Licensee CMO Engagement Sample Clauses

Licensee CMO Engagement. If either Party will satisfy any obligations to Manufacture and supply the TAK-385 Licensed Compound and TAK-385 Licensed Products under this Agreement through the engagement of a CMO, such CMO (a) shall be comparable in expense to other CMOs in the industry performing similar manufacturing work and (b) will have been (at the time of engagement) inspected by the FDA and the applicable Regulatory Authority in the EU or by a Qualified Person in the EU authorized to sign the required certificate (as required by Clinical Directive 2001/20/EC and Annex 13 to the European GMP Guide) and, in any such case, found to be in material compliance with all Applicable Laws, including GMP. [***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
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Related to Licensee CMO Engagement

  • Licensee Licensee represents and warrants that:

  • Licensor any Person from whom a Grantor obtains the right to use any Intellectual Property. Lien: any Person’s interest in Property securing an obligation owed to, or a claim by, such Person, whether such interest is based on common law, statute or contract, including liens, security interests, pledges, hypothecations, statutory trusts, reservations, exceptions, encroachments, easements, rights-of-way, covenants, conditions, restrictions, leases, and other title exceptions and encumbrances affecting Property. Lien Waiver: an agreement, in form and substance satisfactory to Collateral Agent, by which (a) for any material Collateral located on leased premises, the lessor waives or subordinates any Lien it may have on the Collateral, and agrees to permit Collateral Agent to enter upon the premises and remove the Collateral or to use the premises to store or dispose of the Collateral; (b) for any Collateral held by a warehouseman, processor, shipper, customs broker or freight forwarder, such Person waives or subordinates any Lien it may have on the Collateral, agrees to hold any Documents in its possession relating to the Collateral as agent for Collateral Agent, and agrees to deliver the Collateral to Collateral Agent upon request; (c) for any Collateral held by a repairman, mechanic or bailee, such Person acknowledges Collateral Agent’s Lien, waives or subordinates any Lien it may have on the Collateral, and agrees to deliver the Collateral to Collateral Agent upon request; and (d) for any Collateral subject to a Licensor’s Intellectual Property rights, the Licensor grants to Collateral Agent the right, vis-à-vis such Licensor, to enforce Collateral Agent’s Liens with respect to the Collateral, including the right to dispose of it with the benefit of the Intellectual Property, whether or not a default exists under any applicable License.

  • 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.

  • Sublicensee The term “Sublicensee” shall mean any third party to whom Licensee grants a sublicense or similar rights with respect to the rights conferred upon Licensee under this Agreement, as contemplated by Section 2.3. In addition, “Sublicensee” shall include any and all further third party Sublicensees that may be permitted under Section 2.3.

  • Software License Agreement McDATA agrees that all Licensed Software will be distributed to Customers subject to a Software License Agreement (including warranty statement), along with a McDATA Manual, in a manner which is (a) no less protective of BROCADE's Intellectual Property Rights in the Licensed Software than the form attached hereto as Exhibit D, and (b) legally enforceable in the jurisdictions in which the Licensed Software, as incorporated into the McDATA Products, is distributed.

  • 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.

  • Research License Following Selection of each CGI Antigen (or exercise of a Buy-In Right for each CGI Antigen) and subject to the terms and conditions of this Agreement, ABX agrees to grant, and hereby grants, to CGI a nonexclusive sublicense under the Licensed Technology to develop, make, have made, use, import or export or otherwise transfer physical possession of (but not to sell, lease, offer to sell or lease, or otherwise transfer title to) Covered Products related to such CGI Antigen and cells that express or secrete Antibodies to such CGI Antigen, in each case solely for purposes relating to or in connection with research or development (i) of Covered Products for use in the field of Gene Therapy or (ii) involving Genetic Material when used with viral or nonviral gene transfer systems. CGI shall have the right to sublicense the rights granted under this Section 2.5 upon the approval of ABX, which approval shall not be unreasonably withheld. In the event that ABX refuses to approve such a sublicense, ABX shall, to the extent that ABX has the right to do so, grant at CGI's request a nonexclusive sublicense of such rights directly to a non-Affiliate third party designated by CGI on terms and conditions substantially identical to the applicable terms and conditions of this Agreement. The sublicense granted by ABX under this Section 2.5 with respect to a CGI Antigen (and the further sublicenses, if any, granted by CGI under this Section 2.5 with respect to such CGI Antigen) shall terminate at such time as (A) CGI sends ABX an Abandonment Notice pursuant to Section 2.4.1 above regarding such CGI Antigen or (B) CGI enters into a CGI Product Sublicense related to such CGI Antigen; provided, however, that termination of a sublicense under this Section 2.5 with respect to a CGI Antigen pursuant to (B) above shall not affect the duration or survival of a grant of similar rights or sublicense under the CGI Product Sublicense with respect to such CGI Antigen, which rights or sublicense shall terminate or expire only in accordance with the terms of such CGI Product Sublicense. In the event that ABX enters into a Product Sublicense with respect to a CGI Antigen and CGI has not within six (6) months thereafter entered into a CGI Product Sublicense with respect to such CGI Antigen, the sublicense granted under this Section 2.5 with respect to such CGI Antigen shall terminate. It is understood and agreed that (x) as to ABX-Controlled Rights, the grant of rights under this Section 2.5 shall be subject to and limited in all respects by the terms of the applicable ABX In-License(s) pursuant to which such ABX-Controlled Rights were granted to ABX and (y) the rights and sublicenses granted to CGI under this Section 2.5 or any other provision of this Agreement shall be subject in all respects to the GenPharm Cross License.

