Product-by-Product Sample Clauses

Product-by-Product. (i) Product-by-Product (pre-Phase III). In the event of a termination of development of any particular Collaboration Product under this Agreement pursuant to Section 19.3.2, 19.3.3 or 19.3.4, which in each case the notice of termination is given prior to the Development Committee's decision to undertake the first Phase III clinical trial with respect to such Collaboration Product, the terminating party shall reimburse the other party (for purposes of this Section 19.4.2(b)(i), the "Other Party") for [*] of all obligations and commitments incurred by the Other Party to third parties in accordance with the Development Plan and Budget with respect to such product prior to such notice of termination, and [*] of all FTE Expenses budgeted for the Other Party for such product over the [*] following the date of such notice of termination, to the extent that such FTEs are not reassigned to other work to be performed under the Development Program or to programs funded or reimbursed by a third party at [*] or higher. Upon such payment, the terminating party shall have no further obligation under Section 6.1 with respect to such product. If there are not then remaining [*] under the Development Plan and Budget, the same shall be deemed extended at the same number of FTEs in effect at the date of the notice of termination, to the extent that such FTEs are not reassigned to other work to be performed under the Development Program or to programs funded or reimbursed by a third party at [*] or higher. It is further understood and agreed that the Other Party shall have the right to use amounts received under this Section 19.4.2(b)(i) as it deems fit in its sole discretion, and shall have no further obligation with respect to such amounts. For purposes of this Section 19.4.2(b)(i), "FTE Expenses" shall mean the number of the Other Party's FTEs assigned to the Development Program for such terminated product under the Development Plan and Budget in effect at the date of the notice of termination, multiplied by the FTE rate per month then in effect under the Development Plan and Budget. Notwithstanding the foregoing, if within [*] of a termination of a Collaboration Product under this Agreement prior to the Development Committee's decision to undertake the first Phase III clinical trial with respect to such Collaboration Product, this Agreement is terminated pursuant to Section 19.2.1 or 19.3.1, the termination of such Collaboration Product shall be deemed to have occurred aft...
Sample 1
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Product-by-Product. Royalties shall be payable pursuant to this Section 5.4 on a Licensed Product by Licensed Product basis, and shall be imposed only once with respect to any sale of the same unit of Licensed Product.
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Product-by-Product. In the event of a termination by JT of this Agreement for any particular Collaboration Product pursuant to Section 19.3.2 (for purposes of this Section 19.4.4(b), the "Terminated Product"), the Terminated Product shall cease to be a Collaboration Product for purposes of this Agreement. In addition, (i) JT shall assign or cause to be assigned to CG (or if not so assignable, JT shall take all reasonable actions to make available to CG) all regulatory filings and registrations (including MAAs xxx Marketing Approvals) with respect to the Terminated Product that have been made by or under authority of JT, in each case such assignment (or availability) shall be made within thirty (30) days after the applicable notice of termination; (ii) without limiting any other provisions of this Section 19.4.4(b), JT's rights and CG's obligations (but not JT's obligations or CG's rights) under Sections 5.1.1, 7.1, 7.2 and 7.3 shall terminate; (iii) CG shall have an irrevocable, exclusive, worldwide license, with the right to grant and authorize sublicenses, under the JT Technology and any trademarks owned by JT used in association with the Terminated Product (excluding JT's trade name) to make, use, sell, import and otherwise exploit the Terminated Product and/or modifications thereof; (iv) CG's obligation to reimburse JT for amounts under Section 9.8 shall survive with respect to the further commercialization of the Terminated Product, for Third Party Agreements existing as of the notice of termination, provided that CG shall reimburse JT [*] of amounts payable to third parties thereunder as a result of CG's exercise of the license granted under clause (iii); and (v) CG's obligations under Section 4.6 above shall terminate with respect to the Terminated Product and any modifications thereto (it being therefore understood that CG shall have the right (itself or together with or through one or more third parties) to research, develop, sell, market or distribute the Terminated Product and/or modifications thereto). The license granted under clause (iii) shall include the right to enforce proprietary rights included within the JT Technology to the extent necessary for the manufacture, use or sale of the Terminated Product in the Field, and JT shall cooperate fully with CG in connection with such enforcement, including without limitation by joining as a nominal party plaintiff if such joining is necessary for standing purposes, and otherwise in enabling CG to commercialize (dire...
Sample 1
Product-by-Product. In addition after the Completion of the [*] clinical trial with respect to a particular Collaboration Product, JT may terminate this Agreement with respect to such Collaboration Product by notifying CG that it desires to terminate this Agreement with respect to such Collaboration Product, which termination shall be effective [*] after the date of such notice; provided, however, if as a result of such a termination no Collaboration Product would be in "product development" or for which a Market Approval has been obtained in a Major Market Country under the Agreement, such termination shall be deemed a termination of this Agreement under Section 19.3.1 above and be subject to the terms and conditions thereof. As used in this Section 19.3.2, "product development" shall mean pre-Phase I and later clinical development that begins with formal toxicological studies conducted in accordance with Good Laboratory Practices (as then defined by the FDA) and includes the conduct of preclinical studies, to produce data required for inclusion in an IND for such Collaboration Product.
Sample 1
Product-by-Product. As to each Collaboration Product in each country in the applicable Product Territory, this Agreement shall expire on the later of (i) [c.i.] after the First Commercial Sale of such Collaboration Product in such country, or (ii) the date that neither the manufacture, sale nor use of such Collaboration Product [c.i.] by a [c.i.] in such country.
Sample 1
Product-by-Product. If BMS terminates this Agreement pursuant to Section 14.2.1(b) as to one or more specific Products and, if applicable, MDX-1379 (x) in the entire Territory or (y) with respect to one or more country(ies) in the Territory:
Sample 1

Related to Product-by-Product

  • 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.

