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의료기기 신고허가 대상은 아니지만 의료기기 관련 제품의 판매계약서 샘플입니다. 피부관리기기로 의료기기 판매계약과는 여러 구별 포인트가 있습니다. 알러간에 인수된 미국 회사에서 사용한 독점 판매계약서를 참고로 첨부합니다.
샘플 계약서는 언제나 통용될 수 있는 것이 아니지만, 실무자에게 유용한 참고자료가 될 것입니다. 영문계약서를 참고로 첨부합니다.
첨부: 의료기기 아닌 피부관리기기 독점판매계약_영문계약서 샘플
KASAN_비의료기기, 피부관리 기기 판매계약, 총판계약, Distribution Agreement - 영문계약서 샘플 - [자문작성신속저비용].pdf
의료기기주변_피부관리기기_distribution agreement_sample.pdf
10. TERMINATION
10.1 Expiration. Subject to this Section 10 below, this Agreement shall expire, on a Licensed Product-by-Licensed Product and country-by-country basis, on the date on which Kite, its Affiliates and sublicensees permanently cease to research, develop, sell and commercialize the Licensed Product in such country (the “Term”).
10.2 Termination for Convenience. The Licensee Kite may terminate this Agreement, in its sole discretion, upon thirty (30) days prior written notice to the Licensor Cabaret and Dr. Eshhar.
10.3 Termination for Cause. Except as otherwise provided in Section 12, each party may terminate this Agreement upon or after the breach of any material provision of this Agreement by the other party if the other party has not cured such breach within sixty (60) days (or such longer period as such party may reasonably agree if said breach is incapable of cure within such sixty (60) days) after receipt of express written notice thereof by such party.
10.4 Insolvency. This Agreement may be terminated by the Licensor Cabaret in the event of an Insolvency Event occurring in relation to the Licensee Kite, by giving a notice of termination to Kite. The termination shall take effect upon delivery of the notice of termination by Cabaret. “Insolvency Event” shall mean that, with respect to Kite, any of the following occurs: (i) Kite makes any arrangement or composition with or any assignment for the benefit of its creditors generally; (ii) a petition is presented that is not dismissed within 120 days or a court order is made or a resolution is passed for the winding up of Kite or for the making of an administration order or for the appointment of a provisional liquidator or a judicial factor or similar officer in relation to Kite; (iii) an encumbrancer takes possession of or a trustee, receiver, liquidator, provisional liquidator, administrator, manager ad interim, administrative receiver, judicial factor or similar officer is appointed, in each case for all or substantially all of Kite’s intellectual property rights and such appointment materially prejudices Cabaret’s rights under this Agreement; or (iv) Kite does, or suffers to be done in relation to it, any analogous action or proceeding in any jurisdiction anywhere in the world (including without limitation any actions or proceedings relating to bankruptcy law of any nature in the United States of America).
10.5 Effect of Expiration or Termination. Expiration or termination of this Agreement shall not relieve the parties of any obligation accruing prior to such expiration or termination, and the provisions of Sections 5.2, 8, 10.5, 10.6, 11 and 13 shall survive the expiration or termination of this Agreement. Upon any termination of this Agreement, all licenses granted herein shall terminate, nevertheless, Cabaret shall grant a direct license to any Sublicensee of Kite hereunder having the same scope as such sublicense and on terms and conditions no less favorable to such Sublicensee than the terms and conditions of this Agreement, provided that such Sublicensee is not in default of any applicable obligations under this Agreement and agrees in writing to be bound by the terms and conditions of such direct license.
10.6 Termination Fee. In the event that Kite terminates this Agreement termination for convenience under Section 10.2 prior to the third (3rd) anniversary of the Effective Date, Kite shall pay to Cabaret a termination fee in an amount equal to US$500,000 within thirty (30) days of such termination.
10. REPRESENTATIONS, WARRANTIES, AND COVENANTS.
10.1 Mutual Representations and Warranties. Licensor and Licensee (each, a “Representing Party”) each hereby represents and warrants to each other, as of the Effective Date and except as otherwise set forth in Schedule 10.2 (in the case of Licensor) and Schedule 10.3 (the case of Licensee), that:
(a) such Representing Party is a corporation or limited liability company, as applicable, duly organized and subsisting under the laws of its jurisdiction of organization;
(b) such Representing Party has the power, authority, and legal right, and is free, to enter into this Agreement on behalf of itself and its Affiliates and to perform its respective obligations hereunder and to cause its Affiliates to perform their respective obligations hereunder;
(c) such Representing Party has the power, authority, and legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as it is contemplated to be conducted by this Agreement;
(d) this Agreement constitutes a legal, valid, and binding obligation of such Representing Party and is enforceable against it in accordance with its terms, subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered a proceeding at law or equity;
(e) the execution and delivery of this Agreement and the performance of such Representing Party’s and its Affiliates’ obligations hereunder (i) have been duly authorized and approved by all necessary action by such Representing Party, and all necessary consents, approvals, and authorizations of all Regulatory Authorities and other Third Parties required to be obtained by such Representing Party in connection with the execution and delivery of this Agreement and the performance of its obligations hereunder have been obtained; (ii) do not conflict with or violate any requirement of Applicable Laws or any provision of the articles of incorporation, bylaws, limited partnership agreement, or any similar instrument of such Representing Party, as applicable, in any material way; and (iii) do not, and will not, conflict with or otherwise interfere with in such a manner as to result in a violation, breach, or default under or require any consent that has not been obtained under any contract between such Representing Party and any Third Party;
(f) there are no, and shall be no, liens, conveyances, mortgages, assignments, encumbrances, or other agreements that would prevent or impair such Representing Party’s or any of its Affiliates’ full and complete exercise of the terms and conditions of the Agreement;
(g) such Representing Party and its Affiliates shall at all times comply with all Applicable Laws relating or pertaining to their obligations under the Agreement;
(h) with respect to the services provided hereunder to the other Party, its Affiliates, and their respective employees, officers, contractors and agents who perform such services have the experience, capability, and resources to efficiently and skillfully perform the services, and shall perform, where applicable, all such services in a professional and workmanlike manner and in accordance with the generally accepted then-current standards, forms, procedures, and techniques established from time to time by the industry;
(i) all of such Representing Party’s employees, officers, contractors, and consultants have executed agreements requiring assignment to such Representing Party of all inventions created by such persons in the course of their employment by such Representing Party and obligating each such employee, officer, contractor, and consultant to maintain and safeguard the confidentiality of (i) any information that is confidential to such Representing Party or (ii) any information that is confidential to any other Person and that such Representing Party is obligated to maintain and safeguard as confidential; and
(j) neither such Representing Party, nor any of its employees, officers, subcontractors, or consultants who have rendered or will render services relating to the Product: (i) has ever been debarred or is subject or debarment or convicted of a crime for which an entity or person could be debarred under 21 U.S.C. Section 335a or (ii) has ever been under indictment for a crime for which a person or entity could be debarred under said Section 335a.
10.2 Additional Representations, Warranties, and Covenants of Licensor. Licensor hereby represents, warrants, and covenants to Licensee, as of the Effective Date and except as otherwise set forth in Schedule 10.2, that:
(a) Licensor is entitled to grant the rights and licenses purported to be granted to Licensee under this Agreement, and to assign the rights purported to be assigned to Licensee under this Agreement, and is not currently bound by any agreement with any Third Party, or by any outstanding order, judgment, or decree of any court or administrative agency, that restricts it from granting to Licensee the rights, licenses and sublicenses purported to be so granted in this Agreement;
(b) Licensor is the sole and exclusive owner of all right, title, and interest, in, to, and under the Licensed Rights and has the right under the Licensed CPEX Patent Rights and the Licensed Reprise Patent Rights to grant the sublicenses thereunder in accordance with Section 2.2;
(c) the Licensed Rights are free and clear of any liens, charges, encumbrances, or judgments, and Licensor has sufficient rights to grant the licenses and rights purported to be granted herein, free and clear of any security interests, claims, encumbrances, or charges of any kind;
(d) Licensor has not granted, and will not grant during the term of this Agreement, any right, option, license, or interest in or to any of the Licensed Rights that is in conflict with the rights assigned or granted to Licensee under this Agreement;
(e) there is no legal, administrative, arbitration, or other proceeding, suit, claim, or action of any nature, judgment, decree, decision, injunction, writ, or order pending, or to Licensor’s knowledge threatened by, against or involving Licensor, regarding the Licensed Rights, whether at law or in equity, before or by any Third Party, and Licensor has not received any written communications alleging that it has violated, through the manufacture, Development, import, or other exploitation of the Product, any intellectual property rights of any Third Party;
(f) to Licensor’s knowledge:
(i) the patents in the issued Licensed Serenity Patent Rights, the Licensed CPEX Patent Rights, and the Licensed Reprise Patent Rights are valid and enforceable; and
(ii) no Third Party has asserted that any of the Licensed Rights or the Sublicensed Rights is invalid or unenforceable;
(g) all applications, registrations, maintenance and renewal fees due in respect of any of the Licensed Serenity Patent Rights and, to Licensor’s knowledge, the Licensed Reprise Patent Rights and the Licensed CPEX Patent Rights, have been paid and all documents and certificates required to be filed with the relevant agencies for the purpose of maintaining such Licensed Serenity Patent Rights, and to Licensor’s knowledge, the Licensed Reprise Patent Rights and Licensed CPEX Patent Rights have been filed;
(h) none of the Licensed Serenity Patent Rights, the Licensed Serenity Know-How and, to Licensor’s knowledge, none of the Licensed CPEX Patent Rights and the Licensed Reprise Patent Rights were developed with funding from any Governmental Authority such that any Governmental Authority has any march in rights or other rights to use the Licensed Serenity Patent Rights, the License Serenity Know-How, the Licensed Reprise Patent Rights, or the Licensed CPEX Patent Rights;
(i) to Licensor’s knowledge, no Third Party has infringed or misappropriated any of the Licensed Rights or the Sublicensed Rights;
(j) all inventors of any inventions included within the Licensed Serenity Patent Rights and, to the knowledge of Licensor, the Licensed CPEX Patent Rights and the Licensed Reprise Patent Rights have assigned their entire right, title, and interest in and to such inventions and the corresponding patents and patent applications to Licensor, Reprise, or CPEX, as applicable, and have been listed as inventors in the Licensed Serenity Patent Rights, the Licensed CPEX Patent Rights, and the Licensed Reprise Patent Rights, as applicable;
(k) no agreements that Licensor or its Affiliates may have with any Third Party provide such Third Party with any rights of first offer, rights of first refusal, or any other rights to make, have made, use, conduct Clinical Studies for, sell, offer for sale, have sold, import, export, or otherwise Exploit the Product in the Field in the Territory or the right to use the Licensed Rights or the Sublicensed Rights in connection with the Exploitation of the Product in the Field in the Territory; and Licensor has received no notice from a Third Party of any suit, action, proceeding, or arbitration pending or threatened against it that the proposed terms and conditions of this Agreement, and the Parties’ performance in accordance therewith, do or shall conflict or interfere with in a manner resulting in a breach or default under, or other violation of, any agreements that Licensor or its Affiliates may have with any Third Party;
to Licensor’s knowledge, (i) each of the CPEX License Agreement and the Reprise License Agreement is valid and enforceable in accordance with its terms, is in full force and effect, and there are no approvals or consents required to make it effective, (ii) Licensor has supplied Licensee with a true and correct copy of the CPEX License Agreement and the Reprise License Agreement , together with all amendments, waivers, or other changes thereto, (iii) Licensor has performed all material obligations required to be performed by it in connection with the CPEX License Agreement and the Reprise License Agreement, (iv) Licensor shall not materially breach and is not in material breach of the CPEX License Agreement or the Reprise License Agreement, (v) Licensor is not in receipt of any claim of default, cure notice, or show cause notice under the CPEX License Agreement or the Reprise License Agreement, and (vi) there is no current material breach or anticipated material breach by any other party to the CPEX License Agreement or the Reprise License Agreement;
(m)
(i) Licensor is the named sponsor of the First Approved NDA for the Product; and (ii) with respect to all Regulatory Documentation to obtain Regulatory Approvals for the Product in the Field: (A) the data, information and/or all other documents in Licensor’s or its Affiliates submissions were, are and shall be free from fraud or material falsity, and neither Licensor nor its Affiliates has made any material misrepresentation or omission in connection with such data; (B) the Regulatory Approvals have not been and will not be obtained either through bribery or the payment of illegal gratuities by Licensor; (C) the data, information and/or all other documents in Licensor’s or its Affiliates’ submissions are, were and shall be accurate and reliable for purposes of supporting approval of the submissions; and (D) the Regulatory Approvals shall be obtained without illegal or unethical behavior of any kind by Licensor or its Affiliates; provided that Licensor shall not be deemed to be in breach of this Section 10.2(m) if the violation of this Section 10.2(m) results from the action or omission of Licensee of Licensee’s Affiliates, Sublicensees, or contractors (other than Licensor);
(n) Licensor believes in good faith, based on the information set forth in Schedule 10.2(n), that FDA will consider amending or supplementing the First Approved NDA (or the related IND) in the manner described in Schedule 10.2(n); provided, however, that Licensor cannot assure that FDA will approve such amendment or supplement.
(o) except as expressly permitted hereunder, Licensor agrees not to, and agrees to cause its Affiliates and Sublicensees not to (i) assign, transfer, convey or otherwise encumber any right, title or interest in or to the Licensed Rights, the Sublicensed Rights, or any Regulatory Approvals and Documentation in respect of the Product, (ii) grant in any manner any license or other right, title or interest in or to any of the Licensed Rights, the Sublicensed Rights, or the Regulatory Approvals and Documentation in respect of the Product, or (iii) agree to or otherwise become bound by any covenant not to sue for any infringement, misuse or other action or inaction with respect to any of the Licensed Rights, the Sublicensed Rights, or the Regulatory Approvals and Documentation in respect of the Product; and
(p) other than the CPEX License Agreement, the Reprise License Agreement, the Renaissance Supply Agreements, and the other Third Party Supply Agreements, Licensor and/or its Affiliates have not entered into any agreements with any Third Party, pursuant to which any Third Party has granted to Licensor, or Licensor has granted to any Third Party, any rights to licenses to, in or under any of the Licensed Rights or the Sublicensed Rights or other intellectual property rights that relate to the Product, or relating to the manufacture of the Product.
10.3 Additional Representations, Warranties, and Covenants of Licensee. Licensee hereby represents, warrants, and covenants to Licensor, as of the Effective Date and except as otherwise stated in Schedule 10.3, that:
(a) if, during the term of this Agreement Licensee has reason to believe that it or any of its employees, officers, subcontractors, or consultants rendering services relating to the Product: (i) is or will be debarred or convicted of a crime under 21 U.S.C. Section 335a, or (ii) is or will be under indictment under said Section 335a, then Licensee shall immediately notify Licensor in writing;
(b) as of the Effective Date, there is no legal, administrative, arbitration, or other proceeding, suit, claim, or action of any nature, judgment, decree, decision, injunction, writ, or order pending or, to the knowledge of Licensee’s senior management, threatened by, against Licensee regarding this Agreement, whether at law or in equity, before or by any Third Party; and Licensee shall provide notice of any of the foregoing to the extent it affects Licensee’s performance of its obligations under this Agreement;
(c) except for information provided by Licensor, its Affiliates or Sublicensees: (i) the data and information in Licensee’s submissions and modifications of Regulatory Documentation relating to the Product shall be free from fraud or material falsity; (ii) Regulatory Approvals for the Product hereafter obtained will not be obtained either through bribery or the payment of illegal gratuities by Licensee; (iii) the data and information in Licensee’s submissions and modifications of any Regulatory Documentation shall be accurate and reliable; and (iv) any such the Regulatory Approvals will be obtained without illegal or unethical behavior of any kind by Licensee; provided that Licensee shall not be deemed to be in breach of this Section 10.3(c) if the violation of this Section 10.3(c) results from the action or omission of Licensor or its Affiliates, Sublicensees (other than Licensee), or contractors; and
(d) except as expressly permitted hereunder, Licensee agrees not to, and agrees to cause its Affiliates and Sublicensees not to (i) assign, transfer, convey or otherwise encumber any right, title or interest in or to the Licensed Rights, the Sublicensed Rights, or any Regulatory Approvals and Documentation in respect of the Product, (ii) grant in any manner any license or other right, title or interest in or to any of the Licensed Rights, the Sublicensed Rights, or the Regulatory Approvals and Documentation in respect of the Product, (iii) agree to or otherwise become bound by any covenant not to sue for any infringement, misuse or other action or inaction with respect to any of the Licensed Rights, the Sublicensed Rights, or the Regulatory Approvals and Documentation in respect of the Product, or (iv) bring any action or proceeding or otherwise assert any claim under any Applicable Law in the event any licensee (or sublicensee or any entity or person acting on its behalf) initiates any proceeding or otherwise assert any claim in any court, administrative agency, or other forum with jurisdiction over such proceeding or claim, that any of the Licensed Rights or Sublicensed Rights are invalid, unenforceable, or not infringed, violated, or misappropriated. In the event that Licensee or any Affiliate or Sublicensee of Licensee initiates any proceeding or otherwise asserts any claim in violation of clause (iv) of this Section 10.3, and the result thereof is a final decision, ruling, holding, award, or other disposition to the effect that any of the Licensed Rights or Sublicensed Rights are valid, enforceable, or infringed, violated, or misappropriated, then each of the royalty rates set forth in the table in Section 8.3(a) will each be increased by [***] and the party initiating such proceeding or otherwise asserting such claim shall pay the attorneys’ fees and expenses incurred by Licensor in defending against such proceeding or claim.
10.4 Inaccuracies. Without limiting either Party’s rights and remedies at law, in equity or under this Agreement, if, at any point in time (not just at the times when the warranties are deemed granted), either Party becomes aware of any inaccuracies in the foregoing warranties and representations, such Party shall promptly notify the other Party of such inaccuracies, with a detailed written explanation.
KASAN_기술이전, 특허 라이선스 계약서에서 진술 및 보증조항 REPRESENTATIONS AND WARRANTIES 계약조항 샘플.pdf
사안의 개요 및 쟁점
(1) 외국회사 특허권자 vs 국내회사 특허라이선스 체결
(2) 특허발명 – 방법발명, 특허권자로부터 통상실시권 획득
(3) 통상실시권자, 국내회사의 요청으로 특허발명의 전용품 마찰교반용접기를 제작하여 통상실시권자에게 납품한 행위
(4) 쟁점 - 특허권의 간접침해 해당여부
법원 판단 – 간접침해 해당하지 않음
대법원 2017다290095 판결요지
특허법 제127조 제2호는 특허가 방법의 발명인 경우 그 방법의 실시에만 사용하는 물건을 생산․양도․대여 또는 수입하거나 그 물건의 양도 또는 대여의 청약을 하는 행위를 업으로서 하는 경우에는 특허권 또는 전용실시권을 침해한 것으로 본다고 규정하고 있다. 이러한 간접침해 제도는 어디까지나 특허권이 부당하게 확장되지 아니하는 범위에서 그 실효성을 확보하고자 하는 것이다(대법원 2015. 7. 23. 선고 2014다42110 판결 등 참조).
방법의 발명(이하 ‘방법발명’이라고 한다)에 관한 특허권자로부터 허락을 받은 실시권자가 제3자에게 그 방법의 실시에만 사용하는 물건(이하 ‘전용품’이라고 한다)의 제작을 의뢰하여 그로부터 전용품을 공급받아 방법발명을 실시하는 경우에 있어서
그러한 제3자의 전용품 생산․양도 등의 행위를 특허권의 간접침해로 인정하면, 실시권자의 실시권에 부당한 제약을 가하게 되고, 특허권이 부당하게 확장되는 결과를 초래한다.
또한, 특허권자는 실시권을 설정할 때 제3자로부터 전용품을 공급받아 방법발명을 실시할 것까지 예상하여 실시료를 책정하는 등의 방법으로 당해 특허권의 가치에 상응하는 이윤을 회수할 수 있으므로, 실시권자가 제3자로부터 전용품을 공급받는다고 하여 특허권자의 독점적 이익이 새롭게 침해된다고 보기도 어렵다.
따라서 방법발명에 관한 특허권자로부터 허락을 받은 실시권자가 제3자에게 전용품의 제작을 의뢰하여 그로부터 전용품을 공급받아 방법발명을 실시하는 경우에 있어서 그러한 제3자의 전용품 생산, 양도 등의 행위는 특허권의 간접침해에 해당한다고 볼 수 없다.
15. MISCELLANEOUS.
15.1 Agency. Neither Party is, nor shall be deemed to be, an employee, agent, co-venturer, or legal representative of the other Party for any purpose, except as expressly set forth herein. No Party shall be entitled to enter into any contracts in the name of, or on behalf of the other Parties, nor shall either Party be entitled to pledge the credit of the other Parties in any way or hold itself out as having the authority to do so.
15.2 Assignment. Except as expressly provided in this Agreement, neither Party may assign any rights or delegate any duties under this Agreement to any Third Party without the prior written consent of the other Party; provided, however, that (a) Licensor may freely assign its right to receive any payments hereunder without such consent of Licensee, (b) in the case where either Party seeks to assign this Agreement as a whole to an Affiliate or to a Successor in connection with a Change of Control of such Party or of that part of such Party’s business to which this Agreement relates, such consent shall not be unreasonably withheld, delayed, or conditioned, provided that such Party provides written notice to the other Party of such Change of Control and such Successor agrees in writing to be bound as such Party hereunder. This Agreement shall be binding upon and inure to the successors and permitted assignees of the Parties and the name of a Party appearing herein shall be deemed to include the names of such Party’s Successors and permitted assigns to the extent necessary to carry out the intent of this Agreement. Any assignment or transfer not in accordance with this Section 15.2 shall be null and void.
15.3 Further Actions. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.
15.4 Notices. All notices and other communications hereunder shall be in writing and shall be deemed to have been given: (a) when personally delivered or sent by confirmed facsimile or email (with hard copy to follow); (b) one (1) Business Day after sent by reputable overnight express courier (charges prepaid); or (c) five (5) Business Days following mailing by certified or registered mail, postage prepaid and return receipt requested. Unless another address is specified in writing, such notices to Licensor or Licensee shall be sent to the addresses indicated below:
15.5 Amendment. No amendment, modification, or supplement of any provision of this Agreement shall be valid or effective unless made in writing and signed by a duly authorized officer of each Party.
15.6 Waiver. No provision of this Agreement shall be waived by any act, omission or knowledge of a Party or its agents or employees except by an instrument in writing expressly waiving such provision and signed by a duly authorized officer of the waiving Party.
15.7 Counterparts; Electronic Delivery. This Agreement may be executed simultaneously in two counterparts, either of which need not contain the signature of more than one Party but both such counterparts taken together shall constitute one and the same agreement. Signatures to this Agreement transmitted by facsimile, by email in “portable document format” (“.pdf”), or by any other electronic means intended to preserve the original graphic and pictorial appearance of this Agreement shall have the same effect as physical delivery of the paper document bearing original signature.
15.8 Governing Law; Dispute Resolution.
(a) This Agreement shall be governed by and interpreted in accordance with the substantive laws of the State of New York, U.S.A. without regard to its or any other jurisdiction’s choice of law rules that would result in the application of the laws of any jurisdiction other than the State of New York, U.S.A.
(b) Except as otherwise provided in this Agreement, in the event of any dispute, controversy, or claim (“Dispute”) between the Parties in connection with this Agreement, the construction hereof, or the rights, duties or liabilities of either Party under this Agreement, the Parties shall first attempt in good faith to resolve such Dispute by negotiation and consultation between themselves. In the event that such Dispute is not resolved on an informal basis within ten (10) Business Days after one Party provides notice to the other Party of such Dispute, either Party providing such notice may, by written notice to the other Party refer such Dispute to the other Party for attempted resolution by good faith negotiation by the Chief Executive Officers or President of Licensor and the Chief Executive Officer, President or an Executive Vice President within thirty (30) days after such notice is received. In the event that any such Dispute is not resolved under the foregoing provisions, each Party may, at its sole discretion, seek resolution of such Dispute in accordance with Section 15.8(c). Any Disputes of the type described in Section 3.2(i) shall first be subject to the dispute resolution mechanism set forth in Section 3.2(i) before being subject to this Section 15.8.
(c) In the event such officers of the Parties are not able to resolve any such Dispute, either Party may at any time after such thirty (30) day period submit such Dispute to be finally settled by arbitration administered in accordance with the Commercial Arbitration Rules of the American Arbitration Association (“AAA”) in effect at the time of submission. The arbitration shall be heard and determined by three (3) arbitrators. Each such Party shall each appoint one arbitrator and the third arbitrator shall be selected by the two Party-appointed arbitrators, or, failing agreement within thirty (30) days following the date of receipt by the respondent of the claim, by the AAA. Such arbitration shall take place in New York, NY. The arbitration award so given shall be a final and binding determination of the dispute, shall be fully enforceable in any court of competent jurisdiction, and shall not include any damages expressly prohibited by Section 12.1. The Parties agree that all applicable statutes of limitation and time-based defenses (such as estoppel and laches) shall be tolled while the dispute resolution procedures set forth in this Section 15.8(c) are pending.
(d) Notwithstanding anything herein to the contrary, nothing in this Section 15.8 shall preclude either Party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction or other interim equitable relief concerning a Dispute, including in a court of law, if necessary to protect the interests of such Party. This Section 15.8 shall be specifically enforceable.
(e) Notwithstanding the foregoing, any disputes regarding the validity, scope or enforceability of Patent Rights or trademarks shall be submitted to a court of competent jurisdiction in the territory in which such rights apply.
15.10 Severability. Whenever possible, each provision of this Agreement shall be interpreted in such manner as to be effective and valid under Applicable Laws, but if any provision of this Agreement is held to be prohibited by or invalid under Applicable Laws, such provision shall be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of this Agreement. In the event of such invalidity, the Parties shall seek to agree on an alternative enforceable provision that preserves the original purpose of this Agreement.
15.11 Compliance with Applicable Laws. Each Party will comply with all Applicable Laws in performing its obligations and exercising its rights hereunder.
15.12 Remedies. The exercise of any remedies hereunder shall be cumulative and in addition to and not in limitation of any other remedies available to such Party at law or in equity.
15.13 Force Majeure. Neither Party shall be liable for delay or failure in the performance of any of its obligations hereunder if such delay or failure is due to causes beyond its reasonable control, including, without limitation, acts of nature, fires, earthquakes, strikes and labor disputes, acts of war, terrorism, or civil unrest (“Force Majeure”); provided that the affected Party promptly notifies the other Party and further provided that the affected Party shall use its commercially reasonable efforts to avoid or remove such causes of non-performance and to mitigate the effect of such occurrence, and shall continue performance with the utmost dispatch whenever such causes are removed. In the event any such Force Majeure event continues for three (3) months or more, the unaffected Party shall have the right to terminate this Agreement, effective as of the date of delivery of notice, which notice shall not be delivered prior to the end of such three (3) month period.
15.14 Interpretation. Each Party represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting hereof. In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption will apply against the Party which drafted such terms and provisions.
15.15 Construction. In construing this Agreement, unless expressly specified otherwise: (a) unless otherwise specifically provided, any references to Articles, Sections, Exhibits, Schedules, and Appendices are to articles in, sections of, and exhibits, schedules and appendices to, this Agreement; (b) except where the context otherwise requires, use of either gender includes the other gender and use of the singular includes the plural and vice versa; (c) headings and titles are for convenience only and do not affect the construction or interpretation of this Agreement; (d) any list or examples following the word “including” shall be interpreted without limitation to the generality of the preceding words; (e) the words “herein”, “hereof” and “hereunder”, and words of similar import, shall be construed to refer to this Agreement in its entirety and not to any particular provision hereof; (f) except where the context otherwise requires, the word “or” is used in the inclusive sense; (g) all references to “dollars” or “$” herein shall mean US Dollars; (h) any definition of or reference to any agreement, instrument or other document herein shall be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein or therein), (i) any reference to any Applicable Laws herein shall be construed as referring to such Applicable Laws as from time to time enacted, repealed or amended, and (j) any reference herein to any person or entity shall be construed to include the person’s or entity’s successors and assigns.
15.16 Entire Agreement of the Parties. This Agreement and the exhibits attached hereto constitute and contain the complete, final, and exclusive understanding and agreement of the Parties, and cancel and supersede any and all prior and contemporaneous negotiations, correspondence, understandings, and agreements, whether oral or written, between the Parties respecting the subject matter hereof, including without limitation the Confidentiality Agreement, and neither Party shall be liable or bound to any other Party in any manner by any representations, warranties, covenants, or agreements except as specifically set forth herein or therein. Nothing in this Agreement, express or implied, is intended to confer upon either Party, other than the Parties and their respective successors and assigns, any rights, remedies, obligations, or liabilities under or by reason of this Agreement, except as expressly provided herein. To the extent that anything set forth in an exhibit attached hereto conflicts with the terms of this Agreement, the terms of this Agreement shall control.
KASAN_기술이전, 라이선스 등 영문계약서에 사용되는 일반조항 GENERAL PROVISIONS 계약조항 샘플.pdf
3. JOINT STEERING COMMITTEE AND ALLIANCE MANAGERS.
3.1 Generally.
(a) Joint Steering Committee. Licensor and Licensee shall form the Joint Steering Committee. The JSC will have only such powers as are specifically delegated to it in this Agreement, and such powers shall be subject to the terms and conditions set forth in this Agreement.
(b) JSC Subcommittees. The JSC is hereby authorized to appoint one or more JSC Subcommittees to which the JSC may assign responsibility for specific matters (including, without limitation, matters arising with respect to Development, Commercialization, and Manufacturing. Each JSC Subcommittee will have only such powers as are specifically delegated to it by the JSC, and the delegation of any such powers to any JSC Subcommittee shall be subject to the terms and conditions set forth in this Agreement.
(c) Limitation of Power of JSC and JSC Subcommittees. Without limiting the generality of Sections 3(a) and 3(b), neither the JSC nor any JSC Subcommittee shall have any power to amend this Agreement or bind or incur liability on behalf of either Party without such Party’s express prior written authorization.
(d) Compliance with JSC and JSC Subcommittee Decisions. Each Party will comply with the decisions of the JSC and any JSC Subcommittee to the extent such decisions arise from the JSC or such JSC Subcommittee, as applicable, carrying out its powers and responsibilities as set forth in this Agreement and not otherwise inconsistent with the terms and conditions of this Agreement. Notwithstanding the foregoing, and is expressly set forth herein, Licensee shall have the sole and absolute right and discretion to decide matters related to the Commercialization, Manufacturing, or Development of the Product.
3.2 Membership and Governance of JSC and JSC Subcommittees.
(a) Membership.
(i) The JSC will be comprised of six (6) members who, except as otherwise provided in clause (iii) of this Section 3.2(a), are employees of the Parties (each a “JSC Member”), with three (3) JSC Members designated by Licensor and three (3) JSC Members designated by Licensee.
(ii) Each JSC Subcommittee will be comprised of the total number of members (each a “JSC Subcommittee Member”) as is designated by the JSC in forming such JSC Subcommittee, with the number of JSC Subcommittee Members appointed to such JSC Subcommittee from each Party to be designated by the JSC in forming such JSC Subcommittee. In determining the number of JSC Subcommittee Members to serve on any JSC Subcommittee formed by the JSC, the JSC will provide that the number of such JSC Subcommittee Members to be designated by each Party will be reasonable with respect to the experience and expertise of the human resources of each such Party in respect of the matters for which such JSC Subcommittee is responsible.
(iii) Each of Licensor and Licensee, upon prior written notice to the other Party, may (i) replace each person such Party has designated as a JSC Member or a JSC Subcommittee Member for any reason at any time, upon prior written notice to the other Party, (ii) designate a substitute for each person such Party has designated as a JSC Member or JSC Subcommittee Member, and (iii) appoint non-employees of such Party as JSC Members and JSC Subcommittee Members only upon the prior consent and approval of the other Party.
(b) Decision-Making. While the JSC and each JSC Subcommittee will seek to decide matters under their respective consideration by consensus of all of its members, Licensee reserves the right to decide each such matter in its sole and absolute discretion.
(c) Meetings. The JSC and each JSC Subcommittee will meet as agreed upon by the JSC Members or the applicable JSC Subcommittee Members, respectively, in person or by teleconference or video-teleconference; provided that the first meeting of the JSC Committee or such JSC Subcommittee, as applicable, will be within ninety (90) days after the Effective Date.
(d) Observers. Except for matters in respect of which the JSC or any JSC Subcommittee needs to meet in executive session, the meetings of the JSC and any JSC Subcommittee may be attended by non-Member observers at the invitation of an executive officer of either Party (the “Inviting Party”), provided that (i) the Inviting Party provides reasonable prior notice of such invitation to the other Party, (ii) the other Party has consented to such invitation in advance of the applicable meeting, which such consent shall not be unreasonably withheld, delayed or conditioned and (iii) any such observer has agreed in writing to obligations to safeguard the confidentiality and restrictions on use of Confidential Information that are no less restrictive than the obligations in Section 13.2.
(e) Chairperson.
(i) Of JSC. At the first meeting of the JSC following the Effective Date and at the first meeting of the JSC in each calendar year beginning after the Effective Date, the JSC Members will select a chairperson to serve until such person’s successor has been designated in accordance herewith. The chairperson of the JSC shall rotate annually between JSC Members designated by Licensor and those designated by Licensee. The first chairperson of the JSC shall be selected from the JSC Members designated by the Licensee.
(ii) Of Each JSC Subcommittee. Each JSC Subcommittee shall have a chairperson appointed in accordance with the directions of the JSC in establishing such JSC Subcommittee.
(f) Secretary.
(i) Of JSC. The chairperson of the JSC shall designate a secretary of the JSC who will be responsible for calling meetings, preparing and circulating an agenda in advance of each meeting, and preparing and circulating minutes within thirty (30) days after each meeting of such committee setting forth, among other things, a description, in reasonable detail, of the discussions at the meeting and a list of any actions, decisions or determinations approved by the JSC. Such minutes shall be effective only after being approved by both Parties. Definitive minutes of all committee meetings shall be finalized no later than sixty (60) days after the meeting to which the minutes pertain.
(ii) Of Each JSC Subcommittee. Each JSC Subcommittee shall have a secretary appointed in accordance with the directions of the JSC in establishing such JSC Subcommittee.
(g) Term of JSC and JSC Subcommittees.
(i) The JSC shall continue to exist for the Term of this Agreement or upon its termination upon mutual agreement of the Parties.
(ii) Each JSC Subcommittee shall continue to exist for the term to be set forth by the JSC in establishing such JSC Subcommittee, but in no event for a period extending beyond the Term of this Agreement
(h) Alliance Managers.
(i) Each of Licensor and Licensee shall appoint an Alliance Manager, who shall be an individual authorized to act as such Party’s point of contact for communications between and among the Parties relating to the Commercialization, Manufacturing and Supply, and any Development Activities contemplated by this Agreement. Each Party may change its designated Alliance Manager from time to time upon written notice to the other Party. The Alliance Manager of a Party may designate a substitute to temporarily perform the functions of that Alliance Manager by written notice to the other Party.
(ii) Each Alliance Manager shall be charged with creating and maintaining a collaborative work environment between and among the Parties and within the JSC and each JSC Subcommittee.
(iii) Each Alliance Manager will also: (i) be the point of first referral in all matters of conflict resolution; (ii) identify and bring disputes to the attention of the JSC or the relevant JSC Subcommittee, as applicable, in a timely manner; (iii) plan and coordinate cooperative efforts and internal and external communications; and (iv) take responsibility for ensuring that governance activities, such as the conduct of required JSC and JSC Subcommittee meetings and production of meeting minutes occur as set forth in this Agreement, and that relevant action items resulting from such meetings are appropriately carried out or otherwise addressed
(i) Dispute Resolution.
(i) In the event that any dispute arises with respect to matters falling within the scope of the role and the powers and responsibilities of the JSC or any JSC Subcommittee as set forth in or contemplated by this Article 3 or elsewhere in this Agreement, then either Licensor or Licensee or any of the Members of such Committee may notify the Alliance Managers of such disputed matter.
(ii) The Alliance Managers shall discuss in good faith any such disputed matter referred to them in accordance with Section 3.2(i)(i). If the Alliance Managers are unable to resolve any such matter, either Licensor or Licensee may refer the matter to the Chief Executive Officer or President of Licensor and the Chief Executive Officer, President, or an Executive Vice President of Licensee, which such two individuals shall meet at an agreed location or by telephone to resolve the matter within twenty (20) days after the meeting at which such matter arose.
(iii) If such two officers of the Parties are unable to resolve the disputed matter so referred to them in accordance with Section 3.2(i)(ii) within an additional thirty (30) day period, then the following procedures shall apply:
(A) in the case of matters with respect to which Licensee is authorized hereunder to decide in its sole and absolute discretion, including, without limitation, any Commercialization or Manufacturing and Supply matter, Licensee shall have final decision-making rights with respect thereto and shall promptly provide written notice to Licensor of its final position regarding such matter and Licensor will comply with the position taken by Licensee on such matter unless compliance with such position would result in the incurrence of a direct material financial expenditure or imposition of some other non-financial burdensome obligation upon Licensor that would be greater than would have been the case absent compliance with such position, which in such case shall be referred for dispute resolution under Section 15.8 and
(B) in the case of matters with respect to which Licensee is not authorized hereunder to decide such matters in its sole and absolute discretion, such matters shall be referred for dispute resolution under Section 15.8.
3.3 Committee Oversight of Commercialization Activities.
(a) Role. The JSC and any JSC Subcommittee established for the purpose of oversight of Commercialization Activities, will monitor, assess, and make recommendations to Licensee in respect of the Commercialization of the Product contemplated in Article 4 of this Agreement.
(b) Powers and Responsibilities. With respect to Product Commercialization Activities, the powers and responsibilities of the JSC and any JSC Subcommittee established for the purpose of oversight of such Commercialization Activities are limited to the matters set forth in this Section 3.3 and Article 4. Neither the JSC nor any JSC Subcommittee shall have the power to amend, modify, or waive compliance with this Agreement with respect to Commercialization Activities required to be undertaken by Licensee under this Agreement, including, without limitation, the Commercialization Plans for the Product and any Indications. Notwithstanding the foregoing, Licensee reserves the right to decide each such Commercialization matter in its sole and absolute discretion, including amending or modifying any Commercialization Plan.
(c) Annual Review of Commercialization Plan. On an annual basis, beginning in the first full Calendar Year following the Effective Date, no later than sixty (60) days before the end of such Calendar Year, the JSC or any JSC Subcommittee responsible for oversight of Commercialization Activities will review, analyze, and comment on the Annual Commercialization Plan then in effect and any revisions thereto proposed by Licensee or Licensor, which such review, analysis, and comment will include, without limitation:
(i) an assessment of whether the Commercialization Activities contemplated by the Annual Commercialization Plan for the then current Calendar Year have been successfully undertaken and have achieved or are achieving the strategic objectives set forth in the Commercialization Plan;
(ii) an assessment of whether the strategic objectives set forth in the Annual Commercialization Plan, together with any revisions then proposed by Licensee or Licensor, continue to reflect the best interests of the Parties;
(iii) the submission to Licensee of any recommended revisions to the Annual Commercialization Plan then in effect and any revisions then proposed by Licensee or Licensor, in order to reflect the aforementioned assessments.
(d) Regulatory Exclusivity. The JSC and any JSC Subcommittee responsible for oversight of Commercialization Activities shall monitor the process of applying for and securing Regulatory Exclusivity that may be available under the applicable Law of countries in the Territory, including, without limitation, any data or market exclusivity periods such as those periods listed in the FDA’s Orange Book. Each of Licensor and Licensee shall use Commercially Reasonable Efforts to cooperate with each other and to take such reasonable actions to obtain such Regulatory Exclusivity in each country in the Territory.
3.4 Oversight of Manufacturing and Supply Activities.
(a) Role. The JSC and any JSC Subcommittee responsible for oversight of Manufacturing and Supply Activities will monitor, assess, and make recommendations to Licensee in respect of the manufacture and supply of the Product as contemplated in Article 5 for purposes of Commercializing the Product for any Indications that are the subject of Regulatory Approvals and any Development Activities in respect of the Product for the PNE Indication, any Additional Indications and the Nocturia Indication throughout the Territory.
(b) Powers and Responsibilities. With respect to Product Manufacturing Activities, the powers and responsibilities of the JSC and any JSC Subcommittee responsible for oversight of such Manufacturing Activities are limited to the matters set forth in this Section 3.4 and Article 5. Neither the JSC nor any JSC Subcommittee shall have the power to amend, modify or waive compliance with this Agreement with respect to Manufacturing Activities required to be undertaken by Licensee under this Agreement, including, without limitation, the Manufacturing and Supply Plan for the Product. Notwithstanding the foregoing, Licensee reserves the right to decide each such manufacturing and supply matter in its sole and absolute discretion, including amending or modifying any Manufacturing and Supply Plan.
(c) Annual Review of Manufacturing and Supply Plan. On an annual basis, beginning in the first full Calendar Year following the Effective Date, no later than sixty (60) days before the end of such Calendar Year, the JSC or any JSC Subcommittee responsible for oversight of Manufacturing Activities will review, analyze, and comment on the Manufacturing and Supply Plan then in effect, and any revisions thereto proposed by Licensee or Licensor, which such review, analysis, and comment will include, without limitation:
(i) an assessment of whether the Manufacturing Activities contemplated by the Manufacturing and Supply Plan for the then current Calendar Year have been successfully undertaken and have achieved or are achieving the strategic objectives set forth in the Manufacturing and Supply Plan; and
(ii) an assessment of whether the strategic objectives set forth in the Manufacturing and Supply Plan, together with any revisions then proposed by Licensee or Licensor, continue to reflect the best interests of the Parties.
3.5 Oversight of Development Activities.
(a) Role. The JSC and any JSC Subcommittee responsible for oversight of any Development Activities contemplated in Article 6 of this Agreement will monitor such Development Activities. In this role the JSC or such JSC Subcommittee, as applicable, will (i) assist Licensee in overseeing any Development of, Clinical Studies for, and preparation and submission of Regulatory Documentation for obtaining Regulatory Approval of the Product contemplated by any Development Plan, including, without limitation, review of any relevant Regulatory Documents and Regulatory Documentation and (ii) provide a forum for sharing advice, progress, and results and documents, including, without limitation, relevant Clinical Study designs, protocols, study reports, and any other material information with respect to any such Development Activities.
(b) Powers and Responsibilities. With respect to any Product Development Activities, the powers and responsibilities of the JSC and any JSC Subcommittee responsible for oversight of such Development Activities are limited to the matters set forth in this Section 3.5 and Article 6. Neither the JSC nor any JSC Subcommittee shall have the power to amend, modify or waive compliance with this Agreement with respect to Development Activities, including, without limitation, any Development Plan in effect from time to time. Notwithstanding the foregoing, Licensee reserves the right to decide each such Development matter in its sole and absolute discretion, including amending or modifying any Development Plan.
(c) Annual Review of Development Plan. If Licensee determines to engage in any Product Development Activities in accordance with Article 6, on an annual basis, beginning in the first full Calendar Year following the Effective Date, no later than sixty (60) days before the end of such Calendar Year, the JSC and any JSC Committee responsible for oversight of Development Activities that Licensee may so determine to undertake in accordance with Article 6 will review, analyze, and comment on the Development Plan then in effect, and any revisions thereto proposed by Licensee or Licensor, which such review, analysis, and comment will include, without limitation:
(A) an assessment of whether the Development Activities contemplated by the Development Plan for the then current Calendar Year have been successfully undertaken and have achieved or are achieving the strategic objectives set forth in the Development Plan;
(B) an assessment of whether the strategic objectives set forth in the Development Plan, together with any revisions then proposed by Licensee or Licensor, continue to reflect the best interests of the Parties;
(C) the submission to Licensee of any recommended revisions to the Development Plan then in effect and any revisions then proposed by Licensee or Licensor, in order to reflect the aforementioned assessments.
