Common use of Correspondence for Licensed Products Clause in Contracts

Correspondence for Licensed Products. To the extent reasonably practicable and subject to any Third Party confidentiality obligations, Bayer shall provide ImmunoGen with copies of any material documents or correspondence pertaining to ImmunoGen’s manufacture of Preclinical Materials, Clinical Materials or any Licensed Product and prepared for submission to any Regulatory Authority and any material documents or other correspondence received from any Regulatory Authority pertaining to ImmunoGen’s manufacture of Preclinical Materials, Clinical Materials or any Licensed Product. ImmunoGen shall complete its review within [***] after receipt of the proposed submission. When requested in writing, ImmunoGen shall provide reasonable assistance to Bayer in obtaining Regulatory Approvals for Licensed Product. Notwithstanding the foregoing, Bayer shall have the sole responsibility for, and ImmunoGen agrees that Bayer shall be the sole owner of, any Regulatory Approval for the Licensed Product.

Correspondence for Licensed Products. To the extent reasonably practicable and subject to any Third Party confidentiality obligations, Bayer Centocor shall provide ImmunoGen with copies of any material documents or correspondence pertaining to ImmunoGen’s manufacture of Preclinical Materials, Clinical Materials or any Licensed Product and prepared for submission to any Regulatory Authority the FDA and any material documents or other correspondence received from any Regulatory Authority the FDA pertaining to ImmunoGen’s manufacture of Preclinical Materials, Clinical Materials or any Licensed Product. ImmunoGen shall complete its review within [********] days after receipt of the proposed submission. When requested in writing, ImmunoGen shall provide reasonable assistance to Bayer Centocor in obtaining Regulatory Approvals for Licensed Product. Notwithstanding the foregoing, Bayer Centocor shall have the sole responsibility for, and ImmunoGen agrees that Bayer Centocor shall be the sole owner of, any Regulatory Approval for the Licensed Product.