Common use of Overview of Development Clause in Contracts

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 delegations set forth therein shall be subject to the terms and conditions of this Agreement and the RRD Services Agreement, and the satisfactory performance by RRD and Alexza of their obligations pursuant hereto and thereto. The allocations of responsibility described in this Article 2 shall remain subject to further modification in accordance with the terms and conditions of this Agreement and the RRD Services Agreement.

Appears in 1 contract

Samples: Research and Development Agreement (Alexza Pharmaceuticals Inc.)

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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 Holdings shall have overall responsibility for all matters set forth in the Development Plan (pursuant to Article 7 hereof), and shall engage Alexza the Company (pursuant to Article 6 hereof), RRD (pursuant to the RRD Services Agreement), and such independent contractors and agents as it the Company may retain with RRD’s assistance or as Alexza may retain on Symphony Allegro’s behalf (which contractors include entities retained by Alexza the Company prior to the Closing Date pursuant to the Subcontracting Agreements set forth on Schedule 6.2), to act on behalf of Symphony Allegro Holdings 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 Programs, the AZ-004 Program, Alexza Company shall be responsible for the execution of all prenon-clinical and clinical development, all regulatory activities, all scientific and technical services associated with such developmentdevelopment (including manufacturing), and all patent work, including all related matters set forth in the Development Plan for such Programs. (dc) Nothing in Section 2(c2(b) shall in any way limit the authority of the Development Committee (as defined below) or the Symphony Allegro Board Holdings’ managing member (the “Manager”) hereunder, and the engagements and delegations set forth Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. therein shall be subject to the terms and conditions of this Agreement and the RRD Services Agreement, and the satisfactory performance by RRD and Alexza the Company of their its obligations pursuant hereto and thereto. The allocations of responsibility described in this Article 2 shall remain subject to further modification in accordance with the terms and conditions of this Agreement and the RRD Services Agreement.

Appears in 1 contract

Samples: Research and Development Agreement (Oxigene Inc)

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 Icon shall have overall responsibility for all matters set forth in the Development Plan (pursuant to Article 7 hereof), and shall engage Alexza Lexicon (pursuant to Article 6 hereof), RRD (pursuant to the RRD Services Agreement), and such independent contractors and agents as Lexicon may retain on Symphony Icon’s behalf or 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 Lexicon prior to the Closing Date pursuant to the Subcontracting Agreements set forth on Schedule 6.2), to act on behalf of Symphony Allegro Icon 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. (b) With respect to the LG617 Program and the LG103 Program, Lexicon shall be responsible for the execution of all pre-clinical and clinical development, manufacturing, all scientific and technical services associated with such development, and all patent work under work, including all related matters set forth in the Development Plan for such Programs. (bc) Alexza Nothing in Section 2(b) shall in any way limit the authority of the Development Committee (as defined below) or the Symphony Icon Board hereunder, and the engagements and delegations set forth therein shall be subject to the terms and conditions of this Agreement and the RRD Services Agreement, and the satisfactory performance by RRD and Lexicon of their obligations pursuant hereto and thereto. The allocations of responsibility described in this Article 2 shall remain subject to further modification in accordance with the terms and conditions of this Agreement and the RRD Services Agreement. (d) Lexicon hereby acknowledges and agrees to Symphony AllegroIcon’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 Icon Board, (ii) the management and administration of Symphony AllegroIcon, (iii) supervising and monitoring AlexzaLexicon’s implementation of the Programs, and (iv) subject to Section 6.1(a) and without limiting AlexzaLexicon’s role thereunder, such other development-related work as Symphony Allegro Icon may reasonably delegate to RRD in accordance with the Development Plan. (ce) With The Parties acknowledge that, subject to the rights of Symphony Icon under the Operative Documents, Lexicon may enter into arrangements with one or more third parties with respect to the AZ-002 Program development and the AZ-004 Program, Alexza shall be responsible for the execution commercialization of all pre-clinical and clinical development, all scientific and technical services associated one or more Programs or Products; provided that such arrangements are consistent with such development, and all patent work, including all related matters set forth Lexicon’s potential reversionary interest in the Development Plan for Programs and/or Products. In the event Lexicon enters into any 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 hereunderarrangement, and the engagements and delegations set forth therein shall be subject to the terms rights of Symphony Icon under the Operative Documents, Symphony Icon will use reasonable efforts to accommodate requests by Lexicon with respect to the participation of such third party in development activities hereunder relating to such Program or Product, including without limitation, participation or observation rights for Development Committee meetings and conditions of this Agreement and activities; provided such participation shall be limited to the RRD Services Agreement, and the satisfactory performance by RRD and Alexza of their obligations pursuant hereto and thereto. The allocations of responsibility described in this Article 2 shall remain subject to further modification in accordance with the terms and conditions of this Agreement and the RRD Services Agreementapplicable Programs or Products.

Appears in 1 contract

Samples: Research and Development Agreement (Lexicon Pharmaceuticals, Inc./De)

Overview of Development. (a) The Parties shall develop the Programs in a collaborative and efficient manner as set forth in this Article 2manner. Representatives of the Parties shall engage in joint decision-making for the Programs as set forth in Articles 3 and 4 hereof. Symphony Allegro GenIsis shall have overall responsibility for all matters set forth in the Development Plan (pursuant to Article 7 hereof), and shall engage Alexza Isis (pursuant to Article 6 hereof), RRD International LLC (“RRD”) (pursuant to the RRD Services Agreement), and such independent contractors and agents as it may retain with RRD’s assistance or as Alexza RRD and Isis 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)GenIsis’ behalf, to act on behalf of Symphony Allegro GenIsis 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 Isis hereby acknowledges and agrees to Symphony Allegro’s GenIsis’ engagement of RRD to act on its behalf and to carry out the duties assigned to RRD set forth herein and in the RRD Services Agreement, including, but not limited to (i) the management and administration of Symphony GenIsis, (ii) providing personnel and support to the Development Committee and the Symphony Allegro GenIsis Board, (ii) the management and administration of Symphony Allegro, (iii) hiring, on Symphony GenIsis’ behalf, independent contractors and vendors, (iv) supervising and monitoring Alexza’s implementation the development of the Programs, and (ivv) subject to Section 6.1(a) and without limiting Alexza’s role thereunder, such other development-related work as Symphony Allegro GenIsis may reasonably delegate to RRD in accordance with the Development PlanRRD. (c) With respect to the AZ-002 ApoB Program, the GCGR Program and the AZ-004 GCCR Program, Alexza Isis 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(cclause (c) shall in any way limit the authority of the Development Committee (as defined below) or the Symphony Allegro GenIsis Board hereunder, and the engagements and delegations set forth therein shall be subject to the terms and conditions of this Agreement and the RRD Services Agreement, and the satisfactory performance by RRD and Alexza Isis of their obligations pursuant hereto and thereto. The allocations of responsibility described in this Article 2 shall remain subject to further modification in accordance with the terms and conditions of this Agreement and the RRD Services Agreement.

Appears in 1 contract

Samples: Research and Development Agreement (Isis Pharmaceuticals Inc)

Overview of Development. (a) The Parties Gilead shall develop be primarily responsible for Development and seeking Regulatory Approval of the Programs Licensed Product and Gilead Combination Products in a collaborative the Gilead Territory and efficient manner as set forth shall use Commercially Reasonable Efforts with respect thereto for the first Licensed Product in […***…] in both […***…]. Notwithstanding anything to the contrary in this Article 2Agreement (but subject to the Transition & Amendment Agreement), the immediately foregoing obligation with respect to Commercially Reasonable Efforts in […***…] and the […***…] indications shall be Gilead’s sole diligence obligation with respect to Development of Licensed Products and Gilead Combination Products, and Gilead shall have the right, but not any obligation, to Develop other Licensed Products and Gilead Combination Products in other countries in the Gilead Territory or for other indications and no diligence obligation of Gilead shall arise under this Agreement with respect to Development of Gilead Combination Products. Representatives Galapagos shall use Commercially Reasonable Efforts as reasonably requested by Gilead to assist Gilead with Development activities with respect to the P […***…]. Upon initiation of a […***…], Gilead hereby commits, absent Safety Issues, to complete such Clinical Trial (or such portion thereof), subject to Section 13.3(a)(ii). For the avoidance of doubt, the foregoing obligation does not apply to any long term extension of such […***…]. Following each data read-out of such […***…], at the request of Gilead, the Parties shall engage discuss the efficacy and safety implications of such data and, in joint decisionlight of such implications, consider whether to continue, amend or wind-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 down such […***…].” The Parties agree that the Development Plan (pursuant to Article 7 hereof)and Budget supersedes and replaces all existing Development Plans as of the Effective Date, and the Parties shall engage Alexza (pursuant to Article 6 hereof), RRD (pursuant to the RRD Services Agreement), and have no further obligations under any 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 delegations set forth therein shall be subject to the terms and conditions of this Agreement and the RRD Services Agreement, and the satisfactory performance by RRD and Alexza of their obligations pursuant hereto and thereto. The allocations of responsibility described in this Article 2 shall remain subject to further modification in accordance with the terms and conditions of this Agreement and the RRD Services Agreement.

