COMPLIANCE WITH GOVERNMENT. LAWS AND REGULATIONS Compaq expects its suppliers to comply with all applicable laws and regulations governing their business relationships with Compaq.
COMPLIANCE WITH GOVERNMENT. LAWS, REGULATIONS AND ACCEPTED PRACTICES 3. DODRŽOVÁNÍ ZÁKONŮ STÁTU, NAŘÍZENÍ A OSVĚDČENÝCH POSTUPŮ
3.1 3.1 INSTITUTION and the PRINCIPAL INVESTIGATOR shall perform the Study in compliance with generally accepted standards of good clinical practice (“GCP”) as set forth in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Uses (“ICH”), the Protocol, the instructions provided by SPONSOR, applicable rules and regulations concerning the protection of individuals with regard to the processing of personal data and on the free movement of such data, local law and all ZDRAVOTNICKÉ ZAŘÍZENÍ a HLAVNÍ ZKOUŠEJÍCÍ budou tuto Studii provádět v souladu s obecně přijatými pravidly Správné klinické praxe („GCP“) stanovenými Mezinárodní konferencí pro harmonizaci technických požadavků na registraci léčiv pro humánní použití („ICH“), Protokolem, pokyny stanovenými ZADAVATELEM, platnými pravidly a předpisy týkajícími se ochrany jednotlivců z hlediska zpracování osobních údajů a volného pohybu těchto údajů, místními zákony a všemi platnými zákony, pravidly a předpisy, applicable laws, rules and regulations governing the performance of observational studies in the country where the Study is conducted, including but not limited to, Act No. 378/2007 Coll., on Pharmaceuticals and on amendments to some related acts (“Act on Pharmaceuticals”) and Decree No. 226/2008 Coll., on good clinical practice and detailed conditions of clinical trials on medicinal products, as amended, Act No. 372/2011 Coll., on Medical Services and terms and conditions of performance of such services („Act on Medical Services“) or any subsequent amendments or laws substantially replacing any of the foregoing, the Federal Food, Drug, and Cosmetic Act and regulations and guidances of the United States Food and Drug Administration ("FDA") and/or European Directives. které se týkají provádění observačních studií v zemi, kde xx xxxx Studie prováděna, minimálně Federálním zákonem o potravinách, lécích a kosmetice a předpisech a pokynech amerického Úřadu pro potraviny a léky („FDA“), popř. evropskými směrnicemi, včetně zákona č. 378/2007 Sb.Act No. 378/2007 Coll., o léčivech a o změnách některých souvisejících zákonů (zákon o léčivech) a vyhlášky č. 226/2008 Sb. o správné klinické praxi a bližších podmínkách klinického hodnocení léčivých přípravků, ve znění pozdějších předpisů, zákona č. 372/2011 Sb. o zdravotních službách a podmínkách jejich poskyt...
COMPLIANCE WITH GOVERNMENT. Regulations
a) Diosynth shall operate the GMP Facility as a compliant current Good Manufacturing Practices (“cGMP”) facility in accordance with 21 CFR Parts 11, 210, 211, 600, & 610, ICH Q7 GMP Guidance for Active Pharmaceutical Ingredients, and the EU GMP Guide, including any requirements provided for in the Quality Agreement for all aspects of manufacturing, testing, holding, packaging, labeling and delivery of the Product and/or intermediates produced for Sponsor. In addition, Diosynth shall perform the Program in compliance with statutory and regulatory requirements applicable to the Product’s clinical phase, including any other applicable regulations and/or guidance documents promulgated by any applicable Regulatory Authority. Diosynth shall not permit debarred [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission.
COMPLIANCE WITH GOVERNMENT. LAWS AND REGULATIONS Compaq expects its suppliers to comply with all applicable laws and regulations governing their business relationships with Compaq. In addition, Compaq requires that its Suppliers agree to implement and maintain a Small, Woman-Owned, Minority Business Enterprise (SWMBE) program in accordance with Federal Acquisition Regulations (FAR) 52.219-0(d)(ll)(iii). Upon request by Compaq, Suppliers agree to provide Compaq with written certification of its compliance with the SWMBE Federal Acquisition Regulations. COMPAQ IS DEDICATED TO MAINTAINING ITS REPUTATION FOR FAIRNESS AND INTEGRITY. IN MANY WAYS THE FUTURE SUCCESS OF BOTH COMPAQ AND ITS SUPPLIERS DEPENDS ON OUR ABILITY TO BUILD ON THESE HIGH STANDARDS. THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH A *** AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT REQUESTED EXHIBIT G CORPORATE NON DISCLOSURE AGREEMENT There is an existing nondisclosure agreement (NDA-87-200) in place and valid until December 17, 2001. This document is on file with the Business Development and Transacions Services group in Houston. THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH A *** AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT REQUESTED [LOGO] ELECTRONIC BUSINESS ADDENDUM FOR PRODUCTION PURCHASES EXHIBIT H
COMPLIANCE WITH GOVERNMENT. REGULATIONS Tenant shall, at its cost, comply with, including the making by Tenant of any Alteration to the Premises, all present and future regulations, rules, laws, ordinances, and requirements of all governmental authorities (including state, municipal, County and federal governments and their departments, bureaus, boards and officials) arising from the use or occupancy of the Premises.
COMPLIANCE WITH GOVERNMENT. Comply promptly with any requirement of governmental authority.
COMPLIANCE WITH GOVERNMENT. REGULATIONS a) CBI will perform the Program in accordance with the Scope and in accordance with the current state of the Food and Drug Administration's Good Manufacturing Practices. Subject to paragraph b. of Section 4 below, CBI will also comply in all material respects with all applicable government regulatory requirements concerning current Good Manufacturing Practices appropriate to the Program.
COMPLIANCE WITH GOVERNMENT. Comply promptly with any Governmental Requirement or Local Requirement.
COMPLIANCE WITH GOVERNMENT. LAWS AND REGULATIONS Compaq expects its suppliers to comply with all applicable laws and regulations governing their business relationships with Compaq. In addition, Compaq requires that its Suppliers agree to implement and maintain a Small, Woman-Owned, Minority Business Enterprise (SWMBE) program in accordance with Federal Acquisition Regulations (FAR) 52.219-0(d)(ll)(iii). Upon request by Compaq, Suppliers agree to provide Compaq with written certification of its compliance with the SWMBE Federal Acquisition Regulations.
COMPLIANCE WITH GOVERNMENT. Regulations a) CBSI will perform the Program in accordance with the Scope, and with its understanding of cGMP when appropriate to do so as and set forth in the Scope. Subject to paragraph b. of Section 5 below, CBSI will also comply in all material respects with all applicable government regulatory requirements concerning cGMP.
b) Should applicable government regulatory requirements be changed, CBSI will make every reasonable effort to satisfy the new requirements. In the event that compliance with such new regulatory requirements necessitates a material change in the Scope for the [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Program, CBSI will submit to Sponsor a revised technical and cost proposal for Sponsor's acceptance prior to making any changes in the Scope or the Program.
c) In the event of a conflict in government regulations, Sponsor will designate, in writing, which regulations shall be followed by CBSI in its performance of the Program.
