Material Products Sample Clauses

Material Products. (i) The FDA shall revoke, withdraw, suspend, cancel, materially limit, terminate or materially adversely modify any approved Key Permit related to any Material Product; or (ii) any Governmental Authority (other than the FDA) shall revoke, withdraw, suspend, cancel, materially limit, terminate or materially modify any approved Key Permit related to any Material Product (in each case, a “Non-FDA Governmental Action”) and, in any such case, Consolidated Revenues shall decrease by greater than ten percent (10%), as assessed as at the end of each of the four Fiscal Quarters immediately following such Non-FDA Governmental Action by comparing Consolidated Revenues for the four Fiscal Quarter period most recently ended prior to such Non-FDA Governmental Action for which the Issuer was required to deliver financial statements pursuant to Section 7.01(a) or (b) as against Consolidated Revenues for the four Fiscal Quarter period ending on the applicable date of assessment; or (iii) subject to Section 9.01(p), any Safety Notice is issued or initiated in connection with any Material Product after approval by the FDA or any other Governmental Authority and Consolidated Revenues shall decrease by greater than ten percent (10%), as assessed as at the end of each of the four Fiscal Quarters immediately following the issuance or initiation of such Safety Notice by comparing Consolidated Revenues for the four Fiscal Quarter period most recently ended prior to the issuance or initiation of such Safety Notice for which the Issuer was required to deliver financial statements pursuant to Section 7.01(a) or (b) as against Consolidated Revenues for the four Fiscal Quarter period ending on the applicable date of assessment; or
Sample 1Sample 2See All (10)
AutoNDA by SimpleDocs
Material Products. (i) The FDA shall revoke, withdraw, suspend, cancel, materially limit, terminate or materially adversely modify any approved Key Permit related to any Material Product; or (ii) any Governmental Authority (other than the FDA) shall revoke, withdraw, suspend, cancel, materially limit, terminate or materially modify any approved Key Permit related to any Material Product (in each case, a “Non-FDA Governmental Action”) and, in any such case, Consolidated Net Product Sales shall decrease by greater than [***] percent ([***]%), as assessed as at the end of each of the four fiscal quarters immediately following such Non-FDA Governmental Action, in each case, by comparing Consolidated Net Product Sales for such fiscal quarter against Consolidated Net Product Sales for the corresponding fiscal quarter of the prior fiscal year of the Issuer; or (iii) any Safety Notice is issued or initiated in connection with any Material Product after approval by the FDA or any other Governmental Authority and Consolidated Net Product Sales shall decrease by greater than [***] percent ([***]%), as assessed as at the end of each of the four fiscal quarters immediately following the issuance or initiation of such Safety Notice, in each case, by comparing Consolidated Net Product Sales for such fiscal quarter against Consolidated Net Product Sales for the corresponding fiscal quarter of the prior fiscal year of the Issuer; or
Sample 1
Material Products. If any of the following occurs: (i) the FDA shall revoke, withdraw, suspend, cancel, materially adversely limit, terminate or materially adversely modify any approved Required Permit related to any Material Product; (ii) any Governmental Authority (other than the FDA) shall revoke, withdraw, suspend, cancel, materially limit, terminate or materially modify any approved Required Permit related to any Material Product (in each case, a “Non-FDA Governmental Action”) and, in any such case, Consolidated Revenues shall decrease by greater than [***]%, as assessed as at the end of each of the four fiscal quarters immediately following such Non-FDA Governmental Action by comparing Consolidated Revenues for the four fiscal quarter period most recently ended prior to such Non-FDA Governmental Action for which the Borrower was required to deliver financial statements pursuant to Section 7.01(a) or (b) as against Consolidated Revenues for the four fiscal quarter period ending on the applicable date of assessment; or (iii) any Safety Notice is issued or initiated in connection with any Material Product after approval by the FDA or any other Governmental Authority;
Sample 1

Related to Material Products

  • Special Products PURCHASER shall not sell special products from the timber sale area, or allow firewood, shake, or post cutting, or any other special product manufacturing on the timber sale area without prior written approval of STATE. Special products are any products not in log form manufactured from material having a price, or listed as “No Charge,” under the contract. ACCESS AND ROAD MAINTENANCE

  • Additional Products Upon satisfying the minimum order requirements above, Enrolled Affiliate may order Additional Products.

  • Products Products available under this Contract are limited to Software, including Software as a Service, products and related products as specified in Appendix C, Pricing Index. Vendor may incorporate changes to their product offering; however, any changes must be within the scope of products awarded based on the posting described in Section 1.B above. Vendor may not add a manufacturer’s product line which was not included in the Vendor’s response to the solicitation described in Section 1.B above.