KASAN_제약회사의 기술이전, 독점 라이선스, API 공급, 완제품 생산위탁, 완제품구매 계약서에서 개발, 생산, 판매 활동에 관한 JSC 관련 계약조항 영문 샘플.pdf
7. REGULATORY MATTERS.
7.1 Ownership of Product Regulatory Approvals and Documentation. Licensee shall own all Product Regulatory Approvals and Documentation in respect of each country in the Territory.
7.2 Conduct and Management of Regulatory Activities. Licensee will use its Commercially Reasonable Efforts:
(a) to maintain the First Approved NDA in the United States;
(b) to obtain Regulatory Approval for the Product for the Nocturia Indication in each other country in the Territory in accordance with the Development Plan;
and
(c) to obtain Regulatory Approval for the Product for the PNE Indication in each country in the Territory in accordance with the Development Plan.
Any breach by Licensee of its obligations under Section 7.2(a) shall be deemed to be a material breach of this Agreement for purposes of Article 14.
7.3 Transfer to Licensee of Product Regulatory Approvals and Documentation. Following the transfer to Licensee of ownership of the Product Regulatory Approvals and Documentation in each such country in the Territory pursuant to Section 2.3(b),
(a) Licensee or its designee shall be the owner of any and all Product Regulatory Approvals and Documentation in each such country in the Territory, subject to the Right of Reference or Use hereby granted by Licensee to Licensor in Section 2.5(c) for purposes of Development and Commercialization of Products outside the Territory;
(b) Except for the Development and Commercialization of Products by Licensor in the Territory pursuant to Section 6.3, Licensee shall have the responsibility, at its expense, for all regulatory activities (including, without limitation, Development Activities undertaken to support obtaining or maintaining Regulatory Approvals) and interactions relating to the Product in each country in the Territory, including without limitation preparing, obtaining, and maintaining Regulatory Approvals in each country in the Territory and all substantive interactions with such Regulatory Authorities relating thereto; and
(c) Licensee shall determine, in its sole discretion, the content of all such submissions and of all correspondence with Regulatory Authorities relating to the Product in the Territory.
(d) To the extent Licensor has not undertaken any Product Development Activities in the Territory under Section 2.5(c), Section 2.6, Section 6.1 and/or Article 14, Licensor hereby grants to Licensee a Right of Reference or Use in all Regulatory Approvals and Regulatory Documentation in respect of the Compound and any Products in respect of which Licensor is the sponsor for purposes of Licensee’s Development and Commercialization of Products in the Field and in the Territory. In consideration of such grant, Licensee will make one or more payments to Licensor determined in accordance with the same provisions set forth in clauses (ii) and (iii) in Section 2.5(c) in respect of Licensee’s grant of the Right of Reference or Use set forth in clause (i) of Section 2.5(c).
7.4 Regulatory Documentation for Generic Products.
(a) Each Party shall deliver written notice to the other Party of any notice it receives as to the submission, filing, or approval of an application, including, without limitation, an Abbreviated New Drug Application in the United States or the equivalent thereof in any other country in the Territory, in respect of a Generic Product within three (3) days after receipt or such notice thereof.
(b) Licensee shall have the sole right to respond to each such application, provided that Licensee shall consult with Licensor regarding any such application and the response thereto.
7.5 Audits. Licensor will have the continuing right during the Term of this Agreement, upon reasonable prior written notice to Licensee, to inspect, audit, and investigate any facilities, equipment, record-keeping procedures, and records utilized by Licensee and its subcontractors in connection with the Manufacture and Commercialization of the Product and any Development (including, without limitation, the conduct of Clinical Studies) of the Product.
7.6 Regulatory Authority Communications Received by a Party.
(a) Each Party shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection, or communication by or from any Person, including, without limitation, any Regulatory Authority in any country in the Territory, that may affect the safety or efficacy claims of the Product, have a material adverse effect on the Commercialization of the Product, or that otherwise suggests the Product may be in violation of Applicable Laws in such country.
(b) Upon receipt of such information described in Section 7.7(a), the Parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for Licensee to take at Licensee’s expense.
(c) Each Party shall keep the other Party informed, in a timely manner consistent with the reporting requirements of Regulatory Authorities, of notification of any action by any Regulatory Authority, or notification or other information that the Party receives (directly or indirectly) from any such Regulatory Authority, and provide to such other Party copies of all documents, if any, it received from such Regulatory Authority.
(d) Each Party will provide the other Party in a timely manner with a copy of all correspondence received from a Regulatory Authority specifically regarding the matters referred to in this Section 7.7.
7.7 Adverse Event Reporting and Safety Data Exchange.
(a) Licensee shall be responsible, at Licensee’s expense, in each country in the Territory for the monitoring of all clinical experiences, post-marketing experiences, and filing of all required reports with respect to the Product.
(b) Licensor shall transfer to Licensee the patient database, including without limitation the databases, in their entirety, containing pharmacokinetic, pharmacodynamic, efficacy, and safety information, developed in connection with the conduct of Clinical Studies for the Product under U.S. IND 076667, and all information relating thereto, in the format requested by Licensee. Licensor shall have the right to retain a copy of any and all such information transferred to Licensee.
(c) Each Party shall (i) notify the other Party immediately, but in no event later than three (3) Business Days, after becoming aware of any information concerning any complaint involving the possible failure of Product to meet any requirement of Applicable Laws, and any Unexpected Adverse Drug Experience or other serious or unexpected side effect, injury, toxicity, or sensitivity reaction or any unexpected incidents associated with the distribution or use of the Product and (ii) with respect to adverse events, comply with the provisions of this Section 7.7, and the applicable agreements described herein. Specific details regarding the exchange and management of information relating to adverse events related to the use of the Product shall be delineated and product labeling personnel of each Party shall work in good faith together during such time to negotiate an agreement that:
(i) identifies which safety information shall be exchanged, which shall include without limitation all adverse events for any Indication or condition;
(ii) identifies when such information shall be exchanged (which SAE information shall be provided within two (2) Business Days after notification of such SAE);
(iii) provides that Licensee shall (i) have regulatory reporting responsibilities, (ii) manage the global safety database, (iii) be obligated to obtain follow-up information on incomplete safety reports, (iv) review the literature for safety report information, and (v) prepare required periodic safety updates;
(iv) sets forth the roles and responsibilities of the Parties related to review and approval of safety information for inclusion in the Product labeling; provided that Licensee shall have the final decision-making authority with respect to any disputes regarding such activities with respect to Product in accordance with the terms and conditions hereof;
(v) identifies any other details required to appropriately manage safety information for the Product; and
(vi) as soon as reasonably practicable following the Effective Date, but in no event later than sixty (60) days thereafter Licensor and Licensee will agree upon the terms and conditions of the Pharmacovigilance Agreement and will thereupon execute and deliver to the other Party a copy of such Agreement.
7.8 Remedial Actions.
(a) Each Party will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that the Product in the Field may be subject to a Remedial Action.
(b) The Parties will assist each other in gathering and evaluating such information as is required to determine the necessity of conducting a Remedial Action with respect to the Product in the Field in the Territory; provided, however, that Licensee shall have sole responsibility for collecting information from its customers in the Territory, including, without limitation, customer complaints, in accordance with the terms and conditions hereof.
(c) Each Party will maintain adequate records to permit the Parties to trace the manufacture of the Product in the Field and the distribution and use of the Product in the Field. In the event Licensee determines that any Remedial Action with respect to the Product in the Field in the Territory should be commenced or Remedial Action is required by any Governmental Authority having jurisdiction over the matter, Licensee will control and coordinate all efforts necessary to conduct such Remedial Action, provided that Licensee shall consult with Licensor or its designee regarding any such Remedial Action.
(d) The cost and expense of a Remedial Action (including the Parties’ reasonable costs and expenses in conducting such Remedial Action, but excluding claims described in Article 10) shall be allocated as follows:
(i) If such Remedial Action is due to Licensee’s gross negligence or willful misconduct, material breach of this Agreement, or material violation of or substantial noncompliance with any Law, but only to the extent such Remedial Action is due thereto, such costs and expenses shall be borne and paid by Licensee;
(ii) if and to the extent that such Remedial Action is due to Licensor’s gross negligence or willful misconduct, Licensor’s material breach of this Agreement, or Licensor’s material breach of or substantial noncompliance with any Law, but only to the extent such Remedial Action is due thereto, such costs and expenses shall be borne and paid by Licensor; and
(iii) if and to the extent that such Remedial Action is due to reasons other than as set forth in Sections 7.8(d)(i) and (ii), then: (A) Licensor shall bear and pay the costs and expenses incurred by the Parties in connection with a Remedial Action with respect to any lots of the Product subject to such Remedial Action that were manufactured by or for Licensor, as Licensor’s predecessor in interest; and (B) except for the Development and Commercialization of Product in the Territory by Licensor pursuant to Section 6.3, Licensee shall bear and pay the costs and expenses incurred by the Parties in connection with a Remedial Action with respect to any lots of the Product subject to such Remedial Action that were manufactured by or for Licensee and its contractors; provided, however, that nothing in this Section 7.8(d)(iii) is intended to limit or supersede any obligation that Renaissance may have in respect of any such lots of the Product subject to such Remedial Action.
KASAN_제약회사의 API 공급, 완제품 생산위탁, 완제품구매 계약서에서 정부의 제조품목허가 관련 계약조항 영문 샘플.pdf
미국 Cook Inc.과 Boston Scientific Corp.은 의료기기 stent 분야의 경쟁업체입니다. 양사는 1997년 stent에 항암제 paclitaxel을 코팅한 stent (paclitaxel-coated stent) 제품개발을 진행하였습니다. Angiotech사는 paclitaxel 특허권을 보유하고 있었습니다.
양사 모두 exclusive license를 체결하여, 각자 Exclusive right 보유한 licensee입니다. 공존의 의미로 co-exclusive로 표현하기도 합니다. 우리나라 특허법상 전용실시권 공유와 유사한 것으로 이해됩니다.
1. 분쟁대상 계약조항
Licensee Cook & Boston Scientific에 대한 GRANT 조항은 "use, manufacture, have manufactured, distribute and sell, and to grant sublicenses to its Affiliates to use, manufacture, have manufactured, distribute and sell, the Angiotech Technology ... for use in the Licensed Applications."입니다.
한편, "none of the parties could assign their rights or obligations under the agreement without the prior written consent of the other two."과 같은 명시적 제한 조항이 포함되어 있습니다.
2. Cook사의 계약위반 쟁점 행위
Cook사는 2001년 일방적으로 Advanced Cardiovascular Systems, Inc. ("ACS")와 다음과 같은 일련의 계약 5건을 체결하였습니다. (1) a Paclitaxel Coated Stent ("PCS") Distribution Agreement, (2) a Component Supply Agreement, (3) a PCS Development Agreement, (4) a Stent Delivery System Distribution Agreement, (5) a Cross-License Agreement
Cook사는 위 라이선스에서 허용한 판매행위는 최종 소비자에 대한 판매뿐만 아니라 판매를 사업으로 하는 도매상 등 중간상인에 대한 판매도 포함한다는 입장입니다. 판매범위에 특별한 제한을 둘 수 없다고 주장합니다.
허락된 생산행위도 직접 생산뿐만 아니라 제3자에게 대한 위탁생산도 포함된다는 입장입니다. 특히 계약 문언에 "have manufactured"도 포함되어 있습니다.
3. 계약위반 분쟁 및 쟁점
Cook과 Boston Scientific는 경쟁업체로 동일한 exclusive licensee이기 때문에 라이선스 계약범위에 관한 첨예하게 이해관계가 대립됩니다. Cook의 행위에 대해 Boston Scientific에서는 계약상 권리양도금지 조항을 위반하는 사실상 계약이전(de facto assignment)에 해당한다고 주장하였습니다.
반면, Cook사는 ACS는 Angiotech 특허기술에 대한 access도 없고 직접 권리를 획득하지도 않는다는 점을 강조하면서, Angiotech사와 라이선스 계약으로 허용된 권리행사에 불과하다고 주장합니다.
4. 미국법원 1,2심 판결 요지
미국법원은 Cook/ACS 계약을 “a transparent attempt to draft around the limitations clearly expressed within the Angiotech Agreement”로 보았습니다. 오직 Cook사와 Boston Scientific사만 라이선스 독점권의 공유자로서 Angiotech Technology 사용권을 갖는다는 범위제한을 내포하고 있다고 판시하였습니다.
양사에 독점권을 공동으로 부여한 계약에서 당사자들의 진정한 의사는 당사자 2개사 이외에 제3자 타사에 대한 위탁생산 또는 위탁판매를 예정하지 않았다고 보았습니다. 만약 그렇게 된다면 licensee 중 상대방에게 심대한 이해관계를 미치기 때문입니다.
제3자의 위수탁 생산, 판매행위는 계약문언상 포함된 것으로 해석될 수도 있었습니다. 그러나, 당사자의 진정한 의사와 합리적 상식을 고려하여 계약상 허용범위에서 배제한 사례입니다.
17. MANUFACTURE AND SUPPLY OF CAPTISOL.
17.1 Supply.
(a) Subject to the terms and conditions of this Agreement, CyDex agrees to supply to Hospira those quantities of Captisol ordered by Hospira in accordance with Section 3.2 of this Agreement. So long as CyDex is able to deliver Captisol in accordance with the terms of this Agreement, except as provided in Section 3.11 (c) below, Hospira agrees that Hospira and its Affiliates shall during the Term order from CyDex no less than 90% of Hospira and its Affiliates aggregate requirements for Captisol for use in the formulation of Finished Product to be sold in the Major-Market countries.
(b) The parties hereby agree that [*] is CyDex’s Third-Party manufacturer of Captisol as of the Effective Date of this Agreement.
17.2 Purchase Orders. Hospira shall periodically submit firm purchase orders for Captisol to CyDex, which purchase orders shall set forth the specific quantities needed, the grade of Captisol required, delivery date and shipping instructions. Such purchase orders shall be submitted to CyDex at least [*] but not more than [*] prior to the required delivery date specified therein. If any purchase order or other document submitted by Hospira hereunder or any other document passing between the parties contains terms or conditions in addition to or inconsistent with the terms of this Agreement, the terms of this Agreement shall control and prevail and the parties hereby agree that such additional or inconsistent terms shall simply be ignored and deemed not to exist, unless they are expressly identified as being additional to or inconsistent with this Section 3.2 and are signed by officers of both parties.
17.3 Forecasts and Excess Demand. No later than the First Commercial Sale date, Hospira shall provide to CyDex a [*] forecast of its requirements for Captisol, with the first [*] of such forecast constituting a binding commitment upon Hospira to purchase such quantities under firm purchase orders submitted for the respective applicable [*] in accordance with Section 3.2. The balance of the forecast shall merely represent reasonable good-faith estimates for planning purposes only and shall not obligate Hospira to purchase any such amounts. On a [***] basis, Hospira shall update the forecast. If Hospira fails to provide any updated forecast in accordance with this Section 3.3, the forecast last provided by Hospira shall be deemed to be resubmitted as Hospira’s binding forecast for the next succeeding [*] period, and with the same quantity and timing as had been forecasted (or deemed to be forecasted) for the [*] of the prior forecast being repeated as the forecasted quantity and timing for the forecast’s [*]. CyDex shall notify Hospira as soon as possible, but in any event within [*] of the receipt of any forecast, if CyDex will be unable to deliver Captisol in accordance with such forecast. CyDex’s providing of such notification shall not be interpreted in any manner as relieving CyDex of its obligations under this Agreement, nor shall it prevent Hospira from pursuing any and all rights and remedies Hospira may have based on CyDex’s failure to be able to deliver Captisol in accordance with the terms of this Agreement. If any purchase order includes an Excess Demand, then (a) CyDex shall supply the quantity of Captisol which does not constitute an Excess Demand to Hospira in accordance with Section 3.2, and (b) CyDex shall use commercially reasonable efforts to supply the Excess Demand quantities of Captisol requested by Hospira in its purchase orders as soon as commercially possible.
17.4 Delivery Terms.
(a) CyDex agrees to deliver Captisol to Hospira’s carrier at a continental United States factory or warehouse designated by CyDex, in accordance with the purchase orders submitted by Hospira in accordance with Section 3.2 (each such delivery to be accompanied by a copy of the purchase order submitted by Hospira that corresponds to such delivery). All Captisol shall be delivered to Hospira using the carrier and in accordance with the delivery schedule specified by Hospira in its purchase orders. Captisol shall be delivered by CyDex to Hospira. CyDex will provide the carrier with proper instructions regarding how to transport the Captisol in conditions which will not adversely affect the Captisol, including ensuring that the shipment is temperature monitored and the Captisol is kept at an appropriate temperature throughout shipment.
(b) If CyDex is unable to deliver the Captisol on the date specified by Hospira, CyDex shall notify Hospira as soon as possible, but in any event within [***] of receipt of the purchase order. CyDex’s providing of such notification shall not be interpreted in any manner as relieving CyDex of its obligations under this Agreement, nor shall it prevent Hospira from pursuing any and all rights and remedies Hospira may have based on CyDex’s failure to deliver the Captisol in accordance with the terms of this Agreement.
(c) With each shipment of Captisol, CyDex shall, if so requested, provide by reference or otherwise all documentation as is reasonably required by any [*] from time to time in connection with Hospira’s research, development, modification, manufacture, importation, exportation, use, promotion, marketing, distribution, packaging, offering for sale, selling, and otherwise commercially exploitation, as applicable, of Captisol or the Finished Product. If such documentation is not supplied Hospira may reject the Captisol.
17.5 Safety Stock. Within [*] of CyDex’s receipt of the first purchase order from Hospira, CyDex shall establish and maintain a safety stock of at least [*] of Captisol available to Hospira based on Hospira’s latest forecast provided under Section 3.3. CyDex shall keep Hospira reasonably informed of the level of inventory identified as the safety stock and shall notify Hospira in the event any deliveries to Hospira deplete the current safety stock levels.
17.6 Failure to Supply.
(a) CyDex shall maintain sufficient capacity to manufacture Hospira’s projected needs for Captisol during the Term. If CyDex fails to deliver or anticipates that it will be unable to deliver any quantity of Captisol ordered pursuant to the terms of this Agreement for [*], CyDex will promptly notify Hospira. If CyDex fails to deliver any quantity of Captisol for [*], if such notice is received from CyDex, or if upon request by Hospira CyDex fails to provide adequate assurance of its ability to continue to deliver Captisol as required by the terms of this Agreement, then Hospira in its sole discretion and without impairing or limiting any other rights that Hospira may have under this Agreement or under applicable law, including, without limitation, its rights under Sections 2-609 and 2-610 of the Uniform Commercial Code, shall have the right to agree to a revised delivery date or Hospira may: [***] above, CyDex shall assist Hospira, if so requested by Hospira, by [*].
(d) Alternate Manufacturers. If CyDex fails to supply to Hospira, or if CyDex will be unable to supply Hospira with [***]% or more of the quantity of Captisol properly forecasted and ordered by Hospira in accordance with this Agreement, for a period of [*] then CyDex shall immediately provide written notice to Hospira of the [*]. In the event of a [*] in addition to any other rights and remedies Hospira may have under this Agreement, or in equity, or at law:
17.7 Inspection and Acceptance.
(a) CyDex shall test and inspect each lot of Captisol for compliance with Specifications prior to the release and shipment thereof to Hospira. CyDex will provide a Certificate of Analysis with each shipment of each lot of Captisol signed by the responsible quality official of CyDex. This Certificate of Analysis must include the results (whether numerical or otherwise) for each test performed that verifies that the Captisol is in compliance with the Specifications, as well as a statement that the subject lot was manufactured in accordance with the appropriate DMF/CEP. To the extent that any reference standard material is delivered to Hospira along with any shipment of Captisol as a result of Hospira’s request for such material pursuant to Section 3.2 of this Agreement, the Certificate of Analysis shall also include specifications on such material for each criterion listed in Exhibit B hereto, which specifications shall meet or exceed the Specifications.
(b) Hospira may test and inspect the Captisol after receipt and either accept or reject it. Captisol may be rejected if it does not comply with the Specifications or is otherwise defective. Hospira will be deemed to have accepted the Captisol, except as to latent defects which are not reasonably discoverable, if Hospira fails to give notice of rejection within [*] after receipt by Hospira of such Captisol. The written notice of rejection shall be given to CyDex and shall include identification of the lot number and description of the Specification failure or other defect.
(c) Following receipt of written notice of rejection of a particular lot of Captisol, in addition to any other rights or remedies Hospira may have under this Agreement, in equity, or at law, CyDex shall, at Hospira’s option, provide a credit, refund or prompt replacement of Captisol to Hospira; provided, however, that if CyDex does not agree with Hospira’s claim of noncompliance with Specifications or other defect, then the parties shall designate a mutually acceptable Third Party laboratory to make a determination on such matter from a sample obtained from the batch or other quantity shipped to Hospira. The decision of the Third Party laboratory shall be binding on all parties hereto and all expenses related to such Third Party investigation shall be borne by the party found to have been mistaken. Should such Third Party laboratory confirm Hospira’s claim, CyDex shall, at Hospira’s request, promptly provide Hospira with a credit, refund or prompt replacement of Captisol to Hospira.
(d) Hospira shall return any rejected Captisol to CyDex at CyDex’s expense to an address that CyDex may designate within [*] of CyDex receiving written notice of rejection; provided, however, that if CyDex does not agree with Hospira’s claim of noncompliance with Specifications or other defect, Hospira shall not be obligated to return the rejected Captisol to CyDex until [*] after a final determination is made by a Third Party laboratory that such Captisol does not comply with Specifications or is otherwise defective as provided in subparagraph (c) above. Absent such designation of address, Hospira will ship rejected Captisol to CyDex’s facility at [*], or such other address as CyDex may previously have given written notice of to Hospira as being the default address for return of rejected Captisol. All freight, insurance and other costs of such shipment along with any risk of loss shall be borne by CyDex, and shipment will be made from Hospira’s designated plant.
