General Development Obligations Sample Clauses
The General Development Obligations clause sets out the fundamental responsibilities and standards that parties must follow during the development phase of a project or product. Typically, it outlines requirements such as adhering to agreed timelines, meeting specified quality standards, and ensuring compliance with applicable laws and regulations. For example, it may require regular progress updates or mandate the use of certain development methodologies. The core function of this clause is to establish clear expectations and accountability, thereby reducing misunderstandings and ensuring that the development process proceeds smoothly and efficiently.
General Development Obligations. IPC shall use Commercially Reasonable Efforts to develop the Product in accordance with this Agreement. IPC's development responsibilities shall include, without limitation, the following:
General Development Obligations. Spectrum shall use Commercially Reasonable Efforts to develop each Product, for all applicable dosage strengths and Packaging forms listed on Schedules 1.18, 1.19, 1.20 and 1.37. For future products, it is the intent of both Parties for Spectrum to develop all approved dosage strengths and Packaging forms, however, the Committee shall decide which dosage strengths and Packaging forms will be developed. Spectrum’s development responsibilities shall include, without limitation, the following:
2.1.1. Spectrum shall develop a stable final dosage form of each Product, which does not infringe any Third Party Intellectual Property that shall be Therapeutically Equivalent to the corresponding Reference Listed Drug. ***
2.1.2. Spectrum shall manufacture, or ensure that a Third Party manufactures, all supplies of the Products required for Regulatory Approval in facilities that meet the Applicable Laws.
2.1.3. Spectrum shall be responsible for, and maintain, materials, facilities and personnel reasonably necessary to fulfill its obligations under this Agreement.
2.1.4. Spectrum shall keep Par informed of the progress of the development of the Products and shall cooperate with Par and its legal counsel in assessing and avoiding infringement of Third Party Intellectual Property ***, including, but not limited to, providing Par and its legal Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. counsel with proposed and final formulations, results of all testing and analytical studies, API processing and synthesis information, manufacturing processes and access to Spectrum’s technical personnel involved in the development of a Product.
2.1.5. Spectrum shall conduct all reasonable testing and analytical studies required by the FDA to support an ANDA for each Product as applicable.
General Development Obligations. Developers shall develop the Product in accordance with this Agreement with a regulatory filing target of the second half of 2011, Developer’s development responsibilities shall include the following:
2.1.1 Developers shall develop a stable final dosage form of the Product suitable for submission of an application for Regulatory Approval to the FDA for approval to market such Product in the Territory, such that the Product is Bioequivalent to the Reference Product as listed in the Orange Book, as expeditiously as reasonably practicable.
2.1.2 Except as provided in Section 2.5 below, Developers shall be solely responsible for all product development activities necessary to support the filing of the applicable application for Regulatory Approval for the Product, including development of appropriate analytical methods, development of a GMP compliant and commercially competitive manufacturing process; stability studies and other analytical testing; all manufacturing scale up activities; and all necessary preclinical and in vitro studies.
2.1.3 In carrying out its development responsibilities, Developers shall cooperate and coordinate with Stason, and Stason shall have final authority in establishing the final Product Specifications for the Territory. Developers shall cooperate with Stason and its legal counsel in assessing and avoiding infringement of third party Intellectual Property.
2.1.4 Developers, upon request by Stason, shall transfer to Stason all data, information and materials generated or obtained in connection with the Product for use in the Territory, including with respect to the components thereof, and all associated methods and analytical testing, within five (5) business days of completion or generation, of such data, information and materials, on an ongoing basis.
2.1.5 Developers will promptly complete timely requests for information from Stason relating to the development and manufacture of the Product. To the extent that Stason requests access to information or materials reasonably necessary or useful in preparing the applications for Regulatory Approval or necessary or useful in assessing any regulatory issues or Intellectual Property issues or concerns (collectively, the “Product Information”), such as formulation information, methods and processes, analytical and processing techniques, product and API samples, processing techniques and any other information, for these purposes, Developers will promptly disclose such Product Information ...
General Development Obligations. Developers shall develop each Product in accordance with this Agreement, including the decisions of the Development Committee as described below. Unless otherwise decided by the Development Committee or expressly set forth in an applicable Additional Product Addendum as described below, Developer’s development responsibilities shall include, the following;”
Section 2.1.1 of the Development Agreement is hereby deleted in its entirety and replaced with the following:
2.1.1 Developers shall develop a stable final dosage form of the Product suitable for submission of an application for Regulatory Approval for approval to market such Product in the Territory as expeditiously as reasonably practicable.” The introductory paragraph of Section 2.4 of the Development Agreement is hereby deleted in its entirety and replaced with the following: