Product Manufacturing Know-How definition

Product Manufacturing Know-How means the technology, processes, techniques, specifications, inventions, assays, quality control and testing procedures, trade secrets, know-how and other proprietary information to the extent used by or on behalf of Seller exclusively for or exclusively in connection with Manufacturing the Product that are currently in existence and owned or Controlled by Seller; provided, that Product Manufacturing Know-How does not include any of such information that (a) is in the public domain or becomes publicly disclosed (other than as a result of any disclosure by Buyer (prior to the Closing) or Seller (after the Closing), in either case, in breach of its obligations under Section 5.4), or (b) is owned or Controlled by Shionogi.
View Source

Examples of Product Manufacturing Know-How in a sentence

  • During a mutually agreed time period prior to any Regulatory Filing for BioNTech Products planned by BioNTech, Genevant shall make available and transfer to BioNTech, copies of the BioNTech Product Manufacturing Know-How that is listed in Exhibit L and is necessary to enable BioNTech to prepare Regulatory Filings and clinical trials for the BioNTech Products.

  • If a Regulatory Authority requests that BioNTech provide additional BioNTech Product Manufacturing Know-How concerning the manufacture of the BioNTech Products beyond the information listed in Exhibit L, BioNTech will inform Genevant of such request and Genevant will provide such information to BioNTech without any undue delay (and in any event reasonably in advance prior to any timelines set by the Regulatory Authority), provided that Genevant has such information in its possession or control.

  • Provided BioNTech can demonstrate that such additional BioNTech Product Manufacturing Know-How is reasonably necessary to enable BioNTech to prepare Regulatory Filings or clinical trials for the BioNTech Products, Genevant will produce such additional BioNTech Product Manufacturing Know-How to BioNTech without any undue delay.

  • If BioNTech believes any BioNTech Product Manufacturing Know-How related to the manufacture of the BioNTech Products other than that listed in Exhibit L is necessary to enable BioNTech to prepare Regulatory Filings or clinical trials for the BioNTech Products, BioNTech may request such additional Know-How from Genevant.

  • All Genevant Manufacturing Know-How provided to BioNTech pursuant to this Section 6.3(a) (BioNTech Product Initial Manufacturing Know-How) including the BioNTech Product Manufacturing Know-How listed on Exhibit L is herein after referred to as “BioNTech Product Initial Manufacturing Know-How.” All services associated with transfer of any BioNTech Product Initial Manufacturing Know-How will be paid by BioNTech in accordance with the FTE Rate.

  • If DSP files a patent application on a DSP Improvement, DSP Drug Product Manufacturing Know-How or DSP Drug Substance Manufacturing Know-How, then DSP shall, promptly after receiving the filing certificate, provide BIOMARIN with a copy of said application, subject to the requirements of Article 25.

  • To the extent reasonably necessary to implement such manufacturing right, Orion hereby grants GTX a contingent license under Orion's Patent Rights, Orion Know-How, Manufacturing Patents, and Product Manufacturing Know-How to make and [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

  • It is expressly understood that BIOMARIN has received from DSP a part of the Informative Know-How and DSP Drug Product Manufacturing Know-How under the LOI.

  • Also, DSP shall promptly disclose to BIOMARIN the Informative Know-How and DSP Drug Product Manufacturing Know-How which comes into DSP’s possession during the term of this Agreement.

  • In such case, Orion shall as soon as practically possible provide GTX with Product Manufacturing Know-How to the extent reasonably necessary to enable GTX to exercise its back-up manufacturing right pursuant to this Section 15.1, including without limitation providing up to ten (10) person-days of technology transfer assistance at GTX’s site of manufacture of Product using Orion personnel skilled in such manufacturing operations, at no charge to GTX.

Related to Product Manufacturing Know-How

  • 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, 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.

  • Product Know-How means, as owned, licensed or controlled by Seller and exclusively related to the Product Business, including as developed in connection with the Clinical Trials, the research and development information, validation methods and procedures, unpatented inventions, know-how, trade secrets, technical or other data or information, or other materials, methods, procedures, processes, materials, developments or technology, including all biological, chemical, clinical, manufacturing and other information or data, other than such know-how which is or becomes the subject of a patent or of a provisional or filed patent application.

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

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