Health Authority Compliance Sample Clauses

Health Authority Compliance. The Government will ensure that Health Authorities comply with this Agreement and the Physician Master Subsidiary Agreements. If any provision in this Agreement imposes direct obligations on Health Authorities, that provision will be read to be an obligation of the Government to ensure that Health Authorities meet such obligations.
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Health Authority Compliance. (a) The Products subject to the jurisdiction of the United States Food and Drug Administration, or any successor agency thereto (“FDA”) under the Federal Food, Drug and Cosmetic Act (“FDCA”), the EMA or similar Government Authority or Legal Requirements in any jurisdiction, that is, as of the Execution Date, manufactured, tested, developed, distributed, held, sold or marketed by or on behalf of Prophylix is being manufactured, researched, tested, developed, distributed, held, sold and marketed by or on behalf of Prophylix in compliance with all applicable United States and European Union Legal Requirements. (b) Prophylix has provided to Rallybio copies of all documents in the possession (including electronic access permitting downloads via a data room) of Prophylix material to assessing compliance with the FDCA and its implementing regulations (and similar foreign Legal Requirements in the European Union and other jurisdictions) with respect to the Products, including copies of (i) all warning letters and untitled letters, notices of adverse findings and similar correspondence, and (ii) any document concerning any significant oral or written communication received from the FDA, the EMA, or similar Government Authorities in any jurisdiction. Prophylix has provided to Rallybio all material FDA and EMA correspondence and official minutes from meetings with respect to the Products, whether in person, by telephone, or otherwise, in each case that are in the possession of Prophylix (including electronic access permitting downloads via a data room). (c) Prophylix has not received any notice that the FDA or EMA has initiated, or threatened to initiate, any action to suspend the research, study, use, marketing or sale of the Products. (d) With respect to the Products, Prophylix: (i) has not made an untrue statement of a material fact or a fraudulent statement to the FDA, failed to disclose a material fact required to be disclosed to the FDA or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, would provide a basis for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities policy set forth in the FDA’s Compliance Policy Guide Sec. 120.100 (CPG 7150.09), or (ii) has not been convicted of any crime or engaged in any conduct that would result in debarment under 21 U.S.C. 335a or any similar Legal Requirement. (e) Prophylix has not received any written notice or commun...

Related to Health Authority Compliance

  • Safety Compliance Comply with Site safety programs, as they apply to RPR, and if required to do so by such safety programs, receive safety training specifically related to RPR’s own personal safety while at the Site.

  • Public safety compliance The Hirer shall comply with all conditions and regulations made in respect of the premises by the Fire Authority, Local Authority, the Licensing Authority or otherwise, particularly in connection with any event which constitutes regulated entertainment, at which alcohol is sold or provided or which is attended by children. (a) The Hirer acknowledges that they have received information in the following matters: (b) In advance of an entertainment or play the Hirer shall check the following items:

  • 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.

  • 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).

  • 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.

  • Health Care Compliance Neither the Company nor any Affiliate has, prior to the Effective Time and in any material respect, violated any of the health care continuation requirements of COBRA, the requirements of FMLA, the requirements of the Health Insurance Portability and Accountability Act of 1996, the requirements of the Women's Health and Cancer Rights Act of 1998, the requirements of the Newborns' and Mothers' Health Protection Act of 1996, or any amendment to each such act, or any similar provisions of state law applicable to its Employees.

  • Regulatory Compliance Neither Borrower nor any of its Subsidiaries is an “investment company” or a company “controlled” by an “investment company” under the Investment Company Act of 1940, as amended. Neither Borrower nor any of its Subsidiaries is engaged as one of its important activities in extending credit for margin stock (under Regulations X, T and U of the Federal Reserve Board of Governors). Borrower and each of its Subsidiaries has complied in all material respects with the Federal Fair Labor Standards Act. Neither Borrower nor any of its Subsidiaries is a “holding company” or an “affiliate” of a “holding company” or a “subsidiary company” of a “holding company” as each term is defined and used in the Public Utility Holding Company Act of 2005. Neither Borrower nor any of its Subsidiaries has violated any laws, ordinances or rules, the violation of which could reasonably be expected to have a Material Adverse Change. Neither Borrower’s nor any of its Subsidiaries’ properties or assets has been used by Borrower or such Subsidiary or, to Borrower’s knowledge, by previous Persons, in disposing, producing, storing, treating, or transporting any hazardous substance other than in material compliance with applicable laws. Borrower and each of its Subsidiaries has obtained all consents, approvals and authorizations of, made all declarations or filings with, and given all notices to, all Governmental Authorities that are necessary to continue their respective businesses as currently conducted. None of Borrower, any of its Subsidiaries, or any of Borrower’s or its Subsidiaries’ Affiliates or any of their respective agents acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement is (i) in violation of any Anti-Terrorism Law, (ii) engaging in or conspiring to engage in any transaction that evades or avoids, or has the purpose of evading or avoiding or attempts to violate, any of the prohibitions set forth in any Anti-Terrorism Law, or (iii) is a Blocked Person. None of Borrower, any of its Subsidiaries, or to the knowledge of Borrower and any of their Affiliates or agents, acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement, (x) conducts any business or engages in making or receiving any contribution of funds, goods or services to or for the benefit of any Blocked Person, or (y) deals in, or otherwise engages in any transaction relating to, any property or interest in property blocked pursuant to Executive Order No. 13224, any similar executive order or other Anti-Terrorism Law.

  • ETHICS COMPLIANCE All Bidders/Contractors and their employees must comply with the requirements of Sections 73 and 74 of the Public Officers Law, other State codes, rules, regulations and executive orders establishing ethical standards for the conduct of business with New York State. In signing the Bid, Bidder certifies full compliance with those provisions for any present or future dealings, transactions, sales, contracts, services, offers, relationships, etc., involving New York State and/or its employees. Failure to comply with those provisions may result in disqualification from the Bidding process, termination of contract, and/or other civil or criminal proceedings as required by law.

  • 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).

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