Kasan Insight :: 과학, 기술 그리고 법

- 제약/화학/바이오 분야의 실용적 법률정보와 해결방안

8. PAYMENT.

8.1 Initial Fee. In consideration of the license and sublicense granted by Licensor to Licensee in accordance with Sections 2.1 and 2.2, respectively, and the assignments by Licensor to Licensee in accordance with Section 2.3, Licensee shall pay to Licensor a one-time, nonrefundable, non-creditable initial fee of Fifty Million Dollars ($50,000,000) on the Effective Date. 

8.2 Milestone Payments. 

(a) Launch Milestone Payment. Licensee shall notify Licensor promptly of the date of the Noctiva Launch, but in no event later than twenty (20) days thereafter. In further consideration of the license and sublicense granted by Licensor to Licensee in accordance with Sections 2.1 and 2.2, respectively, and the assignments by Licensor to Licensee in accordance with Section 2.3, Licensee shall pay to Licensor a one-time, nonrefundable, non-creditable payment of Twenty Million Dollars ($20,000,000) in respect of such Noctiva Launch on the earlier to occur of: (i) the thirtieth (30th) day immediately following the date of the Noctiva Launch and (ii) June 30, 2018. Such payment shall not require Licensor to provide any invoice in respect thereof.

Tier One Commercialization Milestone Payments. Licensee shall notify Licensor promptly, but in no event later than thirty (30) days, after the first achievement of the relevant sales milestone for the Product as set forth in the table below in this Section 8.2(b). In further consideration of the license and sublicense granted by Licensor to Licensee in accordance with Sections 2.1 and 2.2, respectively, and the assignments by Licensor to Licensee in accordance with Section 2.3, Licensee shall make the following one-time, nonrefundable, non-creditable milestone payments to Licensor within thirty (30) days after receipt of an invoice from Licensor therefor.

(i) Upon the first time Royalty-Bearing Net Sales by Licensee and its Sublicensees of the Product for all Indications in the aggregate reach $50 million on a cumulative basis beginning with the first dollar of Royalty-Bearing Net Sales

(ii) Upon the first time Royalty-Bearing Net Sales by Licensee and its Sublicensees of the Product for all Indications in the aggregate reach $[*] on a cumulative basis beginning with the first dollar of Royalty-Bearing Net Sales

(iv) Upon the first time Royalty-Bearing Net Sales by Licensee and its Sublicensees of the Product for all Indications in the aggregate reach $200 million on a cumulative basis beginning with the first dollar of Royalty-Bearing Net Sales

(b) Tier Two Commercialization Milestone Payments. Licensee shall notify Licensor promptly, but in no event later than thirty (30) days, after the first achievement of the relevant sales milestone for the Product as set forth in the table below in this Section 8.2(c). In further consideration of the license and sublicense granted by Licensor to Licensee in accordance with Sections 2.1 and 2.2, respectively, [and the assignments by Licensor to Licensee in accordance with Section 2.3,] Licensee shall make the following one-time, nonrefundable, non-creditable milestone payments to Licensor within thirty (30) days after receipt of an invoice from Licensor therefor; provided, however, in the event that the last of the milestone payments described in the table below becomes payable, the due date for Licensee to make payment to Licensor of such milestone payment will be the first anniversary of the payment of the $[*] milestone payment in the penultimate row of the table below. 

(i) Upon the first time Royalty-Bearing Net Sales by Licensee and its Sublicensees of the Product for all Indications reach $300 million in any consecutive 12-month period beginning after achievement of milestone (iv) described in Section 8.2(b)

(ii) Upon the first time Royalty-Bearing Net Sales by Licensee and its Sublicensees of the Product for all Indications reach $ 1.5 billion in any consecutive 12-month period beginning after achievement of milestone (iv) described in Section 8.2(b)

(c) Change of Control Payment. If a Change of Control occurs, simultaneously with the consummation of such Change of Control, Licensee shall pay to Licensor the amount of [*] Dollars ($[*]) less the sum of the following allocable portions of any of the milestone payments described in Section 8.2(b) that are paid to Licensor prior to such Change of Control: 

8.3 Royalties; Non-Royalty Commercialization Consideration. 

(a) Royalties. In further consideration of the license and sublicense granted by Licensor to Licensee in accordance with Sections 2.1 and 2.2, respectively, Licensee shall pay Licensor royalties on Net Sales of the Product by Licensee and any of its Sublicensees and Third Party Distributors in accordance with the rates set forth in the tables set forth below in this Section 8.3(a)(i).

