기술이전__글174건

  1. 2019.05.16 특허라이선스, 기술이전 계약서에서 대가지급, Royalty 구성, 산정기준 등 판단기준, 미국판결 사항, 체크포인트, 계약조항 샘플 등 실무적 포인트 몇 가지
  2. 2019.05.16 특허실시, 기술이전, 라이선스 관련 업무진행 단계별 계약서 형식, 특허라이선스 계약서의 구성, 기본적 필수사항, 체크포인트 등 실무적 포인트 몇 가지
  3. 2019.05.16 기술이전, License, 생산위수탁 계약서에서 Royalty Payment 관련 영문계약 조항 샘플 – 독점권 대가 고정액 구조
  4. 2019.05.16 제약회사 기술이전, License, 제조판매 계약서에서 Royalty Payment 관련 영문계약 조항 샘플
  5. 2019.05.16 특허실시허여, 기술이전, 라이선스 계약체결 후 대상특허의 무효 확정 시 실시료 로열티 지급의무 소멸 및 그 시점 – 무효확정 전 미지급 실시료 지급의무 인정: 대법원 2019. 4. 25. 선고 2018다2..
  6. 2019.05.16 특허발명 실시허여, 기술이전, 라이센스 계약서에서 Licensee의 특허유효성 도전 제한, 부쟁의무 계약조항의 효력, 쟁점, 영문 계약조항 샘플
  7. 2019.05.15 Licensor – 벤처회사, 발명자 대학교수, 특허권자 대학, 연구소 vs 제약회사 - Licensee 사이 바이오신약 후보물질 특허기술 라이선스 계약서에서 라이센시의 임상시험 수행 등 개발의무 관련 간략..
  8. 2019.05.15 대학소유 특허의 기술이전, 라이선스 계약에서 재실시허용 조건 위반 사례 - 특허권자 Licensor 미국대학 vs Licensee 벤처회사 + Sub-licensee 대기업 AbbVie : 라이선스 계약분쟁 중 라이센시 특허무효 ..
  9. 2019.05.15 대학교수 발명특허의 기술이전, 라이선스 계약서에서 sublicense 조항, 후속 개량발명의 특허출원 및 등록, 공동발명, Sublicense 및 Royalty 등 Collaboration 분쟁 사례 미국 판결
  10. 2019.05.15 Licensor - 대학교수, 대학, 연구소 및 벤처회사 vs 제약회사 Licensee 사이의 바이오신약 후보물질 특허기술 라이선스 계약서에 포함된 sublicense 관련 계약조항 샘플
  11. 2019.05.15 국제계약서에 통상 들어가는 일반조항 Affiliate 정의조항 사례 – 기술이전, 라이선스 계약서 샘플
  12. 2019.05.14 기술이전, 라이선스 계약서에서 License 대상 IP 및 특허 정의조항, 적용범위, 계약체결 후 발명 출원 및 특허 쟁점, 제3자의 이의신청 또는 침해소송대응 관련 계약서 샘플
  13. 2019.05.14 기술이전, 라이선스 등 국제계약에서 자주 사용되는 "commercially reasonable efforts” “best efforts” “reasonable reasons" 등 추상적, 불명확한 표현, 용어 포함 계약조항 샘플, 쟁점, 해석 및 실무적 대..
  14. 2019.05.13 기술이전, 라이선스, 공동연구개발 협의과정에서 기술정보제공 후 협상 최종단계에서 본계약체결이 무산된 경우 기술제공자의 법적구제수단, 정보수령자의 손해배상책임
  15. 2019.05.13 제약분야 기술이전 및 독점라이선스 계약서 중에서 진술보증 조항 REPRESENTATIONS, WARRANTIES AND COVEANTS – 권리진술 및 독점권 보장의무 등 상세한 내용을 매우 구체적으로 기재하는 방식의 계약조..
  16. 2019.05.13 진술보증 조항 REPRESENTATIONS AND WARRANTIES 관련 분쟁 - M&A 계약서 중 진술 및 보증조항 위반 및 손해배상책임 범위
  17. 2019.05.13 벤처기업의 인수, 합병 시 기술이전 및 라이선스, 공동연구개발계약상 쟁점 - License, Collaboration Agreement 당사자의 M&A 등 경영권 변경사유, change of control 발생 상황에 대비한 계약조항
  18. 2019.05.10 신제품 라이선스 및 생산공급 국제계약서 중에서 면책조항 INDEMNIFICATION, INSURANCE, LIMITATION OF LIABILITY 계약조항 샘플
  19. 2019.05.10 국제계약서 중 비밀보호계약, 비밀유지약정, NDA, CDA 조항 – 비밀정보 범위, 적용 배제대상, 비밀유지 의무, 위반시 조치 등 계약조항 샘플
  20. 2019.05.10 국제계약서에 통상 들어가는 일반조항 GENERAL PROVISIONS 사례 – 제약회사 신제품 라이선스 및 생산공급 계약서 중 일반조항 샘플
  21. 2019.05.10 국제계약분쟁 해결방안 ADR, 공식 중재기관의 Arbitration 외 사적 조정방안 - The International Institute for Conflict Prevention and Resolution (CPR) 선택 계약조항 소개
  22. 2019.04.16 [의료기기쟁점] 의료기기 판매 및 영업 활동 관련 공정거래법 위반 여부
  23. 2019.04.12 [기술이전계약] 신약 물질특허 기술이전 Exclusive License 계약서 중 Development 조항 (1)
  24. 2019.04.12 [기술이전계약] 특허라이선스 분쟁 - License 계약의 대상특허의 범위 - 계약체결 이후 등록된 특허 중에서 License 대상특허로 볼 수 있는 등록특허의 범위: 미국 Endo Pharm Opana® ER 특허분쟁 판결
  25. 2019.04.12 [기술이전계약] 신약물질 기술이전 License 계약서 중 특허관련 계약조항 사례
  26. 2019.04.12 [기술이전계약] 특허권자 Licensor 미국대학 vs Licensee 벤처회사 + Sub-licensee 대기업 AbbVie : 라이선스 계약분쟁 중 라이센시 특허무효 항변 불허 및 부쟁조항 효력인정 미국법원 판결
  27. 2019.01.16 [계약분쟁] 전속계약 등 계속적 계약의 기초인 당사자 신뢰관계 파탄 시 계약 해지 가능
  28. 2019.01.16 [계약분쟁] 계약해제, 해지사유 발생과 계약종료 시 손해 발생 상황 - 귀책 없는 당사자에 대한 손해배상 책임을 물을 수 있는지 여부: 대법원 2016. 4. 15. 선고 2015다59115 판결
  29. 2019.01.16 [계약분쟁] 지체상금 0.15% 약정 – 면책 또는 감액 여부 판단기준: 대법원 2018. 10. 12. 선고 2015다256794 판결
  30. 2019.01.16 [계약분쟁] 위약금 약정 – 손해배상액 예정 vs 위약벌 구별 기준 및 실무적 포인트

 

 

Ø  Types of Royalties :

       Lump Sum, 분할불

ü  Net Present value (현가율(WACC), 이자율 등 적용)

       Running Royalties

ü  정율 (%)

ü  정액 ($ per unit)

ü  Sliding scale

Ø  Minimum Royalty vs Maximum Royalty

Ø  Gross Sales Price vs Net Sales Price

       공제항목 (할인, 반품, tax, 수수료, 광고료, 설치비, 포장, 운송비)

Ø  Royalty Bearing Product

Ø  Tax

Ø  Report & Audit

 

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작성일시 : 2019.05.16 16:00
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기술이전, 라이선스 협상 진행 단계 및 관련 계약서

 

단계별 계약서의 법적 구속력 유무 판단

계약이란: 법적 구속력 있는 합의 + 실무적 포인트 몇 가지

 

● 계약서의 표제를 근거로 판단하지 말 것

양해각서(MOU), 의향서(LOI), 합의서(LOA), 동의서(Letter Agreement), 계약조건 정리표(Term Sheet), 메모(Memo), 합의서(Agreement), 계약서(Contract), Work Plan, Terms & Conditions

 

● 형식(양식)을 근거로 판단하지 말 것

간단한 서한 또는 구두 의사소통도 법적 구속력 있는 합의일 수 있다.

 

● 실질적인 내용과 표현(wording)에 나타난 진정한 의사를 찾을 것

① 당사자들 간의 합의 또는 일방 당사자에 의한 약속이 있는지?

② 확고하거나 최종적인가? 아니면 조건부(정지/해제조건) 또는 잠정적인가?

   () “to perform the works, subject to a final definitive contract”

③ 단순한 이해, 의도, 희망의 표현, 회의록, 사업/작업 계획, 또는 메모에 불과한 것인지?

 

● 실질적 내용과 그것을 반영한 명시적 표현에 집중할 것

① 구체적인 명문 조항들은 이전의 모든 의사소통 또는 다른 정황적 증거들보다 우선 적용된다.

② 불확실, 묵시적 또는 모순된 쟁점들이 있는 경우에만 당사자의 진의를 찾기 위해 이전의 의사소통 또는 다른 정황 증거들이 소개될 수 있다.

③ 동사와 조동사의 정확한 선택과 사용에 유의해야 함

   - Agree, Promise, Commit, Obligate, Guarantee, Warrant vs Intend, Plan, Wish, Desire, Want, Need, Assist, Help

   - Shall, Will, Must, Should vs Would, Could, Might

 

KASAN_특허실시, 기술이전, 라이선스 관련 업무진행 단계별 계약서 형식, 특허라이선스 계약서의 구성, 기본적 필

 

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작성일시 : 2019.05.16 14:26
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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 –

 

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작성일시 : 2019.05.16 13:00
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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

 

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작성일시 : 2019.05.16 12:00
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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 제3). 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 201242666, 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 2018287362 판결 요지판결문 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 201242666, 42673 판결에 이어, 특허권자는 특허무효 확정 이전에 미지급된 특허실시료의 지급을 구할 수 있는 것이 원칙이다.

 

3. 대법원 201242666 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 20172819 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.”

 

KASAN_특허실시허여, 기술이전, 라이선스 계약체결 후 대상특허의 무효 확정 시 실시료 로열티 지급의무 소멸 및

 

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작성일시 : 2019.05.16 10:00
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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 된다면실제의 분쟁이 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 행위는 공정거래법 위반 소지 있음, 해당 계약조항의 효력 불인정 소지 있음, 해당 사안에 대한 판결 없음

 

대법원 2019. 2. 21. 선고 20172819 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 계약

 

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작성일시 : 2019.05.16 08:49
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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.

 

KASAN_Licensor – 벤처회사, 발명자 대학교수, 특허권자 대학, 연구소 vs 제약회사 - Licensee

 

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작성일시 : 2019.05.15 17:30
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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 Biosciences nonexclusive license를 허여하는 계약을 체결하였고, Neurocrine10여년간의 연구개발 끝에 2010년경 대기업 Abbott(현재 AbbVie)와 신약연구개발 성과(신약후보 물질 Elagolix )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 licensee특허비침해 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.

 

KASAN_대학소유 특허의 기술이전, 라이선스 계약에서 재실시허용 조건 위반 사례 - 특허권자 Licensor 미국

 

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작성일시 : 2019.05.15 16:30
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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

 

. 대학기술 라이선스 및 산학협동연구

 

1999 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 Wisconsin 대학교수를 포함한 연구진과 콜레스테롤 저하 효능의 신약개발에 관한 공동연구개발계약을 체결하고, 공동연구개발을 진행하여 다수 신물질의 효과를 확인하였습니다. Xenon사는 그 다음 해 2001 provisional patent application에 대한 우선권을 주장하면서 추가 연구성과를 포함하여 대학과 공동 특허출원을 하였습니다.

 

. 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.

 

. Norvatis 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. , 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.

 

KASAN_대학교수 발명특허의 기술이전, 라이선스 계약서에서 sublicense 조항, 후속 개량발명의 특허출원 및

 

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작성일시 : 2019.05.15 15:30
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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.

