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.

  • All payments under this Agreement shall be made without any deduction or withholding for or on account of any tax (each, a “Withholding Tax”) unless such deduction or withholding is required by Applicable Laws and Guidelines.

  • 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.

  • To the extent permitted by Applicable Laws and Guidelines, Chiesi shall ensure that during the Term of this Agreement and for a period ending [*****] following the expiration labeled shelf life of each unit of Product sold by Chiesi under this Agreement, directly or indirectly through its Third Party agents and/or customers, Chiesi is able to identify the final disposition of each unit of Product.

  • 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.

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

  • Thisprocess is carried out in accordance with Applicable Laws and Guidelines and Brain‐CODE Governance Policyand Security Policies.

  • Chiesi shall be responsible for ensuring that the text of all such sales and marketing materials is in compliance in all material respects with any Applicable Laws and Guidelines and is used solely by Chiesi, its Affiliates and sub-distributors.

  • Kamada shall comply with all Applicable Laws and Guidelines applicable to the conduct of such Phase IV Clinical Studies.

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.

  • Laws and Regulations means federal, state, local and foreign statutes, laws, ordinances, regulations, rules, codes, orders, constitutions, treaties, principles of common law, judgments, decrees or other requirements;

  • Regulatory Requirements means all applicable federal and state statutes, regulations, regulatory guidance, judicial or administrative rulings, requirements of Governmental Contracts and standards and requirements of any accrediting or certifying organization, including, but not limited to, the requirements set forth in a Product Attachment.

  • Codes and Standards means all the applicable codes and standards as indicated in the Technical Specification.

  • Data Protection Laws and Regulations means all laws and regulations, including laws and regulations of the European Union, the European Economic Area and their member states, Switzerland and the United Kingdom, applicable to the Processing of Personal Data under the Agreement.

  • Anti-Corruption Guidelines means the “Guidelines on Preventing and Combating Fraud and Corruption in Projects Financed by IBRD Loans and XXX Credits and Grants”, dated October 15, 2006.

  • Sanctions Laws and Regulations means any sanctions, prohibitions or requirements imposed by any executive order (an “Executive Order”) or by any sanctions program administered by OFAC.

  • Bye-laws means the bye-laws of the Company, as amended from time to time.

  • Applicable Legal Requirements means all laws, statutes, ordinances, codes, orders, principles of common law, permits, judgments, directives and other requirements imposed by federal, state, municipal and other governmental authorities having competent jurisdiction over the subject matter, including, without limitation, applicable environmental laws.

  • Regulatory Requirement means any law, regulation or court order, or any rule, direction, guideline, code, notice or restriction (whether or not having the force of law) issued by any regulatory authority, governmental agency (including tax authority), clearing or settlement bank or exchange, or industry or self-regulatory body, whether in or outside Hong Kong, to which HKICL, we or any other Participant or the respective affiliates or group companies, or you are subject or are expected to comply with from time to time.

  • Privacy Standards means the standards of the privacy of individually identifiable health information, as pursuant to HIPAA.

  • Guidelines means the Instructions to Authors available on the Xxxxxxx Science website, as well as the Aims & Scope applicable to the relevant Xxxxxxx Science publication). Xxxxxxx Science’s nominated service provider, Xxxxxxx Science, offers English language support services which Assignor may elect to utilise in respect of the Work by completing the applicable box in Schedule 1: Details of the Work. The provision of such services by Xxxxxxx Science shall be subject to Xxxxxxx 2 [v.122016] Science’s prevailing terms and rates relating to such type of optional support.

  • Operational requirements means the need to ensure that the Agency is to be operated as effectively, efficiently and economically as possible.

  • Applicable Technical Requirements and Standards means those certain technical requirements and standards applicable to interconnections of generation and/or transmission facilities with the facilities of an Interconnected Transmission Owner or, as the case may be and to the extent applicable, of an Electric Distributor, as published by Transmission Provider in a PJM Manual provided, however, that, with respect to any generation facilities with maximum generating capacity of 2 MW or less (synchronous) or 5 MW or less (inverter-based) for which the Interconnection Customer executes a Construction Service Agreement or Interconnection Service Agreement on or after March 19, 2005, “Applicable Technical Requirements and Standards” shall refer to the “PJM Small Generator Interconnection Applicable Technical Requirements and Standards.” All Applicable Technical Requirements and Standards shall be publicly available through postings on Transmission Provider’s internet website.

  • ECB €STR Guideline means Guideline (EU) 2019/1265 of the European Central Bank of 10 July 2019 on the euro short-term rate (€STR) (ECB/2019/19), as amended from time to time;

  • Ordinances means the ordinances of the City of Waukon, Iowa, as embodied in this Code of Ordinances, ordinances not repealed by the ordinance adopting this Code of Ordinances, and those enacted hereafter.

  • Program Requirements means certain minimum program entry requirements as well as ongoing program requirements, to be fulfilled by Partner, some of which are general PartnerEdge requirements, some of which are specific for the “Sell Engagement” and some of which are specific for the different “Cloud” Product Families, including, without limitation payment of the Program Fee(s), meeting certain minimum annual revenue requirements, upholding a Sell Authorization for at least one “Cloud” Product Family and other requirements as set out in detail in the PartnerEdge Program Guide and the RSPI.

  • Legal Requirement means any treaty, convention, statute, law, regulation, ordinance, license, permit, governmental approval, injunction, judgment, order, consent decree or other requirement of any governmental authority, whether federal, state, or local.

  • Governmental Rules means any and all laws, statutes, codes, rules, regulations, ordinances, orders, writs, decrees and injunctions, of any Governmental Authority and any and all legally binding conditions, standards, prohibitions, requirements and judgments of any Governmental Authority.

  • Safety Standards means all laws, union rules and trade or industry custom or codes of any kind whatsoever, in effect from the date of this Agreement through Final Acceptance of the construction work, pertaining to worker safety and accident prevention applicable to the Project and/or the construction work (including, but not limited to, rules, regulations and standards adopted pursuant to the Occupational Safety and Health Act of 1970, as amended from time to time).

  • Trade Laws means, with respect to any Person, all applicable customs, import and export Laws in jurisdictions in which such Person or any of its Subsidiaries does business or is otherwise subject to jurisdiction.

  • Governmental Requirements means all judgments, orders, writs, injunctions, decrees, awards, laws, ordinances, statutes, regulations, rules, franchises, permits, certificates, licenses, authorizations and the like and any other requirements of any government or any commission, board, court, agency, instrumentality or political subdivision thereof.