Examples of Antibody Product in a sentence
Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use, August 1996.
This Agreement shall terminate in relation to such Antibody Product (as well as all Subsequent Products), but remain in full force and effect with respect to any Antibody Product which has previously been subject to the procedures set out in Article 3.4(a) and which Celltech shall not have previously exercised its opt-out right.
With respect to each Antibody Product receiving Regulatory Approval for Commercialisation, the Manufacturing Lead shall be responsible for [*] Antibody Raw Material for commercial use in the Territory (in quantities as forecast in the Commercialisation Plan and with specifications set forth in the Regulatory Approval of such Antibody Raw Material).
Each Party agrees to conduct its Research activities and Development activities in compliance with all laws, regulations and guidelines that are applicable to the particular stage of Research or Development for the Antibody Product, including, GLP, GCP and GMP, of the relevant jurisdiction as the same may be amended from time to time.
However, Celltech’s opt out right shall apply to any other Antibody Product that Amgen proposes to advance or advances to Late Stage Development, and Articles 3.4(a) and (b) shall apply mutatis mutandis to all such Antibody Products.