Common use of Development Programs Clause in Contracts

Development Programs. Each Development Program initiated by Biogen, if any, shall be based on the study of one of the three Ontogeny Hedgehog Proteins and shall have as its goal the development and commercialization of a product or products comprising one or more Hedgehog-based Molecular Entities that derive from such Ontogeny Hedgehog Protein. Each Party shall have the responsibility, during the term of the Development Program, to conduct those development, manufacturing and commercialization activities that are assigned to such Party in a development and commercialization plan prepared by Biogen and approved by Ontogeny (the "Development and Commercialization Plan") which such approval shall not be unreasonably withheld. It is anticipated that the Development and Commercialization Plan shall provide that (i) the Development Program shall be managed by development and commercialization committees established and staffed by Biogen, provided, however, that non-voting representatives of Ontogeny shall be permitted to attend (1) all meetings of such committees that are devoted solely to the review of the Development Program and all meetings of such committees that are devoted solely to a review of other activities directly related to the development, manufacturing and commercialization of any product(s) comprising a Hedgehog-based Molecular Entity(ies) based on the Ontogeny Hedgehog Protein that is the subject of such Development Program, and (2) only at Biogen's invitation, other Biogen meetings covering the development and commercialization activities related to such Development Program, (ii) Biogen shall have the major responsibility for the development and commercialization of any product(s) comprising a Hedgehog-based Molecular Entity(ies) based on the Ontogeny Hedgehog Protein that is the subject of the Development Program, provided, however, that Ontogeny shall participate with Biogen in (1) the preclinical development of such product(s) (with all data provided to, and considered Confidential Information of, Biogen), (2) at Biogen's option where appropriate, the clinical development of such product(s) in the United States (with all data provided to, and considered Confidential Information of, Biogen), and (3) subject to Biogen's reasonable discretion after mutual good faith discussion between the Parties, the marketing of (not including sales), and the professional education activities with respect to, such product(s) in the Territory, and (iii) Biogen shall have the responsibility for all aspects of the manufacture (either by itself or by one of its Affiliates or using a contract manufacturer or otherwise) of any product(s) comprising a Hedgehog-based Molecular Entity based on the Ontogeny Hedgehog Protein that is the subject of the Development Program, provided, however, Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions. that in the event that Biogen elects to have such product(s) bulk manufactured by more than one manufacturing source in the United States, and Ontogeny is or will be, in Biogen's reasonable opinion, capable of manufacturing bulk commercial product to meet Biogen's commercially reasonable schedule, Biogen shall grant to Ontogeny the right of first refusal to manufacture such product as a second manufacturing source in the United States, under the terms of a manufacturing agreement to be negotiated in good faith by the Parties. In the event that a Development Program is initiated by Biogen, Biogen hereby agrees to provide Ontogeny, at Ontogeny's reasonable request, with copies of or, at Biogen's option, detailed summaries of, those substantive documents relating to the preclinical and clinical development, regulatory affairs, manufacture and/or marketing of any product(s) comprising a Hedgehog-based Molecular Entity(ies) based on the Ontogeny Hedgehog Protein that is the subject of such Development Program, as well as copies of or, at Biogen's option, detailed summaries of, any other substantive documents relating to such product(s) that are reasonably requested by Ontogeny, provided, however, that Biogen may delete information from the above documents that it determines, in its sole commercially reasonable discretion, is sensitive commercial of financial information of Biogen. In the event that a Development Program is initiated by Biogen, Biogen also agrees to hold two (2) strategy meetings per year. The purpose of these meetings will be for Ontogeny and Biogen to discuss the overall strategy and direction of the Development Program(s), including any significant changes since the last strategy meeting. The meetings shall be attended by at least three people from each Party, two of whom will be vice president level or above, and each Party shall provide representation from its business and from its scientific departments. A Development Program, if initiated, shall commence upon the date on which Biogen exercises its option with respect to such Development Program, pursuant to Section 3.6, and shall terminate upon the earliest of (i) the First Commercial Sale in the first Major Market Country of the first Licensed Product comprising a Hedgehog-based Molecular Entity based on the Ontogeny Hedgehog Protein that was the subject of such Development Program, (ii) the receipt by Ontogeny of written notification from Biogen of Biogen's decision to terminate such Development Program (a "Biogen Early Termination Notification"), (iii) a Mandatory Termination (as that term is defined in Section 6.3) with respect to such Development Program and (iv) the termination of this Agreement.