Commercial Supplies means supplies of Licensed Product in final packaged form Manufactured by or on behalf of Celgene in compliance with GMP and meeting 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 offered for commercial sale by Acceleron or Commercialized by Celgene, or their respective Affiliates or Sublicensees, for use in the Field in the Territory.
Commercial Supplies means supplies of Licensed Product in final packaged form Manufactured by or on behalf of Celgene in compliance with GMP and meeting 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 offered for commercial sale by Acceleron or Commercialized by Celgene, or their respective Affiliates or Sublicensees, for use in the Field in the Territory.
Commercial Supplies means supplies of Collaboration Product or Royalty Product, as the case may be, in suitable final packaged form, as specified under a Commercial Supply Agreement, Manufactured in compliance with GMP, and ready to be offered for commercial sale for use in the Field in the Territory by Biogen Idec and/or PDL, and/or their Affiliates, or permitted licensees or sublicensees.
Examples of Commercial Supplies in a sentence
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.
All Clinical Supplies and Commercial Supplies will be Manufactured in accordance with GLP and GMP, as applicable, and Applicable Law.
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.
This Contract is for Industrial and Commercial Supplies and Equipment as specified herein.
The purpose of this Contract is to provide Authorized Users with a means of acquiring Industrial and Commercial Supplies and Equipment which are purchased repetitively or on an emergency basis.
More Definitions of Commercial Supplies
Commercial Supplies means supplies of Licensed Product in final packaged form Manufactured by or on behalf of Genocea in compliance with GMP and meeting FDA Guidance for Biologies 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 offered for commercial sale or Commercialized by Genocea and/or its Affiliates or Sublicensees, for use in the Field in the Territory.
Commercial Supplies means the supply of the Product in bulk formulation (either packaged or pre-packaged) made to DSP by Intercept pursuant to Section 6.2 of this Agreement and the Commercial Supply Agreement.
Commercial Supplies means supplies of the Covered Products in suitable final package form, as specified under the separate Commercial Supply Agreement (as defined in Schedule 3) between the Parties, manufactured in compliance with GMP.
Commercial Supplies or “Commercial Supply” means supplies of a Licensed Product for commercial sale or as promotional samples or evaluation product, or for use in Post-Marketing Clinical Trials.
Commercial Supplies has the meaning set forth in Section 3.8.2(b).
Commercial Supplies means the supplies of the Licensed Product by PUMA to STA for the purposes of being sold by STA within the Territory, manufactured in compliance with current cGMPs, in suitable form and ready to be offered for sale in the Territory, or any other supply of the Licensed Product not being a Clinical Supply.
Commercial Supplies means supplies of a Product (i) for the Commercialization of Product in the Field by TenX or its permitted sublicensees, or (ii) for compassionate use or use in investigator-sponsored Clinical Studies.