ACCESS TO FDA FILES Sample Clauses

ACCESS TO FDA FILES. A and ORTHO agree that each shall have access to and the exclusive and irrevocable right to refer to and cross-reference each other's INDs, NDAs and supplements thereto consistent with the purposes of this AGREEMENT and the TECHNOLOGY LICENSE AGREEMENT and with respect to K-A not for any diagnostic purpose and each agrees to provide all appropriate documentation necessary to achieve the purposes of this AGREEMENT. ORTHO's access and utilization under this Paragraph shall include use within and outside the LICENSED TERRITORY. The parties agree to notify the FDA of the right to cross-reference the above- described documents and to execute and file all the necessary papers and documents required to allow each to exercise its rights under this AGREEMENT.
Sample 1
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ACCESS TO FDA FILES. (i) With respect to EPO, AMGEN and ORTHO agree that each shall have access to and the exclusive and irrevocable right to refer to and cross- reference each other's INDs, NDAs and supplements thereto consistent with the purposes of this AGREEMENT and the TECHNOLOGY LICENSE AGREEMENT and with respect to AMGEN not for any purpose other than dialysis and each agrees to provide all appropriate documentation necessary to achieve the purposes of this AGREEMENT. The parties agree to notify the FDA of the right to cross-reference the above- described documents and to execute and file all the necessary papers and documents required to allow each to exercise its rights under this AGREEMENT. (ii) With respect to HEPATITIS B and IL-2, AMGEN and ORTHO agree that ORTHO shall have access to and the exclusive and irrevocable right to refer to and cross-reference AMGEN's INDs, NDAs and supplements thereto consistent with the purposes of this AGREEMENT and AMGEN agrees to provide all appropriate documentation to achieve the purposes of this AGREEMENT. AMGEN further agrees, upon request by ORTHO, to further notify the FDA of ORTHO's right to cross-reference the above-described documents and to execute and file all the necessary papers and documents required to allow ORTHO to exercise its rights under this AGREEMENT. (iii) With respect to HEPATITIS B, AMGEN and ORTHO agree that AMGEN shall have access to and the exclusive and irrevocable right to refer to and utilize ORTHO's INDs, NDAs and supplements thereto provided that AMGEN demonstrates such is necessary for it to pursue its registration of HEPATITIS B in China and for no other purpose.
Sample 1

Related to ACCESS TO FDA FILES

  • Access to Files A copy of any completed evaluation which is to be placed in a nurse’s file shall be first reviewed with the nurse. The nurse shall initial such evaluation as having been read and shall have the opportunity to add her views to such evaluation prior to it being placed in her file. It is understood that such evaluations do not constitute disciplinary action by the Hospital against the nurse. Each nurse shall have reasonable access to all her files for the purpose of reviewing their contents in the presence of her supervisor. A copy of the evaluation will be provided to the nurse at her request. No document shall be used against a nurse where it has not been brought to her attention in a timely manner. Any letter of reprimand, suspension or other sanction will be removed from the record of a nurse eighteen months following the receipt of such letter, suspension or other sanction provided that the nurse’s record has been discipline free for one year. Newly hired part-time nurses shall beconsidered to be on probation for a period of sixty tours worked hours of work for nurses whose regular hours of work are other than the standard work day). If retained the sixty tours hours) worked. With the written consent of the or her designate, such probationary period may be extended. Where the Hospital requests an extension of the probationary period, it will provide notice to the Association at least fourteen calendar days prior to the expected date of expiration of the initial probationary period. It is to the probationary period will not exceed an additional sixty tours hours) worked and, where requested, the Hospital will advise the nurse and the Association of the basis of such extension. A nurse who transfers from casual part-time or full-time to regular not has previously completed one since her date of last hire. Where no such probationary period has been served, the number of tours worked (hours worked for nurses whose regular hours of work are other than the standard work day) during the nine months immediately preceding the transfer shall be credited towards the probationary period.

  • Access to Site 3.05.1 Contractor may enter and leave the premises at all reasonable times without charge. Contractor and its employees may use the common areas and roadways of the premises where it is to perform the services together with all facilities, equipment, improvements, and services provided in connection with the premises for common use. This excludes parking for Contractor’s personnel. Contractor shall repair any damage caused by it or its employees as a result of its use of the common areas.

