Overview of Development. Subject to the terms and conditions of this Agreement, Licensee shall be responsible for the Development of the Product for use in the Field in the Territory as set forth herein. Licensee shall use [***] to conduct, in accordance with the Development Plan, the Development Activities, including bridging studies, clinical studies, and Clinical Trials (including post-Regulatory Approval studies). Licensee shall use [***] to perform the Development Activities for the Product to (a) enable obtaining Regulatory Approval in the Territory for the Product in the Field and (b) maximize the commercial potential for the Product in the Field in the Territory. Notwithstanding the foregoing, Lxxxx acknowledges that [***]. Lxxxx also acknowledges the experimental and uncertain nature of Development and that the Development Plan may not yield the intended results. Accordingly, Lxxxx acknowledges that Licensee cannot guarantee it will obtain Regulatory Approval.
Overview of Development. The Parties acknowledge and agree that the Development of Licensed Product in the Licensed Territory shall be coordinated and consistent with the worldwide (outside of the Licensed Territory) Development of Licensed Product.
Overview of Development. Subject to the terms and conditions of this Agreement, the Parties shall collaborate with respect to the Development of the Product for use in the Field in the Territory as set forth in the Development Plan. Auxilium shall conduct the General Development Activities, Auxilium shall conduct that part of the Territory Exclusive Development Activities which occur prior to Product Approval, and Pfizer shall conduct that part of the Territory Exclusive Development Activities which occur after Product Approval, and Pfizer shall conduct the Territory Discretionary Development Activities in accordance with the Development Plan as provided in this Article 4. ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
Overview of Development. Subject to the terms and conditions of this Agreement, Licensee shall be responsible for the Development of the Product as set forth herein. Licensee shall use Commercially Reasonable Efforts to perform Development Activities for the Product to achieve the development milestones set forth in Section 8.2.
Overview of Development. Acerus shall conduct any Required Clinical Trials and will keep Aytu reasonably informed, through the JCC, with respect to such Required Clinical Trials. Upon written request by Acerus, Aytu will use good faith efforts to provide Acerus any reasonably necessary information for such Required Clinical Trials. Following the A&R Closing Date, the conduct of all Clinical Trials other than Required Clinical Trials will be the sole responsibility and at the sole discretion of Acerus.
Overview of Development. Ono shall conduct, in accordance with the Development Plan, the Territory Development Activities, including bridging studies, clinical studies, Phase IV Clinical Studies (and other post-Regulatory Approval studies). Ono shall perform the Territory Development Activities so as to (i) enable obtaining Regulatory Approval in the Territory for Product in the Field and (ii) maximize the commercial potential for Product in the Field in the Territory.
Overview of Development. The Parties’ respective responsibilities for the Development of the Licensed Products and Gilead Combination Products are set forth in this Article 3 and in the Development Plan. Gilead shall be primarily responsible for Development and seeking Regulatory Approval of the Licensed Product and Gilead Combination Products in the Territory and shall use Commercially Reasonable Efforts with respect thereto for the first Licensed Product in each of the Major Markets in each of the Target Indications. Notwithstanding anything to the contrary in this Agreement, the immediately foregoing obligation with respect to Commercially Reasonable Efforts in the Major Markets and the Target Indications shall be Gilead’s sole diligence obligation with respect to Development of Licensed Products and Gilead Combination Products, and Gilead shall have the sole right, but not any obligation, to Develop other Licensed Products and Gilead Combination Products in other countries or for other indications and no diligence obligation of Gilead shall arise under this Agreement with respect to Development of Gilead Combination Products. Galapagos shall use Commercially Reasonable Efforts as requested by Gilead to assist Gilead with Development activities with respect to […***…].
Overview of Development. Subject to the terms and conditions of this Agreement, the Parties shall collaborate with respect to the Development of the Product for use in the Field in the Territory as set forth herein. Auxilium shall conduct the General Development Activities and the Manufacturing Development Activities, and shall conduct the Territory Development Activities and the Territory-Specific Analytical Release Testing Characterization which the Parties mutually agree that Auxilium shall conduct. Asahi shall conduct, in accordance with the Development Plan, the Territory Development Activities, including bridging studies, clinical studies, physician/investigator – initiated studies, Phase IV Clinical Studies (and other post-Regulatory Approval studies) and the Territory-Specific Analytical Release Testing and Characterization necessary for obtaining or maintaining Regulatory Approvals or is otherwise required to conduct to comply with Laws. Auxilium shall use Commercially Reasonable Efforts to perform the General Development Activities for the Product for each indication in the Field (i.e., (i) Dupuytren’s Contracture, (ii) Peyronie’s Disease and (iii) such other New Indications as the Parties agree to include hereunder in accordance with Section 2.6, if any) to enable obtaining Regulatory Approval for each such indication. Auxilium shall, to the extent mutually agreed by the Parties, further use Commercially Reasonable Efforts to perform the Manufacturing Development Activities, the Territory Development Activities and the Territory-Specific Analytical Release Testing and Characterization. Asahi shall use Commercially Reasonable Efforts to perform the Territory Development Activities for the Product for each indication in the Field (i.e., (a) Dupuytren’s Contracture, (b) Peyronie’s Disease and (c) such other New Indications as the Parties agree to include hereunder in accordance with Section 2.6 (if any) to enable obtaining Regulatory Approval in the Territory for the Product for each such indication. Asahi shall further use Commercially Reasonable Efforts to perform the Territory-Specific Analytical Release Testing Characterization.
Overview of Development. The Parties shall undertake the development of Product in a collaborative and efficient manner in accordance with this Article 3. The clinical development of Product in the Territory under this Agreement shall be governed by a written development plan (the “Development Plan”), as such Development Plan may be revised from time to time in accordance with Section 3.2(a).
Overview of Development. Subject to the terms and conditions of this Agreement, Licensee shall conduct, in accordance with the Development Plan, the Territory Development Activities, including bridging studies, clinical studies, Phase IV Clinical Studies (and other post-Regulatory Approval studies). Licensee shall perform the Territory Development Activities (with the necessary assistance of Amarin to the extent such assistance is required by Applicable Laws in the Territory) so as to (i) enable obtaining Regulatory Approval in the Territory for Product in the Field and (ii) maximize the commercial potential for Product in the Field in the Territory.
