Non-Compliance; Failure to Manufacture Sample Clauses

Non-Compliance; Failure to Manufacture. In the event that any regulatory agency shall determine, as a result of an inspection described in Section 9.4(a) above, that Lonza is not in compliance with applicable Legal Requirements or otherwise not in compliance with cGMP with respect to the manufacture of Bulk Drug or performance of Services, Lonza shall at its expense use best efforts to cure such non-compliance as soon as practicable. In the event that Lonza is unable to manufacture Bulk Drug for a particular period of time because of the action of a regulatory agency, then, except in the event of Trubion's negligence or more culpable act or omission, the provisions of Section 19 hereof shall apply, provided, however, that it is understood that Lonza's inability to manufacture Bulk Drug for the reasons set forth in this Section 9.4 shall not automatically be deemed a Force Majeure Event if Lonza's inability to manufacture was caused by Lonza's negligent or more culpable act or omission.
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Non-Compliance; Failure to Manufacture. In the event that any regulatory agency shall determine, as a result of an inspection described in Section 9.5(a) above, that BIP is not in compliance with applicable laws or regulations, BIP shall at its expense (but subject to Section 6.3(b) hereof) use all reasonable efforts to cure such non-compliance as soon as practicable if such determination was made by the FDA or the EMEA. Any potential BIP curative efforts referred to in the immediately preceding sentence related to any such determinations by regulatory agencies other than the FDA or the EMEA shall be mutually agreed upon by the Parties. In the event BIP receives a Warning Letter from the FDA or EMEA and as a result BIP is unable to manufacture Bulk Drug Substance, Drug Product and/or Finished Product for a particular period, then the provisions of Section 20.4 and Section 20.5 hereof shall apply, MUTATIS MUTANDIS, it being understood that BIP's inability to manufacture Bulk Drug Substance, Drug Product and/or Finished Product for the reasons set forth in this Section 9.5 shall not automatically be deemed a Force Majeure Event if BIP's inability to manufacture was caused by BIP's gross negligence or willful misconduct.
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Non-Compliance; Failure to Manufacture. In the event that the FDA shall -------------------------------------- determine, as a result of an inspection described in Section 9.5(a) -------------- above, that Genentech is not in compliance with applicable laws or regulations or otherwise not in compliance with cGMP with respect to the manufacture of Bulk Drug, Genentech shall at its expense use Commercially Reasonable Best Efforts to cure any such non-compliance with cGMP, and use Commercially Reasonable Efforts to cure any other such non-compliance as soon as practicable. In the event that any regulatory agency other than the FDA shall determine that Genentech is not in material compliance with applicable laws and regulations relating to the manufacture of Bulk Drug, the Parties shall discuss any potential Genentech curative efforts in good faith. In the event Genentech receives a Warning Letter from the FDA and as a result Genentech is unable to manufacture Bulk Drug for a particular period, then, except in the event of Genentech's gross negligence or willful misconduct, the provisions of Sections 20.3, 20.4 and 20.5 hereof shall ---------------------------- apply, it being understood that Genentech's inability to manufacture Bulk Drug for the reasons set forth in this Section 9.5 shall be deemed ----------- to be a Force Majeure Event unless Genentech's inability to manufacture was caused by Genentech's gross negligence or willful misconduct.
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Non-Compliance; Failure to Manufacture. In the event that any regional, national, federal, state or local regulatory agency in the Territory shall determine, as a result of an inspection described in Section 10.5.1 above, that Lonza is not in compliance with applicable laws or regulations or otherwise not in compliance with cGMP with respect to the manufacture of Bulk Drug, Lonza shall at its expense use Commercially Reasonable Best Efforts to cure any such non-compliance as soon as practicable.
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Non-Compliance; Failure to Manufacture. If any Regulatory Authority shall determine, as a result of an inspection described in Section 9.4(a) or the PAI, that PATHEON is not in compliance with Applicable Laws, PATHEON shall at its sole expense use all reasonable efforts to cure such non-compliance as soon as practicable and in any event as required by the Regulatory Authority. If PATHEON is unable to manufacture Bulk and/or Finished Product for a particular period because of the action of a Regulatory Authority, the provisions of Section 18.4 shall apply, provided that PATHEON’s inability to manufacture Bulk and/or Finished Product for the reasons set forth in this Section 9.4 shall not be deemed a Force Majeure Event unless caused by such an event. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
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Non-Compliance; Failure to Manufacture. In the event that any Regulatory Agency in the Territory shall determine, as a result of an inspection described in Section 10.5.1 above, that Wyeth is not in compliance with applicable United States laws or regulations or otherwise not in compliance with cGMP with respect to the manufacture, testing, storage, or packaging of Product, Wyeth shall use its Commercially Reasonable Efforts to remedy any such non-compliance as soon as practicable subject to the provisions of Article 8.
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Non-Compliance; Failure to Manufacture. If any Regulatory Authority shall determine, as a result of an inspection described in Section 9.4(a) or the PAI, that PATHEON is not in compliance with Applicable Laws, PATHEON shall at its sole expense use all reasonable efforts to cure such non-compliance as soon as practicable and in any event as required by the Regulatory Authority. If PATHEON is unable to manufacture Bulk and/or Finished Product for a particular period because of the action of a Regulatory Authority, the provisions of Section 18.4 shall apply, provided that PATHEON’s inability to manufacture Bulk and/or Finished Product for the reasons set forth in this Section 9.4 shall not be deemed a Force Majeure Event unless caused by such an event.
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Related to Non-Compliance; Failure to Manufacture

  • FDA Compliance The Company: (A) is and at all times has been in material compliance with all statutes, rules or regulations of the FDA and other comparable governmental entities applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”); (B) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any governmental entity alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such Authorizations; (D) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA or any governmental entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) has not received notice that the FDA or any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity is considering such action; and (F) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).

  • HIPAA Compliance To the extent that and for so long as a Loan Party is a “covered entity” within the meaning of HIPAA, such Loan Party (i) has undertaken or will promptly undertake all applicable surveys, audits, inventories, reviews, analyses and/or assessments (including any required risk assessments) of all areas of its business and operations required by HIPAA; (ii) has developed or will promptly develop a detailed plan and time line for becoming HIPAA Compliant (a “HIPAA Compliance Plan”); and (iii) has implemented or will implement those provisions of such HIPAA Compliance Plan in all material respects necessary to ensure that such Loan Party is or becomes HIPAA Compliant.

  • Non-Compliance To the extent that, at the time of Final Inspection, the condition of the Aircraft does not comply with this Agreement, Lessee will at Lessor's option:-

  • FCPA Compliance The Company has not and, to the best of the Company’s knowledge, none of its employees or agents at any time during the last five years have (i) made any unlawful contribution to any candidate for foreign office, or failed to disclose fully any contribution in violation of law, or (ii) made any payment to any federal or state governmental officer or official, or other person charged with similar public or quasi-public duties, other than payments required or permitted by the laws of the United States or any jurisdiction thereof.

  • Epidemic Failure In the event that CONTRACTUAL PRODUCTS under warranty have the same or similar functional defect during a time period of three (3) months and the number of defected CONTRACTUAL PRODUCTS exceed [***] of the quantity delivered within this time period, this [***] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. shall be an “Epidemic Failure” as mentioned in the following. The term “Epidemic Failure” shall exclusively apply to delivered CONTRACTUAL PRODUCTS with a number of pieces of more than ten thousand (>10.000) during three (3) months. If either CONTRACTUAL PARTY learns of the existence or likely existence of an Epidemic Failure, then such CONTRACTUAL PARTY will inform the other CONTRACTUAL PARTY as soon as possible. The CONTRACTUAL PARTIES shall then work together to jointly devise a containment action plan. As soon thereafter as reasonably possible, the CONTRACTUAL PARTIES will develop a corrective action plan to remedy the Epidemic Failure. Phoenix Contact shall use its best efforts to implement such remedy as quickly as possible at Phoenix Contact’s own expense, which efforts shall include receiving all shipments of affected Product back (freight collect), repairing or replacing all such affected Products in accordance with the agreed remedy devised by the Parties, shipping the repaired or replaced Products back to ENPHASE at Phoenix Contact’s expense, and implementing the agreed remedy in all newly manufactured Products. Phoenix Contact shall be responsible for the reasonable following costs and expenses actually incurred and substantiated as a result of all aspects of implementing the agreed remedy on the affected Products: reasonable costs of the retrieval, packing, shipping and transportation of such Products, and the re-deployment of repaired or replacement Products (including all labor, consulting, contractor and the like charges, incurred by ENPHASE, only if Phoenix Contact has agreed in writing that ENPHASE is allowed to do the aforementioned activities). For the avoidance of doubt all damages defined in Article 11.4 shall be direct damages and shall be subject to Article 14.2.

