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 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.

Examples of Clinical Supplies in a sentence

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

• Number and Amount of 504/CDC Loans, FY2005-FY2019($ amounts in billions) Source: U.S. Small Business Administration, Office of Congressional and Legislative Affairs, “WDS Report Amount and Count Summary, September 30, 2019: DRAFT Table 2.7. Approvals by Program and Cohort,” October 18, 2018; and U.S. Small Business Administration, “SBA Lending Statistics for Major Programs (as of September 30, 2019),” at https://www.sba.gov/sites/default/files/2019-10/WebsiteReport_asof_20190930.pdf.

• 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.

• Clinical Supplies will be provided by Merck as summarized in Table 11.

More Definitions of Clinical Supplies

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 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.

Clinical Supplies means supplies of Licensed Product Manufactured by or on behalf of Genocea in compliance with GLP and GMP and meeting the FDA Guidance for Biologies License Applications (BLA), Product License Applications/Establishment License Applications, New Drug Applications, and supplements and amendments to those applications to Center for Biologies 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. THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

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 Product and, if applicable, placebo, to be used for the conduct of Development in the Territory.

Clinical Supplies means supplies of the Licensed Product, manufactured, packaged and labeled in such form and strength as agreed by the Parties, and ready to be used for the conduct of human clinical trials of the Licensed Product in the Field by the Parties.