Manufacture by Licensee Sample Clauses

Manufacture by Licensee. Subject to Section 8.5, Licensee shall not be permitted to manufacture Compound or Licensed Products or drug substance of the Licensed Product inside or outside of the Licensed Territory without the prior written consent of Mirati. For clarity, after the completion of the Manufacturing Technology Transfer, Licensee shall be permitted to manufacture or have manufactured the Compound or Licensed Products or drug substance of the Licensed Product in the Licensed Territory.
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Manufacture by Licensee. 5.4.1. From time to time, the Parties, through the JMC, will evaluate the option to perform a technology transfer for the Manufacture of Licensed Products designated for the Territory from Licensor to Licensee in the light of demand increase and supply requirements considering the forecasts provided by Licensee under the Commercial Supply Agreement. [***]. 5.4.2. Without limiting the foregoing, in the event of a supply shortage or supply failure that results in Licensor being unable to supply the quantities of Licensed Product set out in Licensee's Binding Forecast under either the clinical supply agreement negotiated pursuant to Section 5.2 or the Commercial Supply Agreement, then Licensor shall allocate its available supply of Licensed Product between Licensee, itself, its Affiliates and Third Party licensees: (a) first to supply patients who are already on study drug in registration Clinical Trials or early access programs before commercial supply; (b) then for commercial supply on a pro-rata basis determined based on [***], and (c) then for new patients in registration Clinical Trials, all as to be further set out in the Commercial Supply Agreement. 5.4.3. If Licensor fails to supply at least [***] of Licensee’s Binding Forecast (a) during [***] or (b) during [***], then (i) the Parties shall discuss in good faith and at Licensee’s request, Licensor shall use Commercially Reasonable Efforts to secure any approvals required under the Lonza Agreement to perform a manufacturing technology transfer to, at Licensee’s election, either Licensee, its Affiliate or a qualified Third Party CMO acceptable to Licensor (such acceptance not to be unreasonably withheld, conditioned or delayed) and (ii) if such approval is granted, the Parties shall amend this Agreement, to include additional provisions related to such manufacturing technology transfer and the Manufacture of Licensed Compound and Licensed Product in the Territory by or for Licensee. Licensee acknowledges and agrees that any such manufacturing technology transfer and any associated amendment to this Agreement shall be subject to the terms of the Lonza Agreement and any approvals required by the Lonza Agreement. ​ ​
Manufacture by Licensee. Licensee shall not be permitted to manufacture Licensed Product inside or outside of the Territory without the written consent of Company. During the Term, upon Licensee’s request, Company shall (a) discuss with Licensee in good faith and (b) have the discretion to determine whether to transfer the manufacture capabilities of the Licensed Product in the Territory by (i) designating a Company Affiliate or a contract manufacturing organization (a “CMO”) to manufacture the Licensed Product in the Territory, (ii) transferring to such Affiliate or CMO the Information Controlled by Company or its Affiliates to the extent necessary or reasonably useful for the manufacture of Licensed Product in the Territory, (iii) permitting such Affiliate or CMO to deliver Licensed Product so manufactured by the CMO directly to Licensee, its Affiliates or permitted sublicensees; provided, however, Company shall have no obligation to transfer the manufacture capabilities of the Licensed Product in the Territory to Licensee.

Related to Manufacture by Licensee

  • By Licensee Licensee shall defend, indemnify, and hold harmless Licensor, its Affiliates, sublicensees, the licensors under the Existing Licenses, and their respective shareholders, members, partners, officers, trustees, faculty, students, contractors, agents, and employees (individually, a “Licensor Indemnified Party” and, collectively, the “Licensor Indemnified Parties”) from and against any and all Third Party liability, loss, damage, action, claim, fee, cost, or expense (including attorneys’ fees) (individually, a “Third Party Liability” and, collectively, the “Third Party Liabilities”) suffered or incurred by the Licensor Indemnified Parties from claims of such Third Parties that result from or arise out of: […***…]; provided, however, that Licensee shall not be liable for claims based on any breach by Licensor of the representations, warranties, or obligations of this Agreement or the gross negligence or intentional misconduct of any of the Licensor Indemnified Parties. Without limiting the foregoing, Licensee must defend, indemnify, and hold harmless the Licensor Indemnified Parties from and against any Third Party Liabilities resulting from: (a) any […***…] or other claim of any kind related to the […***…] by a Third Party of a […***…] by Licensee, its Affiliates, any Sublicensees, their respective assignees, or vendors; (b) any claim by a Third Party that the […***…]; and (c) […***…] conducted by or on behalf of Licensee, its Affiliates, any Sublicensees, their respective assignees, or vendors relating to the Licensed Technology or Licensed Products, including any claim by or on behalf of a […***…].

