cGMP COMPLIANCE REQUIREMENTS Sample Clauses

cGMP COMPLIANCE REQUIREMENTS. 37 ARTICLE H.15 BUY AMERICAN ACT - BALANCE OF PAYMENTS PROGRAM CERTIFICATE........................38 ARTICLE H.16.APPLICATION FOR INDEMNIFICATION PURSUANT TO PUBLIC LAW 85-804.....................38 ARTICLE H.17.REQUIREMENT TO PROCURE AND MAINTAIN INSURANCE PURSUANT TO HHSAR 352.228-7, INSURANCE - LIABILITY TO THIRD PERSONS (DEC 1991)............................................39 ARTICLE H.18.INTELLECTUAL PROPERTY AND DATA RIGHTS.............................................39 ARTICLE H.19.
Sample 1
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cGMP COMPLIANCE REQUIREMENTS. The contractor shall be responsible for assuring compliance with both product and establishment standards consistent with the phase of clinical development. The product and establishment standards and cGMPs include, but are not limited to, the following: 1. Safety and effectiveness (identity, purity, strength, quality, potency, safety, efficacy, release and in-process specifications) 2. Adverse event, error and accident, and product complaint reporting systems 3. Development and validation of the production process 4. Reporting changes to the production process as required by 21 CFR 601.12 5. Quality assurance oversight and change control for master and batch production records 6. Quality control methodology as it relates to the production process 7. Submission of protocols and samples for lot release where applicable 8. Content of the license application 9. Labeling 10. Contracts with the establishment(s) at which manufacturing and testing is being performed 11. Validation, maintenance and proper functioning of all equipment and systems, as well as the facility itself 12. Environmental and other required monitoring 13. Reporting changes at applicable facilities to the SAIC-Xxxxxxxxx and FDA, as required in 21 CFR 601.12 14. Training of personnel
Sample 1

Related to cGMP COMPLIANCE REQUIREMENTS

  • Compliance Requirements A. Nondiscrimination. The Contractor agrees to comply, and to require its subcontractor(s) to comply, with the nondiscrimination provisions of MCL 37.2209. The Contractor further agrees to comply with the provisions of Section 9:158 of Chapter 112 of the Xxx Arbor City Code and to assure that applicants are employed and that employees are treated during employment in a manner which provides equal employment opportunity.

  • 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.

  • Quality Assurance Requirements There are no special Quality Assurance requirements under this Agreement.

  • Listing and Maintenance Requirements Compliance The Company has not in the two years preceding the date hereof received written notice from any stock exchange, market or trading facility on which the Common Stock is or has been listed or quoted to the effect that the Company is not in compliance with the listing, maintenance or other requirements of such exchange, market, trading or quotation facility. The Company has no reason to believe that it does not now or will not in the future meet any such requirements.

  • Standards Compliance Registry Operator shall comply with relevant existing RFCs and those published in the future by the Internet Engineering Task Force (IETF), including all successor standards, modifications or additions thereto relating to the DNS and name server operations including without limitation RFCs 1034, 1035, 1123, 1982, 2181, 2182, 2671, 3226, 3596, 3597, 4343, and 5966. DNS labels may only include hyphens in the third and fourth position if they represent valid IDNs (as specified above) in their ASCII encoding (e.g., “xn--ndk061n”).

  • 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).

  • Basic Requirements To be eligible for PayPal’s Seller Protection program, all of the following basic requirements must be met, as well as any applicable additional requirements: • The primary address for your PayPal account must be in the United States. • The item must be a physical, tangible good that can be shipped, except for items subject to the Intangible Goods Additional Requirements. Transactions involving items that you deliver in person in connection with payment made in your physical store, may also be eligible for PayPal’s Seller Protection program so long as the buyer paid for the transaction in person by using a PayPal goods and services QR code. • You must ship the item to the shipping address on the Transaction Details page in your PayPal account for the transaction. If you originally ship the item to the recipient’s shipping address on the Transaction Details page but the item is later redirected to a different address, you will not be eligible for PayPal’s Seller Protection program. We therefore recommend not using a shipping service that is arranged by the buyer, so that you will be able to provide valid proof of shipping and delivery. • The shipping requirement does not apply to eligible transactions involving items that you deliver in person; provided, however, that you agree to provide us with alternative evidence of delivery or such additional documentation or information relating to the transaction that we may request. • You must respond to PayPal’s requests for documentation and other information in a timely manner as requested in our email correspondence with you or in our correspondence with you through the Resolution Center. If you do not respond to PayPal’s request for documentation and other information in the time requested, you may not be eligible for PayPal’s Seller Protection program. • If the sale involves pre-ordered or made-to-order goods, you must ship within the timeframe you specified in the listing. Otherwise, it is recommended that you ship all items within 7 days after receipt of payment. • You provide us with valid proof of shipment or delivery. • The payment must be marked “eligible” or “partially eligible” in the case of Unauthorized Transaction claims, or “eligible” in the case of Item Not Received claims, for PayPal’s Seller Protection program on the Transaction Details page. • In the case of an Unauthorized Transaction claim, you must provide valid proof of shipment or proof of delivery that demonstrates that the item was shipped or provided to the buyer no later than two days after PayPal notified you of the dispute or reversal. For example, if PayPal notifies you of an Unauthorized Transaction claim on September 1, the valid proof of shipment must indicate that the item was shipped to the buyer no later than September 3 to be eligible for PayPal’s Seller Protection program. PayPal determines, in its sole discretion, whether your claim is eligible for PayPal’s Seller Protection program. PayPal will make a decision, in its sole discretion, based on the eligibility requirements, any information or documentation provided during the resolution process, or any other information PayPal deems relevant and appropriate under the circumstances. To be eligible for PayPal’s Seller Protection program for a buyer’s Item Not Received claim, you must meet both the basic requirements and the additional requirements listed below: • Where a buyer files a chargeback with the issuer for a card-funded transaction, the payment must be marked “eligible” for PayPal’s Seller Protection on the Transaction Details page. • You must provide proof of delivery as described below.

  • Compliance with Reporting Requirements The Company is subject to and in full compliance with the reporting requirements of Section 13 or Section 15(d) of the Exchange Act.

  • Maintenance Requirements The Contractor shall ensure and procure that at all times during the Maintenance Period, the Project Highway conforms to the maintenance requirements set forth in Schedule-E (the “Maintenance Requirements”).

  • Interface Requirements 2.4.5.1 The NID shall be equal to or better than all of the requirements for NIDs set forth in the applicable industry standard technical references.

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