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. (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. 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. The Parties will collaborate to conduct a program of research and development of Licensed Antibodies in accordance with the Research Plan, including antibody discovery and biology efforts through Candidate Selection (the “Research Program”), as further described in this ARTICLE 3. The objective of the Research Program is to Research one or more Licensed Antibodies that meet the target criteria set forth in the Research Plan. The time period beginning on the Effective Date and ending on the earlier of (a) the third anniversary of the Effective Date and (b) the date of Candidate Selection in accordance with Section 3.7 is referred to as the “Research Program Term.”
1Overview. The provisions of this ARTICLE 6 shall apply to the Manufacture of the Product unless otherwise agreed by mutual Party Written Consent.
1Overview. Subject to the Combined Major Market Medical Affairs Plan and oversight by the JMAT, JDC, JCC and the JSC, and the terms of this Agreement (including ARTICLE 3 with respect to Genmab’s right to provide MSLs in the United States), each Party shall have the right and responsibility for Medical Affairs Activities in support of the Product in its Party Major Market(s) in accordance with this Agreement, including as provided in this ARTICLE 7, including by performing activities for such Party Major Market(s) as follows: (a) preparing materials for use in connection with Medical Affairs Activities in its Party Major Market(s), (b) preparing training materials and training programs for personnel engaged in such Medical Affairs Activities and implementing such training, and (c) making decisions with respect to its Party Tactical Matters in connection with such Medical Affairs Activities; provided, that, in each case ((a) through (c)), such activities shall be consistent with the Party Major Market Medical Affairs Plan, Combined Major Market Medical Affairs Plan, and US Coordination Plan, including the tactical and strategic matters described in such plans, and otherwise conducted in accordance with this Agreement (including ARTICLE 3 with respect to the United States). Notwithstanding the foregoing, each Party will be permitted to list the Product as part of its portfolio in any country in the Major Markets (including the other Party’s Party Major Market(s)) in settings where the Party has a “corporate presence” (e.g., within a booth at a conference or congress), including by providing totems or videos with respect to the Product in any such setting; provided, that (i) any such totems or videos and any other signs or materials used by a Party in connection therewith comply with the Medical Affairs Plans, the Publication Charter and all other applicable terms and conditions of this Agreement, (ii) the activities of the Parties at conferences and congresses in the United States will be subject to the US Coordination Plan, and (iii) in any other country in the Major Markets, any request for information relating to the Product by an applicable HCP requesting information in the other Party’s Party Major Market(s) will be referred to the other Party if practicable (i.e., the applicable HCP will be directed to the other Party’s booth, if available).
1Overview. Without limiting any other amendments to the terms or conditions of the Collaboration Agreement that may be contained in this Agreement, the Parties agree that the Collaboration Agreement is hereby further amended as provided in this ARTICLE 12.
1Overview. The Parties shall establish a joint steering committee (“JSC”) to perform the functions set forth in Section 2.2(b) (JSC Responsibilities) and oversee such portion of the Parties’ activities under this Agreement that are subject to the Development cost-sharing arrangements described in Article 3, and to facilitate communication and decision making between the Parties with respect to the Development, Manufacture and Commercialization of Compounds and Products. The JSC may create additional committees, such as a JCC, in accordance with Section 2.2(b)(xii). The Parties shall establish a joint development committee (“JDC”) to perform the functions set forth in Section 2.3(b) (JDC Responsibilities) and oversee that portion of the Development of the Compounds and Products that are subject to the cost-sharing arrangements described in Article 3. Each Party will provide the other Party in writing with the name, title, e-mail address and telephone number of its initial JSC and JDC members.