(e) Hospira’s rights of rejection, return, refund and replacement set forth in this Section 3.7 shall not apply to any Captisol that is non-conforming due to damage that occurs after delivery of such Captisol to Hospira’s carrier at the point of origin that is caused by Hospira, any of its Affiliates’ or their respective employees or agents’ negligence or willful misconduct, including but not limited to, misuse, neglect, improper storage, transportation or use beyond any dating provided.
17.8 Quality Agreement. The parties shall on the Effective Date enter into a separate Quality Agreement, in the form attached hereto as Exhibit D. The parties shall comply with the terms of the Quality Agreement, and any breach of the Quality Agreement shall be deemed a breach of this Agreement.
17.9 Quality Assurance. Each lot of Captisol to be supplied to Hospira hereunder shall be subject to a quality assurance inspection by CyDex in accordance with CyDex’s then current quality assurance standards and the Quality Agreement, which standards shall be designed to ensure that the Captisol meets the requirements of the Specifications and is manufactured per Good Manufacturing Practices.
17.10 Process Change Provisions and Procedure.
(a) General. To the extent pertaining to Captisol to be delivered pursuant to this Agreement, all modifications, changes, additions or deletions to the (i) Specifications; (ii) changes in the expiration period for Captisol; (iii) composition or source of any raw material for Captisol; (iv) method of producing, processing or testing Captisol; (v) change in subcontractors for producing, processing or testing Captisol; or (vi) site of manufacture for Captisol, which CyDex intends to carry out must be evaluated and documented by CyDex. [*], CyDex shall if so required amend its DMF/CEP through the appropriate notification to the FDA and any other applicable Regulatory Authorities. [*].
(b) Required Changes. Any changes relating to the Specifications or manufacturing processes for Captisol hereunder that are required by any applicable laws or other Regulatory Authority requirements in any Major Market, or by medical concerns related to the toxicity, safety and/or efficacy of Captisol shall hereinafter be referred to as “Required Changes”. The parties shall cooperate in making such changes promptly.
KASAN_제약회사의 API 공급, 완제품 생산위탁, 완제품구매 계약서에서 원료공급 및 생산 관련 계약조항 영문 샘플.pdf
18. LICENSE AND EXCLUSIVITY COMPENSATION.
18.1 Payments; Extension of Exclusivity Period.
(a) Upfront License Fee and Prepayment. Hospira shall within [*] after the Effective Date (and in any event, before December 30, 2011) pay to CyDex a non-refundable upfront license fee of $500,000, in consideration of the rights granted Hospira under this Agreement. In addition, Hospira shall within [*] after the Effective Date (and in any event, before December 30, 2011) pay to CyDex $2,500,000 by wire transfer as a one-time materials purchase prepayment usable only as a cumulative $2,500,000 credit toward future purchases of Captisol hereunder. Such credit shall be applied to the first $2,500,000 of Captisol purchased hereunder, until exhausted. In the event that this Agreement is terminated, then to the extent so provided in Section 11.4 CyDex shall immediately make a payment to Hospira in the amount of any such remaining prepayment credit.
(b) Extension of Exclusivity Period. To retain the benefits of having the Exclusivity Period remain in force for additional time, Hospira shall have the option to extend one or more times the expiration date of the Exclusivity Period. Not more than [*] before and not less than [*] before the Exclusivity Period would otherwise expire (taking into account any previous proper extension or extensions of the Exclusivity Period pursuant to this Section 4.1(b)), CyDex shall deliver to Hospira written notice that the Exclusivity Period is set to expire. Hospira may, in its sole discretion, extend the Exclusivity Period by making a non-refundable payment, by wire transfer, of $[*] to CyDex within [*] after the receipt of CyDex’s notice. Each such extension shall extend the erstwhile expiration date of the Exclusivity Period for [*] beyond when it would otherwise have expired. For avoidance of doubt: (i) such option to extend can be exercised in compliance with this Section 4.1(b) multiple times, but no extension can extend the Exclusivity Period beyond the end of the Term, (ii) if CyDex does not provide notice to Hospira at least [*] before the end of the then current term of the Exclusivity Period, the Exclusivity Period will automatically extend for [*] after Hospira’s receipt of any such notice and Hospira shall have the right to further extend the Exclusivity Period as set forth above by making the required payment within [*] after receipt of CyDex’s notice, and (iii) the Exclusivity Period cannot be resuscitated after it has expired or terminated.
18.3 Taxes. All amounts due hereunder exclude all applicable sales, use, and other taxes and duties, and Hospira will be responsible for payment of all such taxes (other than taxes based on CyDex’s income), arising from the payment of amounts due under this Agreement. The parties agree to cooperate with one another and use reasonable efforts to avoid or reduce tax withholding or similar obligations in respect of payments made by Hospira to CyDex under this Agreement. To the extent Hospira is required to deduct and withhold taxes on any payment to CyDex, Hospira shall pay the amounts of such taxes to the proper governmental authority in a timely manner and promptly transmit to CyDex official receipts issued by the appropriate taxing authority and/or an official tax certificate, or such other evidence as CyDex may reasonably request, to establish that such taxes have been paid. CyDex shall provide Hospira any tax forms that may be reasonably necessary in order for Hospira to not withhold tax or to withhold tax at a reduced rate under an applicable bilateral income tax treaty. CyDex shall use reasonable efforts to provide any such tax forms to Hospira at least [***] before the due date for any payment for which CyDex desires that Hospira apply a reduced withholding rate. Each party shall provide the other with reasonable assistance to enable the recovery, as permitted by applicable law, of withholding taxes, value added taxes, or similar obligations resulting from payments made under this Agreement, such recovery to be for the benefit of the party bearing such withholding tax or value added tax.
19. RECORDS; AUDIT.
19.1 Records and Reports.
(a) Records. During the Term and for a period of [*], Hospira shall, and shall require its Affiliates to, maintain accurate records relating to Net Sales of the Finished Product.
(b) Reports. During the Term, Hospira shall provide CyDex with written a report that identifies whether each respective Section 4.1(c) milestone has been achieved.
19.2 Audit. Upon reasonable prior notice, such Section 5.1 records shall be available during regular business hours for examination and audit at the expense of CyDex by an independent certified public accountant selected by CyDex and reasonably acceptable to Hospira, for the sole purpose of verifying Net Sales. CyDex shall [*]. Such records may not be audited more often than [*] and the records for any period may not be audited more than once. During any audit, the scope of such audit shall only include, with respect to those items of deduction for which Hospira, under its then-current system, calculates using a fixed allocation system, a review of actual allocated deductions thereunder unless and until such time as Hospira has changed its system to reflect actual deductions for such category of deductions. In the event that Hospira begins tracking actual costs and deductions on a product by product basis generally (which it has no obligation to do hereunder), Hospira will implement such actual tracking for purposes of this Agreement in lieu of fixed allocation percentages and the calculation of such actual costs and deductions shall thereafter become subject to audit pursuant to this Section 5.2. All information learned in the course of any audit or inspection under this Section 5.2 shall be deemed to be Confidential Information of Hospira, subject to the terms and provisions of Section 7 below.
KASAN_기술이전, License, 생산위수탁 계약서에서 Royalty Payment 관련 영문계약 조항 샘플 – 독점권 대가 고정액 구조.pdf
8. PAYMENT.
8.1 Initial Fee. In consideration of the license and sublicense granted by Licensor to Licensee in accordance with Sections 2.1 and 2.2, respectively, and the assignments by Licensor to Licensee in accordance with Section 2.3, Licensee shall pay to Licensor a one-time, nonrefundable, non-creditable initial fee of Fifty Million Dollars ($50,000,000) on the Effective Date.
8.2 Milestone Payments.
(a) Launch Milestone Payment. Licensee shall notify Licensor promptly of the date of the Noctiva Launch, but in no event later than twenty (20) days thereafter. In further consideration of the license and sublicense granted by Licensor to Licensee in accordance with Sections 2.1 and 2.2, respectively, and the assignments by Licensor to Licensee in accordance with Section 2.3, Licensee shall pay to Licensor a one-time, nonrefundable, non-creditable payment of Twenty Million Dollars ($20,000,000) in respect of such Noctiva Launch on the earlier to occur of: (i) the thirtieth (30th) day immediately following the date of the Noctiva Launch and (ii) June 30, 2018. Such payment shall not require Licensor to provide any invoice in respect thereof.
Tier One Commercialization Milestone Payments. Licensee shall notify Licensor promptly, but in no event later than thirty (30) days, after the first achievement of the relevant sales milestone for the Product as set forth in the table below in this Section 8.2(b). In further consideration of the license and sublicense granted by Licensor to Licensee in accordance with Sections 2.1 and 2.2, respectively, and the assignments by Licensor to Licensee in accordance with Section 2.3, Licensee shall make the following one-time, nonrefundable, non-creditable milestone payments to Licensor within thirty (30) days after receipt of an invoice from Licensor therefor.
(i) Upon the first time Royalty-Bearing Net Sales by Licensee and its Sublicensees of the Product for all Indications in the aggregate reach $50 million on a cumulative basis beginning with the first dollar of Royalty-Bearing Net Sales
(ii) Upon the first time Royalty-Bearing Net Sales by Licensee and its Sublicensees of the Product for all Indications in the aggregate reach $[*] on a cumulative basis beginning with the first dollar of Royalty-Bearing Net Sales
(iv) Upon the first time Royalty-Bearing Net Sales by Licensee and its Sublicensees of the Product for all Indications in the aggregate reach $200 million on a cumulative basis beginning with the first dollar of Royalty-Bearing Net Sales
(b) Tier Two Commercialization Milestone Payments. Licensee shall notify Licensor promptly, but in no event later than thirty (30) days, after the first achievement of the relevant sales milestone for the Product as set forth in the table below in this Section 8.2(c). In further consideration of the license and sublicense granted by Licensor to Licensee in accordance with Sections 2.1 and 2.2, respectively, [and the assignments by Licensor to Licensee in accordance with Section 2.3,] Licensee shall make the following one-time, nonrefundable, non-creditable milestone payments to Licensor within thirty (30) days after receipt of an invoice from Licensor therefor; provided, however, in the event that the last of the milestone payments described in the table below becomes payable, the due date for Licensee to make payment to Licensor of such milestone payment will be the first anniversary of the payment of the $[*] milestone payment in the penultimate row of the table below.
(i) Upon the first time Royalty-Bearing Net Sales by Licensee and its Sublicensees of the Product for all Indications reach $300 million in any consecutive 12-month period beginning after achievement of milestone (iv) described in Section 8.2(b)
(ii) Upon the first time Royalty-Bearing Net Sales by Licensee and its Sublicensees of the Product for all Indications reach $ 1.5 billion in any consecutive 12-month period beginning after achievement of milestone (iv) described in Section 8.2(b)
(c) Change of Control Payment. If a Change of Control occurs, simultaneously with the consummation of such Change of Control, Licensee shall pay to Licensor the amount of [*] Dollars ($[*]) less the sum of the following allocable portions of any of the milestone payments described in Section 8.2(b) that are paid to Licensor prior to such Change of Control:
8.3 Royalties; Non-Royalty Commercialization Consideration.
(a) Royalties. In further consideration of the license and sublicense granted by Licensor to Licensee in accordance with Sections 2.1 and 2.2, respectively, Licensee shall pay Licensor royalties on Net Sales of the Product by Licensee and any of its Sublicensees and Third Party Distributors in accordance with the rates set forth in the tables set forth below in this Section 8.3(a)(i).
(b) Third Party Royalties.
(i) CPEX and Reprise. Licensor will be responsible for payment of any amounts payable to CPEX and Reprise under the terms of the CPEX License Agreement and the Reprise License Agreement, respectively.
(ii) Other Third Parties.
(A) In the event that after the Effective Date Licensee reasonably determines that it is necessary or advisable for Licensee to obtain a license under any Patent Rights from any Third Party in order for Licensee (each a “Third Party License”; collectively, “Third Party Licenses”), its Sublicensees, and any Third Party Distributors to Commercialize the Product in the Field in any country in the Territory as contemplated by this Agreement, the Parties shall discuss the best course of action to resolve such potential license requirement, provided that such discussions shall not limit or delay Licensee’s right to obtain any such Third Party Licenses.
(B) With respect to any such Third Party Licenses that Licensor reasonably agrees are necessary for Licensee to be able to Commercialize the Product in the Field in any country in the Territory, Licensee shall have the right to set off an amount equal to [*] percent ([*]%) of the aggregate of any and all payments required to be paid by Licensee to the licensors under such Third Party Licenses in respect of any Calendar Quarter against payments otherwise payable to Licensor under Section 8.3(a) in respect of such Calendar Quarter; provided, however, that in no event shall the aggregate set off in any Calendar Quarter resulting from such payments in respect of such Third Party Licenses exceed an amount equal to [*] percent ([*]%) of the royalty payments otherwise payable to Licensor under Section 8.3(a) in respect of such Calendar Quarter.
(c) Royalty Term. Licensee’s obligation under Sections 8.3(a) to pay Licensor royalties on Net Sales of the Product in each country in Territory will apply to any and all sales or other dispositions of such the Product in such country made during the Term of this Agreement.
(d) Generic Product. If, during the Royalty Term, one or more Third Parties is selling in any country in the Territory any product that is a Generic Product in relation to the Product being sold in such country by Licensee or any of its Sublicensees or Third Party Distributors, Licensee’s royalty obligations under Section 8.3(a) for sales in such country of the Product shall be reduced as follows:
If the Generic TRxs-to-Total TRxs Percentage in such country during such Calendar Quarter is: Licensee’s royalty obligations under Section 8.3(a) shall be reduced by the Percentage Indicated Below
8.4 Reports and Payments. During the Term of this Agreement following the First Commercial Sale of the Product by Licensee, its Sublicensees, or its Third Party Distributors, within five (5) Business Days after the filing by Licensee of each Form 10-K or Form 10-Q, Licensee shall pay to Licensor the royalty payments payable by Licensee for the Calendar Quarter preceding the Calendar Quarter in which such Form 10-K or 10-Q, as applicable, is filed, and shall provide a report showing, on a country-by-country basis:
(a) the net quantity of the Product sold, total gross sales, an itemized list of the deductions applied to total gross sales, and Net Sales of the Product sold in the Calendar Quarter in respect of which such report has been prepared;
(b) the calculation in Dollars of royalty payments due hereunder with respect to such Net Sales, including any deductions for any offsets in accordance with Section 8.3(b)(ii);
(c) withholding taxes on Net Sales, if any, required by Applicable Laws to be deducted with respect to such royalties; and
(d) the rate of exchange used by Licensee in determining the amount of Dollars payable hereunder.
If no royalty or other payment is due for any period hereunder, Licensee shall so report.
Currency of Payment. All payments to be made under this Agreement shall be made in Dollars by electronic funds transfer to such bank accounts as Licensor may designate from time to time. When Licensee or any of its Sublicensee of Third Party Distributors sells the Product for monies other than Dollars, Licensee will convert any non-Dollar currencies into Dollars with the exchange rate for the purchase of Dollars with such domestic currency as quoted by The Wall Street Journal, New York edition, at an average rate for the Calendar Quarter for which the payment is made.
8.5 Accounting.
(a) Licensee shall determine Net Sales with respect to the Product sold using its standard accounting procedures, consistent with GAAP, as if the Product was a solely owned product of Licensee, except as specifically provided in this Agreement. In the case of amounts to be determined by Third Parties (for example, Net Sales by Sublicensees), such amounts shall be determined in accordance with generally accepted accounting principles in effect in the country in which such Third Party is engaged. Licensor and Licensee also recognize that such procedures may change from time to time and that any such changes may affect the definition of Net Sales. Licensor and Licensee agree that, where such changes are economically material to Licensor, adjustments shall be made to compensate Licensor in order to preserve the same economics as are reflected under this Agreement under Licensee’s accounting procedures in effect prior to such change. Where the change is or would be material to Licensor, Licensee shall provide an explanation of the proposed change and an accounting of the effect of the change on the relevant revenue, cost, or expense category.
(b) In the event of the payment or receipt of noncash consideration in connection with the performance of activities under this Agreement Licensee shall advise Licensor of such transaction, including without limitation Licensee’s assessment of the fair market value of such noncash consideration and the basis therefor. Such transaction shall be accounted for on a cash equivalent basis, as mutually agreed by Licensor and Licensee in good faith.
(c) Withholding Tax. Notwithstanding anything to the contrary herein, in the event that withholding taxes apply with respect to any amounts due from Licensee hereunder, Licensee shall be entitled to withhold from any payment due to Licensor under this Agreement any taxes that Licensee is required to pay and such withholding shall decrease by an equivalent amount the payment due to Licensor. Licensee shall provide Licensor with notification of any anticipated withholding requirements with as much advance notice as practicable and shall cooperate in good faith with Licensor to legally minimize such withholding taxes. Licensee will timely pay to the proper governmental authority the amount of any taxes withheld and will provide Licensor with an official tax certificate or other evidence of tax obligation, together with proof of payment from the relevant governmental authority sufficient to enable Licensor to claim such payment of taxes.
8.6 Books and Records; Audit Request.
(a) During the term of this Agreement and for three (3) years thereafter, Licensee shall keep and maintain, and shall cause each of its Affiliates, and Sublicensees, if any, to keep and maintain, at their respective regular places of business complete and accurate books, records, and accounts in accordance with GAAP, or other accounting standards mandated by the U.S. Securities and Exchange Commission if applicable to Licensee, in sufficient detail to reflect all amounts required to be paid under this Agreement, as well as any other books, records or accounts required to be maintained in connection with the Product under any Applicable Laws, necessary to permit the audits contemplated under Section 8.8(b). Prior to destroying any books, records or accounts which are material to the Parties’ rights and obligations under this Agreement, Licensee must seek prior written consent from Licensor, which consent may not be unreasonably withheld.
(b) During the term of this Agreement and for three (3) years thereafter, Licensor shall have access to and the right to examine such relevant records and accounts that Licensee is required to maintain pursuant to Section 8.8(a) at Licensee’s premises for the sole purpose of verifying the accuracy of any report or payment made under this Agreement in the three (3) preceding years; provided, however, that any such examination: (i) shall not occur more than once during each Calendar Year (except that if as a result of any audit pursuant to this Section 8.8(b), an error in favor of Licensee exceeding five percent (5%) of any payments previously reported as owed by Licensee to Licensor is discovered, the frequency of audits under this Section 8.10(b) shall not be so limited); (ii) shall be during normal business hours upon reasonable prior written notice which shall in no event be less than thirty (30) days; and (iii) shall not unreasonably interfere with Licensee’s operations and activities. If Licensor desires to audit such records, it shall engage an independent, certified public accountant reasonably acceptable to Licensee, to examine such records under conditions of confidentiality with respect thereto at least as stringent as those specified in Article 13. The expense of any such audit shall be borne by Licensor; provided, however, that, if an error of more than five percent (5%) in favor of Licensor is discovered as a result of such audit, then such expenses shall be paid by Licensee. If such accountant concludes that additional payment amounts were owed to Licensor during any period, Licensee shall pay such payment amount (including without limitation interest thereon from the date such amounts were payable) within thirty (30) days after the date Licensor delivers to Licensee such accountant’s written report so concluding, unless Licensee notifies Licensor of any dispute regarding the audit. If such accountant concludes that Licensee has overpaid any amounts to Licensor during any period, in Licensor’s discretion, Licensee may credit such amounts against future payments due Licensor or Licensor may pay such amounts (including without limitation interest thereon from the date such amounts were payable), unless Licensor notifies Licensee of any dispute regarding the audit. Any Information received by Licensor pursuant to this Section 8.10 shall be deemed to be Confidential Information of Licensee for purposes of Article 13.
8.7 Blocked Currency. If by Applicable Laws or fiscal policy of a particular country, conversion into Dollars or transfer of funds of a convertible currency to the United States is restricted or forbidden, royalties accrued in such country shall be paid to Licensor in the country in local currency by deposit in a local bank designated by Licensor for such deposit, unless Licensor and Licensee otherwise agree.
8.8 Interest. If Licensor does not receive payment of any sum due to it on or before the due date, simple interest shall thereafter accrue on the sum due to Licensor from the due date until the date of payment at a rate equal to three month Dollar LIBOR Rate, as reported in the online edition of The Wall Street Journal as of Noon (New York Time) on such due date, or the maximum rate allowable by Applicable Laws, whichever is less.
8.9 Transaction Expenses. Licensee shall upon execution and delivery of this Agreement pay the documented reasonable fees and expenses of Licensor’s advisors and counsel incurred by Licensor in structuring, negotiating, memorializing, and otherwise undertaking the transaction contemplated by this Agreement. Notwithstanding the foregoing, Licensee’s obligation under this Section 8.11 shall be limited to an amount not to exceed $2,000,000.
KASAN_제약회사 기술이전, License, 제조판매 계약서에서 Royalty Payment 관련 영문계약 조항 샘플.pdf
1. 특허무효 확정된 경우 특허발명 실시계약에 미치는 효력에 관한 기본법리
특허가 무효로 확정되면 특허권은 특허법 제133조 제1항 제4호의 경우를 제외하고는 처음부터 없었던 것으로 간주된다(특허법 제133조 제3항). 그러나 특허발명 실시계약이 체결된 이후에 계약의 대상인 특허권이 무효로 확정된 경우 특허발명 실시계약이 계약 체결 시부터 무효로 되는지는 특허권의 효력과는 별개로 판단하여야 한다.
특허발명 실시계약을 체결하면 특허권자는 실시권자의 특허발명 실시에 대하여 특허권 침해로 인한 손해배상이나 그 금지 등을 청구할 수 없고, 특허가 무효로 확정되기 전에는 특허권의 독점적ㆍ배타적 효력에 따라 제3자의 특허발명 실시가 금지된다.
이러한 점에 비추어 특허발명 실시계약의 목적이 된 특허발명의 실시가 불가능한 경우가 아니라면 특허 무효의 소급효에도 불구하고 그와 같은 특허를 대상으로 하여 체결된 특허발명 실시계약이 그 계약의 체결 당시부터 원시적으로 이행불능 상태에 있었다고 볼 수는 없고, 다만 특허 무효가 확정되면 그때부터 특허발명 실시계약은 이행불능 상태에 빠지게 된다고 보아야 한다(대법원 2014. 11. 13. 선고 2012다42666, 42673 판결 등 참조).
