Response to Biosimilar Applicants Sample Clauses

Response to Biosimilar Applicants. Anything contained in Section 9.5 of the Agreement to the contrary notwithstanding, the Parties, acting through the JPC, shall cooperate in responding to a Biosimilar Application for which the Co-Development Product is the “reference product.”
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Response to Biosimilar Applicants. Notwithstanding the provisions of Section 8.4 (Third Party Infringement and Defense), each Party will promptly notify the other Party in writing of any notification or certification filed under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), including notices as described in a § 351(k) application under the BPCIA, claiming that a Patent Right is invalid or that infringement will not arise from the manufacture, use or sale of any Licensed Product, or any biosimilar with respect to such Licensed Product, by a Third Party. The Parties’ rights to bring infringement actions with respect to such infringement actions and Third Party challenges are set forth in Section 8.4 (Third Party Infringement and Defense), 52 provided that Takeda may determine the strategy (in consultation with Innate) for the litigation of patents in connection with the BPCIA and for implementing the procedures set forth under Section 8.4 (Third Party Infringement and Defense). Any such action will be in the name of such Party or Parties as may be required to effectively institute and maintain such action, and the Parties will execute such documents as necessary for the prosecution of any such action. Without limiting the foregoing, Takeda will be responsible for any filings with respect to any Licensed Product under the BPCIA, including providing lists of patents which may include Licensed Patent Rights, if applicable, and Innate hereby authorizes Takeda to undertake such filings and agrees to provide such other information as Takeda reasonably requests.
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Response to Biosimilar Applicants 
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  • How to File an Appeal of a Prescription Drug Denial For denials of a prescription drug claim based on our determination that the service was not medically necessary or appropriate, or that the service was experimental or investigational, you may request an appeal without first submitting a request for reconsideration. You or your physician may file a written or verbal prescription drug appeal with our pharmacy benefits manager (PBM). The prescription drug appeal must be submitted to us within one hundred and eighty (180) calendar days of the initial determination letter. You will receive written notification of our determination within thirty (30) calendar days from the receipt of your appeal. Your appeal may require immediate action if a delay in treatment could seriously jeopardize your health or your ability to regain maximum function, or would cause you severe pain. To request an expedited appeal of a denial related to services that have not yet been rendered (a preauthorization review) or for on-going services (a concurrent review), you or your healthcare provider should call: • our Grievance and Appeals Unit; or • our pharmacy benefits manager for a prescription drug appeal. Please see Section 9 for contact information. You will be notified of our decision no later than seventy-two (72) hours after our receipt of the request. You may not request an expedited review of covered healthcare services already received.

  • Information Request The Owner Trustee shall provide any information regarding the Issuer in its possession reasonably requested by the Servicer, the Administrator, the Seller or any of their Affiliates, in order to comply with or obtain more favorable treatment under any current or future law, rule, regulation, accounting rule or principle.

  • DATA REQUESTS Upon the written request of the District, the State Auditor’s Office, the Appraisal District, or the Comptroller during the term of this Agreement, the Applicant, the District or any other entity on behalf of the District shall provide the requesting party with all information reasonably necessary for the requesting party to determine whether the Applicant is in compliance with its rights, obligations or responsibilities, including, but not limited to, any employment obligations which may arise under this Agreement.