Development Diligence. Pfizer will use its Commercially Reasonable Efforts to Develop and seek Regulatory Approval for [ * ] Product [ * ] in the Field [ * ]. Pfizer will [ * ] with respect to the Development or Regulatory Approval of Products under this Agreement.
Development Diligence. Pfizer will use Commercially Reasonable Efforts to Develop (including to seek Regulatory Approval for) at least one (1) Licensed Product in one (1) Major Market Country for each Research Project Target for which Pfizer exercises its Option. Except as provided in Section 2.2 and this Section 3.2.1, Pfizer will have no other diligence obligations with respect to the Development or Regulatory Approval of Licensed Products under this Agreement. For avoidance of doubt, any actions taken by Pfizer’s Affiliates or Sublicensees under this Agreement shall be treated as actions taken by Pfizer in regard to satisfaction of the requirements of this Section 3.2.1.
Development Diligence. Novartis shall dedicate commercially reasonable efforts, during each [**] month period, necessary to continue the advancement of Licensed Compounds and Licensed Products with respect to at least one Profile towards the next clinical Development milestone or approval milestone, as described in Sections 7.4.2 or 7.4.3, respectively. If Novartis (itself or through its Affiliates or sublicensees) fails to dedicate commercially reasonable efforts, during any [**] month period, necessary to continue the advancement of Licensed Compounds and Licensed Products with respect to at least one Profile towards such next milestone, then any dispute regarding Novartis’ failure of development diligence with respect to such Profile shall be resolved in accordance with Article 13.
Development Diligence. Novartis shall itself, or through its Affiliates or sublicensees, use Commercially Reasonable Efforts to Develop Licensed Compounds and Products in the Field in the Territory. Subject to compliance with the foregoing, the Development of the Product(s) shall be in Novartis’ sole discretion. For the purposes of clarity, Commercially Reasonable Efforts in this context shall not be deemed to require Novartis to Develop every Licensed Compound or Product in each indication in each country in the Territory.
Development Diligence. Except with respect to Shared Products, following Vertex’s exercise of the Option for a Collaboration Target, Vertex (acting directly or through one or more Affiliates or Sublicensees) will use Commercially Reasonable Efforts to Develop, obtain Marketing Approvals for [***] in [***].
Development Diligence. Subject to Article 8 (Manufacturing and Technology Transfer), NVS will use Commercially Reasonable Efforts to Develop and obtain Marketing Approval for at least [***] Product in each of the In-Vivo Field and Ex-Vivo Field and for at least [***] Ophthalmic Product that Modulates each Ophthalmic Target.
Development Diligence. Without prejudice to any other remedies available at law or otherwise provided for in this Agreement, MTPC shall have the right to terminate this Agreement in the event that LICENSEE, its Affiliate or its sublicensee fails to meet any of the following milestones for the Product:
(a) Filing of the first IND in one of the Major Countries within [*] months after the Effective Date;
(b) Onset of the first Phase II(b) Study within [*] months after the first IND filing;
(c) Onset of the first Phase III Study within [*] months after completion of the last Phase II(b) Study; and
(d) Filing of the first NDA within [*] years after the first IND filing; Provided, however, that MTPC shall not have the right to terminate this Agreement if the failure of LICENSEE, its Affiliate or its sublicensee to meet any of the milestones set forth above is due to or caused by any of the following:
(1) Reason(s) beyond the reasonable control of LICENSEE, its Affiliate or its sublicensee. For the avoidance of doubt and without prejudice to other reasons, the following reasons will be deemed beyond the reasonable control of LICENSEE, its Affiliate or its sublicensee: a requirement by the FDA or other applicable regulatory agency that LICENSEE, its Affiliate or its sublicensee (i) perform additional studies or trials, (ii) reformulate or alter the manufacturing process of any Product, (iii) cease any clinical trial or redesign any clinical trial, or (iv) perform any other action or cease to perform any action that otherwise delays the clinical development of any Product. LICENSEE, its Affiliate or its sublicensee will present to MTPC evidence of such FDA or other applicable regulatory agency action.
