Within the Territory. Subject to the terms and conditions of this Agreement, MPP hereby grants to Licensee a non-exclusive, non-transferable, non-sublicensable license under the Territory Patents and MSD Know-How to manufacture the Product at a facility that is in the Territory (excluding any Sanctions Targets as defined in Section 6.3) and that is approved by a SRA or prequalified by the World Health Organization:
Within the Territory. Subject to the terms and conditions of this Agreement, MSD hereby grants to MPP a non-exclusive, non-transferrable license under the Territory Patents and MSD Know-How to enter into Sublicences with Sublicensees for the latter to manufacture the Substance at a facility that is in the Territory (excluding any Sanctions Targets as defined in Section 4.5) and that is approved by a SRA or prequalified by the World Health Organization;
Within the Territory. Within the Territory, the Parties agree to Commercialize the ISR subject to the following terms:
Within the Territory. UP shall solely manage all applications, requests for authorization, submissions of Information and data and for all interactions with the FDA or applicable governing health authority for the purpose of attempting to obtain registration of the Products within the Territory in accordance with the Initial Assessment Period or the UP Development Program. UP shall have the final authority to make all clinical and regulatory decisions with respect to the registration of Products within the Territory in its sole reasonable discretion. UP shall provide AltaRex with sufficient time to review and approve all material submissions of Information and data prior to submission to the FDA or applicable governing health authority, and AltaRex shall participate and collaborate in the process of Product registration including, without limitation, participation in meetings with regulatory authorities and interaction with UP staff, contractors and consultants on a regular basis regarding the development and commercialization of Products. UP shall solely and exclusively own all regulatory applications, approvals, clinical data and Product registrations obtained by UP or its Affiliates with respect to Products within the Territory, including retaining control and ownership of each Drug Master File related to the Licensed Technology within the Territory. For the avoidance of doubt, the foregoing materials shall be deemed to be Data.
Within the Territory. In the Territory, for so long as Serono’s exclusive license rights have not been terminated hereunder and subject to the rights of BioMarin’s licensors, if any, Serono shall have the right, at its sole expense, but not the obligation, to initiate and conduct legal proceedings to enforce (i) BioMarin Patents solely against a Third Party infringing such BioMarin Patents by the manufacture, use, sale or importation of a Licensed Product, or (ii) Joint Patents; in addition, Serono shall have the sole right, but not the obligation, to initiate and conduct legal proceedings to enforce Serono Patents. Serono shall have exclusive control over the conduct of any such patent infringement proceedings, including the right to settle or compromise such proceedings consistent with Serono’s licenses hereunder. All expenses relating to any such proceedings, including lawyers’ fees and costs, shall be solely borne by Serono. If Serono elects to commence an action for infringement, and BioMarin is a legally indispensable party to such action, BioMarin shall have the right to assign to Serono its right, title and interest in the subject patent(s) or patent application(s) in lieu of joining as an indispensable party, should that be sufficient for purposes of commencing and maintaining the action. During the Term, BioMarin will endeavor to ensure that any BioMarin personnel (as might reasonably be requested for assistance by Serono for any Third Party infringement action) shall be available to cooperate with Serono, at Serono’s request and sole expense. If Serono elects not to pursue any such legal proceeding with respect to BioMarin Patents or Joint Patents, Serono shall notify BioMarin of Serono’s election not to pursue such legal proceeding promptly, but no later than one hundred twenty (120) days with respect to BioMarin Patents and one hundred eighty (180) days with respect to Joint Patents after Serono becomes aware of the Third Party’s infringement and BioMarin may pursue such proceeding and shall be entitled to any recovery resulting therefrom.
Within the Territory. Within the Territory, CVT shall have and retain full, exclusive (even as to MIOL) sublicensable rights under the CVT Know-How and CVT Patent Rights (including CVT’s interest in any Joint Know-How and Joint Patent Rights) as well as the Trademarks as follows: (i) to develop the Product (including the conduct of clinical trials outside the Territory) for any potential use or indication including, but not limited to, in connection with any Joint Development, any Development prior to any MIOL Later Opt-In, any CVT Development under Section 11.4 and any CVT Projects under Section 11.6 (subject only to MIOL’s non-exclusive license right in the Territory under Section 3.1(e) above in the event the Parties enter into any Development Agreement relating to Joint Development); (ii) to make and have made the Product (subject only to MIOL’s non-exclusive license right under Section 3.1(d) above if MIOL exercises its Manufacturing Option); (iii) to package the Product solely for the purposes of (A) CVT’s packaging of the Product for MIOL for the EU only until MIOL is operationally ready to exercise its packaging rights under Section 3.1(a) and take over such packaging of the Products, and (B) CVT’s exercise of its retained rights under Section 3.2(a) and this Section 3.2(b) to conduct Phase IV studies in the Territory which are CVT’s responsibility under Section 7.2(a) below; (iv) to Detail the Product in accordance with Article 10.0 below; (v) to develop, make, have made, use, register, sell, have sold, import and export the Product in the Territory as set forth in Section 11.4; and (vi) for activities relating to governmental obligations, regulatory requirements, investor meetings, trade promotion, discussing CVT business and any and all uses of Trademarks outside the Territory. [****] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Confidential treatment has been requested with respect to the omitted portions. Table of Contents
