Compliance and Regulatory Discussions; Right of Reference Sample Clauses

Compliance and Regulatory Discussions; Right of Reference. 3.3.1 Sponsor shall ensure that all directions from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are followed. Further, Sponsor shall ensure that all Regulatory Approvals from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are obtained prior to initiating performance of the Study. Sponsor shall provide Xxxxx with reasonable advance notice of meetings or other non-written communications with a Regulatory Authority regarding the Combination, and the opportunity to participate in each such meeting or other non-written communication to the extent such meeting or communication involves the Lilly Compound or any other matter that is reasonably likely to have an effect on the Lilly Compound. Sponsor shall participate in and lead all discussions with any Regulatory Authority regarding the Study; subject to Xxxxx’x right to participate in all such meetings. In such case that Sponsor intends to provide a communication that relates to the Xxxxx Xxxxxxxx, Sponsor will provide Xxxxx with the opportunity to review and provide comments to Sponsor within [*] of receipt thereof from Sponsor, and, if [*] to the extent that [*]. 3.3.2 Sponsor will promptly provide Xxxxx with a copy of any written reports (or excerpts thereof) from Regulatory Authorities and a written summary of meetings or other non-written communications with a Regulatory Authorities, in each case, related to the Lilly Compound within [*] of such meeting or communication and shall provide Xxxxx with draft copies of any responses to Regulatory Authority that may relate to the Lilly Compound within [*] prior to submission to the Regulatory Authority. Sponsor shall not provide any responses related to the Lilly Compound to any Regulatory Authority without Xxxxx’x prior written approval of such responses (not to unreasonably withheld, conditioned, or delayed). 3.3.3 Each Party grants to the other Party a non-exclusive, non-transferable (except in connection with a permitted assignment, sublicense or subcontract) “right of reference” (as defined in US FDA 21 CFR 314.3(b) and US FDA 21 CFR 312.23(b)), or similar “right of reference” as defined in Applicable Law, with respect to Clinical Data, solely as necessary for the other Party to prepare, submit and maintain regulatory submissions related to the other Party’s Compound and Regulatory Approvals. 3.3.4 If Lilly determines it is necessary, Xxxxx will authorize FDA and other applicable Regula...
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Related to Compliance and Regulatory Discussions; Right of Reference

  • Geographic Area and Sector Specific Allowances, Conditions and Exceptions The following allowances and conditions shall apply where relevant. Where the Employer does work which falls under the following headings, the Employer agrees to pay and observe the relevant respective conditions and/or exceptions set out below in each case.

  • Proposing Integration Activities in the Planning Submission No integration activity described in section 6.3 may be proposed in a CAPS unless the Funder has consented, in writing, to its inclusion pursuant to the process set out in section 6.3(b).

  • 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.

  • Financial Viability and Regulatory Compliance 2.6.1 Contractor warrants and represents that its corporate entity is in good standing with all applicable federal, state, and local licensing authorities and that it possesses all requisite licenses to perform the services required by this contract. Contractor further warrants and represents that it owes no outstanding delinquent federal, state or local taxes or business assessments. 2.6.2 Contractor agrees to promptly disclose to the MPHA any IRS liens or licensure suspension or revocation that may adversely affect its capacity to perform the services outlined within this contract. The failure by Contractor to disclose such issue to the MPHA in writing within 5 days of such notification received will constitute a material breach of this contract. 2.6.3 Contractor further agrees to promptly disclose to the MPHA any change of more than 50% of its ownership and/or any declaration of bankruptcy that Contractor may undergo during the term(s) of this contract. The failure of Contractor to disclose any change of more than 50% of its ownership and/or its declaration of bankruptcy within 5 days of said actions shall constitute a material breach of this contract. 2.6.4 All disclosures made pursuant to this section of the contract shall be made in writing and submitted to MPHA within the time periods required herein.

  • Technical Objections to Grievances It is the intent of both Parties of this Agreement that no grievance shall be defeated merely because of a technical error, other than time limitations in processing the grievance through the grievance procedure. To this end, an arbitration board shall have the power to allow all necessary amendments to the grievance and the power to waive formal procedural irregularities in the processing of a grievance, in order to determine the real matter in dispute and to render a decision according to equitable principles and the justice of the case.

  • Litigation and Regulatory Cooperation During and after the Executive’s employment, the Executive shall cooperate fully with the Company in the defense or prosecution of any claims or actions now in existence or which may be brought in the future against or on behalf of the Company which relate to events or occurrences that transpired while the Executive was employed by the Company. The Executive’s full cooperation in connection with such claims or actions shall include, but not be limited to, being available to meet with counsel to prepare for discovery or trial and to act as a witness on behalf of the Company at mutually convenient times. During and after the Executive’s employment, the Executive also shall cooperate fully with the Company in connection with any investigation or review of any federal, state or local regulatory authority as any such investigation or review relates to events or occurrences that transpired while the Executive was employed by the Company. The Company shall reimburse the Executive for any reasonable out-of-pocket expenses incurred in connection with the Executive’s performance of obligations pursuant to this Section 7(f).

  • Musculoskeletal Injury Prevention and Control The hospital in consultation with the Joint Health and Safety Committee (JHSC) shall develop, establish and put into effect, musculoskeletal prevention and control measures, procedures, practices and training for the health and safety of employees.

  • Notice and Cooperation Each Party shall provide to the other Party prompt written notice of any actual or threatened infringement of the Product Trademarks in the Territory and of any actual or threatened claim that the use of the Product Trademarks in the Territory violates the rights of any Third Party. Each Party agrees to cooperate fully with the other Party with respect to any enforcement action or defense commenced pursuant to this Section 7.7.

  • Regulatory References A reference in this Agreement to a section in the HIPAA Rules means the section as in effect or as amended.

  • Human and Financial Resources to Implement Safeguards Requirements The Borrower shall make available necessary budgetary and human resources to fully implement the EMP and the RP.

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