Procedure for sponsors - Substantial Modifications Sample Clauses

Procedure for sponsors - Substantial Modifications. 5.1. Submission of a substantial modification regarding a clinical trial approved in the CTR pilot Substantial modifications (SM) regarding clinical trials that were approved in the CTR pilot procedure will also need to be submitted following the CTR pilot procedure. Upon submission, the SM cover letter and any other communication should clearly state: CTR pilot number : XXX – CTA 20XX-XXXXXX-XX – SM n°XX The submission dossier must comply with the requirements of annex II of the CTR. 5.2. Payment of the fee for a substantial modification No fee is currently due for the submission of a CTA substantial modification in the CTR pilot (nor to the agency, nor to the evaluating Ethics Committee).
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Procedure for sponsors - Substantial Modifications. 5.1. Submission of a substantial modification regarding a clinical trial approved in the CTR pilot project Substantial modifications (SM) regarding clinical trials that were approved in the CTR pilot procedure will also need to be submitted following the CTR pilot project procedure. Upon submission, the SM cover letter and any other communication should clearly state: CTR pilot project number : XXX – CTA 20XX-XXXXXX-XX – Substantial modification The submission dossier must comply with the requirements of annex II of the CTR. 5.2. Payment of the fee for a substantial modification The usual fee of 622,45 EUR must be paid to the national contact point per substantial modification. Payment must be made on the following account : 000-0000000-00 Contact details of the bank : Poste financière Chaussée d'Anvers 59 B-1100, Bruxelles (Belgium) SWIFT code: XXXXXXXX IBAN code: XX00 0000 0000 0000 For payments from abroad the transfer fees are paid by the payer. The proof of payment of the fee must be added to the section G. of the substantial modification dossier. Please mention "Pilot XXX – CTA 20XX-XXXXXX-XX – Substantial modification" on the bank statement. For each file a separate payment should be made. A unique fee of 320.05 EUR must be directly paid by the sponsor to the EC that was responsible for the assessment of the initial dossier. The proof of payment of the fee to the EC is provided by the sponsor to the national contact point together with the SM submission dossier.

Related to Procedure for sponsors - Substantial Modifications

  • Modification for Catastrophe In event of Catastrophic Damage, Forest Service, in consultation with Purchaser, shall outline on Sale Area Map: (a) Any areas of catastrophe-affected live and dead timber meeting Utilization Standards and having undesignated timber so situated that it should be logged with the designated timber; (b) If needed, any such areas where the damaged undesignated timber can reasonably be logged separately; and (c) Areas of affected or unaffected timber that are to be eliminated from Sale Area. Forest Service shall locate and post the boundaries of all such areas, as needed. After Sale Area Map has been outlined under this Subsection, Forest Service may propose contract modification to permit the harvest of catastrophe-affected timber. If Purchaser accepts Forest Service proposed modifications, this contract shall be modified to include rates redetermined under B3.32 and other related revisions as necessary, such as revision of Operating Schedule to ensure prompt removal of affected timber when necessary to avoid further loss and provision for additional contract time, if needed.

  • PROCEDURE FOR APPROVAL OF SETTLEMENT Acceptance of this Settlement Agreement shall be sought at a hearing of the Central Regional Council of the MFDA on a date agreed to by counsel for Staff and the Respondent.

