Kasan Insight :: 과학, 기술 그리고 법

- 제약/화학/바이오 분야의 실용적 법률정보와 해결방안

유전자 치료제 공동개발 계약서 중의 중재조항 – 제12조 2항

중재법 규정 – 중재합의 대상에 대한  민사소송 – 부적법, 소각하 대상

중재법 제8조(중재합의의 방식) ① 중재합의는 독립된 합의 또는 계약에 중재조항을 포함하는 형식으로 할 수 있다. ② 중재합의는 서면으로 하여야 한다.

③ 다음 각 호의 어느 하나에 해당하는 경우는 서면에 의한 중재합의로 본다. <개정 2016. 5. 29.>

1. 구두나 행위, 그 밖의 어떠한 수단에 의하여 이루어진 것인지 여부와 관계없이 중재합의의 내용이 기록된 경우

2. 전보, 전신, 팩스, 전자우편 또는 그 밖의 통신수단에 의하여 교환된 전자적 의사표시에 중재합의가 포함된 경우. 다만, 그 중재합의의 내용을 확인할 수 없는 경우는 제외한다.

3. 어느 한쪽 당사자가 당사자 간에 교환된 신청서 또는 답변서의 내용에 중재합의가 있는 것을 주장하고 상대방 당사자가 이에 대하여 다투지 아니하는 경우

④ 계약이 중재조항을 포함한 문서를 인용하고 있는 경우에는 중재합의가 있는 것으로 본다. 다만, 중재조항을 그 계약의 일부로 하고 있는 경우로 한정한다. <개정 2016. 5. 29.>

중재법 제9조(중재합의와 법원에의 제소) ① 중재합의의 대상인 분쟁에 관하여 소가 제기된 경우에 피고가 중재합의가 있다는 항변을 하였을 때에는 법원은 그 소를 각하하여야 한다. 다만, 중재합의가 없거나 무효이거나 효력을 상실하였거나 그 이행이 불가능한 경우에는 그러하지 아니하다. ② 피고는 제1항의 항변을 본안에 관한 최초의 변론을 할 때까지 하여야 한다. ③ 제1항의 소가 법원에 계속 중인 경우에도 중재판정부는 중재절차를 개시 또는 진행하거나 중재판정을 내릴 수 있다.

원고회사 라이센시의 주장 요지

(1)   민사소송으로 청구하는 내용 - 라이선스 계약 대상 특허권, 특허출원의 지분 1/2 명의이전청구, 연구개발 결과물 마스터세포은행 (Master Cell Bank, MCB) + 제조용 세포은행 (Working Cell bank, WCB)의 1/2 지분 소유권 확인청구, 연구개발 결과 데이터 및 자료의 제공(인도) 청구

(2)   중재조항에도 불구하고 민사소송 제기할 수 있는 사안으로 주장   

피고회사 라이센서의 주장 요지

(1)   계약관련 모든 분쟁을 대한상사중재원의 중재로 해결하기로 합의함, 민사소송은 중재합의를 위반하여 제기된 부적법한 소로 각하해야 함

서울중앙지방법원 판결 요지 – 중재합의 위반 소로 부적법함 – 소 각하 판결

판단기준 법리 – 대법원 2011. 12. 22. 선고 2010다76573 판결

장래의 분쟁을 중재에 의하여 해결하겠다는 중재합의가 있는 것으로 인정되는 경우, 중재합의의 대상인 분쟁의 범위를 명확하게 특정하여 한정하였다는 등의 특별한 사정이 없는 한 당사자들 사이의 특정한 법률관계에서 비롯되는 모든 분쟁을 중재에 의하여 해결하기로 정한 것으로 봄이 상당하다(대법원 2007. 5. 31. 선고 2005다74344 판결 참조).

