Investigational Applications Sample Clauses

Investigational Applications. 3.7.1 If an IND is required, ICD will be the IND Sponsor and will submit an IND. All Clinical Investigators must have completed registration documents on file (1572 forms). 3.7.2 When ICD files the IND, Collaborator agrees to provide ICD background data and information necessary to support the IND. Collaborator further agrees to provide a letter of cross-reference to all pertinent regulatory filings sponsored by Collaborator. Collaborator’s employees will be reasonably available to respond to inquiries from the FDA regarding information and data contained in the Collaborator’s IND, DMF, other filings, or other information and data provided to ICD by the Collaborator pursuant to this Article 3. 3.7.3 If Collaborator supplies Confidential Information to ICD in support of an IND filed by ICD, this information will be protected in accordance with the corresponding confidentiality provisions of Article 8. 3.7.4 Collaborator may sponsor its own clinical trials and hold its own IND for studies performed outside the scope of this CRADA. These studies, however, should not adversely affect the ability to accomplish the goal of the Research Plan, for example, by competing for the same study population. All data from those clinical trials are proprietary to Collaborator for purposes of this CRADA.
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Investigational Applications. 3.7.1 If an IND is required, the Parties will decide which Party will be the IND Sponsor and the IND Sponsor will submit an IND. All Clinical Investigators must have completed registration documents on file (1572 forms). 3.7.2 When a Party files the IND, the other Party agrees to provide the filing party background data and information necessary to support the IND. The Parties further agree to provide a letter of cross-reference to all data and pertinent regulatory filings sponsored by a Party under this CRADA. Both Parties’ employees will be reasonably available to respond to inquiries from the FDA regarding information and data contained in the Party’s IND, DMF, other filings, or other information and data provided to one Party by the other Partypursuant to this Article 3. 3.7.3 If a Party supplies Confidential Information to the other Party in support of an IND that is filed, this information will be protected in accordance with the corresponding confidentiality provisions of Article 8. 3.7.4 Collaborator may sponsor its own clinical trials and hold its own IND for studies performed outside the scope of this CRADA. All data from those clinical trials are proprietary to Collaborator for purposes of this CRADA. PHS ICT-CRADA Case Ref. No. MODEL ADOPTED June 18, 2009 Page 44 of 52 Confidential PUBLIC HEALTH SERVICE COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT FOR INTRAMURAL-PHS CLINICAL RESEARCH Amend Section 3.8 to read as follows:
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Investigational Applications. If an IND (or the equivalent application in other countries) is required, VA will be the IND sponsor, and will submit the IND to FDA. Collaborator agrees to provide to VA background data and information necessary to support the IND.
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Investigational Applications. 3.7.1 If an IND is required, IC will be the IND Sponsor and will submit an IND. All Clinical Investigators must have completed registration documents on file (1572 forms). 3.7.2 When IC files the IND, Collaborator agrees to provide IC background data and information necessary to support the IND in electronic Common Technical Document (eCTD) format: Suspected Adverse Reactions; and formulation and preclinical data, including toxicology findings. Collaborator further agrees to provide a letter of cross-reference to all pertinent regulatory filings sponsored by Collaborator. Collaborator’s employees will be reasonably available to respond to inquiries from the FDA regarding information and data contained in the Collaborator’s IND, DMF, other filings, or other information and data provided to IC by the Collaborator pursuant to this Article 3. 3.7.3 At least annually, the Collaborator will review the Investigator’s Brochure (IB) and will provide the updated IB in eCTD format, or if necessary, confirmation that no updates were made to the IB. PHS ICT-CRADA Agreement Ref. No. 03434 MODEL ADOPTED June 18, 2009 Page 7 of 30 Confidential Revised October 18, 2018 3.7.4 If Collaborator supplies Confidential Information to IC in support of an IND filed by IC, this information will be protected in accordance with the corresponding confidentiality provisions of Article 8. 3.7.5 Collaborator may sponsor its own clinical trials and hold its own IND for studies performed outside the scope of this CRADA. These studies, however, should not adversely affect the ability to accomplish the goal of the Research Plan, for example, by competing for the same study population. All data from those clinical trials are proprietary to Collaborator for purposes of this CRADA.
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Investigational Applications. 3.7.1 If an IND is required, IC will be the IND Sponsor and will submit an INDthe Parties will file and/or amend sponsorship of INDs as agreed upon in Appendix A of this CRADA. All Clinical Investigators must have completed registration documents on file (1572 forms). 3.7.2 When ICD a Party files the IND, Collaborator the other Party agrees to provide ICD the filing party background data and information necessary to support the IND. Collaborator The Parties further agrees to provide a letter of cross-reference to all data and pertinent regulatory filings sponsored by Collaborator. Collaborator’s a Party under this CRADA. Both Parties’ employees will be reasonably available to respond to inquiries from the FDA regarding information and data contained in the Collaborator’s Party’s IND, DMF, other filings, or other information and data provided to ICD one Party by the Collaborator other Party pursuant to this Article 3. 3.7.3 If Collaborator a Party supplies Confidential Information to ICDthe other Party in support of an IND that is filed, by ICD this information will be protected in accordance with the corresponding confidentiality provisions of Article 8. 3.7.4 Collaborator may sponsor its own clinical trials and hold its own IND for studies performed outside the scope of this CRADA. These studies, however, should not adversely effect the ability to accomplish the goal of the Research Plan, for example, by competing for the same study population. All data from those clinical trials are proprietary to Collaborator for purposes of this CRADA. Amend Section 3.11 to read as follows:
