Celgene Responsibilities. Subject to the oversight of the Joint Development Committee, Celgene shall be solely responsible for managing all Celgene Development Activities relating to Licensed Compounds or Licensed Products. Without limiting the foregoing, upon completion or abandonment of the initial Phase 2A Clinical Trial for a Licensed Compound or related Licensed Product, any and all further Phase 2A Clinical Trials (or early-stage Development activities) for such Licensed Compound or Licensed Product shall be performed by Celgene, unless otherwise agreed by the Joint Development Committee; provided that any Phase 2A Clinical Trials that are ongoing at the time of such completion or abandonment of such initial Phase 2A Clinical Trial shall remain the responsibility of Acceleron. Celgene shall use Commercially Reasonable Efforts to carry out the Celgene Development Activities as set forth in the applicable Development Plan/Budget to Develop Licensed Compounds and Licensed Products. Celgene shall use Commercially Reasonable Efforts to Develop and seek Regulatory Approval for Licensed Products in the Major Market Countries.
Celgene Responsibilities. Notwithstanding that EPIZYME is primarily responsible for the conduct of the activities set forth in the Research Plan, and subject to Section 4.7, CELGENE shall be responsible for, and shall use Commercially Reasonable Efforts to perform, the activities assigned to CELGENE under the Research Plan.
Celgene Responsibilities. Celgene shall be responsible for Manufacturing, or having Manufactured by its designee, all supply of Licensed Products not included within Agios Clinical-Scale Manufacturing Responsibilities and Agios Commercial-Scale Manufacturing Responsibilities, including drug product manufacturing and processing, filling, packaging, labeling, shipping and storage of Licensed Products for all Clinical Trials (other than Phase I Studies) and for Commercialization of Licensed Products (collectively, the “Celgene Manufacturing Responsibilities”). Celgene shall fulfill a substantial portion of the Celgene Manufacturing Responsibilities from within Celgene’s or its designee’s manufacturing facility located in Switzerland or another country mutually agreed in writing by the Parties such that the Licensed Products are treated as manufactured in Switzerland or such other country for purposes of Section 954(d) of the Code and Section 1.954-3(a)(2) of the Treasury Regulations (or any other similar provision of the Code or Treasury Regulations in effect as of any time); provided that Celgene may obtain raw materials from any country as determined by Celgene for use in connection with the Celgene Manufacturing Responsibilities, and provided further that if Agios disagrees that the fulfillment of the Celgene Manufacturing Responsibilities is such that the Licensed Products are so treated, Celgene shall deliver to Agios an opinion of an independent nationally recognized law or accounting firm that the Licensed Products should be so treated.
Celgene Responsibilities. Subject to the terms and conditions of this Agreement, Celgene will assume sole responsibility for Manufacture of the Licensed Products and Companion Diagnostics for Development and Commercialization in the Territory (collectively, the “Celgene Manufacturing Responsibilities”).
Celgene Responsibilities. Subject to the oversight of the Joint Development Committee, Celgene shall be solely responsible for managing all Celgene Development Activities relating to Licensed Compounds or Licensed Products. Celgene shall use Commercially Reasonable Efforts to carry out (a) the Celgene Development Activities as set forth in the Celgene Development Plan/Budget to Develop Licensed Compounds and Licensed Products in the Celgene Field and (b) any Celgene Development Activities in the PH Field as set forth in the PH Field Development Plan/Budget. Celgene shall use Commercially Reasonable Efforts to Develop and seek Regulatory Approval for Licensed Products in the Celgene Field in the Major Market Countries.
Celgene Responsibilities. Following Juno’s exercise of the Commercialization Opt-In Right, Celgene shall remain responsible for:
(a) the form and content of the Commercialization Plan for Commercialization of Celgene Program Co-Co Products for ROW Territory Administration, [***], and for all activities relating to the Commercialization of Celgene Program Co-Co Products;
(b) booking all sales of Celgene Program Co-Co Products in the relevant territory;
(c) execution of [***], including [***], and [***], including [***]; and
(d) all market access activities, including [***] in the relevant territory.
Celgene Responsibilities. During the Research Term, CELGENE may perform the activities assigned to CELGENE under the Research Plan. It is anticipated that CELGENE would be primarily responsible for GLP toxicology studies.
Celgene Responsibilities. During the Term, on a Program-by-Program basis, Celgene may perform the activities assigned to Celgene under the applicable IDP or Research Plan. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Celgene Responsibilities. As of the Effective Date, Celgene shall be responsible for all drug product manufacturing and processing and filling of Licensed Products for all Clinical Trials (“Celgene Clinical-Scale Manufacturing Responsibilities”) and for Commercialization of Licensed Products (the “Celgene Commercial-Scale Manufacturing Responsibilities”) (Celgene Clinical-Scale Manufacturing Responsibilities and Celgene Commercial-Scale Manufacturing Responsibilities, collectively, the “Celgene Manufacturing Responsibilities”). Celgene shall fulfill a substantial portion of the Celgene Commercial-Scale Manufacturing Responsibilities from [**] for purposes of Section 954(d) of the Code and Section 1.954-3(a)(2) of the Treasury Regulations (or any other similar provision of the Code or Treasury Regulations in effect as of any time); provided that Celgene may obtain raw materials from any country as determined by Celgene for use in connection with the Celgene Manufacturing Responsibilities, and provided further that [**].
Celgene Responsibilities. Celgene shall be responsible for Manufacturing, or having Manufactured by its designee, all supply of Licensed Products, including drug product manufacturing and processing, filling, packaging, labeling, shipping and storage of Licensed Products for all Clinical Trials (other than Ongoing Clinical Trials conducted by Agios pursuant to Section 3.1) and for Commercialization of Licensed Products (collectively, the “Celgene Manufacturing Responsibilities”).
