Notice of Regulatory Action. To the extent permitted by applicable Law, each Seller shall promptly notify the applicable Purchaser of any action, claim, inquiry, audit, investigation or examination taken or made by a Government Authority that may affect the conduct of a Serviced Appointment and shall consult with such Purchaser as to any changes in duties or other arrangements hereunder to be taken in connection therewith.
Notice of Regulatory Action. If any Regulatory Authority takes or gives notice of its intent to take any regulatory action with respect to any Research Program activity of Ambrx, then Ambrx shall promptly notify BMS of such contact, inspection or notice or action. The JRC shall review and comment on any such responses to Regulatory Authorities that pertain to the Compounds and/or Products; provided that BMS shall have the final decision making authority with respect to such responses to the extent relating to the Compounds and/or Products.
Notice of Regulatory Action. If any Third Party, including a Regulatory Authority, takes or gives notice of its intent to take any regulatory action with respect to any activity of a Party pursuant to this Agreement, which regulatory action could reasonably be expected to materially adversely affect any Development, Manufacture, or Commercialization activities with respect to Product in the Licensed Field or in the Retained Field in the Territory, then such Party shall promptly notify the other Party of such notice or action, and the Parties shall discuss an appropriate response in good faith.
Notice of Regulatory Action. EURAND shall provide RELIANT with immediate notification of its receipt of any of the following related to the manufacture, production or testing of Product: a copy of any list of observations (Form FD 483), Warning Letter, Information Letter, Regulatory Letter or the like issued by the FDA as well as provide RELIANT an opportunity to review any written response prior to submission to the issuing agency. However, EURAND maintains sole responsibility for any matter pertaining to such inspections.
Notice of Regulatory Action. If any Regulatory Authority takes or gives notice of its intent to take any regulatory action with respect to any activity of CytomX related to the Preclinical Development Program or otherwise directed to Compounds or Products, then CytomX shall promptly notify BMS through the JRC, or Alliance Manager after Research Term, of such contact, inspection or notice or action. To the extent applicable, CytomX shall be responsible for preparing draft responses to any such regulatory action and to provide such draft responses to BMS through the JRC or Alliance Manager after Research Term. The JRC (and BMS) shall review and comment on any such responses to Regulatory Authorities that pertain to the Compounds and/or Products; provided that BMS shall have the final decision making authority with respect to such responses to the extent relating to the Compounds and/or Products.
Notice of Regulatory Action. ASL shall provide Reliant with immediate notification of its receipt of any of the following related to the manufacture, production or testing storage of the Active Ingredient; a copy of any list of observations (Form FD483), Warning Letters, Information Letters, Regulatory Letters or the like issued by the FDA as well as provide Reliant an opportunity to review any written response prior to submission to the FDA. ASL shall maintain sole responsibility for any matter pertaining to such inspections.
Notice of Regulatory Action. Promptly, written notice of (i) the issuance of any notice of charges, cease-and-desist order (temporary or otherwise), or order to take affirmative action by any Governmental Authority or Regulatory Authority against the Borrower, any Bank or any other Subsidiary, or any director, officer, employee or agent of the Borrower, any Bank or any other Subsidiary, (ii) the service of any notice of intention to remove from office or notice of intention to suspend from office by any Governmental Authority or Regulatory Authority upon any director or officer of the Borrower, any Bank or any other Subsidiary, (iii) the issuance of a notice of termination of the status of any Bank as an insured bank under the Federal Deposit Insurance Corporation Act, as amended, or (iv) the entering into of any agreement or memorandum of understanding between any Governmental Authority or Regulatory Authority and the Borrower, any Bank or any other Subsidiary, or any director, officer, employee or agent of the Borrower, any Bank or any other Subsidiary.
Notice of Regulatory Action. If any Regulatory Authority takes or gives notice of its intent to take any regulatory action with respect to any activity of Zai relating to any Licensed Product, then Zai shall notify Deciphera of such contact, inspection, or notice or action within [***] after receipt of such notice (or, if action is taken without notice, within [***] of Zai becoming aware of such action). Deciphera shall have the right to review and comment on any other responses to Regulatory Authority that pertain to a Licensed Product in the Territory.
Notice of Regulatory Action. If any Regulatory Authority takes or gives notice of its intent to take any regulatory action with respect to any activity of Zai relating to any Product, then Zai shall notify TPTX of such contact, inspection, or notice or action within [***] Business Days after receipt of such notice (or, if action is taken without notice, within [***] Business Days of Zai becoming aware of such action). TPTX shall have the right to review and comment on any responses to Regulatory Authority that pertain to a Product in the Territory.
Notice of Regulatory Action. If any Regulatory Authority takes or gives notice of its intent to take any regulatory action with respect to any activity of BeiGene relating to the Licensed Product, then BeiGene shall notify Leap of such notice within [***] of its receipt thereof. Leap shall have the right to review and comment on any responses to Regulatory Authorities that pertain to a Licensed Product promptly and in any event [***] of receipt of such proposed response. BeiGene will [***] to a Licensed Product in the Territory if BeiGene is the holder of Regulatory Approvals and Regulatory Submissions for such Licensed Product in the Territory and will [***]. The costs and expenses of any regulatory action in the Territory will be borne by BeiGene. In addition, each Party shall promptly notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from a Third Party that, in the case of notice to Leap, would reasonably be expected to materially affect the Development or Commercialization of the Licensed Products, and in the case of notice to BeiGene, would reasonably be expected to materially affect the Development or Commercialization of the Licensed Products in the Field in the Territory.54
