer, its Affiliates or Sublicensees for a Candidate Strain arising and selected under such TDP. During its conduct of a Program arising from a given TDP, Customer may designate the Collaboration Strain for such Program as follows: (i) At any time during its conduct of such Program, Customer will designate one (1) lead strain from the Selected Strains for such Program as the Collaboration Strain by providing written notice to Ginkgo of such designation, with the remaining Selected Strains considered back-up strains (the “Back-Up Strains”). During its conduct of such Program, Customer will have the right to substitute a Back-Up Strain for the Collaboration Strain for such Program by delivering written notice to Ginkgo of such substitution, identifying in such written notice the Back-Up Strain being substituted. (ii) Upon receipt by Ginkgo of any such written substitution notice from Customer, the selected Back-Up Strain will be designated the new Collaboration Strain and the previous Collaboration Strain will be considered a Back-Up Strain. (iii) For clarity, each Program will have only one Collaboration Strain to be Commercialized by, as applicable, Customer, its Affiliates or Sublicensees. To the extent Customer or any of its Affiliates or Sublicensees desires to advance a Back-Up Strain for a given Program following the approval of a BLA for the Collaboration Strain for such Program, the designation of such Back-Up Strain as a Collaboration Strain must be pursuant to a separate Program arising from a new TDP ini...