  • ARTICLE GRIEVANCE PROCEDURE The parties to this Agreement are agreed that it is of the utmost importance to adjust complaints and grievances as quickly as possible. Unless agreed to by both the Company and the Union, no grievance shall be presented, the alleged circumstances of which originated or occurred, or should have come to the attention of the employee concerned, more than five (5) working days prior to its original presentation in writing at Step A grievance shall consist of a dispute concerning interpretation and/or application of any Article, Schedule or Clause in this Agreement. Should a grievance arise it shall be handled as follows. Prior to filing a formal grievance, an employee will, with the assistance of his xxxxxxx, refer the on an informal basis to his immediate Supervisor. If the grievance cannot be settled as a result of this discussion, then it may be dealt with as follows: STEP The employee shall a written grievance with his immediate Supervisor within five (5) working days of the incident giving rise to the complaint. The immediate Supervisor shall answer the grievance within five (5) working days. The grievance shall specify the Article or Articles and subsections of the Agreement of which a violation is alleged, indicate the relief sought and be signed by the employee. STEP Should the employee be dissatisfied with the disposition of the grievance at Step the grievance may be referred to the Plant Manager within five (5) working days after receipt of the immediate Supervisor's reply at Step The Plant Manager shall convene a meeting with the and Chief Xxxxxxx and shall answer the grievance in writing within five (5) working days of such meeting. STEP If no settlement is reached at Step the the Union Grievance Committee and representatives of Management shall meet to discuss the grievance within five (5) working days of receipt of the reply of the Plant Manager. The Union's National Representative will be in attendance at this meeting. If the grievance is not settled within five (5) working days it may be referred to arbitration as hereinafter provided. The Union or the Company may initiate a grievance beginning at Step of the Grievance Procedure. Such grievance shall be filed within five (5) working days of the incident giving rise to the complaint and be in the form prescribed in Step Any such grievance may be referred to arbitration under Article by either the Union in the case of a Union grievance or the Company in the case of a Company grievance. The Union may not institute a grievance directly affecting an employee or employees which such employee or employees could themselves institute and the regular Grievance Procedure shall not thereby be by-passed except where the grievance would affect the Bargaining Unit as a whole. This Clause shall not preclude a group grievance signed by a group of employees commencing at Step Any complaint or grievance which is not commenced or processed through the next stage of the Grievance or Arbitration Procedure within the time specified shall be deemed to have been dropped. However, time limits specified in the Grievance Procedure may be extended by mutual agreement in writing between the Company and the Union. An employee who has been discharged or suspended may file a written grievance at Step within five (5) working days of the discharge or suspension. In taking disciplinary action within twenty-four (24) months from the date of a suspension or dismissal (reinstatement) for a similar infraction, the Company may consider the employee's entire record preceding suspension or dismissal (reinstatement), as the case may be. In taking disciplinary action within twelve 2) months from the date of an oral or written warning for a similar infraction, the Company may consider the employee's entire record preceding the employee's oral or written warning, as the case may be.

  • Review by the Association of Procurement Decisions The Procurement Plan shall set forth those contracts which shall be subject to the Association’s Prior Review. All other contracts shall be subject to Post Review by the Association.

  • Procedure for Termination, Amendment, Extension or Waiver A termination of this Agreement pursuant to Section 7.01, an amendment of this Agreement pursuant to Section 7.03 or an extension or waiver of this Agreement pursuant to Section 7.04 shall, in order to be effective, require in the case of Parent, Sub or the Company, action by its Board of Directors.

  • Implementation of Corrective Action Plan After the Corrective Action Plan is finalized, the Purchasers shall use reasonable best efforts to implement the finalized Corrective Action Plan on the timeline set forth therein and provide periodic reports (as provided for therein) to the Sellers on the status of their implementation of the Corrective Action Plan.

  • Deviation from Grievance Procedure The Employer agrees that, after a grievance has been discussed at Step 2 of the grievance procedure the Employer or his representatives shall not initiate any discussion or negotiations with respect to the grievance, either directly or indirectly with the aggrieved employee without the consent of the xxxxxxx or the Union.

  • Compliance; Modification The Asset Representations Reviewer will cooperate with and provide information to the Issuer regarding the Asset Representations Reviewer’s compliance with this Section 4.10. The Asset Representations Reviewer and the Issuer agree to modify this Section 4.10 as necessary from time to time for either party to comply with applicable law.

  • Procedure for Surrender of Rights Rights may be surrendered to the Right Agent, together with a written request for exchange or transfer, and thereupon the Right Agent shall issue in exchange therefor one or more new Rights as requested by the registered holder of the Rights so surrendered, representing an equal aggregate number of Rights; provided, however, that in the event that a Right surrendered for transfer bears a restrictive legend, the Right Agent shall not cancel such Right and issue new Rights in exchange therefor until the Right Agent has received an opinion of counsel for the Company stating that such transfer may be made and indicating whether the new Rights must also bear a restrictive legend.

  • Review by the Bank of Procurement Decisions The Procurement Plan shall set forth those contracts which shall be subject to the Bank’s Prior Review. All other contracts shall be subject to Post Review by the Bank.

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