Device Master Record Sample Clauses

Device Master Record. As used herein, “Device Master Record” shall mean the compilation of the records containing the procedures and specifications for a Production Instrument.
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Device Master Record. 11 3.7 PACKAGING SPECIFICATIONS...........................................12 3.8
Device Master Record. (a) INHALE shall establish, and may amend from time to time in writing, the DMR for the Devices, Base Units, Transjectors and Xxxxxxxx. Each CM shall manufacture the Devices, Base Units, Transjectors and Xxxxxxxx according to the then current DMR, and each CM shall periodically report to INHALE on its performance. The Parties acknowledge that there may be [**], and that [**] Each CM shall agree to any changes in the DMR so long as they (a) are required by the Regulatory Approvals or the Applicable Regulations or (b) are compatible with the scope of such CM's overall business, and if not, the Parties shall discuss such changes to the DMR in good faith. INHALE shall allow the CMs a commercially reasonable period of time to implement changes to the DMR. The CMs agree to implement such changes in an expeditious and commercially prudent manner. [**] [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. [**] Any changes to the DMR shall also be subject to the change control procedure set forth in Section 3.9.
Device Master Record. NOVA will maintain the DMR and all associated documentation in compliance with FDA QSR requirements and ISO 13485 standards, and shall make the DMR available (including electronic copies thereof) to Cerus on request. All changes to the DMR will be controlled by NOVA’s change request procedures and Cerus will be on the required approval list.
Device Master Record. Aspect shall be responsible for generating its own Device Master Record for the Aspect Product, except the DSC-XP. Aspect shall maintain traceability at the board level on the DSC-XP. Dixtal shall be responsible for generating the Device Master Record for the assembled DSC-XP. It is understood that the Aspect BIS Module Kit shall be a component of the Dixtal BIS Module. Dixtal shall be responsible for obtaining and maintaining all applicable governmental authorizations and regulatory approvals required to distribute the combination of Aspect and Dixtal products in the Dixtal BIS Module as provided in Section 13.3.
Device Master Record. Supplier shall maintain working drawings for manufacturing and testing the Products, including without limitation, drawings and specifications for component parts to be acquired from specified vendors, test and acceptance procedures and criteria, assembly and subassembly specifications, drawings and requirements, costed xxxx of materials, and manufacturing procedures (collectively called the "DMR"). Aastrom shall own the DMR and all other manufacturing information relative to the Products, which shall be considered Aastrom's confidential information under Section 11 hereof.

Related to Device Master Record

  • Computer Records World Omni and the Depositor will cause their accounting and computer records to be marked to indicate the sale and assignment of the Receivables from World Omni to the Depositor and from the Depositor to the Trust.

  • Computer Tape The Computer Tape made available by the Seller to the Trust on the Closing Date was complete and accurate as of the Cutoff Date and includes a description of the same Receivables that are described in the Schedule of Receivables.

  • Shareholder Records, Reports and Services (1) The Transfer Agent shall maintain all shareholder accounts, which shall contain all required tax, legally imposed and regulatory information; shall provide shareholders, and file with federal and state agencies, all required tax and other reports pertaining to shareholder accounts; shall prepare shareholder mailing lists; shall cause to be printed and mailed all required prospectuses, annual reports, semiannual reports, statements of additional information (upon request), proxies and other mailings to shareholders; and shall cause proxies to be tabulated.

  • Books, Records and Regulatory Filings (a) The Sub-Adviser agrees to maintain and to preserve for the applicable periods any such records as are required to be maintained by the Sub-Adviser with respect to the Fund by the 1940 Act and rules adopted thereunder, and by any other applicable laws, rules and regulations. The Sub-Adviser further agrees that all records that it maintains for the Fund are the property of the Fund and it will promptly surrender any of such records upon request; provided, however, that the Sub-Adviser may retain copies of such records for the applicable periods they are required by law to be retained, and thereafter shall destroy such records.

  • Research Records Each Party shall maintain records of each Research Program (or cause such records to be maintained) in sufficient detail and in good scientific manner as will properly reflect all work done and results achieved by or on behalf of such Party in the performance of such Research Program. All laboratory notebooks shall be maintained for no less than [***].

  • Computer Software All computer applications software, owned or licensed, whether for general business usage (e.g., accounting, word processing, graphics, spreadsheet analysis, etc.), or specific, unique-to-the-business usage, and all computer operating, security or programming software, owned or licensed by Seller and used in the operation of the Business; and

  • Clinical Data The descriptions of the results of any studies and tests conducted by or on behalf of, or sponsored by, the Company or its subsidiaries, or in which the Company has participated, that are described in the Disclosure Package and the Prospectus, or the results of which are referred to in the Disclosure Package and the Prospectus do not contain any misstatement of material fact or omit to state a material fact necessary to make such statements not misleading. The Company has no knowledge of any studies or tests not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Disclosure Package or Prospectus.

  • Sub-Adviser Review of Materials Upon the Adviser’s request, the Sub-Adviser shall review and comment upon selected portions, relating to the Sub-Adviser and/or Strategy (including the Allocated Portion), of the Registration Statement, other offering documents and ancillary sales and marketing materials prepared by the Adviser for the Fund, and participate, at the reasonable request of the Adviser and as agreed to by the Sub-Adviser, in educational meetings with placement agents and other intermediaries about portfolio management and investment-related matters of the Fund. The Sub-Adviser will promptly inform the Fund and the Adviser if any information in the Registration Statement is (or will become) inaccurate or incomplete.

  • Company Software “Company Software” shall mean any software (including software development tools and software embedded in hardware devices, and all updates, upgrades, releases, enhancements and bug fixes) owned, developed (or currently being developed), used, marketed, distributed, licensed or sold by an Acquired Corporation at any time (other than non-customized third-party software that is not incorporated into any Company Product and is licensed to an Acquired Corporation solely in object code form and solely for internal use on a non-exclusive basis).

  • Samples Distributor shall provide to Subdistributor samples and prototypes that are not intended for resale to the extent such are made available by its Suppliers and at the same cost (if any) assessed by its Suppliers. Subdistributor shall promptly return all samples and prototypes to Distributor on the expiration or earlier termination of this Agreement as provided for in 0. Distributor retains all rights, title, and interest in and to all samples and prototypes before, during, and after the Term; and Loaned Instruments. Within a reasonable amount of time following the execution of this Agreement, Distributor will loan up to 2 sets of Instruments to the Subdistributor. Thereafter, Distributor may, at its discretion, loan additional sets of Instruments to Subdistributor from time to time pursuant to this provision. Any Instruments loaned to Subdistributor pursuant to this provision are referred to as “Loaned Instruments”. Subdistributor shall be permitted, in turn, to loan the Loaned Instruments to Customers that have purchased Products for use in connection with the Products; however, such Loaned Instruments will remain the property of Distributor and may be retrieved and retaken by Distributor at any time. Orders for Products and Instruments Purchase Orders. Subdistributor shall submit to Distributor written purchase orders for the Products and Instruments it elects to purchase and distribute pursuant to this Agreement, which orders shall include: (i) a list of the Products and Instruments ordered, (ii) the quantities of such Products and Instruments, and (iii) precise instructions for packaging, invoicing and shipping.

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