LTS Clause Samples

LTS. Without regard to LTS insurance, LTS shall indemnify and hold NeurogesX harmless from any third party claims, damages, losses, costs and expenses (including attorney’s fees) (“Claims”) that arise from LTS’ gross negligence or willful misconduct in connection with the use, development, manufacturing, sale, distribution or application of the Patch.
LTS. LTS shall obtain and maintain during the term of this Agreement and thereafter liability insurance covering its activities under this Agreement at a level no lower than that set forth in Exhibit F, to the extent such coverage is available at terms and conditions not substantially more unfavorable than LTS’ present insurance coverage. LTS shall certify to NeurogesX each year of the extent of its insurance coverage, and shall promptly notify NeurogesX in the event its liability insurance covering its activities under this Agreement falls below the level set forth in Exhibit F.
LTS. Exhibit E hereto contains a true and correct description of the insurance policies maintained by LTS as of the Effective Date and the exclusions applicable thereto. LTS shall, during the term of this Agreement and for such period thereafter as necessary to cover the insured risks, (a) use its Commercially Reasonable Efforts to maintain such insurance policies for coverage of LTS’ liabilities under this Agreement or obtain and maintain replacement insurance policies in amounts not less than the insurance policies maintained by LTS as of the Effective Date and subject to exclusions not broader than those to which the insurance policies maintained by LTS as of the Effective Date are subject and (b) take all necessary actions to secure coverage under such policies for its liabilities under this Agreement. LTS shall notify NuPathe promptly, in writing, of any material change to its insurance policies or coverage, other than an increase in limits of liability. At NuPathe’s request during the term of this Agreement or any renewal term, LTS shall provide NuPathe with Certificates of LTS’ then current insurance policies identified in this Section 10.2.
LTS. LTS represents and warrants that: (a) Subject to the limited liability provisions set forth in this Agreement, the Drug Product delivered to the common carrier in accordance with Section 2.10 shall (i) be in conformity with the Specifications and (ii) be Manufactured in accordance with the Specifications, all Regulatory Requirements and the Quality Agreement. (b) Neither LTS nor any person employed by it to Manufacture the Drug Product (a) has been debarred or is the subject of a debarment pursuant to the Generic Drug Enforcement Act of 1992, amending the Federal Food, Drug and Cosmetic Act at 21 U.S.C. 335a, in connection with the Services, or (b) has a disqualification hearing pending or has been disqualified by the FDA pursuant to 21 C.F.R. § 312.70; (c) The Drug Product delivered to NuPathe will be free and clear of all liens and Encumbrances; and (d) After investigation, to LTS’ knowledge, other than NuPathe’s Intellectual Property, LTS owns or controls all the Intellectual Property, including, without limitation, LTS Intellectual Property, necessary to Manufacture the Drug Product in accordance with the terms of this Agreement, has the full right, power and authority to grant the licenses granted to NuPathe hereunder and, after investigation to LTS’ knowledge, the use of LTS Intellectual Property does not infringe the rights of any third party. (e) LTS will have (upon successful completion of the required activities according to the Equipment Funding Agreement concluded between LTS AG and NuPathe dated June 1, 2010) the capacity to Manufacture [**] million Units of Drug Product under this Agreement over any consecutive twelve (12) month period.
LTS. Table 1 presents the performance of each group key agreement operation presented in millions of clock cycles. We state that the significant performance difference between the two generation of target processors is not only related to the improvements in micro-architecture design, but it is also because of extended arithmetic support, i.e. MULX and ADDX operations on Skylake processors. Based on the optimized results in [5, 8], we expect to achieve significant performance improvement by implementing target-specific finite field arithmetic in AMD assembly language. We leave the design of hardened and more optimized implementations for future work.
LTS. LTS shall not have the right to suspend performance (including without limitation refusing or withholding delivery of Drug Product) under this Agreement (i) unless and until LTS has obtained a final determination under Section 12.1 that NuPathe has materially failed to perform its obligations under this Agreement relating thereto, (ii) unless NuPathe has failed to pay an undisputed invoice for the Supply Price of Drug Product for longer than [**] days and does not pay such invoice within ten (10) business days following written notice from LTS, (iii) unless NuPathe has failed to timely pay undisputed invoices exceeding, in the aggregate, $[**] ($[**] in connection with delivery of Drug Product from Andernach) and does not pay such invoices within ten (10) business days following written notice from LTS; (iv) unless, following good faith discussions with NuPathe, LTS, in its reasonable discretion, believes that continued performance would be in contravention of any Regulatory Requirement or other law; and (v) unless there is an infringement claim relating to the Drug Product, provided that, if LTS suspends performance pursuant to the immediately preceding subsection (iv) or (v), such suspension shall be deemed to be a Failure Event for which there shall be no Cure Period.

