Licensor Development Plan; Compliance Sample Clauses

Licensor Development Plan; Compliance. Except as otherwise expressly set forth in Section 4.5 (Novartis Development Activities), Licensor shall be responsible for, and shall perform, (i) the Licensor Clinical Trial Activities and (ii) notwithstanding the Completion of the Licensor Clinical Trial and IND assignment, the Licensor Clinical Trial Follow-Up Activities, in each case (i) and (ii) at its sole cost and expense (subject to Section 4.1(b) (Amendments to the Licensor Development Plan)), solely in accordance with the Licensor Development Plan or, as it relates to the Licensor Clinical Trial Follow-Up Activities, as otherwise required by Applicable Law or Regulatory Authorities, and shall use Commercially Reasonable Efforts to complete, all such activities in accordance with the timelines set forth therein. Licensor shall perform all Licensor Clinical Trial Activities and Licensor Clinical Trial Follow-Up Activities in good scientific manner and in compliance with all Applicable Laws, and shall allocate sufficient equipment and personnel as necessary to perform all Licensor Clinical Trial Activities in accordance with the Licensor Development Plan.
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Related to Licensor Development Plan; Compliance

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

  • Program Compliance The School Board shall be responsible for monitoring the program to provide technical assistance and to ensure program compliance.

  • Office of Supplier Development The State of Florida supports its business community by creating opportunities for business enterprises to participate in procurements and contracts. The Department encourages supplier development through certain certifications and provides advocacy, outreach, and networking through regional business events. For additional information, please contact the Office of Supplier Development (OSD) at ▇▇▇▇▇▇▇@▇▇▇.▇▇.▇▇▇.

  • Supplier Development lf the Buyer identifies problems in supplier performance based on supplier monitoring, he shall initiate improvement measures at the Supplier. The Buyer shall pursue the possibilities of continuous improvement of the Supplier. The supplier audit is a form of supplier development; the exchange of information and experience between the Buyer and the Supplier also serves this purpose.

  • FERPA Compliance In connection with all FERPA Records that Contractor may create, receive or maintain on behalf of University pursuant to the Underlying Agreement, Contractor is designated as a University Official with a legitimate educational interest in and with respect to such FERPA Records, only to the extent to which Contractor (a) is required to create, receive or maintain FERPA Records to carry out the Underlying Agreement, and (b) understands and agrees to all of the following terms and conditions without reservation: