Regulatory Communications and Inspections Sample Clauses

Regulatory Communications and Inspections. All information, documents and updates with regard to the Manufacture of Product which are required by any Agency shall be provided by BVL in a timely manner to the Agency, or, if needed in connection with a regulatory filing of Customer, shall be provided directly to Customer, within five (5) days of Customer’s request, and BVL shall submit to all inquiries and inspections by any such Agency. All Product-specific documents provided directly by BVL to any Agency shall be provided to Customer in a reasonable amount of time in advance of submission to such Agency to allow Customer to comment, and in no case shall final copies of such documents be provided to Customer later than five (5) business days after such documents are provided to any Agency. BVL shall notify Customer Immediately (or, if during a weekend, upon the next business day) of all scheduled or unscheduled Product-specific Agency inspections, and Customer shall have the right to be present for such inspection, including, but not limited to, daily and post-inspection wrap-up sessions. BVL shall notify Customer Promptly of any inspections that are not Product-specific, but are directed generally at a Facility used to Manufacture Product, but Customer shall not have the right to be present for such inspection. Any and all Product-specific written communications or notices of inspection received from any Agency shall be provided by BVL to Customer no later than two (2) business days after such communications are received by BVL. Any and all other written communications or notices of inspection received from any Agency that are likely to impact Product shall be provided by BVL to Customer no later than two (2) business days after BVL has reasonably identified that such communications are likely to impact Product; provided, however, BVL may redact the confidential information of Third Parties from such communications prior to providing same to Customer. 3.5.1. BVL shall also notify Customer Immediately of any notices, observations or other written communications from an Agency regarding any deficiencies that have or are likely to have a material adverse effect on the Product or BVL’s ability to perform its obligations under this Agreement, and BVL shall discuss with Customer BVL’s plans to address such deficiencies and shall keep Customer apprised of its progress in remedying such deficiencies. 3.5.2. Customer shall provide BVL with copies of all Agency approval letters for Product for both clinical ...
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Regulatory Communications and Inspections. Schering shall take all reasonable steps necessary for the Schering Facilities to obtain and maintain approval by the FDA as a manufacturer of Finished Product under Indevus’ NDA for Product. Schering will provide Indevus with reasonable advance notice of any related FDA inspections (or within five (5) Business Days after any unannounced contact, inspection or audit commences) and, at the conclusion of such inspections, provide Indevus in writing with the results and outcome of such inspection, an estimate of the timeline associated with correcting any deficiencies identified by such inspection, and copies of any observations by the FDA (such as 483 comments) that would in any event become publicly available, including pursuant to The Freedom of Information Act, 5 U.S.C. § 552, as amended, and the HHS Freedom of Information Regulations (45 CFR Part 5). Indevus shall provide such assistance in connection with such inspection as may be reasonably requested by Schering. Schering shall discuss with the Supply Team any comments related to and affecting Schering’s performance of any Manufacturing activities and shall be responsible for and shall take appropriate actions to correct in a timely manner any deficiencies identified by such inspection. Schering shall retain copies in accordance with Regulatory Standards, and will also inform Indevus in writing as to any written communications or correspondence between Schering and the FDA relating to Schering’s activities under this Agreement within five (5) Business Days after receiving or providing such communication or correspondence.
Regulatory Communications and Inspections. Institution shall immediately notify CRO and Sponsor of, and provide CRO and Sponsor copies of, any inquiries, correspondence or communications to or from any Regulatory Authority relating to the Study, including, but not limited to, requests for inspection of the Study Site’s facilities. Institution shall permit CRO and Sponsor or a third party designated by Sponsor to attend any such • kontrola a/nebo ověření úplnosti CRF a důsledného dodržování protokolu, • kontrola a/nebo ověření zdrojových dokumentů, mimo jiné včetně záznamů nemocnice/kliniky, které jsou relevantní pro přípravu CRF. Jakákoli kontrola a/nebo ověření zdrojových dokumentů ze strany zadavatele nebo CRO bude provedena s náležitým ohledem na zachování lékařského tajemství. Poskytovatel zajistí, aby byl zkoušející lékař přítomen při zahajovací návštěvě a závěrečné návštěvě pracoviště a aby byl k dispozici při každé monitorovací návštěvě. V případě, že zkoušející lékař nebude během monitorovacích návštěv k dispozici, poskytovatel zajistí, aby byl pro projednání případných problémů k dispozici spoluzkoušející nebo člen personálu poskytovatele určený zkoušejícím lékařem. Zadavatel má právo kopírovat materiály, včetně těch, které představují důvěrné informace nebo vynálezy v rámci studie. Pokud se v souladu s platnými právními předpisy nebo standardy zadavatele stanoví, že studijní pracoviště není dostatečně vhodné pro řádné provádění studie, a poskytovatel tyto nedostatky neodstraní v přiměřené lhůtě po oznámení těchto nedostatků, může zadavatel, nebo CRO v souladu s pokyny zadavatele, podle svého výhradního uvážení odmítnout zahájení studie nebo se může rozhodnout studii ukončit a vypovědět tuto smlouvu. 8.3 Komunikace s regulačními úřady a inspekce. Poskytovatel musí neprodleně informovat CRO a zadavatele o jakýchkoli dotazech, korespondenci nebo sděleních zaslaných jakémukoli regulačnímu úřadu nebo od něj přijatých a týkajících se studie a poskytne CRO a zadavateli jejich kopie, mimo jiné včetně žádostí o inspekci v prostorách studijního pracoviště. Poskytovatel umožní CRO a zadavateli nebo třetí straně určené zadavatelem účastnit se
Regulatory Communications and Inspections. Helsinn will promptly, but in any event not later than three (3) Business Days after notice or the same day as any unannounced contact, inspection or audit commences, inform Indevus of any contact, inspection or audit by any Regulatory Authority or governmental agency (other than ISO 14001 and FCOS inspections), related to or affecting the API or a Helsinn Facility where the API is manufactured. Authorized representatives of Indevus shall have the right to be present during the inspection and/or during the close-out session with any Regulatory Authority inspectors. Helsinn will promptly provide Indevus with copies of any government-issued inspection observation reports (including without limitation FDA Form 483s, warning letters, citations and/or equivalent or similar forms from other Regulatory Authorities) and/or agency correspondence that may reasonably be expected to affect the API or a Helsinn Facility where the API is manufactured, or that relates to any related license or permit issued to Helsinn in connection with the API manufacture. Helsinn and Indevus will cooperate in resolving any concerns with any Regulatory Authority and Helsinn will provide Indevus with a written copy of any proposed response at least five (5) Business Days prior to submitting such response and of the actual responses submitted to any Regulatory Authority and with a summary of the corrective action(s) taken or planned by Helsinn. Helsinn will do all its best efforts to rectify or resolve any deficiencies noted by any Regulatory Authority that relate to Helsinn’s ability to supply API hereunder. Helsinn will also inform Indevus of any action taken by any governmental agency against Helsinn or any of its officers and employees which may reasonably be expected to adversely affect the API or Helsinn’s ability to supply API hereunder within 24 hours after the action is taken. Helsinn will also provide Indevus with copies of all other communications or correspondence between Helsinn and any Regulatory Authority relating to Helsinn’s activities under this Agreement within forty-eight (48) hours after receiving or providing such communication or correspondence.