 

KASAN_Licensor - 대학교수, 대학, 연구소 및 벤처회사 vs 제약회사 Licensee 사이의 바이오신약

 

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작성일시 : 2019.05.15 14:30
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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.

 

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작성일시 : 2019.05.15 08:26
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1. License 대상특허 범위 쟁점: 미국 Endo Pharm Opana® ER 특허분쟁 판결

특허 license에서 자주 쟁점이 되는 사항이고 실제 발생할 수 있는 사안입니다. 아래 그림에서 표시한 각 특허 사이의 관계와 License Agreement 조항의 문언표현을 살펴보시기 바랍니다.

 

 

 

(1) license 대상특허 범위 및 쟁점

License 계약서에 라이선스 대상특허 '250 및 그 후속특허 "including any continuation, continuation-in-part and divisional patent applications that claim priority to Opana® ER Patents"로 표현되어 있습니다. 여기서 '250 특허가 Opana® ER Patents에 해당합니다.

 

계약체결 후 등록된 위 '216 특허와 '122 특허가 위와 같은 계약문언의 범위에 해당하는지 여부가 쟁점입니다. 그림에서 보듯 노란색 '250 특허와 녹색의 쟁점 특허 2건은 직접 연결된 관계가 아닙니다.

 

다만, 청색으로 표시한 '357 출원이 중간에 개입되어 있습니다. 그것을 매개로 녹색표시특허들도 노란색 특허와 동일하게 license 대상특허로 해석할 수 있는지 문제됩니다.

 

(2) 미국법원 판결

CAFC 판결은 위와 같은 상황에서 '216 특허와 '122 특허는 license 대상 특허범위에 포함되지 않는다고 판결하였습니다. 기타 묵시적 license도 인정하지 않았습니다. , licensor Endolicensee Actavis, Roxanegeneric 제품 발매에 대해 기존 등록특허에 관하여 체결한 license의 존재에도 불구하고 다시 추가 등록한 '216 특허와 '122 특허에 기초한 특허권을 행사할 수 있다고 보았습니다.

 

Generic 제품발매 회사로서는 불의타에 해당하는 황당한 상황을 맞았습니다. CAFC 3인 합의재판부 중 1명의 소수의견 Dissent Opinion에서는 license 대상을 특허로 표현한 것과 제품으로 표현한 것을 엄격하게 구별해야 하고, 적어도 제품을 기준으로 라이선스 계약을 체결한 경우 위 특허도 라이선스 대상특허에 해당한다는 의견 설시가 흥미롭습니다. 공감할 내용이 많은데도 불구하고 아쉽게도 소수의견에 그쳤습니다. 특허 라이선스 실무공부 삼아 읽어 보시기 바랍니다.

 

(3) No Implied License 조항

CAFC 판결에서는 계약서의 다음과 같이 묵시적 라이선스를 허용하지 않는다는 계약조항을 중요한 판단근거로 삼았습니다. 라이선스 계약 실무상 매우 중요한 포인트입니다.

 

“Endo does not grant to Actavis [or Roxane] . . . any license, right or immunity, whether by implication, estoppel or otherwise, other than as expressly granted herein.”

 

참고자료로 다른 계약서에서 표준형식의 조항을 인용합니다. "No Other Rights. No rights, other than those expressly set forth in this Agreement are granted to either Party hereunder, and no additional rights will be deemed granted to either Party by implication, estoppel, or otherwise. All rights not expressly granted by either Party to the other hereunder are reserved."

 

Licensee의 묵시적 라이선스 주장은 부제소조항(not to sue)에도 근거를 두고 있습니다. licensee에 대한 소송을 제기하지 않는다는 계약조항은 곧 후속 등록 특허권에 대한 license 합의로도 해석할 수 있다는 주장입니다.

 

그라나, CAFC 판결은 위와 같이 묵시적 허락을 배제하는 명시적 계약조항을 우선해야 한다고 명확하게 밝혔습니다. 묵시적 라이선스 이론이 적용될 수 있고, 따라서 상충되는 해석이 가능한 상황에서도, 처분문서에 해당하는 계약서에 명시적으로 기재된 묵시적 라이선스를 배제한다는 문언이 훨씬 더 강력한 효력을 발휘한다는 점을 명확하게 판시하였습니다.

 

위 판결은 Licensee 입장에서 조금 억울한 면이 있을 것입니다. 실무적 대응방안으로는 특허만을 라이선스 대상범위의 기준으로 설정하는 것보다 여기에 더하여 제품기술을 라이선스 범위설정의 기준으로 함께 설정한다면 안정할 것입니다.

 

기술이전이나 license 당시에는 등록되지 않았고 독립된 특허출원도 아니었으나 그 후 분할출원, 연속출원 등을 통해 등록되는 특허문제는 매우 중요합니다. 관련 쟁점에 관한 좋은 참고가 될 분쟁사례와 판결입니다. CAFC 판결문을 소수의견까지 모두 꼼꼼하게 살펴보시길 권합니다.

 

2. 영문계약조항 사례 샘플

(1) Example Definition, 계약대상 특허정의 조항

Patent Rights” means, with respect to each country in the Territory (except as otherwise stated to be with respect to any country in or outside the Territory), (a) patent applications (including provisional applications) pending in such country, (b) any patents issuing in such country from such patent applications (including certificates of invention), (c) all patents and patent applications issued or pending, as applicable, in such country based on, corresponding to or claiming the priority date(s) of any of the foregoing, (d) rights in such country derived from any of (a), (b) or (c), including any substitutions, extensions (including supplemental protection certificates), registrations, confirmations, reissues, divisionals, continuations, continuations in part, reexaminations, renewals, revalidations, revivals, patents of addition, and (e) all patents and patent applications issued or pending, as applicable, in such country claiming overlapping priority therefrom.

 

(2) Example 라이선스 계약조항 샘플

9. INTELLECTUAL PROPERTY MATTERS.

9.1 Existing Intellectual Property.

(a) Other than as provided in this Agreement, neither Party grants any right, title, or interest in any Patent Right, information, or other intellectual property right Controlled by such Party to the other Party.

 

(b) Except as otherwise provided herein, Licensor shall be responsible for the preparation, filing, prosecution (including, without limitation, any interferences, inter partes proceedings, reissue proceedings, cancellations, oppositions, and reexaminations), and maintenance of any and all Licensed Serenity Patent Rights. Licensor shall consult with Licensee, and consider Licensee’s comments, in good faith with respect to the preparation, filing, prosecution, and maintenance of any Licensed CPEX Patent Rights or Licensed Reprise Patent Rights to the extent that Licensor has the right, under any agreement with any applicable licensor, to file, prosecute, and maintain such Licensed Patent Rights.

 

(c) Licensee agrees and acknowledges that Licensor intends to continue to use, in Licensor’s discretion, patent counsel currently retained by Licensor to prosecute and maintain the Licensed Serenity Patent Rights. Licensee shall execute, acknowledge and deliver any instruments, and to do all such other acts, as may be necessary or appropriate in order to enable such patent counsel to continue to prosecute and maintain such Licensed Serenity Patent Rights. The Parties shall reasonably consult with each other, and shall consider any comments from each other in good faith, with respect to the preparation, filing, prosecution, and maintenance of such Licensed Serenity Patent Rights and patent strategy for the Licensed Serenity Patent Rights. Licensee shall reimburse Licensor for all costs and expenses incurred by Licensor after the Effective Date in the preparation, filing, prosecution, and maintenance of any Licensed Serenity Patent Rights in the Territory, up to an amount not to exceed [*] Dollars ($[*]), which is the estimated cost set forth on Schedule 9.1(c). Licensor shall provide to Licensee copies of any papers relating to the filing, prosecution or maintenance of the Licensed Serenity Patent Rights promptly upon their being filed or received. Licensee shall not knowingly take any action during prosecution and maintenance of the Licensed Serenity Patent Rights.

 

(d) Licensor shall not knowingly permit any of the Licensed Serenity Patent Rights to be abandoned in any country in the Territory without Licensor first giving Licensee an opportunity to assume full responsibility for the continued prosecution and maintenance thereof. In the event that Licensee decides not to continue the prosecution or maintenance of a Licensed Serenity Patent Rights in any country in the Territory, Licensor will provide Licensee with notice of this decision at least thirty (30) days prior to any pending lapse or abandonment thereof. In the event that Licensee elects to assume responsibility for such prosecution and maintenance within thirty (30) days of Licensor’s notice, Section 9.1(c) shall thereafter apply to such Licensed Serenity Patent Rights except that the role of Licensee and Licensor shall be reversed thereunder (except further that Licensee will continue to be responsible for all costs and expenses thereafter incurred in the preparation, filing, prosecution, and maintenance of any Licensed Serenity Patent Rights). Any such Serenity Patent Right that is subject to such election by Licensee shall otherwise continue to be subject to all of the terms and conditions of the Agreement in the same way as the other Licensed Serenity Patent Rights.

 

9.2 Inventions by Licensee.

Disclosure. Licensee shall promptly disclose to Licensor the invention of any Licensee Inventions.

 

Ownership. As between the Parties, all Licensee Inventions will be owned and Controlled by Licensee.

 

Patent Filings.

(i) Licensee, at its expense, will have sole discretion and responsibility to prepare, file, prosecute, and maintain any patent applications and patents claiming Licensee Inventions. The Parties’ respective patent counsel shall meet no fewer than once per Calendar Year to discuss strategies for the preparation, filing, prosecution, and maintenance of any such patent applications and patents claiming Licensee Inventions. Licensee shall consider in good faith any comments provided by Licensor with respect to the foregoing. In the event of any dispute between Parties with respect to such strategies, either Party may notify the Alliance Managers for purposes of resolving such dispute; provided, however, that Licensee shall have the final decision-making authority with respect to any such dispute.

 

(ii) Licensee shall not knowingly permit any Patent Rights with claims to any Licensee Inventions to be abandoned in any country without Licensee first giving Licensor an opportunity to assume full responsibility for the continued prosecution and maintenance thereof. In the event that Licensee decides not to continue the prosecution or maintenance of any Patent Right claiming a Licensee Invention in any country, Licensee will provide Licensor with notice of this decision at least thirty (30) days prior to any pending lapse or abandonment thereof. In the event that Licensor elects to assume responsibility for such prosecution and maintenance within thirty (30) days of Licensor’s notice, Section 9.1(c) shall thereafter apply to such Patent Right claiming such Licensee Invention except that the role of Licensee and Licensor shall be reversed thereunder.

 

9.3 Infringement, Violation, or Misappropriation by Third Parties.

 

(a) Notice. Each Party shall promptly notify the other Party in writing of any alleged or threatened infringement, violation, or misappropriation by any Third Party of the Licensed Rights or the Sublicensed Rights of which it becomes aware, and following such notification, the Parties shall confer as to any response thereto. The notice shall set forth the facts of such infringement, violation, or misappropriation in reasonable detail.

 

(b) Response to Infringement, Violation, or Misappropriation by Third Parties.

(i) If a Third Party is infringing, violating, or misappropriating, or either Party reasonably believes a Third Party may be infringing, violating, or misappropriating any Enforceable IP Right in any country in the Territory, Licensee shall have the first right, but not the obligation, to institute, prosecute, and control any action or proceeding with respect to such infringement, violation, or misappropriation by counsel of its own selection, at its expense. Licensor shall have the right to participate in such action and be represented, if it so desires, by counsel of its own selection and at its own expense. To the extent required by Applicable Laws, Licensor agrees to be joined as a party plaintiff (with Licensor having the right to be represented, if it so desires, by counsel of its own selection and at its own expense) if necessary for Licensee to bring and prosecute such action or proceeding, and to give Licensee reasonable assistance and authority to bring and prosecute such action or proceeding. If Licensee fails to bring an action or proceeding within ninety (90) days after receiving or giving written notice pursuant to Section 9.3(a), then Licensor shall have the right, but not the obligation, to bring and control any such action by counsel of its own selection, at its expense (with Licensee having the right to participate in such action and be represented, if it so desires, by counsel of its own selection and at its own expense). To the extent required by Applicable Laws, Licensee agrees to be joined as a party plaintiff (with Licensee having the right to be represented, if it so desires, by counsel of its own selection and expense therein) if necessary for Licensor to bring and prosecute such action or proceeding, and to give Licensor reasonable assistance and authority to bring and prosecute such action or proceeding. No settlement of any such action or consent judgment or other voluntary final disposition which restricts the scope, or adversely affects the enforceability, of an Enforceable IP Right may be entered into by either Party without the prior written consent of the other Party, which consent shall not be unreasonably withheld, delayed or conditioned.