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Investigational Applications. 3.7.1 If an IND is required to perform the research and development activities under this CRADA, then the IC will submit an IND and ensure all Clinical Investigators have completed all necessary registration documents (1572 forms). 3.7.2 If IC files its own IND pursuant to Paragraph 3.7.1 above, then Collaborator agrees to provide IC any background data and information under its control necessary to support the IND. Collaborator further agrees to provide a letter of cross-reference to all pertinent regulatory filings sponsored by Collaborator. Collaborator’s employees will be reasonably available to respond to inquiries from the FDA regarding information and data contained in the Collaborator’s IND, DMF, other filings, or other information and data provided to IC by the Collaborator pursuant to this Article 3. If Collaborator files its own IND filings pursuant to Paragraph 3.7.4 below, then IC agrees to provide Collaborator any background data and information under its control necessary to support the IND and to provide a letter of cross reference to its IND and respond to inquiries related to information provided by IC, as applicable. 3.7.3 If Collaborator supplies Confidential Information to IC in support of an IND filed by IC, this information will be protected in accordance with the corresponding confidentiality provisions of Article 8. 3.7.4 Collaborator may sponsor its own clinical trials and hold its own IND for studies performed outside the scope of this CRADA. These studies, however, should not adversely affect the ability to accomplish the goal of the Research Plan during the term of the CRADA, for example, by competing for the same study population. All data from those clinical trials are proprietary to Collaborator for purposes of this CRADA. [*****] Raptor Pharmaceutical Corp. has requested confidential treatment of certain portions of this offer letter which have been omitted and filed separately with the U.S. Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934.
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Investigational Applications. 3.7.1 The Collaborator, as indicated in the Research Plan, will submit an IND and all required documents to the FDA. The Collaborator will comply with all FDA requirements, including obtaining and maintaining all Clinical Investigator registration documents (1572 forms). 3.7.2 Collaborator agrees to provide IC with copies of all ND submissions related to the Clinical Trial at the time of their submission to the FDA. Collaborator further agrees to notify IC of any FDA correspondence related to the Clinical Trial, and agrees to include IC representatives in any meeting with the FDA related to this Clinical Trial. 3.7.3 Any Confidential Information supplied to the IC by Collaborator in support of an IND filed by Collaborator will be protected by IC in accordance with the corresponding confidentiality provisions of Article 8.
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Investigational Applications. 3.7.1 If an IND is required, IC will be the IND Sponsor and will submit an IND. All Clinical Investigators must have completed registration documents on file (1572 forms). 3.7.2 When IC files the IND, Collaborator agrees to provide IC background data and information necessary to support the IND. Collaborator further agrees to provide a letter of cross-reference to all pertinent regulatory filings sponsored by Collaborator. Collaborator’s employees will be reasonably available to respond to inquiries from the FDA regarding information and data contained in the Collaborator’s IND, DMF, other filings, or other information and data provided to IC by the Collaborator pursuant to this Article 3. 3.7.3 If Collaborator supplies Confidential Information to IC in support of an IND filed by IC, this information will be protected in accordance with the corresponding confidentiality provisions of Article 8. 3.7.4 Collaborator may sponsor its own clinical trials and hold its own IND for studies performed outside the scope of this CRADA. These studies, however, should not adversely affect the ability to accomplish the goal of the Research Plan, for example, by competing for the same study population. All data from those clinical trials are proprietary to Collaborator for purposes of this CRADA. PHS ICT-CRADA Agreement Ref. No. NCI # 03111 MODEL ADOPTED June 18, 2009 Page 6 of 42 Revised May 15, 2014
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Investigational Applications. 3.7.1 If an IND is required, IC will be the IND Sponsor and will submit an IND. All Clinical Investigators must have completed registration documents on file (1572 forms). 3.7.2 When IC files the IND, Collaborator agrees to provide IC background data and information necessary to support the IND. Collaborator further agrees to provide a letter of cross-reference to all pertinent regulatory filings sponsored by Collaborator. Collaborator’s employees will be reasonably available to respond to inquiries from the FDA regarding information and data contained in the Collaborator’s IND, DMF, other filings, or other information and data provided to IC by the Collaborator pursuant to this Article 3. PHS ICT-CRADA Agreement Ref. No. MODEL ADOPTED June 18, 2009 Page 6 of 25 Revised May 15, 2014 3.7.3 If Collaborator supplies Confidential Information to IC in support of an IND filed by IC, this information will be protected in accordance with the corresponding confidentiality provisions of Article 8. 3.7.4 Collaborator may sponsor its own clinical trials and hold its own IND for studies performed outside the scope of this CRADA. These studies, however, should not adversely affect the ability to accomplish the goal of the Research Plan, for example, by competing for the same study population. All data from those clinical trials are proprietary to Collaborator for purposes of this CRADA.
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Related to Investigational Applications