Related to LTS

  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

  • Manufacturer A firm that operates or maintains a factory or establishment that produces on the premises, the materials or supplies obtained by the Contractor. Regular Dealer - A firm that owns, operates, or maintains a store, warehouse, or other establishment in which the materials or supplies required for the performance of the contract are bought, kept in stock, and regularly sold to the public in the usual course of business. A regular dealer engages in, as its principal business and in its own name, the purchase and sale or lease of the products in question. A regular dealer in such bulk items as steel, cement, gravel, stone, and petroleum products need not keep such products in stock, if it owns and operates distribution equipment for the products. Brokers and packagers are not regarded as manufacturers or regular dealers within the meaning of this section. United States Department of Transportation (USDOT) - Federal agency responsible for issuing regulations (49 CFR Part 26) and official guidance for the DBE program.

  • Manufacturing Technology Transfer Except as provided in Section 4.3(f)(iii)(1) and Section 6.10, with respect to any Collaboration Product (or LGC Reserved Product, if applicable) for which LGC (or its Affiliate) performed CMC Development or CMC Manufacturing, if (a) Cue does not elect for LGC to perform CMC Step 2, CMC Step 3, or CMC Step 4 (or with respect to LGC Reserved Products, upon completion of CMC Step 1), or (b) upon failure of the Parties to reach agreement with respect to a Clinical Supply Agreement or a Commercial Supply Agreement or (c) [***] under this Agreement and does not cure such breach within [***] days (provided, that if such breach is not reasonably capable of cure within such [***] day period, then such cure period shall be automatically extended for an additional [***] day period as long as LGC continues to use diligent efforts to cure such breach in accordance with a reasonable cure plan and if such breach is not reasonably capable of cure within such combined [***] day period, then Cue shall reasonably consider consenting to any extension of such cure period as long as LGC continues to use diligent efforts to cure such breach in accordance with a reasonable cure plan), as applicable, then, in each case upon the written request of Cue, LGC shall use Commercially Reasonable Efforts to make a technology transfer to an Approved CMO the Manufacturing processes (including materials and such other information) but solely as is necessary to enable the Manufacture of such Collaboration Product (including the Collaboration Compound therein) (or LGC Reserved Product, including the LGC Reserved Compound therein, if applicable) by such Approved CMO to comparable biochemical structure, quality and purity as that Manufactured by LGC or its Affiliate or CMO, provided that neither Cue, LGC or any Third Party shall perform such a technology transfer to any CMO [***] without LGC’s consent, not to be unreasonably withheld, conditioned or delayed if LGC has approved the CMO to manufacture Collaboration Products (or LGC Reserved Products, if applicable). LGC shall conduct such technology transfer as soon as reasonably practicable after receiving such written notice, using good faith efforts to support supply needed to achieve timelines in the Cue Territory Development Plan (or Cue’s development plan for LGC Reserved Products, if applicable) or Cue Territory Commercialization Plan, as applicable. LGC shall conduct the first technology transfer for each Collaboration Product (or LGC Reserved Products, if applicable) [***] (provided that [***]) for a period of up to [***] months from the date Cue or its designee has provided notice it is ready to receive the technology transfer, provided, that such [***] month period [***]. After the expiration of the initial such [***] month period for a Collaboration Product (or LGC Reserved Products, if applicable), if required to complete the technology transfer to enable the Manufacture of such Collaboration Product (including the Collaboration Compound therein) (or LGC Reserved Product, including the LGC Reserved Compound therein, if applicable) by such Approved CMO to comparable biochemical structure, quality and purity as that Manufactured by LGC, LGC shall continue to provide support to Cue for up to an additional [***] period for up to [***] hours at the FTE Rate and thereafter at [***]. Thereafter, LGC will also provide [***] for such Collaboration Product (or LGC Reserved Products, if applicable). Neither Cue nor its Affiliates or Cue Collaborators shall reverse engineer any materials provided hereunder by LGC. Notwithstanding anything in this Agreement to the contrary, LGC’s CMC information may only be shared with an Approved CMO.

  • PRODUCT MANUFACTURER'S SUPPLIERS Only those dealers/distributors listed by the manufacturer will be considered authorized to act on behalf of the Product Manufacturer.

  • AMD AMD shall keep records in sufficient detail to enable FoundryCo to determine that AMD has complied with its second sourcing limitations in Section 2.1(b) and its GPU Product volume sourcing commitments in Section 2.1(c). AMD shall permit said records to be inspected, at FoundryCo’s expense, upon reasonable advance notice, during regular business hours by an independent auditor selected by FoundryCo and approved by AMD, which approval shall not be unreasonably withheld. The audit shall be for the purpose of verifying that AMD has complied with its second source restrictions in Section 2.1(b) and its GPU Product sourcing commitments in Section 2.1(c). Inspections conducted under this Section 8.1(b) shall be at FoundryCo’s expense, unless AMD has a non-compliance variance adverse to FoundryCo of [****] percent ([****]%) or more of (i) the relevant [****] percent ([****]%) second source restriction or (ii) the GPU Minimum Percentage for the applicable audited period, in which case AMD shall bear the reasonable expenses of such audit.