 

(ii) Each Party shall share in any recoveries obtained in connection with any action or proceeding described in Section 9.3(b)(i) as follows:

(A) each Party’s costs and expenses incurred in connection with bringing and prosecuting any such action or proceeding, including without limitation attorneys’ fees, first shall be reimbursed from such recoveries, and if such recovery is insufficient to cover all such costs and expenses of both Parties, it shall be shared in proportion to the total of such costs and expenses incurred by each Party, and

(B) if Licensee controlled such action or proceeding Licensee shall receive one hundred percent (100%) of such remaining recoveries, provided that such recoveries shall be deemed Net Sales for purposes of Section 8.3(a)(i); and if Licensor controlled such action or proceeding, each Party shall receive fifty percent (50%) of such remaining recoveries, provided that Licensee’s portion shall not be deemed as Net Sales for purposes of Section 8.3(a)(i) in such case.

 

(c) Withdrawal. If either Party brings an action or proceeding under Section 9.3(b)(i) and subsequently ceases to pursue or withdraws from such action or proceeding, it shall promptly notify the other Party and the other Party may substitute itself for the withdrawing Party under the terms of Section 9.3(b)(i).

 

(d) Oppositions by Parties. If either Party desires to bring an opposition, action for declaratory judgment, nullity action, interference, reexamination, inter partes proceeding, or other attack upon the validity, title, or enforceability of any intellectual property right Controlled by a Third Party that Covers the Product in the Field in any country in the Territory, such Party shall so notify the other Party and the Parties shall promptly confer to determine whether to bring such action or the manner in which to settle such action. Each Party shall be entitled to separate representation in any such action by counsel of its own choice and at its own expense, and shall cooperate fully with the other Party. The costs of any such action shall be borne by the Party bringing the action, and such Party shall retain any recoveries obtained in connection therewith.

 

9.4 Infringement of Third Party Rights.

(a) Notice. If the Exploitation of the Product pursuant to this Agreement results in a claim, action, suit, or proceeding that such activity infringes or misappropriates the intellectual property rights of a Third Party (“Third Party Infringement Claim”), the Party first receiving notice thereof shall promptly notify in writing the other Party thereof. The notice shall set forth the facts of the Third Party Infringement Claim in reasonable detail.

 

(b) Litigation.

(i) Licensee shall have the sole right, but not the obligation, to defend, at its expense, against any Third Party Infringement Claim. Licensee shall have full control over the defense and settlement of such Third Party Infringement Claim, provided that Licensee shall not settle any Third Party Infringement Claim that is subject to indemnification pursuant to Section 11.1 without the prior written consent of Licensor, which consent shall not be unreasonably withheld, delayed, or conditioned. Licensor shall cooperate with Licensee, at Licensee’s expense and reasonable request, in such defense and shall have the right to be represented by counsel of its own choice, at Licensor’s expense. Licensee will pay any losses incurred in defense or settlement of, or imposed pursuant to settlement of or judgment on, such Third Party Infringement Claim.

 

(ii) If Licensee decides not to commence a defense against any Third Party Infringement Claim pursuant to Section 9.4(b)(i), then Licensee will promptly notify Licensor of such decision in a timely manner so as to allow Licensor, who shall have the right, but not the obligation, to commence such a defense by counsel of its own selection, at its expense (with Licensee having the right to participate in such defense and be represented, if it so desires, by counsel of its own selection and at its own expense). Licensor shall thereupon have full control over the defense and settlement of such Third Party Infringement Claim, provided that Licensor shall not settle any Third Party Infringement Claim without the prior written consent of Licensee, which consent shall not be unreasonably withheld, delayed, or conditioned. Licensee shall cooperate with Licensor, at Licensor’s expense and reasonable request, in such defense and shall have the right to be represented by counsel of its own choice, at Licensee’s expense. Licensor will pay any losses incurred in defense or settlement of, or imposed pursuant to settlement of or judgment on, such Third Party Infringement Claim, subject to Section 11.1.

 

(iii) Notwithstanding any provisions set forth herein to the contrary, Licensor shall be responsible for continuing to manage, at Licensor’s expense, that certain litigation with Ferring Pharmaceuticals that is described in Schedule 10.2. Notwithstanding the foregoing, any settlement of any such action or consent judgment or other voluntary final disposition with respect to the litigation with Ferring Pharmaceuticals described in Schedule 10.2, which restricts the scope, or adversely affects the enforceability, of an Enforceable IP Right may not be entered into by Licensor without the prior written consent of the Licensee, which consent shall not be unreasonably withheld, delayed or conditioned.

 

(c) Oppositions by Third Parties. If any patent, trademark, copyright, or other intellectual property right within the Licensed Rights or the Sublicensed Rights becomes after the Effective Date the subject of any proceeding commenced by a Third Party in connection with an opposition, reexamination request, action for declaratory judgment, nullity action, interference, inter partes proceeding, or other attack upon the validity, title, or enforceability thereof, then Licensee shall control such defense at its sole cost. Licensee shall permit Licensor to participate in the proceeding to the extent permissible under Applicable Laws, and to be represented by its own counsel in such proceeding, at Licensor’s expense. If Licensee elects not to defend against such action with respect to any such intellectual property right with the Licensed Rights or the Sublicensed Rights within ninety (90) days after first receiving notice or otherwise becoming aware of such action or proceeding, then Licensor shall have the right to assume defense of such Third Party action at its own expense. Any awards or amounts received in bringing any such action shall be first allocated to reimburse the Parties’ expenses in such action, and any remaining amounts shall be retained by the Party defending against such proceeding.

 

KASAN_기술이전, 라이선스 계약서에서 License 대상 IP 및 특허 정의조항, 적용범위, 계약체결 후 발명

 

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작성일시 : 2019.05.14 13:36
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영문 계약조항 샘플

Example: Commercially Reasonable Efforts” means efforts that are consistent with the type and scope of efforts that a similarly-situated company within the pharmaceutical industry would devote to a product of similar risk profile and profit potential, but in no event less than the type and scope of efforts that the applicable Party would devote to any of its other products of similar risk profile and profit potential. Without limiting the foregoing, Commercially Reasonable Efforts require that such Party: (i) assign responsibility for the relevant activities to specific employees who are responsible for progress and monitor such progress on a regular basis; (ii) set and consistently seek to achieve specific and meaningful objectives and timelines for carrying out such activities; and (iii) consistently make and implement decisions and allocate resources consistent with the efforts described above.

 

Example: 1.22 “Commercially Reasonable Efforts” means, from to time to time with respect to the performance at such time of any Development, Commercialization or other obligation of a Party under this Agreement that expressly requires efforts characterized as such, the performance by such Party of such obligation by expending reasonable, diligent, good faith efforts to accomplish such obligation as a similarly situated pharmaceutical company would use to accomplish a similar obligation under similar circumstances through the exercise of reasonable business judgment, where the assessment of being similarly situated would be undertaken by reference to company size and financial position, competitive factors in the relevant market relating to the proprietary position of the relevant product in terms of market and profit potential, the safety and effectiveness profile of the relevant product, strategic value, and applicable regulatory matters; provided, that, with respect to the Development and Commercialization of the Compound or the Product, such efforts shall be substantially equivalent to those efforts and resources that a pharmaceutical company would generally devote to its own internally discovered compounds or products of similar market and profit potential, safety and effectiveness profile, strategic value, and regulatory matters at a similar stage in their development or life cycle, with respect to which it does not owe license payments, milestone payments, royalties or similar financial obligations to licensors or other Persons, and based on conditions then prevailing, with the goal of maximizing the revenue potential of such compounds or products. Commercially Reasonable Efforts shall be determined on a country by country basis.

 

Example: Each party agreed to use best efforts to take all actions necessary or desirable to consummate the transactions contemplated by this Agreement.

 

Example: Either Party shall have the right to terminate this Agreement, provided that the Party intending to terminate the Agreement shall provide one hundred twenty (120) days prior written notice to the other Party and a reasonable reason for termination of this Agreement.

 

1. 불명확한 영문 표현을 포함한 계약조항

 

불명확하고 추상적인 표현은 가능하면 계약서에 사용하지 않는 것이 바람직합니다. 그러나 회피하고 싶어도 ""측에서 고수하여 어쩔 수 없는 상황도 있습니다. 예를 들면, 외국회사와 독점수입판매계약을 체결하면서 국내회사에게 그 제품판매를 위해 가능한 최선의 노력(best efforts)을 다해야 한다는 조항을 넣을 수 있습니다. 국내회사 노력에도 불구하고 판매가 부진하면 위 계약조항의 위반여부를 둘러싸고 분쟁이 발생할 수 있습니다.

 

또한, 합리적인 이유(reasonable reason)를 제시할 수 있다면 언제든지 일정기간 사전 최고기간을 거쳐 그 계약을 해지할 수 있다는 조항도 분쟁의 소지가 많습니다. 이것도 ""은 피하고 싶지만 ""측에서 고수한다면 어쩔 수 없습니다.

 

2. 불명확한 영문표현의 해석

 

추상적이고 불명확한 용어라고 해도 그 의미와 적용범위를 전혀 짐작할 수 없는 정도는 아닙니다. 통상 계약규범으로서 역할을 할 수 있는 한정된 범위로 해석할 수 있습니다.

 

예를 들어, "reasonable reason"은 그 계약의 해당업계에서 통용되는 합리적 상식에 기초한 계약해지 사유로 보아야 할 것입니다. 계약수행이 객관적으로 불가능한 force majeure는 물론 그보다 약하지만 영미법상의 frustration(우리 법의 사정변경의 원칙을 적용할 만한 사유 등)에 해당하는 사유라면 이에 해당하여 계약해지를 할 수 있을 것입니다. 나아가, frustration 보다 더 약한 사유이지만 그와 유사한 정도이거나 그와는 구별될 수 있지만 계약서에서 명시적으로 열거한 계약해지 사유와 동급으로 판단되는 사유하면 이에 해당한다고 볼 수 있습니다.

 

한편, 그보다 더 약한 사유까지 그 스펙트럼을 아무리 확장한다고 해도 일방 당사자가 원하면 언제라도 자유롭게 계약해지를 할 수 있다는 의미로 해석할 수 없습니다. 참고로, 임의 해지에 해당하는 영문표현으로는 "termination for convenience at any time" 또는 "termination at will"이라는 분명하게 구별할 수 있는 별도의 계약 문언이 사용됩니다.

 

한편, best efforts” 또는 “best endeavours”는 “최선의 노력” 또는 “최대한의 노력”으로 번역될 수 있지만 무한정의 노력을 의미하는 것이 아닙니다. 영미판례법에 따르면, 그 범위는 자신의 이익과 결과달성을 위한 열망에 따라 행동하는 신중하고 이성적이며 굳게 결심한 사람이 수행할 것을 믿어지는 조치나 단계를 모두 거쳤다면 최선의 노력을 다한 것으로 평가할 수 있습니다. 그보다 더 나아가 심각한 재정적 위험을 감수하거나 자신의 상업적 기반 등을 약화시키면서까지 노력을 다할 필요는 없고, 실패할 것이 명백한 조치를 취할 것을 요구할 수 없습니다.

 

3. 실무적 대응방안

 

계약서에서 추상적, 불명확한 용어를 사용하지 않는 것이 최선입니다. 피할 수 없는 경우에도 계약 문언의 의미를 미리 알고 대처한다면 그 리스크를 적절하게 관리할 수 있습니다. 추상적 용어와 동일선상에 있는 것으로 볼 수 있어 그 용어나 표현의 의미를 해석하는데 기준이 될 수 있는 용어나 표현들을 병렬로 넣어둔다면 큰 도움이 될 것입니다.

