Clinical Supplies definition

Clinical Supplies means supplies of Licensed Compound and Licensed Product Manufactured by or on behalf of Celgene or Acceleron in compliance with GLP and GMP and meeting the FDA Guidance for Biologics License Applications, Product License Applications/Establishment License Applications, New Drug Applications, and supplements and amendments to those applications to Center for Biologics Evaluation and Research (CBER) and EMA guidances, in each case, if required given the intended use, and ready to be used for the conduct of pre-clinical or human clinical trials of such Licensed Product in the Field.

Clinical Supplies means API and finished drug Product for use in a Clinical Study.

Clinical Supplies means supplies of Collaboration Product or Royalty Products, as the case may be, in suitable form, whether Manufactured by PDL or by Biogen Idec, as specified under this Agreement or under any Manufacturing agreement between the Parties, Manufactured in compliance with GMP, if required given the intended use, and ready to be used for the conduct of pre-clinical and/or human clinical trials of such Product in the Field by the Parties pursuant to the Development Plan and Annual Workplan/Budget.

Examples of Clinical Supplies in a sentence

• All Clinical Supplies and Commercial Supplies will be Manufactured in accordance with GLP and GMP, as applicable, and Applicable Law.

• In addition, the Manufacturing process used for Clinical Supplies and Commercial Supplies shall be in accordance with the IND, NDA, or other Regulatory Approval, as applicable, for the Licensed Product or Licensed Compound.

• In the event that the Clinical Supplies or Commercial Supplies are being Manufactured by a Third Party under contract, to the extent permitted by the terms of such contract, Celgene shall assign such contracts to Acceleron.

• Clinical Supplies will be provided by Merck as summarized in Table 7.

• Notwithstanding any other provision of this Agreement, Acceleron shall not be obligated to reimburse or share with Celgene any capital expenditures costs required for Celgene to Manufacture and supply Clinical Supplies for Phase 3 Clinical Trials or Post-Approval Clinical Trials.

More Definitions of Clinical Supplies

Clinical Supplies means supplies of Licensed Compound and Licensed Product Manufactured by or on behalf of Celgene or Acceleron in compliance with GLP and GMP and meeting the FDA Guidance for Biologics License Applications, Product License Applications/Establishment License Applications, New Drug Applications, and supplements and amendments to those applications to Center for Biologics Evaluation and Research (CBER) and EMEA guidances, in each case, if required given the intended use, and ready to be used for the conduct of pre-clinical or human clinical trials of such Licensed Product in the Field.

Clinical Supplies means finished Drug Product for use in Clinical Trials.

Clinical Supplies means API and finished drug Collaboration Product for use in a Clinical Study.

Clinical Supplies means Compound formulated into Product or matching placebos to be used exclusively for conducting clinical studies to gain Regulatory Approval in the Territory.

Clinical Supplies means supplies of Licensed Product, Placebo (where relevant), Comparator (where relevant), combination drug (where relevant) and diluent ready to be used for the conduct of pre-clinical studies and/or Clinical Studies of Licensed Product in the Field pursuant to the Development Plan. For the purposes of the foregoing, “Comparator” shall mean an investigational or marketed drug used as a reference in a Clinical Study.

Clinical Supplies means supplies of Products, manufactured, packaged and labeled in compliance with cGMP, in such form and dosage as is determined by Advancis pursuant to the Development Plan, and suitable for use in the conduct of pre-clinical and/or human clinical trials of the Products in the United States by the Parties pursuant to the Development Plan.

Clinical Supplies means supplies of the Products, Placebo and diluent to be used for the conduct of pre-clinical studies and/or Clinical Studies of a Product in the Field pursuant to a Development Plan.