Kasan Insight :: 과학, 기술 그리고 법

- 제약/화학/바이오 분야의 실용적 법률정보와 해결방안

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

[질문 또는 상담신청 입력하기]

KASAN_[NDA분쟁] 비밀보호계약, 비밀유지약정, NDA, CDA에서 비밀보호대상 조항 위반여부 쟁점 미국소송 사례.pdf

[질문 또는 상담신청 입력하기]

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.

KASAN_특허라이선스 계약에서 Licensee의 주문에 따라 특허발명의 전용품을 제조, 납품한 행위 – 특허간접침해에 해당하지 않음 대법원 2019. 2. 28. 선고 2017다290095 판결.pdf

[질문 또는 상담신청 입력하기]

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

[질문 또는 상담신청 입력하기]