(b) Third Party Royalties. 

(i) CPEX and Reprise. Licensor will be responsible for payment of any amounts payable to CPEX and Reprise under the terms of the CPEX License Agreement and the Reprise License Agreement, respectively. 

(ii) Other Third Parties.

(A) In the event that after the Effective Date Licensee reasonably determines that it is necessary or advisable for Licensee to obtain a license under any Patent Rights from any Third Party in order for Licensee (each a “Third Party License”; collectively, “Third Party Licenses”), its Sublicensees, and any Third Party Distributors to Commercialize the Product in the Field in any country in the Territory as contemplated by this Agreement, the Parties shall discuss the best course of action to resolve such potential license requirement, provided that such discussions shall not limit or delay Licensee’s right to obtain any such Third Party Licenses.

(B) With respect to any such Third Party Licenses that Licensor reasonably agrees are necessary for Licensee to be able to Commercialize the Product in the Field in any country in the Territory, Licensee shall have the right to set off an amount equal to [*] percent ([*]%) of the aggregate of any and all payments required to be paid by Licensee to the licensors under such Third Party Licenses in respect of any Calendar Quarter against payments otherwise payable to Licensor under Section 8.3(a) in respect of such Calendar Quarter; provided, however, that in no event shall the aggregate set off in any Calendar Quarter resulting from such payments in respect of such Third Party Licenses exceed an amount equal to [*] percent ([*]%) of the royalty payments otherwise payable to Licensor under Section 8.3(a) in respect of such Calendar Quarter.

(c) Royalty Term. Licensee’s obligation under Sections 8.3(a) to pay Licensor royalties on Net Sales of the Product in each country in Territory will apply to any and all sales or other dispositions of such the Product in such country made during the Term of this Agreement. 

(d) Generic Product. If, during the Royalty Term, one or more Third Parties is selling in any country in the Territory any product that is a Generic Product in relation to the Product being sold in such country by Licensee or any of its Sublicensees or Third Party Distributors, Licensee’s royalty obligations under Section 8.3(a) for sales in such country of the Product shall be reduced as follows: 

If the Generic TRxs-to-Total TRxs Percentage in such country during such Calendar Quarter is: Licensee’s royalty obligations under Section 8.3(a) shall be reduced by the Percentage Indicated Below

8.4 Reports and Payments. During the Term of this Agreement following the First Commercial Sale of the Product by Licensee, its Sublicensees, or its Third Party Distributors, within five (5) Business Days after the filing by Licensee of each Form 10-K or Form 10-Q, Licensee shall pay to Licensor the royalty payments payable by Licensee for the Calendar Quarter preceding the Calendar Quarter in which such Form 10-K or 10-Q, as applicable, is filed, and shall provide a report showing, on a country-by-country basis: 

(a) the net quantity of the Product sold, total gross sales, an itemized list of the deductions applied to total gross sales, and Net Sales of the Product sold in the Calendar Quarter in respect of which such report has been prepared; 

(b) the calculation in Dollars of royalty payments due hereunder with respect to such Net Sales, including any deductions for any offsets in accordance with Section 8.3(b)(ii);

(c) withholding taxes on Net Sales, if any, required by Applicable Laws to be deducted with respect to such royalties; and

(d) the rate of exchange used by Licensee in determining the amount of Dollars payable hereunder.

If no royalty or other payment is due for any period hereunder, Licensee shall so report.

Currency of Payment. All payments to be made under this Agreement shall be made in Dollars by electronic funds transfer to such bank accounts as Licensor may designate from time to time. When Licensee or any of its Sublicensee of Third Party Distributors sells the Product for monies other than Dollars, Licensee will convert any non-Dollar currencies into Dollars with the exchange rate for the purchase of Dollars with such domestic currency as quoted by The Wall Street Journal, New York edition, at an average rate for the Calendar Quarter for which the payment is made.

