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.
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.

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 Pacific Mutual, PEN, Selling Broker-Dealer and General Agent agree to cooperate fully in any insurance regulatory investigation or proceeding or judicial proceeding arising in connection with the Contracts distributed under this Agreement. Pacific Mutual, PEN, Selling Broker-Dealer and General Agent further agree to cooperate fully in any securities regulatory investigation or proceeding with respect to Pacific Mutual, PEN, Selling Broker-Dealer and General Agent, their affiliates and their agents or representatives to the extent that such investigation or proceeding is in connection with the Contracts distributed under this Agreement. Without limiting the foregoing:

  • Communications and Notices All notices, requests and other communications made or given in connection with the Loan Documents shall be in writing and, unless receipt is stated herein to be required, shall be deemed to have been validly given if delivered personally to the individual or division or department to whose attention notices to a party are to be addressed, or by private carrier, or registered or certified mail, return receipt requested, or by telecopy with the original forwarded by first-class mail, in all cases, with charges prepaid, addressed as follows, until some other address (or individual or division or department for attention) shall have been designated by notice given by one party to the other: To Borrower: Consolidated Stainless, Inc. 0000 Xxxx Xxxxxx Xxxxxx Orlando, FL 32803 Attention: Xxxxxx X. Xxxxx, President Telecopier No.: (000) 000-0000 with a copy to: Saul, Ewing, Xxxxxx & Xxxx LLP Centre Square West 0000 Xxxxxx Xxxxxx, 00xx Xxxxx Xxxxxxxxxxxx, XX 00000 Attention: Xxxx X. Xxxxxx, Esquire Telecopier No.: (000) 000-0000 with a copy to: Greenberg, Traurig, Hoffman, Lipoff, Xxxxx & Quentel Citicorp Center 000 X. 00xx Xxxxxx Xxx Xxxx, XX 00000 Attention: Xxxxxxx Xxxxxx, Esquire Telecopier No.: (000) 000-0000 To Bank: Mellon Bank, N.A. 0000 Xxxxxx Xxxxxx, 0xx Xxxxx Xxxxxxxxxxxx, XX 00000 Attention: Xxxxxx Xxxxxx, Vice President Telecopier No.: (000) 000-0000 with a copy to: Klehr, Harrison, Xxxxxx, Branzburg & Xxxxxx LLP 0000 Xxxxxx Xxxxxx Xxxxxxxxxxxx, XX 00000 Attention: Xxxxxxx X. Xxxxxxx, Esquire Telecopier No.: (000) 000-0000 with a copy to: Wolf, Block, Xxxxxx & Xxxxx-Xxxxx LLP 000 Xxxxx 00xx Xxxxxx Xxxxxxxxxxxx, XX 00000 Attention: Xxxxxx Xxxxxx, Esquire Telecopier No.: (000)000-0000

  • Communications Regulatory Matters (A) Schedule 5.13(A) sets forth a true and complete list of the following information for each License issued to each Loan Party or its Subsidiaries: the name of the licensee, the type of service, the expiration date and the geographic area covered by such License.

  • Audits and Inspections The Parties’ audit and inspection rights related to this Agreement shall be governed by the terms of the Clinical Quality Agreement.

  • Site Visits and Inspections; Regulatory Examinations During the term of this Agreement, authorized representatives of the Fund may conduct periodic site visits of the Transfer Agent’s facilities and inspect the Transfer Agent’s records and procedures solely as they pertain to the Transfer Agent’s services for the Fund under or pursuant to this Agreement. Such inspections shall be conducted at the Fund’s expense (which shall include costs related to providing materials, copying, faxing, retrieving stored materials, and similar expenses) and shall occur during the Transfer Agent’s regular business hours and, except as otherwise agreed to by the parties, no more frequently than twice a year. In connection with such site visit and/or inspection, the Fund shall not attempt to access, nor will it review, the records of any other clients of the Transfer Agent and the Fund shall conduct the visit/inspection in a manner that will not interfere with the Transfer Agent’s normal and customary conduct of its business activities, including the provision of services to the Fund and to other clients. The Transfer Agent shall have the right to immediately require the removal of any Fund representatives from its premises in the event that their actions, in the reasonable opinion of the Transfer Agent, jeopardize the information security of its systems and/or other client data or otherwise are disruptive to the business of the Transfer Agent. The Transfer Agent may require any persons seeking access to its facilities to provide reasonable evidence of their authority. The Transfer Agent may also reasonably require any of the Fund’s representatives to execute a confidentiality agreement before granting such individuals access to its facilities. The Transfer Agent will also provide reasonable access to the Fund’s governmental regulators, at the Fund’s expense, solely to (i) the Fund’s records held by the Transfer Agent and (ii) the procedures of the Transfer Agent directly related to its provision of services to the Fund under the Agreement.

  • Documents and Communications The Collateral Trustee will permit each Secured Debt Representative and each holder of Secured Obligations upon reasonable written notice from time to time to inspect and copy, at the cost and expense of the party requesting such copies, any and all Security Documents and other documents, notices, certificates, instructions or communications received by the Collateral Trustee in its capacity as such.

  • 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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