Non-Compliance of Product Sample Clauses

Non-Compliance of Product. Cadence will be responsible for reviewing batch documentation for each batch of Product and for providing Xxxxxx with authorization to ship such Product batch. Cadence has the right to reject, at the expense of Xxxxxx, Products that deviate from the Product Specifications or Applicable Laws. Cadence or its designated agent shall review the batch documentation as set forth in the Quality Agreement and shall give Xxxxxx written notice (a “Deficiency Notice”) of all claims for Products that deviate from the Product Specifications or Applicable Laws within [***] ([***]) days after Cadence’s receipt of the final, Xxxxxx-approved Batch Disposition Certificate for the batch of Product in question (or, in the case of any defects not reasonably susceptible to discovery upon receipt of such final, Xxxxxx-approved Batch Disposition Certificate, within [***] ([***]) days after discovery thereof by Cadence, but in no event after the expiration date of the Product). Should Cadence fail to provide Xxxxxx with the Deficiency Notice within the applicable [***] ([***])-day period, then the Product shall be deemed to have been accepted by Cadence on the [***] day after Cadence’s receipt of the final, Xxxxxx-approved Batch Disposition Certificate or discovery of the deficiency, as applicable. Except as set out in Section 15.2, Xxxxxx shall have no liability for any deviations for which Cadence has failed to provide notice within the applicable [***]-day period. Xxxxxx shall use Commercially Reasonable Efforts to replace the non-compliant Product promptly. Any API consumed in producing non-compliant Product will be included in the annual yield loss calculation as set forth in Section 8.4. 10.2.1 If Xxxxxx and Cadence do not agree as to whether or not the Product is non-compliant with the Product Specifications, then the Parties shall agree upon a specialized laboratory of recognized reputation for the purpose of determining the results. Any determination by such laboratory shall be final and binding upon the Parties hereto.
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Non-Compliance of Product. Cadence will be responsible for reviewing batch documentation for each batch of Product and for providing Bxxxxx with authorization to ship such Product batch. Cadence has the right to reject and return, at the expense of Bxxxxx, all or any portion of any shipment of Products that deviates from the Product Specifications or cGMPs, without invalidating any remainder of such shipment. Cadence or its designated agent shall inspect the Products manufactured by Bxxxxx upon receipt of such Products and related Certificate(s) of Analysis and shall give Bxxxxx written notice (a “Deficiency Notice”) of all claims for Products that deviate from the Product Specifications or cGMPs within thirty (30) days after Cadence’s receipt of such Products and related Certificate(s) of Analysis (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, within thirty (30) days after discovery thereof by Cadence, but in no event after the expiration date of the Product). Should Cadence fail to provide Bxxxxx with the Deficiency Notice within the applicable thirty (30)-day period, then the delivery shall be deemed to have been accepted by Cadence on the 30th day after delivery or discovery, as applicable. Except as set out in Section 15.2, Bxxxxx shall have no liability for any deviations for which Cadence has failed to provide notice within the applicable 30-day period.
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Non-Compliance of Product 
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Related to Non-Compliance of Product

  • 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).

  • 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.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • 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).

  • DBE/HUB Compliance The Engineer’s subcontracting program shall comply with the requirements of Attachment H of the contract (DBE/HUB Requirements).

  • Research Use Reporting To assure adherence to NIH GDS Policy, the PI agrees to provide annual Progress Updates as part of the annual Project Renewal or Project Close-out processes, prior to the expiration of the one (1) year data access period. The PI who is seeking Renewal or Close-out of a project agree to complete the appropriate online forms and provide specific information such as how the data have been used, including publications or presentations that resulted from the use of the requested dataset(s), a summary of any plans for future research use (if the PI is seeking renewal), any violations of the terms of access described within this Agreement and the implemented remediation, and information on any downstream intellectual property generated from the data. The PI also may include general comments regarding suggestions for improving the data access process in general. Information provided in the progress updates helps NIH evaluate program activities and may be considered by the NIH GDS governance committees as part of NIH’s effort to provide ongoing stewardship of data sharing activities subject to the NIH GDS Policy.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

  • 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.

  • 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.

  • 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:

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