Occam Items definition

Occam Items means the following, to the extent provided under this Agreement: Biolimus A9, Occam's Polymer Coating, Occam's Drug/Polymer Composite Formulation, Occam's Lubricious Coating, and the Coating Services.

Examples of Occam Items in a sentence

  • Pursuant to the FDA's, the MHLW's, or any other applicable regulatory agency's regulations and policies, Xtent may be required to report to such regulatory agency information that reasonably suggests that the Coated Stents may have caused or contributed to the death or serious injury, and Occam may be required to report to such regulatory agency information that reasonably suggests that the Occam Items may have caused or contributed to the death or serious injury.

  • Xtent and its regulatory consultants under reasonable confidentiality requirements, shall have access to all quality assurance and cGMP audits of Occam Items for the purpose of assessment of regulatory compliance.

  • In addition, except in connection with a Change of Control, any attempted transfer by Xtent of the technology related to the Occam Items shall be subject to the prior written approval of Occam.

  • If the parties determine that the product failure is due to a defect in Occam Items, the reasonable costs and expenses of the investigation and recall shall be borne by Occam.

  • Occam shall keep Xtent informed of the progress of any regulatory actions related to the Occam Items and shall provide updates at least once per calendar quarter, and more often if necessary.

  • Occam shall permit the FDA, MHLW or other regulatory agencies to conduct inspections of its facilities as such regulatory agencies may request, and shall cooperate with the FDA, MHLW or such other regulatory agencies with respect to such inspections and any related matters, in each case as related to any Occam Items.

  • At Occam's own expense, it shall perform stability testing on Biolimus A9, Occam's Polymer Coating, and Occam's Drug/Polymer Composite Formulation as used within the Occam Items.

  • Title to all Occam Items other than Coating Services provided hereunder shall pass as provided herein free and clear of any security interest, lien, or other encumbrance.

  • It is understood that nothing in this Section creates any additional license or right with respect to Occam Items beyond that set forth in Article II hereof.

  • As to Process Improvements invented solely or jointly by Xtent, Occam agrees to grant Xtent, and hereby grants Xtent, for consideration herein acknowledged, a non-exclusive, paid up, perpetual and irrevocable right and license, under all of the intellectual property rights in such Process Improvements, to make, use, sell and offer to sell any product, other than the Occam Items, and to practice any method or process.

Related to Occam Items

  • Punch List Items means such items (i) as are reasonably necessary or appropriate to fully complete the construction, equipping and furnishing of the Hotel in accordance with this Contract and (ii) that, unless otherwise agreed by Buyer in its sole discretion, (a) individually and in the aggregate do not and will not prohibit, cause a delay in or otherwise adversely affect, under applicable Legal Requirements, the Franchise Agreement or otherwise, the opening of the Hotel for business to the public or the continued occupancy and operation of the Hotel as contemplated under the Brand and (b) may be corrected or completed, subject to delays caused by Force Majeure, within not more than sixty (60) days.

  • Third Party Items means Third Party Content and Third Party Products.

  • Items means the finished goods or services which are intended for export from the United States, either directly or as an Indirect Export, meet the U.S. Content requirements in accordance with Section 2.01(b)(ii) of this Agreement and are specified in Section 4.A. of the Loan Authorization Agreement.

  • Contractor’s Equipment means all apparatus, machinery, vehicles and other things required for the execution and completion of the Works and the remedying of any defects. However, Contractor’s Equipment excludes Temporary Works, Employer’s Equipment (if any), Plant, Materials and any other things intended to form or forming part of the Equipment.

  • Contract Item or “Contract Items” means the list of items identified in Section

  • The Works/ Project means the works to be executed or done under this contract.

  • Source-image receptor distance means the distance from the source to the center of the input surface of the image receptor.

  • Product Data are illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by the Contractor to illustrate materials or equipment for some portion of the Work.

  • The Works/Project means the works to be executed or done under this contract.

  • Developed Materials means Materials created, made, or developed by Contractor or Subcontractors, either solely or jointly with the Judicial Branch Entities or JBE Contractors, in the course of providing the Work under this Agreement, and all Intellectual Property Rights therein and thereto, including, without limitation, (i) all work-in-process, data or information, (ii) all modifications, enhancements and derivative works made to Contractor Materials, and (iii) all Deliverables; provided, however, that Developed Materials do not include Contractor Materials.

  • HIV/AIDS means human immunodeficiency virus/acquired immune deficiency syndrome;

  • embedded generator means a generator who is not a market participant and whose generation facility is connected to a distribution system of a distributor, but does not include a generator who consumes more electricity than it generates;

  • Excluded Items means any items which the Committee determines shall be excluded in fixing Performance Goals, including, without limitation, any gains or losses from discontinued operations, any extraordinary gains or losses and the effects of accounting changes.

  • Multiple tomogram system means a computed tomography X-ray system which obtains X-ray transmission data simultaneously during a single scan to produce more than one tomogram.

  • 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.

  • Escrow Items means those items that are described in Section 3.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Category 4 Data is data that is confidential and requires special handling due to statutes or regulations that require especially strict protection of the data and from which especially serious consequences may arise in the event of any compromise of such data. Data classified as Category 4 includes but is not limited to data protected by: the Health Insurance Portability and Accountability Act (HIPAA), Pub. L. 104-191 as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), 45 CFR Parts 160 and 164; the Family Educational Rights and Privacy Act (FERPA), 20 U.S.C. §1232g; 34 CFR Part 99; Internal Revenue Service Publication 1075 (xxxxx://xxx.xxx.xxx/pub/irs-pdf/p1075.pdf); Substance Abuse and Mental Health Services Administration regulations on Confidentiality of Alcohol and Drug Abuse Patient Records, 42 CFR Part 2; and/or Criminal Justice Information Services, 28 CFR Part 20.

  • Derivative Work means a work that is based on one or more preexisting works (such as a revision, translation, dramatization, motion picture version, abridgment, condensation, enhancement, modification, or any other form in which preexisting work may be recast, transformed, or adapted) which, if created without the authorization of the copyright owner of the preexisting work, would constitute copyright infringement.

  • Distributor’s Equipment means the Fittings and Metering Equipment owned by the Distributor, the Distributor’s agent, or any other third party with whom the Distributor has contracted with for the use by the Distributor of the party’s Fittings or Metering Equipment that are from time to time installed in, over or on Consumer’s Premises;

  • Contractor Materials means Materials owned or developed prior to the provision of the Work, or developed by Contractor independently from the provision of the Work and without use of the Court Materials or Confidential Information.

  • Digital audio-visual works which means a series of related images which, when shown in succession, impart an impression of motion, together with accompanying sounds, if any;

  • Samples mean representative physical examples of materials, equipment or workmanship, used to confirm compliance with requirements and/or to establish standards for use in execution of the Work.

  • Customer-generator means a user of a net metering system.

  • Supplier’s Team means the Supplier and, where applicable, any Relevant Person, and all other employees, consultants, agents and sub-contractors which the Supplier engages in any way in relation to the supply of the Services or the Goods; and

  • Derivative Works means any work, whether in Source or Object form, that is based on (or derived from) the Work and for which the editorial revisions, annotations, elaborations, or other modifications represent, as a whole, an original work of authorship. For the purposes of this License, Derivative Works shall not include works that remain separable from, or merely link (or bind by name) to the interfaces of, the Work and Derivative Works thereof.