Companion Diagnostic Activities definition

Companion Diagnostic Activities means those activities associated with creating and executing the Companion Diagnostic Validation Plan and conducting regulatory activities involved in preparing and filing a PMA for the Companion Diagnostic, including any ***Confidential Treatment Requested and all such activities performed prior to the Effective Date. The Companion Diagnostic Activities shall conclude upon PMA Approval.

Examples of Companion Diagnostic Activities in a sentence

  • The Parties have agreed upon an initial Companion Diagnostic Activities budget of […***…] for the estimated period of […***…] beginning in January 2010; such budget is attached hereto as Exhibit A.

  • Each Party shall promptly disclose to the other all inventions conceived or reduced to practice in the course of performing the Companion Diagnostic Activities, including all invention disclosures or other similar documents submitted to such Party by its employees or agents describing such inventions.

  • Subject to the terms and conditions of this Agreement, Ambit hereby grants to Genoptix, during the term of the Companion Diagnostic Activities, a non-exclusive, fully-paid up license, without the right to sublicense, under intellectual property rights owned by or licensed to (but only to the extent Ambit has the right to further sublicense) Ambit that are necessary for performance of the Companion Diagnostic Activities, solely for Genoptix to perform the Companion Diagnostic Activities.

  • The JCDC shall be responsible for approving any modifications to such budget or any future budget with respect to Companion Diagnostic Activities.

  • Each Party shall perform the Companion Diagnostic Activities for which it is responsible in good scientific manner and in compliance with all applicable Laws.

  • Inventorship of inventions conceived and reduced to practice in the course of performing the Companion Diagnostic Activities shall be determined in accordance with United States patent laws.

  • Ambit will ensure that all of its employees and agents who perform the Companion Diagnostic Activities are contractually obligated to assign any Developed IP to Ambit.

  • For clarity, Ambit is not responsible for any expenses incurred by Genoptix in the course of performing Companion Diagnostic Activities to the extent that they exceed the budget approved by the Parties or the JCDC in accordance with Section 6.1(a) or they are not Companion Diagnostic Expenses.

  • Genoptix shall provide the JCDC with monthly updates on: (1) development and validation of the Companion Diagnostic; (2) status of preparation of the PMA for the Companion Diagnostic; (3) feedback on interactions with the CDRH concerning requirements for the Companion Diagnostic; and (4) any actual variances or expected variances to the approved budget for Companion Diagnostic Activities.

Related to Companion Diagnostic Activities

  • Companion Diagnostic means a device which is essential for the safe and effective use of a corresponding medicinal product to:

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • licensed activities means things authorised to be done by the licence

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Interscholastic Activities means athletic or non-athletic/academic activities where students compete on a school vs. school basis.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Commercializing means to engage in Commercialization and “Commercialized” has a corresponding meaning.

  • Intrascholastic Activities means athletic or non-athletic/academic activities where students compete with students from within the same school.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Commercialization Costs means the sum of the following costs and expenses incurred by the Parties or their respective Affiliates, in Commercializing the Shared Products (and related Manufacturing activities) in the Territory, in each case, to the extent incurred in accordance with the Commercialization Plan and Commercialization Budget:

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • Extracurricular activities means: a voluntary activity sponsored by the school or local education agency or an organization sanctioned by the local education agency. Extracurricular activities include, but are not limited to, preparation for and involvement in public performances, contests, athletic competitions, demonstrations, displays, and club activities.

  • Medical Affairs Activities means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Compounds or Licensed Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Licensed Product.

  • Licensed Compound means (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).

  • Licensed Programs means, collectively, NeoSystems’ and any Third Party Vendor computer software programs to be provided to Client for use on certain hardware on Client’s premises or a third party’s premises as set forth in an Agreement. The Licensed Programs shall include any fixes, work-arounds, updates, revisions, modifications, enhancements and any derivative works that are provided to Client by NeoSystems under an Agreement.

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • Licensed Program means the executable processing programs of licensed information, which is composed of various modules in the Licensed Software package provided by the Licensor.

  • Development Program means the implementation of the development plan.

  • Research Program has the meaning set forth in Section 2.1.

  • Licensed Services means all functions performed by the Licensed System.

  • Collaborating physician means the physician who,

  • Commercialized shall have corresponding meanings.

  • 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.

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.