(h) Licensee has all rights necessary to grant Licensee`s intellectual property licenses and rights of infringement under regulatory materials that Licensee grants to Takeda in this Agreement. (j) no claim or dispute in the Territory has been asserted by any person or threatened to Takeda`s knowledge, and Takeda is not aware of the claims, whether or not invoked: (i) that any of the Takeda Compound patents is invalid or unenforceable; (ii) the regulatory materials authorized by Takeda to the licensee; Takeda Compound patents, Takeda know-how or the disclosure, copying, creation, assignment or license of regulatory materials by Takeda to licensee, which violates, violates or violates any intellectual property or proprietary right of any person; or (iii) in connection with the development of the product. Takeda will immediately inform the licensee after learning of any right or dispute in the territory that has been invoked or threatened by a person who claims anything of the foregoing. 1.78 “Phase 3 clinical trial” means a clinical trial related to the marketing authorization of a defined-dose drug or a series of defined doses, the purpose of which is to determine the efficacy and safety of such a product in a manner generally consistent with paragraph 312.21(c) of the CFR, as amended (or its successor rules) and its equivalents in other legal systems; to enable the creation and submission of an NDA to the FDA or other relevant regulatory authority. 13.4 Denunciation for patent challenge. Takeda may at any time, upon written notice to Licensee, terminate this Agreement in its entirety if Licensee or any of Licensee`s associated companies or its sublicensor(s), directly or indirectly, with the assistance of a third party, initiates opposition proceedings, the validity or enforceable of a Supplementary Protection Certificate with respect to (a “Patent Proceeding”) of a Takeda patent or other patent with respect to: f challenge or oppose a Takeda patent or other patent. r of Takeda, which claims or discloses the composition of the material or the manner in which the product is manufactured or used throughout the region, with the exception of a country located in the territory where this Agreement was denounced before the commencement of such patent proceedings. However, Takeda`s right to terminate this Agreement pursuant to this Section 13.4 does not apply to a related business of the licensee that first becomes a related business of the licensee after the effective date of a merger or acquisition event, or to a subcontractor, if such related enterprise or sublicensor prior to such merger or acquisition event or the granting of such assignment z a carried out activities in the context of legal proceedings. provided that such partner or associated subcontractor immediately suspends any activity aimed at promoting such patent proceedings and withdraws or terminates such patent proceedings in connection with [***] such a merger or acquisition or sublicense event. (a) During the lifetime, Licensee has the right to negotiate and obtain from one or more third parties, after appropriate consultation with Takeda, a license under one or more patents (with the exception of a license granted to settle a dispute under Section 9.6) (each of these third party licenses is referred to as a “third party license”) in the absence of a license under such third-party patents; The use of the applicable combination or the applicable field product in the field, in a manner consistent with the licensee`s obligation to make economically reasonable efforts to develop and market the active substance and the product under this Agreement, would, in the licensee`s assessment, in good faith, infringe such patents to third parties. .

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