VILAZODONE MANUFACTURING TECHNOLOGY definition

VILAZODONE MANUFACTURING TECHNOLOGY means all know-how owned or controlled by MERCK KGAA and its AFFILIATES relating to the production of VILAZODONE API (as defined in Section 3.1) and VILAZODONE drug products laid down in a) a development report including identification of critical steps and a description of polymorphism including conditions for formation and transformation and stability thereof (if a report is not available, all available information to enable preparation of a report); and b) manufacturing instructions of the most recent manufacturing campaign including amount and ratio of all materials, equipment, operating parameters (e.g., time, temperature, pressure) expected yields for all steps starting from commercially available starting materials, in-process controls including analytical methods, specifications for intermediates, starting materials, solvents, reagents, and ancillary materials if defined; and c) batch analysis results for batches used in toxicity and clinical studies, including impurity profile, date of manufacture, manufacturing process information and batch size. VILAZODONE MANUFACTURING TECHNOLOGY also includes all know-how MERCK KGAA and its AFFILIATES own or control at the time the VILAZODONE MANUFACTURING TECHNOLOGY is transferred to GENAISSANCE related to the production of VILAZODONE tablets, i.e. the development report (if a report is not available, all available information to enable preparation of a report), manufacturing instructions including equipment operating parameters; and in-process controls including analytical methods.

Examples of VILAZODONE MANUFACTURING TECHNOLOGY in a sentence

  • If necessary, MERCK KGAA will update and maintain its DMF with VILAZODONE MANUFACTURING TECHNOLOGY before PHASE III CLINICAL TRIALS and again before NDA submission, and as may be otherwise necessary to reflect current manufacturing methods, until such time when GENAISSANCE submits its own IND or DMF.

  • We accept that the alliance may have resulted in improved schedules and possibly lower fares to some markets, but these appear to primarily be markets that are either well served already (such as Europe), or markets that are being targeted by other alliances involving Air New Zealand.14 Markets that are considered to be primary drivers of traffic for the Air New Zealand/Singapore Airlines Alliance.

  • GENAISSANCE shall be liable to MERCK KGAA for all damages and all other available remedies for any unauthorized use or exploitation by GENAISSANCE or its AFFILIATES or sublicensees of the MERCK KGAA PATENTS, RESULTING IP, MERCK KGAA KNOW-HOW and VILAZODONE MANUFACTURING TECHNOLOGY after the date of the valid termination of this AGREEMENT.

  • Subject to the following provisions of this paragraph, MERCK KGAA hereby grants GENAISSANCE an option to obtain a semi-exclusive, paid-up, license under the VILAZODONE MANUFACTURING TECHNOLOGY, MERCK KGAA PATENTS and MERCK KGAA KNOW-HOW to make and have made VILAZODONE and PRODUCTS for so long as GENAISSANCE has a license to the MERCK KGAA PATENTS and MERCK KGAA KNOW-HOW under Section 2.1 (which is also applicable in the case MERCK KGAA is a contract manufacturer for GENAISSANCE).

  • However, the records may be accessed in cases such as employment screening or by rules of the DJJ.

  • Upon exercising the option stated above, GENAISSANCE shall pay MERCK KGAA a exercise fee of [***] Euros (€[***]) for this license, with [***] Euros (€[***]) to be paid upon exercising the option and [***] Euros (€[***]) to be paid upon completion of the transfer of such VILAZODONE MANUFACTURING TECHNOLOGY from MERCK KGAA.

  • Except in respect of RESULTING IP and RESULTING IP PATENTS, GENAISSANCE’s licenses to the MERCK KGAA PATENTS, the MERCK KGAA KNOW-HOW and the VILAZODONE MANUFACTURING TECHNOLOGY shall terminate and GENAISSANCE shall transfer rights in any IND and all data and documents relating to the PRODUCT to MERCK KGAA within [***] of such reversion or termination.

Related to VILAZODONE MANUFACTURING TECHNOLOGY

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • 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.

  • Manufacturing Process means any process for—

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • Bioassay means the determination of kinds, quantities or concentrations and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these rules, “radiobioassay” is an equivalent term.

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

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

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Product Technology means the Product Know-How and Product Patents.

  • Distillery manufacturing license means a license issued in accordance with

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Collaboration Know-How means all Know-How conceived, discovered, developed or otherwise made by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing (solely or jointly by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing) in the course of [***].

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • Manufacturing site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Biological Materials means certain tangible biological materials that are necessary for the effective exercise of the Patent Rights, which materials are described on Exhibit A, as well as tangible materials that are routinely produced through use of the original materials, including, for example, any progeny derived from a cell line, monoclonal antibodies produced by hybridoma cells, DNA or RNA replicated from isolated DNA or RNA, recombinant proteins produced through use of isolated DNA or RNA, and substances routinely purified from a source material included in the original materials (such as recombinant proteins isolated from a cell extract or supernatant by non-proprietary affinity purification methods). These Biological Materials shall be listed on Exhibit A, which will be periodically amended to include any additional Biological Materials that Medical School may furnish to Company.

  • Remanufacturing means the activity of overhauling, retrofitting, fabricating, or repairing a product or its component parts for ultimate sale at retail.

  • Marijuana products means concentrated marijuana products and marijuana products that are comprised of marijuana and other ingredients and are intended for use or consumption, such as, but not limited to, edible products, ointments, and tinctures.

  • Licensee Technology means the Licensee Know-How and Licensee Patents.

  • Background Technology means all Software, data, know-how, ideas, methodologies, specifications, and other technology in which Contractor owns such Intellectual Property Rights as are necessary for Contractor to grant the rights and licenses set forth in Section 14.1, and for the State (including its licensees, successors and assigns) to exercise such rights and licenses, without violating any right of any Third Party or any Law or incurring any payment obligation to any Third Party. Background Technology must: (a) be identified as Background Technology in the Statement of Work; and (b) have been developed or otherwise acquired by Contractor prior to the date of the Statement of Work, or have been developed by Contractor outside of its performance under the Statement of Work. Background Technology will also include any general consulting tool or methodology created by Contractor, which will not be required to be identified in the Statement of Work.

  • Licensor Technology means the Licensor Patents and the Licensor Know-How.

  • API means the American Petroleum Institute.

  • Product Know-How means all the know how, trade secrets, expertise, inventions, discoveries, technical information and other unpatented information related solely and specifically to the Product, that is owned or controlled by Seller or its Affiliates and used in the Territory, including, but not limited to, all information presently used by the Seller to make, have made, use or sell the Product.

  • Hemp products means all products made from industrial hemp,