FDCA Compliance Sample Clauses

FDCA Compliance. With respect to the conduct or operation of the Business or use of the Purchased Assets, (i) the OrthoRecon Products and product candidates are and have been, since January 1, 2008, developed, manufactured, tested, distributed, promoted and marketed in material compliance with all applicable requirements under the FDCA and comparable Laws in any non-U.S. jurisdiction, including those relating to investigational use, premarket clearance or approval, registration and listing, good manufacturing practices, good clinical practices, good laboratory practices, labeling, advertising, record keeping and filing of required reports, (ii) Seller and each of its Subsidiaries have maintained, since January 1, 2008, materially accurate and complete documentation showing that components supplied to and accepted by Seller and each of its Subsidiaries are manufactured in accordance with Seller’s or its Subsidiaries’ specifications therefor, (iii) the processes used to produce the OrthoRecon Products are described in documents maintained by Seller and each of its Subsidiaries in a materially complete and accurate manner, and such documents have been made available to Purchaser and (iv) such processes are adequate to ensure that commercial quantities of the OrthoRecon Products conform to the specifications established therefor and will not be adulterated or misbranded under the FDCA, in each case in all material respects.
Sample 1
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FDCA Compliance. Buyer and Seller presently believe this Agreement does not relate to the purchase of any food, drug, cosmetic or device, or substance, the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, drug, cosmetic or device (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding any food, drug, cosmetic or device). However, if Seller and Buyer agree upon the use of one of Seller's Material(s) for this type of application, Seller shall guarantee that the thing or things comprising each shipment or other delivery hereafter made by Seller to Buyer, as of the date of such shipment or delivery, is not adulterated or misbranded within the meaning of the U.S. Federal Food, Drug and Cosmetic Act, as amended, or within the meaning of applicable U.S. State laws or Municipal ordinances in which the definitions of adulteration and misbranding are substantially the same as those contained in the U.S. Act, and not an article which may not, under the provisions of Section 404 or 505 of the U.S. Act, be introduced into interstate commerce; is of a suitable grade and complies with all requirements of the Food and Drugs Act of Canada and the Regulations made thereunder, and with the Canadian Federal, Provincial and Municipal laws in that regard; and, that if any such article is a coal-tar color or contains a *CONFIDENTIAL TREATMENT REQUESTED coal-tar color, that said color was manufactured by Seller, and is from a batch certified in accordance with the applicable regulations promulgated under the U.S. Federal Food, Drug and Cosmetic Act, as amended, and Regulations issued under the Food & Drug Act of Canada, as amended, or that Seller has in its possession a guaranty to the same effect from the manufacturer of said color. Seller agrees to indemnify and save harmless Buyer from any claim or action howsoever arising from Seller's failure to comply with the terms of this paragraph.
Sample 1

Related to FDCA Compliance

  • CEQA Compliance The District has complied with all assessment requirements imposed upon it by the California Environmental Quality Act (Public Resource Code Section 21000 et seq. (“CEQA”) in connection with the Project, and no further environmental review of the Project is necessary pursuant to CEQA before the construction of the Project may commence.

  • OSHA Compliance To the extent applicable to the services to be performed under this Agreement, Contractor represents and warrants, that all articles and services furnished under this Agreement meet or exceed the safety standards established and promulgated under the Federal Occupational Safety and Health Law (Public Law 91-596) and its regulations in effect or proposed as of the date of this Agreement.

  • 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.

  • FERPA Compliance In connection with all FERPA Records that Contractor may create, receive or maintain on behalf of University pursuant to the Underlying Agreement, Contractor is designated as a University Official with a legitimate educational interest in and with respect to such FERPA Records, only to the extent to which Contractor (a) is required to create, receive or maintain FERPA Records to carry out the Underlying Agreement, and (b) understands and agrees to all of the following terms and conditions without reservation:

  • 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).

  • CRA Compliance Neither Buyer nor any Buyer Subsidiary has received any notice of non-compliance with the applicable provisions of the CRA and the regulations promulgated thereunder. As of the date hereof, Buyer Sub received a CRA rating of “satisfactory” or better from the FDIC in its most recent examination. Buyer knows of no fact or circumstance or set of facts or circumstances which would be reasonably likely to cause Buyer or any Buyer Subsidiary to receive any notice of non-compliance with such provisions or cause the CRA rating of Buyer or any Buyer Subsidiary to decrease below the “satisfactory” level.

  • HIPAA Compliance If this Contract involves services, activities or products subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Contractor covenants that it will appropriately safeguard Protected Health Information (defined in 45 CFR 160.103), and agrees that it is subject to, and shall comply with, the provisions of 45 CFR 164 Subpart E regarding use and disclosure of Protected Health Information.

  • ADA Compliance A. The Americans with Disabilities Act (42 U.S.C. § 12101, et seq.) and the regulations thereunder (28 C.F.R. § 35.130) (“ADA”) prohibit discrimination against persons with disabilities by the State, whether directly or through contractual arrangements, in the provision of any aid, benefit, or service. As a condition of receiving this Agreement, the Company certifies that services, programs, and activities provided under this Agreement are and will continue to be in compliance with the ADA. B. The Company further certifies that all facilities utilized by the Company in the performance of this Agreement comply with State accessibility laws.