8.5 Accounting. 

(a) Licensee shall determine Net Sales with respect to the Product sold using its standard accounting procedures, consistent with GAAP, as if the Product was a solely owned product of Licensee, except as specifically provided in this Agreement. In the case of amounts to be determined by Third Parties (for example, Net Sales by Sublicensees), such amounts shall be determined in accordance with generally accepted accounting principles in effect in the country in which such Third Party is engaged. Licensor and Licensee also recognize that such procedures may change from time to time and that any such changes may affect the definition of Net Sales. Licensor and Licensee agree that, where such changes are economically material to Licensor, adjustments shall be made to compensate Licensor in order to preserve the same economics as are reflected under this Agreement under Licensee’s accounting procedures in effect prior to such change. Where the change is or would be material to Licensor, Licensee shall provide an explanation of the proposed change and an accounting of the effect of the change on the relevant revenue, cost, or expense category.

(b) In the event of the payment or receipt of noncash consideration in connection with the performance of activities under this Agreement Licensee shall advise Licensor of such transaction, including without limitation Licensee’s assessment of the fair market value of such noncash consideration and the basis therefor. Such transaction shall be accounted for on a cash equivalent basis, as mutually agreed by Licensor and Licensee in good faith.

(c) Withholding Tax. Notwithstanding anything to the contrary herein, in the event that withholding taxes apply with respect to any amounts due from Licensee hereunder, Licensee shall be entitled to withhold from any payment due to Licensor under this Agreement any taxes that Licensee is required to pay and such withholding shall decrease by an equivalent amount the payment due to Licensor. Licensee shall provide Licensor with notification of any anticipated withholding requirements with as much advance notice as practicable and shall cooperate in good faith with Licensor to legally minimize such withholding taxes. Licensee will timely pay to the proper governmental authority the amount of any taxes withheld and will provide Licensor with an official tax certificate or other evidence of tax obligation, together with proof of payment from the relevant governmental authority sufficient to enable Licensor to claim such payment of taxes. 

8.6 Books and Records; Audit Request. 

(a) During the term of this Agreement and for three (3) years thereafter, Licensee shall keep and maintain, and shall cause each of its Affiliates, and Sublicensees, if any, to keep and maintain, at their respective regular places of business complete and accurate books, records, and accounts in accordance with GAAP, or other accounting standards mandated by the U.S. Securities and Exchange Commission if applicable to Licensee, in sufficient detail to reflect all amounts required to be paid under this Agreement, as well as any other books, records or accounts required to be maintained in connection with the Product under any Applicable Laws, necessary to permit the audits contemplated under Section 8.8(b). Prior to destroying any books, records or accounts which are material to the Parties’ rights and obligations under this Agreement, Licensee must seek prior written consent from Licensor, which consent may not be unreasonably withheld.

 (b) During the term of this Agreement and for three (3) years thereafter, Licensor shall have access to and the right to examine such relevant records and accounts that Licensee is required to maintain pursuant to Section 8.8(a) at Licensee’s premises for the sole purpose of verifying the accuracy of any report or payment made under this Agreement in the three (3) preceding years; provided, however, that any such examination: (i) shall not occur more than once during each Calendar Year (except that if as a result of any audit pursuant to this Section 8.8(b), an error in favor of Licensee exceeding five percent (5%) of any payments previously reported as owed by Licensee to Licensor is discovered, the frequency of audits under this Section 8.10(b) shall not be so limited); (ii) shall be during normal business hours upon reasonable prior written notice which shall in no event be less than thirty (30) days; and (iii) shall not unreasonably interfere with Licensee’s operations and activities. If Licensor desires to audit such records, it shall engage an independent, certified public accountant reasonably acceptable to Licensee, to examine such records under conditions of confidentiality with respect thereto at least as stringent as those specified in Article 13. The expense of any such audit shall be borne by Licensor; provided, however, that, if an error of more than five percent (5%) in favor of Licensor is discovered as a result of such audit, then such expenses shall be paid by Licensee. If such accountant concludes that additional payment amounts were owed to Licensor during any period, Licensee shall pay such payment amount (including without limitation interest thereon from the date such amounts were payable) within thirty (30) days after the date Licensor delivers to Licensee such accountant’s written report so concluding, unless Licensee notifies Licensor of any dispute regarding the audit. If such accountant concludes that Licensee has overpaid any amounts to Licensor during any period, in Licensor’s discretion, Licensee may credit such amounts against future payments due Licensor or Licensor may pay such amounts (including without limitation interest thereon from the date such amounts were payable), unless Licensor notifies Licensee of any dispute regarding the audit. Any Information received by Licensor pursuant to this Section 8.10 shall be deemed to be Confidential Information of Licensee for purposes of Article 13. 

