Sepracor's Technical Information definition

Sepracor's Technical Information means the file, for each Product, which is provided by Sepracor to Patheon and which contains documents relating to such Product, including, without limitation:
Sample 1

Examples of Sepracor's Technical Information in a sentence

  • Sepracor shall be solely responsible for obtaining or maintaining any permits or other regulatory approvals in respect of the Products or Sepracor's Technical Information, including, without limitation, all marketing and post-marketing approvals.

  • Such batch numbers and expiration dates shall be affixed on the Products and on the shipping carton of each Product as outlined in Sepracor's Technical Information and as required by cGMPs. The system used by Patheon for batch numbering and expiration dates is detailed in Schedule E hereto.

  • Patheon shall handle, store, purchase and test all Components (with the exception of those that are supplied by Sepracor) at Patheon's expense and in accordance with this Agreement and Sepracor's Technical Information.

  • Products shall be transported in accordance with Sepracor's Technical Information.

  • Such Evaluation shall be binding on the parties, and if the Evaluation certifies that any Products deviate from Sepracor's Technical Information or cGMPs, Sepracor may reject those Products in the manner contemplated by Section 5.8(c) and Patheon shall pay the costs of the Evaluation.

  • Item Detail Sepracor Patheon 1 Provide Sepracor's Technical Information.

  • Patheon shall package the Products with labels, product inserts and other packaging as set out in Sepracor's Technical Information.

  • X 3 Provide updates to methods and Sepracor's Technical Information.

  • Each time Patheon ships Products to Sepracor, it shall provide Sepracor with a certificate of analysis that sets out the test results for each batch of Products, and that certifies that such batch has been evaluated by its Quality Control/Quality Assurance department and that the Products comply with Sepracor's Technical Information.

  • If Sepracor accepts a proposed fee change, the proposed change in Sepracor's Technical Information shall be implemented, and the fee change shall become effective only with respect to those orders of Products that are manufactured in accordance with the revised Sepracor's Technical Information.

Related to Sepracor's Technical Information

  • Technical Information means technical data or computer software, as those terms are defined in the clause at DFARS 252.227-7013, Rights in Technical Data-Non Commercial Items, regardless of whether or not the clause is incorporated in this solicitation or contract. Examples of technical information include research and engineering data, engineering drawings, and associated lists, specifications, standards, process sheets, manuals, technical reports, technical orders, catalog-item identifications, data sets, studies and analyses and related information, and computer software executable code and source code.

  • Controlled technical information means technical information with military or space application that is subject to controls on the access, use, reproduction, modification, performance, display, release, disclosure, or dissemination. Controlled technical information would meet the criteria, if disseminated, for distribution statements B through F using the criteria set forth in DoD Instruction 5230.24, Distribution Statements on Technical Documents. The term does not include information that is lawfully publicly available without restrictions.

  • Licensed Know-How means all Know-How that (a) is Controlled by Pfizer or any of its Affiliates as of the effective date of the Pfizer-MPP Agreement, (b) directly relates to the use of the Compound, Product or Licensed Product in the Field, and (c) is not in the public domain or otherwise generally known. For the avoidance of doubt, (i) Licensed Know-How shall not include any Know-How to the extent solely and directly related to any other Pfizer compound or to the extent related to the use of the Compound, Product or Licensed Product outside the Field and (ii) Licensed Know-How includes only that Know-How, designated by Pfizer in its sole discretion, necessary for the manufacture, registration and commercialization of the Compound and/or Licensed Product for use in the Field. For the avoidance of doubt, Licensed Know-How excludes any Know-How related to ritonavir that has been (either as of the Effective Date or at any time during the term of this Agreement) in-licensed by Pfizer from any Third Party.

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

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

  • 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.

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

  • 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 [***].

  • 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.

  • Medical information means any individually identifiable information, in electronic or physical form, regarding the individual’s medical history or medical treatment or diagnosis by a health care professional.

  • Licensor Know-How means any and all Know-How that (a) is Controlled by Licensor or any of its Affiliates as of the Effective Date or at any time thereafter during the Term and (b) pertains to the Manufacture, use or sale of Licensed Products, including Research Inventions (other than Research Patents).

  • Product Information has the meaning specified in Section 10.12(a).

  • Developed Technology means any Technology including, without limitation, any enhancements, substitutions or improvements to the Core Technology that is (a) discovered, developed or otherwise acquired by DURA pursuant to the terms of the Development Agreement or (b) otherwise acquired by or on behalf of Xxxxxx Corp. II during the term of the Development Agreement.

  • 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.

  • 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.

  • Licensee Know-How means all Information and Inventions Controlled by Licensee or its Affiliates (other than the Takeda Know-How and Joint Know-How) during the Term that are necessary to Exploit a Licensed Compound or a Licensed Product. Licensee Know-How excludes any Information contained within or Inventions Covered by a published Licensee Patent Right.

  • 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.

  • Know-How means all know-how, trade secrets, inventions, data, processes, techniques, procedures, compositions, devices, methods, formulas, protocols and information, whether or not patentable, which are not generally publicly known, including, without limitation, all chemical, biochemical, toxicological, and scientific research information, whether in written, graphic or video form or any other form or format.

  • SAP Technology Solution(s means SAP NetWeaver Foundation for Third Party Applications, SAP Business Technology Platform (excluding when used solely as a Connectivity App between an SAP Application and ERP), SAP Signavio Solutions and SAP Process Insights (including any renamed, prior and/or successor versions of any of the foregoing made generally available by SAP if any but excluding when any of the foregoing are used as a User Interface for ERP.

  • Program Technology means Program Know-How and Program Patents.

  • Program Know-How means all Information and inventions that are conceived, discovered, developed, or otherwise made by or on behalf of either Party or its Affiliates or sublicensees in connection with the work conducted under or in connection with this Agreement.

  • Proprietary Materials means any tangible chemical, biological or physical research materials that are furnished by or on behalf of one Party to the other Party in connection with this Agreement, regardless of whether such materials are specifically designated as proprietary by the transferring Party.

  • Licensed Materials means any materials that Executive utilizes for the benefit of the Company (or any Subsidiary thereof), or delivers to the Company or the Company’s Customers, which (a) do not constitute Work Product, (b) are created by Executive or of which Executive is otherwise in lawful possession and (c) Executive may lawfully utilize for the benefit of, or distribute to, the Company or the Company’s Customers.

  • Licensed Information means any information concerning the Licensed Program, which is owned by the Licensor and is licensed to the Licensee together with the Licensed Program. Licensed Information includes such information as input form, user manual, interface format and input/output format and is delivered to and used by the Licensee as confidential information or proprietary property of the Licensor.

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