By Prometheus Sample Clauses

By Prometheus. Under the terms and subject to the conditions of this Agreement, Prometheus hereby grants GSK and its Affiliates the non-exclusive, royalty-free right under the Prometheus Intellectual Property and the Product Developments (collectively, the "Prometheus Rights") to utilize the Prometheus Rights, solely to perform GSK's obligations hereunder.
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By Prometheus. This Quality Agreement takes the form of a detailed checklist of the activities associated with the distribution, warehousing and promotion of the Product. Responsibility for each activity is assigned to either AstraZeneca and/or Prometheus in the appropriate box in the Delegation Responsibility Checklist that follows. To facilitate routine communications between the parties, a list of contacts is provided in Attachment A. For each responsibility listed, the respective party is required to put into effect all applicable procedures and take all necessary actions to effectuate such responsibility in accordance with cGMPs and applicable local, state and federal laws. This Quality Agreement is subject to the terms of the Agreement. In the event of any inconsistency between this Quality Agreement and the Agreement, the Agreement shall control, except that any dispute arising out of or relating to this Quality Agreement (other than a dispute regarding an inconsistency as aforesaid) shall be governed by Article 7 of this Quality Agreement. Nothing in this Quality Agreement shall limit, diminish, or affect in any way a party's obligation to comply with cGMPs and applicable local, state and federal laws including, without limitation, the guidance and directives set forth in: (i) FDA regulations for current good manufacturing practices as contained in 21 CFR Parts 210, 211; ii) 21 CFR Part 11; (iii) FDA Regulatory Inspection Guides; (iv) FDA Guidance for Industry; (v) Applicable State Boards of Pharmacy; and (vi) the Prescription Drug Marketing Act, as amended. This Quality Agreement shall continue in effect until the termination of the Agreement; or such time that Prometheus no longer has the right to market, distribute, and promote the Product. Table of Contents RESPONSIBILITY DELEGATION CHECKLIST 2 1.0 REGULATORY AUTHORIZATIONS AND COMMUNICATIONS 2 2.0 GMP COMPLIANCE 2 2.1 Organization and Personnel 2 2.2 Buildings and Facilities 3 2.3 Equipment and Utility Services 3 3.0 PROCESS CONTROLS 3 3.1 PRODUCT Retains 4 3.2 Change Control 4 4.0 QUALITY ASSURANCE/CONTROL 5 4.1 Records Retention 5 4.2 Customer Complaints and Adverse Events 5 4.3 Market Actions 6 4.4 Annual Product Reviews 7 5.0 PRODUCT DISTRIBUTION 7 5.1 Stop Shipment 8 5.2 PRODUCT Disposition/Rejection/Destruction 8 6.0 ASTRAZENECA OVERSIGHT 8 6.1 Audits 8 6.2 Regulatory Inspections/Notifications 9 6.3 SITE Presence 10 6.4 Review & Revision of Quality Agreement 10 7.0 DISPUTE RESOLUTION 10 8.0 STABILITY S...
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By Prometheus. If The Regents should violate or fail to perform any term or covenant of this Agreement, then Prometheus may give written notice of such default ("Notice of Default") to The Regents. If The Regents should fail to repair such default within 90 days after the date such notice takes effect, Prometheus will have the right to terminate this Agreement and the licenses herein by a second written notice ("Notice of Termination") to The Regents. If a Notice of Termination is sent to The Regents, this Agreement will automatically terminate on the date such notice takes effect. Such termination will not impair any accrued right of Prometheus. These notices will be subject to Article 15 (Notices).
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By Prometheus. During the Term of this Agreement, neither Prometheus nor any of its Affiliates shall, directly or indirectly, Exploit a Significant Direct Competitor that is not a Licensed Product in the Prometheus Territory, or otherwise assist or transfer or license rights to any business that Prometheus knows intends to use such assistance or rights to Exploit a Significant Direct Competitor in the Prometheus Territory. Each of the Parties hereto recognizes that the restrictions contained in, and the terms of, this Section 2.4.2 are properly required for the adequate protection of Rosetta’s rights hereunder, and agree that if any provision in this Section 2.4.2 is determined by any court to be unenforceable by reason of its extending for too great a period of time or over too great a geographic area, or by reason of its being too extensive in any other respect, such covenant shall be interpreted to extend only for the longest period of time and over the greatest geographic area, and to otherwise have the broadest application as shall be enforceable. [***]. If Prometheus or any of its Affiliates are acquired by or merge with a Third Party that has a Significant Direct Competitor that is not a Licensed Product, neither Prometheus nor any of its Affiliates will have any obligations under this Section 2.4.2 with respect to such Significant Direct Competitor; provided that the division, subsidiary or business group of the surviving party in such change of control that pursues such Significant Direct Competitor shall not have access to, and shall not refer to, rely upon or use in any manner, the Licensed Intellectual Property with respect to such Significant Direct Competitor, except with Rosetta’s prior written consent and on the condition that such Significant Direct Competitor be treated as a Licensed Product hereunder.
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Related to By Prometheus

  • Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

  • 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.

