Common use of Development Obligation Clause in Contracts

Development Obligation. (a) After the Effective Date, BI shall use its [ * ] and shall accept the corresponding responsibility, at its sole cost and expense, for the development, safety of, and all required periodic reporting to Competent Authorities required to obtain all regulatory approvals for, the Licensed Product(s) for the Field in the Major Market countries. (b) After the Effective Date, BI shall provide to ImmunoGen regular written reports every [ * ], setting forth (i) significant developments with respect to Licensed Product, and (ii) the status and progress of the development and/or registration activities related to the Licensed Product. (c) BI shall promptly advise ImmunoGen in writing upon the filing for regulatory approval to market a Licensed Product, and upon receipt of regulatory approval to market a Licensed Product, in each case in each country of the Territory. (d) ImmunoGen shall use [ * ] to [ * ] and [ * ] the [ * ] for Drug Product to meet BI's requirements for conduct of clinical trials, according to the development plan attached as Schedule F and thereby agrees to maintain the basic assumptions included in Schedule F which may be amended by the Parties during the development. During this [ * ] and [ * ], ImmunoGen will keep BI informed on a regular basis and BI shall be entitled to advise and contribute to such process, as appropriate. (e) ImmunoGen shall provide the necessary documentation and assist BI in preparation of the chemical, pharmaceutical, and analytical sections of regulatory submissions for IND or foreign equivalent.

Appears in 1 contract

Sources: Development and License Agreement (Immunogen Inc)

Development Obligation. (a) After the Effective Date, BI shall use its [ * ] and shall accept the corresponding responsibility, at its sole cost and expense, for the development, safety of, and all required periodic reporting to Competent Authorities required to obtain all regulatory approvals for, the Licensed Product(s) for the Field in the Major Market countries. (b) After the Effective Date, BI shall provide to ImmunoGen regular written reports every every[ * ], setting forth (i) significant developments with respect to Licensed Product, and (ii) the status and progress of the development and/or registration activities related to the Licensed Product. (c) BI shall promptly advise ImmunoGen in writing upon the filing for regulatory approval to market a Licensed Product, and upon receipt of regulatory approval to market a Licensed Product, in each case in each country of the Territory. (d) ImmunoGen shall use [ * ] to [ * ] and [ * ] the [ * ] for Drug Product [ * ] to meet BI's requirements [ * ]for conduct [ * ] of clinical trials[ * ] , according to the development plan [ * ] attached as Schedule F [ * ] and thereby agrees to maintain the basic assumptions [ * ] included in Schedule F [ * ]which may be amended by the Parties during the development. During this [ * ] and and[ * ], ImmunoGen will keep BI informed on a regular basis and BI shall [ * ] be entitled [ * ] to advise [ * ] and contribute [ * ] to such processsuch[ * ], as appropriate. (e) ImmunoGen shall provide the necessary documentation and assist BI in preparation of the chemical, pharmaceutical, and analytical sections of regulatory submissions for IND or foreign equivalent.

Appears in 1 contract

Sources: Development and License Agreement (Immunogen Inc)