Appears in 1 contract

Samples: Transition & Amendment Agreement (Galapagos Nv)

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Overview of Development. (a) The Parties shall develop the Programs in a collaborative and efficient manner manner, as set forth in this Article 2. below. (a) Representatives of the Parties shall engage in joint decision-making for the Programs as set forth in Articles 3 and 4 hereof4. Symphony Allegro Dynamo shall have overall responsibility for all matters set forth in the Development Plan (pursuant to Article 7 hereof), and shall engage Alexza Dynavax (pursuant to Article 6 hereof), RRD International, LLC (“RRD”) (pursuant to the RRD Services Agreement), and such independent contractors and agents as it may retain with RRD’s assistance or as Alexza RRD and Dynavax may retain on Symphony AllegroDynamo’s behalf (which contractors may include entities retained by Alexza Dynavax prior to the Closing Date pursuant to the Subcontracting Agreements set forth on Schedule 6.2Date), to act on behalf of Symphony Allegro Dynamo and carry out the duties set forth therein and [ * ] = 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. herein, including managementincluding, supervisory without limitation, management 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 Dynavax hereby acknowledges and agrees to Symphony AllegroDynamo’s engagement of RRD to act on its behalf of Symphony Dynamo and to carry out the duties assigned to RRD set forth herein and in the RRD Services Agreement. In accordance with this 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 Parties each hereby agree that Dynavax shall have primary responsibility for implementation of the Programs; provided, and (iv) however, that any implementation responsibility which may be delegated to RRD following the Closing Date shall be executed subject to Section 6.1(a) the oversight of the Symphony Dynamo Board 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 PlanCommittee. Notwithstanding the foregoing, nothing in this Section 2(b) shall limit the rights and responsibilities of the Development Committee as set forth in the Symphony Dynamo Charter and the Development Committee Charter. (c) With respect to the AZ-002 Hepatitis B Program, the Hepatitis C Program and the AZ-004 Cancer Program, Alexza Dynavax 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(cclause (c) shall in any way limit the authority of the Development Committee (as defined below) or the Symphony Allegro Dynamo Board hereunder, and the engagements and delegations set forth therein shall be subject to the terms and conditions of this Agreement and the RRD Services Agreement, and the satisfactory performance by RRD and Alexza Dynavax of their obligations pursuant hereto and thereto. The allocations of responsibility described in this Article 2 shall remain subject to further modification in accordance with the terms and conditions of this Agreement and the RRD Services Agreement.

Appears in 1 contract

Samples: Research and Development Agreement (Dynavax Technologies Corp)

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. The Symphony Allegro Collaboration shall have overall responsibility for all Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. matters set forth in the Development Plan (pursuant to Article 7 hereof), and shall engage Alexza the Company (pursuant to Article 6 hereof), RRD (pursuant to the RRD Services Agreement), and such independent contractors and agents as the Company may retain on the Symphony Collaboration’s behalf or 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 the Company prior to the Closing Date pursuant to the Subcontracting Agreements set forth on Schedule 6.2), to act on behalf of the Symphony Allegro Collaboration 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(b) With respect to the Programs, the Company shall be responsible for the execution of all non-clinical and clinical development, manufacturingall regulatory activities, all scientific and technical services associated with such developmentdevelopment (including manufacturing), and all patent work under work, including all related matters set forth in the Development Plan for such Programs. (bc) Alexza Nothing in Section 2(b) shall in any way limit the authority of the Development Committee (as defined below) or the Symphony Collaboration Board hereunder, and the engagements and delegations set forth therein shall be subject to the terms and conditions of this Agreement and the RRD Services Agreement, and the satisfactory performance by the Company and RRD of their obligations pursuant hereto and thereto. The allocations of responsibility described in this Article 2 shall remain subject to further modification in accordance with the terms and conditions of this Agreement and the RRD Services Agreement. (d) The Company hereby acknowledges and agrees to the Symphony AllegroCollaboration’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 Collaboration Board, (ii) the management and administration of the Symphony AllegroCollaboration, (iii) supervising and monitoring Alexzathe Company’s implementation of the Programs, and (iv) subject to Section 6.1(a) and without limiting Alexzathe Company’s role thereunder, such other development-related work as the Symphony Allegro Collaboration 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 delegations set forth therein shall be subject to the terms and conditions of this Agreement and the RRD Services Agreement, and the satisfactory performance by RRD and Alexza of their obligations pursuant hereto and thereto. The allocations of responsibility described in this Article 2 shall remain subject to further modification in accordance with the terms and conditions of this Agreement and the RRD Services Agreement.

Appears in 1 contract

Samples: Research and Development Agreement (Oxigene Inc)

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