 

그리고 계약서 문언에는 반영되지 않더라도 그 용어에 관한 당사자의 의사를 엿볼 수 있는 메모, 회의록, 협상 이메일 등 보조자료를 잘 보존한다면 추후 분쟁을 해결하는데 도움이 될 것입니다.

 

예를 들어, 최선노력조항이라면 법적 위험을 줄이기 위해서는 노력조항에 따라 당사자가 구체적으로 어떤 의무를 부담하게 되는지 리스트업하여 계약서에 부속문서로 명시하거나 적어도 사전에 메모라도 교환하는 것이 안전합니다. 또한 노력조항의 범위도 간접적으로 제한할 수 있으므로 노력조항의 충족을 위해 투입해야 하는 업무시간, 예산, 인적자원 등의 범위를 한정하는 방법으로 리스크를 줄일 수도 있습니다.

 

KASAN_기술이전, 라이선스 등 국제계약에서 자주 사용되는 commercially reasonable effort

 

 

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작성일시 : 2019.05.14 08:31
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1. 기술이전 과정에서 체결하는 일련의 계약과 법적 책임 소재

본 계약을 체결하기 전에 양당사자가 의향서(LOI, Letter of Intent), 비밀유지약정(NDA, Non-Disclosure Agreement), 양해각서(MOU, Memorandum of Understanding), Term Sheet 등을 체결하는 경우가 많습니다. 그런데, 어떤 사정으로 본계약 체결까지 이르지 못하고 협상 중 거래가 무산되었다면 당사자에게 어떤 법적책임이 있을까요?

 

본계약을 체결하지 못했지만 그 전 단계에서 다양한 약정들을 체결하고 협상이 거의 마무리 단계에 이른 경우부터 어떤 계약서도 체결하지 못한 협상 초기 단계까지 다양한 스펙트럼이 존재합니다. 당연하게 협상 당사자의 법적책임도 다양할 것입니다. MOU, NDA 등에 구속력 없다는 문구를 명시적으로 넣더라도 법적효력을 인정하는 사항이 있습니다. 또한, 어떤 형식적 계약서도 체결하지 않았더라도 계약법상 책임이 아니라 불법행위법상 책임을 물을 수 있는 경우도 있습니다.

 

단순하지 않고 사안마다 신중하게 검토해야 하는 복잡한 문제입니다. 그 법적책임은 각 구체적 사안에 따라 달라질 것입니다. 아래 참고사례를 살펴보겠습니다.

 

2. 기술이전 협상

A회사는 B가 개발한 신규기술을 이전 받아서 관련 제품을 생산 판매하려고 협의를 진행하였습니다. 협상과정에서 기술이전계약을 체결할 것을 상호 확인하였고 A사는 임원회의를 통해서 B의 기술을 이전 받아 사업을 진행하기로 내부적으로 결론을 내렸고 곧 B에게 해당기술을 이전 받아 사업을 진행하고 기술료를 지급할 것을 내용으로 하는 계약을 체결하기로 합의하였다는 확인서를 작성해주었습니다. 본 계약은 아니고 일종의 의향서로 볼 수 있습니다.

 

그런데, A사는 그 후 다시 사업성 검토를 통해 해당 프로젝트에 관한 기술이전계약을 체결하지 않기로 최종 결정하였습니다.

 

기술이 부족한 경우 회사들은 공동개발 또는 기술도입 이전을 통하여 새로운 사업을 진행하거나 확장하고 있습니다. 이 경우에 최종적으로 계약을 체결하고 사업이 정상적으로 진행되는 경우도 있지만, 위와 같이 여러 가지 이유로 본 계약체결 전에 중단되는 경우도 많습니다.

 

3. 계약체결 무산에 따른 당사자의 책임여부 및 범위

일반적으로는 계약을 체결하기 전에는 계약 협의 당사자에게는 계약상 책임이 없습니다. 그러나 특별한 경우, 즉 계약 체결을 위한 준비단계 또는 계약의 성립과정에서 당사자 일방이 그에게 책임 있는 사유로 상대방에게 손해를 끼친 경우에는 이를 배상할 책임(민법 제750)이 있습니다. 당사자에 의해서 형성된 신뢰에 따라서 상대방이 기대된 행동을 하였으나 당사자 일방이 상당한 이유 없이 계약 체결을 거부하여 상대방에게 손해가 발생한 경우에는 불법행위 책임이 발생하게 되는 것입니다.

 

민법에는 다음과 같은 계약체결상의 과실책임이라는 특별한 불법행위 책임 규정이 있습니다.

 

민법 제535(계약체결상의 과실) 목적이 불능한 계약을 체결할 때에 그 불능을 알았거나 알 수 있었을 자는 상대방이 그 계약의 유효를 믿었음으로 인하여 받은 손해를 배상하여야 한다. 그러나 그 배상액은 계약이 유효함으로 인하여 생길 이익액을 넘지 못한다. 전항의 규정은 상대방이 그 불능을 알았거나 알 수 있었을 경우에는 적용하지 아니한다.

 

이는 계약 목적이 객관적으로 이행이 불가능하다는 사실을 알고 있던 당사자에게만 책임을 인정하고 있습니다. 위 사안에서 기술이전이 교섭행위 이전에 이미 이행불가능한 것은 아닐 것이므로 A사에게 민법상의 계약체결상의 과실책임은 성립할 여지가 없을 것입니다.

 

한편, 대법원은 어느 일방이 교섭단계에서 계약이 확실하게 체결되리라는 정당한 기대 내지 신뢰를 부여하여 상대방이 그 신뢰에 따라 행동하였음에도 상당한 이유 없이 계약의 체결을 거부하여 손해를 입혔다면 이는 신의성실의 원칙에 비추어 볼 때 계약자유 원칙의 한계를 넘는 위법한 행위로서 불법행위를 구성한다고 판시하였습니다(대법원 2003. 4. 11. 선고 200153059 판결).

 

따라서 (1) 어느 일방이 교섭단계에서 계약이 확실하게 체결되리라는 정당한 기대 내지 신뢰를 부여하여, (2) 상대방이 그 신뢰에 따라 행동하였음에도, (3) 상당한 이유 없이 계약의 체결을 거부하여 손해를 입혔다면, 신의성실의 원칙을 위반하여 불법행위 책임을 구성하게 될 것입니다.

 

4. 구체적 사안에 적용 및 실무적 포인트

위 사안에서 불법행위 책임의 성립여부를 살펴보면, 먼저 A사가 상대방에게 계약이 체결될 것이라는 신뢰를 형성한 것이고, B가 기술이전계약이 곧 체결될 것을 믿고 관련 업무절차를 준비하였거나 추가 연구 등에 투자하였다는 등의 사정으로 시간 또는 비용을 투자하였다면, A사의 상당한 이유가 없는 계약체결 거절로 B의 관련 투자가 무용하게 되는 손해가 발생하였다면, 위 대법원 설시 법리에 따라 A사는 이러한 손해를 배상할 불법행위 책임이 발생할 수 있습니다.

 

이때 손해배상의 범위는 A사에게는 계약이 유효하게 성립할 것으로 기대하여 상대방에게 발생한 신뢰이익, 즉 그러한 신뢰가 없었더라면 통상 지출하지 아니하였을 비용에 대하여만 배상할 책임이 있습니다. 상대방에게 계약 협상과정에서 통상 들어가는 비용, 즉 계약 체결여부와 무관하게 들어가는 비용까지 A사에게 책임을 묻지 못합니다.

 

정리하면, 원칙적으로 최종 계약이 성립되기 전까지는 계약상 책임을 물을 수 없습니다. 그러나, 협상과정에서 대법원 판결에서 제시한 바와 같은 계약체결을 신뢰한 특별한 사정이 있었다면 최종 계약을 체결하지 않는 당사자에게는 불법행위로 인한 손해배상 책임 인정될 수 있습니다. 다만, 그 손해배상의 범위는 계약성립을 믿고 지출된 특별한 손해에 한정되므로, 특별한 사정으로 없다면 그 액수는 경미한 경우가 대부분일 것입니다. 손해배상을 청구하는 측이 위와 같은 특별한 사정의 존재를 주장 입증해야 합니다.

 

KASAN_기술이전, 라이선스, 공동연구개발 협의과정에서 기술정보제공 후 협상 최종단계에서 본계약체결이 무산된 경우

 

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작성일시 : 2019.05.13 14:44
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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_제약분야 기술이전 및 독점라이선스 계약서 중에서 진술보증 조항 REPRESENTATIONS, WARRAN

 

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작성일시 : 2019.05.13 13:00
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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 없다는 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 200819678 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 201264253 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.

 

, 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 2015207044 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. 3자가 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 진

 

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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.

 

KASAN_벤처기업의 인수, 합병 시 기술이전 및 라이선스, 공동연구개발계약상 쟁점 - License, Collab

 

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작성일시 : 2019.05.13 10:37
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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,

 

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작성일시 : 2019.05.10 13:47
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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, 비밀

 

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작성일시 : 2019.05.10 11:00
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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

 

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작성일시 : 2019.05.10 10:00
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The International Institute for Conflict Prevention and Resolution (CPR) is a non-profit think tank that combines a decades-old heritage of thought leadership with the innovation of its diverse and collaborative membership to offer the most cutting edge dispute resolution services and resources available.

 

ALTERNATIVE DISPUTE RESOLUTION

 

The parties recognize that bona fide disputes as to certain matters may arise from time to time during the term of this Agreement which relate to either party’s rights and/or obligations. To have such a dispute resolved by this Alternative Dispute Resolution (“ADR”) provision, a party [*].

 

If the matter has not been resolved within [*], either party may initiate an ADR proceeding as provided herein. The parties shall have the right to be represented by counsel in such a proceeding.

 

1. To begin an ADR proceeding, a party shall provide written notice to the other party of the issues to be resolved by ADR. Within [*] after its receipt of such notice, the other party may, by written notice to the party initiating the ADR, add additional issues to be resolved within the same ADR.

 

2. Within [*] days following receipt of the original ADR notice, the parties shall select a mutually acceptable neutral to preside in the resolution of any disputes in this ADR proceeding. If the parties are unable to agree on a mutually acceptable neutral within such period, either party may request the President of the CPR Institute for Dispute Resolution (“CPR”), 366 Madison Avenue, 14th Floor, New York, New York 10017, to select a neutral pursuant to the following procedures:

 

(a) The CPR shall submit to the parties a list of not less than [*] within [*] after receipt of the request, along with a Curriculum Vita for each candidate. No candidate shall be an employee, director, or shareholder of either party or any of their subsidiaries or Affiliates.

 

(b) Such list shall include a statement of disclosure by each candidate of any circumstances likely to affect his or her impartiality.

 

(c) Each party shall number the candidates in order of preference (with the number one (1) signifying the greatest preference) and shall deliver the list to the CPR within [*] following receipt of the list of candidates. If a party believes a conflict of interest exists regarding any of the candidates, that party shall provide a written explanation of the conflict to the CPR along with its list showing its order of preference for the candidates. Any party failing to return a list of preferences on time shall be deemed to have no order of preference.

 

(d) If the parties collectively have identified fewer than [*] deemed to have conflicts, the CPR immediately shall designate as the neutral the candidate for whom the parties collectively have indicated the greatest preference. If a tie should result between [*], the CPR may designate either candidate by lot. If the parties collectively have identified [*] or more candidates deemed to have conflicts, the CPR shall review the explanations regarding conflicts and, in its sole discretion, may either (i) immediately designate as the neutral the candidate for whom the parties collectively have indicated the greatest preference, or (ii) issue a new list of not less than [*], in which case the procedures set forth in subparagraphs 2(a)-2(d) shall be repeated.

 

3. No earlier than [*] or later than [*] after selection, the neutral shall hold a hearing to resolve each of the issues identified by the parties. The ADR proceeding shall take place at a location agreed upon by the parties. If the parties cannot agree, the neutral shall designate a location other than the principal place of business of either party or any of their subsidiaries or Affiliates.

