1Overview. Subject to the terms and conditions of this Agreement, the Parties shall collaborate to conduct Development of the Combination Therapy in the Field in the Territory, and the Parties will Commercialize their respective Products for the Combination Therapy in the Field in the Territory. To the extent mutually agreed in the Development Plan, certain Development activities may be conducted outside the Territory (but only for the purpose of seeking Regulatory Approval and Commercialization in the Territory), and all references in this Agreement to Development in the Territory shall be construed accordingly.
1Overview. Subject to this Article 7 with respect to the Combination Therapy in the Territory, each Party shall have the right, at such Party’s sole discretion and cost, to Commercialize such Party’s Product worldwide, itself or with or through its Affiliates or any Third Parties. Affimed and its Affiliates shall have the sole right to Promote the Combination Therapy in the approved Indications in the Territory, provided that the foregoing shall not limit Artiva’s right to reference the Promotional Materials for the Combination Therapy in connection with the Commercialization of the Artiva Product or participate in trade shows or conducting similar activities relating to the Combination Therapy, in each case in accordance with Applicable Law and provided that Artiva shall in each case only use Promotional Material for the Combination Therapy which has been approved by Affimed and, to the extent required, by the JCC pursuant to Section 3.3(b)(iii). For the avoidance of doubt, each Party shall be solely responsible for maintaining all Regulatory Approvals for the Combination Therapy in the Territory at its sole cost in accordance with Section 6.2(c).
1Overview. Subject to the terms and conditions of this Agreement, including Proteovant’s exercise of its Opt-In Right in accordance with Article 4, during the Term, on a Licensed Target Program-by-Licensed Target Program basis, from and after the applicable Option Exercise Date, Blueprint, by itself or through its Affiliates and Sublicensees, will be solely responsible, at its sole cost and expense, for the Commercialization of Licensed Compounds and Licensed Products in the Field in the Territory.
1Overview. Aarvik shall conduct Collaboration activities in accordance with the applicable statements of work approved by XxxxXxxx (the “SOWs”), each of which shall set forth the research activities for each Work Item in detail. Subject to terms and conditions contained in this Agreement, the Collaboration with respect to the Target Pair shall commence on the Original Effective Date and end upon the completion of all activities in accordance with the applicable SOWs (the “Research Term”). During the Research Term, Aarvik shall use [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. Commercially Reasonable Efforts to carry out its responsibilities as assigned to it under this Agreement and each SOW and to perform such other obligations as the JRC may assign to it from time to time consistent with this Agreement or the applicable SOW’s. Aarvik shall perform, and/or shall cause its Affiliates and Third Party contractors to perform, its activities under each SOW in compliance with all Applicable Laws and in accordance with good scientific and business practices at all times.
1Overview. (a)A Transaction is formed where a Bid and an Offer match and are accepted in accordance with the rules in this clause 13.
1Overview. (a)In the Field in the Territory. Except for any regulatory activities related to CSPC’s Manufacturing of the Licensed Products under this Agreement or the Master Supply Agreement, which shall be exclusively controlled and conducted by CSPC, Elevation has the exclusive right to conduct, and subject to the remainder of this Section 9 (Regulatory), is solely responsible for all aspects of, activities related to (i) setting the regulatory strategy for seeking Regulatory Approvals (including any Pricing Approvals) for Licensed Products in the Field in the Territory upon consultation with CSPC, and (ii) seeking and obtaining Regulatory Approvals in the Field in the Territory. As between the Parties, Elevation shall bear all of its costs and expenses incurred in connection with such regulatory activities.
1Overview. 2.1.1Commissioning is a quality assurance process that works to ensure that the building’s design intent is fully realized. A systematic approach is employed to review, verify and document that the specified components and systems have been designed, installed, started up properly and then functionally tested to verify and document proper operation through all modes and conditions. A final commissioning report document or Systems Manual is produced that will outline the events and findings of the commissioning project. It will include an accounting of all findings, final resolutions and recommendations. Commissioning does not replace or eliminate any requirements for reviews, inspections or other quality control measures by any other firm, organization, or party. The A/E, CM if any, Contractors, and Project Manager, as applicable, maintain their obligations as a function of their roles and responsibilities. The process begins in the design stages and extends through project completion, closeout, and warrantee reviews. Functional testing of the systems may include actual seasonal systems tests.
1Overview. As between the Parties, and subject to the terms and conditions of this Agreement, Licensee shall control, and bear all responsibility, costs and expenses associated with, the Commercialization of the IPI-145 Product in the Field in the Territory. THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
1Overview. Lilly shall be responsible for Commercializing the Products in the Field in the Territory and shall have the sole right to make decisions relating to such activities, with the oversight of the JSC; provided however, that if each of the following applies: (a) Rigel has not provided a Stage 1 Opt-Out Notice or Stage 2 Opt-Out Notice, and has timely and in full contributed its share of R552 Development Costs under this Agreement, (b) [*] Rigel’s Commercialization infrastructure, capabilities, experience and expertise in the United States are adequate for the purposes contemplated herein, and (c) the Parties have executed a Co-Commercialization Agreement as described in the penultimate sentence of this Section 5.1; then Rigel shall have the right to co-Commercialize Non-CNS Penetrant Products in the U.S. by providing up to [*] of the total Detail commitment for each such Product in the U.S., where such Details may be focused on specific Indications. If Rigel has not provided a Stage 1 Opt-Out Notice or Stage 2 Opt-Out Notice, Lilly shall promptly notify Rigel of the anticipated launch date of each Non-CNS Penetrant Product in the U.S. (no later than [*] months prior to such anticipated date) and Rigel may elect to conduct such co-Commercialization activities with respect to such Non-CNS Penetrant Product by providing written notice thereof no later than [*] months prior to such anticipated launch date, subject to Rigel achieving and maintaining each of the conditions set forth in the foregoing (a) through (c). Upon such election, the Parties shall negotiate in good faith and enter into a co-Commercialization agreement setting forth the terms and conditions of such co-Commercialization activities, including compensation to Rigel for the conduct of such co-Commercialization activities in accordance with market practice and taking the overall costs and efficiencies of such contemplated co-Commercialization activities into consideration (each a “Co-Commercialization Agreement”), at least [*] months prior to the anticipated launch date. Such cost and efficiency considerations will include each Party’s sales infrastructure, disease state call points, and physical sales coverage by prescribing deciles.
1Overview. Subject to Section 6.2 (Transfer of Technology and Manufacturing Responsibilities), Lilly, itself or through one or more Affiliates or Third Parties selected by Lilly, will be solely responsible for the Manufacture and supply of the Compounds and Products in bulk and finished form for use in Development and Commercialization under this Agreement, provided that Rigel shall be responsible for those Manufacturing activities allocated to Rigel under: (a) the R552 Development Plan, and (b) the CNS Penetrant Development Plan, as required for the CNS Program during the CNS Research Term through the delivery to Lilly of the Rxxx Data Package and, if applicable in the case of Rigel Rxxx Continuation, the Rxxx Continuation Data Package (which may, in case of (a), include any ongoing clinical supply activities contemplated under such plan with respect to the applicable Compounds or Products).