  • Access to NID 2.7.3.1 NewPhone may access the customer’s premises wiring by any of the following means and NewPhone shall not disturb the existing form of electrical protection and shall maintain the physical integrity of the NID: 2.7.3.1.1 BellSouth shall allow NewPhone to connect its Loops directly to BellSouth’s multi-line residential NID enclosures that have additional space and are not used by BellSouth or any other telecommunications carriers to provide service to the premises; 2.7.3.1.2 Where an adequate length of the customer’s premises wiring is present and environmental conditions permit, either Party may remove the customer premises wiring from the other Party’s NID and connect such wiring to that Party’s own NID; 2.7.3.1.3 Either Party may enter the subscriber access chamber or dual chamber NID enclosures for the purpose of extending a cross-connect or spliced jumper wire from the customer premises wiring through a suitable “punch-out” hole of such NID enclosures; or 2.7.3.1.4 NewPhone may request BellSouth to make other rearrangements to the customer premises wiring terminations or terminal enclosure on a time and materials cost basis. 2.7.3.2 In no case shall either Party remove or disconnect the other Party’s loop facilities from either Party’s NIDs, enclosures, or protectors unless the applicable Commission has expressly permitted the same and the disconnecting Party provides prior notice to the other Party. In such cases, it shall be the responsibility of the Party disconnecting loop facilities to leave undisturbed the existing form of electrical protection and to maintain the physical integrity of the NID. It will be NewPhone’s responsibility to ensure there is no safety hazard, and NewPhone will hold BellSouth harmless for any liability associated with the removal of the BellSouth Loop from the BellSouth NID. Furthermore, it shall be the responsibility of the disconnecting Party, once the other Party’s loop has been disconnected from the NID, to reconnect the disconnected loop to a nationally recognized testing laboratory listed station protector, which has been grounded as per Article 800 of the National Electrical Code. If no spare station protector exists in the NID, the disconnected loop must be appropriately cleared, capped and stored. 2.7.3.3 NewPhone shall not remove or disconnect ground wires from BellSouth’s NIDs, enclosures, or protectors. 2.7.3.4 NewPhone shall not remove or disconnect NID modules, protectors, or terminals from BellSouth’s NID enclosures. 2.7.3.5 Due to the wide variety of NID enclosures and outside plant environments, BellSouth will work with NewPhone to develop specific procedures to establish the most effective means of implementing this section if the procedures set forth herein do not apply to the NID in question.

  • Access to Review Materials The Servicer will give the Asset Representations Reviewer access to the Review Materials for all of the Subject Receivables within sixty (60) calendar days after receipt of the review notice in one or more of the following ways in the Servicer’s reasonable discretion: (i) by electronic posting of Review Materials to a password-protected website to which the Asset Representations Reviewer has access, (ii) by providing originals or photocopies of documents relating to the Subject Receivables at one of the properties of the Servicer or (iii) in another manner agreed by the Servicer and the Asset Representations Reviewer. The Servicer may redact or remove PII from the Review Materials so long as all information in the Review Materials necessary for the Asset Representations Reviewer to complete the Asset Review remains intact and unchanged.

  • Access to Data Operator shall make Data in the possession of the Operator available to the LEA within five (5) business days of a request by the LEA.

  • Records and Files The CNA shall maintain records, reports, and files to document the inspections conducted by the CNA and any necessary corrective action taken (as appropriate). Copies of all QCP related inspection reports and other documents shall be made available to the Commission when requested. All such documents shall be maintained by the CNA.

  • Access to Public Records No records of District shall be made available for public inspection or copying by NWRDC, NWESD, or XXXXX without express written authorization of District. Requests pursuant to RCW 42.17 for inspection or copying of public records of District, held or maintained by NWRDC shall be referred to District.