따라서 특허발명 실시계약 체결 이후에 특허가 무효로 확정되었더라도 특허발명 실시계약이 원시적으로 이행불능 상태에 있었다거나 그 밖에 특허발명 실시계약 자체에 별도의 무효사유가 없는 한, 특허권자는 원칙적으로 특허발명 실시계약이 유효하게 존재하는 기간 동안 실시료의 지급을 청구할 수 있다.
2. 특허무효 확정된 경우 특허발명 실시계약 상 특허무효 확정 전 기간에 지급해야 할 실시료를 구할 수 있는지 여부
대법원 2019. 4. 25. 선고 2018다287362 판결 요지 – 판결문 첨부
특허발명 실시계약이 체결된 이후에 계약의 대상이 된 특허가 진보성이 없다는 이유로 무효로 확정된 사안에서, 위 실시계약이 원시적 불능이라고 할 수 없어 특허권자가 이미 지급받은 특허실시료를 반환할 의무가 없다고 한 대법원 2012다42666, 42673 판결에 이어, 특허권자는 특허무효 확정 이전에 미지급된 특허실시료의 지급을 구할 수 있는 것이 원칙이다.
3. 대법원 2012다42666 판결 사안 – 특허무효 소급효 제한 적용 – 라이선스 계약 취소 불인정 + 기 지급한 로열티 반환청구 불인정 + 장래 로열티 지급의무 소멸
(1) 특허실시계약의 체결 이후 대상특허가 무효로 확정된 경우 특허권자가 실시권자로부터 이미 지급받은 특허실시료를 부당이득으로 반환할 의무가 있는지 여부 - 부정
(2) 실시계약의 체결 이후 계약의 대상이 된 특허가 무효로 확정된 경우 착오를 이유로 특허발명 실시계약을 취소할 수 있는지 여부 – 부정
“특허발명 실시계약에 의하여 특허권자는 실시권자의 특허발명 실시에 대하여 특허권 침해로 인한 손해배상이나 그 금지 등을 청구할 수 없게 될 뿐만 아니라 특허가 무효로 확정되기 이전에 존재하는 특허권의 독점적ㆍ배타적 효력에 의하여 제3자의 특허발명 실시가 금지되는 점에 비추어 보면, 특허발명 실시계약의 목적이 된 특허발명의 실시가 불가능한 경우가 아닌 한 특허무효의 소급효에도 불구하고 그와 같은 특허를 대상으로 하여 체결된 특허발명 실시계약이 그 계약의 체결 당시부터 원시적으로 이행불능 상태에 있었다고 볼 수는 없고, 다만 특허무효가 확정되면 그때부터 특허발명 실시계약은 이행불능 상태에 빠지게 된다고 보아야 한다.
따라서 특허발명 실시계약 체결 이후에 특허가 무효로 확정되었더라도 앞서 본 바와 같이 특허발명 실시계약이 원시적으로 이행불능 상태에 있었다거나 그 밖에 특허발명 실시계약 자체에 별도의 무효사유가 없는 한 특허권자가 특허발명 실시계약에 따라 실시권자로부터 이미 지급받은 특허실시료 중 특허발명 실시계약이 유효하게 존재하는 기간에 상응하는 부분을 실시권자에게 부당이득으로 반환할 의무가 있다고 할 수 없다.
특허는 그 성질상 특허등록 이후에 무효로 될 가능성이 내재되어 있는 점을 감안하면, 특허발명 실시계약 체결 이후에 계약의 대상인 특허의 무효가 확정되었더라도 그 특허의 유효성이 계약체결의 동기로서 표시되었고 그것이 법률행위의 내용의 중요부분에 해당하는 등의 사정이 없는 한, 착오를 이유로 특허발명 실시계약을 취소할 수는 없다고 할 것이다.”
4. 실시권자 Licensee의 특허권자 Licensor 상대로 대상특허에 대한 무효심판청구 가능 - 특허무효의 경우 계약상 실시료 Royalty 지급의무 범위 소멸: 대법원 2019. 2. 21. 선고 2017후2819 전원합의체 판결
“특허권의 실시권자에게는 실시료 지급이나 실시 범위 등 여러 제한 사항이 부가되는 것이 일반적이므로, 실시권자는 무효심판을 통해 특허에 대한 무효심결을 받음으로써 이러한 제약에서 벗어날 수 있다.
그리고 특허에 무효사유가 존재하더라도 그에 대한 무효심결이 확정되기까지는 그 특허권은 유효하게 존속하고 함부로 그 존재를 부정할 수 없으며, 무효심판을 청구하더라도 무효심결이 확정되기까지는 상당한 시간과 비용이 소요된다.
이러한 이유로 특허권에 대한 실시권을 설정받지 않고 실시하고 싶은 사람이라도 우선 특허권자로부터 실시권을 설정받아 특허발명을 실시하고 그 무효 여부에 대한 다툼을 추후로 미루어 둘 수 있으므로, 실시권을 설정받았다는 이유로 특허의 무효 여부를 다투지 않겠다는 의사를 표시하였다고 단정할 수도 없다.”
특허발명의 실시허략, 기술이전 라이선스를 체결하면서 계약서에서 Licensee는 대상특허의 무효도전(patent challenge)을 할 수 없다는 명시적 조항을 둔 경우 Licensee가 무효주장을 할 수 있는지 문제됩니다. Licensee에게 대상 특허의 유효성에 대해 다투지 않을 의무를 계약으로 강제할 수 있는지 여부가 쟁점입니다.
원칙적으로 licensee 입장에서 대상특허의 무효도전을 하는 것은 허용됩니다. 미국연방대법원 Lear v. Adkins (1969) 판결에서 “a licensee cannot be estopped from challenging the validity of a patent merely because it benefitted from the license agreement.”라고 명시적으로 라이센시의 특허도전을 허용하였습니다.
그러나, 라이선스 계약위반으로 이미 성립된 계약위반책임을 회피하기 위해 사후적으로 제기하는 특허무효주장은 허용되지 않는다는 것이 미국법원 판결입니다. Studiengesellshaft Kohle v. Shell Oil (CAFC 1997) 판결: Lear does not apply where a licensee seeks to avoid contractual obligations already owed at the time of the suit. It "must prevent the injustice of allowing a licensee to exploit the protection of the contract and patent rights and then later to abandon conveniently its obligations under those same rights."
앞서 소개한 사안 - Licensee Neurocrine의 계약위반책임 항변으로 계약대상특허의 무효 주장을 배척한 판결
미국법원은 sublicense 허용조건으로 licensor의 사전동의를 받도록 한 계약조항을 위반한 행위에 대한 손해배상을 구하는 범위내에서 licensee의 특허무효 항변이 허용되지 않는다고 판결하였습니다.
다만, 사안을 구별하여, 특허권자가 특허기술 사용에 대한 장래 royalty를 청구하는 경우는 licensee의 특허무효 항변이 허용될 수 있다는 취지의 판결입니다. 이 부분에 대한 라이선스 계약위반 사항은 없기 때문입니다.
라이선스 계약을 준수하면서 대상특허 무효도전 허용 – MedImmune 판결
미연방대법원은 MedImmune 판결에서 Licensee는 계약상 로열티를 계속 지불하면서도 특허무효 확인 소송을 제기할 수 있다고 판결하였습니다. 라이센스 계약에 위배하여 로열티의 지급을 중지하는 경우, 특허권자로부터 제소당하여 침해에 대한 고의가 인정되면 3배까지 배상금을 지불하여야 할 위험이 있으므로 해당 특허의 무효를 확신하여도 마지못해 로열티를 지불하게 된다면 ‘실제의 분쟁’이 발생한 것이라고 볼 수 있다고 보았습니다.
우리나라 공정위 특허라이선스 계약 관련 심사지침 - ‘무효인 특허의 존속 등을 위하여 부당하게 실시권자가 관련 특허의 효력을 다투는 것을 금지하는 행위’는 공정거래법 위반 소지 있음, 해당 계약조항의 효력 불인정 소지 있음, 해당 사안에 대한 판결 없음
대법원 2019. 2. 21. 선고 2017후2819 전원합의체 판결: 실시권자 Licensee의 특허권자 Licensor 상대로 대상특허에 대한 무효심판청구 가능 - 특허무효의 경우 계약상 실시료 Royalty 지급의무 범위 소멸:
“특허권의 실시권자에게는 실시료 지급이나 실시 범위 등 여러 제한 사항이 부가되는 것이 일반적이므로, 실시권자는 무효심판을 통해 특허에 대한 무효심결을 받음으로써 이러한 제약에서 벗어날 수 있다.
그리고 특허에 무효사유가 존재하더라도 그에 대한 무효심결이 확정되기까지는 그 특허권은 유효하게 존속하고 함부로 그 존재를 부정할 수 없으며, 무효심판을 청구하더라도 무효심결이 확정되기까지는 상당한 시간과 비용이 소요된다.
이러한 이유로 특허권에 대한 실시권을 설정받지 않고 실시하고 싶은 사람이라도 우선 특허권자로부터 실시권을 설정받아 특허발명을 실시하고 그 무효 여부에 대한 다툼을 추후로 미루어 둘 수 있으므로, 실시권을 설정받았다는 이유로 특허의 무효 여부를 다투지 않겠다는 의사를 표시하였다고 단정할 수도 없다.”
Licensor 이익을 위한 부쟁조항 예문 Example
라이센시의 특별한 상황에서는 인정한 미연방대법원 MedImmune 판결이 나온 지 벌써 10년이 지났습니다. 현재에도 Licensee의 부쟁의무 조항에 대해 정답을 명확하게 말할 수 없을 정도로 매우 어려운 쟁점사항(issue)입니다. 최근 본 미국 블로그 내용 중에서 라이선스 실무자에게 참고자료로 도움될 것 같은 계약문구 examples을 간략하게 인용합니다.
Examples of Patent Challenge Definition Clause
Example 1: “if licensee or its affiliate under a license commences an action in which it challenges the validity, enforceability or scope of any of the patent rights under, then [a remedy will be triggered, such as termination of the license, doubling of the royalty rate, or some other event].”
Example 2: “in the event any licensee (or sublicensee or any entity or person acting on its behalf) initiates any proceeding or otherwise asserts any claim challenging the validity or enforceability of any licensed patent right in any court, administrative agency or other forum, then [a remedy will be triggered].”
Example 3: “any legal or administrative challenge to the validity, patentability, enforceability and/or non-infringement of any of the licensed patent or otherwise opposing the licensed patent.”
Examples of Licensor’s Remedies
- Right to Terminate the License
- Increase in Royalty Rates
- Liquidated Damages
- Reimbursement of Legal Fees
KASAN_특허발명 실시허여, 기술이전, 라이센스 계약서에서 Licensee의 특허유효성 도전 제한, 부쟁의무 계약조항의 효력, 쟁점, 영문 계약조항 샘플.pdf
1.3 “Commercially Reasonable Efforts” shall mean the efforts, expertise and resources normally used by a Party to develop, use, Manufacture and commercialize a product owned by it or to which it has rights, which is of similar market potential at a similar stage in its development or product life, taking into account issues of safety and efficacy, product profile, difficulty in developing the product, competitiveness of the marketplace for the product, the proprietary position of the product, the regulatory structure involved, the availability and level of reimbursement for such treatment by Third Party payors or health insurance plans, the potential total profitability of the applicable product(s) marketed or to be marketed and other relevant factors affecting the cost, risk and timing of Development and the total potential reward to be obtained if a product is commercialized.
7.1 Research and Development Efforts. The Licensee Kite shall use its Commercially Reasonable Efforts to conduct such research, development and preclinical and human clinical trials as are necessary to obtain regulatory approval to manufacture and market Licensed Products, and shall use good faith efforts to obtain regulatory approval to market, and following approval to commence marketing and market each such Licensed Product in such countries as Kite determines are commercially feasible. Kite, shall be responsible, at its sole cost and expense, for the development of Licensed Products in the Field. Kite, shall be responsible for: clinical trials with respect to the Licensed Products and filing required regulatory submissions and dealings with Regulatory Authorities with respect to Licensed Products. Kite shall also be responsible for reporting to the appropriate regulatory authorities adverse events related to Licensed Products as required by applicable law. Kite, shall also be responsible for communications with the FDA regarding such filings and Licensed Products; provided that Cabaret shall be consulted regarding any discussions or meetings with the FDA regarding Licensed Products, and following each meeting between the FDA and Kite regarding a Licensed Product, Kite shall provide Cabaret with a written summary of such meeting. Kite undertakes to use its Commercially Reasonable Efforts to ensure that the Licensed Products marketed by it will, and it shall, in carrying out its obligations hereunder, comply with all legal requirements. Kite shall notify Cabaret within [*] after Kite becomes aware of the First Commercial Sale of a Licensed Product in each country. Kite shall have the right to perform all such obligations on its own behalf, or through an Affiliate, Sublicensee or contractor (which shall constitute performance by Kite hereunder).
7.2 Records. The Licensee Kite shall maintain records, in sufficient detail and in good scientific manner, which shall reflect all work done and results achieved in the performance of its research and development regarding the Licensed Products.
7.3 Reports. Within [*] following the end of each June and December during the term of this Agreement, the Licensee Kite shall prepare and deliver to the Licensor Cabaret a written summary report which shall describe (a) the research performed to date employing the Licensed IP Rights, (b) the progress of the development, and testing of Licensed Products in clinical trials, and (c) the status of obtaining regulatory approvals to market and its commercialization activities for Licensed Products. Kite promptly shall notify Cabaret upon the initiation of any formal investigation, review or inquiry of Kite by regulatory authorities or governmental authorities concerning (i) non-clinical or clinical research relating to a Licensed Product; or (ii) the distribution, promotion or sale of a Licensed Product.
1. 사안의 개요
Gonadotropin releasing hormone (GnRH)은 전립선암, 자궁암, 유방암을 포함하여 많은 내분비계 질환과 관련된 것으로 알려져 있습니다. NY 소재 Mt. Sinai 의과대학 Dr. Sealfon 교수는 1998년경 GnRH 관련 질병치료제 개발의 기본 tool에 해당하는 연구개발성과에 대한 2건의 특허를 등록하고, 1999. 8. 27. San Diego 소재 벤처기업 Neurocrine Biosciences에 nonexclusive license를 허여하는 계약을 체결하였고, Neurocrine는 10여년간의 연구개발 끝에 2010년경 대기업 Abbott(현재 AbbVie)와 신약연구개발 성과(신약후보 물질 Elagolix 등)에 대한 exclusive license 계약을 체결하였습니다.
최초 라이선스 계약서 중 sublicense 허용조항은 다음과 같습니다. – The Licensee Neurocrine may "grant sublicenses under the License only with the prior written consent" of the Licensor Mt. Sinai.
Neurocrine에서 AbbVie와 라이선스 계약을 체결하면서 Mt. Sinai 의과대학의 사전동의를 받지 않았습니다. 그것이 라이선스 계약위반에 해당하는지, 손해배상책임 여부가 문제됩니다.
한편, Elagolix는 현재 FDA 허가심사 중인데, Mt. Sinai 의과대학에서 향후 신약에 대한 Royalty를 받을 수 있는지 등이 중대한 문제입니다.
2. 특허라이선스와 Licensee의 특허무효 부쟁의무
원칙적으로 licensee 입장에서 대상특허의 무효항변을 제기하는 것은 허용됩니다. 미국연방대법원 Lear v. Adkins (1969) 판결: a licensee cannot be estopped from challenging the validity of a patent merely because it benefitted from the license agreement.
그러나, 라이선스 계약위반으로 이미 성립된 책임을 회피하기 위해 사후적으로 제기하는 특허무효주장은 허용되지 않는다는 것이 미국법원 판결입니다. Studiengesellshaft Kohle v. Shell Oil (CAFC 1997) 판결: Lear does not apply where a licensee seeks to avoid contractual obligations already owed at the time of the suit. It "must prevent the injustice of allowing a licensee to exploit the protection of the contract and patent rights and then later to abandon conveniently its obligations under those same rights."
3. 미국법원의 Licensee Neurocrine의 대상특허 무효 항변 배척 판결
미국법원은 sublicense 허용조건으로 licensor의 사전동의를 받도록 한 계약조항을 위반한 행위에 대한 손해배상을 구하는 범위내에서 licensee의 특허무효 항변이 허용되지 않는다고 판결하였습니다.
다만, 사안을 구별하여, 특허권자가 특허기술 사용에 대한 장래 royalty를 청구하는 경우는 licensee의 특허무효 항변이 허용될 수 있다는 취지의 판결입니다. 이 부분에 대한 라이선스 계약위반 사항은 없기 때문입니다.
참고로 licensee는 특허비침해 주장도 하였지만, 미국법원은 위 사안에서 라이선스 계약위반에 대한 항변으로 허용될 수 없다고 명확하게 판결하였습니다.
대학의 특허발명에 출발하여 벤처기업에서 10여년간 연구개발한 성과를 다시 대규모 제약회사에 라이선스하여 최종적으로 신약허가신청까지 성공한 사례입니다. 여기서 최초 대학과 체결한 라이선스 계약에 관한 분쟁으로 라이선스 실무자들에게 흥미로운 사건입니다.
중도 합의로 종결되어 최종 손해배상금액까지 결정한 최종 판결이 나오지 않을 가능성이 높지만 비록 중간판결일지라도 모니터링해볼 흥미로운 사례라고 생각합니다.
미국법원 사건 정보 Case: Icahn School of Medicine at Mount Sinai v. Neurocrine Biosciences, Inc., No. 15 Civ. 9414, S.D.N.Y.
1. 머리말
대학기술을 license하여 산학공동협력연구 Research Collaboration Agreement를 체결하는 경우 후속 연구개발성과에 대한 권리귀속, 그 기술을 대기업 등 제3자에게 다시 license하거나 이전하는 등 사업화하여 수익을 창출할 수 있는 sublicense 단계에서의 수익배분 문제는 핵심쟁점 중 하나입니다.
최대한 파이를 키워야만 서로 나누어 가질 조각도 커진다는 기본전제는 분명합니다. 먼저 파이를 키우는 후속 연구개발과 sublicense는 서로 적극적으로 지원해야 합니다. 그 다음 파이조각 나누기는 쉽지 않습니다. 왜냐하면, 후속 연구개발성과에 대한 권리관계 판단이 쉽지 않기 때문입니다. 통상 sublicense는 원천기술보다 후속 연구개발성과를 본 후 원천기술에 그것을 포함하여 대상으로 하거나 원천기술보다 후속 연구개발성과를 주된 대상기술로 하기 때문입니다. 후속연구개발에 대한 기여도가 똑같지 않기 때문에 소유권 또는 지분권 등에 관한 분쟁 가능성이 높습니다.
특히 대학교수가 licensee 기업으로부터 위탁연구용역을 수주하는 경우도 많기 때문에 위탁연구 관련 발명의 발명자에 해당하는지 아니면 단순 외주 용역에 불과한지, 특히 소속대학은 직무발명 법리에 근거한 지분권이 있는지 등등 복잡한 문제가 생깁니다. 아래에서 미국대학 중 기술이전 실적이 많고 또 소송 등 권리행사에 적극적인 Wisconsin 대학의 분쟁사례 판결을 참고로 소개합니다.
2. 기술이전 및 산학협력연구
가. 대학기술 라이선스 및 산학협동연구
1999년 Wisconsin 대학교수는 SCD 저해화합물의 콜레스테롤 저하 효능을 발견하였고, Wisconsin 대학산학협력단에서 2000년 연구결과에 대한 provisional patent application을 출원하였습니다. 그 후 캐나다 제약회사 Xenon에서 특허출원기술을 포함한 exclusive license agreement 및 Wisconsin 대학교수를 포함한 연구진과 콜레스테롤 저하 효능의 신약개발에 관한 공동연구개발계약을 체결하고, 공동연구개발을 진행하여 다수 신물질의 효과를 확인하였습니다. Xenon사는 그 다음 해 2001년 provisional patent application에 대한 우선권을 주장하면서 추가 연구성과를 포함하여 대학과 공동 특허출원을 하였습니다.
나. 후속 연구개발성과에 대한 회사의 단독 특허출원
한편, Xenon은 계속하여 license 대상 물질을 넘어서 그 범위를 확대하여 수천개의 화합물의 약효를 확인하는 추가 연구개발 프로젝트를 추진하였고, 이때 위스콘신 대학이 아닌 제3의 외부 전문 연구기관과 위탁연구용역을 진행하였습니다.
그 결과 효능이 뛰어난 PPA 군 화합물 20여개를 선택한 후, 다시 Wisconsin 대학의 교수에게 보내 효능을 재확인하는 위탁연구용역을 하였습니다. 그 최종 결과물을 갖고 Xenon사 단독으로 PPA군 화합물에 대한 후속 특허출원을 하였습니다.
다. Norvatis에 sublicense 성사 및 분쟁발생
Xenon사는 후속으로 단독 출원했던 신약후보물질 PPA 관련 기술에 대해, 대형 제약회사 Novartis와 특허출원 후 3,4년이 지나 기술이전 및 license하는 계약을 체결하였습니다.
Wisconsin 대학은 Xenon의 후속 연구성과물에 대한 단독 특허출원 기술내용, PPA 기술내용도 Wisconsin 대학과 공동 출원한 선행 특허출원의 청구범위에 속하고, 대학과 체결한 exclusive license 적용대상이므로 계약상 sublicense에 해당하고, 따라서 약정한 sublicense fee를 대학에 지불해야 한다고 주장합니다.
반면, licensee Xenon사에서는 후속 연구성과 PPA 관련 기술내용은 대학과 무관하게 독자적인 연구개발의 성과물로서 단독소유라고 주장하였습니다.
