FOR COMBINATION PRODUCT Sample Clauses

FOR COMBINATION PRODUCT. FOREST shall pay to ALMIRALL non-refundable milestone payments to accrue on the following events for the Combination Product: - Feasibility of the formulation of the Combination Product (feasibility meaning delivery by ALMIRALL of data that shows that [***] or if clinical Development is undertaken - [***] following the receipt by FOREST of top line data from completed Phase Ill clinical trials provided by the Development Plan where the [***] corresponding primary endpoint is achieved with statistical significance and safety and efficacy data obtained are sufficient for use as pivotal trials for filing an NDA with a reasonable expectation of FDA Approval [***] it being understood that in the event this milestone is not due FOREST shall not be obliged to submit the corresponding NDA - Combination Product Final Approval: [***] In total [***]
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FOR COMBINATION PRODUCT. (continued)
FOR COMBINATION PRODUCT. General and legal responsibility for combination product requirements in accordance with CFR, including, but not limited to, the use of the Product with any other medical products, components, devices (including the pen device), labels or otherwise [*] [*] Responsibilities of Management (§ 820.20 CFR), with executive responsibility at the Facility of Xxxxxx Pharma, are well defined and documented in the quality system in effect at the Facility of Xxxxxx Pharma where the Product is Manufactured. Radius shall review Xxxxxx Pharma’s quality system during initial and periodic audits, to verify compliance with the management responsibility requirements [*] [*] Ensure compliance of the Product with the requirements of 21 CFR 820.30 [*] [*] Transfer the design, as referred to under 21 CFR 820.30, section (g), of the Pen (the combination device) to Xxxxxx Pharma, to be in accordance with the Specifications [*] [*] Document acceptance of such design transfer and incorporation into the Specifications [*] [*] Provide to Xxxxxx Pharma, and accept responsibility for, the technical and functional requirement specifications [*] [*] Propose selective, specific design input requirements, based on the technical and functional requirement specifications [*] [*] Review and approve Xxxxxx Pharma-proposed design input requirements, if acceptable [*] [*] Validate, and accept responsibility for, the design, as referred to under section 21 CFR 820.30, section (g), including assessment and verification that the design output meets the Radius design input (according to Radius’ design validation procedures) [*] [*] Upon request by Radius and in accordance with separate written agreement, perform testing of the design output to support Radius’ design verification [*] [*] Approve, adopt and accept responsibility for, design changes, as referred to under 21 CFR 820.30, section (i) [*] [*] Communicate any changes to the design to Xxxxxx Pharma, via revision of the Specifications to be implemented via the change control provisions of this QA [*] [*] Retain, and accept responsibility for, the design history file and the development plan, including as referred to under 21 CFR 820.30, section (j) [*] [*] APPENDIX 5: DELINEATION OF RESPONSIBILITIES (6/6) , Revison 01

Related to FOR COMBINATION PRODUCT

  • Combination Product The term “

  • Combination Products If a LICENSED PRODUCT is sold to any third party in combination with other products, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in such Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT shall be calculated by multiplying the NET SALES of the COMBINATION PRODUCT by the fraction A/(A+B), where A is the average NET SALES price of such LICENSED PRODUCT in the relevant country, as sold separately, and B is the total average NET SALES price of all OTHER PRODUCTS in the COMBINATION PRODUCT in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold separately, NET SALES for royalty determination shall be determined by the formula [C / (C+D)], where C is the aggregate average fully absorbed cost of the Licensed Product components during the prior Royalty Period and D is the aggregate average fully absorbed cost of the other essential functional components during the prior Royalty Period, with such costs being determined in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENT.

  • Licensed Product The term “Licensed Product” shall mean any product (a) the manufacture, use, importation, sale or offer for sale of which would, in the absence of the license granted by this Agreement, infringe a Valid Claim of any of the Licensed Patent Rights, or (b) that is comprised of, utilizes or incorporates Licensed Biological Materials, or (c) that is discovered, developed or made using a Licensed Process.

  • Diagnostic procedures to aid the Provider in determining required dental treatment.

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.

  • 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.

  • RE-WEIGHING PRODUCT Deliveries are subject to re- weighing at the point of destination by the Authorized User. If shrinkage occurs which exceeds that normally allowable in the trade, the Authorized User shall have the option to require delivery of the difference in quantity or to reduce the payment accordingly. Such option shall be exercised in writing by the Authorized User.

  • Recycled Products The Contractor agrees to comply with all the requirements of Section 6002 of the Resource Conservation and Recovery Act (RCRA), as amended (42 U.S.C. 6962), including but not limited to the regulatory provisions of 40 CFR Part 247, and Executive Order 12873, as they apply to the procurement of the items designated in Subpart B of 40 CFR Part 247. References: 42 U.S.C. 6962, 40 CFR Part 247, Executive Order 12873 (More than $10,000)

  • Single Source Selection Services for tasks in circumstances which meet the requirements of paragraph 3.10 of the Consultant Guidelines for Single Source Selection, may, with the Association's prior agreement, be procured in accordance with the provisions of paragraphs 3.9 through 3.13 of the Consultant Guidelines.

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