By ImClone Sample Clauses

By ImClone. In the event of the termination of this Agreement pursuant to Sections 14.2, 14.3, or 14.4 and to the extent that the Final Product, any procedure in the manufacture thereof, any API or other component used for formulation of Final Product, any fill/finish or packaging, or any QC/QA or release activities is, at the time of such termination, manufactured, performed or conducted by ImClone or any of its Affiliates with respect to Japan (or by Third Parties contracted to do so by or on behalf of ImClone or any of its Affiliates) (collectively, “ImClone Manufactured Components”), then, notwithstanding any provision to the contrary under the Existing Agreements, ImClone shall use commercially reasonable efforts to manufacture and supply, perform or conduct same to or for the benefit of Merck/MJ and BMS/BMKK with such ImClone Manufactured Components, solely for Development and Commercialization purposes in Japan of Cetuximab and Final Product (as may required by Confidential Treatment has been requested by ImClone Systems Incorporated for portions of this document. BMS/BMKK and Merck/MJ for the Japan market during such period), for a period of not more than [**] months post-termination, at a price equal to the sum of (i) [**] of ImClone’s Fully Burdened Manufacturing Costs, plus (ii) any [**] that are fairly and reasonably allocable to the manufacture by it, its Affiliates or contractors of Final Product, API or any component of the foregoing and supplied by it under this Section 8.8 for use or Commercialization in Japan on or after such termination date (other than Third Party Payments to the extent that the same would otherwise fall within ImClone’s indemnification obligations under Section 13.1 or within an exclusion for which ImClone is responsible under any of Sections 13.2(a)-(h)); provided, that, subject to Section 8.3: (A) ImClone shall not be obligated to so supply Merck (except where and to the extent that Merck or its Affiliates are obligated to supply or manufacture same for BMS/BMKK for the Japan market) if the basis for termination pursuant to Section 14.2, 14.3, or 14.4 was a material breach by Merck or its Affiliates of this Agreement or the Merck-ImClone Agreement; and (B) ImClone shall not be obligated to so supply BMS (except where and to the extent that BMS or its Affiliates are obligated to supply or manufacture same for Merck/MJ for the Japan market) if the basis for termination pursuant to Section 14.2, 14.3, or 14.4 was a material breach ...
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By ImClone. If ImClone, any of its Affiliates, or its or their licensees or sublicensees (other than BMS, Merck, or their respective Affiliates) acting under the authority of such license or sublicense should Develop (after the date that a product became a Competing Product), promote or otherwise commercialize a Competing Product in Japan (whether by itself, through an Affiliate, through co-promotion or co-marketing, or through the grant of a license or sublicense to a Third Party to manufacture or Commercialize a Competing Product), then the other Parties to this Agreement shall have no right to terminate the rights granted to ImClone under this Agreement with respect to Cetuximab or Final Product so long as ImClone continues thereafter to fulfill its obligations and to discharge its responsibilities under this Agreement; provided, that (x) the foregoing shall not change or affect any obligations of a Party under, or any remedies that may be available to a Party under, the Existing Agreements with respect to such Competing Product, (y) shall not, subject to the foregoing, affect any other rights or remedies that are otherwise available to a Party at law or in equity, and (z) the following shall apply:

Related to By ImClone

  • Licensed Technology The term "Licensed Technology" shall mean the ------------------- Licensed Patents, plus all improvements thereto developed by Licensor, and all related data, know-how and technology.

  • No Improper Use of Materials During his or her employment with the Company, Employee will not improperly use or disclose any Confidential Information or trade secrets, if any, of any former employer or any other person to whom Employee has an obligation of confidentiality, and Employee will not bring onto the premises of the Company any unpublished documents or any property belonging to any former employer or any other person to whom Employee has an obligation of confidentiality unless consented to in writing by that former employer or person.