또한, 설령 그 기술내용이 선출원 특허의 청구범위에 속한다고 하더라도 미국법상 공동 출원인 Xenon사는 타 공유자의 동의 없이 자유롭게 license 하는 등 실시할 권리가 있다고 주장합니다. 즉, 특허공유자는 타 공유자에게 수익 배분의 부담 없이 자유롭게 공유 특허발명을 양도 또는 라이선스를 할 수 있기 때문에 Norvatis로부터 받은 로열티 수입 중 일부를 위스콘신 대학에 배분해 주어야 할 의무는 없다고 주장합니다.
3. 미국법원 판결
Xenon사의 방어논리 중 핵심포인트는 미국특허법상 공동출원인, 특허공유자의 특허기술전체에 대한 자유로운 실시권에 기초한 것입니다. 미국법원은 특허법상 공유자의 권리의무관계는 당사자 사이의 계약으로 달리 정할 수 있고, 그 경우 당사자 사이 계약내용이 이 우선 적용된다는 기본원칙을 명확하게 밝혔습니다.
Xenon사는 Wisconsin 대학 산학협력단과 체결한 계약서에서 sublicense를 허용하고 그 경우 대학에 일정한 sublicense fee를 지불하기로 약정하였고, 그와 같은 계약은 공동출원인, 공유특허권자 사이에서도 유효한데, Xenon사에서 그와 같은 계약을 위반했다고 판결하였습니다.
결국 Xenon사는 exclusive license agreement에서 약정한 바에 따라 Norvatis로부터 받은upfront payment는 물론 향후 running royalty 중 일부를 sublicense fee로서 위스콘신 산단에 지불해야 한다는 판결입니다.
한편, 추가 PPA 화합물 20여개를 Wisconsin 대학교수에게 보내 효능을 재확인하기 위한 위탁연구용역에 관련 쟁점이 있습니다. Wisconsin 대학은 공동연구개발계약 범위 내에 속하고 대학교수는 공동발명자, 대학은 그 직무발명의 승계인으로서 권리 공유자라는 입장입니다. 미국법원은 회사 단독 소유권을 부정하고 산단에 공유자 권리를 인정하였습니다.
우리나라에서도 대학교수와 위탁연구용약을 자주 합니다. 그 결과물에 대해 대학 산학협력단의 지분권을 부인하고 의뢰자 회사의 단독 권리를 주장하는 경우가 많습니다. 해당 교수가 발명자로 인정된다면, 직무발명 등 관련 법에 따라 판단해 본다면, 설령 해당 대학교수가 용인하더라도 회사의 단독 소유 주장은 인정받기 어렵다 생각합니다.
1.26 “Sublicense” shall mean any right granted, sublicense conferred or agreement entered into, between the Licensee and a Third Party permitting any use of the Licensed IP Rights, directly or indirectly, to make, or have made, develop, offer for sale, sell or otherwise commercialize any Licensed Product; provided, however, that a Sublicense shall exclude a bona fide agreement for the evaluation, testing, research, development on behalf of Kite or its Affiliates, or manufacturing on behalf of the Licensee or its Affiliates, or a distributor or reseller agreement, all pursuant to which no Sublicense Revenues are paid to the Licensee.
1.27 “Sublicense Revenues” shall mean, with respect to a Sublicense, the aggregate cash (or cash equivalent) or stock or securities (or their equivalent) consideration received by the Licensee or its Affiliates to the extent in consideration for such Sublicense, including consideration for an option to obtain such Sublicense. Such consideration shall include without limitation any upfront, license initiation or signing fees, license maintenance fees, milestone payments, unearned portion of any minimum annual royalty payment or equity. Sublicense Revenues shall exclude [*].
3. LICENSE GRANT
3.1 Licensed IP Rights. Subject to Section 3.2 below, the Licensor Cabaret hereby grants to the Licensee Kite an exclusive (other than as set forth in Section 3.2 and 3.4 below) worldwide royalty bearing license (with the right to grant sublicenses through multiple tiers as set forth hereunder) under the Licensed IP Rights to research, have researched, develop , have developed, make, have made, use, offer for sale, sell, import, export, commercialize and otherwise exploit Licensed Products for use in the Field. Subject to the conditions set forth in Section 3.9 the foregoing license includes the right to grant sublicenses under the Licensed IP Rights, provided that, with respect to sublicenses granted under, Kite shall (a) grant such sublicenses only for consideration and at arm’s-length transactions, and (b) grant such sublicenses only pursuant to written agreements that contain such terms and conditions as may be required for Kite to comply with this Agreement.
3.2 License Restrictions. The license granted in Section 3.1 above is and shall remain at all times subject to the following restrictions (and Kite shall ensure that any of its Sublicensee’s shall be subject such restrictions): (i) the Licensor Dr. Eshhar, the Regents and the Government of the United States (the “Government”) reserve the right to use the Patents Rights and associated technology licensed under the Inter-Institutional Agreement last executed on June 22, 2012 (“UCSF IIA”), between Dr. Eshhar, BioSante and The Regents, and disclosed to Kite under Section 2.2.5 above, and the Inter-institutional Agreement dated 19.11.2013 (“NIH Agreement”), for educational and research purposes; (ii) nothing in this Agreement shall confer by estoppel, implication or otherwise, any license or rights under any patents of the Regents other than those patents rights detailed in the USCF IIA, regardless of whether such patents are dominant or subordinate to the Patents Rights defined in the UCSF IIA; (iii) Kite shall not use the name or trademark or logo of the University of California or any campus thereof; in each case to the extent required by the UCSF HA; (iv) the license is subject to the provisions of 37 C.F.R. Part 401 and the rights retained by the Government under the NIH Agreement; and (v) until the last to expire of U.S. Patent 8,211,422 issued July 3, 2012 from Patent Application 08/547,263 filed October 24, 1995 entitled “Chimeric Receptor Genes and Cells Transformed Therewith” and US Patent Application 13/281,560 filed October 26, 2011 entitled “Chimeric Receptor Genes and Cells Transformed Therewith” (hereinafter referred to as the “NIH Patent Estate”) any products embodying the Licensed Patent Rights, or produced through use of the Licensed Patent Rights, shall be manufactured substantially in the United States unless a waiver is granted by the NIH; provided that NIH may waive this requirement upon Kite’s written request which shall not be unreasonably denied; (vi) until the last to expire of the NIH Patent Estate, the Government shall have the irrevocable, royalty-free, paid-up right to practice and have practiced the NIH Patent Estate and Eshhar patents 5,906,936 and 7,741,465, throughout the world by or on behalf of the Government and on behalf of any foreign government or international organization pursuant to any existing or future treaty or agreement to which the Government is a signatory; (vii) until the last to expire of the NIH Patent Estate, the NIH reserves the right to require Cabaret, or its licensees, to grant sublicenses to the patent rights to responsible applicants, on terms that are reasonable under the circumstances when necessary to fulfill health or safety needs or when necessary to meet requirements for public use specified by Federal regulations; and (viii) until the last to expire of the NTH Patent Estate, in addition to the reserved right of Section 3.2(vi), the NIH reserves the right to require Cabaret to grant research licenses to the patent rights on reasonable terms and conditions, for the purpose of encouraging basic research, whether conducted at an academic or corporate facility.
3.4 No implied licenses are set forth herein. Except for those licenses expressly granted hereunder in the Field, Cabaret does not grant to Kite any other licenses, either within or without the Field. Kite specifically understands and agrees that except as explicitly set forth herein, Cabaret reserves all rights under the Licensed IP Rights to make, have made, use, sell, offer for sale, import, export, distribute and otherwise exploit products incorporating the Licensed IP Rights outside the Field. Without derogating from the generality in Section 3.2 above, Dr. Eshhar and Cabaret reserve the right to use all Licensed IP Rights licensed hereunder for educational and noncommercial research purposes in any and all fields.
3.5 In-Licenses. The Licensor Cabaret shall timely pay in full all amounts required to be paid by Cabaret, and timely perform in full all obligations required to be performed by Cabaret, under all In-Licenses. Cabaret promptly shall provide the Licensee Kite with copies of all notices and other deliveries received under the In-Licenses. Without the prior express written consent of Kite, Cabaret shall not (and shall take no action or make no omission to) modify or waive any provision of any In-License that could impair the value of the licenses to Kite herein, or to terminate or have terminated any In-License. If any In-License is terminated for any reason, Cabaret shall make all reasonable efforts to ensure that the Licensor thereunder shall grant a direct license under the Licensed IP Rights thereunder to Kite containing terms and conditions no less favorable to Kite than the terms (including the payment terms) of such In-License, and Kite shall have the right to offset all payments thereunder against any amounts owing to Cabaret hereunder.
3.6 Availability of the Licensed IP Rights. The Licensor Cabaret shall provide the Licensee Kite with a copy of all information available to Cabaret relating to the Licensed IP Rights or Licensed Products.
3.7 Technical Assistance. Cabaret and Dr. Eshhar shall provide such technical assistance to Kite as Kite reasonably requests regarding the Licensed IP Rights. Kite shall pay to Cabaret and Dr. Eshhar their documented reasonable out-of-pocket costs of providing such technical assistance.
3.8 Right of First Offer. In the event that Cabaret proposes to enter into an agreement with any Third Party for the grant to any Third Party of any license, immunity, right or interest of any type whatsoever in or under the Licensed Patent Rights outside the Field, Cabaret shall as soon as practicable notify Kite of such intention (the “Company Notice”), and the Licensee Kite shall have the right, to be exercised by notice to Cabaret to express its interest to negotiate with Cabaret regarding receipt of such license within a period of [*] after the date of the Company Notice (such period, the “Negotiation Period”). During the Negotiation Period, Kite will notify Cabaret within [*] of its interest to negotiate with Cabaret, and in such event Cabaret shall negotiate in good faith with Kite regarding receipt of such license. To the extent that Kite notified Cabaret of its interest to negotiate with Cabaret, as set forth above, prior to the expiration of the Negotiation Period, Cabaret shall not enter into any definitive binding agreement of any kind with a Third Party in relation to such license (other than relating to access to information).
3.9 Sublicenses. The Licensee Kite shall be entitled to grant Sublicenses, provided, however, that all Sublicenses shall be subject to the following conditions:
3.9.1 The Licensee Kite shall execute a written sublicense with each Sublicensee, which mirrors the restrictive terms hereof and shall provide Cabaret with a copy of each such written sublicense within [*] of execution (and all amendments and modifications thereto within [*] of execution). Kite shall report pursuant to the terms of this Agreement Net Sales of the Licensed Product by all Sublicensees and
3.9.2 The Licensee Kite shall use reasonable efforts to add to the Sublicense agreement a clause stating that, in case of a default of payment due by Kite of royalties owing on Net Sales by a Sublicensee, which is not cured within [*] after notice in accordance with this Agreement, then upon the written request of Cabaret, such Sublicensee will make future royalty payments and furnish the reports and documents that are required to be paid or furnished by Kite pursuant to this Agreement with respect to Net Sales by such Sublicensee directly to Cabaret.
3.9.3 The Licensee Kite shall, and by this Agreement herewith does, agree to cause its Sublicensees to assume and agree to perform all of the relevant covenants and obligations of Kite to Cabaret contained in this Agreement as fully and to the same extent as if its Sublicensees were Kite hereunder and guarantees Cabaret that its Sublicensees shall abide by each and every applicable provision of this Agreement.
4.5 Sublicense Fees. Subject to the terms and conditions of this Agreement, with respect to each Sublicense with respect to a Licensed Product, Kite shall pay to Cabaret sublicense fees equal to the applicable percentage set forth below of the Sublicense Revenue therefrom (based on the effective date of such Sublicense) (“Sublicense Fees”):
Notwithstanding the foregoing, with respect to any Sublicense Fees paid to Cabaret on account of Sublicense Revenues received by Kite from a Sublicensee in connection with the achievement of any technical, development, regulatory through commercial launch milestone event for a Licensed Product, Kite shall deduct from such Sublicense Fees the milestone payments made by Kite to Cabaret pursuant to Section 4.5 above with respect to the same Licensed Product.
“Affiliates” shall mean any company which directly or indirectly controls, is controlled by, or is under common control of a party to this agreement.
“Affiliate” shall mean, with respect to any Person, any other Person which directly or indirectly controls, is controlled by, or is under common control with, such Person. A Person shall be regarded as in control of another Person if it owns, or directly or indirectly controls; at least fifty percent (50%) of the voting stock or other ownership interest of the other Person, or if it directly or indirectly possesses the power to direct or cause the direction of the management and policies of the other Person by any means whatsoever.
“Affiliate” means, with respect to any party, any entity controlling, controlled by, or under common control with such party, during and for such time as such control exists. For these purposes, “control” shall refer to the ownership, directly or indirectly, of at least [*]% of the voting securities or other ownership interest of the relevant entity.
“Affiliate” means any Person who, directly or indirectly through one or more intermediates, controls or is controlled by or is under common control with another Person, but only for so long as such relationship exists. For purposes of this definition, the term “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”) as used with respect to a Person means the possession, directly or indirectly through one or more intermediates, of the power to direct, or cause the direction of, the management or policies of such Person, whether through the ownership of voting securities, by contract or otherwise. Such power will be deemed to exist in the case of ownership, directly or through one or more Affiliates, of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or fifty percent (50%) or more of the equity interest, in the case of any other type of legal entity, or status as a general partner in any partnership. The Parties acknowledge that, in the case of certain entities organized under the laws of certain countries, the maximum percentage ownership permitted by Law for a foreign investor may be less than fifty percent (50%), and in such case such lower percentage shall be substituted in the preceding sentence; provided, that such foreign investor has the power to direct the management and policies of such entity.
KASAN_국제계약서에 통상 들어가는 일반조항 Affiliate 정의조항 사례 – 기술이전, 라이선스 계약서 샘플.pdf
10. REPRESENTATIONS, WARRANTIES, AND COVENANTS.
10.1 Mutual Representations and Warranties. Licensor and Licensee (each, a “Representing Party”) each hereby represents and warrants to each other, as of the Effective Date and except as otherwise set forth in Schedule 10.2 (in the case of Licensor) and Schedule 10.3 (the case of Licensee), that:
(a) such Representing Party is a corporation or limited liability company, as applicable, duly organized and subsisting under the laws of its jurisdiction of organization;
(b) such Representing Party has the power, authority, and legal right, and is free, to enter into this Agreement on behalf of itself and its Affiliates and to perform its respective obligations hereunder and to cause its Affiliates to perform their respective obligations hereunder;
(c) such Representing Party has the power, authority, and legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as it is contemplated to be conducted by this Agreement;
(d) this Agreement constitutes a legal, valid, and binding obligation of such Representing Party and is enforceable against it in accordance with its terms, subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered a proceeding at law or equity;
(e) the execution and delivery of this Agreement and the performance of such Representing Party’s and its Affiliates’ obligations hereunder (i) have been duly authorized and approved by all necessary action by such Representing Party, and all necessary consents, approvals, and authorizations of all Regulatory Authorities and other Third Parties required to be obtained by such Representing Party in connection with the execution and delivery of this Agreement and the performance of its obligations hereunder have been obtained; (ii) do not conflict with or violate any requirement of Applicable Laws or any provision of the articles of incorporation, bylaws, limited partnership agreement, or any similar instrument of such Representing Party, as applicable, in any material way; and (iii) do not, and will not, conflict with or otherwise interfere with in such a manner as to result in a violation, breach, or default under or require any consent that has not been obtained under any contract between such Representing Party and any Third Party;
(f) there are no, and shall be no, liens, conveyances, mortgages, assignments, encumbrances, or other agreements that would prevent or impair such Representing Party’s or any of its Affiliates’ full and complete exercise of the terms and conditions of the Agreement;
(g) such Representing Party and its Affiliates shall at all times comply with all Applicable Laws relating or pertaining to their obligations under the Agreement;
(h) with respect to the services provided hereunder to the other Party, its Affiliates, and their respective employees, officers, contractors and agents who perform such services have the experience, capability, and resources to efficiently and skillfully perform the services, and shall perform, where applicable, all such services in a professional and workmanlike manner and in accordance with the generally accepted then-current standards, forms, procedures, and techniques established from time to time by the industry;
(i) all of such Representing Party’s employees, officers, contractors, and consultants have executed agreements requiring assignment to such Representing Party of all inventions created by such persons in the course of their employment by such Representing Party and obligating each such employee, officer, contractor, and consultant to maintain and safeguard the confidentiality of (i) any information that is confidential to such Representing Party or (ii) any information that is confidential to any other Person and that such Representing Party is obligated to maintain and safeguard as confidential; and
(j) neither such Representing Party, nor any of its employees, officers, subcontractors, or consultants who have rendered or will render services relating to the Product: (i) has ever been debarred or is subject or debarment or convicted of a crime for which an entity or person could be debarred under 21 U.S.C. Section 335a or (ii) has ever been under indictment for a crime for which a person or entity could be debarred under said Section 335a.
10.2 Additional Representations, Warranties, and Covenants of Licensor. Licensor hereby represents, warrants, and covenants to Licensee, as of the Effective Date and except as otherwise set forth in Schedule 10.2, that:
(a) Licensor is entitled to grant the rights and licenses purported to be granted to Licensee under this Agreement, and to assign the rights purported to be assigned to Licensee under this Agreement, and is not currently bound by any agreement with any Third Party, or by any outstanding order, judgment, or decree of any court or administrative agency, that restricts it from granting to Licensee the rights, licenses and sublicenses purported to be so granted in this Agreement;
(b) Licensor is the sole and exclusive owner of all right, title, and interest, in, to, and under the Licensed Rights and has the right under the Licensed CPEX Patent Rights and the Licensed Reprise Patent Rights to grant the sublicenses thereunder in accordance with Section 2.2;
(c) the Licensed Rights are free and clear of any liens, charges, encumbrances, or judgments, and Licensor has sufficient rights to grant the licenses and rights purported to be granted herein, free and clear of any security interests, claims, encumbrances, or charges of any kind;
(d) Licensor has not granted, and will not grant during the term of this Agreement, any right, option, license, or interest in or to any of the Licensed Rights that is in conflict with the rights assigned or granted to Licensee under this Agreement;
(e) there is no legal, administrative, arbitration, or other proceeding, suit, claim, or action of any nature, judgment, decree, decision, injunction, writ, or order pending, or to Licensor’s knowledge threatened by, against or involving Licensor, regarding the Licensed Rights, whether at law or in equity, before or by any Third Party, and Licensor has not received any written communications alleging that it has violated, through the manufacture, Development, import, or other exploitation of the Product, any intellectual property rights of any Third Party;
(f) to Licensor’s knowledge:
(i) the patents in the issued Licensed Serenity Patent Rights, the Licensed CPEX Patent Rights, and the Licensed Reprise Patent Rights are valid and enforceable; and
(ii) no Third Party has asserted that any of the Licensed Rights or the Sublicensed Rights is invalid or unenforceable;
(g) all applications, registrations, maintenance and renewal fees due in respect of any of the Licensed Serenity Patent Rights and, to Licensor’s knowledge, the Licensed Reprise Patent Rights and the Licensed CPEX Patent Rights, have been paid and all documents and certificates required to be filed with the relevant agencies for the purpose of maintaining such Licensed Serenity Patent Rights, and to Licensor’s knowledge, the Licensed Reprise Patent Rights and Licensed CPEX Patent Rights have been filed;
(h) none of the Licensed Serenity Patent Rights, the Licensed Serenity Know-How and, to Licensor’s knowledge, none of the Licensed CPEX Patent Rights and the Licensed Reprise Patent Rights were developed with funding from any Governmental Authority such that any Governmental Authority has any march in rights or other rights to use the Licensed Serenity Patent Rights, the License Serenity Know-How, the Licensed Reprise Patent Rights, or the Licensed CPEX Patent Rights;
(i) to Licensor’s knowledge, no Third Party has infringed or misappropriated any of the Licensed Rights or the Sublicensed Rights;
(j) all inventors of any inventions included within the Licensed Serenity Patent Rights and, to the knowledge of Licensor, the Licensed CPEX Patent Rights and the Licensed Reprise Patent Rights have assigned their entire right, title, and interest in and to such inventions and the corresponding patents and patent applications to Licensor, Reprise, or CPEX, as applicable, and have been listed as inventors in the Licensed Serenity Patent Rights, the Licensed CPEX Patent Rights, and the Licensed Reprise Patent Rights, as applicable;
(k) no agreements that Licensor or its Affiliates may have with any Third Party provide such Third Party with any rights of first offer, rights of first refusal, or any other rights to make, have made, use, conduct Clinical Studies for, sell, offer for sale, have sold, import, export, or otherwise Exploit the Product in the Field in the Territory or the right to use the Licensed Rights or the Sublicensed Rights in connection with the Exploitation of the Product in the Field in the Territory; and Licensor has received no notice from a Third Party of any suit, action, proceeding, or arbitration pending or threatened against it that the proposed terms and conditions of this Agreement, and the Parties’ performance in accordance therewith, do or shall conflict or interfere with in a manner resulting in a breach or default under, or other violation of, any agreements that Licensor or its Affiliates may have with any Third Party;
to Licensor’s knowledge,
(i) each of the CPEX License Agreement and the Reprise License Agreement is valid and enforceable in accordance with its terms, is in full force and effect, and there are no approvals or consents required to make it effective, (ii) Licensor has supplied Licensee with a true and correct copy of the CPEX License Agreement and the Reprise License Agreement , together with all amendments, waivers, or other changes thereto, (iii) Licensor has performed all material obligations required to be performed by it in connection with the CPEX License Agreement and the Reprise License Agreement, (iv) Licensor shall not materially breach and is not in material breach of the CPEX License Agreement or the Reprise License Agreement, (v) Licensor is not in receipt of any claim of default, cure notice, or show cause notice under the CPEX License Agreement or the Reprise License Agreement, and (vi) there is no current material breach or anticipated material breach by any other party to the CPEX License Agreement or the Reprise License Agreement;
(m) (i) Licensor is the named sponsor of the First Approved NDA for the Product; and (ii) with respect to all Regulatory Documentation to obtain Regulatory Approvals for the Product in the Field: (A) the data, information and/or all other documents in Licensor’s or its Affiliates submissions were, are and shall be free from fraud or material falsity, and neither Licensor nor its Affiliates has made any material misrepresentation or omission in connection with such data; (B) the Regulatory Approvals have not been and will not be obtained either through bribery or the payment of illegal gratuities by Licensor; (C) the data, information and/or all other documents in Licensor’s or its Affiliates’ submissions are, were and shall be accurate and reliable for purposes of supporting approval of the submissions; and (D) the Regulatory Approvals shall be obtained without illegal or unethical behavior of any kind by Licensor or its Affiliates; provided that Licensor shall not be deemed to be in breach of this Section 10.2(m) if the violation of this Section 10.2(m) results from the action or omission of Licensee of Licensee’s Affiliates, Sublicensees, or contractors (other than Licensor);
(n) Licensor believes in good faith, based on the information set forth in Schedule 10.2(n), that FDA will consider amending or supplementing the First Approved NDA (or the related IND) in the manner described in Schedule 10.2(n); provided, however, that Licensor cannot assure that FDA will approve such amendment or supplement.