  • No Material Noncompliance Except as disclosed in the Prospectus, no material noncompliance with the applicable servicing criteria with respect to securitizations of residential mortgage loans involving the Servicer as a servicer has been disclosed or reported by the Servicer within the past three (3) years.

  • Covenant Compliance the information (including detailed calculations) required in order to establish whether the Company was in compliance with the requirements of Section 10.1 through Section 10.9, inclusive, during the quarterly or annual period covered by the statements then being furnished (including with respect to each such Section, where applicable, the calculations of the maximum or minimum amount, ratio or percentage, as the case may be, permissible under the terms of such Sections, and the calculation of the amount, ratio or percentage then in existence); and

  • Compliance with 1934 Act; Public Information Failures For so long as the Buyer beneficially owns the Note, Warrant, Conversion Shares, or any Exercise Shares, the Company shall comply with the reporting requirements of the 1934 Act; and the Company shall continue to be subject to the reporting requirements of the 1934 Act. During the period that the Buyer beneficially owns the Note, if the Company shall (i) fail for any reason to satisfy the requirements of Rule 144(c)(1), including, without limitation, the failure to satisfy the current public information requirements under Rule 144(c) or (ii) if the Company has ever been an issuer described in Rule 144(i)(1)(i) or becomes such an issuer in the future, and the Company shall fail to satisfy any condition set forth in Rule 144(i)(2) (each, a “Public Information Failure”) then, as partial relief for the damages to the Buyer by reason of any such delay in or reduction of its ability to sell the Securities (which remedy shall not be exclusive of any other remedies available pursuant to this Agreement, the Note, or at law or in equity), the Company shall pay to the Buyer an amount in cash equal to three percent (3%) of the Purchase Price on each of the day of a Public Information Failure and on every thirtieth day (pro rated for periods totaling less than thirty days) thereafter until the date such Public Information Failure is cured. The payments to which a holder shall be entitled pursuant to this Section 4(k) are referred to herein as “Public Information Failure Payments.” Public Information Failure Payments shall be paid on the earlier of (i) the last day of the calendar month during which such Public Information Failure Payments are incurred and (iii) the third business day after the event or failure giving rise to the Public Information Failure Payments is cured. In the event the Company fails to make Public Information Failure Payments in a timely manner, such Public Information Failure Payments shall bear interest at the rate of 5% per month (prorated for partial months) until paid in full.

  • Equipment Failures In the event of equipment failures beyond the Administrator's control, the Administrator shall take reasonable and prompt steps to minimize service interruptions but shall have no liability with respect thereto. The Administrator shall develop and maintain a plan for recovery from equipment failures which may include contractual arrangements with appropriate parties making reasonable provision for emergency use of electronic data processing equipment to the extent appropriate equipment is available.

  • Reporting Covenant Required Complies Transaction Report (in connection with Advance) With each request for an Advance Yes No Monthly Transaction Report Within 30 days of month end when Streamline Period is in effect for 6 months after the Effective Date and each month thereafter, within 20 days of month end when Streamline Period is in effect Yes No Weekly Transaction Report No later than Friday each week when Streamline Period is not in effect Yes No Cash holdings report Within 30 days of month end Yes No Quarterly financial statements with Compliance Certificate Within 5 days of filing with the SEC, but no later than 45 days after fiscal quarter end Yes No Monthly financial statements with Compliance Certificate Within 30 days of month end Yes No Monthly Borrowing Base Reports Within 30 days of month end when Streamline Period is in effect Yes No Weekly Borrowing Base Reports No later than Friday each week when Streamline Period is not in effect Yes No Annual financial statement (CPA Audited) + Compliance Certificate Within 5 days of filings with the SEC but no later than 90 days after FYE Yes No 10‑Q, 10‑K and 8-K Within 5 days after filing with SEC Yes No Annual operating budgets for upcoming fiscal year and board approval of such annual operating budgets Within 45 days prior to the FYE but evidence of board approval to be delivered by September 15 of such fiscal year Yes No Report of any legal actions pending or threatened in writing against Borrower or any of its Subsidiaries that could result in damages or costs to Borrower or any of its Subsidiaries of, individually or in the aggregate, $1,000,000 or more Promptly Yes No

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