Clinical Material Sample Clauses

Clinical Material. (a) The Company possesses or has access through a third party manufacturer on commercially reasonable terms to (i) sufficient quantities of all materials that Company believes are reasonably necessary to manufacture clinical trial materials in quantities sufficient to perform those certain Phase 1/2 clinical trials described in Section 3.29(a) of the Company Disclosure Schedule, and (ii) the capabilities to carry out all associated chemistry, manufacturing, and controls (“CMC”) activities for bulk drug substances. (b) The Company has in its possession, or has access to, all material documentation of the CMC activities undertaken in the development of its products to date.

Clinical Material. Debiopharm represents and warrants that Exhibit D to this Transition Agreement sets forth the approximate quantity and the location of all currently available clinical material in the possession or control of Debiopharm as of the Termination Date, including API starting material, API finished product, bulk finished product and clinical drug product, including the LC14020A Material (collectively, the “CMC Materials”), and, except as designated as non-cGMP at Exhibit D, the CMC Materials were manufactured in accordance with cGMP. As of the Termination Date, Curis shall be the owner of all remaining Product clinical material within lot LC14020A, which is comprised of [**] blister packages that hold a total of [**] tablets (the “LC14020A Material”), and which Curis will have the right to use in clinical studies. Within [**] days after receipt of payment for the LC14020A Material in accordance with paragraph 2.2(a)(i) of this Transition Agreement, Debiopharm shall deliver the LC14020A Material to Curis or its designee at the address specified by Curis in writing. During the Transition Period, Debiopharm and Curis shall determine which of the CMC Materials listed in Exhibit D shall be kept in storage, transferred to Curis or disposed of in accordance with all applicable laws and regulations. Debiopharm will retain the agreed and selected CMC Materials to be kept in storage for a maximum period of [**] months as of the Termination Date for Curis’ future use; for the sake of clarity, Debiopharm will not be responsible for the retesting of such CMC Materials, including currently ongoing stability and other testing programs. Curis will pay Debiopharm for such CMC Materials to be kept in storage at a rate that is equal to its invoiced costs (as converted to United States dollars at the Termination Date). Debiopharm will provide Curis with sufficient documentation to substantiate invoiced cost (i.e., manufacturing contracts and related invoices). During the Transition Period, Debiopharm will provide contact information, including primary contact name, email address and telephone number for vendors listed in Exhibit D.

Clinical Material. (a) The Company has access, on terms that are commercially reasonable, to sufficient quantities of all materials that the Company believes are necessary to manufacture clinical trial materials in quantities sufficient to perform the Phase I Clinical Trial of the IL6 Avimer and to carry out all associated chemistry, manufacturing, and controls (“CMC”) activities, including, but not limited to, process characterization, process validation, specification development, and stability testing, as applicable to the stage of development of the product. (b) The Company has in its possession, or has access to, all documentation of the CMC activities undertaken in the development of the IL6 Avimer.

Clinical Material. (a) The Company has access on commercially reasonable terms to sufficient quantities of all materials that Company believes are necessary to manufacture clinical trial materials in quantities sufficient to perform Pivotal Studies of MKC-1 and to carry out all associated chemistry, manufacturing, and controls (“CMC”) activities, including but not limited to process characterization, process validation, specification development, and stability testing, as applicable to the stage of development of the product. (b) The Company has in its possession, or has access to, all documentation of the CMC activities undertaken in the development of MKC-1 to date.

Clinical Material. Target has access on commercially reasonable terms to sufficient quantities of all clinical trial materials, and/or all materials that Target believes are necessary to manufacture clinical trial materials, in quantities sufficient to perform Phase 3 clinical trials of ceftaroline and to carry out all associated chemistry, manufacturing, and controls activities, including but not limited to process characterization, process validation, specification development, and stability testing, as applicable to the stage of development of the product..