Commercialization Diligence Obligations definition

Commercialization Diligence Obligations has the meaning set forth in Section 7.2 (Commercialization Diligence Obligations).
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Commercialization Diligence Obligations has the meaning set forth in Section 5.4 (Commercialization Diligence).
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Examples of Commercialization Diligence Obligations in a sentence

  • Each such report will contain sufficient detail to enable Licensee to assess Takeda’s compliance with its obligations set forth in Section 7.2 (Commercialization Diligence Obligations) and will include a rolling [***] year forecast of estimated Net Sales for TAK-385 Licensed Products.

  • Each such report will contain sufficient detail to enable Takeda to assess Licensee’s compliance with its obligations set forth in Section 7.2 (Commercialization Diligence Obligations) and will include a rolling [***] year forecast of estimated Net Sales for TAK-385 Licensed Products.

  • Any material breach by or on behalf of Roche of the diligence obligations set forth in this Section 6.5 (Roche Commercialization Diligence Obligations) with respect to the Commercialization of a Licensed Product will be a material breach of this Agreement and will be subject to the provisions of Section 14.2 (Termination for Breach).

  • Each such report will contain reasonably sufficient detail to enable Kiniksa to assess Partner’s compliance with its Commercialization diligence obligations set forth in Section 9.1 (Commercialization Diligence Obligations).

  • Each such report will contain sufficient detail to enable Blueprint to assess Zai’s compliance with its Commercialization diligence obligations set forth in Section 9.1 (Commercialization Diligence Obligations).

  • Each amended Commercialization Plan will meet the requirements set forth in Section 5.2.1 (Plan), and will be subject to the review and approval of the JSC as set forth in Section 2.2.3(b); provided that GEHC will not be in breach of its Commercialization Diligence Obligations solely as a result of its failure to carry out the tasks assigned to it under any Commercialization Plan during the pendency of the JSC’s approval of any updates or amendments to such Commercialization Plan involving such tasks.

  • Each such report will contain reasonably sufficient detail to enable Kiniksa to assess Partner’s compliance with its Commercialization diligence obligations set forth in Section 9.1 (Commercialization Diligence Obligations) and will include at least the following information for each country or region in the Territory, as well as any other information as may be required by each Third Party IP Agreement: (a) [***], (b) [***], (c) [***], (d) [***], and (e) [***].

  • The Parties stipulate and agree that a material breach of CStone’s diligence obligations set forth under Section 5.1 (Development Diligence and Responsibilities) or Section 9.1 (Commercialization Diligence Obligations), or of CStone’s payment obligations set forth under Article 10 (Payments), will be considered a material breach of a material obligation under this Agreement for purposes of this Section 15.2.2 (Termination for Material Breach).

  • Without limiting the generality of Section 6.1 (Commercialization in the Field in the Territory) or Section 6.2.1 (Commercialization Diligence Obligations), in connection with the Commercialization of the Licensed Products in the Field in the Territory, Licensee will comply with all Applicable Law in all material respects.

  • Takeda will have no other diligence obligations under this Agreement to Commercialize any Products, and Arrowhead’s sole and exclusive remedy with respect to any breach of Takeda’s diligence obligations under this Section 7.1.2 (Commercialization Diligence Obligations) will be its right to terminate this Agreement in accordance with Section 15.4 (Termination for Material Breach).

Related to Commercialization Diligence Obligations

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

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

  • Collaboration Know-How means all Know-How and Materials discovered, created, conceived, developed or reduced to practice in the course of performing activities under the Collaboration Program (whether solely by one Party or jointly by the Parties, in each case with their Affiliates or any Third Parties or any employees, consultants or agents of any of the foregoing which perform activities under the Collaboration Program).

  • 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)).

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

  • Research Program Term has the meaning set forth in Section 2.2.

  • Collaboration Patent Rights means Patent Rights claiming Collaboration Know-How.

  • Collaboration Patents means any and all Patents that claim or cover any of the Collaboration Know-How.

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

  • Research Project means a discrete scientific endeavor to answer a research question or a set of research questions related to medical marijuana and is required for a medical marijuana research license.

  • 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:

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Development Milestone Payment shall have the meaning set forth in Section 9.2(a).

  • Development Program means the implementation of the development plan.

  • Clinical Supply Agreement shall have the meaning set forth in Section 7.2.

  • Licensed Compound means [***].

  • Program Materials means the documents and information provided by the Program Administrator specifying the qualifying EEMs, technology requirements, costs and other Program requirements, which include, without limitation, program guidelines and requirements, application forms and approval letters.

  • Development Phase means the period before a vehicle type is type approved.

  • 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 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.

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • 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.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Research facility means buildings and structures, including machinery and equipment, used or to be used primarily for research or experimentation to improve or develop new tangible goods or materials or to improve or develop the production processes thereto.

  • Development Site means any parcel or lot on which exists or which is intended for building development other than the following: