Clinical and Commercial Manufacturing. (a) Development Supply for Phase I Clinical Trials. Licensor will be solely responsible for supplying Collaboration Compounds and/or finished Products necessary for the conduct of the Initial Phase I Clinical Trials conducted by Licensor.
Clinical and Commercial Manufacturing. Subject to the terms and conditions of this Agreement, Merck shall have the right and obligation subject to Commercially Reasonable Efforts to manufacture any Compound and Licensed Product itself or through one or more Sublicensees or other Third Parties selected by Merck. Such right shall be exclusive with respect to Commercial Supply and with respect to Clinical Supply, except that Licensor shall be allowed to continue to procure stability and validation batches and Clinical Supply for the Clinical Trials and the NDA within the Sarcoma Program including active pharmaceutical ingredient and drug product, and other Clinical Trials for which Threshold is responsible, under the existing agreement with [* * *] or through agreement with other suppliers of drug product (and shall have the right to have such Clinical Supply made by Syngene, Inc. or such other drug product suppliers) to the extent set forth herein. Licensor may conclude additional agreements with [* * *] or suppliers of drug product only with respect to Licensor’s requirements of stability and validation batches and Clinical Supply as provided in the foregoing, as long as such agreements (or work orders) are for quantities and under commercial terms consistent with those currently contemplated by Licensor (as described on Schedule 8.1), but Licensor shall not make any other commitments with respect to the purchase of Clinical Supply or Commercial Supply, provided that Licensor shall not make any further commitment to any such suppliers before suitably qualified personnel of each Party have had the opportunity to discuss in good faith the manufacturing approach taken by Threshold for the Sarcoma Program; if so requested by Merck, Licensor shall reasonably and in good faith consider to procure stability and validation batches and Clinical Supply for the Clinical Trials and the NDA within the Sarcoma Program including active pharmaceutical ingredient and drug product from alternative vendors or other than as described on Schedule 8.1, or amend or revise the data packages to be supplied by such vendors to suit Merck’s needs for global Clinical Supply or global Commercial Supply, provided such changes or discussions do not delay the Sarcoma Program. Starting from the Effective Date, for a period of [* * *], Licensor shall use Commercially Reasonable Efforts to make its employees and/or consultants or agents that are knowledgeable on the manufacture of the Compound and any Licensed Products available t...
Clinical and Commercial Manufacturing. Viking shall have the exclusive right to manufacture or have manufactured any Licensed Product itself or through one or more Sublicensees selected by Viking.
Clinical and Commercial Manufacturing. Company shall have the exclusive right to manufacture Licensed Product itself or through one or more Affiliates or Sublicensees or other Third Parties selected by Company.
Clinical and Commercial Manufacturing. Merck shall have the exclusive right to manufacture the Target Compound and Product itself or through one or more Affiliates or Sublicensees or other Third Parties selected by Merck.
Clinical and Commercial Manufacturing. Dermelix will have the exclusive right to manufacture Licensed Products itself or through one or more Affiliates or Sublicensees selected by Dermelix, in its sole discretion. Dermelix will bear all costs and expenses associated with manufacturing of Licensed Products.
Clinical and Commercial Manufacturing. Recursion shall have sole right and decision-making authority for all manufacturing and labeling of the Compound and/or Product(s), including clinical and commercial manufacturing and labeling. Recursion has the right to manufacture the Compound and Products itself or through one or more Sublicensees or subcontractors selected by Recursion in accordance with this Agreement. Recursion shall be solely responsible for all costs and expenses associated with such activities.
Clinical and Commercial Manufacturing. Ares shall have the exclusive right to manufacture the Subject mAb² and Licensed Product itself or through one or more Affiliates or Sublicensees or other Third Parties selected by Xxxx.
Clinical and Commercial Manufacturing. After the Closing Date, OnCore (or its Affiliates, Sublicensees or other Third Parties designated by OnCore) shall have the exclusive right to manufacture the Licensed Compounds and Licensed Products for use in the Field. After the Closing Date, Licensor shall make Representatives that are knowledgeable regarding the Licensor Technology, the Licensed Compounds or Licensed Products available to OnCore for scientific and technical explanations, advice and on-site support, that may reasonably be required by OnCore, relating to the manufacture of a Licensed Compound and Licensed Product (the “Manufacturing Support”), including manufacturing scale-up. All such Manufacturing Support shall be at OnCore’s expense and at industry standard rates.
Clinical and Commercial Manufacturing. After the Effective Date, Checkmate (or its Affiliates, Sublicensees or other Third Parties designated by Checkmate) shall have the exclusive right to manufacture the Licensed Compounds and Licensed Products for use in the Field. After the Effective Date, Licensor shall make Representatives that are knowledgeable regarding the Licensor Technology, the Licensed Compounds or Licensed Products available to Checkmate for scientific and technical explanations, advice and on-site support, that may reasonably be required by Checkmate, relating to the manufacture of a Licensed Compound and Licensed Product (the “Manufacturing Support”), including manufacturing scale-up. All such Manufacturing Support shall be at Checkmate’s expense and at industry standard rates.
