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.”
Sample 1
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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.
Sample 1
Response to Biosimilar Applicants 
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Related to Response to Biosimilar Applicants

  • Response to Notice Within ten business days of receiving the Claim Notice, the Respondent must notify the Claimant of its representative to negotiate the dispute.

  • Response to Demand Letter Within 10 days after the receipt of the Demand Letter, RMC shall either: (a) cure the breach to OIG’s satisfaction and pay the applicable Stipulated Penalties or (b) request a hearing before an HHS administrative law judge (ALJ) to dispute OIG’s determination of noncompliance, pursuant to the agreed upon provisions set forth below in Section X.E. In the event RMC elects to request an ALJ hearing, the Stipulated Penalties shall continue to accrue until RMC cures, to OIG’s satisfaction, the alleged breach in dispute. Failure to respond to the Demand Letter in one of these two manners within the allowed time period shall be considered a material breach of this CIA and shall be grounds for exclusion under Section X.D.

  • Notification to Unsuccessful Job Applicants The parties agree that any unsuccessful candidate for an ONA job posting will be notified, in writing, within one (1) week of the decision being made and prior to the posting of the name of the successful candidate. The parties further agree that the above notification will be copied to the ONA Bargaining Unit President.

  • Rationale/Justification The Cisco Certified Network Associate Security (CCNA® Security) certification represents industry acknowledgement of technical skill attainment of competencies in the IT Security program.

  • 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.

  • New Application for Licensure Any time after the three-month period has lapsed from the Effective Date of this Agreement and Respondent has paid the Administrative Penalty set forth in Section III, Paragraph 1 of this Order, Respondent may apply for a new mortgage loan originator license or, as applicable, petition for the reinstatement of an MLO Activity Endorsement in any or all of the Participating States with the understanding that each State Mortgage Regulator reserves the rights to fully investigate such application for licensure or petition for reinstatement of an MLO Activity Endorsement and may either approve or deny such application or petition pursuant to the normal process for such licensing or endorsement investigations. No license application or petition described in this paragraph will be denied solely based on the facts, circumstances, or consensual resolution provided for in this Agreement. Respondent further agrees that Respondent must satisfy the Administrative Penalty provision prior to submitting an application for a new mortgage loan originator license or, as applicable, petition for the reinstatement of an MLO Activity Endorsement.

  • Domain Name Dispute Policy If you reserved or registered a domain name through us, or transferred a domain name to us from another registrar, you agree to be bound by the Dispute Policy and the usDRP, as defined below, that is incorporated herein and made a part of this Agreement by reference. Please take the time to familiarize yourself with these policies.

  • Response to Objections Each Party retains the right to respond to any objection raised by a Participating Class Member, including the right to file responsive documents in Court no later than five court days prior to the Final Approval Hearing, or as otherwise ordered or accepted by the Court.

  • PRICE LISTS AND PRODUCT INFORMATION Contractors should provide an electronic version of the proposed price list in an Excel format or pdf on a jump drive. Also provide a dealer list, if applicable in an Excel format with "read and write" capabilities on the same jump drive. No costs or expenses associated with providing this information in the required format shall be charged to the State of Arkansas. At the time of contract renewal contractor will furnish OSP with an updated dealer list and published price list.

  • Submitting Investigator An investigator who submitted a genomic dataset to an NIH designated data repository (e.g., dbGaP).

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