Overview of Product Development. The Parties desire and intend to collaborate with respect to the Development of the Licensed Product in the Licensed Field in the Territory, to the extent set forth in this Agreement. Takeda’s Development of the Licensed [***] Products in the Takeda Field and Ultragenyx’s Development of the Licensed [***] Products in the Ultragenyx Field and Licensed Analog Products in the Licensed Field shall be conducted in a manner consistent with the [***] Development Plans and using Commercially Reasonable Efforts.
Overview of Product Development. The Parties desire and intend to collaborate with respect to the Development of Licensed Products in the Sanofi Field and in the KaloBios Field in the Territory, under the direction of the JSC, as and to the extent set forth in this Agreement. In general, Sanofi shall be responsible, at its sole cost and expense, for the Development and Regulatory Approval of Licensed Products in the Sanofi Field in the Territory. During the Sanofi Option Period, KaloBios shall be responsible, at its cost and expense, for the Development and Regulatory Approval of Licensed Products in the KaloBios Field in the Territory. KaloBios will use Commercially Reasonable Efforts to Develop the Licensed Product for [***] in the KaloBios Field for the treatment of Cystic Fibrosis, or otherwise as the Parties may agree (not to be unreasonably withheld), as and to the extent provided in this Agreement. In addition, KaloBios shall be responsible for certain Development activities for the Licensed Products, at Sanofi’s cost and expense, as specifically described in the Sanofi Development Plan (as defined below) for the Sanofi Field, and as the Parties may otherwise reasonably agree in writing during the Term pursuant to any amendment thereto.
Overview of Product Development. Each Party’s Development of the Compound and the Product in the Field in or for its respective territory and Licensee’s performance of the Licensee Japan Development Activities shall be conducted in a manner consistent with the principle of seeking and maintaining Regulatory Approvals in the Field in such Party’s respective territory (and in Japan with respect to Licensee’s performance of the Licensee Japan Development Activities) that include the appropriate Labeling for the Product in light of the clinical data. [***], Licensee shall notify Takeda so that Licensee and Takeda can discuss in good faith whether such data support conducting immuno-bridging Clinical Trials to obtain Regulatory Approval of the Product for non-infant (including children up to 18 years old, adults and older adults 65 years of age and older) populations. After such discussions between the Parties, Licensee shall determine whether the clinical data support conducting such immuno-bridging Clinical Trials, provided that Licensee will consider in good faith any comments of Takeda with respect to such determination. If Licensee determines that the clinical data support conducting such immuno-bridging Clinical Trials, then as soon as is reasonably practical after making such determination, Licensee shall seek advice from the key Regulatory Authorities (e.g.; FDA, EMA, and PMDA) regarding the acceptability of immune-bridging Clinical Trials to obtain Regulatory Approval of the Product for non-infant (including children up to 18 years old, adults and older adults 65 years of age and older) populations (the “Immuno-Bridging Regulatory Authority Consultations”). Licensee shall (1) notify Takeda in advance any Immuno-Bridging Regulatory Authority Consultations, (2) consider in good faith any advice provided by Takeda with respect to any Immuno-Bridging Regulatory Authority Consultations, (3) unless prohibited by the PMDA, allow Takeda to attend any such meetings (including telephone and web meetings) with the PMDA regarding Immuno-Bridging Regulatory Authority Consultations, and (4) keep Takeda informed in a timely manner of any communications from or to the applicable Regulatory Authority regarding all Immuno-Bridging Regulatory Authority Consultations.
Overview of Product Development. Licensee’s Development of the Compound and the Product in the Field in or for the Territory shall be conducted in a manner consistent with the principle of seeking and maintaining Regulatory Approvals in the Field in the Territory that include the appropriate Labeling for the Product in light of the clinical data. Notwithstanding any language to the contrary in this Agreement, including the previous sentence, (i) except for the Permitted Product Formulations, Licensee shall not have the right to Develop any other Product formulation, and (ii) except for the Permitted Trials and Studies, Licensee shall not have any right to perform any other Clinical Trials or Product related studies.
Overview of Product Development. The Parties desire and intend to collaborate with respect to the Development of the Products in the Field for the Territory, to the extent set forth in this Agreement.
Overview of Product Development. (a) In the United States. Arena US has filed the Initial Product NDA with the FDA, and Arena shall be responsible (as provided in Section 3.10(a)) for conducting, or causing Arena US to conduct, the regulatory activities with respect to the FDA for the Initial Product through achievement of initial Regulatory Approval in the United States for the Initial Product. If the FDA requires additional clinical trials or other development work on the Initial Product to obtain or maintain such Regulatory Approval (such as a required Phase 4 clinical trial or outcome study), or if the Parties agree to conduct other additional clinical trials or other development work on the Initial Product after such Regulatory Approval (such as to expand the labeling for the Initial Product in the Territory), such clinical trials or other development work shall be conducted as provided in Section 3.2(a) and (b), respectively.
