Overview of Development. (a) The Parties shall develop the Programs in a collaborative and efficient manner as set forth in this Article 2. Representatives of the Parties shall engage in joint decision-making for the Programs as set forth in Articles 3 and 4 hereof. Symphony Allegro shall have overall responsibility for all matters set forth in the Development Plan (pursuant to Article 7 hereof), and shall engage Alexza (pursuant to Article 6 hereof), RRD (pursuant to the RRD Services Agreement), and such independent contractors and agents as it may retain with RRD’s assistance or as Alexza may retain on Symphony Allegro’s behalf (which contractors include entities retained by Alexza prior to the Closing Date pursuant to the Subcontracting Agreements set forth on Schedule 6.2), to act on behalf of Symphony Allegro and carry out the duties set forth therein and herein, including management, supervisory and accounting functions, [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
1. pre-clinical and clinical development, manufacturing, scientific and technical services associated with such development, and patent work under the Programs.
(b) Alexza hereby acknowledges and agrees to Symphony Allegro’s engagement of RRD to act on its behalf and to carry out the duties assigned to RRD herein and in the RRD Services Agreement, including, but not limited to (i) providing personnel and support to the Development Committee and the Symphony Allegro Board, (ii) the management and administration of Symphony Allegro, (iii) supervising and monitoring Alexza’s implementation of the Programs, and (iv) subject to Section 6.1(a) and without limiting Alexza’s role thereunder, such other development-related work as Symphony Allegro may reasonably delegate to RRD in accordance with the Development Plan.
(c) With respect to the AZ-002 Program and the AZ-004 Program, Alexza shall be responsible for the execution of all pre-clinical and clinical development, all scientific and technical services associated with such development, and all patent work, including all related matters set forth in the Development Plan for such Programs.
(d) Nothing in Section 2(c) shall in any way limit the authority of the Development Committee (as defined below) or the Symphony Allegro Board hereunder, and the engagements and delegati...
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. 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.
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. 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. 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 * Confidential Information, indicated by […***…], has been omitted from this filing and filed separately with the Securities and Exchange Commission. 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. 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. 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. 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.
Overview of Development. The Parties shall undertake the development of Product in a collaborative and efficient manner in accordance with this Article 3. The pre-clinical and 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).
