Licensed CMO definition

Licensed CMO has the meaning set forth in Section 4.1.2(a)(ii).

Examples of Licensed CMO in a sentence

  • Deliver, at Roche’s election, to one of either (i) Roche, or (ii) a Licensed CMO solely to Manufacture API on Roche’s behalf, copies of the Isis Manufacturing and Analytical Know-How relating to Products in Isis’ possession not previously provided hereunder, which is necessary for the exercise by Roche, its Affiliates or a Third Party of the Manufacturing rights granted under Section 4.1.1.

  • If Roche provides Isis with a written request that Xxxx xxxxx a license under the Isis Manufacturing and Analytical Patents and Isis Manufacturing and Analytical Know-How to a CMO designated by Roche that is not a Licensed CMO, solely for such CMO to manufacture Products for Roche, its Affiliate or Sublicensee in a manufacturing facility owned or operated by such CMO, [***].

  • Neither Akcea nor Ionis, nor any of their respective Affiliates, will commit any acts or permit the occurrence of any omissions that would cause or result in the termination of any In-License Agreement or any agreement with a Licensed CMO listed on Schedule 5.2(ii) in its entirety or with respect to any rights under such agreement for which such termination would adversely affect Pfizer’s rights or obligations under this Agreement.

  • If Roche provides Isis with a written request that Isis grant a license under the Isis Manufacturing and Analytical Patents and Isis Manufacturing and Analytical Know-How to a CMO designated by Roche that is not a Licensed CMO, solely for such CMO to manufacture Products for Roche, its Affiliate or Sublicensee in a manufacturing facility owned or operated by such CMO, [***].

  • If Roche provides Ionis with a written request that Xxxxx xxxxx a license under the Ionis Manufacturing and Analytical Patents and Ionis Manufacturing and Analytical Know-How to a CMO designated by Roche that is not a Licensed CMO, solely for such CMO to manufacture Products for Roche, its Affiliate or Sublicensee in a manufacturing facility owned or operated by such CMO, [***].

  • Deliver, at Roche’s election, to one of either (i) Roche, or (ii) a Licensed CMO solely to Manufacture API on Roche’s behalf, copies of the Isis Manufacturing and Analytical Know-How relating to Products in Isis’ possession not previously provided hereunder, which is necessary for the exercise by Roche, its Affiliates or a Third Party of the Manufacturing rights granted under S ection 4.1.1.

  • Deliver, at Roche’s election, to one of either (i) Roche or (ii) a Licensed CMO solely to Manufacture API and Finished Drug Product on Roche’s behalf, copies of the Ionis Manufacturing and Analytical Know-How relating to Products in Ionis’ possession not previously provided hereunder, which is necessary for the exercise by Roche, its Affiliates or a Third Party of the Manufacturing rights granted under Section 7.1.1.

  • Neither Akcea nor Ionis, nor any of their respective Affiliates, will amend, modify, terminate, or waive any rights under any In-License Agreement or any agreement with a Licensed CMO listed on Schedule 5.2(ii), in a manner that would adversely affect Pfizer’s rights or obligations under this Agreement without Pfizer’s prior written consent.

  • If Roche provides Ionis with a written request that Xxxxx xxxxx a license under the Ionis Manufacturing and Analytical Patents and Ionis Manufacturing and Analytical Know- How to a CMO designated by Roche that is not a Licensed CMO, solely for such CMO to Manufacture Products for Roche, its Affiliate or Sublicensee in a manufacturing facility owned or operated by such CMO, Ionis will [***].

Related to Licensed CMO

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • Hemp products means all products made from industrial hemp,

  • Licensed producer means a person or entity licensed to produce medical cannabis.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Licensed Technology means the Licensed Patents and the Licensed Know-How.

  • Licensee Technology means the Licensee Know-How and Licensee Patents.

  • Product Technology means the Product Know-How and Product Patents.

  • Licensed Field means all fields of use.

  • Licensor Technology means the Licensor Patents and the Licensor Know-How.

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Licensed Territory means worldwide.

  • Licensed Fields of Use means the fields of use identified in Appendix B.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Licensed Field of Use means all fields.

  • Licensed System means, collectively:

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Licensed Know-How means any and all unpatented and/or non-patentable technical data, documents, materials, samples and other information and know‐how that is Controlled by LICENSOR or any of its Affiliates as of the Effective Date or thereafter during the Term that relates to, or is otherwise reasonably necessary or reasonably useful for, the use, Development, manufacture, or Commercialization of the Product. Licensed Know-How shall not include Licensed Patents.

  • Licensed Program means the executable processing programs of licensed information, which is composed of various modules in the Licensed Software package provided by the Licensor.