(b) In the Additional Territory. Eisai shall have the right and responsibility for conducting, or causing its Affiliate to conduct, all regulatory and clinical activities with respect to each Regulatory Authority in the Additional Territory for the Initial Product in accordance with this Agreement. If (i) any such Regulatory Authority in a country in the Additional Territory requires additional clinical trials or other development work on the Initial Product to obtain or maintain a Regulatory Approval in such country (such as a required clinical trial or outcome study), or (ii) if the Parties agree to conduct other additional clinical trials or other development work on the Initial Product after such Regulatory Approval in such country (such as to expand the labeling for the Initial Product in such country), such clinical trials or other development work shall be conducted pursuant to and in accordance with a Development Plan established by the Parties for such development work, and under the management of the JDC, as provided in Section 3.2(c) and (d), respectively, except as otherwise provided in Section 3.2(f).
(c) Further, if the Parties agree, pursuant to Section 3.3, to develop an Additional Product for one or more countries in the Territory, any clinical trials and other development work with respect to such Additional Product shall be conducted by the Parties pursuant to a Development Plan established by the Parties for such Additional Product under Section 3.4 and shall be funded by the Parties according to the Parties’ agreement under Section 3.3 with...
Overview of Product Development. Arena US has filed the Initial Product NDA with the FDA, and Arena shall be responsible (as provided in Section 3.10(a)) for conducting, or causing Arena US to conduct, the regulatory activities with respect to the FDA for the Initial Product through achievement of initial Regulatory Approval for the Initial Product. If the FDA requires additional clinical trials or other development work on the Initial Product to obtain or maintain such Regulatory Approval (such as a required Phase 4 clinical trial or outcome study), or if the Parties agree to conduct other additional clinical trials or other development work on the Initial Product after such Regulatory Approval (such as to expand the labeling for the Initial Product in the Territory), such clinical trials or other development work shall be conducted as provided in Section 3.2(a) and (b), respectively. Further, if the Parties agree, pursuant to Section 3.3, to develop an Additional Product, any clinical trials and other development work with respect to such Additional Product shall be conducted by the Parties pursuant to a Development Plan established by the Parties for such Additional Product under Section 3.4 and shall be funded by the Parties according to the Parties’ agreement under Section 3.3 with respect to such Additional Product.
Overview of Product Development. The Parties desire and intend to collaborate with respect to the Development of the Product in the Field, as and to the extent set forth in this ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. **** Indicates that the amount of information omitted was a page or more in length, and such information has been filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Agreement. The general allocation of responsibilities for conducting Development of the Product shall be as follows: (a) CTI will oversee and shall be responsible for performing the Development activities in the Licensed Territory, including for the sponsorship of Licensed Territory Specific Studies; and (b) Chroma will oversee and shall be responsible for performing the Development activities in the ROW Territory, including for the sponsorship of Extraterritorial Studies; in each case unless otherwise agreed to by the JDC.
Overview of Product Development. The Parties desire and intend to collaborate with respect to the Development of the Product in the Licensed Territory in the Field, as and to the extent set forth in this Agreement. The general allocation of responsibilities for conducting Development of the Product shall be as follows: (1) Cell Genesys shall be responsible for performing the VITAL Studies and the Currently Ongoing Studies; and (2) except as provided in the following sentence, the JDC will allocate responsibility for the performance of any Additional Studies between the Parties. The JCC will allocate between the Parties responsibility for the performance of those Additional Studies which are of the type that typically fall within the oversight of Takeda’s commercial functions, including, without limitation, certain Phase 4 Clinical Studies, investigator-sponsored trials and reimbursement studies.
Overview of Product Development. The Parties desire and intend to collaborate with respect to the Development of Product in the Field, under the direction of the JDC and JSC, as and to the extent set forth in this Agreement. In general, the Parties shall jointly manage and conduct a series of core studies that are required to obtain Regulatory Approval for Product by both the FDA and the EMEA for a first Indication (the “Core Studies”). Norgine, its Affiliates and sublicensees shall be responsible for other Development activities required for the Regulatory Approval of Product in the Licensed Territory (including by the EMEA to the extent such activities are not covered by the Core Studies) (the “Norgine Independent Studies”), and Tranzyme, its Affiliates and licensees shall be responsible for Development activities required for the Regulatory Approval of Product in the Retained Territory (including by the FDA to the extent such activities are not covered by the Core Studies) (the “Tranzyme Independent Studies”, and together with Norgine Independent Studies, the “Independent Studies”). For clarity, the Parties agree to take into consideration the need for Norgine to obtain pricing and reimbursement approval in the Licensed Territory in designing the Core Studies and to use Commercially Reasonable Efforts to design the Core Studies in a manner that Norgine may use the data and results generated therefrom to satisfy the requirements of the Major Markets in Europe for such pricing and reimbursement approvals. In the event any clinical trial(s) is required for Norgine to obtain any pricing and reimbursement approvals in addition to the Core Studies, then such additional clinical trial(s) shall be deemed Norgine Independent Studies.
