Inspections Non Compliance Failure to Manufacture Sample Clauses

Inspections Non Compliance Failure to Manufacture. (a) Inspections. PATHEON will inform RELYPSA in writing within [***] of receipt of any notice of inspection or other communication from a Regulatory Authority and within [***] of any Regulatory Authority request for Bulk and/or Finished Product samples, Batch documentation, or other information related to Bulk or Finished Product, and shall supply RELYPSA with copies of any correspondence or portions of correspondence which relate to Bulk and/or Finished Product, as well as any other documents related thereto reasonably requested by RELYPSA. RELYPSA may send representatives to the Patheon Facility and may participate in any portion of such inspection directed to Bulk or Finished Product (and [***]).
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Inspections Non Compliance Failure to Manufacture 

Related to Inspections 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).

  • 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

  • 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.

  • 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).

  • 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:

  • CONTRACT COMPLIANCE REQUIREMENT The HUB requirement on this Contract is 0%. The student engagement requirement of this Contract is 0 hours. The Career Education requirement for this Contract is 0 hours. Failure to achieve these requirements may result in the application of some or all of the sanctions set forth in Administrative Policy 3.10, which is hereby incorporated by reference.

  • 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.

  • 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.

  • Non-Compliance 11.1 The provisions of 31 CFR Part 205.29 and 31 CFR Part 205.30 shall apply in cases of non-compliance with the terms of this Agreement.

  • Inspection/Testing In order to assess Supplier’s work quality and/or compliance with this Order, upon reasonable notice by Buyer: (a) all goods, materials and services related to the items purchased hereunder, including, raw materials, components, assemblies, work in process, tools and end products shall be subject to inspection and testing by Buyer, its customer, representative or regulatory authorities at all places, including sites where the goods are made or located or the services are performed, whether at Supplier’s premises or elsewhere; and (b) all of Supplier’s facilities, books and records relating to this Order shall be subject to inspection by Buyer or its designee. If specific Buyer and/or Buyer’s customer tests, inspection and/or witness points are included in this Order, the goods shall not be shipped without an inspector’s release or a written waiver of test/inspection/witness with respect to each such point; however, Buyer shall not be permitted to unreasonably delay shipment; and Supplier shall notify Buyer in writing at least twenty (20) days prior to each of Supplier’s scheduled final and, if applicable, intermediate test/inspection/witness points. Supplier agrees to cooperate with such/audit inspection including, completing and returning questionnaires and making available its knowledgeable representatives. Buyer’s failure to inspect or test goods, materials or services or Buyer’s failure to reject or detect defects by inspection or testing shall not relieve Supplier from its warranty obligations or any of its other obligations or responsibilities under this Order. Supplier agrees to provide small business as well as minority and/or women owned business utilization and demographic data upon request.

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