  • 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.

  • Marking of Licensed Products To the extent commercially feasible and consistent with prevailing business practices, Company shall xxxx, and shall cause its Affiliates and Sublicensees to xxxx, all Licensed Products that are manufactured or sold under this Agreement with the number of each issued patent under the Patent Rights that applies to such Licensed Product.

  • 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 Labeling The labeling of all Licensed Products sold or offered for sale under this Agreement shall expressly state that the Licensed Product is manufactured under a license from the Medicines Patent Pool.

  • SOURCE CODE ESCROW FOR LICENSED PRODUCT If Source Code or Source Code escrow is offered by either Contractor or Product manufacturer or developer to any other commercial customers, Contractor shall either: (i) provide Licensee with the Source Code for the Product; or (ii) place the Source Code in a third party escrow arrangement with a designated escrow agent who shall be named and identified to the State, and who shall be directed to release the deposited Source Code in accordance with a standard escrow agreement acceptable to the State; or (iii) will certify to the State that the Product manufacturer/developer has named the State, acting by and through the Authorized User, and the Licensee, as a named beneficiary of an established escrow arrangement with its designated escrow agent who shall be named and identified to the State and Licensee, and who shall be directed to release the deposited Source Code in accordance with the terms of escrow. Source Code, as well as any corrections or enhancements to such source code, shall be updated for each new release of the Product in the same manner as provided above and such updating of escrow shall be certified to the State in writing. Contractor shall identify the escrow agent upon commencement of the Contract term and shall certify annually that the escrow remains in effect in compliance with the terms of this clause. The State may release the Source Code to Licensees under this Contract who have licensed Product or obtained services, who may use such copy of the Source Code to maintain the Product.

  • AUDIT OF LICENSED PRODUCT USAGE Contractor shall have the right to periodically audit, no more than annually, at Contractor’s expense, use of licensed Product at any site where a copy of the Product resides provided that: (i) Contractor gives Licensee(s) at least thirty (30) days advance written notice, (ii) such audit is conducted during such party’s normal business hours, (iii) the audit is conducted by an independent auditor chosen on mutual agreement of the parties. Contractor shall recommend a minimum of three (3) auditing/accounting firms from which the Licensee will select one (1). In no case shall the Business Software Alliance (BSA), Software Publishers Association (SPA), Software and Industry Information Association (SIIA) or Federation Against Software Theft (FAST) be used directly or indirectly to conduct audits, or be recommended by Contractor; (iv) Contractor and Licensee are each entitled to designate a representative who shall be entitled to participate, and who shall mutually agree on audit format, and simultaneously review all information obtained by the audit. Such representatives also shall be entitled to copies of all reports, data or information obtained from the audit; and (v) if the audit shows that such party is not in compliance, Licensee shall be required to purchase additional licenses or capacities necessary to bring it into compliance and shall pay for the unlicensed capacity at the NYS Net Price in effect at time of audit, or if none, then at the Contractor’s U.S. Commercial list price. Once such additional licenses or capacities are purchased, Licensee shall be deemed to have been in compliance retroactively, and Licensee shall have no further liability of any kind for the unauthorized use of the software.

  • Product Recalls (a) If either Party reasonably decides or is required by any government authority or court of competent jurisdiction, to initiate a product recall, withdrawal or field correction with respect to, or if there is any governmental seizure of, the Product, the Party initiating or required to initiate such action will notify the other Party promptly of the details regarding such action, including providing copies of all relevant documentation concerning such action. The Parties will assist each other in investigating any such situation and all regulatory contacts that are made and all activities concerning seizure, recall, withdrawal or field correction will be jointly coordinated by HSL and LMI. (b) If any such recall, withdrawal, field correction or seizure occurs due solely to (i) failure of any Product produced by HSL hereunder to conform to Specifications (including, without limitation, being adulterated or misbranded) or any warranty or other requirement set forth in this Agreement, (ii) the failure of HSL to comply in all material respects with any applicable law, rule, regulation, guideline, standard, court order or decree or (iii) the negligent or intentional wrongful act or omission of HSL in connection with the production of Product hereunder, then HSL shall bear the **** of any such seizure, recall, withdrawal or field correction and shall reimburse LMI for its ****, including any purchase price payments made to HSL and related taxes to the extent related to such recalled Product. To the extent any such recall, withdrawal, field correction or seizure occurs for any reason other than that set forth in the immediately preceding sentence, then LMI shall bear the **** of any such seizure, recall, withdrawal or field correction. If both HSL and LMI contribute to the cause of a seizure, recall, withdrawal or field correction, the cost and expense thereof will be shared in proportion to each Party’s contribution to the problem. For the purposes of this Agreement, the expenses of any recall, withdrawal, field correction or seizure shall include, without limitation, the out-of-pocket expenses of notification and destruction or return of the recalled Product and all other out-of-pocket costs incurred in connection with such recall but shall not include a Party’s lost profits. HSL’s reimbursement for the costs of LMI Materials related to such recall, withdrawal or field correction is limited by Section 5.6(c).

  • Combination Product The term “

  • Limited Product Warranty Repair or Replacement within 12 years

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