 

4. At least [*] prior to the hearing, each party shall submit the following to the other party and the neutral:

 

(a) a copy of all exhibits on which such party intends to rely in any oral or written presentation to the neutral;

 

(b) a list of any witnesses such party intends to call at the hearing, and a short summary of the anticipated testimony of each witness;

 

(c) a proposed ruling on each issue to be resolved, together with a request for a specific damage award or other remedy for each issue. The proposed rulings and remedies shall not contain any recitation of the facts or any legal arguments and shall not exceed one (1) page per issue.

 

(d) a brief in support of such party’s proposed rulings and remedies, provided that the brief shall not exceed thirty (30) pages. This page limitation shall apply regardless of the number of issues raised in the ADR proceeding.

 

Except as expressly set forth in subparagraphs 4(a)-4(d), no discovery shall be required or permitted by any means, including depositions, interrogatories, requests for admissions, or production of documents.

 

5. The hearing shall be conducted on consecutive days and shall be governed by the following rules:

 

(a) Each party shall be entitled to [*] of hearing time to present its case. The neutral shall determine whether each party has had the [*] to which it is entitled.

 

(b) Each party shall be entitled, but not required, to make an opening statement, to present regular and rebuttal testimony, documents or other evidence, to cross-examine witnesses, and to make a closing argument. Cross-examination of witnesses shall occur immediately after their direct testimony, and cross-examination time shall be charged against the party conducting the cross-examination.

 

(c) The party initiating the ADR shall begin the hearing and, if it chooses to make an opening statement, shall address not only issues it raised but also any issues raised by the responding party. The responding party, if it chooses to make an opening statement, also shall address all issues raised in the ADR. Thereafter, the presentation of regular and rebuttal testimony and documents, other evidence, and closing arguments shall proceed in the same sequence.

 

(d) Except when testifying, witnesses shall be excluded from the hearing until closing arguments.

 

(e) Settlement negotiations, including any statements made therein, shall not be admissible under any circumstances. Affidavits prepared for purposes of the ADR hearing also shall not be admissible. As to all other matters, the neutral shall have sole discretion regarding the admissibility of any evidence.

 

6. Within [*] following completion of the hearing, each party may submit to the other party and the neutral a post-hearing brief in support of its proposed rulings and remedies, provided that such brief shall not contain or discuss any new evidence and shall not exceed thirty (30) pages. This page limitation shall apply regardless of the number of issues raised in the ADR proceeding.

 

7. The neutral shall rule on each disputed issue within [*] following completion of the hearing. Such ruling shall adopt in its entirety the proposed ruling and remedy of one of the parties on each disputed issue but may adopt one party’s proposed rulings and remedies on some issues and the other party’s proposed rulings and remedies on other issues. The neutral shall not issue any written opinion or otherwise explain the basis of the ruling.

 

8. The neutral shall be paid [*]:

 

(a) If the neutral rules in favor of one party on all disputed issues in the ADR, the losing party shall pay [*].

 

(b) If the neutral rules in favor of one party on some issues and the other party on other issues, the neutral shall issue with the rulings a written determination as to how such fees and expenses shall be allocated between the parties. [*].

 

9. The rulings of the neutral and the allocation of fees and expenses shall be binding, non-reviewable, and non-appealable, and may be entered as a final judgment in any court having jurisdiction.

 

10. Except as provided in paragraph 9 or as required by law, the existence of the dispute, any settlement negotiations, the ADR hearing, any submissions (including exhibits, testimony, proposed rulings, and briefs), and the rulings shall be deemed Confidential Information. The neutral shall have the authority to impose sanctions for unauthorized disclosure of Confidential Information.

 

11. The hearings shall be conducted in the English language.

 

KASAN_국제계약분쟁 해결방안 ADR, 공식 중재기관의 Arbitration 외 사적 조정방안 - The Inte

 

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작성일시 : 2019.05.10 09:18
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서울고등법원 20145141 판결도 존슨앤드존슨에서 재판매가격 유지행위를 공정거래법 위반으로 판결하였습니다.

 

서울고등법원은 판결문에서 "재판매가격을 정해 그 가격대로 판매할 것을 지시하는 행위가 단지 참고가격이나 희망가격으로 제시된 것이라면 위법하다고 볼 수 없지만, 그 지시 등을 따르도록 하는데 실효성을 확보할 수 있는 수단이 있다면 이는 공정거래법이 금지하는 재판매가격 유지행위에 해당한다"고 위법 판단기준을 제시한 후,

 

구체적을 아큐브 사안에서는 "존슨앤드존슨은 직원 또는 아르바이트생 등으로 하여금 거래 안경점과 비거래 안경점에서 아큐브 제품을 구입하게 하는 등 소비자 판매가격 준수 상태를 점검했고, 이를 어긴 안경점에 대해서는 최대 1개월까지 제품공급을 중단한 만큼 재판매가격 유지행위를 한 것으로 인정할 수 있다"고 판단하였습니다.

 

, 본사에서 소매점의 판매가격을 정해놓고 이를 실제로 준수하도록 강제했다는 것으로서, 이와 같은 판매가격 강제정책은 공정거래법에서 금지하는 재판매가격 유지행위에 해당한다는 판결입니다.

 

앞서 블로그에 올린 중국 사례도 비슷합니다. 참고자료로 다시 올려 드립니다.

 

다국적 제약회사 Johnson & Johnson v. 중국 총판회사 Ruibang 사이에서 의료기구 판매가격을 둘러싼 분쟁에서 제조사 Johnson& Johnson을 공정거래법 위반으로 판단하여 총판에 대한 손해배상 책임을 인정한 사례 - 중국 상해고급법원 2013. 8. 4. 선고 판결

 

다국적 제약회사 Johnson& Johnson은 중국회사 Ruibang과 중국 내 판매총판 계약을 체결하였습니다. 두 회사는 15년 동안 J&J의 다양한 의료기기 및 기구에 관한 중국 판매 사업에 관한 Distribution Agreement를 매년 갱신하는 방식으로 사업관계를 유지해 왔습니다.

 

양사가 2008 1월 서명한 갱신 계약서에는 특정 제품을 J&J에서 설정한 가격 이하로는 판매할 수 없다는 명시적 조항이 들어 있습니다. 그런데, 그 해 3 Ruibang은 중국 북경대학병원 납품계약 입찰에서 J&J에서 설정한 최저가격보다 더 낮은 가격으로 입찰하여 낙찰 받았습니다. 소위 저가 입찰을 하여 납품계약을 성사시킨 것입니다. 이에 J&J에서는 Ruibang에 대해 계약위반을 경고하였으며, 그 후 특정병원에 대한 Ruibang의 딜러 자격을 박탈하였고, 추가적으로 해당 제품 전체에 관한 딜러쉽 자체를 박탈하였습니다. 나아가, 2009년 총판계약 갱신을 할 때에 이르러서는 계약 전체의 갱신을 거절하였습니다. 이에 총판자격을 상실하게 된 Ruibang 2010 J&J를 상대로 공정거래법 위반혐의로 제소하였습니다.

 

위 사건에서 중국법원은 1,2심 모두 J&J의 공정거래법 위반행위를 인정하여 Ruibang에게 손해배상 책임을 인정하는 판결을 하였습니다. 이것은 중국에서 제조회사와 판매회사 사이에 판매회사의 재판매가격을 제한하는 행위를 공정거래법 위반으로 판단한 첫 판결이라고 합니다. 선진국으로 갈수록 공정거래법이 중요해지는 경향이 있는데, 이제 중국에서도 사업을 하는 과정에 공정거래법을 신중하게 검토하고 관련 이슈를 고려해야 한다는 점을 시사합니다.

 

공정거래법상 제판매가격제한에 관한 쟁점에 판시한 우리나라 대법원 판결을 소개한 뉴스레터를 참고로 포스팅합니다.

 

·     의약품 도매상에 대한 재판매가격유지 행위와 공정거래법 위반 여부 -

 

공정거래법 관련 대법원 판결: 대법원은 2010. 11. 25. 제약업계에 중대한 영향을 미칠만한 판결을 하였습니다. (대법원 2010. 11. 25. 선고 20099543 판결) 공정거래위원회로부터 시정조치 및 과징금 처분을 받았던 다수의 제약회사가 상고했던 공정거래법 사건으로 1 6개월이 넘는 기간 동안 신중한 심리를 거처 드디어 몇 가지 쟁점사항에 대한 중요한 판결을 하였습니다. 그 내용 중에서 의약품 판매와 관련된 도매상의 저가입찰에 관련된 사항을 Q&A 형식으로 정리해 설명드립니다.

 

사례: 제약회사 은 최근 1원 낙찰이 문제되자 거래선인 도매상 에게 전문의약품 A를 병원에 공급할 때 절대로 보험약가 이하로 공급하지 않는다는 약정서 체결을 요구하여 서명 받았다.

 

Q. 사이 위 약정서는 효력이 있는가?  

 

A. 양 당사자 내부에서는 계약자유 원칙상 유효라고 할지라도 대외적 관계에서 공정거래법 위반 문제가 있습니다. 제약회사 전문의약품 A를 도매상 에게 판매하면서 다시 A를 병원에 판매할 때의 가격(‘재판매가격’)을 통제하려는 행위는 공정거래법에서 위법한 행위로 규정하고 있습니다. 공정거래법 제29조 제1항은 “사업자는 재판매가격유지행위를 하여서는 아니 된다.”라고 규정하여 원칙적으로 금지하고 있고, 2조 제6호에서 “재판매가격유지행위라 함은 사업자가 상품 또는 용역을 거래함에 있어서 거래상대방인 사업자 또는 그 다음 거래단계별 사업자에 대하여 거래가격을 정하여 그 가격대로 판매 또는 제공할 것을 강제하거나 이를 위하여 규약기타 구속조건을 붙여 거래하는 행위“라고 그 의미를 정의하고 있습니다.

 

쉽게 얘기하면 상품유통 과정에서 상위에 있는 사업자가 다음 거래 단계의 판매가격을 정하려는 행위를 금지하는 것입니다. 그 취지는 자유로운 경쟁을 촉진하여 최종 소비자 가격이 낮아지도록 유도한다는 것입니다. 따라서, 상위단계 사업자인 제약회사가 상품유통의 다음 단계 사업자인 도매상의 판매가격을 통제하려는 위 약정 행위는 재판매가격유지행위에 해당하고, 이를 요구한 제약회사 은 공정거래법을 위반한 책임이 있습니다.

 

사례: 제약회사 은 도매상 스스로 약정한 것과는 달리 전문의약품 A를 특정병원에 1원에 입찰을 하자 거래중단을 경고한 후 재발방지를 서약하는 각서를 받았다.

 

Q. 사이 위 각서는 효력이 있는가?  

 

A. 마찬가지로 제약회사 의 행위는 “재판매가격유지행위”에 해당하여 위법하므로 실질적으로 효력이 없습니다. 오히려 공정거래법 위반책임만 지게 됩니다.

 

Q. 공정거래법을 위반한 제약회사에게 공정거래위원회는 어떤 법적 조치를 취할 수 있는가?  

 

A. 공정거래위원회는 위반행위의 중지 및 시정을 명령할 수 있습니다. 또한, 시정명령을 받았다는사실을 신문에 공표하도록 명령할 수 있습니다. 또한, 과징금을 부과할 수 있는데, 액수는 위법한 재판매가격유지행위로 인한 매출액의 2% 범위내의 금액, 만약 매출이 없는 경우에는 5억원 이내의 금액을 부과할 수 있습니다. 한편, 공정위 시정명령에 응하지 아니하는 등 불복하면 형사처벌을 받게 됩니다.

