Examples of Lead Product in a sentence
With respect to the Lead Product, Dicerna and its Affiliates shall generate, prepare, maintain and retain all Regulatory Documentation that is required to be maintained or retained pursuant to and in accordance with, to the extent applicable, good laboratory and clinical practice and Applicable Law and all such information shall be true, complete and correct in all material respects and what it purports to be.
Dicerna has the right and obligation to perform Lead Product Non-Clinical and Manufacturing Activities through IND Approval and for the initial Phase 1 Clinical Trial, subject to the terms and conditions of this Agreement and the Clinical-Phase Supply Agreement (and related quality agreement).
Dicerna will manufacture the Lead Product under GMP; provided, however, that if Dicerna uses a contract manufacturer or other subcontracted element of the supply chain, Xxxxx will have the right to audit and approve (or reject) such contract manufacturer in advance, provided that such approval shall not be unreasonably withheld, delayed or conditioned.
Under the Clinical-Phase Supply Agreement, Xxxxx shall be responsible for covering the costs for the manufacture of the Products at Dicerna’s fully loaded costs, except that Dicerna shall be responsible to cover the costs for the manufacture of the Lead Product through the initial Phase 1 Clinical Trial.
Except as expressly provided and agreed otherwise in the Research Plan for the Lead Product, Xxxxx shall not be required to conduct any Research or Development efforts for the Lead Product that are included in the Lead Product Non-Clinical or Manufacturing Activities prior to IND Approval, provided that that Xxxxx shall be responsible to prepare and submit the IND filing and seek IND Approval as further described in Section 4.6.