(2) Activities performed in the best interest of the Product as reasonably determined by LICENSEE, its Affiliate or its sublicensee, subject to MTPC’s approval , not to be unreasonably withheld. For the avoidance of doubt and without prejudice to other activities, the following activities will be deemed in the best interest of the Product: (i) an expanded clinical program scope; (ii) additional safety studies, including drug-drug interaction studies and special population studies; (iii) reformulation efforts; or (iv) business development efforts following initiation of a Phase II(b)
Development Diligence. Licensee, directly or indirectly through Affiliates or Sublicensees, shall use Commercially Reasonable Efforts to Develop and to seek Regulatory Approval for at least one Licensed Product in the Field according to a development plan prepared by Licensee in its sole discretion within [***] after the Effective Date, and updated thereafter by Licensee in its sole discretion on an annual basis as reasonably necessary in connection with the Development and Regulatory Approval of the Licensed Product (“Development Plan”).
Development Diligence. Under the supervision of the JDC and during the Development Term, Dermira shall use Commercially Reasonable Efforts to perform all activities assigned to it in the Development Plan and UCB shall use Commercially Reasonable Efforts to undertake such of the activities under the Development Plan subcontracted to it by Dermira. In addition, except as otherwise set forth in Section 5.1, Dermira shall be responsible for the payment of all Development Costs incurred under the Development Plan, including the Cost of Goods for of Product and Comparator Drugs and Placebo ordered in connection with such Development activities, all as set out in the JDC-Approved Development Budget. For clarity, Dermira shall not be required to reimburse UCB for any Development Costs incurred by UCB except to the extent set forth in the Development Plan, as identified in the JDC-Approved Development Budget as being subject to reimbursement by Dermira. Each Party shall use Commercially Reasonable Efforts to perform such activities assigned to it under the Development Plan and/or as set forth in the Development Responsibility Matrix and/or Regulatory Responsibility Matrix (in the case of UCB, including its supply responsibilities) in good scientific manner, in accordance with Applicable Law, GMP (except in relation to Comparator Drug and Comparator Placebo), GCP and ICH Guidelines, as applicable, as well as the terms of this Agreement and the Safety Agreement. The JDT shall coordinate the Parties’ performance of such activities in a fair, efficient and expeditious manner. Each Party shall allocate appropriate resources, effort, equipment and personnel for the effective implementation and performance of its specified responsibilities set out in Development Plan, including in the case of UCB, its regulatory and supply responsibilities as set forth in this Agreement, so as to complete such activities fully and promptly, and in accordance with the Development Plan and the timelines set out therein. If either Party suspects that there may be a delay in meeting any timelines set out in the Development Plan, it shall promptly raise such issue with the JDT.
Development Diligence. Following the Collaboration Period, Pfizer will use Commercially Reasonable Efforts to Develop and seek Regulatory Approval for at least [**] in at least one indication in [**], at its own cost. No later than [**] days following the EOP2 Meeting with the FDA and EMA, Pfizer shall provide Spark with [**] (the “Pivotal Trial Development Plan”), [**]. Without limiting its obligations in the first sentence of this Section 4.9.1 and its rights under Section 4.9.4, Pfizer will use its Commercially Reasonable Efforts to conduct the Pivotal Trial Development Plan [**] thereunder, it being understood that [**] within the control of Pfizer may [**] outlined in the Pivotal Trial Development Plan. Pfizer may [**] the Pivotal Trial Development Plan [**], provided that any such [**] with Pfizer’s exercise of its required Commercially Reasonable Efforts, and shall promptly provide to Spark with such [**] Pivotal Trial Development Plan. Except as outlined above or as otherwise set forth in this Agreement, Pfizer will have no other diligence obligations with respect to the Development or Regulatory Approval of Licensed Products under this Agreement. Pfizer shall ensure that the Pivotal Trial Development Plan and [**] submitted to Spark shall be the same as or substantially consistent with the corresponding plan used by Pfizer for internal planning and management purposes.