  • Regulatory Investigations TCI and TLIC agree to cooperate fully in any insurance or judicial regulatory investigation or proceeding arising in connection with Contracts distributed under this Agreement. TCI and TLIC further agree to cooperate fully in any securities regulatory inspection, inquiry, investigation or proceeding or any judicial proceeding with respect to TLIC, TCI, their affiliates and their representatives to the extent that such inspection, inquiry, investigation or proceeding or judicial proceeding is in connection with Contracts distributed under this Agreement. Without limiting the foregoing: (a) TCI will be notified promptly of any customer complaint or notice of any regulatory inspection, inquiry investigation or proceeding or judicial proceeding received by TLIC with respect to TCI or any representative or which may affect TLIC’s issuance of any Contracts marketed under this Agreement; and (b) TCI will promptly notify TLIC of any customer complaint or notice of any regulatory inspection, inquiry, investigation or judicial proceeding received by TCI or any representative with respect to TLIC or its affiliates in connection with any Contracts distributed under this Agreement. In the case of a customer complaint, TCI and TLIC will cooperate in investigating such complaint and shall arrive at a mutually satisfactory response.

  • COMPLAINTS AND INVESTIGATIONS 1. This article applies to complaints or allegations made externally and not from normal supervisory activities. 2. A department head shall be responsible for ensuring that all allegations of misconduct or other complaints against an employee on which any action is to be taken or a record is to be made shall be investigated. The investigator shall be allowed to interview the complainant prior to notifying the employee.