  • By Licensor Licensor will indemnify and hold harmless Licensee and its and members, managers, directors, officers, shareholders, employees, agents, representatives and affiliates (collectively, the "Licensee Indemnified Parties"), on an After Tax Basis, from and against all claims, losses, damages (including loss of profits and consequential damages awarded to unrelated third parties, if any, but excluding loss of profits and consequential damages otherwise suffered by the Licensee Indemnified Parties), expenses, judgements, costs and liabilities (including reasonable attorneys' fees and costs) (collectively, "Losses") incurred by the Licensee Indemnified Parties arising from Licensor's breach of any obligation, representation or warranty contained in this Agreement. Notwithstanding the foregoing any claims for indemnification that any Licensee Indemnified Parties may have pursuant to this Section 7.2(a) will exclude claims based on information known by Lifford (or its Affiliates, including Bloomfield) as of the Funding Date whether or not such information formed the basis of the issues raised by Bloomfield during Due Diligence (as defined in the Operating Agreement) and whether or not asserted prior to the Walk Away Notice (as defined in the Operating Agreement) or thereafter. In the event of a dispute regarding a claim for indemnification, the Licensee Indemnified Party will have the burden of proof in establishing the validity and amount of the claim, and Licensor will have the burden of proof in establishing any defense to such claim, including but not limited to, a defense asserted by Licensor that Lifford (or its Affiliates) had knowledge of the requisite facts. Notwithstanding the foregoing, Licensor will not be obligated to provide indemnification where there is any admission of guilt by any Licensee Indemnified Party charged with violation of the law as to the content of any Company Program.

  • 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.

  • Sublicensees Licensee shall have the right (but not the obligation) to sublicense those rights granted to it under Section 2.1 only as set forth in, and subject to the terms and conditions of, Section 2.5 and this Section 2.3.2, to (a) any Person (other than a Specified Person) with the prior written consent of Lxxxx, which consent will not be unreasonably withheld, conditioned or delayed; provided that Licensee may contract in the ordinary course of business with any Third Party contract research organization (“CRO”) or contract development and manufacturing organization (“CMO”) to handle certain clinical Development or Manufacturing activities, in Licensee’s reasonable discretion, without requiring Lilly’s consent; provided further that such CRO or CMO are working on Licensee’s behalf, (b) any of its Affiliates (only for so long as they remain Affiliates), provided that Licensee provides prior written notice (at least 20 Business Days in advance) to Lilly of any sublicenses to be granted to any Affiliate or its request for approval of any sublicense to be granted to any other Person, which shall include in each case a description of the rights to be granted and the purpose therefor, the identity of the proposed Sublicensee and the countries involved, or (c) a Specified Person. Each Affiliate or other Person to which any such sublicense is granted is referred to herein as a “Sublicensee.” Licensee shall remain responsible for the performance by each of its Sublicensees and shall cause each of its Sublicensees to comply with the applicable provisions of this Agreement, and Licensee shall be liable for the acts or omissions of its Sublicensees under or in connection with this Agreement (as if such acts or omission were those of Licensee). Without limiting the foregoing, Licensee shall: (x) ensure that each of its Sublicensees accepts in writing all applicable terms and conditions of this Agreement, including the non-compete, reporting, audit, inspection and confidentiality provisions hereunder; (y) under the agreements between Licensee and each of its Sublicensees, include a provision pursuant to which either (a) Lilly is named as a third-party beneficiary or (b) a mechanism (for example, a power of attorney) is implemented for Lxxxx to enforce all applicable terms and conditions of this Agreement against the Sublicensee in a manner reasonably satisfactory to Lilly, provided that, in each case, Lxxxx shall not proceed against any Sublicensee unless Lxxxx has first provided Licensee with written notice of the Sublicensee’s breach and Licensee has not, within 90 days after receipt of such notice, caused the Sublicensee to cease the breaching activity or otherwise cure the breach, in each case, to the reasonable satisfaction of Lxxxx; and (z) terminate all relevant agreements with any such Sublicensee in the case of any breach of such terms and conditions by such Sublicensee. A Sublicensee shall have the right to grant further sublicenses, subject to complying with the terms of this Section 2.3.2 with respect to further Sublicensees. For the avoidance of doubt, (i) Licensee will remain directly responsible for all amounts owed to Lilly under this Agreement, and (ii) each Sublicensee is subject to the negative and restrictive covenants set forth in Sections 2.2.1 and 2.4, respectively. Licensee hereby expressly waives any requirement that Lxxxx exhaust any right, power or remedy, or proceed against a subcontractor, for any obligation or performance hereunder prior to proceeding directly against Licensee. Notwithstanding anything to the contrary, (A) all sublicenses granted hereunder shall automatically terminate upon expiration or termination of this Agreement for any reason and (B) if the Parties enter into an agreement pursuant to Section 2.5 with respect to the Product, then as of the effective date of such agreement all sublicenses granted with respect to the Product shall automatically terminate, except as otherwise mutually agreed by the Parties in writing (and in no event shall any negotiations for any such agreement pursuant to Section 2.5 be conditioned on or otherwise affected by whether Lxxxx agrees to allow any such sublicenses to continue).