 

Q. 재판매가격유지행위가 예외적으로 허용되는 경우는 있는가?

 

A. 원칙적으로는 극히 예외적으로 허용됩니다. , 최저재판매가격유지행위가 당해 상표 내의 경쟁을 제한하는 것으로 보이는 경우라 할지라도, 시장의 구체적 상황에 따라 그 행위가 관련 상품시장에서의 상표 간 경쟁을 촉진하여 결과적으로 소비자후생을 증대하는 등 정당한 이유가 있는 경우에는 이를 예외적으로 허용합니다. 대법원은 그와 같은 정당한 이유가 있는지 여부는 관련시장에서 상표 간 경쟁이 활성화되어 있는지 여부, 그 행위로 인하여 유통업자들의 소비자에 대한 가격 이외의 서비스 경쟁이 촉진되는지 여부, 소비자의 상품 선택이 다양화되는지 여부, 신규사업자로 하여금 유통망을 원활히 확보함으로써 관련 상품시장에 쉽게 진입할 수 있도록 하는지 여부 등을 종합적으로 고려하여야 할 것이며, 이에 관한 증명책임은 관련 규정의 취지상 사업자에게 있다고 보아야 한다고 밝혔습니다.

 

그러나, 대법원은 위 사안에서 제약회사가 도매상들로 하여금 보험약가 수준으로 가격을 유지하도록 요구하는 행위는 위와 같은 정당한 이유에 해당하지 않는다고 판결하였습니다.

 

Q. 제약회사 이 도매상 의 극단적 난매행위를 저지할 방지할 방법은 없는가?

 

A. 앞으로 거래를 중단하는 것입니다. 다만, 공정거래법은 부당한 거래거절행위 또한 공정거래법 위반행위로 금지하고 있으므로 거래중단을 하기 전에 이에 해당하지 않도록 신중한 검토가 필요합니다.

 

사례: 제약회사 은 도매상들에게 지역과 거래대상 병원을 할당하였다. 그런데, 도매상 은 이를 어기고 몰래 자신에게 지정되지 않는 A 병원에 제품을 공급하였다.

 

Q. 제약회사 이 도매상 의 행위를 제재할 수 있는가?  

 

A. 거래지역이나 거래대상을 제한하는 행위는 양 당사자 내부에서는 계약자유 원칙상 유효라고 할지라도 대외적 관계에서 공정거래법 위반 문제가 있습니다. 위 판결 사안에서 제약회사들은 도매상들에 대하여 지정 납품처 아닌 곳에의 납품을 금지하고, 이를 어기는 도매상들을 적발하여 각서를 징구하거나, 경고장 발송, 거래 정리 등의 조치를 취하였습니다. 이와 같은 사안에서 대법원은 거래상대방을 제한하는 행위는 도매상들에 대하여 실질적인 구속력이 있었으므로, 공정거래법이 금지하고 있는 구속조건부거래에 해당한다고 판결하였습니다.

 

따라서, 제약회사 공정거래법 위반행위에 대해 재판매가격유지행위와 마찬가지로 시정조치 및 과징금 부과 등의 제재를 받게 됩니다.  

 

KASAN_[의료기기쟁점] 의료기기 판매 및 영업 활동 관련 공정거래법 위반 여부.pdf

 

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작성일시 : 2019.04.16 14:00
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기술이전 License 중 많은 경우가 기술이전 이후부터 상업적 발매까지 추가 연구개발에 많은 비용과 시간이 필수적으로 투입되어야만 합니다. 대표적으로 신약기술 이전 License 케이스가 이와 같습니다.

 

Licensor 수입의 대부분은 Running Royalty이므로 상업적 판매까지 제품개발이 성공적으로 완료되는지 여부는 License 양 당사자 모두에게 매우 중대한 영향을 미칩니다. 그와 같은 중대한 development 관련 사항 중 License 계약서에 반영되어야 할 내용은 어떤 것인지 사례를 통해 살펴보겠습니다.

 

아래에서 일본제약회사와 다국적 제약회사가 체결한 신약의 물질특허에 대한 Exclusive License Agreement Development 조항을 간략하게 살펴보겠습니다. Licensor 일본회사 Shionogi에서 신약물질 특허권을 보유하고, Licensee AstraZeneca에 대해 해당 특허의 전용실시권 허여 및 상업화 권리를 부여하는 기술이전 license 계약입니다.

 

비록 Crestor License Agreement는 조금 오래 된 계약서이지만, 실제 엄청난 성공을 거둔 신약개발 기술이전 프로젝트로서 실무자가 참고자료로 살펴볼 필요가 있다고 생각합니다.

 

참고로, 최근에는 양 당사자가 참여하는 Joint Steering Committee (JSC), Joint Development Committee (JDC)를 구성하여, 정기적 회의를 통해 후속 연구개발의 진행, 성과평가, 조정, 결정 등을 해나가는 방식이 자주 활용되고 있습니다. 이를 위해 처음부터 License Agreement에 이와 같은 JSC 등에 관한 계약조항을 두는 경우가 많습니다.

 

Article 3.  Development

 

3.1

SHIONOGI shall disclose the KNOW-HOW, which is necessary, useful or advisable for ZENECA to obtain the HEALTH REGISTRATION APPROVAL and to develop, manufacture, use, distribute, market and sell the LICENSED PRODUCTS, in each country of the TERRITORY, after the execution of this Agreement without delay to the extent not done so already.  If the visits of SHIONOGI’s representative(s) to ZENECA’s facilities are reasonably requested by ZENECA relating to the disclosure of KNOW-HOW to ZENECA, SHIONOGI will send an appropriate representative(s) to ZENECA’s facilities; provided that ZENECA shall bear the expenses of travel and accommodations for such representative(s).

 

SHIONOGI will provide ZENECA with all reasonable assistance required in order to transfer the KNOW-HOW to ZENECA in a timely manner.  Such assistance will include, but shall not be limited to those items listed in the Schedule attached.

 

3.3

ZENECA shall develop and register the PRODUCTS in the TERRITORY on its sole responsibility as if the PRODUCTS had been derived from ZENECA’s own research pipeline.  Prior to October 31, 1998, ZENECA shall prepare a development schedule (hereinafter referred to as the “DEVELOPMENT SCHEDULE”), and shall allow SHIONOGI the opportunity to comment upon it.  The DEVELOPMENT SCHEDULE shall contain the estimated time schedule of pre-clinical studies, clinical trials, New Drug Application (“NDA”) filings, launches and other related activities to be conducted by ZENECA with respect to the PRODUCTS in Europe, the U.S.A. and Japan.  The first DEVELOPMENT SCHEDULE (hereinafter referred to as the “ORIGINAL DEVELOPMENT SCHEDULE”) shall be attached to this Agreement as Appendix III.

  

3.4

ZENECA may also pursue the feasibility for the development and commercialization of the COMBINATION PRODUCTS.  If ZENECA decides to carry out the development of any COMBINATION PRODUCTS leading to their commercialization, ZENECA shall promptly inform SHIONOGI of such intention in writing and provide SHIONOGI with the development schedule therefor.

 

3.5

If ZENECA reasonably foresees or becomes aware of any delay of six (6) months or more in the actual development of the PRODUCTS as compared with the timing set forth in the ORIGINAL DEVELOPMENT SCHEDULE or any later modified DEVELOPMENT SCHEDULE, ZENECA shall promptly inform SHIONOGI of such delay in writing.  Whereupon ZENECA may modify such DEVELOPMENT SCHEDULE upon consultation with SHIONOGI, but for the avoidance of doubt, such consultation shall be for information only and ZENECA will not be required to obtain SHIONOGI’s approval to any such modification.

 

3.6

Any and all development costs for the LICENSED PRODUCTS in the TERRITORY shall be solely borne by ZENECA.

 

3.7

ZENECA shall provide SHIONOGI with a bi-annual report on the progress in the development of LICENSED PRODUCTS in the TERRITORY in order to keep SHIONOGI informed of the progress.  ZENECA also agrees to have meetings with SHIONOGI in a timely manner (at least once a year) in order to report on the progress in the development of LICENSED PRODUCTS in the TERRITORY.  If any application of Investigational New Drug (“IND”), Clinical Trial Exemption (“CTX”) and/or NDA is filed with the competent authorities in Europe, the U.S.A. and Japan, ZENECA shall provide SHIONOGI with a summary of all dossier submitted to such authorities (including any amendments thereto).  The provisions of Article 8.1 shall apply to any information disclosed hereunder, and SHIONOGI shall not be permitted to use any such information for any purpose other than evaluating the progress of ZENECA’s development of the LICENSED PRODUCTS.

 

3.8

Upon completion of phase II clinical trials for the LICENSED PRODUCTS, ZENECA shall have the right to terminate this Agreement by informing in writing SHIONOGI of its intention to terminate this Agreement as well as the background of such decision.  On termination of this Agreement pursuant to this Article 3.8, ZENECA shall not be obliged to make any further payments under Article 4.

3.9

If and when the HEALTH REGISTRATION APPROVAL is obtained in any country of the TERRITORY, ZENECA shall promptly inform SHIONOGI of such HEALTH REGISTRATION APPROVAL and send to SHIONOGI a copy of the approval letter, along with an English translation thereof, of such HEALTH REGISTRATION APPROVAL issued by the competent health authority of such country.  The provisions of Article 8.1 shall apply to any information disclosed hereunder, and SHIONOGI shall not be permitted to use any such information for any purpose other than evaluating the progress of ZENECA’s development of the LICENSED PRODUCTS.

 

3.10

If ZENECA chooses to market the LICENSED PRODUCTS in Japan and/or Taiwan with a partner other than ZENECA’s AFFILIATE in such countries, ZENECA shall offer to SHIONOGI the first opportunity to be ZENECA’s marketing partner for the LICENSED PRODUCTS in Japan and/or Taiwan.  With regard to the terms and conditions of the marketing of LICENSED PRODUCTS in Japan and/or Taiwan, SHIONOGI and ZENECA shall negotiate such terms and conditions in good faith.  If the PARTIES are unable to agree upon such terms and conditions, ZENECA shall be free to offer the opportunity to a THIRD PARTY on terms and conditions no more favorable than those offered to SHIONOGI.

 

KASAN_[국제계약실무] 신약 물질특허 기술이전 Exclusive License 계약서 중 Development

 

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작성일시 : 2019.04.12 18:00
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  1. 영문계약서 2019.08.30 18:57 [댓글주소] [수정/삭제] [댓글에 댓글달기]

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특허 license에서 자주 쟁점이 되는 사항이고 실제 발생할 수 있는 사안입니다. 아래 그림에서 표시한 각 특허 사이의 관계와 License Agreement 조항의 문언표현을 꼼꼼하게 잘 살펴보시기 바랍니다.

 

 

1. license 대상특허 범위 및 쟁점

License 계약서에 라이선스 대상특허 '250 및 그 후속특허 "including any continuation, continuation-in-part and divisional patent applications that claim priority to Opana® ER Patents"로 표현되어 있습니다. 여기서 '250 특허가 Opana® ER Patents에 해당합니다.

 

계약체결 후 등록된 위 '216 특허와 '122 특허가 위와 같은 계약문언의 범위에 해당하는지 여부가 쟁점입니다. 그림에서 보듯 노란색 '250 특허와 녹색의 쟁점 특허 2건은 직접 연결된 관계가 아닙니다.

 

다만, 청색으로 표시한 '357 출원이 중간에 개입되어 있습니다. 그것을 매개로 녹색표시특허들도 노란색 특허와 동일하게 license 대상특허로 해석할 수 있는지 문제됩니다.

 

2. 미국법원 판결

CAFC 판결은 위와 같은 상황에서 '216 특허와 '122 특허는 license 대상 특허범위에 포함되지 않는다고 판결하였습니다. 기타 묵시적 license도 인정하지 않았습니다. , licensor Endolicensee Actavis, Roxanegeneric 제품 발매에 대해 기존 등록특허에 관하여 체결한 license의 존재에도 불구하고 다시 추가 등록한 '216 특허와 '122 특허에 기초한 특허권을 행사할 수 있다고 보았습니다.

