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With respect to regulation, two terms are defined: Postmarketing requirements are studies and clinical trials that sponsors are required to conduct and postmarketing commitments are studies or clinical trials that a sponsor has agreed to conduct, but that are not required by a statue or regulation. [10]
Reasonable and non-discriminatory (RAND) terms, also known as fair, reasonable, and non-discriminatory (FRAND) terms, denote a voluntary licensing commitment that standards organizations often request from the owner of an intellectual property right (usually a patent) that is, or may become, essential to practice a technical standard. [1]
A Law Reference Collection, 2011, ISBN 1624680003 and ISBN 978-1-62468-000-7; Trinxet, Salvador. Trinxet Reverse Dictionary of Legal Abbreviations and Acronyms, 2011, ISBN 1624680011 and ISBN 978-1-62468-001-4. Raistrick, Donald. Index to Legal Citations and Abbreviations. 3rd ed. London: Sweet & Maxwell, 2008. This book focuses more on British ...
Offer and acceptance are generally recognized as essential requirements for the formation of a contract (together with other requirements such as consideration and legal capacity). Analysis of their operation is a traditional approach in contract law .
The law of contracts varies from state to state; there is nationwide federal contract law in certain areas, such as contracts entered into pursuant to Federal Reclamation Law. The law governing transactions involving the sale of goods has become highly standardized nationwide through widespread adoption of the Uniform Commercial Code .
The SLP is composed of at least one general partner ("GP") and one or several limited partner(s). The partner may be a GP and an LP at the same time. While the GP is jointly and separately liable for any commitments of the company on their private assets and property, the liability of the LP is limited to the extent of their contributed participation interest.
The FDA animal efficacy rule (also known as animal rule) applies to development and testing of drugs and biologicals to reduce or prevent serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic agents (chemical, biological, radiological, or nuclear substances), where human efficacy trials are not feasible or ethical. [1]
A common definition of compliance is:'Observance of external (international and national) laws and regulations, as well as internal norms and procedures, to protect the integrity of the organization, its management and employees with the aim of preventing and controlling risks and the possible damage resulting from these compliance and ...