Data Exclusivity Protection definition

Data Exclusivity Protection means in a particular country with respect to a Licensed Product, any Law that prevents (notwithstanding any exceptions or provisos, save to the extent that such exceptions or provisos may be applied in the particular case) the use of, or reliance upon, clinical data generated by Licensee (or its Affiliate or Sublicensee) by a Third Party to obtain regulatory approval for a product, where such Third Party has not obtained the rights to market or sell such product as a licensee, sublicensee or distributor of Licensee or any of its Affiliates, licensees or Sublicensees with respect to such product.

Examples of Data Exclusivity Protection in a sentence

  • Pharmaceutical Data Exclusivity Protection, in PHARMACEUTICAL INNOVATION, COMPETITION AND PATENT LAW: ATRILATERAL PERSPECTIVE, (Josef Drexl and Nari Lee eds., Edward Elgar Publishing 2013).

  • Bagley eds., Oxford University Press 2014).Pharmaceutical Data Exclusivity Protection, in PHARMACEUTICAL INNOVATION, COMPETITION AND PATENT LAW: ATRILATERAL PERSPECTIVE, (Josef Drexl and Nari Lee eds., Edward Elgar Publishing 2013).

Related to Data Exclusivity Protection

  • Technology protection measure means a specific technology that blocks or filters Internet access to visual depictions that are:

  • Cathodic protection means a technique designed to prevent the corrosion of a metal surface by making that surface the cathode of an electrochemical cell. For example, protection can be accomplished with an impressed current system or a galvanic anode system.

  • Commercial applicator means a person who, by contract or for hire, engages in the

  • Vehicle protection product means a vehicle protection device, system, or service that is:

  • Electrical protection barrier means the part providing protection against any direct contact to the high voltage live parts.

  • Massive Multiauthor Collaboration Site (or “MMC Site”) means any World Wide Web server that publishes copyrightable works and also provides prominent facilities for anybody to edit those works. A public wiki that anybody can edit is an example of such a server. A “Massive Multiauthor Collaboration” (or “MMC”) contained in the site means any set of copyrightable works thus published on the MMC site.

  • Community protection zone means the area within eight

  • Step therapy protocol means a protocol or program that establishes the specific

  • Information Technology (IT) System means the combination of hardware components, software, and other equipment to make a system whose core purpose is to accomplish a data processing need such as the automatic acquisition, storage, analysis, evaluation, manipulation, management, movement, control, display, switching, interchange, transmission or reception of data. IT systems include ground systems in support of flight hardware. IT systems do not include—

  • Procurement Code means §13-1-101, et seq., XXXX 0000, as amended and supplemented from time to time.

  • Collaboration Technology means all Collaboration Patents and Collaboration Know-How.

  • Data Safeguards means the highest industry-standard safeguards (including administrative, physical, technical, and procedural safeguards) against the destruction, loss, misuse, unauthorized disclosure, or alteration of the JBE Data or Confidential Information, and such other related safeguards that are set forth in Applicable Laws, a Statement of Work, or pursuant to JBE policies or procedures.

  • Respiratory protective equipment means an apparatus, such as a respirator, used to reduce an individual's intake of airborne radioactive materials.

  • Therapeutic school means a residential group living facility:

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Sexual Exploitation and Abuse “(SEA)” means the following:

  • Production, Use or Storage of Nuclear Material means the production, manufacture, enrichment, conditioning, processing, reprocessing, use, storage, handling and disposal of Nuclear Material.

  • Cathodic protection tester means a person who can demonstrate an understanding of the principles and measurements of all common types of cathodic protection systems as applied to buried or submerged metal piping and tank systems. At a minimum, such persons must have education and experience in soil resistivity, stray current, structure-to-soil potential, and component electrical isolation measurements of buried metal piping and tank systems.

  • Licensed health care provider means a physician, physician assistant, chiropractor, advanced registered nurse practitioner, nurse, physical therapist, or athletic trainer licensed by a board.

  • Brand Name Drug means a Prescription Drug that has been given a name by a manufacturer or distributor to distinguish it as produced or sold by a specific manufacturer or distributor and may be used and protected by a trademark.

  • MFN Protection has the meaning set forth in Section 2.14(e)(iii).

  • Fire Protection means all aspects of fire safety including but not limited to fire prevention, firefighting or Fire Suppression, pre-fire planning, fire investigation, public education and information, training or other staff development;

  • Data Protection means the implementation of appropriate administrative, technical or physical means to guard against unauthorized intentional or accidental disclosure, modification, or destruction of data.

  • Licensed health care professional means a person who possesses a professional medical license that is valid in Oregon. Examples include, but are not limited to, a registered nurse (RN), nurse practitioner (NP), licensed practical nurse (LPN), medical doctor (MD), osteopathic physician (DO), respiratory therapist (RT), physical therapist (PT), physician assistant (PA), or occupational therapist (OT).

  • ERCOT Protocols means the document adopted by ERCOT, including any attachments or exhibits referenced in that document, as amended from time to time, that contains the scheduling, operating, planning, reliability, and Settlement (including Customer registration) policies, rules, guidelines, procedures, standards, and criteria of ERCOT. For the purposes of determining responsibilities and rights at a given time, the ERCOT Protocols, as amended in accordance with the change procedure(s) described in the ERCOT Protocols, in effect at the time of the performance or non-performance of an action, shall govern with respect to that action.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.