Related to Regulatory Communications and Inspections

  • 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 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.

  • Direct Website Communications (a) The Borrower may, at its option, provide to the Administrative Agent any information, documents and other materials that it is obligated to furnish to the Administrative Agent pursuant to the Credit Documents, including, without limitation, all notices, requests, financial statements, financial and other reports, certificates and other information materials, but excluding any such communication that (A) relates to a request for a new, or a conversion of an existing, borrowing or other extension of credit (including any election of an interest rate or interest period relating thereto), (B) relates to the payment of any principal or other amount due under the Credit Agreement prior to the scheduled date therefor, (C) provides notice of any default or event of default under this Agreement or (D) is required to be delivered to satisfy any condition precedent to the effectiveness of the Credit Agreement and/or any borrowing or other extension of credit thereunder (all such non-excluded communications being referred to herein collectively as “Communications”), by transmitting the Communications in an electronic/soft medium in a format reasonably acceptable to the Administrative Agent to the Administrative Agent at an email address provided by the Administrative Agent from time to time; provided that (i) upon written request by the Administrative Agent, the Borrower shall deliver paper copies of such documents to the Administrative Agent for further distribution to each Lender until a written request to cease delivering paper copies is given by the Administrative Agent and (ii) the Borrower shall notify (which may be by facsimile or electronic mail) the Administrative Agent of the posting of any such documents and provide to the Administrative Agent by electronic mail electronic versions (i.e., soft copies) of such documents. Each Lender shall be solely responsible for timely accessing posted documents or requesting delivery of paper copies of such documents from the Administrative Agent and maintaining its copies of such documents. Nothing in this Section 13.17 shall prejudice the right of the Borrower, the Administrative Agent, any other Agent or any Lender to give any notice or other communication pursuant to any Credit Document in any other manner specified in such Credit Document. The Administrative Agent agrees that the receipt of the Communications by the Administrative Agent at its e-mail address set forth above shall constitute effective delivery of the Communications to the Administrative Agent for purposes of the Credit Documents. Each Lender agrees that notice to it (as provided in the next sentence) specifying that the Communications have been posted to the Platform shall constitute effective delivery of the Communications to such Lender for purposes of the Credit Documents. Each Lender agrees (A) to notify the Administrative Agent in writing (including by electronic communication) from time to time of such Lender’s e-mail address to which the foregoing notice may be sent by electronic transmission and (B) that the foregoing notice may be sent to such e-mail address. (b) The Borrower further agrees that any Agent may make the Communications available to the Lenders by posting the Communications on Intralinks or a substantially similar electronic transmission system (the “Platform”), so long as the access to such Platform (i) is limited to the Agents, the Lenders and Transferees or prospective Transferees and (ii) remains subject to the confidentiality requirements set forth in Section 13.16. (c) THE PLATFORM IS PROVIDED “AS IS” AND “AS AVAILABLE”. THE AGENT PARTIES (AS DEFINED BELOW) DO NOT WARRANT THE ACCURACY OR COMPLETENESS OF THE BORROWER MATERIALS OR THE ADEQUACY OF THE PLATFORM, AND EXPRESSLY DISCLAIM LIABILITY FOR ERRORS IN OR OMISSIONS FROM THE BORROWER MATERIALS. NO WARRANTY OF ANY KIND, EXPRESS, IMPLIED OR STATUTORY, INCLUDING ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OF THIRD PARTY RIGHTS OR FREEDOM FROM VIRUSES OR OTHER CODE DEFECTS, IS MADE BY ANY AGENT PARTY IN CONNECTION WITH THE BORROWER MATERIALS OR THE PLATFORM. In no event shall the Administrative Agent or any of its Related Parties (collectively, the “Agent Parties” and each an “Agent Party”) have any liability to the Borrower, any Lender, the Letter of Credit Issuer or any other Person for losses, claims, damages, liabilities or expenses of any kind (whether in tort, contract or otherwise) arising out of the Borrower’s or the Administrative Agent’s transmission of Borrower Materials through the internet, except to the extent the liability of any Agent Party resulted from such Agent Party’s (or any of its Related Parties’ (other than any trustee or advisor)) gross negligence, bad faith or willful misconduct or material breach of the Credit Documents. (d) The Borrower and each Lender acknowledge that certain of the Lenders may be “public-side” Lenders (Lenders that do not wish to receive material non-public information with respect to the Borrower, its Subsidiaries or their securities) and, if documents or notices required to be delivered pursuant to the Credit Documents or otherwise are being distributed through the Platform, any document or notice that the Borrower has indicated contains only publicly available information with respect to the Borrower may be posted on that portion of the Platform designated for such public-side Lenders. If the Borrower has not indicated whether a document or notice delivered contains only publicly available information, the Administrative Agent shall post such document or notice solely on that portion of the Platform designated for Lenders who wish to receive material nonpublic information with respect to the Borrower, its Subsidiaries and their securities. Notwithstanding the foregoing, the Borrower shall use commercially reasonable efforts to indicate whether any document or notice contains only publicly available information.

  • 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.