 

Generic 제품발매 회사로서는 불의타에 해당하는 황당한 상황을 맞았습니다. CAFC 3인 합의재판부 중 1명의 소수의견 Dissent Opinion에서는 license 대상을 특허로 표현한 것과 제품으로 표현한 것을 엄격하게 구별해야 하고, 적어도 제품을 기준으로 라이선스 계약을 체결한 경우 위 특허도 라이선스 대상특허에 해당한다는 의견 설시가 흥미롭습니다. 공감할 내용이 많은데도 불구하고 아쉽게도 소수의견에 그쳤습니다. 특허 라이선스 실무공부 삼아 읽어 보시기 바랍니다.

 

3. No Implied License 조항

CAFC 판결에서는 계약서의 다음과 같이 묵시적 라이선스를 허용하지 않는다는 계약조항을 중요한 판단근거로 삼았습니다. 라이선스 계약 실무상 매우 중요한 포인트입니다.

 

“Endo does not grant to Actavis [or Roxane] . . . any license, right or immunity, whether by implication, estoppel or otherwise, other than as expressly granted herein.”

 

참고자료로 다른 계약서에서 표준형식의 조항을 인용합니다. "No Other Rights. No rights, other than those expressly set forth in this Agreement are granted to either Party hereunder, and no additional rights will be deemed granted to either Party by implication, estoppel, or otherwise. All rights not expressly granted by either Party to the other hereunder are reserved."

 

Licensee의 묵시적 라이선스 주장은 부제소조항(not to sue)에도 근거를 두고 있습니다. licensee에 대한 소송을 제기하지 않는다는 계약조항은 곧 후속 등록 특허권에 대한 license 합의로도 해석할 수 있다는 주장입니다.

 

그라나, CAFC 판결은 위와 같이 묵시적 허락을 배제하는 명시적 계약조항을 우선해야 한다고 명확하게 밝혔습니다. 묵시적 라이선스 이론이 적용될 수 있고, 따라서 상충되는 해석이 가능한 상황에서도, 처분문서에 해당하는 계약서에 명시적으로 기재된 묵시적 라이선스를 배제한다는 문언이 훨씬 더 강력한 효력을 발휘한다는 점을 명확하게 판시하였습니다.

 

위 판결은 Licensee 입장에서 조금 억울한 면이 있을 것입니다. 실무적 대응방안으로는 특허만을 라이선스 대상범위의 기준으로 설정하는 것보다 여기에 더하여 제품기술을 라이선스 범위설정의 기준으로 함께 설정한다면 안정할 것입니다.

 

기술이전이나 license 당시에는 등록되지 않았고 독립된 특허출원도 아니었으나 그 후 분할출원, 연속출원 등을 통해 등록되는 특허문제는 매우 중요합니다. 관련 쟁점에 관한 좋은 참고가 될 분쟁사례와 판결입니다. CAFC 판결문을 소수의견까지 모두 꼼꼼하게 살펴보시길 권합니다.

 

KASAN_[라이선스계약분쟁] License 계약의 대상특허의 범위 - 계약체결 이후 등록된 특허 중에서 Licen

 

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세계적 블록버스터 신약의 물질특허에 대한 Exclusive License 및 추가 R&D Collaboration Agreement 중에서 특허관련 계약조항을 인용하고 간략하게 살펴보겠습니다. 신약물질을 개발한 일본 제약회사 Shionogi에서 신약물질 특허권을 보유하고, 대형 제약회사 AstraZeneca에 대해 해당 특허의 전용실시권 허여 및 상업화 권리를 부여하는 기술이전 license 계약입니다. 이미 상당한 시간이 지난 오래 된 계약서이지만, 실제 엄청난 성공을 거둔 신약개발 기술이전 프로젝트로서. 실무자가 참고자료로 살펴볼 가치가 높다 생각합니다.

 

Article 7.  Inventions (추가 연구개발 발명에 대한 권리관계 규정. 단독 발명의 경우 개발회사에 권리귀속 확인 + 공동발명은 공동으로 결정 권한 보유 및 비용 등 책임도 분담 규정)

 

Inventions which are made and which relate to the COMPOUNDS and/or LICENSED PRODUCTS shall belong to the PARTY making such invention.  Each PARTY shall have the right to file, prosecute and maintain patent applications and patents covering inventions made solely by that PARTY.  

 

If an invention is made jointly by the PARTIES, such invention shall be jointly owned.  Neither PARTY shall file any patent application(s) containing such joint invention and/or any information or data received from the other PARTY without the prior written consent of the PARTY providing the information or data.  

 

SHIONOGI and ZENECA shall mutually determine whether or not patent applications should be filed concerning such joint inventions, which PARTY shall be responsible for filing and prosecuting any patent applications filed, and share the costs in filing any patent applications, obtaining and maintaining any patents covering joint inventions.

 

Article 9.  Representation and Warranty (진술 및 보증조항. 특허유효 및 권리 소유관계, 타인의 권리침해 여부 등에 관한 성실한 조사 및 그 결과에 따른 인식범위로 보증책임 제한. 무제한 보증 아님.)

 

9.1

SHIONOGI represents and warrants that it is the owner of the entire right, title and interest in the PATENTS listed in Appendix II hereto and KNOW-HOW, and is entitled to grant the licenses specified herein.  SHIONOGI further hereby represents and warrants that, to the best of its knowledge, the PATENTS owned or controlled by SHIONOGI or SHIONOGI’s AFFILIATES are being procured from the respective Patent Offices in accordance with all applicable laws and regulations.

 

9.2

SHIONOGI represents and warrants that it has full corporate power to enter into this Agreement and to carry out the provisions hereof.

 

9.3

ZENECA represents and warrants that it has full corporate power to enter into this Agreement and to carry out the provisions hereof.

 

9.4

SHIONOGI represents that, as of the EFFECTIVE DATE, it is not aware of any infringement or threatened infringement of the PATENTS or KNOW-HOW by a THIRD PARTY.

 

9.5

SHIONOGI represents and warrants that, to the best of SHIONOGI’s knowledge, ZENECA’s exploitation or use of the PATENTS and/or KNOW-HOW hereunder will not infringe any patent or other intellectual property right enjoyed by any THIRD PARTY (with the exception of Hoechst European Patent Applications No.  88120057.0 and any foreign applications or patents corresponding thereto).

 

9.6

SHIONOGI represents that, as of the EFFECTIVE DATE, SHIONOGI has no knowledge from which it can reasonably be inferred that the PATENTS are invalid.

 

Article 11.  PATENTS (특허출원, 심사 및 등록과장에서 라이센시의 검토 및 참여권리 보장. 특허권리 확보에 라이센시 참여권 부여)

 

11.1

SHIONOGI has the responsibility to file, prosecute and maintain the PATENTS and shall bear all cost for the PATENTS, including fees and expenses paid to outside legal counsel and experts, direct costs of in-house counsel and filing, prosecution and maintenance expenses associated therewith.

 

11.2

SHIONOGI shall provide ZENECA with an opportunity to review and comment on the nature and text of new or pending applications for the PATENTS.

 

11.3

SHIONOGI shall advise ZENECA on an annual basis of progress in the prosecution of all patent applications and in the maintenance or extension of patents falling within the PATENTS and shall, on request, furnish ZENECA with a copy of the patent application, patent or other document pertinent to prosecution, maintenance or extension of such applications and patents.

 

11.4

No significant steps regarding prosecution of the PATENTS will be taken by SHIONOGI without prior consultation with ZENECA.  In particular, no steps concerning European Patent Application No.  92111090.4 or US Patent 5,260,440 will be taken by SHIONOGI without prior consultation with ZENECA.

 

11.5

If SHIONOGI elects not to continue to prosecute a patent application or not to maintain or extend any patent application or patent within the PATENTS, SHIONOGI shall notify ZENECA not less than two (2) months before any relevant deadlines.  Thereafter ZENECA shall have the right to pursue at its expense, and at its sole discretion, the prosecution, extension or maintenance of such application or patent.  Any costs incurred by ZENECA pursuant to this shall be offset against royalties payable under Article 4.

 

11.6

ZENECA may request SHIONOGI to seek additional patent protection for the COMPOUNDS or LICENSED PRODUCTS in the TERRITORY, for example, by way of patent registration, patent of importation or revalidation, or the like.  If SHIONOGI chooses to seek such additional patent protection, it shall do so at its own cost and in its own name.  If SHIONOGI chooses not to seek such additional patent protection, ZENECA may require SHIONOGI to do so; provided ZENECA reimburses SHIONOGI for any reasonable expenses incurred in doing so.  Such patent property shall then be included within the definition of PATENTS.

 

11.7

SHIONOGI shall immediately advise ZENECA of any certification filed under the U.S.  “Drug Price Competition and Patent Term Restoration Act of 1984” (“ANDA ACT”) claiming that any PATENTS are invalid or claiming that the PATENTS will not be infringed by the manufacture, use or sale of a product for which an application under ANDA ACT is filed.

 

11.8

The PARTIES will cooperate with each other in gaining patent term extension(s) or the like, where applicable to the PATENTS in the TERRITORY, for example, under the U.S.  “Drug Price Competition and Patent Term Restoration Act of 1984” or under a supplementary protection certificate in European countries.

 

11.10

Upon reasonable request of ZENECA, SHIONOGI will provide ZENECA with all necessary assistance relating to the PATENTS, including allowing ZENECA access to SHIONOGI’s files and documents and access to SHIONOGI’s personnel who may have possession of relevant information.

 

Article 12.  Infringement of PATENTS (라이선스 대상 특허권을 제3자가 침해할 경우 양당사자의 침해대응 책임 및 협력 방안, 대상 특허실시로 타인 권리를 침해하는 경우 분쟁 대응 책임 및 협력 방안 규정)

 

12.1

In the event that ZENECA or SHIONOGI supposes that a THIRD PARTY may be infringing any of the PATENTS by the manufacture, use, distribution, marketing or sale of the COMPOUNDS and/or LICENSED PRODUCTS, ZENECA or SHIONOGI shall promptly notify the other PARTY in writing, identifying the infringer and the infringement complained of and furnishing the information upon which such determination is based.  ZENECA shall be entitled, in its sole discretion but after notifying SHIONOGI, to take any measures deemed appropriate to stop such infringing activities by such THIRD PARTY in the TERRITORY or to grant to the infringing THIRD PARTY adequate rights and licenses necessary for continuing such activities in the TERRITORY so long as ZENECA remains in compliance with Article 4.  Upon reasonable request by ZENECA and at ZENECA’s cost, SHIONOGI shall give ZENECA all reasonable information and assistance including allowing ZENECA access to SHIONOGI’s files and documents and access to SHIONOGI’s personnel who may have possession of relevant information, and if necessary to prosecute any legal action, joining in the legal action as a party.

 

12.2

ZENECA shall bear the cost of any action or measures taken in accordance with Article 12.1 and shall be entitled to receive any damages or remuneration received as a result of such action or measures.

 

12.3

In the event ZENECA decides, within sixty (60) days of becoming aware of an infringement, in its sole discretion, not to take any action against a THIRD PARTY deemed to infringe the PATENTS, ZENECA shall inform SHIONOGI in writing and SHIONOGI thereafter shall be entitled to pursue an action to stop such infringement in its own name and for its own account.  Upon reasonable request by SHIONOGI and at SHIONOGI’s cost, ZENECA shall give SHIONOGI all reasonable information and assistance.  Any damages or remuneration received as a result of such action shall be received by SHIONOGI.

 

12.4

In the event of any actual or threatened suit against ZENECA or its AFFILIATES, SUBLICENSEES or customers alleging that the exploitation or use of the PATENTS and/or KNOW-HOW hereunder infringes the patent or other intellectual property rights of a THIRD PARTY, ZENECA shall promptly give written notice to SHIONOGI.  SHIONOGI will provide to ZENECA all reasonable assistance requested by ZENECA to defend or settle such suit and in particular SHIONOGI will promptly make available to ZENECA, free of charge, all information in its possession or control which will assist ZENECA in defending or otherwise dealing with such suit.  ZENECA shall have the right to defend in its sole discretion such suit but shall consult with SHIONOGI before settling such suit.  ZENECA shall not settle the suit without obtaining prior written consent of SHIONOGI which consent shall not be unreasonably withheld.  If damages or costs are awarded against ZENECA for such infringement, or if the outcome of the suit is that ZENECA is ordered to or agrees to make payments or pay royalties to a THIRD PARTY in order to secure the right to continue the exploitation or use of the PATENTS and/or KNOW-HOW hereunder, then the following percentages of such damages, payments, or royalties shall be offset against royalties payable by ZENECA under Article 4: [***].