8.7 Blocked Currency. If by Applicable Laws or fiscal policy of a particular country, conversion into Dollars or transfer of funds of a convertible currency to the United States is restricted or forbidden, royalties accrued in such country shall be paid to Licensor in the country in local currency by deposit in a local bank designated by Licensor for such deposit, unless Licensor and Licensee otherwise agree. 

8.8 Interest. If Licensor does not receive payment of any sum due to it on or before the due date, simple interest shall thereafter accrue on the sum due to Licensor from the due date until the date of payment at a rate equal to three month Dollar LIBOR Rate, as reported in the online edition of The Wall Street Journal as of Noon (New York Time) on such due date, or the maximum rate allowable by Applicable Laws, whichever is less. 

8.9 Transaction Expenses. Licensee shall upon execution and delivery of this Agreement pay the documented reasonable fees and expenses of Licensor’s advisors and counsel incurred by Licensor in structuring, negotiating, memorializing, and otherwise undertaking the transaction contemplated by this Agreement. Notwithstanding the foregoing, Licensee’s obligation under this Section 8.11 shall be limited to an amount not to exceed $2,000,000.

KASAN_제약회사 기술이전, License, 제조판매 계약서에서 Royalty Payment 관련 영문계약 조항 샘플.pdf

[질문 또는 상담신청 입력하기]

1. 특허무효 확정된 경우 특허발명 실시계약에 미치는 효력에 관한 기본법리

특허가 무효로 확정되면 특허권은 특허법 제133조 제1항 제4호의 경우를 제외하고는 처음부터 없었던 것으로 간주된다(특허법 제133조 제3항). 그러나 특허발명 실시계약이 체결된 이후에 계약의 대상인 특허권이 무효로 확정된 경우 특허발명 실시계약이 계약 체결 시부터 무효로 되는지는 특허권의 효력과는 별개로 판단하여야 한다.

특허발명 실시계약을 체결하면 특허권자는 실시권자의 특허발명 실시에 대하여 특허권 침해로 인한 손해배상이나 그 금지 등을 청구할 수 없고, 특허가 무효로 확정되기 전에는 특허권의 독점적ㆍ배타적 효력에 따라 제3자의 특허발명 실시가 금지된다.

이러한 점에 비추어 특허발명 실시계약의 목적이 된 특허발명의 실시가 불가능한 경우가 아니라면 특허 무효의 소급효에도 불구하고 그와 같은 특허를 대상으로 하여 체결된 특허발명 실시계약이 그 계약의 체결 당시부터 원시적으로 이행불능 상태에 있었다고 볼 수는 없고, 다만 특허 무효가 확정되면 그때부터 특허발명 실시계약은 이행불능 상태에 빠지게 된다고 보아야 한다(대법원 2014. 11. 13. 선고 2012다42666, 42673 판결 등 참조).

따라서 특허발명 실시계약 체결 이후에 특허가 무효로 확정되었더라도 특허발명 실시계약이 원시적으로 이행불능 상태에 있었다거나 그 밖에 특허발명 실시계약 자체에 별도의 무효사유가 없는 한, 특허권자는 원칙적으로 특허발명 실시계약이 유효하게 존재하는 기간 동안 실시료의 지급을 청구할 수 있다. 