  • By Licensee Except for claims for which Oracle is obligated to indemnify Licensee under Section 7.2, Licensee shall defend, at Licensee's expense, any and all claims brought against Oracle, and shall pay all damages awarded by a court of competent jurisdiction, or such settlement amount negotiated by Licensee, arising out of or in connection with Licensee's reproduction, development or distribution of product(s) developed using the TCK. Licensee's obligation to provide a defense under this Section 7.5 shall arise provided that Oracle: (a) provides notice of the claim promptly to Licensee; (b) gives Licensee sole control of the defense and settlement of the claim; (c) provides to Licensee, at Licensee's expense, all available information, assistance and authority to defend; and (d) has not compromised or settled such proceeding without Licensee's prior written consent.

  • By Licensor Licensor will indemnify, defend and hold harmless Licensee and its Affiliates, and their respective directors, officers and employees (“Licensee Indemnitees”) from and against any and all Third Party Claims and associated Liabilities to the extent arising directly or indirectly from any material breach by Licensor of the terms of this Agreement..

  • Licensed Patent Rights The term “Licensed Patent Rights” shall mean rights arising out of or resulting from:

  • Joint Patent Rights 11.8.1 Genmab shall have the first right, but not the obligation, to file, prosecute, maintain and defend Patent Rights relating to Joint Inventions (“Joint Patent Rights”) throughout the Territory, at its sole expense, and Genmab shall give timely notice to CureVac, and, if during the Research Period, with a copy to the IP Sub-Committee, of any desire to not file patent applications claiming Joint Patent Rights or to cease prosecution and/or maintenance of Joint Patent Rights on a country-by-country basis and, in such cases, shall permit CureVac, in its sole discretion, to file such patent applications or to continue prosecution, maintenance or defense of such Joint Patent Rights at its own expense. At the latest [*****] before filing, the prosecuting Party shall give the non-prosecuting Party an opportunity to review and comment upon the text of any application with respect to such Joint Patent Right, shall consult with the non-prosecuting Party with respect thereto, shall not unreasonably refuse to address any of the non-prosecuting Party’s comments and supply the non-prosecuting Party with a copy of the application as filed, together with notice of its filing date and serial number. The prosecuting Party shall keep the non-prosecuting Party reasonably informed of the status of the actual and prospective prosecution, and maintenance, including but not limited to any substantive communications with the competent patent offices that may affect the scope of such filings, and the prosecuting Party shall give the non-prosecuting Party a timely, prior opportunity to review and comment upon any such substantive communication and shall consult with such non- prosecuting Party with respect thereto, and shall not unreasonably refuse to address any of such non-prosecuting Party’s comments.

  • 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.

  • 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.

  • Licensed Patents Licensee shall be responsible for all further patent prosecution with respect to the Licensed Patents and Licensed Technologies set out in Exhibit “A”. Licensee may select the patent agent for the prosecution of the Licensed Patents, subject to the approval of Licensor as the patent owner, which approval will not be unreasonably withheld. Licensee shall provide Licensor with copies of all relevant documentation related to the filing and prosecution of the Licensed Patents so that Licensor may be informed and apprised of and meaningfully consulted as to the continuing prosecution. Licensor shall keep all such documentation confidential. In the event the Licensee does not agree that any given patent application or patent should be filed, prosecuted or maintained (hereinafter referred to as a “Refused Licensed Patent”) in a particular jurisdiction(s) Licensee shall indicate such disagreement in writing (hereinafter “Refusal Notice”) and upon Licensor’s receipt of such Refusal Notice Licensor shall have the right unilaterally to make, prosecute and maintain such Refused Licensed * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission Patent in such jurisdiction(s) in the name of its owners, at Licensor’s expense, and Licensee shall not have any rights or obligations to such Refused Licensed Patent in such jurisdiction(s); provided, however, that Licensee shall retain all of its ownership rights in any Refused Licensed Patent that is a Co-Owned Technology. In such case Licensor shall provide Licensee with copies of all relevant documentation related to the filing and prosecution of the Refused Licensed Patents so that Licensee may be informed and apprised of and be meaningfully consulted with as to the continuing prosecution. Licensor shall have no obligation to continue prosecution or maintenance of any Refused Licensed Patent and may abandon same without any prior notice or any obligation to Licensee. Both Licensee and Licensor shall make best efforts to respond promptly to any request from the other Party for input or assistance with respect to matters pertaining to the Licensed Patents. Licensee shall use reasonable efforts to amend any patent application to include claims reasonably requested by the other Party and required to protect the Licensed Technology. In addition to Licensee’s obligations pursuant to section 4.1 above, Licensee shall be solely responsible for all patent and legal costs relating to the Licensed Patents and Licensed Technology (excluding Refused Licensed Patents) from the Effective Date onward, including all costs relating to the transfer of the Licensed Patents to the new patent agents selected by Licensee and approved by Licensor. For any patent and legal costs relating to the Licensed Patents and Licensed Technology (excluding Refused Licensed Patents) paid by Licensor after the Effective Date (including, without limitation, those expenses related to patentability assessments and drafting, filing, prosecution, maintenance, and taxes (the “Patent Costs”)), Licensee shall promptly reimburse Licensor for such Patent Costs upon receipt of an invoice from Licensor for such expenses. For any work in progress with respect to the Licensed Patents for which the Patent Costs have not already been paid by Licensor to its patent firm prior to the transfer of the Licensed Patents to Licensee’s patent agent, Licensor will direct its patent firm to copy Licensee on all such invoices from said patent firm and Licensee will promptly pay said invoices directly to Licensor’s patent firm.

  • 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.

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