Cooperation during Audit by Hexal Sample Clauses

Cooperation during Audit by Hexal. The Institution shall cooperate, and shall cause the Principal Investigator and the Staff to cooperate, with Hexal and its contractors and agents in the event of any internal audits, upon reasonable notice and during normal business hours. The Institution shall furthermore make available to Hexal and its contractors and agents (for examination and duplication) all documentation, data and information relating to the Trial. Subject medical records will be made available where appropriate for the purpose of source document verification procedures as part of the audit. The Institution also shall make the Principal Investigator and Staff available to Hexal and its contractors and agents to explain and discuss such documentation, data and information. For the avoidance of doubt audits shall be supported at no cost by the Principal Investigator and Staff members. (d)
Sample 1
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Cooperation during Audit by Hexal. The Institution shall cooperate, and shall cause the Staff to cooperate, with Hexal and its contractors and agents in the event of any interna! audits, upon reasonable notice and during xxxxx!business hours. The Institution shall furthermore make available to Hexal and its contractors and agents (for examination and duplication) all documentation , data and information relating to the Tria!. Subject medical records related to the Tria! (primarily documentation supporting the inclusion criteria and enrollment of the subject into the Tria!) will be made available where appropriate for the purpose of source document verification procedures as part of the audit, where such disclosure shall be in compliance with all confidentiality obligations set forth in paragraph 6 of this Agreement. The Institution also shall make the Staff available to Hexal and its contractors and agents to explain and discuss such documentation, data and information. Inspection by Competent Authority.The lnstitution and acknowledges that the Tria!is subjected to inspections by regulatory agencies worldwide, including but not limited to the State Institute for Drug Control (Statní ustav pro kontrolu leciv - SÚKL). If a Competent Authority wishes to inspect the Institution or the Principal lnvestigator in connection with their participation in the Tria!, then the lnstitution and the Staff shall, to the extent reasonably practicab[e, (i) immediately notify Hexal thereof and use their best efforts to obtain approval for Hexal or its agents to be present at the inspection and (ii) cooperate with the relevant Competent Authorities and comply with the legitimate requirements of an inspection. Tbis also includes the making available (for examination and duplication) of documentation, data and information relating to the Tria!. Subject medical records shall be made available where required for source document verification procedures as part of the inspection.
Sample 1

Related to Cooperation during Audit by Hexal

  • Termination This Agreement may be terminated at any time prior to the Closing:

  • Governing Law This Agreement shall be governed by and construed in accordance with the laws of the State of New York.

  • Definitions For purposes of this Agreement:

  • Indemnification In the event any Registrable Securities are included in a Registration Statement under this Agreement:

  • Confidentiality (a) Subject to Section 7.15(c), during the Term and for a period of three

  • Miscellaneous The Vendor acknowledges and agrees that continued participation in TIPS is subject to TIPS sole discretion and that any Vendor may be removed from the participation in the Program at any time with or without cause. Nothing in the Agreement or in any other communication between TIPS and the Vendor may be construed as a guarantee that TIPS or TIPS Members will submit any orders at any time. TIPS reserves the right to request additional proposals for items or services already on Agreement at any time.

  • Insurance The Company and the Subsidiaries are insured by insurers of recognized financial responsibility against such losses and risks and in such amounts as are prudent and customary in the businesses in which the Company and the Subsidiaries are engaged, including, but not limited to, directors and officers insurance coverage. Neither the Company nor any Subsidiary has any reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain similar coverage from similar insurers as may be necessary to continue its business without a significant increase in cost.

  • IN WITNESS WHEREOF the parties hereto have executed this Agreement as of the day and year first above written.

  • Term The term of this Agreement will be ten (10) years from the Effective Date (as such term may be extended pursuant to Section 4.2, the “Term”).

  • Counterparts This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

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