Kasan Insight :: 과학, 기술 그리고 법

- 제약/화학/바이오 분야의 실용적 법률정보와 해결방안

16. GRANT OF RIGHTS. 

16.1 License Grants from CyDex to Hospira.

(a) Licensed Patents. Subject to the terms and conditions of this Agreement, CyDex hereby grants to Hospira a world-wide, nontransferable (except with respect to the assignment provision in Section 12.13), sublicensable, [*] during the Term under the Licensed Patents, solely to [*] the Finished Product in the Territory. For the duration of the Exclusivity Period, such license shall be exclusive even as to CyDex and its Affiliates; after the expiration of the Exclusivity Period, such license shall be non-exclusive. Notwithstanding the foregoing, to the extent that any Licensed Patents are licensed to CyDex or its Affiliates by a Third Party on a non-exclusive basis, Hospira acknowledges that the license granted to Hospira in this Section 2.1(a) to any such Licensed Patents shall during the Exclusivity Period be exclusive as to CyDex and its Affiliates and non-exclusive as to any Third Party licensee who obtained a license to any such Licensed Patents other than from CyDex or any of its Affiliates or any of their sublicensees. Hospira may not sublicense the Licensed Patents, except as expressly set forth in Section 2.2 and Section 2.3 below.

(b) Other Intellectual Property License. Subject to the terms and conditions of this Agreement, CyDex hereby grants to Hospira a world-wide, nontransferable (except with respect to the assignment provision in Section 12.13), sublicensable, [*] during the Term to all other CyDex Intellectual Property, including, without limitation, to CyDex’s rights in and to the Captisol Data Package, solely to [*] the Finished Product in the Territory. For the duration of the Exclusivity Period, such license shall be exclusive even as to CyDex and its Affiliates; after the expiration of the Exclusivity Period, such license shall be non-exclusive. Notwithstanding the foregoing, to the extent that any contents of the Captisol Data Package are licensed to CyDex or its Affiliates by a Third Party on a non-exclusive basis, the license granted to Hospira in this Section 2.1(b) to any such contents of the Captisol Data Package shall during the Exclusivity Period be exclusive as to CyDex and its Affiliates and non-exclusive as to any Third Party licensee who obtained a license to any such contents of the Captisol Data Package other than from CyDex or any of its Affiliates or any of their sublicensees. Hospira may not sublicense its rights to the Captisol Data Package, except as expressly set forth in Section 2.2 and Section 2.3 below.

(c) Scope of Licenses. CyDex grants no licenses or rights to use other than as expressly set forth herein. Hospira agrees not to use Captisol supplied hereunder other than as expressly set forth herein. Unless otherwise expressly provided in this Agreement, CyDex grants no rights to Hospira to manufacture, import, sell or offer for sale bulk Captisol.

(d) Bankruptcy Code. All rights and licenses granted under or pursuant to this Agreement by CyDex to Hospira are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101 of the Bankruptcy Code. The parties agree that Hospira, as a licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code.

(e) Disclosure of and Compliance with Licenses. Exhibit C sets forth a list of all licenses under which, pursuant to Section 2.1, Hospira is granted a sub-license by CyDex and/or its Affiliates. If CyDex or any of its Affiliates enters into any future license agreements under which, pursuant to Section 2.1, Hospira is granted a sub-license by CyDex and/or its Affiliates, CyDex will promptly disclose such license agreements to Hospira. CyDex shall comply and shall cause its Affiliates to comply with the provisions of all such licenses, including without limitation all such licensing provisions of the [*].

