Applicable Laws and Guidelines definition

Applicable Laws and Guidelines means all applicable provisions of constitutions, statutes, laws, rules, treaties, regulations, orders, decrees and guidelines of all applicable governmental authorities or agencies in a territory, jurisdiction or region, including without limitation (i) all applicable federal, state and local laws, regulations and guidelines of the Territory or any applicable portion thereof and (ii) all regulations or guidelines of the European Commission, the EMA or other applicable Regulatory Authority, including GCP and GMPs.
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Applicable Laws and Guidelines means the American Medical Association Guidelines on Gifts to Physicians from Industry, the PhRMA Guiding Principles on Direct to Consumer Advertisements about Prescription Medicines, and the PhRMA Code on Interactions with Healthcare Professionals, and all federal, state and local laws, and the rules and regulations of all Agencies, in effect from time to time applicable to the marketing, promotion, distribution and sale of the Product in the Territory, including the Act (including guidances and guidelines published by the FDA on its publicly available web site), PDMA, all applicable provisions of the Social Security Act, the requirements of the Medicare Anti-Kickback statute, Section 1128B(b) of the Social Security Act (42U.S.C.§1320(a)-7b(b)), obligations of disclosure and reporting contained in the Social Security Act, including without limitation, the reporting obligations set forth in 42 U.S.C. §§ 1320a-3a and 1320(a)-7(b), all state fraud and abuse statutes, the “Safe Harbor Regulations” that are found at 42 C.F.R. §1001.952 et seq., and consumer protection and false claims statutes and regulations.
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Applicable Laws and Guidelines means (a) all applicable laws, rules, regulations, requirements, guidelines and policies that govern or apply to the conduct of the Study in the Czech Republic, including, but not limited to applicable ICH guidelines (including the ICH guideline, E6: Good Clinical Practice: Consolidated Guideline, “Good Clinical Practices”). „Platné zákony a směrnice“ znamenají (a) všechny platné zákony, pravidla, předpisy, požadavky, směrnice a strategie, které upravují provádění Studie nebo na jejich provádění platí v České republice, mimo jiné včetně platné směrnice ICH (včetně směrnice ICH, E6: Správná klinická praxe: Konsolidovaná směrnice, „Správná klinická praxe“). "Study" means the research that is to be conducted at Institution, under the supervision and direction of Principal Investigator, pursuant to the Protocol and subject to the terms and conditions of this Agreement and the Applicable Laws and Guidelines. „Studie“ znamená část výzkumu, který má být prováděn ve Zdravotnickém zařízení, a to pod dohledem a vedením Hlavního zkoušejícího, podle Protokolu a s přihlédnutím k podmínkám této Smlouvy a k Platným zákonům a směrnicím. “Confidential Information” means all confidential, proprietary or trade secret information disclosed by or on behalf of Sponsor (“disclosing party”) to Institution or Principal Investigator or members of the Study Team (collectively, the “receiving party”) under or pursuant to this Agreement and all information that is derived from the Study, including, but not limited to, the CRFs, and all data, methods, plans, safety information, findings and conclusions, enrollment data, information pertaining to the status of the Study, communications to and from the relevant Regulatory Agency, and correspondence to or from any clinical events committee or data safety „Důvěrné informace“ znamenají všechny důvěrné nebo majetkové informace nebo obchodní tajemství, které sdělí Zadavatel nebo které jsou sděleny jeho jménem (dále jen „sdělující osoba“) Zdravotnickému zařízení nebo Hlavnímu zkoušejícímu nebo členům Personálu provádějícího studii (společně dále jen „příjemce“) podle této Smlouvy a všechny informace, které vycházejí ze Studie, zejména formuláře pro záznamy subjektů hodnocení (case report forms, CRF) a veškeré údaje, metodika, plány, bezpečnostní údaje, zjištění a závěry, údaje o zařazení do hodnocení, informace týkající se průběhu Studie a korespondence s příslušným regulačním úřadem a korespondence s výborem pro řešení příhod při klinickém ho...
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Examples of Applicable Laws and Guidelines in a sentence

  • Subject to Applicable Laws and Guidelines, the value reported to the Centers for Medicare & Medicaid Services (“CMS”) shall be the amount expended by the controlling Party, irrespective of the division of or reconciliation of expenses between the Parties.

  • Notwithstanding anything to the contrary in this Agreement, neither Party nor any of its Affiliates shall be required to take, or shall be deemed in breach of this Agreement for not taking, any action that is not in compliance with such Party’s Internal Policies (so long as such action is still compliant with Applicable Laws and Guidelines) or that such Party reasonably believes is not in compliance with Applicable Laws, Guidelines or the USPPs.

  • Such program will comply with the Applicable Laws and Guidelines in each country.

  • Kamada shall comply with all Applicable Laws and Guidelines applicable to the conduct of such Phase II/III Clinical Study.

  • The presentation of the final pack (e.g. monthly pack, two monthly pack) and its content, including the Device (for first treatment) and Device Accessories (for routine deliveries) will be discussed and decided between the Parties and in accordance with marketing, reimbursement considerations and Applicable Laws and Guidelines in each country.

  • Kamada shall comply in all material respects with all Applicable Laws and Guidelines applicable to the design, manufacture, labeling, packaging, storage, testing, release, shipping and handling of the Product in the Territory, including maintaining qualified manufacturing and quality facilities and/or procedures in accordance with EU cGMP pharmaceutical standards.

  • Chiesi shall comply with all Applicable Laws and Guidelines applicable to the conduct of such Additional Clinical Studies.

  • AstraZeneca shall notify Abraxis promptly of any communications with any Agency concerning the Product within seven (7) Business Days of receipt of any such communication and shall, to the extent permitted by Applicable Laws and Guidelines, attach copies of all such communications to the notice sent pursuant to this Section 13.2.2.

  • Kamada warrants that, as of the time of delivery by Kamada to Chiesi of the Product in accordance with this Agreement, all Products will (a) be free of defects in design, material and workmanship and conform to the Specifications, and (b) comply in all material respects with all Applicable Laws and Guidelines applicable to the Product in the Territory.

  • Without derogating from the above, the Parties shall, within [*****] following the execution of this Agreement, enter into a SDEA in accordance with Applicable Laws and Guidelines, which shall include, without limitation, provisions for exchange of adverse event and pregnancy exposure data concerning the Product.

Related to Applicable Laws and Guidelines

  • Applicable Laws and Regulations means all duly promulgated applicable federal, State and local laws, regulations, rules, ordinances, codes, decrees, judgments, directives, or judicial or administrative orders, permits and other duly authorized actions of any Governmental Authority having jurisdiction over the relevant parties, their respective facilities, and/or the respective services they provide.

  • Applicable Laws means the requirements relating to the administration of equity-based awards under U.S. state corporate laws, U.S. federal and state securities laws, the Code, any stock exchange or quotation system on which the Common Stock is listed or quoted and the applicable laws of any foreign country or jurisdiction where Awards are, or will be, granted under the Plan.

  • Applicable Laws/ Rules means the laws/ Rules of Islamic Republic of Pakistan/Punjab, as they may be issued and enforced from time to time.

  • Legal Requirements means any federal, state, local, municipal, foreign or other law, statute, constitution, principle of common law, resolution, ordinance, code, order, edict, decree, rule, regulation, ruling or requirement issued, enacted, adopted, promulgated, implemented or otherwise put into effect by or under the authority of any Governmental Entity.

  • Applicable law and regulations means the Federal Credit Union Act and rules and regulations issued thereunder or other applicable federal and state statutes and rules and regulations issued thereunder as the context indicates.