  • Complaints Investigation The employee who complains of harassment under the provisions of the Human Rights Code must first comply with the Employer’s harassment policy procedures before filing a grievance or human rights complaint.

  • Regulatory Applications (a) Western and PNB and their respective Subsidiaries shall cooperate and use their respective reasonable best efforts to prepare all documentation, to effect all filings and to obtain all permits, consents, approvals and authorizations of all third parties and Governmental Authorities necessary to consummate the transactions contemplated by this Agreement. Western and PNB shall use their reasonable best efforts to make all required bank regulatory filings, including the appropriate filing with the Regulatory Authorities. Each of Western and PNB shall have the right to review in advance, and to the extent practicable each will consult with the other, in each case subject to applicable laws relating to the exchange of information, with respect to all material written information submitted to any third party or any Governmental Authority in connection with the transactions contemplated by this Agreement. In exercising the foregoing right, each of the parties hereto agrees to act reasonably and as promptly as practicable. Each party hereto agrees that it will consult with the other party hereto with respect to the obtaining of all material permits, consents, approvals and authorizations of all third parties and Governmental Authorities necessary or advisable to consummate the transactions contemplated by this Agreement and each party will keep the other party appraised of the status of material matters relating to completion of the transactions contemplated hereby. (b) Each party agrees, upon request, to furnish the other party with all information concerning itself, its Subsidiaries, directors, officers and shareholders and such other matters as may be reasonably necessary or advisable in connection with any filing, notice or application made by or on behalf of such other party or any of its Subsidiaries to any third party or Governmental Authority.

  • Background Investigation The BOARD is prohibited from knowingly employing a person who has been convicted of committing or attempting to commit certain criminal offenses. If the required criminal background investigation is not completed at the time this Contract is signed, and the subsequent investigation report reveals that there has been a prohibited conviction, this Contract shall immediately become null and void.

  • Provisional Application Upon signature of this Compact, and until this Compact has entered into force in accordance with Section 7.3, the Parties will provisionally apply the terms of this Compact; provided that, no MCC Funding, other than Compact Implementation Funding, will be made available or disbursed before this Compact enters into force.

  • Investigation and Prevention DST shall reasonably assist Fund in investigating of any such unauthorized access and shall use commercially reasonable efforts to: (A) cooperate with Fund in its efforts to comply with statutory notice or other legal obligations applicable to Fund or its clients arising out of unauthorized access and to seek injunctive or other equitable relief; (B) cooperate with Fund in litigation and investigations against third parties reasonably necessary to protect its proprietary rights; and (C) take reasonable actions necessary to mitigate loss from any such authorized access.

  • Grievance Investigations Where an employee has asked or is obliged to be represented by the Institute in relation to the presentation of a grievance and an employee acting on behalf of the Institute wishes to discuss the grievance with that employee, the employee and the representative of the employee will, where operational requirements permit, be given reasonable leave with pay for this purpose when the discussion takes place in the headquarters area of such employee and leave without pay when it takes place outside the headquarters area of such employee.

  • Compliance Investigations Upon City’s request, Contractor agrees to provide to City, within sixty calendar days, a truthful and complete list of the names of all subcontractors, vendors, and suppliers that Contractor has used in the past five years on any of its contracts that were undertaken within San Diego County, including the total dollar amount paid by Contractor for each subcontract or supply contract. Contractor further agrees to fully cooperate in any investigation conducted by City pursuant to City's Nondiscrimination in Contracting Ordinance. Contractor understands and agrees that violation of this clause shall be considered a material breach of the Contract and may result in Contract termination, debarment, and other sanctions.

  • Regulatory Examinations The Sub-Advisor will cooperate promptly and fully with the Advisor and/or the Trust in responding to any regulatory or compliance examinations or inspections (including information requests) relating to the Trust, the Fund or the Advisor brought by any governmental or regulatory authorities having appropriate jurisdiction (including, but not limited to, the SEC).

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