Common use of Contribution of the Parties Clause in Contracts

Contribution of the Parties. 2.1.1 The Parties agree to duly cooperate as to the purpose of this Agreement in performing an investigation regarding the manufacturing of clinical samples and later commercial supplies of the Products, clinical trials and registration based on the Design and the manufacturing technology and know-how provided by BDSI regarding the Product including, but not limited to clinical trials and registration, all in accordance with and as to the extent further specified and provided in this Agreement. 2.1.2 Based on Technical Information as disclosed by BDSI, LTS shall use Commercially Reasonable Efforts to develop the Process to manufacture the Product for BDSI in accordance with the applicable Product Specifications and the Project Plan. 2.1.3 Solely for the purpose of LTS’s performance of its obligations to BDSI hereunder, BDSI will disclose to LTS all necessary BDSI Technology concerning formulation, ingredients and compounding ratio of the Product, the Product specification values, manufacturing method and other technology and know-how of the Product. Such disclosures will be deemed to be the Confidential Information of BDSI for all purposes hereunder. 2.1.4 LTS shall use its Commercially Reasonable Efforts to supply quantities of Product to BDSI according to the Project Plan. All Products supplied by LTS hereunder shall: (a) conform to the Product Specifications; and (b) be manufactured, labelled, packaged and tested (while in the possession or control of LTS) in accordance with GMP and the applicable laws and regulations relating to the manufacture, labelling, packaging and testing of the Product. 2.1.5 LTS shall use its Commercially Reasonable Efforts to prepare as soon as possible those sections of any applicable regulatory documents of an Authority which concern the development of the Process or the manufacturing of the Product by LTS and shall provide those sections to BDSI as soon as possible for inclusion in any applicable regulatory filings with an Authority which concern the Product. To the extent disclosure of LTS’ proprietary information is required for such purposes, Section 10.7. shall govern. 2.1.6 BDSI shall provide ***. 2.1.7 To the extent required by law, BDSI shall use its Commercially Reasonable Efforts to ensure that LTS has the right to reasonably audit the supplier of the Active Principle for compliance with relevant regulatory requirements including GMP. 2.1.8 BDSI or its Affiliates or its licensees shall be responsible for the clinical trials, the registration of the Product with the proper health, customs and other Authorities, as applicable, to be carried out in BDSI’s sole discretion. 2.1.9 LTS shall ***.

Appears in 1 contract

Sources: Process Development Agreement (Biodelivery Sciences International Inc)

Contribution of the Parties. 2.1.1 The Parties agree to duly cooperate as to the purpose of this Agreement in performing an investigation regarding the manufacturing of clinical samples and later commercial supplies of the Products, clinical trials and registration based on the Design and the manufacturing technology and know-how provided by BDSI regarding the Product including, but not limited to clinical trials and registration, all in accordance with and as to the extent further specified and provided in this Agreement. 2.1.2 Based on Technical Information as disclosed by BDSI, LTS shall use Commercially Reasonable Efforts to develop the Process to manufacture the Product for BDSI in accordance with the applicable Product Specifications and the Project Plan. 2.1.3 Solely for the purpose of LTS’s performance of its obligations to BDSI hereunder, BDSI will shall disclose to LTS all necessary BDSI Technology concerning formulation, ingredients and compounding ratio of the Product, the Product specification values, manufacturing method and other technology and know-how of the Product. Such disclosures will be deemed to be the Confidential Information of BDSI for all purposes hereunder. 2.1.4 LTS shall use its Commercially Reasonable Efforts to supply quantities of Product to BDSI according to the Project Plan. All Products supplied by LTS hereunder shall: (a) conform to the Product Specifications; and (b) be manufactured, labelled, packaged and tested (while in the possession or control of LTS) in accordance with GMP and the applicable laws and regulations relating to the manufacture, labelling, packaging and testing of the Product. 2.1.5 LTS shall use its Commercially Reasonable Efforts to prepare as soon as possible those sections of any applicable regulatory documents of an Authority which concern the development of the Process or the manufacturing of the Product by LTS and shall provide those sections to BDSI as soon as possible for inclusion in any applicable regulatory filings with an Authority which concern the Product. To the extent disclosure of LTS’ proprietary information is required for such purposes, Section 10.7. shall govern. . 2.1.6 BDSI shall provide LTS ***.* 2.1.7 To the extent required by law, BDSI shall use its Commercially Reasonable Efforts to ensure that LTS has the right to reasonably audit the supplier of the Active Principle for compliance with relevant regulatory requirements including GMP. 2.1.8 BDSI or its Affiliates or its licensees shall be responsible for the clinical trials, the registration of the Product with the proper health, customs and other Authorities, as applicable, to be carried out in BDSI’s sole discretion. 2.1.9 LTS shall only **** 2.2.0 If the Parties decide to commence the commercial manufacture of the Product, LTS shall be in charge of exclusive manufacturing for the Products in the Territory at any of LTS’ manufacturing sites subject to LTS’ sole discretion.

Appears in 1 contract

Sources: Process Development Agreement (Biodelivery Sciences International Inc)