(o) except as expressly permitted hereunder, Licensor agrees not to, and agrees to cause its Affiliates and Sublicensees not to (i) assign, transfer, convey or otherwise encumber any right, title or interest in or to the Licensed Rights, the Sublicensed Rights, or any Regulatory Approvals and Documentation in respect of the Product, (ii) grant in any manner any license or other right, title or interest in or to any of the Licensed Rights, the Sublicensed Rights, or the Regulatory Approvals and Documentation in respect of the Product, or (iii) agree to or otherwise become bound by any covenant not to sue for any infringement, misuse or other action or inaction with respect to any of the Licensed Rights, the Sublicensed Rights, or the Regulatory Approvals and Documentation in respect of the Product; and
(p) other than the CPEX License Agreement, the Reprise License Agreement, the Renaissance Supply Agreements, and the other Third Party Supply Agreements, Licensor and/or its Affiliates have not entered into any agreements with any Third Party, pursuant to which any Third Party has granted to Licensor, or Licensor has granted to any Third Party, any rights to licenses to, in or under any of the Licensed Rights or the Sublicensed Rights or other intellectual property rights that relate to the Product, or relating to the manufacture of the Product.
10.3 Additional Representations, Warranties, and Covenants of Licensee. Licensee hereby represents, warrants, and covenants to Licensor, as of the Effective Date and except as otherwise stated in Schedule 10.3, that:
(a) if, during the term of this Agreement Licensee has reason to believe that it or any of its employees, officers, subcontractors, or consultants rendering services relating to the Product: (i) is or will be debarred or convicted of a crime under 21 U.S.C. Section 335a, or (ii) is or will be under indictment under said Section 335a, then Licensee shall immediately notify Licensor in writing;
(b) as of the Effective Date, there is no legal, administrative, arbitration, or other proceeding, suit, claim, or action of any nature, judgment, decree, decision, injunction, writ, or order pending or, to the knowledge of Licensee’s senior management, threatened by, against Licensee regarding this Agreement, whether at law or in equity, before or by any Third Party; and Licensee shall provide notice of any of the foregoing to the extent it affects Licensee’s performance of its obligations under this Agreement;
(c) except for information provided by Licensor, its Affiliates or Sublicensees: (i) the data and information in Licensee’s submissions and modifications of Regulatory Documentation relating to the Product shall be free from fraud or material falsity; (ii) Regulatory Approvals for the Product hereafter obtained will not be obtained either through bribery or the payment of illegal gratuities by Licensee; (iii) the data and information in Licensee’s submissions and modifications of any Regulatory Documentation shall be accurate and reliable; and (iv) any such the Regulatory Approvals will be obtained without illegal or unethical behavior of any kind by Licensee; provided that Licensee shall not be deemed to be in breach of this Section 10.3(c) if the violation of this Section 10.3(c) results from the action or omission of Licensor or its Affiliates, Sublicensees (other than Licensee), or contractors; and
(d) except as expressly permitted hereunder, Licensee agrees not to, and agrees to cause its Affiliates and Sublicensees not to (i) assign, transfer, convey or otherwise encumber any right, title or interest in or to the Licensed Rights, the Sublicensed Rights, or any Regulatory Approvals and Documentation in respect of the Product, (ii) grant in any manner any license or other right, title or interest in or to any of the Licensed Rights, the Sublicensed Rights, or the Regulatory Approvals and Documentation in respect of the Product, (iii) agree to or otherwise become bound by any covenant not to sue for any infringement, misuse or other action or inaction with respect to any of the Licensed Rights, the Sublicensed Rights, or the Regulatory Approvals and Documentation in respect of the Product, or (iv) bring any action or proceeding or otherwise assert any claim under any Applicable Law in the event any licensee (or sublicensee or any entity or person acting on its behalf) initiates any proceeding or otherwise assert any claim in any court, administrative agency, or other forum with jurisdiction over such proceeding or claim, that any of the Licensed Rights or Sublicensed Rights are invalid, unenforceable, or not infringed, violated, or misappropriated. In the event that Licensee or any Affiliate or Sublicensee of Licensee initiates any proceeding or otherwise asserts any claim in violation of clause (iv) of this Section 10.3, and the result thereof is a final decision, ruling, holding, award, or other disposition to the effect that any of the Licensed Rights or Sublicensed Rights are valid, enforceable, or infringed, violated, or misappropriated, then each of the royalty rates set forth in the table in Section 8.3(a) will each be increased by [*] and the party initiating such proceeding or otherwise asserting such claim shall pay the attorneys’ fees and expenses incurred by Licensor in defending against such proceeding or claim.
10.4 Inaccuracies. Without limiting either Party’s rights and remedies at law, in equity or under this Agreement, if, at any point in time (not just at the times when the warranties are deemed granted), either Party becomes aware of any inaccuracies in the foregoing warranties and representations, such Party shall promptly notify the other Party of such inaccuracies, with a detailed written explanation.
1. 진술 및 보증조항 관련 분쟁
정유회사의 M&A 주식양수도계약서에서 '양도인은 양수인에게 주식양수도계약 체결일 및 양수도 실행일에 일체의 행정법규를 위반한 사실이 없고, 이와 관련하여 행정기관으로부터 조사를 받고 있거나 협의를 진행하는 것은 없다’는 내용의 진술 및 보증조항, 나아가 '양수도 실행일 이후 보증 위반사항이 발견된 경우나 약속사항 위반으로 손해가 발생할 경우 500억원을 초과하지 않는 범위 내에서 배상하기로 한다'는 책임조항이 포함되어 있었습니다.
그런데, 양도인 회사는 군용유류 구매입찰에서 담합행위 등 공정거래법을 위반했다는 이유로 거액의 과징금 납부명령을 받았고 거액의 손해배상청구소송까지 제기 받았습니다. 이에 양수인이 진술 및 보증조항 위반을 이유로 책임조항을 적용하여 양도인에 대한 손해배상청구 소송을 제기하였습니다.
2. 항소심 서울고등법원 2008나19678 판결
항소심 법원은 양수인도 진술 및 보증위반 사항을 알면서도 계약을 체결했다는 이유로 양도인의 책임을 인정하지 않았습니다. 판결문 중 핵심부분을 인용하면 다음과 같습니다. "양수인도 이 사건 담합행위에 직접 참여했던 탓에 주식양수도계약 체결 당시에 이미 이 사건 진술 및 보증 조항의 위반사실을 알고 있었고, 계약협상 및 가격산정에 반영할 수 있었음에도 방치하였다가 이후 위반사실이 존재한다는 사정을 들어 양도인 피고에게 책임을 묻는 것은 공평의 이념 및 신의칙상 허용될 수 없으므로, 양도인 피고는 위와 같은 악의의 주식양수인인 원고에 대하여 이 사건 진술 및 보증 조항의 위반에 따른 책임을 부담하지 않는다."
3. 대법원 2012다64253 판결
원심판결을 파기 환송하였습니다. "이 사건 주식양수도계약의 양수도 실행일 이후에 이 사건 진술 및 보증 조항의 위반사항이 발견되고 그로 인하여 손해가 발생하면, 원고가 그 위반사항을 계약체결 당시 알았는지 여부와 관계없이, 피고들이 원고에게 그 위반사항과 상당인과관계 있는 손해를 배상하기로 하는 합의를 한 것으로 봄이 상당하다.
양수인 원고가 이 사건 진술 및 보증조항과 관련된 이 사건 담합행위를 알고 있었고 이 사건 담합행위로 인한 공정거래위원회의 제재 가능성 등을 이 사건 주식양수도대금 산정에 반영할 기회를 가지고 있었다고 하더라도 그러한 점만으로 원고의 손해배상청구가 공평의 이념 및 신의칙에 반한다고 볼 수 없다."
4. 실무적 함의
대법원 판결은 계약서 문언이 가장 중요하다는 원칙을 다시 한번 확인하였습니다. 비록 계약체결 당시 당사자가 진술 및 보증 조항의 위반사실을 알고 있었다고 해도 계약서 효력을 함부로 부정할 수 없다고 명확하게 판결하였습니다.
처분문서인 계약서의 계약문언이 그 객관적 의미가 명확하다면 특별한 사정이 없는 한 문언대로의 의사표시의 존재와 내용을 인정하여야 합니다. 설령 공평의 이념이나 신의칙을 적용해야 할 사정이 있다고 하더라도, 이과 같은 일반원칙에 근거하여 계약의 효력을 부정하거나 계약상 책임을 제한하는 것은 사적 자치의 원칙이나 법적 안정성에 대한 중대한 위협이 될 수 있으므로 신중을 기하여 극히 예외적으로 인정하여야 한다는 입장입니다.
즉, 무엇보다 계약서 문언을 가장 중시하고 신의칙이나 공평이념 등을 아주 예외적으로 극히 신중하게 적용하라는 취지입니다. 가능성을 완전히 배제하는 것은 아니지만 현실적으로 실제 사례에서 그와 같은 특별한 경우는 인정되기 어렵다는 의미입니다.
5. 진술 및 보증 조항 위반과 손해배상책임 범위: 대법원 2018. 7. 20. 선고 2015다207044 판결
(1) M&A 계약에서 진술 및 보증 조항을 둔 목적은, 계약 종결과 이행 이후 진술 및 보증하였던 내용과 다른 사실이 발견되어 일방 당사자에게 손해가 발생한 경우에 상대방에게 그 손해를 배상하게 함으로써, 불확실한 상황에 관한 경제적 위험을 배분하고 사후에 현실화된 손해를 감안하여 매매대금을 조정할 수 있게 하기 위한 것이다.
(2) M&A 대상회사에 대한 소송이나 분쟁의 존재는 우발채무에 따른 손실로 이어질 가능성이 있어 진술 및 보증의 대상으로 삼는 것이다.
(3) 매도인이 대상회사에 대한 소송이나 분쟁을 고지하지 않았고 이후 대상회사에 실제로 우발채무가 발생한 경우 언제나 그 전부가 손해배상의 범위에 포함된다고 볼 수는 없다. 제3자가 대상회사를 상대로 터무니없는 소송을 제기하였음에도 매도인이 이를 알리지 않은 상태에서 M&A 계약이 종결, 이행되었는데, 매도인에게 책임을 물을 수 있으므로 매수인으로서는 실질적 피해가 없다는 이유로 대상회사로 하여금 별다른 다툼 없이 거액의 합의금을 지급하도록 하는 경우와 같이, 매도인에게 과도한 책임을 지우는 결과를 초래할 수 있기 때문이다.
(4) 그러나 소송 또는 분쟁으로부터 직접 그리고 자연스럽게 도출되거나 합리적으로 예상가능한 범위의 손해에 관하여는 매도인이 그에 관한 배상책임을 부담하여야 한다.
(5) 매수인이 거래 종결 후 대상회사 주식을 매각하는 경우 대부분 매수인은 후속 매수인에게 진술 및 보증을 하고 그 위반으로 인한 책임을 부담하게 된다.
(6) 만약 매도인의 진술 및 보증 조항 위반으로 매수인의 주식 매각 이후 대상회사에 손실이 발생하고, 그로 인해 매수인이 새로운 매수인에 대하여 책임을 부담하게 되었음에도, 매수인이 주식을 매각하여 주주의 지위에 있지 않다는 이유로 당초의 매도인에게 책임을 물을 수 없는 결과에 이른다면 경제적 위험의 적정한 배분이라는 진술 및 보증 조항의 목적에 반하게 된다.
(7) 따라서 당사자들 사이에 특별한 합의가 없다면 매수인이 대상회사의 주식을 처분하더라도 손해배상청구 및 액수 산정에 별다른 영향을 미치지 않는다.
KASAN_진술보증 조항 REPRESENTATIONS AND WARRANTIES 관련 분쟁 - M&A 계약서 중 진술 및 보증조항 위반 및 손해배상책임 범위.pdf
License 후 공동연구개발을 진행하지만 완료까지 오랜 기간이 소요되는 경우, 기술보유 licensor 벤처회사가 투자유치 또는 M&A 등으로 지배권 변동이 발생하기도 합니다. Licensee의 경쟁회사에서 licensor 회사를 M&A하는 경우는 물론, 제품라인이 중복되거나 연구개발전략이 전혀 달리하는 등 다양한 사유로 collaboration 관계를 지속하기 어려운 상황을 맞기도 합니다.
이와 같은 상황에 대비하여 미리 해결방안을 계약조항으로 규정해 두는 것이 바람직합니다. 다양한 쟁점이 있겠지만, 최근 올려드린 자문의 계약서 중 해당 조항을 뽑아 아래와 같이 인용합니다. 찬찬히 읽어 보고 살펴보시기 바랍니다.
정의 - "CHANGE IN CONTROL" shall mean, with respect to either Party, any of the following events: (i) the acquisition by any Major Pharmaceutical Company of "beneficial ownership" directly or indirectly, of 50% or more of the shares of such Party's capital stock, the holders of which have general voting power under ordinary circumstances to elect at least a majority of such Party's Board of Directors or equivalent body (the "Board of Directors") (the "Voting Stock"); (ii) the approval by the shareholders of such Party of a merger, share exchange, reorganization, consolidation or similar transaction of such Party (a "Transaction"), if any party to the transaction is a Major Pharmaceutical Company other than a Transaction which would result in the beneficial owners of Voting Stock of such Party immediately prior thereto continuing to beneficially own (either by such Voting Stock remaining outstanding or being converted into voting securities of the surviving entity) more than 50% of the Voting Stock of such Party or such surviving entity immediately after such Transaction; or (iii) approval by the shareholders of such Party of a complete liquidation of such Party or a sale or disposition of all or substantially all of the assets of such Party.
처리방안 계약조항 - CHANGE IN CONTROL. In the event there shall be a Change in Control with respect to either Party, the Party not involved in the Change in Control shall have a period of ninety (90) days following the Change in Control to give notice to the other Party that it desires to terminate this Agreement. If such notice is given, then the Parties shall arrange for a valuation of the value of their respective interests in this Agreement using the procedures set forth in Section 12.7(b)(i).
Upon receipt of the valuation, the Party not involved in the Change in Control shall have the option within thirty (30) days of receipt of the valuation either to (i) withdraw its notice terminating this Agreement or (ii) confirm its desire to terminate, in that case the Party experiencing the Change in Control shall elect either to (a) purchase the other Party's interest at the established value or (b) sell its own interest to the other Party at the appraised value of its interest. The Parties shall negotiate in good faith such other terms and conditions and take such other actions as shall be necessary to effect the sale or purchase contemplated hereby within the shortest possible time.
신약 기술이전 및 공동연구개발 계약
8.5. Change of Control.
8.5.1. Change of Control Notice. Astellas will notify Ironwood in writing, referencing this Section 8.5.1 of this Agreement, immediately upon any Change of Control of Astellas, and will provide such notice where possible at least 60 days prior to the Change of Control.
8.5.2. Consequences of a Change of Control.
(a) In the event that Astellas is subject to a Change of Control which could reasonably be expected to lead to an Impairment (as defined below), Astellas will notify Ironwood at least [**] days prior to the closing of such transaction, and Ironwood may elect, in its sole discretion, to (i) continue this Agreement in accordance with its terms, (ii) terminate this Agreement on [**] months notice, during which period this Agreement would continue in effect in accordance with its terms, such notice to be delivered within [**] days after the Fair Market Value is determined pursuant to this Section 8.5.2(a). Within [**] days following Ironwood’s receipt of notice from Astellas of a Change of Control that could reasonably be expected to lead to an Impairment, Ironwood will provide notice to Astellas requesting a determination of the Fair Market Value upon a termination of this Agreement pursuant to this Section 8.5.2(a), and the failure to so request such valuation will be deemed the election to continue this Agreement in accordance with its terms. Such determination must be made by the Parties in good faith, and if such determination is not made within [**] days of the request, then as determined by a Valuation Panel. In connection with such termination, Ironwood will be required to pay Astellas an amount equal to the upfront portion of the Fair Market Value within ten days of the effective date of the termination, and, as they become due, payment of any ongoing, and/or recurring license fees, royalties, and other payments that may be part of Fair Market Value.
(b) For purposes of this Section 8.5.2, an “Impairment” will only be deemed to occur if (a) it is reasonably anticipated that the entity resulting from such Change of Control will be unable to perform its obligations in accordance with the terms of this Agreement, as reasonably determined based on objective criteria available to both Parties, including without limitation, the new entity’s financial position and product pipeline, (b) the product line of the entity that survives following the Change of Control includes a product in an Oral Formulation in the Field that is in clinical development which is indicated for the treatment of IBSC, CC, OIC (unless as to any such indication, the JSC has determined not to pursue Development for such indication) or any other indication for which the Product is then being Commercialized in the Territory pursuant to this Agreement.
14. TERM AND TERMINATION.
14.1 Term. The term of this Agreement shall commence as of the Effective Date and shall continue in effect until it is terminated as specifically provided in this Agreement.
14.2 Termination for Material Breach.
(a) If either Party (the “non-breaching Party”) believes the other Party (the “alleged breaching party”) is in material breach of any of such alleged breaching Party’s obligations under this Agreement, the non-breaching Party may give notice of such breach to the alleged breaching Party, and the alleged breaching Party shall have sixty (60) days in which to remedy such material breach or establish that it is not in material breach hereunder. Subject to Section 14.2(b), if such alleged material breach is not remedied in the time period set forth above, the non-breaching Party shall be entitled, without prejudice to any of its other rights conferred on it by this Agreement, and in addition to any other remedies available to it by law or in equity, to terminate this Agreement upon written notice to the alleged breaching Party.
(b) If the alleged breaching Party disputes in good faith the existence or materiality of a breach specified in a notice provided by the non-breaching Party pursuant to Section 14.2(a), and the alleged breaching Party provides notice to the non-breaching Party of such dispute within fifteen (15) days after receipt of such notice, the non-breaching Party shall not have the right to terminate this Agreement unless and until the existence of such material breach by the alleged breaching Party has been determined in accordance with the dispute resolution procedures set forth in Section 15.8 (each such termination delay, a “Toll Period”) and the breaching Party fails to cure such default within sixty (60) days following such determination; provided that, if it is determined that such material breach occurred and such breach is not cured within such sixty (60) day period, then, for purposes of Section 14.4(c)(iii), this Agreement shall be deemed to have been terminated as of the date of delivery of notice of such breach under Section 14.2(a). During the pendency of such a dispute, all of the terms and conditions of this Agreement shall remain in effect and the Parties shall continue to perform all of their respective obligations hereunder.
14.3 Termination upon Insolvency. To the extent permitted under Applicable Laws, either Party may terminate this Agreement with respect to the other Party if, at any time, such other Party shall file in any court or agency pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of such other Party or of its assets, or if such other Party proposes a written agreement of composition or extension of its debts, or if such other Party shall be served with an involuntary petition against it, filed in any insolvency proceeding, and such petition shall not be dismissed within forty-five (45) days after the filing thereof, or if such other Party shall propose or be a party to any dissolution or liquidation, or if such other Party shall make an assignment for the benefit of its creditors.
14.4 Termination upon Force Majeure. Either Party may terminate this agreement due to a Force Majeure event pursuant to Section 15.13.
14.5 Consequences of Expiration or Termination.
(a) Upon termination of this Agreement by either Party pursuant to Sections 14.2, 14.3, or 14.4,
(i) all of the licenses granted by Licensor to Licensee shall therewith immediately terminate and any sublicenses granted by Licensee thereunder will be subject to the provisions set forth in Section 2.4(f);
(ii) Licensee must assign and transfer to Licensor, and shall cause its Affiliates and Sublicensees to assign and transfer to Licensor, without additional compensation, all of their right, title, and interest in to, and under, subject to any licenses or sublicenses granted by Licensee that expressly survive any such termination pursuant to Section 2.4(f), all clinical and related study data based on use of Products, all Regulatory Filings and Regulatory Approvals for Products in respect of each country in the Territory; and the Renaissance Supply Agreements.
(b) If at the time of any such termination of this Agreement by Licensor pursuant to Sections 14.2 or 14.3 Licensee has in its possession or under its control any inventory of the Product approved and allocated for sale in the Territory, Licensee shall for a period not to exceed six (6) months following the effective date of such termination be permitted to sell any such inventory of the Product in the Field in the Territory, and the licenses hereunder shall continue on a nonexclusive basis until all such units of the Product have been sold, provided that (A) the Product shall not be sold at a discount to a purchaser that is greater than the average discount provided to such purchaser for the Product during the twelve (12) month period preceding such termination and, in addition, such sales shall not result in the applicable wholesaler inventory levels for the Product exceeding the average levels for the twelve (12) month period preceding such termination, and (B) Licensee continues to pay, during the applicable Royalty Term, the applicable royalty and, if applicable, sales milestones, on resulting applicable Net Sales of Product in the Territory by it Licensee, its Sublicensees or any Third Party Distributors.
(c) In the event of a material breach of this Agreement by Licensor that is not successfully disputed or cured by Licensor in accordance with Section 14.2(b), Licensee may elect to terminate this Agreement or continue the Agreement; provided, that in the event Licensee elects to continue the Agreement in lieu of terminating the Agreement in accordance with Section 14.2, Licensee will have the right in its discretion to fully reduce the royalty payments or milestone payments required under Article 8 by the amount of damages suffered by Licensee due to such material breach by Licensor, which such amount will be determined by an independent third party with requisite expertise and agreed upon by the Parties, with any dispute as to the determination being subject to the dispute resolution process set forth in Section 15.8(b).
