Common use of Communications with Regulatory Authorities Clause in Contracts

Communications with Regulatory Authorities. As between the Parties, EYEFITE shall be responsible for all communications with any Regulatory Authority relating to the Licensed Product or Licensed Compound in the Territory during the term of this Agreement. As relating to the Licensed Product or Licensed Compound, EYEFITE (or its Affiliates or Sublicensees) shall promptly provide CANFITE with copies of all (i) material written communications to or from any Regulatory Authority, and (ii) written meeting minutes or summaries of material meetings, conferences and discussions with Regulatory Authorities. Except as necessary to comply with the Laws, CANFITE shall not initiate any communications with any Regulatory Authority concerning the Licensed Compound or the Licensed Product without first obtaining EYEFITE’s approval. (a) EYEFITE shall promptly inform CANFITE of any action, correspondence or reports to or from governmental authorities (other than Regulatory Authorities) that would reasonably be expected to materially affect the current or anticipated development or commercialization of the Licensed Product or Licensed Compound, and shall furnish CANFITE with copies of any relevant documents relating thereto.

Appears in 3 contracts

Samples: License Agreement (Can-Fite BioPharma Ltd.), License Agreement (Can-Fite BioPharma Ltd.), License Agreement (Denali Concrete Management Inc)

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Communications with Regulatory Authorities. As between the Parties, EYEFITE XTL shall be responsible for all communications with any Regulatory Authority relating to the Licensed Product or Licensed Compound in the Territory during the term of this Agreement. As Subject to Section 3.3, as relating to the Licensed Product or Licensed Compound, EYEFITE XTL (or its Affiliates or Sublicensees) shall promptly provide CANFITE DOV with copies of all (i) material written communications to or from any Regulatory Authority, and (ii) written meeting minutes or summaries of material meetings, conferences and discussions with Regulatory Authorities. Except as necessary to comply with the Laws, CANFITE DOV shall not initiate any communications with any Regulatory Authority concerning the Licensed Compound or the Licensed Product without first obtaining EYEFITEXTL’s approval. (a) EYEFITE XTL shall promptly inform CANFITE DOV of any action, correspondence or reports to or from governmental authorities Governmental Authorities (other than Regulatory Authorities) that would reasonably be expected to materially affect the current or anticipated development or commercialization of the Licensed Product or Licensed Compound, and shall furnish CANFITE DOV with copies of any relevant documents relating thereto.

Appears in 2 contracts

Samples: License Agreement (Dov Pharmaceutical Inc), License Agreement (XTL Biopharmaceuticals LTD)

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