Combination Product Component definition
Combination Product Component means a therapeutically active compound, a proprietary device (if applicable), or a proprietary formulation (but not an excipient, coating, capsule, or other non-proprietary delivery system or formulation) that is not a Licensed Product and that is included in a Combination Product. For the sake of clarity, a drug delivery device that is used for the delivery of drug products in general and is readily available for hospital, clinic, and/or in-home use, such as a syringe, intravenous inject port, and the like, would not be deemed a proprietary device and therefore, would not be deemed a Combination Product Component. In addition, a proprietary formulation or proprietary device shall only include formulation or devices that are developed by or on behalf of Licensee or in-licensed, purchased or otherwise procured by the Licensee, its Affiliates, and/or sublicensees from a third party for value.
Combination Product Component means one or more product(s) or processe(s) that:
1.9.1 is contained within or used in a Licensed Product;
1.9.2 is not itself a Licensed Product;
1.9.3 after removal of Combination Product Component from each Licensed Product containing or using Combination Product Component, the manufacture, having manufactured, use, sale, offer for sale or importation of each resulting product would be an infringement, but for the license granted to Licensee pursuant to this Agreement, of the same unexpired claims of patents and pending claims of patent applications included in Regents’ Patent Rights as the Licensed Product containing or using it;
1.9.4 is sold separately, apart from the Combination Product, by Licensee, an Affiliate or sublicensee;
1.9.5 does not function together with one or more other parts of the Licensed Product that is not a Combination Product Component so as to produce the intended result for which the Licensed Product is sold; and
1.9.6 the addition of which to the Licensed Product containing or using the Combination Product Component creates a Licensed Product with a higher market price than the Licensed Product without the Combination Product included.
Combination Product Component means [***].
Examples of Combination Product Component in a sentence
Notwithstanding the foregoing, such right shall not apply to any payment for a third-party license required solely in connection with the manufacture, use or Sale of a Combination Product Component.
Any credit pursuant to this Paragraph shall be available to the Licensee with respect to the full royalty payable pursuant to Paragraphs 7.1.2 and 8.1, but no such credit shall be available with respect to any Combination Product if the Third Party license is necessary solely because of a Combination Product Component that is not a Licensed Product.
Any credit pursuant to this Paragraph 8.3 shall not be available to the Licensee with respect to any royalties owed by Licensee to third parties for any Combination Product Component.
More Definitions of Combination Product Component
Combination Product Component means a therapeutically active compound, a proprietary device (if applicable), or a proprietary formulation that is not a Licensed Product but is covered by the intellectual property rights owned or controlled by the Licensee, without which compound or device the Licensed Product would deliver less therapeutic effect (but no an excipient, coating, capsule or other non-proprietary delivery system or formulation) that is not a Licensed Product but that is included in a Combination Product. For the sake of clarity, a drug delivery device that is Patent License Agreement – Exclusive [Page 3 of 28] ● used for the delivery of drug products in general and is readily available for hospital, clinic and/or in-home use, such as a syringe, intravenous inject ports and the like, would not be deemed a proprietary device and therefore, would not be deemed a Combination Product Component. In addition, a proprietary formulation or proprietary device shall only include formulation or devices that are developed by or on behalf of Licensee or in-licensed, purchased or otherwise procured by the Licensee, its Affiliates and/or sublicensees from a third party for value.
Combination Product Component shall have the meaning set forth in the definition of “Combination Product.”