(d) In the event of the insolvency or bankruptcy of Licensor that gives rise to Licensee’s right to terminate this Agreement in accordance with Section 14.3, Licensee may elect to terminate this Agreement or continue the Agreement (subject, to the extent applicable, Section 14.7).
14.6 General Surviving Obligations. The rights and obligations set forth in this Agreement shall extend beyond the expiration or termination of the Agreement only to the extent expressly provided for herein, or to the extent that the survival of such rights or obligations are necessary to permit their complete fulfillment or discharge. Expiration or termination of this Agreement for any reason shall not (a) release either Party from any obligation that has accrued prior to the effective date of such expiration or termination (including without limitation the obligation to pay amounts accrued and due under this Agreement prior to the effective date of such termination but that are unpaid or become payable thereafter), (b) preclude either Party from claiming any other damages, compensation, or relief that it may be entitled to upon such expiration or termination, or (c) terminate any right to obtain performance of any obligation provided for in this Agreement that shall survive expiration or termination. Without limiting the foregoing, the Parties have identified various rights and obligations which are understood to survive, as follows. In the event of expiration or termination of this Agreement for any reason, the following provisions shall survive in addition to others specified in this Agreement to survive in such event: Sections 7.7, 7.8, 9.1(a), 9.2(b), 9.5(a), and Articles 1 (to the extent that any term defined therein is used in any of the sections or articles specified in this list as surviving termination of this Agreement), 8, 11, 12, 13, 14, and 15.
14.7 Rights in Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by either Party are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy Code, licenses of right to “intellectual property” as defined under Section 61 of the United States Bankruptcy Code. The Parties agree that the Parties, as licensees of such rights under this Agreement, shall retain and may fully exercise all of their rights and elections under the United States Bankruptcy Code. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against either Party under the United States Bankruptcy Code, the other Party will be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property, which, if not already in the non-subject Party’s possession, shall be promptly delivered to it (a) upon any such commencement of a bankruptcy proceeding upon the non-subject Party’s written request therefor, unless the Party subject to such proceeding elects to continue to perform all of its obligations under this Agreement, or (b) if not delivered under clause (a) above, following the rejection of this Agreement by or on behalf of the Party subject to such proceeding upon written request therefor by the non-subject Party.
KASAN_국제계약서 중에서 기술이전 및 독점라이선스 계약서 중 기간, 계약위반 등으로 인한 계약종료, 계약종료 후 처리 등 TERM AND TERMINATION 조항 샘플.pdf
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
23. INDEMNIFICATION; INSURANCE; LIMITATION OF LIABILITY.
23.1 General Indemnification by CyDex. CyDex shall defend, indemnify and hold Hospira and its Affiliates and Sublicensees, and each of their respective directors, officers, agents and employees, harmless from and against any and all losses, judgments, damages, liabilities, settlements, penalties, fines, costs and expenses (including the reasonable costs and expenses of attorneys and other professionals) (collectively “Losses”) incurred as a result of any claim, demand, action or other proceeding (each, a “Claim”) by a Third Party, to the extent such Losses arise out of: (a) the manufacture, use, handling, promotion, marketing, distribution, importation, sale or offering for sale of Captisol by CyDex, its Affiliates or any of their agents, or (b) CyDex’s breach of this Agreement, including without limitation any of its representations and warranties set forth in Section 8, or (c) any negligent or willful misconduct by CyDex or its Affiliates or any of their respective distributors, officers, directors employees or agents, in each case to the extent that such Losses are not due to Hospira’s or any of its Affiliates’ or Sublicensees’, or any of their respective directors’, officers’, agents’ or employees’ breach of this Agreement or negligence or willful misconduct.
23.2 General Indemnification by Hospira. Hospira shall defend, indemnify and hold CyDex and its Affiliates, and each of their respective directors, officers, agents and employees, harmless from and against any and all Losses incurred as a result of any Claim by a Third Party, to the extent such Losses arise out of: (a) the manufacture, use, handling, promotion, marketing, distribution, importation, sale or offering for sale of the Finished Product by Hospira, its Affiliates and Sublicensees, or (b) Hospira’s breach of this Agreement, including without limitation any of its representations and warranties set forth in Section 8, or (c) any negligent or willful misconduct by Hospira or its Affiliates or any of their respective distributors, officers, directors employees or agents, in each case to the extent that such Losses are not due to CyDex’s or any of its Affiliates’ or any of their respective directors’, officers’, agents’ or employees’ breach of this Agreement or negligence or willful misconduct.
23.4 Procedure.
(a) The person intending to claim indemnification under Section 9 (an “Indemnified Party”) shall promptly notify the other party (the “Indemnifying Party”) of any Claim in respect of which the Indemnified Party intends to claim such indemnification, and a reasonable explanation of the basis for the Claim and the amount of alleged Losses to the extent of the facts then known by the Indemnified Party. (Notwithstanding the foregoing, no delay or deficiency on the part of the Indemnified Party in so notifying the Indemnifying Party will relieve the Indemnifying Party of any liability or obligation under this Agreement except to the extent the Indemnifying Party has suffered actual prejudice directly caused by the delay or other deficiency.) The Indemnifying Party shall assume the defense thereof; provided, however, that if the Indemnifying Party assumes the defense, the Indemnified Party shall have the right to employ counsel separate from counsel employed by the Indemnifying Party in any such action and to participate in the defense thereof, but the fees and expenses of such counsel employed by the Indemnified Party shall be at the sole cost and expense of the Indemnified Party unless the Indemnifying Party consents to the retention of such counsel or unless the named parties to any action or proceeding include both the Indemnifying Party and the Indemnified Party and a representation of both the Indemnifying Party and the Indemnified Party by the same counsel would be inappropriate due to the actual or potential differing interests between them. And provided further that, if the Indemnifying Party shall fail to assume the defense of and reasonably defend such Claim, the Indemnified Party shall have the right to retain or assume control of such defense and the Indemnifying Party shall pay (as incurred and on demand) the fees and expenses of counsel retained by the Indemnified Party.
(b) The Indemnifying Party shall not be liable for the indemnification of any Claim settled (or resolved by consent to the entry of judgment) without the written consent of the Indemnifying Party (which shall not be unreasonably withheld or delayed). Also, if the Indemnifying Party shall control the defense of any such Claim, the Indemnifying Party shall have the right to settle such Claim; provided, that the Indemnifying Party shall obtain the prior written consent (which shall not be unreasonably withheld or delayed) of the Indemnified Party before entering into any settlement of (or resolving by consent to the entry of judgment upon) such Claim unless (A) there is no finding or admission of any violation of law or any violation of the rights of any Third Party by an Indemnified Party, no requirement that the Indemnified Party admit fault or culpability, and no adverse effect on any other claims that may be made by or against the Indemnified Party and (B) the sole relief provided is monetary damages that are paid in full by the Indemnifying Party and such settlement does not require the Indemnified Party to take (or refrain from taking) any action.
(c) Regardless of who controls the defense, the other party hereto shall reasonably cooperate in the defense as may be requested. Without limitation, the Indemnified Party, and its directors, officers, advisers, agents and employees, shall reasonably cooperate with the Indemnifying Party and its legal representatives in the investigations of any Claim.
23.5 Insurance. CyDex will procure and maintain, at its own expense, for the duration of the Agreement, and for [*] thereafter if written on a claims made or occurrence reported form, the types of insurance specified below with carriers rated [*]. Best or like rating agencies:
a. Workers’ Compensation accordance with applicable statutory requirements and shall provide a waiver of subrogation in favor of Hospira;
b. Employer’s Liability with a limit of liability in an amount of not less than $[***];
c. Commercial General Liability including premises operations, products & completed operations, blanket contractual liability, personal injury including fire legal liability for bodily injury and property damage in an amount not less than $[***];
d. Commercial Automobile Liability for owned, hired and non-owned motor vehicles with a combined single limit in an amount not less than $[*];
e. Excess Liability including product liability with a combined single limit in an amount of not less than $[*];
f. Commercial Crime or Fidelity Bond in an amount of not less than $[*] including an endorsement for Third Party liability without the requirement of a conviction.
g. Cargo Legal Liability insurance covering all risks of physical loss or damage to cargo handled by CyDex. The limit of liability shall not be less than $[*].
23.6 Limitation of Liability. EXCEPT FOR (1) PERSONAL INJURY, INCLUDING DEATH, (2) TANGIBLE PROPERTY DAMAGE, (3) EACH PARTY’S INDEMNIFICATION OBLIGATIONS, (4) DAMAGES ARISING OUT OF AN INTENTIONAL BREACH OF THE CONFIDENTIALITY OBLIGATIONS HEREIN, (5) DAMAGES ARISING OUT OF CYDEX’S BREACH OF SECTION 2.4, AND (6) DAMAGES FOR WHICH CYDEX IS RESPONSIBLE PURSUANT SECTION 3.6, 3.7 OR 6.4.
KASAN_신제품 라이선스 및 생산공급 국제계약서 중에서 면책조항 INDEMNIFICATION, INSURANCE, LIMITATION OF LIABILITY 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
21. CONFIDENTIALITY.
21.1 Definition. Hospira and CyDex each recognizes that, during the Term, it may be necessary for a party (the “Disclosing Party”) to provide Confidential Information (as defined herein) to the other party (the “Receiving Party”) that is highly valuable, the disclosure of which would be highly prejudicial to such party. The disclosure and use of Confidential Information will be governed by the provisions of this Section 7. Neither Hospira nor CyDex shall use the other’s Confidential Information except as expressly permitted in this Agreement. For purposes of this Agreement, “Confidential Information” means all information disclosed by the Disclosing Party to the Receiving Party in any form whatsoever, including but not limited to product specifications, data, know-how, formulations, product concepts, sample materials, business and technical information, financial data, batch records, trade secrets, processes, techniques, algorithms, programs, designs, drawings, and any other information related to a party’s present or future products, sales, suppliers, customers, employees, investors or business. Without limiting the generality of the foregoing, CyDex’s Confidential Information includes all materials provided as part of the Captisol Data Package.
21.2 Obligation. CyDex and Hospira agree that they will disclose the other’s Confidential Information to its (or its respective Affiliates’) own officers, employees, consultants and agents only if and to the extent reasonably necessary to carry out their respective responsibilities under this Agreement or in accordance with the exercise of their rights under this Agreement, and such disclosure shall be limited to the extent reasonably possible consistent with such responsibilities and rights. Except as provided in the previous sentence, neither party shall disclose Confidential Information of the other to any Third Party without the other’s prior written consent. Any disclosure to a Third Party shall be pursuant to the terms of a non-disclosure agreement substantially similar to the requirements of this Section 7. The party which disclosed Confidential Information of the other to any Third Party shall be responsible and liable for any disclosure or use by such Third Party (or its disclosees) which would have violated this Agreement if committed by the party itself. Neither party shall use Confidential Information of the other except as expressly allowed by and for the purposes of this Agreement. Each party shall take such action to preserve the confidentiality of each other’s Confidential Information as it would customarily take to preserve the confidentiality of its own Confidential Information (but in no event less than a reasonable standard of care). Unless otherwise specified in this Agreement and subject to terms and conditions in this Agreement, if so requested by the other party a party shall promptly return all relevant records and materials in its possession or control containing or embodying the other party’s Confidential Information (including all copies and extracts of documents); provided, however, that each party may retain one archival copy (and such electronic copies that exist as part of the party’s computer systems, network storage systems and electronic backup systems) of such records and materials solely to be able to monitor its obligations that survive under this Agreement.
21.3 Exceptions. The use and non-disclosure obligations set forth in this Section 7 shall not apply to any Confidential Information, or portion thereof, that the Receiving Party can demonstrate by appropriate documentation:
(a) at the time of disclosure is in the public domain;
(b) after disclosure, becomes part of the public domain, by publication or otherwise, through no fault of the Receiving Party or its disclosees;
(c) is independently developed by Receiving Party personnel with no reference or access to the Confidential Information; or
(d) is made available to the Receiving Party by an independent third party without obligation of confidentiality, provided, however, that to the Receiving Party’s knowledge, such information was not obtained by said third party, directly or indirectly, from the Disclosing Party hereunder.
In addition, the Receiving Party may disclose information to a court or ADR forum in the process of seeking to enforce through such court or ADR forum its own rights under this Agreement, and also may disclose information that is required to be disclosed by law, by a valid order of a court or by order or regulation of a governmental agency including but not limited to, regulations of the Securities and Exchange Commission, or in the course of litigation, provided that in all cases the Receiving Party shall give the other party prompt notice of the pending disclosure and make a reasonable effort to obtain, or to assist the Disclosing Party in obtaining, a protective order or confidential-treatment order preventing or limiting (to the greatest possible extent and for the longest possible period) the disclosure and/or requiring that the Confidential Information so disclosed be used only for the purposes for which the law or regulation required, or for which the order was issued.
21.4 Injunction. Each party agrees that should it breach or threaten to breach any provisions of this Section 7, the Disclosing Party will suffer irreparable damages and its remedy at law will be inadequate. Upon any breach or threatened breach by the Receiving Party of this Section 7, the Disclosing Party shall be entitled to seek from any court of competent jurisdiction temporary, preliminary and/or permanent injunctive relief in addition to any other remedy which it may have, without need to post any bond or security, in addition to any and all other legal and equitable rights and remedies available to the Disclosing Party.
21.5 Public Announcements. If a press release is required by law or the applicable rules of a national securities exchange to be issued upon execution of this Agreement or reasonably soon thereafter, the parties will mutually agree on such a press release. Neither party shall make any subsequent public announcement concerning this Agreement or the terms hereof not previously made public without the prior written approval of the other party with regard to the form, content, and precise timing of such announcement, except as may be required to be made by either party in order to comply with applicable law, regulations, court orders, or tax or securities filings. Such consent shall not be unreasonably withheld or delayed by such other party. Before any such public announcement, the party wishing to make the announcement will submit a draft of the proposed announcement to the other party in sufficient time to enable such other party to consider and comment thereon. The parties agree that a party may disclose this Agreement’s existence and terms, and material developments or material information generated under this Agreement, in (i) securities filings with the Securities and Exchange Commission (or equivalent foreign agency) to the extent required by law, or (ii) under conditions of confidentiality/nonuse in connection with investment and similar corporate transactions. Notwithstanding the above, once a public announcement has been made, either party shall be free to disclose to third parties any information contained in said public announcement.
KASAN_국제계약서 중 비밀보호계약, 비밀유지약정, NDA, CDA 조항 – 비밀정보 범위, 적용 배제대상, 비밀유지 의무, 위반시 조치 등 계약조항 샘플.pdf
26.1 Relationship of Parties. Each of the parties hereto is an independent contractor and nothing in this Agreement is intended or shall be deemed to constitute a partnership, agency, employer-employee or joint venture relationship between the parties. No party shall have the right to, and each party agrees not to purport to, incur any debts or make any commitments or contracts for the other.
26.2 Compliance with Law. Each of the parties shall comply with all applicable international, federal, state and local laws, rules and regulations, including, but not limited to, import/export restrictions, laws, rules and regulations governing product quality and safety and patent, copyright and trade secret protection.
26.3 Arbitration.
(a) Procedure. The parties recognize that bona fide disputes may arise which relate to the parties’ rights and obligations under this Agreement. The parties agree that except as provided in Section 7.4, any such dispute shall be resolved by alternative dispute resolution in accordance with the procedure set forth in Exhibit F.
(b) Confidentiality of Proceedings. All arbitration proceedings hereunder shall be confidential and the arbitrator(s) shall issue appropriate protective orders to safeguard each party’s Confidential Information. Except as required by law, no party shall make (or instruct the arbitrator(s) to make) any public announcement with respect to the proceedings or decision of the arbitrator(s) without prior written consent of the other party.
(c) Binding Effect. The provisions of this Section 12.3 shall survive any expiration or termination of this Agreement, and shall be severable and binding on the parties hereto, notwithstanding that any other provision of this Agreement may be held or declared to be invalid, illegal or unenforceable.
26.4 Force Majeure. Neither party shall be liable for failure to perform, or delay in the performance of, its obligations under this Agreement (other than payment obligations) when such failure or delay is caused by an event of force majeure. For purposes of this Agreement, an event of force majeure means any event or circumstance beyond the reasonable control of the affected party, including but not limited to, war, insurrection, riot, fire, flood or other unusual weather condition, explosion, act of God, peril of the sea, strike, lockout or other industrial disturbance, sabotage, embargo, act of governmental authority, compliance with governmental order or national defense requirements, or inability to obtain fuel, power, raw materials, labor or transportation facilities. A failure of supply by CyDex’s supplier shall only be deemed an event of force majeure affecting CyDex if caused by a force majeure event affecting such supplier. If, due to any event of force majeure, either party shall be unable to fulfill its obligations under this Agreement (other than payment obligations), the affected party shall immediately notify the other party of such inability and of the period during which such inability is expected to continue and the time for performance [*].
26.6 Notices. Any notice, request, or communication under this Agreement shall be effective only if it is in writing and personally delivered; sent by certified mail, postage pre-paid; facsimile with receipt confirmed; or by nationally recognized overnight courier with signature required, addressed to the parties at the addresses stated below or such other persons and/or addresses as shall be furnished in writing by any party in accordance with this Section 12.6. Unless otherwise provided, all notices shall be sent:
12.8 Use of Name; Publicity. No party shall use the name, trademark, trade name or logo of the other party, its Affiliates or their respective employee(s) in any publicity, promotion, news release or public disclosure relating to this Agreement or its subject matter, without the prior express written permission of the other party, except as may be required by law or the rules of NASDAQ or the New York Stock Exchange. In the event of a required public announcement, the party making such announcement shall provide the other party with a copy of the proposed text before such announcement sufficiently in advance of the scheduled release of such announcement to afford such other party a reasonable opportunity to review and comment upon the proposed text and the timing of such disclosure.
12.9 Governing Law. This Agreement shall be governed by and construed in accordance with the internal laws of the State of New York (without giving effect to any conflicts of law principles that require the application of the law of a different state). The United Nations Convention on the International Sale of Goods is hereby expressly excluded.
12.10 Entire Agreement; Amendment. This Agreement, together with the Quality Agreement, constitutes the entire agreement of the parties relating to the subject matter hereof and thereof and supersedes any and all prior or contemporaneous agreements, written or oral, between CyDex (and/or any of its Affiliates) and Hospira (and/or any of its Affiliates) relating to the subject matter hereof and thereof; provided, that any confidentiality/nonuse provisions of any prior agreement are not superseded and will remain in effect solely with respect to information provided under the terms of such prior agreement that is not subsequently provided to a Party under the terms of this Agreement. If the Quality Agreement contains terms or conditions inconsistent with the terms of this Agreement, the terms of the Quality Agreement will control and prevail solely with respect to quality issues, and the terms of this Agreement shall control and prevail for all other matters. This Agreement cannot be amended except by way of an express writing signed by both parties.
12.11 Binding Effect. This Agreement shall be binding upon, and the rights and obligations hereof shall apply to, CyDex and Hospira and any successor(s) and permitted assigns. The name of a party appearing herein shall be deemed to include the names of such party’s successors and permitted assigns to the extent necessary to carry out the intent of this Agreement.
12.12 Waiver. The rights of either party under this Agreement may be exercised from time to time, singularly or in combination, and the exercise of one or more such rights shall not be deemed to be a waiver of any one or more of the others. No waiver of any breach of a term, provision or condition of this Agreement shall be deemed to have been made by either party unless such waiver is addressed in writing and signed by an authorized representative of that party. The failure of either party to insist upon the strict performance of any of the terms, provisions or conditions of this Agreement, or to exercise any option contained in this Agreement, shall not be construed as a waiver or relinquishment for the future of any such term, provision, condition or option or the waiver or relinquishment of any other term, provision, condition or option.
12.13 Severability. If any provision of this Agreement is determined by a final and binding court or arbitration judgment to be invalid, illegal or unenforceable to any extent, such provision shall not be not affected or impaired up to the limits of such invalidity, illegality or unenforceability; the validity, legality and enforceability of the remaining provisions of this Agreement shall not be affected or impaired in any way; and the parties agree to negotiate in good faith to replace such invalid, illegal and unenforceable provision (or portion of provision) with a valid, legal and enforceable provision that achieves, to the greatest lawful extent under this Agreement, the economic, business and other purposes of such invalid, illegal or unenforceable provision (or portion of provision).
12.14 Assignment. Neither party may assign its rights or obligations under this Agreement without the prior written consent of the other party; provided, however, that either party may assign this Agreement, in whole or in part, without such consent, to an Affiliate of such party or to any Third Party successor by merger or acquisition or by divestiture or spin-off of substantially all of the business to which this Agreement relates, upon written notice to the other party of any such assignment and, in the case of an assignment to an Affiliate, such party hereby guarantees the performance of any such Affiliate, and, in the case of a Third Party assignment, such Third Party shall assume the obligations of the assigning party under this Agreement. No assignment shall relieve any party of responsibility for the performance of any obligation, which such party may have or incur hereunder.
12.15 Third Party Beneficiaries. The terms and provisions of this Agreement are intended solely for the benefit of each party hereto and their respective Affiliates, related Indemnified Parties (as set forth in Section 9), successors or permitted assigns and it is not the intention of the parties to confer third-party beneficiary rights upon any other person, including without limitation Sublicensees.
12.17 Headings. The descriptive headings of this Agreement are for convenience only, and shall be of no force or effect in construing or interpreting any of the provisions of this Agreement.
12.18 Interpretation. The language used in this Agreement is the language chosen by the parties to express their mutual intent, and no provision of this Agreement will be interpreted for or against any party because that party or its attorney drafted the provision.
12.19 Counterparts. This Agreement may be executed in counterparts, each of which shall constitute an original document, but both of which shall constitute one and the same instrument.
KASAN_국제계약서에 통상 들어가는 일반조항 GENERAL PROVISIONS 사례 – 제약회사 신제품 라이선스 및 생산공급 계약서 중 일반조항 샘플.pdf