  • APPROVAL OF GENERAL COMMUNICATIONS Competitive Supplier shall cooperate with and assist the Town in the drafting and sending of messages and information to Eligible Consumers concerning the Program or any matter arising under or related to this Agreement or the Program. Competitive Supplier shall, prior to sending any direct mail, advertising, solicitation, bill insert, electronic mail, or other similar written or electronic communication (collectively, “General Communications”) to Participating Consumers (but excluding individually drafted or tailored communications responding to a specific complaint or communication of an individual consumer), provide a copy of such General Communication to the Town for its review (for consistency with the Town’s purposes and goals) and approval. The Town shall have the right to disapprove such General Communications and suggest revisions if it finds the communication inconsistent with the purposes and goals of the Town, factually inaccurate, or likely to mislead provided, however, that: (i) the communication shall be deemed approved if the Town fails to respond within ten (10) Business Days, and (ii) no approval shall be necessary for any communication (a) regarding any emergency situation involving any risk to the public health, safety or welfare; (b) that has been approved by the Department, the DOER; or (c) in the nature of routine monthly or periodic bills, or collection notices, except that any bill insert or message included at the bottom of such bill not within the scope of (a) or (b) above shall require advanced review and approval by the Town; and (iii) no approval or lack of approval shall relieve the Competitive Supplier of its obligations and responsibility for its actions and omissions under this Agreement, or other than as set forth in sub-clause ‘i’ of this Section 7.6, result in a waiver of any rights, remedies or defenses of the Town. The Town may reject or exclude any proposed General Communication that, in its reasonable judgment, is contrary to the interests and objectives of the Program or the Town.

  • Routine Communications All routine communications related to the Contract shall be sent to the Department’s Contract Manager. If any of the Contractor’s contract information changes during the life of the Contract, the Contractor shall notify the Department’s Contract Manager; such updates do not necessitate a formal amendment to the Contract. Communications relating to a Customer contract or purchase order should be addressed to the contact person identified in the contract or purchase order. Routine communications may be my email, regular mail, or telephone.

  • Tests and Inspections § 15.5.1 Tests, inspections and approvals of portions of the Work shall be made as required by the Design-Build Documents and by applicable laws, statutes, ordinances, codes, rules and regulations or lawful orders of public authorities. Unless otherwise provided, the Design-Builder shall make arrangements for such tests, inspections and approvals with an independent testing laboratory or entity acceptable to the Owner, or with the appropriate public authority, and shall bear all related costs of tests, inspections and approvals. The Design-Builder shall give the Owner timely notice of when and where tests and inspections are to be made so that the Owner may be present for such procedures. The Owner shall bear costs of (1) tests, inspections or approvals that do not become requirements until after bids are received or negotiations concluded, and (2) tests, inspections or approvals where building codes or applicable laws or regulations prohibit the Owner from delegating their cost to the Design-Builder. § 15.5.2 If the Owner determines that portions of the Work require additional testing, inspection or approval not included under Section 15.5.1, the Owner will instruct the Design-Builder to make arrangements for such additional testing, inspection or approval by an entity acceptable to the Owner, and the Design-Builder shall give timely notice to the Owner of when and where tests and inspections are to be made so that the Owner may be present for such procedures. Such costs, except as provided in Section 15.5.3, shall be at the Owner’s expense. § 15.5.3 If such procedures for testing, inspection or approval under Sections 15.5.1 and 15.5.2 reveal failure of the portions of the Work to comply with requirements established by the Design-Build Documents, all costs made necessary by such failure shall be at the Design-Builder’s expense. § 15.5.4 Required certificates of testing, inspection or approval shall, unless otherwise required by the Design-Build Documents, be secured by the Design-Builder and promptly delivered to the Owner. § 15.5.5 If the Owner is to observe tests, inspections or approvals required by the Design-Build Documents, the Owner will do so promptly and, where practicable, at the normal place of testing. § 15.5.6 Tests or inspections conducted pursuant to the Design-Build Documents shall be made promptly to avoid unreasonable delay in the Work.

  • Public Communications (1) Subject to compliance with applicable Securities Laws, immediately after the execution of this Agreement, or such later time prior to the next opening of markets in Toronto or New York as is agreed to by the Company and the Purchaser, the Company and the Purchaser shall issue a news release announcing the entering into of this Agreement, which news release shall be satisfactory in form and substance to each of the Company and the Purchaser, each acting reasonably, and, thereafter, file such news release, a corresponding material change report in prescribed form and this Agreement in accordance with applicable Securities Laws. (2) No Party shall issue any press release or make any other public statement or disclosure with respect to this Agreement or the Arrangement without the consent of the other Party (which consent shall not be unreasonably withheld, conditioned or delayed), and the Company must not make any filing with any Governmental Entity (except as contemplated by this Article 4) with respect to this Agreement or the Arrangement without the consent of the Purchaser (which consent shall not be unreasonably withheld, conditioned or delayed); provided that any Party that is required to make disclosure by Law shall use its commercially reasonable efforts to give the other Party prior oral or written notice (and if such prior notice is not possible, to give notice immediately following the making of any such disclosure or filing) and a reasonable opportunity to review or comment on the disclosure or filing (other than with respect to confidential information contained in such disclosure or filing). The Party making such disclosure shall give reasonable consideration to any comments made by the other Party or its counsel, and if such prior notice is not possible, shall give such notice immediately following the making of such disclosure or filing. (3) The Company and the Purchaser agree to cooperate in the preparation of formal presentations, if any, to any Company Shareholders or other securityholders of the Company or the analyst community regarding the Arrangement, and the Company agrees to consult with the Purchaser in connection with any formal meeting with analysts that it may have, provided, however, that the foregoing shall be subject to the Company’s overriding obligation to make any disclosure or filing required by applicable Laws or stock exchange rules and if the Company is required to make any such disclosure, it shall use its commercially reasonable efforts to give the Purchaser a reasonable opportunity to review and comment thereon prior to its dissemination.