대법원 판결 사건의 원심판결 요지 - ① 이 사건 각 도급계약서 제111조 제1항은 중재합의의 대상이 되는 분쟁으로 ‘사실관계에 대한 이견 기타 분쟁’을 규정하고 있고, 같은 조 제4항에서는 중재인이 일정한 순서(1. 계약문서 표현의 문자상 의미, 2. 계약문서 전체 규정에 비추어 합리적으로 나타나는 계약당사자의 의도, 3. 중재에 진행되는 시점에 유효한 대한민국 법률)에 따라 본 계약의 제 조건을 해석하거나 당사자의 권리·의무 또는 책임을 정하도록 규정하고 있어 중재합의의 기본규정인 제111조 자체에서 이미 사실관계뿐만 아니라 계약이나 관련 법률의 해석도 중재의 대상임을 전제하고 있으며, 더욱이 제17조는 “본 계약에서 정하지 아니한 사항 또는 계약문서의 내용 중 불명확한 사항 등이 있거나 그 해석에 관하여 당사자 사이에 차이가 있는 경우, 발주자가 합리적으로 해석하거나 보충하고, 계약상대자가 이에 대해 이견이 있어도 ‘제111조의 중재판정이 달리 판단할 때까지’ 발주자의 해석 또는 보충에 따른다.”고 규정하고 있는데 이 제17조 역시 계약의 해석에 관한 사항도 중재의 대상임을 당연한 전제로 하고 있음이 분명하므로, 이 사건 각 도급계약에서의 중재조항은 그 도급계약서의 문리해석상 사실관계에 대한 분쟁뿐만 아니라 계약해석이나 법률문제에 관한 분쟁도 그 대상으로 하고 있다고 보기에 충분하고, ② 어떤 법률관계상의 분쟁에서 사실문제, 계약해석문제, 법률문제는 유기적으로 관련을 맺고 있는 것이고, 사실관계의 확정은 분쟁해결을 위한 재판의 전제가 되는 한 요소일 뿐이어서 사실관계의 확정만으로 분쟁을 해결할 수 없는 것인데, 중재인이 사실관계에 관하여만 판정을 하도록 한다면 결국 법원이 중재판정을 전제로 다시 재판을 할 수밖에 없게 되는 것이어서, 이는 중재에 의하여 사법상의 분쟁을 적정·공평·신속하게 해결하고자 하는 중재법의 목적과 중재법이 정한 경우를 제외하고는 법원이 중재에 관여할 수 없도록 한 중재법 제6조의 취지에 반하는 결과를 초래하며, ③ 중재란 본래 법원의 재판으로 해결하여야 할 분쟁을 당사자 사이의 합의로 법원이 아닌 중재인의 판정에 의해 해결하고자 하는 제도인 만큼, 중재의 대상은 법원의 재판권이 미칠 수 있는 사항인 법률상의 분쟁을 의미하는 점, 중재의 경우 중재인은 분쟁의 대상에 대한 사실문제, 법률문제 등 모든 것에 대하여 판정할 수 있는 점에서 사실문제만을 판단의 대상으로 할 수 있는 중재감정과 구별되는 점, 원고의 주장대로 ‘사실관계’만이 중재의 대상이라고 한다면 이에 대한 중재판정의 집행을 쉽게 상정할 수 없는 점 등을 더하여 보면, 이 사건 각 도급계약상 중재조항은 계약해석이나 법률문제에 대한 분쟁도 중재의 대상으로 한 것으로 보아야 한다.

대법원 판단요지 - 이 사건 각 도급계약서의 중재 관련 조항들이 중재합의의 대상을 ‘사실관계에 대한 분쟁’에 한정하는 것으로 명확하게 특정하고 있다고 볼 수 없으므로, 위 중재 관련 조항들은 이 사건 각 도급계약으로부터 비롯되는 모든 분쟁을 중재에 의하여 해결하기로 정한 것으로 봄이 상당하다.

분쟁사안애서 법원의 구체적 판단 이유

첨부: 서울중앙지방법원 2018. 5. 18. 선고 2017가합570338 판결

서울중앙지방법원 2018. 5. 18. 선고 2017가합570338 판결_바이로메드.pdf

KASAN_바이오 벤처회사와 제약회사 사이 유전자 치료제 신약공동개발 및 라이선스 계약서에서 분쟁해결 방안 중재조항의 적용범위 판단 서울 서울중앙지방법원 2018. 5. 18. 선고 2017가합570338 .pdf

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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

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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