16.2 Sublicensing. Hospira shall have the right to grant sublicenses to any Third Party (collectively “Sublicensees”) under the licenses granted to Hospira pursuant to Section 2.1; [*]

16.3 Contracting. Hospira and any of its Affiliates may manufacture the Finished Product (but, except as otherwise expressly provided in this Agreement, not the bulk Captisol if the manufacture of bulk Captisol would be Covered by a Licensed Patent for which there is a Valid Claim or if such manufacture would require a license to CyDex Intellectual Property) or contract the manufacture of the Finished Product (but, except as otherwise expressly provided in this Agreement, not the manufacture of bulk Captisol if the manufacture of bulk Captisol would be Covered by a Licensed Patent for which there is a Valid Claim or if such manufacture would require a license to CyDex Intellectual Property) with any Third Party manufacturers selected by Hospira (each a “Contract Manufacturer”). To the extent necessary to engage a Contract Manufacturer for the Finished Product, Hospira shall be permitted under this Agreement to grant any such Contract Manufacturer a sublicense under the licenses granted to Hospira pursuant to Section 2.1; provided that Hospira shall comply with the requirements of Section 2.2. For the sake of clarity, Hospira, its Affiliates and any of their Contract Manufacturers may at all times manufacture [***] provided that the manufacture of such [*] is not Covered by a Licensed Patent for which there is a Valid Claim and such manufacture would not require a license to CyDex Intellectual Property.

16.4 Negative Covenants by CyDex.

(a) During the Exclusivity Period, neither CyDex nor any of its Affiliates shall directly themselves, or grant any Third Party any right or license to any of the CyDex Intellectual Property to research, develop, modify, make, have made, import, export, use, promote, market, distribute, package, offer for sale, sell, or otherwise commercially exploit the Finished Product or any Competing Product.

(b) During the Exclusivity Period, neither CyDex nor any of its Affiliates shall themselves nor provide any Third Party any assistance whatsoever to [*].

(c) During the Exclusivity Period, neither CyDex nor any of its Affiliates shall supply Captisol to any Third Party other than a Hospira designee to utilize Captisol to [*] the Finished Product or any Competing Product. If during the Exclusivity Period any such Third Party, or any other Third Party that acquires any Captisol, commences to [*] the Finished Product or any Competing Product, CyDex must immediately cease and cause its Affiliates and any other Third Parties to immediately cease supplying Captisol to the offending Third Party for the duration of the Exclusivity Period or until (if sooner) assurances reasonably satisfactory to Hospira that the infringing use has ended and will not resume have been obtained.

16.6 Negative Covenants by Hospira.

(a) Notwithstanding anything to the contrary in this Agreement, Hospira agrees not to [*] any Finished Product or Captisol in [*].

(b) Hospira covenants and agrees that it and its Affiliates, Sublicensees and Contract Manufacturers shall not re-sell any Captisol purchased pursuant to this Agreement (except as incorporated into the Finished Product), and shall not use any Captisol purchased pursuant to this Agreement except in connection with the Finished Product.

(c) Notwithstanding anything to the contrary herein, Hospira shall only have a license or right to use or reference CyDex’s DMF/CEP in conjunction with Captisol supplied by CyDex or manufactured by Hospira or any Hospira designee pursuant to Section 3.6.

KASAN_제약회사의 신제품 라이선스 및 생산공급 계약서 중 독점 LICENSE 부여 및 독점권 보장 계약조항 샘플.pdf

22. REPRESENTATIONS AND WARRANTIES. 

22.1 Mutual Representations and Warranties. Each party represents and warrants to the other (as of the Effective Date) as follows:

(a) it is a corporation duly organized and validly existing under the laws of the state or country of its incorporation;

(b) it has the complete and unrestricted power and right to enter into this Agreement and to perform its obligations hereunder;

(c) this Agreement has been duly authorized, executed and delivered by such party and constitutes a legal, valid and binding obligation of such party enforceable against such party in accordance with its terms except as enforceability may be limited by applicable bankruptcy, insolvency, reorganization, receivership, moratorium, fraudulent transfer, or other similar laws affecting the rights and remedies of creditors generally and by general principles of equity;

(d) the execution, delivery and performance of this Agreement by such party does not conflict with any agreement, instrument or understanding, oral or written, to which such party is a party or by which such party may be bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having authority over such party; without limiting the warranties in this Section,

(e) all consents, approvals and authorizations from all governmental authorities or other third parties required to be obtained by such party in connection with the execution and delivery of this Agreement have been obtained;

(f) no person or entity has or will have, as a result of the transactions contemplated by this Agreement, any right, interest or valid claim against or upon such party for any commission, fee or other compensation as a finder or broker because of any act by such party or its agents; and

(g) it has not entered into any agreement with any Third Party that is in conflict with the rights granted to the other party pursuant to this Agreement;

(h) there are no suits, claims, or proceedings pending, or to its best knowledge and belief, after due inquiry, threatened against it or any of its Affiliates in any court or by or before any governmental body or agency which would affect its ability to perform its obligations under this Agreement.