  • PCI Compliance A. The Acquiring Bank will provide The Merchant with appropriate training on PCI PED and/or DSS rules and regulations in respect of The Merchants obligations. Initial training will be provided and at appropriate intervals as and when relevant changes are made to such rules and regulations. B. The Acquiring Bank will ensure that The Merchant is kept informed of any relevant new, or changes to, PCI PED and/or DSS compliance rules and regulations. C. The Merchant will comply with PCI PED and/or DSS, and resulting obligations, in respect of establishing, and maintaining, the required security controls. D. The Merchant will ensure that all its appropriate staff (existing and new) are knowledgeable in their responsibilities with respect to PCI PED and/or DSS compliance. E. The Merchant must be able to demonstrate compliance with PCI PED and/or DSS and maintain measures necessary to successfully pass regular compliance certification checks. F. The Merchant will notify The Acquiring Bank immediately should it become evident that data security standards have been compromised. The Merchant will also provide all assistance necessary to assist The Acquiring Bank and its agents to investigate and obtain any required evidence of a security breach. G. The Merchant hereby agrees and undertakes to fully indemnify The Acquiring Bank from and against all actions, claims, losses, charges, costs and damages which The Acquiring Bank may suffer or incur as a result of The Merchants failure to comply with PCI PED and/or DSS. H. Further to the conditions set out in Section 34 below, The Acquiring Bank reserves the right to terminate this agreement with The Merchant if The Merchant: i. Refuses to accept, or commence, any remedial action(s) required under its obligation to PCI PED and/or DSS. ii. Fails to maintain its PCI PED and/or DSS obligations and/or consistently fails compliance certification checks. iii. Receives continuing penalties Fraud notifications or alerts of in any case where the Acquiring bank may be asked by the schemes to take action against the Merchant. اهيلع ةقداصملا تمت دق هنأ نم ةيلمع يأ ذيفنت دعب دكأتلا رجاتلا ىلع بجي .10 لمحتب هرارقإ متو ةقاطبلا لماح ةطساوب بولطملا وحنلا ىلعو ةرشابم .ةيلمعلا كلت ذيفنت نع هتيلوؤسم لماك يأ تحت ةيلمع نم رثكأ ىلإ ةيلمعلا ةميق ميسقتب موقي لاأب رجاتلا دهعتي .11 لاير )500( ةميقب نيتيلمع ذفني نأ لاثملا ليبس ىلعف ،قلاطلإا ىلع فرظ ةعباتلا عفدلا ةقاطب سفن مادختساب لاير )1000( يلامجلإا اهغلبم عئاضبل اذه ربتعي ثيحب ؛ىرخأ عفد تاقاطب ةيأ وأ تاعوفدملل ةيدوعسلا ةكبشلل ءاغلإ و زاهجلا فاقيا ةلاحلا هذه يف كنبلل قحيو ،اًمامت ًاروظحم فرصتلا .ةيقافتلاا ةكبشلا ةقاطبب لقأ وأ رثكأ وأ لايرب ةرركم تايلمع ءارجإ رجاتلل قحي لا .12 غلابم وأ تايلمع ددع قيقحت ضرغب هب ةصاخلا نامتئلاا ةقاطب وأ ةيدوعسلا ءاغلإ و زاهجلا فاقيا كنبلل قحيو .هيلع ةررقملا موسرلا عفد بنجتل تايلمع .رجاتلا باسح نم ةررقملا موسرلا مصخ يف قحلاب ظافتحلاا عم ةيقافتلاا لمحُي نل هلاعأ ةحضوملا تامازتللااو تاءارجلإاب ديقتلا مدعو هقافخإ نأ رجاتلا رقي وأ فيلاكت وأ تابلاطم وأ ىوعد ةيأ نع اهريغ وأ تناك ةينوناق ،ةيلوؤسم ةيأ كنبلا ةراسخ وأ ةيمكارتلا رارضلأا وأ رئاسخلا كلذ يف امب رئاسخ وأ رارضأ وأ فيراصم مازتللااب رجاتلا للاخإ ببسب رجاتلا كنب اهدبكتي وأ اهل ضرعتي دق يتلا ،حابرلأا مدع ببسب ركذ امم يلأ رجاتلا كنب ضرعت لاح يفو .ةدراولا تابلطتملاو تاميلعتلاب ىوعد نم هيلع بترتي دق ام عيمج رجاتلا لمحتي ،ةروكذملا تاءارجلإاب رجاتلا مازتلا مدع ةجيتن رجاتلا كنب قحلت دق رئاسخ وأ رارضأ وأ فيراصم وأ فيلاكت وأ تابلاطم وأ .تاءارجلإاو طورشلاو تابلطتملا هذهب رجاتلا مازتلا عفدلا تاقاطب ةعانص رايعم عم قفاوتلا .9 PCI Compliance مادختساب ةصاخلا دعاوقلا ىلع بسانملا بيردتلا رجاتلل رجاتلا كنب مدقي .أ ،عفدلا تاقاطب ةعانصب قلعتت يتلاو ةيرسلا ةيصخشلا ماقرلأا لاخدإ زاهج تامازتلاب قلعتي اميف عفدلا تاقاطب ةعانص تانايب ةيامح رايعم ىلع اًضيأو تارييغت يأ ىلع وأ ديدج وه ام ىلع رجاتلا علاطإ ماود نم رجاتلا كنب دكأتي .ب ماقرلأا لاخدإ زاهج مادختساب ةصاخلا مازتللاا دعاوقو تاعيرشتلاب ةقلاع تاذ تانايب ةيامح رايعمب وأ ،عفدلا تاقاطبب قلعتي ام لك وأ ةيرسلا ةيصخشلا .عفدلا تاقاطب ةعانص ،عفدلا تاقاطبل ةيرسلا ةيصخشلا ماقرلأا لاخدإ ئدابمو ريياعمب رجاتلا مزتلي .ج قلعتي اميف ةرداصلا اهتاعيرشتو ،عفدلا تاقاطب تانايب نمأ ريياعمب اًضيأو .ةبولطملا ةيامحلا طباوض قيبطتو سيسأتب )نيدجتسملاو نييلاحلا( نيصتخملا نيفظوملا علاطإ نم رجاتلا دكأتي .د ةيصخشلا ماقرلأا لاخدإب ةصاخلا مازتللاا دعاوقب قلعتي اميف مهتايلوؤسمب .عفدلا تاقاطب تانايب نمأ ريياعمو ،عفدلا تاقاطبل ةيرسلا ةيصخشلا ماقرلأا لاخدإب ةصاخلا مازتللاا دعاوق حضوي نأ رجاتلا ىلع بجي .ـه ةظفاحملاو ،عفدلا تاقاطب تانايب نمأ ريياعم كلذكو عفدلا تاقاطبل ةيرسلا مازتللاا ىدمل ةيرودلا تارابتخلاا ةداهش زايتجلا ةيرورضلا ريياعملا ىلع .حاجنب ريياعم كاهتنا نم ققحتلا روف رجاتلا كنب راعشإب رجاتلا موقي نأ بجي .و كنب ةدعاسمل يرورض وه ام لك ميدقت رجاتلا ىلع بجي اًضيأو ،ةيامحلا ةبولطملا نيهاربلاو ةلدلأا يف قيقحتلا نم نيصتخملا هيفظومو رجاتلا .ةيامحلا قارتخا تابثلإ رجاتلا كنبل ةلماكلا ةيامحلاب ةيقافتلاا هذه بجومب رجاتلا مزتليو دهعتي .ز تابلاطم وأ ىوعد ةيأ نع ،اهريغ وأ تناك ةينوناق ،ةيلوؤسم ةيأ هليمحت مدعو رارضلأا وأ رئاسخلا كلذ يف امب رئاسخ وأ رارضأ وأ فيراصم وأ فيلاكت وأ ببسب رجاتلا كنب اهدبكتي وأ اهل ضرعتي دق يتلا ،حابرلأا ةراسخ وأ ةيمكارتلا كنب ظفتحي ،هاندأ 34 مقر ةداملا يف اهعضو مت يتلا طورشلا ىلإ ةفاضإ .ح :يتلآاب رجاتلا مايق ةلاح يف رجاتلا عم ةيقافتلاا هذه ءاهنإ قحب رجاتلا هتامازتلا هيلع هيلمت بولطم يزارتحا ءارجإ يأ ذاختا وأ لوبق هضفر .i وأ عفدلا تاقاطبل ةيرسلا ةيصخشلا ماقرلأا لاخدإ ئدابمو ريياعمب .عفدلا تاقاطب تانايب نمأ ريياعمب ماقرلأا لاخدإ ئدابمو ريياعمو دعاوقب مازتللااو ةظفاحملا يف هقافخإ .ii ،عفدلا تاقاطب تانايب نمأ ريياعمب وأ عفدلا تاقاطبل ةيرسلا ةيصخشلا .مازتللاا تارابتخا زايتجا يف لشفلا و/وأ تاريذحتلاو تاهيبنتلا هملاتسا وأ هيلع ةرمتسملا تامارغلا ضرف .iii تاعوفدملا ماظن لبق نم ةيلمع يأ صوصخب ريوزتلاب ةقلعتملا مزلالا ءارجلإا ذاختا رجاتلا كنب نم بلطي دق اهللاخ نم يتلاو ،يملاعلا 10. Transaction(s) to be in Saudi Riyals: All MADA-POS transactions must be denominated in Saudi Riyals (SR).

  • AML Compliance The Dealer Manager represents to the Company that it has established and implemented anti-money laundering compliance programs in accordance with applicable law, including applicable FINRA Conduct Rules, Exchange Act Regulations and the USA PATRIOT Act, specifically including, but not limited to, Section 352 of the International Money Laundering Abatement and Anti-Terrorist Financing Act of 2001 (the “Money Laundering Abatement Act,” and together with the USA PATRIOT Act, the “AML Rules”) reasonably expected to detect and cause the reporting of suspicious transactions in connection with the offering and sale of the Offered Shares. The Dealer Manager further represents that it is currently in compliance with all AML Rules, specifically including, but not limited to, the Customer Identification Program requirements under Section 326 of the Money Laundering Abatement Act, and the Dealer Manager hereby covenants to remain in compliance with such requirements and shall, upon request by the Company, provide a certification to the Company that, as of the date of such certification (a) its AML Program is consistent with the AML Rules and (b) it is currently in compliance with all AML Rules, specifically including, but not limited to, the Customer Identification Program requirements under Section 326 of the Money Laundering Abatement Act.

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