Manufacturing Right definition

Manufacturing Right shall have the meaning set forth in Section 6.7(b).
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Manufacturing Right shall have the meaning set forth in Section 2.8.3.
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Manufacturing Right has the meaning set forth in Section 7.11(b).
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Examples of Manufacturing Right in a sentence

  • Notwithstanding the foregoing, if KAYAKU is unable to supply Study Product or Product due to force majeure, then it shall notify EICCOSE of that inability as promptly as possible, and EICCOSE shall have the right to exercise its Manufacturing Right under Section 5.3 immediately (regardless of whether Phase 2 studies have then been successfully completed).

  • Buyer shall not purchase any product for which Seller has the Manufacturing Right from any Person other than Seller or its successor during the Exclusivity Period, and Seller shall give first priority to all manufacturing orders submitted by Buyer during the Exclusivity Period.

  • This Escrow Agreement and the escrow established pursuant to this Escrow Agreement shall terminate upon (i) notice of such termination by Cisco, (ii) upon termination of the MPA; (iii) upon termination of the Manufacturing Right as indicated in Section 13.4 of the MPA; or (iii) notice of such termination by Escrow Agent for non-payment of Escrow Agent’s fees, after providing Cisco the ability to cure the non-payment.

  • Through June 26, 2004, we have incurred $8.2 million in costs, of which $3.0 million has been capitalized as a Manufacturing Right and included in intangible assets.

  • If a suspension of performance which, but for the occurrence of such force majeure, would constitute a material breach hereunder continues or is reasonably anticipated to continue for more than one hundred and [***] after the date of the occurrence, the unaffected party shall have the right to terminate this Agreement, which, in connection with a termination by Forest, shall entitle Forest to exercise the Manufacturing Right under Section 7.11.

  • NovaDel will reimburse BioAlliance for all reasonable and documented out of pocket costs incurred by BioAlliance and, if applicable, its Sublicensees, in exercising the Manufacturing Right, including, without limitation, documented costs incurred for laboratory trials, transferring the NovaDel Technology, Information and data, and writing and filing any regulatory documentation.

  • Without limiting any other right of Cypress under this Agreement, upon the Exercise Date if the Manufacturing Right is exercised pursuant to Section 8.11(b)(i), Xxxxxx Xxxxx agrees to reimburse Cypress for all reasonable and documented out-of-pocket costs incurred by Cypress and, if applicable, its sub-licensees, in exercising the Manufacturing Right, including, without limitation, documented costs incurred for transferring the Manufacturing Know-How, laboratory trials, and writing and filing of a DMF.

  • LBS shall not refuse to or delay to confirm such demonstration, or refuse to or delay to grant the Manufacturing Right to Newsoara without any reasonable technical cause.

  • NovaDel shall further provide BioAlliance and its Sublicensees with all necessary Information and data regarding the Manufacture of Licensed Product to the extent necessary for BioAlliance and its Sublicensees to prepare and defend any inquiries from the FDA (if applicable), EMEA or any other Regulatory Authority in the Territory with respect to the Licensed Product, or to exercise the Manufacturing Right, to satisfy all applicable regulatory requirements.

  • In furtherance of the foregoing, if Forest exercises the Manufacturing Right, Xxxxxx Xxxxx shall provide Forest (without cost to Forest, except as provided in Section 9.3(c), if applicable) with copies of all reasonable relevant data and Manufacturing Know-How necessary or useful for Forest to qualify an alternative facility or to manufacture Bulk Compound, as applicable.

Related to Manufacturing Right

  • 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.

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, 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 Process means any process for—

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Xxxx Back Items;

  • API means the American Petroleum Institute.

  • Manufacturing Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • The Equipment/Product means all the Air conditioners along with the accessories which the Vendor is required to supply to the Bank under the Contract.

  • Final Product means a reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.

  • 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.

  • 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.

  • 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.

  • Manufacture means the production of products in a factory using labour, materials, components and machinery and includes other related value-adding activities.

  • Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

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

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • Manufacturing Agreement has the meaning set forth in Section 4.3.

  • Product Specifications means the specifications, features and/or terms of any "Contract" (as defined in the LME Rules) listed for trading on the LME, as described in the LME Rules;

  • Additional Product means any Product identified as such in the Product Terms and chosen by Enrolled Affiliate under this Enrollment.

  • Manufacturing and Supply Agreement means the Manufacturing and Supply Agreement by and between Biogen and Bioverativ, in the form attached hereto as Exhibit C.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Hemp products means all products made from industrial hemp,