Governmental Communications and Inspections Sample Clauses

Governmental Communications and Inspections. Service Provider shall as soon as is reasonably possible notify Seragen of any communications from or inspections by the FDA or any other governmental agency, state or federal, including, without limitation, any communication or directive from the FDA or any other governmental agency, state or federal, commencing or threatening seizure of any manufactured product or other removal from the market of a manufactured product. If a written communication, Service Provider shall attach a copy; otherwise, Service Provider shall provide a reasonable description to Seragen of any such communication or inspection. Seragen shall have the right to be present at any such inspection and to review in advance and approve any response to such communication or investigation submitted by Service Provider. If the written communication is in regard to any product or any manufacturing process or regulatory filing for which Seragen is the license holder, Seragen will be the respondent. Service Provider will have the right to review such communication. Service Provider will cooperate fully in providing the information needed for the communication.
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Governmental Communications and Inspections. Each Party shall notify the other as soon as is reasonably possible following any communications from the FDA, EMEA or any other governmental agency (local, state or federal) relating to the services or the GTC Product, including any communication or directive from the FDA, EMEA or any other governmental agency (state or federal) regarding the GTC Product. If such a communication is a written communication, then the notifying Party shall provide a copy to the other Party. Otherwise, the notifying Party shall provide a reasonable description to the other Party of the communication. Both Parties shall have the right to review in advance any response to the communication submitted by the other Party. The wording and submission of a final response to a communication directed to LONZA or regarding LONZA’s Premises shall be the final responsibility of LONZA, except that any final response to a communication directed to GTC shall be the final responsibility of GTC, in consultation with LONZA. The Parties shall reasonably cooperate with each other in providing the information needed for any such communication. As it relates to this Service Agreement, LONZA may undergo regulatory inspections by FDA, EMEA or other regulatory authorities in connection with the pre-approval and post-approval of the GTC Product or other regulatory inspections specific to the services for the GTC Product. LONZA shall be solely responsible for coordinating and conducting such inspections. LONZA shall allow two (2) representatives of GTC to attend any pre-approval and post-approval inspection meetings involving the GTC Product. In addition, LONZA shall work with GTC in developing any response to observations by regulatory authorities relating to any pre- or post-approval inspection. The wording and submission of a final response to a communication directed to LONZA or regarding LONZA’s Premises shall be the final responsibility of LONZA, except that any final response to a communication directed to GTC Product shall be the final responsibility of GTC, in consultation with LONZA.
Sample 1
Governmental Communications and Inspections. The Parties will notify each other within twenty-four (24) hours of their receipt of notice of any inspections of the Facility relating to Fermentation Pellets, First Gen PDS and/or Second Gen PDS, whether prescheduled or unannounced, by a Regulatory Agency and if possible shall give the other Party the opportunity to be present and observe such an inspection. The findings of these inspections shall be provided to the other Party in a manner which protects the confidential information of third parties, to the extent they relate to or impact the manufacture, testing, packaging, storage, or handling of Fermentation Pellets, First Gen PDS and/or Second Gen PDS for SERAGEN or the provision of services to SERAGEN. Both parties shall notify each other within twenty-four (24) hours of receipt of any communications from a Regulatory Agency relating to the Facility or the Product manufactured in the Facility, including any communication or directive from a Regulatory Agency commencing or threatening seizure of any Fermentation Pellets, First Gen PDS and/or Second Gen PDS or other removal of any Fermentation Pellets, First Gen PDS and/or Second Gen PDS. If such communication is a written communication, the notifying Party shall attach a copy of the communication. Otherwise, the notifying Party shall provide a reasonable description to the other Party of the communication. The Parties shall have the right to review in advance any response to the communication or investigation submitted by the other party related to the Product. The Parties shall cooperate fully with each other in providing the information needed for any such communication. The wording and final submission of a response to a communication or investigation shall be the final responsibility of the addressee, provided SERAGEN retains the right to approve in advance the wording and final submission.
Sample 1

Related to Governmental Communications and Inspections

  • Information and Inspection Pledgor shall (i) promptly furnish Bank any information with respect to the Collateral requested by Bank; (ii) allow Bank or its representatives to inspect and copy, or furnish Bank or its representatives with copies of, all records relating to the Collateral and the Obligation; and (iii) promptly furnish Bank or its representatives with any other information Bank may reasonably request.

  • Other Information and Inspections In each case subject to the last sentence of this Section 6.3, each Restricted Person will furnish to each Lender any information which Administrative Agent or any Lender may from time to time request concerning any covenant, provision or condition of the Loan Documents or any matter in connection with Restricted Persons' businesses and operations. In each case subject to the last sentence of this Section 6.3, each Restricted Person will permit representatives appointed by Administrative Agent (including independent accountants, auditors, agents, attorneys, appraisers and any other Persons) to visit and inspect during normal business hours any of such Restricted Person's property, including its books of account, other books and records, and any facilities or other business assets, and to make extra copies therefrom and photocopies and photographs thereof, and to write down and record any information such representatives obtain, and each Restricted Person shall permit Administrative Agent or its representatives to investigate and verify the accuracy of the information furnished to Administrative Agent or any Lender in connection with the Loan Documents and to discuss all such matters with its officers, employees and, upon prior notice to Borrower, its representatives. Each of the foregoing inspections shall be made subject to compliance with applicable safety standards and the same conditions applicable to any Restricted Person in respect of property of that Restricted Person on the premises of Persons other than a Restricted Person or an Affiliate of a Restricted Person, and all information, books and records furnished or requested to be furnished, or of which copies, photocopies or photographs are made or requested to be made, all information to be investigated or verified and all discussions conducted with any officer, employee or representative of any Restricted Person shall be subject to any applicable attorney-client privilege exceptions which the Restricted Person determines is reasonably necessary and compliance with conditions to disclosures under non-disclosure agreements between any Restricted Person and Persons other than a Restricted Person or an Affiliate of a Restricted Person and the express undertaking of each Person acting at the direction of or on behalf of any Lender Party to be bound by the confidentiality provisions of Section 10.6 of this Agreement.

