Non-GMP Process Development Clause Samples
Non-GMP Process Development. Subject to (a) KKC obtaining any necessary consents as set forth in Section 2.9, (b) Lonza agreeing to perform the activities contemplated by this Section 2.6 on behalf of Aevi or the Lonza Technology being sublicensed to another contract manufacturer such that such contract manufacturer can perform the activities contemplated by this Section 2.6 on behalf of Aevi, and (c) the successful requalification of the Existing Clinical Material (as set forth in Section 2.2), Aevi will use commercially reasonable efforts to conduct or have conducted the non-GMP process development for the purpose of demonstrating that Aevi can manufacture Licensed Products that are biologically equivalent to the Existing Clinical Materials. As soon as reasonably practicable following the CDOA Effective Date, Aevi will provide to KKC a plan to effect the foregoing, which will include the identity of any person other than a Party or any of its Affiliates (each, a “Third Party”) that Aevi proposes to use in the conduct of such non-GMP process development.
Non-GMP Process Development. Subject to (a) KHK obtaining any necessary consents as set forth in Section 2.7, (b) Lonza agreeing to perform the activities contemplated by this Section 2.4 on behalf of Medgenics or the Lonza Technology being sublicensed to another contract manufacturer such that such contract manufacturer can perform the activities contemplated by this Section 2.4 on behalf of Medgenics, and (c) the successful requalification of the Existing Clinical Material (as set forth in Section 2.2), Medgenics will use commercially reasonable efforts to conduct or have conducted the non-GMP process development for the purpose of demonstrating that Medgenics can manufacture Licensed Products that are biologically equivalent to the Existing Clinical Materials. As soon as reasonably practicable following the CDOA Effective Date, Medgenics will provide to KHK a plan to effect the foregoing, which will include the identity of any person other than a Party or any of its Affiliates (each, a “Third Party”) that Medgenics proposes to use in the conduct of such non-GMP process development. ***** Confidential Information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to this omitted information.