  • 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.

  • Field Audits and Examination Reports; Confidentiality; Disclaimers by Lenders; Other Reports and Information By becoming a party to this Agreement, each Lender: (a) is deemed to have requested that Agent furnish such Lender, promptly after it becomes available, a copy of each field audit or examination report (each a "Report" and collectively, "Reports") prepared by Agent, and Agent shall so furnish each Lender with such Reports, (b) expressly agrees and acknowledges that Agent does not (i) make any representation or warranty as to the accuracy of any Report, and (ii) shall not be liable for any information contained in any Report, (c) expressly agrees and acknowledges that the Reports are not comprehensive audits or examinations, that Agent or other party performing any audit or examination will inspect only specific information regarding Borrowers and will rely significantly upon the Books, as well as on representations of Borrowers' personnel, (d) agrees to keep all Reports and other material, non-public information regarding Borrowers and their Subsidiaries and their operations, assets, and existing and contemplated business plans in a confidential manner; it being understood and agreed by Borrowers that in any event such Lender may make disclosures (a) to counsel for and other advisors, accountants, and auditors to such Lender, (b) reasonably required by any bona fide potential or actual Assignee or Participant in connection with any contemplated or actual assignment or transfer by such Lender of an interest herein or any participation interest in such Lender's rights hereunder, (c) of information that has become public by disclosures made by Persons other than such Lender, its Affiliates, assignees, transferees, or Participants, or (d) as required or requested by any court, governmental or administrative agency, pursuant to any subpoena or other legal process, or by any law, statute, regulation, or court order; provided, however, that, unless prohibited by applicable law, statute, regulation, or court order, such Lender shall notify Administrative Borrower of any request by any court, governmental or administrative agency, or pursuant to any subpoena or other legal process for disclosure of any such non-public material information concurrent with, or where practicable, prior to the disclosure thereof, and (e) without limiting the generality of any other indemnification provision contained in this Agreement, agrees: (i) to hold Agent and any such other Lender preparing a Report harmless from any action the indemnifying Lender may take or conclusion the indemnifying Lender may reach or draw from any Report in connection with any loans or other credit accommodations that the indemnifying Lender has made or may make to Borrowers, or the indemnifying Lender's participation in, or the indemnifying Lender's purchase of, a loan or loans of Borrowers; and (ii) to pay and protect, and indemnify, defend and hold Agent, and any such other Lender preparing a Report harmless from and against, the claims, actions, proceedings, damages, costs, expenses, and other amounts (including, attorneys fees and costs) incurred by Agent and any such other Lender preparing a Report as the direct or indirect result of any third parties who might obtain all or part of any Report through the indemnifying Lender. In addition to the foregoing: (x) any Lender may from time to time request of Agent in writing that Agent provide to such Lender a copy of any report or document provided by Borrowers to Agent that has not been contemporaneously provided by Borrowers to such Lender, and, upon receipt of such request, Agent shall provide a copy of same to such Lender, (y) to the extent that Agent is entitled, under any provision of the Loan Documents, to request additional reports or information from Borrowers, any Lender may, from time to time, reasonably request Agent to exercise such right as specified in such Lender's notice to Agent, whereupon Agent promptly shall request of Administrative Borrower the additional reports or information reasonably specified by such Lender, and, upon receipt thereof from Administrative Borrower, Agent promptly shall provide a copy of same to such Lender, and (z) any time that Agent renders to Administrative Borrower a statement regarding the Loan Account, Agent shall send a copy of such statement to each Lender.

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