  • Access to Records after Closing (a) For a period of ------------------------------- six years after the Closing Date, Parent and its representatives shall have reasonable access to all of the books and records of the Companies to the extent that such access may reasonably be required by Parent in connection with matters relating to or affected by the operations of the Companies prior to the Closing Date. Such access shall be afforded by Buyer upon receipt of reasonable advance notice and during normal business hours. Parent shall be solely responsible for any costs or expenses incurred by it pursuant to this Section 13.6(a). If Buyer --------------- or the Companies shall desire to dispose of any of such books and records prior to the expiration of such six-year period, Buyer shall, prior to such disposition, give Parent a reasonable opportunity, at Parent's expense, to segregate and remove such books and records as Parent may select. (b) For a period of six years after the Closing Date, Buyer and its representatives shall have reasonable access to all of the books and records relating to the Companies which Parent or any of its Affiliates may retain after the Closing Date. Such access shall be afforded by Parent and its Affiliates upon receipt of reasonable advance notice and during normal business hours. Buyer shall be solely responsible for any costs and expenses incurred by it pursuant to this Section 13.6(b). If Parent or any of its Affiliates shall --------------- desire to dispose of any of such books and records prior to the expiration of such six-year period, Parent shall, prior to such disposition, give Buyer a reasonable opportunity, at Buyer's expense, to segregate and remove such books and records as Buyer may select.

  • Access to Records The Contractor and its subcontractors, if any, shall maintain all books, documents, papers, accounting records, and other evidence pertaining to all costs incurred under this Contract. They shall make such materials available at their respective offices at all reasonable times during this Contract, and for three (3) years from the date of final payment under this Contract, for inspection by the State or its authorized designees. Copies shall be furnished at no cost to the State if requested.

  • Access to Books and Records (a) The Borrower and the Guarantors will make and keep books, records and accounts in which full, true and correct entries in conformity with GAAP are made of all financial dealings and transactions in relation to its business and activities, including, without limitation, an accurate and fair reflection of the transactions and dispositions of the assets of the Borrower and the Guarantors. (b) The Borrower and the Guarantors will permit, to the extent not prohibited by applicable law or contractual obligations, any representatives designated by the Administrative Agent or the Collateral Trustee or any Governmental Authority that is authorized to supervise or regulate the operations of a Lender, as designated by such Lender, upon reasonable prior written notice and, so long as no Event of Default has occurred and is continuing, at no out-of-pocket cost to the Borrower and the Guarantors, to (x) visit and inspect the Collateral and the properties of the Borrower and the Guarantors, (y) examine its books and records, and (z) discuss its affairs, finances and condition with its officers and independent accountants, all at such reasonable times during normal business hours and as often as reasonably requested (it being understood that a representative of the Borrower will be present) subject to any restrictions in any applicable Collateral Document; provided that if an Event of Default has occurred and is continuing, the Borrower and the Guarantors shall be responsible for the reasonable costs and expenses of any visits of the Administrative Agent, the Collateral Trustee and the Lenders, acting together (but not separately); provided, further, that with respect to Collateral and matters relating thereto, the rights of Administrative Agent, the Collateral Trustee and the Lenders under this Section 5.13 shall, subject to the inspection provisions of the applicable Collateral Documents, be limited to the following: upon the request of the Administrative Agent or the Collateral Trustee, the applicable Grantor will permit the Administrative Agent and/or the Collateral Trustee or any of its agents or representatives, at reasonable times and intervals upon reasonable prior notice, to (x) visit during normal business hours its offices, sites and properties and (y) inspect any documents relating to (i) the existence of such Collateral, (ii) with respect to Collateral other than Pledged Routes, Pledged Slots and Pledged Gate Leaseholds, the condition of such Collateral, and (iii) the validity, perfection and priority of the Liens on such Collateral, and to discuss such matters with its officers, except to the extent the disclosure of any such document or any such discussion would result in the applicable Grantor’s violation of its contractual or legal obligations. All confidential or proprietary information obtained in connection with any such visit, inspection or discussion shall be held confidential by the Administrative Agent, the Collateral Trustee and each of their respective agents and representatives and shall not be furnished or disclosed by any of them to anyone other than their respective bank examiners, auditors, accountants, agents and legal counsel, and except as may be required by any court or administrative agency or by any statute, rule, regulation or order of any Governmental Authority.

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