22.2 Captisol Warranties. CyDex warrants that the Captisol delivered hereunder shall:

(a) at the time of delivery and until the applicable Captisol expiration date be in compliance with and meet any and all specifications as set out in the DMF/CEP as referenced in the Regulatory Filings and Regulatory Approvals and in compliance with Good Manufacturing Practices.

(b) at the time of delivery and until the applicable Captisol expiration date be free from defects in materials and manufacture and shall continue to conform to the Specifications.

(c) have been manufactured in accordance with the DMF/CEP and in accordance with all applicable statutes, ordinances and regulations of the FDA and any other then applicable Major-Market national, supra-national and United States Regulatory Authorities, including without limitation, the Act and Good Manufacturing Practices.

(d) not, when delivered, be adulterated or misbranded within the meaning of the Act or any similar laws or regulations of applicable Major-Market national, supra-national and United States Regulatory Authorities or be an article which may not, under provisions of any applicable Major-Market national, supra-national or United States law, be sold by CyDex to Hospira.

(e) at the time of delivery have at least [*]% of its original shelf life.

(f) at the time of delivery be free and clear of all liens, claims, charges and encumbrances and that CyDex shall have title to the Captisol.

22.4 Reference Standard Warranty. CyDex further warrants that any reference standard material delivered to Hospira pursuant to this Agreement shall meet the specifications outlined in the applicable Certificate of Analysis provided pursuant to Section 3.7.

22.6 No Debarred Service Providers. CyDex represents and warrants that to neither CyDex, nor any of its Affiliates, employees or agents working on Hospira’s behalf, has ever been, is currently, or is the subject of a proceeding that could lead to that party becoming, as applicable, a Debarred Entity or Individual. CyDex further covenants, represents and warrants that if, during the Term of this Agreement, it, or any of its Affiliates, employees or agents working on Hospira’s behalf, becomes or is the subject of any FDA investigation or debarment proceeding that could lead to that party becoming, as applicable, a Debarred Entity or Individual, CyDex shall immediately notify Hospira, and Hospira shall have the right to immediately terminate this Agreement. This provision shall survive termination or expiration of this Agreement. For purposes of this provision, the following definitions shall apply:

(a) A “Debarred Individual” is an individual who has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) from providing services in any capacity to a person that has an approved or pending drug Captisol application.

(b) A “Debarred Entity” is a corporation, partnership or association that has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) from submitting or assisting in the submission of any abbreviated drug application, or a subsidiary or Affiliate of a Debarred Entity.

22.7 No-Conflict by CyDex. CyDex also represents and warrants that the execution, delivery and performance of this Agreement does not conflict with any of the [*]; and that CyDex has the right to grant Hospira the licenses set forth herein to all CyDex Intellectual Property, including, without limitation, the Licensed Patents.

22.8 Disclaimer. THE WARRANTIES SET FORTH IN THIS SECTION 8 ARE PROVIDED IN LIEU OF, AND EACH PARTY HEREBY DISCLAIMS, ALL OTHER WARRANTIES, EXPRESS AND IMPLIED, RELATING TO THE SUBJECT MATTER OF THIS AGREEMENT, CAPTISOL, THE LICENSED PATENTS OR THE CAPTISOL DATA PACKAGE, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NON-INFRINGEMENT OF THIRD PARTY RIGHTS.

KASAN_제약회사 라이선스 및 생산공급 계약서 중에서 진술 및 보증조항 REPRESENTATIONS AND WARRANTIES 계약조항 샘플.pdf