  • Licensee “Licensee” means the individual or company that has entered into an Agreement with the Embassy. “Offer” means a response to a solicitation that, if accepted, would bind the offeror to perform the resultant Agreement.

  • Manufacture of Products All Products marketed through Grantor's Web ------------------------- Site shall be manufactured, packaged, prepared, and shipped in accordance with the specifications and requirements described on Exhibit A hereto as it may be modified from time to time. Quality control standards relating to the Product's weight, color, consistency, micro-biological content, labeling and packaging are also set forth on Exhibit A. In the event that Exhibit A is incomplete, Products shall be manufactured and shipped in accordance with industry standards.

  • 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.

  • Restricted Use by Licensee Except as expressly authorized by the terms of license, Licensee shall not: (i) Copy the Product; (ii) Cause or permit reverse compilation or reverse assembly of all or any portion of the Product; (iii) Export the Licensed Software in violation of any U.S. Department of Commerce export administration regulations.

  • Licensed Technology (a) LICENSOR is not aware of any interference, infringement, misappropriation, or other conflict with any intellectual property rights of third parties, and LICENSOR has never received any charge, complaint, claim, demand, or notice alleging any such interference, infringement, misappropriation, or violation (including any claim that LICENSOR must license or refrain from using any intellectual property rights of any third party). To the knowledge of LICENSOR, no third party has interfered with, infringed upon, misappropriated, or otherwise come into conflict with any of the LICENSED TECHNOLOGY. (b) Exhibit A identifies each patent or registration which has been issued to LICENSOR with respect to any of the LICENSED TECHNOLOGY and identifies each pending patent application or application for registration which LICENSOR has made with respect to any of the LICENSED TECHNOLOGY. LICENSEE acknowledges that LICENSOR has previously made available to LICENSEE correct and complete copies of all such patents, registrations and applications (as amended to-date) in LICENSOR’s possession and has made available to LICENSEE correct and complete copies of all other written documentation in LICENSOR’s possession evidencing ownership and prosecution (if applicable) of each such item. (c) Exhibit A identifies each item of LICENSED TECHNOLOGY that is assigned to LICENSOR or that LICENSOR uses pursuant to license, sublicense, agreement, or permission. LICENSOR has made available to LICENSEE correct and complete copies of all such licenses, sublicenses, agreements, patent prosecution files and permissions (as amended to-date) in LICENSOR’s possession. With respect to each item of LICENSED TECHNOLOGY required to be identified in Exhibit A and to the knowledge of LICENSOR: (i) the license, sublicense, agreement, or permission covering the item is legal, valid, binding, enforceable, and in full force and effect; (ii) the license, sublicense, agreement, or permission will continue to be legal, valid, binding, enforceable, and in full force and effect on identical terms following the consummation of the transactions contemplated hereby; (iii) no Party to the license, sublicense, agreement, or permission is in breach or default, and no event has occurred which with notice or lapse of time would constitute a breach or default or permit termination, modification, or acceleration thereunder; (iv) no party to the license, sublicense, agreement, or permission has repudiated any provision thereof; (v) the underlying item of LICENSED TECHNOLOGY is not subject to any outstanding lien or encumbrance, injunction, judgment, order, decree, ruling, or charge; (vi) no action, suit, proceeding, hearing, investigation, charge, complaint, claim, or demand is pending or is threatened which challenges the legality, validity, or enforceability of the underlying item of LICENSED TECHNOLOGY; and (vii) except as provided in Exhibit A, LICENSOR has not granted any license or similar right to the LICENSED TECHNOLOGY within the GENERAL FIELD or PARTHENOGENESIS FIELD.

  • Third Party Materials The Application may display, include, or make available third-party content (including data, information, applications, and other products, services, and/or materials) or provide links to third-party websites or services, including through third- party advertising ("Third-Party Materials"). You acknowledge and agree that Company is not responsible for Third-Party Materials, including their accuracy, completeness, timeliness, validity, copyright compliance, legality, decency, quality, or any other aspect thereof. Company does not assume and will not have any liability or responsibility to you or any other person or entity for any Third-Party Materials. Third-Party Materials and links thereto are provided solely as a convenience to you, and you access and use them entirely at your own risk and subject to such third parties' terms and conditions.

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