Common use of Attendance at Regulatory Meetings; Correspondence Clause in Contracts

Attendance at Regulatory Meetings; Correspondence. Each Party shall provide the others with prior notice of all meetings and teleconferences between representatives of the notifying Party and regulatory authorities regarding any Collaboration Product for use in the Territory. Except as otherwise provided herein, the Party receiving such notice shall have the right to have representatives participate in all such meetings and teleconferences. Each Party shall use reasonable efforts to provide the other Party with a reasonable opportunity to review and comment upon submissions to, and correspondence with, any regulatory agency in the Territory with respect to Collaboration Products prior to the filing or delivery of such submissions or correspondence. Without limiting the foregoing, each Party shall use reasonable efforts to confirm in writing to the other Party all communications with a regulatory authority with respect to a Regulatory Approval (including filings therefor) and to provide to the other Party copies of all documents sent to or received from such regulatory authority regarding such Regulatory Approvals.

Appears in 2 contracts

Samples: Collaboration Agreement (Biomarin Pharmaceutical Inc), Collaboration Agreement (Genzyme Corp)

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Attendance at Regulatory Meetings; Correspondence. Each ------------------------------------------------- Party shall provide the others with prior notice of all meetings and teleconferences between representatives of the notifying Party and regulatory authorities regarding any Collaboration Product for use in the Territory. Except as otherwise provided herein, the Party receiving such notice shall have the right to have representatives participate in all such meetings and teleconferences. Each Party shall use reasonable efforts to provide the other Party with a reasonable opportunity to review and comment upon submissions to, and correspondence with, any regulatory agency in the Territory with respect to Collaboration Products prior to the filing or delivery of such submissions or correspondence. Without limiting the foregoing, each Party shall use reasonable efforts to confirm in writing to the other Party all communications with a regulatory authority with respect to a Regulatory Approval (including filings therefor) and to provide to the other Party copies of all documents sent to or received from such regulatory authority regarding such Regulatory Approvals.

Appears in 1 contract

Samples: Collaboration Agreement (Biomarin Pharmaceutical Inc)

Attendance at Regulatory Meetings; Correspondence. Each Party shall provide the others other with prior notice of all meetings and teleconferences between representatives of the notifying Party and regulatory authorities Regulatory Authorities regarding any Collaboration Product intended for use sale in any part of the Territory. Except as otherwise provided herein, the Party receiving such notice shall have the right to have representatives participate in present as observers at all such meetings and teleconferences. Each Party shall use reasonable efforts to provide the other Party with a reasonable opportunity to review and comment upon submissions to, and correspondence with, any regulatory agency Regulatory Authority in the Territory Territory, with respect to Collaboration Products prior to the filing or delivery of such submissions or correspondence. Without limiting the foregoing, each Party shall use reasonable efforts to confirm in writing to the other Party all communications with a regulatory authority Regulatory Authority with respect to a Regulatory Approval (including filings therefor) and to provide to the other Party copies of all documents sent to or received from such regulatory authority Regulatory Authority regarding such Regulatory Approvals.

Appears in 1 contract

Samples: Collaboration Agreement (Mirati Therapeutics, Inc.)

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Attendance at Regulatory Meetings; Correspondence. Each ------------------------------------------------- Party shall provide the others with prior notice of all meetings and teleconferences between representatives of the notifying Party and regulatory authorities regarding any Collaboration Product for use in the Territory. Except as otherwise provided herein, the Party receiving such notice shall have the right to have representatives participate in all such meetings and teleconferences. Each Party shall use reasonable efforts to provide the other Party with a reasonable opportunity to review and comment upon submissions to, and correspondence with, any regulatory agency in the Territory with respect to Collaboration Products prior to the filing or delivery of such submissions or correspondence. Without limiting the foregoing, each Party shall use reasonable efforts to confirm in writing to the other Party all communications with a regulatory authority with respect to a Regulatory Approval (including filings therefor) and to provide to the other Party copies of all documents sent to or received from such regulatory authority regarding such Regulatory Approvals.. [* CONFIDENTIAL TREATMENT REQUESTED]

Appears in 1 contract

Samples: Collaboration Agreement (Biomarin Pharmaceutical Inc)

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