  • Product ACCEPTANCE Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User(s) shall have thirty (30) days from the date of delivery to accept hardware products and sixty (60) days from the date of delivery to accept all other Product. Where the Contractor is responsible for installation, acceptance shall be from completion of installation. Failure to provide notice of acceptance or rejection or a deficiency statement to the Contractor by the end of the period provided for under this clause constitutes acceptance by the Authorized User(s) as of the expiration of that period. The License Term shall be extended by the time periods allowed for trial use, testing and acceptance unless the Commissioner or Authorized User agrees to accept the Product at completion of trial use. Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User shall have the option to run testing on the Product prior to acceptance, such tests and data sets to be specified by User. Where using its own data or tests, Authorized User must have the tests or representative set of data available upon delivery. This demonstration will take the form of a documented installation test, capable of observation by the Authorized User, and shall be made part of the Contractor’s standard documentation. The test data shall remain accessible to the Authorized User after completion of the test. In the event that the documented installation test cannot be completed successfully within the specified acceptance period, and the Contractor or Product is responsible for the delay, Authorized User shall have the option to cancel the order in whole or in part, or to extend the testing period for an additional thirty (30) day increment. Authorized User shall notify Contractor of acceptance upon successful completion of the documented installation test. Such cancellation shall not give rise to any cause of action against the Authorized User for damages, loss of profits, expenses, or other remuneration of any kind. If the Authorized User elects to provide a deficiency statement specifying how the Product fails to meet the specifications within the testing period, Contractor shall have thirty (30) days to correct the deficiency, and the Authorized User shall have an additional sixty (60) days to evaluate the Product as provided herein. If the Product does not meet the specifications at the end of the extended testing period, Authorized User, upon prior written notice to Contractor, may then reject the Product and return all defective Product to Contractor, and Contractor shall refund any monies paid by the Authorized User to Contractor therefor. Costs and liabilities associated with a failure of the Product to perform in accordance with the functionality tests or product specifications during the acceptance period shall be borne fully by Contractor to the extent that said costs or liabilities shall not have been caused by negligent or willful acts or omissions of the Authorized User’s agents or employees. Said costs shall be limited to the amounts set forth in the Limitation of Liability Clause for any liability for costs incurred at the direction or recommendation of Contractor.

  • Competing Products The provisions of Section 21 are set forth on attached Exhibit H and are incorporated in this Section 21 by this reference.

  • Third Party Products 12.1 Third-party products provided to you by NCR Voyix for use with your subscription to the Service are subject to any terms provided by their supplier, including but not limited to those terms and conditions set forth in the exhibits attached hereto. Third-party terms and conditions are subject to change at any time by the supplier, and you agree that your use of such third-party products and services is governed by such supplier’s terms and conditions. You hereby release NCR Voyix from any and all liability associated with any damages or claims arising out of or related to third-party products. UNLESS NCR Xxxxx SPECIFICALLY AGREES OTHERWISE IN WRITING, YOU ACKNOWLEDGE AND AGREE THAT SUCH THIRD-PARTY PRODUCTS ARE PROVIDED “AS-IS” WITHOUT A WARRANTY FROM NCR Voyix. ACCORDINGLY, NCR Voyix EXPRESSLY DISCLAIMS ALL WARRANTIES OF ANY NATURE WITH RESPECT TO ANY SUCH THIRD-PARTY PRODUCTS, WHETHER ORAL OR WRITTEN, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT OF ANY THIRD-PARTY RIGHTS. 12.2 Third-party products and services may be advertised or made available to you for purchase directly from their supplier by email or other electronic communications, including notifications made through the Service or the Account Portal. Any representations or warranties that may be provided in connection with any such third-party products or services are provided solely by their supplier. NCR Voyix will not be responsible for any of your dealings or interactions with any of those third-party suppliers.

  • Additional Products and Services Subject to the allocation of funds, the CPO may add similar equipment, supplies, services, or locations, within the scope of this Agreement, to the list of equipment, supplies, services, or locations to be performed or provided by giving written notification to Contractor. For purposes of this Section, the “Effective Date” means the date specified in the notification from the CPO. As of the Effective Date, each item added is subject to this Agreement, as if it had originally been a part, but the charge for each item starts to accrue only on the Effective Date. In the event the additional equipment, supplies, services, or locations are not identical to the items(s) already under this Agreement, the charges therefor will then be Contractor’s normal and customary charges or rates for the equipment, supplies, services, or locations classified in the Fees and Costs (Exhibit “F”).

  • Manufacturing License Subject to the terms of this Agreement, including without limitation Section 2.2, Theravance grants to GSK an exclusive license under the Theravance Patents and Theravance Know-How to make and have made API Compound or formulated Alliance Product in the Territory.

  • Field Orders The documents listed in Paragraph 9.01.A are attached to this Agreement (except as expressly noted otherwise above).

  • New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!