INAD definition

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INAD means (a) an Investigational New Animal Drug Application (as defined by Applicable Law) submitted to the FDA for authorization for clinical investigation of a pharmaceutical product in the Company Field or (b) any foreign equivalent thereof that is submitted to applicable Regulatory Authorities in other countries or regulatory jurisdictions in the Territory.

INAD means Investigational New Animal Drug, a drug for which there is a valid exemption in effect under section 512(j) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.360b(j), to conduct experiments. (40 CFR §451.2(h))‌

Examples of INAD in a sentence

Administer and manage the National INAD Project under the direction and supervision of the Service’s INAD Sponsor; and, maintain a National INAD Project Coordinator and sufficient staff to manage and administer INADs for Cooperators in the project area, prepare applications for INAD exemptions, and collect and submit to the FDA any necessary reports.
Monitor the use of investigational new animal drugs at their aquaculture and fisheries management facilities in accordance with INAD Study Protocols including proper drug storage, labeling, handling, dispensing, inventory control, record keeping, and reporting of data relating to the use and control of investigational new animal drugs in clinical investigations authorized by National INAD Program INAD exemptions sponsored by the Service.
In regard to project administration, the National INAD Project Coordinator shall provide office space, equipment and personnel support for administration of the National INAD Project which will be funded by Cooperator payments.
Non-compliance with these requirements can jeopardize the National INAD Project and FDA's renewal of INADs. In the event of confirmed non-compliance, this Agreement shall be immediately terminated by the Service and no further use of investigational new animal drugs will be allowed under the INADs covered by this Agreement.
The goal of this Agreement is to consolidate the INAD process, eliminate duplication of effort, reduce workloads and costs, ensure needed drugs, chemicals, and therapeutants are made available to all aquaculture programs in the United States, ensure compliance with FDA guidelines, and ensure the submission of data that is necessary for future drug approval and labeling.

More Definitions of INAD

INAD means Investigational New Animal Drug, which is a drug for which there is a valid exemption in effect under Section 512(j) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360b(j), to conduct experiments.

INAD means an investigational new animal drug exemption pursuant to 21 C.F.R. Part 511.

INAD means an investigational new animal drug, for which a file is maintained by the FDA/CVM as part of a phased review of any Registration Application.

INAD means investigational new animal drug exemption as defined by the FDA;

INAD means an Investigational New Animal Drug filed with the FDA or the equivalent application or filing filed with any equivalent agency or government authority outside of the United States (including any supra-national agency such as in the European Union) necessary to commence animal clinical trials in such jurisdiction, and including all regulations at 21 CFR § 511.1, and equivalent foreign regulations. 1.20 “IND” means an Investigational New Drug Application filed with the FDA or the equivalent application or filing filed with any equivalent agency or government authority outside of the United States (including any supra-national agency such as in the European Union) necessary to commence human clinical trials in such jurisdiction, and including all regulations at 21 CFR § 312 et. esq., and equivalent foreign regulations. 1.21 “Initial Public Offering” shall mean the closing of the issuance and sale of shares of Tarsus’ capital stock in a public offering pursuant to an effective registration statement under the Securities Act. 1.22 “Know-How” means all know-how relating to the Compound or any Licensed Product, including, without limitation, inventions (whether patentable or not), technology, discoveries, methods, techniques, and scientific information, medical information, all manufacturing, preclinical, and clinical data, materials, samples, protocols, specifications, processes, structures, trade secrets, analytical and quality control information and procedures, pharmacological, toxicological, and clinical test data and results, stability data, and studies and procedures. 1.23 “Licensed Know-How” means all Know-How Controlled by Elanco as of the Effective Date. 1.24 “Licensed IP” means the Licensed Patents and the Licensed Know-How. 1.25 “Licensed Patents” means (a) the patents and patent applications set forth in Exhibit A hereto or otherwise Controlled by Elanco or any of its Affiliates as of the Effective Date and Covering any product that contains a Compound as an active pharmaceutical ingredient (alone or with other active ingredients) in any forms, presentations, formulations or dosage strengths, or any manufacture or use of the foregoing, (b) any patent or patent application Covering any product that contains a Compound as an active pharmaceutical ingredient (alone or with other active ingredients) in any forms, presentations, formulations or dosage strengths, or any manufacture or use of the foregoing where the patent or patent application Covers...

INAD or “Investigational New Animal Drug” is equivalent to a human IND Drug Application, but is to be used for animal FDA drug approvals. It is required to be approved by the FDA prior to any animal clinical studies are initiated.

INAD means an Investigational New Animal Drug filed with the FDA or the equivalent application or filing filed with any equivalent agency or government authority outside of the United States (including any supra-national agency such as in the European Union) necessary to commence animal clinical trials in such jurisdiction, and including all regulations at 21 CFR § 511.1, and equivalent foreign regulations. 1.17 “IND” means an Investigational New Drug Application filed with the FDA or the equivalent application or filing filed with any equivalent agency or government authority outside of the United States (including any supra-national agency such as in the European Union) necessary to commence human clinical trials in such jurisdiction, and including all regulations at 21 CFR § 312 et. esq., and equivalent foreign regulations. 1.18 “Know-How” means all know-how relating to the Compound or any Licensed Product, including, without limitation, inventions (whether patentable or not), technology, discoveries, methods, techniques, and scientific information, medical information, all manufacturing, preclinical, and clinical data, materials, samples, protocols, specifications, processes, structures, trade secrets, analytical and quality control information and procedures, pharmacological, toxicological, and clinical test data and results, stability data, and studies and procedures. 1.19 “LianBio Agreement” means that certain Development and License Agreement entered into by and between Tarsus and LianBio Ophthalmology Limited, as of March 26, 2021. 1.20 “LianBio Milestone and Upfront Payments” means the aggregate amount of upfront payments and milestone payments received by Tarsus under the LianBio Agreement. 1.21 “Licensed Know-How” means all Know-How Controlled by Elanco as of the Effective Date. 1.22 “Licensed IP” means the Licensed Patents and the Licensed Know-How. 1.23 “Licensed Patents” means (a) the patents and patent applications set forth in Exhibit A hereto or otherwise Controlled by Elanco or any of its Affiliates as of the Effective Date and Covering any product that contains a Compound as an active pharmaceutical ingredient (alone or with other active ingredients) in any forms, presentations, formulations or dosage strengths, or any manufacture or use of the foregoing, (b) any patent or patent application Covering any product that contains a Compound as an active pharmaceutical ingredient (alone or with other active ingredients) in any forms, presentation...