  • Information and Inspection Rights The Company shall permit, and shall cause each of its Subsidiaries to permit, the Purchaser, its representatives or any independent auditor or legal counsel appointed by the Purchaser, during normal business hours following reasonable notice by the Purchaser to the Company, to (i) visit and inspect any of the properties of the Company or any of its Subsidiaries, (ii) examine the books of account and records of the Company or any of its Subsidiaries, and (iii) discuss the affairs, finances and accounts of the Company or any of its Subsidiaries with the directors, officers, and management employees of the Company or any of its Subsidiaries.

  • 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.

  • Governmental and Third-Party Notices and Consents (a) Each Party shall use its Reasonable Best Efforts to obtain, at its expense, all waivers, permits, consents, approvals or other authorizations from Governmental Entities, and to effect all registrations, filings and notices with or to Governmental Entities, as may be required for such Party to consummate the transactions contemplated by this Agreement and to otherwise comply with all applicable laws and regulations in connection with the consummation of the transactions contemplated by this Agreement. (b) The Company shall use its Reasonable Best Efforts to obtain, at its expense, all such waivers, consents or approvals from third parties, and to give all such notices to third parties, as are required to be listed in Section 2.4 of the Disclosure Schedule.

  • AUDITS AND INVESTIGATIONS 27.1 Each invoice paid by UNDP shall be subject to a post-payment audit by auditors, whether internal or external, of UNDP or by other authorized and qualified agents of UNDP at any time during the term of the Contract and for a period of three (3) years following the expiration or prior termination of the Contract. 27.2 UNDP may conduct investigations relating to any aspect of the Contract or the award thereof, the obligations performed under the Contract, and the operations of the Contractor generally relating to performance of the Contract at any time during the term of the Contract and for a period of three 27.3 The Contractor shall provide its full and timely cooperation with any such inspections, post- payment audits or investigations. Such cooperation shall include, but shall not be limited to, the Contractor’s obligation to make available its personnel and any relevant documentation for such purposes at reasonable times and on reasonable conditions and to grant to UNDP access to the Contractor’s premises at reasonable times and on reasonable conditions in connection with such access to the Contractor’s personnel and relevant documentation. The Contractor shall require its agents, including, but not limited to, the Contractor’s attorneys, accountants or other advisers, to reasonably cooperate with any inspections, post-payment audits or investigations carried out by UNDP hereunder. 27.4 UNDP shall be entitled to a refund from the Contractor for any amounts shown by such audits or investigations to have been paid by UNDP other than in accordance with the terms and conditions of the Contract. The Contractor also agrees that, where applicable, donors to UNDP whose funding is the source of, in whole or in part, the funding for the procurement of Goods and/or Services which are the subject of this Contract, shall have direct recourse to the Contractor for the recovery of any funds determined by UNDP to have been used in violation of or inconsistent with this Contract.

  • Communications and Notices Any notice to the Contractor shall be deemed sufficient when deposited in the United States Mail postage prepaid; faxed; e-mailed; delivered to a telegraph office fee prepaid; or hand-carried and presented to an authorized employee of the Contractor at the Contractor’s address as listed on the signature page of the contract or at such address as the contractor may have requested in writing.

  • Inspections and Reports 2.1 The department may inspect, in the manner and at reasonable times it considers appropriate, all the contractor's facilities and activities under this contract. 2.2 The contractor shall make progress and other reports in the manner and at the times the department reasonably requires.

  • Audits and Inspections At any time during normal business hours and as often as the City may deem necessary, Service Provider shall make available to the City for the City’s examination all of Service Provider’s records and documents with respect to all matters covered by this Agreement and, furthermore, Service Provider will permit the City to audit, examine and make copies, excerpts or transcripts from such records, and to make audits of all contracts, invoices, materials, payrolls, records of personnel, conditions of employment and other data relating to all matters covered by this Agreement.

  • Communications and Computer Lines Tenant may install, maintain, replace, remove or use any communications or computer wires and cables (collectively, the “Lines”) at the Project in or serving the Premises, provided that (i) Tenant shall obtain Landlord’s prior written consent to the installation of any such Lines (such consent not to be unreasonably withheld), use an experienced and qualified contractor approved in writing by Landlord (such approval not to be unreasonably withheld), and comply with all of the other provisions of Articles 7 and 8 of this Lease, (ii) an acceptable amount of space for additional Lines shall be maintained for future occupants of the Project, as determined in Landlord’s reasonable opinion, (iii) the Lines (including riser cables) shall be appropriately insulated to prevent excessive electromagnetic fields or radiation, and shall be surrounded by a protective conduit reasonably acceptable to Landlord, (iv) any Lines servicing the Premises shall comply with all Applicable Laws, (v) as a condition to permitting the installation of new Lines, Landlord may require that Tenant remove existing Lines located in or serving the Premises that will no longer be used by Tenant and repair any damage in connection with such removal, and (vi) Tenant shall pay all costs in connection therewith. Landlord reserves the right to require that Tenant remove any Lines located in or serving the Premises which are installed in violation of these provisions, or which are at any time in violation of any Applicable Laws or represent a dangerous or potentially dangerous condition. Upon the expiration of the Lease Term, or immediately following any earlier termination of this Lease, Tenant shall, at Tenant’s sole cost and expense, remove all Lines installed by Tenant, and repair any damage caused by such removal.

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