  • Sublicense Fees Licensee will pay Sublicense Fees indicated in Section 3.1(e) of the Patent & Technology License Agreement on or before the Quarterly Payment Deadline for the Contract Quarter.

  • Research Program Term The Research Program shall be conducted during the period of five years commencing as of the Agreement Date ("Research Program Term"). Upon not later than seventy-five (75) days' prior written notice JT may, in its sole judgment, terminate the Research Program at the end of the third (3/rd/) year and fourth (4/th/) year of the Research Program. The RMC may terminate the Research Program any time during the Research Program Term if it unanimously determines the Research Program is no longer scientifically useful or that all potential Products would not be commercially viable. In case of such an early termination by JT or the RMC, JT shall be exempt from any payment(s) under Section 10(a) that would have become due and payable after the effective date of such early termination. Following any termination of the Research Program (i) that occurs simultaneously with the termination of this Agreement in accordance with Section 13 (i.e., no compound or Lead Compound has been designated previously a Collaboration Lead Compound in accordance with Section 3(b) and no Independent Lead Compound is being developed in accordance with Section 3(m)) or (ii) that is followed at some future date by the termination by JT of Development or co-promotion of any Collaboration Lead Compound and/or Product pursuant to Sections 3(l) or 5(c), respectively, or development of an Independent Lead Compound in accordance with Section 3(m) (A) any licenses granted by Tularik to JT will terminate, (B) JT will grant to Tularik an exclusive, sublicensable, worldwide license, to make, use and sell compounds, Collaboration Lead Compounds or Products under JT's interest in Program Patents and Program Know-How and (C) under the terms and conditions to be separately agreed, JT will also grant to Tularik a nonexclusive, sublicensable, worldwide license under any JT Patent Rights and Know-How to the extent necessary to practice the license granted under the Program Patents and Program Know-How in (B) (including, with respect to compounds, a limited number of JT's library compounds approved by JT); provided, however, that in the event the Research Program terminates but the Agreement has not terminated with respect to designated Collaboration Lead Compounds, Independent Lead Compounds and/or Products as provided in Section 2(g)(ii), Sections 2(g)(A), (B) and (C) shall apply only to those compounds, Collaboration Lead Compounds, Independent Lead Compounds and Products for which Development or co-promotion shall have been terminated and/or to those compounds or Lead Compounds that have not been designated previously a Collaboration Lead Compound in accordance with Section 3(b) or an Independent Lead Compound in accordance with Section 3(m); provided further that in the event that JT elects to pursue a Discontinued Compound or a Non-Proposed Compound on or before the first anniversary of the expiration or termination of the Research Program Term pursuant to Section 3(b)(iii) or 3(b)(iv), respectively, Sections 2(g)(A), (B) and (C) shall not apply to such Discontinued Compound or Non-Proposed Compound until such time as JT shall have terminated the Development or co-promotion of such Discontinued Compound or Non- Proposed Compound. Tularik will then be free to pursue clinical development and registration of such compounds, Lead Compounds and/or Products without obligation to JT except as provided in Section 4(f) or Section 5(c), as appropriate.

  • Software License ICS will grant the Business Manager a non-exclusive and royalty-free right and license to use and copy software owned by ICS and to use certain third party software according to the terms of the applicable third party licenses to ICS, all in connection with the Business Manager’s obligations under the Agreement. ICS will provide the Business Manager with all upgrades to the licensed software.

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