Applicable Law

Applicable Law. Shall mean any statute or law or any judgment, order, decree, rule, or regulation of any court or Governmental Entity to which a specified Person or property is subject.

Applicable Law. Means any applicable statute, law (including common law), regulation, rule, ruling, order, writ, injunction, or decree of or by any Governmental Authority.

Applicable Law. Means all applicable provisions of (i) constitutions, treaties, statutes, laws (including the common law), rules, regulations, ordinances, codes or orders of any Governmental Entity, (ii) any consents or approvals of any Governmental Entity and (iii) any orders, decisions, injunctions, judgments, awards, decrees of or agreements with any Governmental Entity

Applicable Law. Any law (including common law), statute, regulation, rule, executive order, ordinance, judgment, ruling, published regulatory policy or guideline, injunction, consent, order, exemption, license, approval or permit enacted, issued, promulgated, adjudged, entered or enforced by a Governmental Authority.

Applicable Law. Means all applicable ordinances, rules, regulations, laws, requirements and court orders of any kind whatsoever of any competent Authority or other competent governmental entity, as amended from time to time including cGMP (if applicable) and in effect during the term of this Agreement.

Applicable Law. Means any applicable statute, law, regulation, ordinance, rule, judgment, rule of common law, treaty, order, decree, authorization, approval (including any Governmental Approval), concession, grant, franchise, license, agreement, directive, guideline, guidance, policy, requirement or other governmental restriction or any similar form of decision of, or determination by (or any interpretation or administration of any of the foregoing by), any Governmental Authority, whether in effect as of the... date hereof or hereafter. View More

Applicable Law. All Laws, including cGMP, relevant to each Party's obligations under this Agreement, including, without limitation, any rules, regulations, guidelines or other requirements of the FDA and any other Governmental Authority with respect to the manufacture of the Products and rules, regulations, guidelines or other requirements of the MHLW applicable to the promotion, marketing, distribution and sale of the Products in the Territory

Applicable Law. All federal, state, local, national and regional statutes, laws, rules, regulations and directives applicable to a particular activity hereunder, including performance of clinical trials, medical treatment and the processing and protection of personal and medical data, that may be in effect from time to time, including those promulgated by the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA) and any successor agency to the FDA or EMA or any agency or... authority performing some or all of the functions of the FDA or EMA in any jurisdiction outside the United States or the European Union (each a Regulatory Authority and collectively, Regulatory Authorities), and including without limitation cGMP and GCP (each as defined below); all data protection requirements such as those specified in the EU Data Protection Directive and the regulations issued under the United States Health Insurance Portability and Accountability Act of 1996 (HIPAA); export control and economic sanctions regulations which prohibit the shipment of United States-origin products and technology to certain restricted countries, entities and individuals; anti-bribery and anti-corruption laws pertaining to interactions with government agents, officials and representatives; laws and regulations governing payments to healthcare providers; and any United States or other country's or jurisdiction's successor or replacement statutes, laws, rules, regulations and directives relating to the foregoing. View More

Applicable Law. The FDCA (as defined below) and all other laws, regulations, rules and guidelines promulgated by a Regulatory Authority, relating to the packaging of the Products and the storage of the Products, including, but not limited to, current Good Manufacturing Practices ("cGMP") as specified in the United States Code of Federal Regulations, as amended from time to time. For purposes of this Agreement, the parties acknowledge and agree that notwithstanding anything to the contrary herein contained,... Sharp shall only be obligated to comply with the Applicable Laws of the United States and the Commonwealth of Pennsylvania that relate to the storage and packaging of the Product or Packaged Product and shall have no obligations to comply with any other Applicable Laws. View More

Applicable Law. All laws, statutes, directives, codes, ordinances, rules, regulations, municipal by-laws, judicial, arbitral, administrative, ministerial, departmental or regulatory judgments, orders, decisions, rulings or awards, consent orders, consent decrees and policies of any Governmental Authority