  • By Licensee Licensee shall defend, indemnify, and hold harmless Licensor, the REGENXBIO Licensors, and their respective shareholders, members, 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 to the extent 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:

  • By Licensor Licensor represents and warrants that:

  • License; Use Upon delivery to an Authorized Person or a person reasonably believed by Custodian to be an Authorized Person of the Fund of software enabling the Fund to obtain access to the System (the “Software”), Custodian grants to the Fund a personal, nontransferable and nonexclusive license to use the Software solely for the purpose of transmitting Written Instructions, receiving reports, making inquiries or otherwise communicating with Custodian in connection with the Account(s). The Fund shall use the Software solely for its own internal and proper business purposes and not in the operation of a service bureau. Except as set forth herein, no license or right of any kind is granted to the Fund with respect to the Software. The Fund acknowledges that Custodian and its suppliers retain and have title and exclusive proprietary rights to the Software, including any trade secrets or other ideas, concepts, know-how, methodologies, or information incorporated therein and the exclusive rights to any copyrights, trademarks and patents (including registrations and applications for registration of either), or other statutory or legal protections available in respect thereof. The Fund further acknowledges that all or a part of the Software may be copyrighted or trademarked (or a registration or claim made therefor) by Custodian or its suppliers. The Fund shall not take any action with respect tot the Software inconsistent with the foregoing acknowledgement, nor shall the Fund attempt to decompile, reverse engineer or modify the Software. The Fund may not xxx, sell, lease or provide, directly or indirectly, any of the Software of any portion thereof to any other person or entity without Custodian’s prior written consent. The Fund may not remove any statutory copyright notice or other notice included in the Software or on any media containing the Software. The Fund shall reproduce any such notice on any reproduction of the Software and shall add any statutory copyright notice or other notice to the Software or media upon Custodian’s request.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Manufacturing Technology Transfer With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • 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.

  • No Infringement of Third Party IP Rights Neither the Company nor any Subsidiary is infringing, misappropriating or otherwise violating, or has ever infringed, misappropriated or otherwise violated, any Intellectual Property Right of any other Person. The conduct of the business of the Company and its Subsidiaries has not infringed, misappropriated or otherwise violated any Intellectual Property Right of any other Person or constituted unfair competition or trade practices under the laws of any jurisdiction, and when conducted in substantially the same manner after the date of this Agreement will not infringe, misappropriate or otherwise violate any Intellectual Property Right of any other Person, including patents issuing on patent applications filed as of the date of this Agreement, or constitute unfair competition or trade practices under the laws of any jurisdiction (except to the extent due to Company’s ownership by Buyer or its affiliates). Without limiting the generality of the foregoing: (i) no product or service ever produced, distributed, used, provided or sold by or on behalf of the Company or any Subsidiary has ever infringed, misappropriated or otherwise violated any Intellectual Property Right of any other Person; (ii) no infringement, misappropriation or similar Action, or any Action alleging unfair competition or trade practices, is pending or has been threatened against the Company or any Subsidiary or against any other Person who may be entitled to be indemnified, defended, held harmless or reimbursed by the Company or any Subsidiary with respect to such Action; (iii) neither the Company nor any Subsidiary has received any notice or other communication (in writing or otherwise) relating to any actual, alleged or suspected infringement, misappropriation or violation of any Intellectual Property Right of another Person, or any actual, alleged or suspected engagement by the Company or any Subsidiary in unfair competition or trade practices under the laws of any jurisdiction; (iv) neither the Company nor any Subsidiary is bound by any Contract to indemnify, defend, hold harmless or reimburse any other Person with respect to any infringement, misappropriation or violation of any Intellectual Property Right (other than as set forth in Section 3.13(h) of the Disclosure Schedule); and (v) no Action involving any Licensed IP is pending or has been threatened, except for any such Action that, if adversely determined, would not adversely affect (A) the use or exploitation of such Licensed IP by the Company or any Subsidiary or (B) the distribution, hosting, delivery or sale of any Company Product. Neither the Company nor any Subsidiary has ever sought or obtained an opinion of counsel regarding any possible infringement, misappropriation, violation or unlawful use of another Person’s Intellectual Property Rights or the validity or enforceability of another Person’s Intellectual Property Rights.

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