 

Notwithstanding the foregoing, in any event described above, SHIONOGI shall be entitled to receive at least [***] percent ([***]%) of the royalties due under Article 4 hereof from ZENECA in any one calendar year.

 

KASAN_[국제계약실무] 신약물질 기술이전 License 계약서 중 특허관련 계약조항 사례.pdf

 

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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 Biosciencesnonexclusive license를 허여하는 계약을 체결하였고, Neurocrine10여년간의 연구개발 끝에 2010년경 대기업 Abbott(현재 AbbVie)와 신약연구개발 성과(신약후보 물질 Elagolix )에 대한 exclusive license 계약을 체결하였습니다.

 

최초 라이선스 계약서 중 sublicense 허용조항은 다음과 같습니다. Neurocrine may "grant sublicenses under the License only with the prior written consent" of 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 특허무효 주장은 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 무효항변 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 licensee특허비침해 주장도 하였지만, 미국법원은 위 사안에서 라이선스 계약위반에 대한 항변으로 허용될 수 없다고 명확하게 판결하였습니다.

 

대학의 특허발명에 출발하여 벤처기업에서 10여 년간 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 중간 판결 일지라도 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.

 

KASAN_[기술이전계약] 특허권자 Licensor 미국대학 vs Licensee 벤처회사 Sub-license

 

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작성일시 : 2019.04.12 15:00
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대법원 2013. 4. 11. 선고 201159629 판결

계속적 계약은 당사자 상호간의 신뢰관계를 기초로 하는 것으로서, 당해 계약의 존속 중에 당사자 일방의 부당한 행위 등으로 인하여 계약의 기초가 되는 신뢰관계가 파괴되어 계약의 존속을 기대할 수 없는 중대한 사유가 있는 때에는 상대방은 계약을 해지함으로써 장래에 향하여 효력을 소멸시킬 수 있다.

 

한편 계속적 계약 중 계약의 이행을 위하여 일정 규모의 설비가 필요하고 비교적 장기간의 거래가 예상되는 계속적 공급계약 해지의 경우, 계약의 존속을 기대할 수 없는 중대한 사유가 있는지는 계약을 체결하게 된 경위, 공급자와 수요자 사이의 관계, 공급계약의 내용, 공급자가 계약의 이행을 위하여 설치한 설비의 정도, 설치된 설비의 원상복구 가능성, 계약이 이행된 정도, 해지에 이르게 된 과정 등 제반 사정을 종합적으로 고려하여 판단하여야 한다.”

 

대법원 2015. 4. 23. 선고 201119102 판결

계속적 계약은 당사자 상호간의 신뢰관계를 기초로 하는 것으로서, 당해 계약의 존속 중에 당사자 일방의 계약상 의무 위반이나 기타 부당한 행위 등으로 인하여 계약의 기초가 되는 신뢰관계가 파괴되어 계약관계를 그대로 유지하기 어려운 정도에 이르렀다면 상대방은 그 계약관계를 해지함으로써 장래에 향하여 그 효력을 소멸시킬 수 있지만(대법원 1995. 3. 24. 선고 9417826 판결, 대법원 2002. 11. 26. 선고 20025948 판결 등 참조),

 

그와 같이 계약관계를 유지하기 어려운 정도에 이른 사정에 관하여는 계약관계의 소멸을 주장하는 사람이 증명할 책임이 있다.”

 

KASAN_[계약분쟁] 전속계약 등 계속적 계약의 기초인 당사자 신뢰관계 파탄 시 계약 해지 가능.pdf

 

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(1)   계약 상대방의 채무불이행을 이유로 한 계약의 해지 또는 해제는 손해배상의 청구에 영향을 미치지 아니한다(민법 제551). 다른 특별한 사정이 없는 한 그 손해배상책임 역시 채무불이행으로 인한 손해배상책임과 다를 것이 없으므로, 상대방에게 고의 또는 과실이 없을 때에는 배상책임을 지지 아니한다(민법 제390).

 

(2)   이는 상대방의 채무불이행과 상관없이 일정한 사유가 발생하면 계약을 해지 또는 해제할 수 있도록 하는 약정해지해제권을 유보한 경우에도 마찬가지이고 그것이 자기책임의 원칙에 부합한다.

 

(3)   계약의 내용이 통상의 경우와 달리 어느 일방에게 무거운 책임을 부과하게 하는 경우에는 계약 문언은 엄격하게 해석하여야 하므로, 당사자의 고의 또는 과실과 무관한 사유를 약정해지 또는 해제사유로 정한 경우에 그 사유로 계약을 해지 또는 해제하면서 귀책사유와 상관없이 손해배상책임을 지기로 한 것이 계약 내용이라고 해석하려면, 계약의 내용과 경위, 거래관행 등에 비추어 그렇게 인정할 만한 특별한 사정이 있어야 한다.

 

(4)   계약의 해지 또는 해제에 따른 손해배상을 청구하는 경우에 채권자는 계약이 이행되리라고 믿고 지출한 비용의 배상을 청구할 수 있다.

 

(5)   이때 지출비용 중 계약의 체결과 이행을 위하여 통상적으로 지출되는 비용은 통상의 손해로서 상대방이 알았거나 알 수 있었는지와 상관없이 배상을 청구할 수 있으며, 이를 초과하여 지출한 비용은 특별한 사정으로 인한 손해로서 상대방이 이를 알았거나 알 수 있었던 경우에 한하여 배상을 청구할 수 있다(민법 제393).

 

(6)   다만 지출비용 상당의 배상은 과잉배상금지의 원칙에 비추어 이행이익의 범위를 초과할 수 없다.”

 

KASAN_[계약분쟁] 계약해제, 해지사유 발생과 계약종료 시 손해 발생 상황 - 귀책 없는 당사자에 대한 손해배상

 

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대법원 판결요지

지체상금이 당사자의 지위, 계약의 목적과 내용, 지체상금을 예정한 동기, 공사도급액에 대한 지체상금의 비율, 지체상금의 액수, 지체의 사유, 당시의 거래관행 등 여러 사정에 비추어 부당히 과다하다고 인정되는 경우에는 법원이 이를 감액할 수 있다. 이때 감액사유에 대한 사실인정이나 비율을 정하는 것은 형평의 원칙에 비추어 현저히 불합리하다고 인정되지 않는 한 사실심 법원의 전권에 속하는 사항이다.

 

사실심 판단 항소심 서울고등법원 2014. 10. 30. 선고 20142006945 판결

(1)   계약서 조항 - 지체상금률: 0.15%, 6 (지체상금) ① 계약담당자는 계약상대자가 계약서에서 정한 공급기한 내에 물품을 공급하지 아니한 때에는 매 지체일수마다 계약서에서 정한 지체상금률을 계약금액 또는 공급대가에 곱하여 산출한 금액을 지체상금으로 결정하고 이를 해당 공급대가에서 공제한다.

 

(2)   면책 주장 부분 - 서울고등법원 판결요지

 

채무자 원고는, 주요부품을 공급하기로 한 도시바 및 도시바의 하도급업체인 히타치전선이 2011. 3. 11. 발생한 일본 대지진으로 피해를 입어 히타치전선의 도시바에 대한 부품 공급 및 도시바의 원고에 대한 부품 공급이 순차 지연되었는바, 당시 사정상 부품공급업체를 변경하는 것이 사실상 불가능하였고 피고도 최초 부품 공급업체로 도시바를 선정하는 것과 지진 발생 이후 부품공급업체를 종전대로 유지하는 것에 동의하였으며, 원고가 도시바에게 생산일정을 독촉하고 생산라인을 늘리는 등 최선의 노력을 하였음에도 결국 기관차의 공급이 지체된 것이므로, 이는 일반조건 제24조 제3항 제1, 4호가 정한 불가항력 또는 원고의 책임에 속하지 않은 사유로 지체된 경우에 해당하여 지체상금 지급책임이 면책된다고 주장한다.

 

일반적으로 쌍무계약에 있어서 채무자가 불가항력이 있었음을 이유로 그로 인한 지체상금 지급책임을 면하려면 그 원인이 채무자의 지배영역 밖에서 발생한 사건으로서 채무자가 통상의 수단을 다하였어도 이를 방지하는 것이 불가능하였음이 인정되어야 한다(대법원 2007. 8. 23. 선고 200559475, 59482, 59499 판결 등 참조). 그리고 이러한 불가항력은 채무자의 채무불이행으로 인한 책임을 면제하고 그로 인한 손해를 상대방에게 전가하는 셈이 되므로 그 요건을 엄격하게 심사할 필요가 있다. 면책 불인정

 

(3)   감액 주장 부분 - 서울고등법원 판결요지

 

채무자 원고는 설령 원고의 지체상금 지급의무가 면책되지 않는다 하더라도, 이 사건 계약에 따른 지체상금 약정은 손해배상의 예정에 해당하고 원고가 납품기한을 준수하지 못하게 된 주된 원인은 부품공급업체의 지진 피해로 인한 것이고, 원고가 이러한 부품업체의 공급 지연을 극복하기 위하여 최선의 노력을 다한 점, 지체상금액이 9,670,044,646원으로서 부당하게 과다한 점에 비추어, 이 사건 지체상금액은 경제적 약자인 원고에게 부당한 압박을 가하여 공정성을 잃는 결과를 야기하므로 대폭 감액되어야 한다고 주장한다.

 

이에 대하여 피고는 지체상금 약정이 위약벌 약정이라고 주장하나, 물품제조·납품 계약에 있어서 지체상금 약정을 한 경우 민법 제398조 제4항에 의하여 손해배상의 예정으로 추정되고 이를 위약벌로 해석하기 위해서는 특별한 사정이 주장·입증되어야 하는데(대법원 2002. 1. 25. 선고 9957126 판결 참조), 피고가 이러한 특별한 사정을 증명하지 못하였으므로 피고의 위 주장은 받아들이지 아니한다.

 

한편 민법 제398조 제2항에서는손해배상의 예정액이 부당히 과다한 경우에는 법원은 적당히 감액할 수 있다.”고 규정하고 있는바, 여기서부당히 과다한 경우'라 함은 채권자와 채무자의 각 지위, 계약의 목적 및 내용, 손해배상액을 예정한 동기, 채무액에 대한 예정액의 비율, 예상손해액의 크기, 그 당시의 거래관행 등 모든 사정을 참작하여 일반 사회관념에 비추어 그 예정액의 지급이 경제적 약자의 지위에 있는 채무자에게 부당한 압박을 가하여 공정성을 잃는 결과를 초래한다고 인정되는 경우를 뜻하는 것으로 보아야 한다(대법원 9957126 판결 참조).

 

살피건대, 지체상금률 0.15% 국가계약법 제11조 제1, 법 시행령 제74조 제1, 법 시행규칙 제75조 제2호에 따른 것으로서 특별히 이례적으로 높은 비율로 보기 어렵고, 지체상금액 약 96억원은 계약금액 3500억원의 2.77%에 해당하여 이 사건 계약으로 인한 원고의 영업이익 범위 내로 보이고 계약금액에서 차지하는 비율도 그렇게 과다하다고 볼 수 없는 점, 피고로서도 원고의 납품 지체로 인하여 전기기관차의 투입이 지연되었고 이로 인한 운송 차질로 손해가 발생하였을 것은 분명한 점 등을 고려하여 원고의 이 부분 주장을 받아들이지 아니한다. 결론: 감액 불인정

 

KASAN_[계약분쟁] 지체상금 0.1 약정 – 면책 또는 감액 여부 판단기준 대법원 2018. 10. 12. 선고

 

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