Applicable Law
Applicable Law. Federal, state and local laws, statutes, codes and regulations of any Regulatory Authority having jurisdiction over a Party or the PRODUCT in the Territory or in any other country in which the PRODUCT is Manufactured, including cGMP and the Drug Supply Chain Security Act, in each case that are applicable to such Party's activities under this Agreement.
Found in
Amag Pharmaceuticals contract
Applicable Law. Means, with respect to any Party to this Agreement, all domestic or foreign federal, state or local statute, law, ordinance, rule, administrative interpretation, regulation, order, writ, injunction, directive, judgment, decree, policy, guideline or other legal requirement (whether legislatively, judicially, or administratively promulgated) applicable to such Party or its Affiliates, properties, assets, officers, directors, employees or agents.
Found in
OPGEN INC contract
Applicable Law. Means all applicable UK, United States and European Union ordinances, rules, regulations, laws, guidelines, guidances, requirements and court orders of any kind whatsoever of any Authority, as amended from time to time including, without limitation, cGMP (if applicable) together with those of such additional jurisdictions as the parties may from time to time agree in writing.
Applicable Law. Means all applicable provisions of all international, federal, state, and local statutes, laws, rules, regulations, administrative codes, ordinances, decrees, orders, decisions, injunctions, award judgments, permits, and licenses of or from governmental authorities, including without limitation those relating to or governing the use or regulation of the subject item and the listing standards or agreements of any national or international securities exchange.
Found in
MRI INTERVENTIONS, INC. contract
Applicable Law. Means all laws, regulations, rules and guidances of any federal, state, local or foreign governmental authority pertaining to a Party's performance hereunder, as amended from time to time.
Found in
Molecular Templates, Inc. contract
Applicable Law. Means all applicable laws, statutes, rules, regulations and guidelines, including all good manufacturing practices and all applicable standards or guidelines promulgated by a regulatory authority
Found in
Sarepta Therapeutics, Inc. contract
Applicable Law. All laws, rules, regulations and requirements applicable to the Production of any Product, including but not limited to laws of the United States when the Product is designated by Juice Plus+ to be distributed in the United States, and the applicable laws of other countries or jurisdictions when the Product is designated by Juice Plus+ to be distributed in those jurisdictions. When they are applicable the Applicable Law of the United States shall include the U.S. Federal Food, Drug and Cosmetic...
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Applicable Law. With respect to any Person, any Canadian (whether federal, territorial, provincial, local, regional or municipal) or foreign statute, code, law, ordinance, rule, administrative interpretation, regulation, order, writ, injunction, directive, judgment, decree or other requirement, all as in effect as of the Closing, of any Governmental Authority applicable to such Person or any of its properties, assets, officers, directors, employees, consultants or agents (in connection with such officer's,...
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Found in
BioAmber Inc. contract
Applicable Law. Shall mean the FD&C Act, and all other laws, regulations (including cGMP), rules and guidelines of any relevant Regulatory Agency (whether Federal, State, municipal or other, in the U.S., European Union, Japan, and any other country where the API is manufactured by or on behalf of Hovione) pertaining to the development, manufacture, packaging, labeling, storage, import, export, distribution, marketing, sale and/or intended use of the API or the Finished Product.
Found in
OptiNose, Inc. contract
Applicable Law. Means, collectively, all applicable statutes, treaties, conventions, rules, guidelines, regulations, ordinances, codes and administrative or judicial precedents or authorities of the Republic of Indonesia, including, but not limited to regulations pertaining to the deposit of Proceeds into a foreign exchange bank in Indonesia, the interpretation or administration thereof by any governmental authority charged with the enforcement, interpretation or administration thereof, and all applicable...
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All Definitions
Found in
Freeport-McMoRan Inc. contract