2. 특허무효 확정된 경우 특허발명 실시계약 상 특허무효 확정 전 기간에 지급해야 할 실시료를 구할 수 있는지 여부

대법원 2019. 4. 25. 선고 2018다287362 판결 요지 – 판결문 첨부

특허발명 실시계약이 체결된 이후에 계약의 대상이 된 특허가 진보성이 없다는 이유로 무효로 확정된 사안에서, 위 실시계약이 원시적 불능이라고 할 수 없어 특허권자가 이미 지급받은 특허실시료를 반환할 의무가 없다고 한 대법원 2012다42666, 42673 판결에 이어, 특허권자는 특허무효 확정 이전에 미지급된 특허실시료의 지급을 구할 수 있는 것이 원칙이다.

3. 대법원 2012다42666 판결 사안 – 특허무효 소급효 제한 적용 – 라이선스 계약 취소 불인정 + 기 지급한 로열티 반환청구 불인정 + 장래 로열티 지급의무 소멸

(1)   특허실시계약의 체결 이후 대상특허가 무효로 확정된 경우 특허권자가 실시권자로부터 이미 지급받은 특허실시료를 부당이득으로 반환할 의무가 있는지 여부 - 부정

(2)   실시계약의 체결 이후 계약의 대상이 된 특허가 무효로 확정된 경우 착오를 이유로 특허발명 실시계약을 취소할 수 있는지 여부 – 부정

“특허발명 실시계약에 의하여 특허권자는 실시권자의 특허발명 실시에 대하여 특허권 침해로 인한 손해배상이나 그 금지 등을 청구할 수 없게 될 뿐만 아니라 특허가 무효로 확정되기 이전에 존재하는 특허권의 독점적ㆍ배타적 효력에 의하여 제3자의 특허발명 실시가 금지되는 점에 비추어 보면, 특허발명 실시계약의 목적이 된 특허발명의 실시가 불가능한 경우가 아닌 한 특허무효의 소급효에도 불구하고 그와 같은 특허를 대상으로 하여 체결된 특허발명 실시계약이 그 계약의 체결 당시부터 원시적으로 이행불능 상태에 있었다고 볼 수는 없고, 다만 특허무효가 확정되면 그때부터 특허발명 실시계약은 이행불능 상태에 빠지게 된다고 보아야 한다.

따라서 특허발명 실시계약 체결 이후에 특허가 무효로 확정되었더라도 앞서 본 바와 같이 특허발명 실시계약이 원시적으로 이행불능 상태에 있었다거나 그 밖에 특허발명 실시계약 자체에 별도의 무효사유가 없는 한 특허권자가 특허발명 실시계약에 따라 실시권자로부터 이미 지급받은 특허실시료 중 특허발명 실시계약이 유효하게 존재하는 기간에 상응하는 부분을 실시권자에게 부당이득으로 반환할 의무가 있다고 할 수 없다. 

특허는 그 성질상 특허등록 이후에 무효로 될 가능성이 내재되어 있는 점을 감안하면, 특허발명 실시계약 체결 이후에 계약의 대상인 특허의 무효가 확정되었더라도 그 특허의 유효성이 계약체결의 동기로서 표시되었고 그것이 법률행위의 내용의 중요부분에 해당하는 등의 사정이 없는 한, 착오를 이유로 특허발명 실시계약을 취소할 수는 없다고 할 것이다.”

4. 실시권자 Licensee의 특허권자 Licensor 상대로 대상특허에 대한 무효심판청구 가능 - 특허무효의 경우 계약상 실시료 Royalty 지급의무 범위 소멸: 대법원 2019. 2. 21. 선고 2017후2819 전원합의체 판결

“특허권의 실시권자에게는 실시료 지급이나 실시 범위 등 여러 제한 사항이 부가되는 것이 일반적이므로, 실시권자는 무효심판을 통해 특허에 대한 무효심결을 받음으로써 이러한 제약에서 벗어날 수 있다.

그리고 특허에 무효사유가 존재하더라도 그에 대한 무효심결이 확정되기까지는 그 특허권은 유효하게 존속하고 함부로 그 존재를 부정할 수 없으며, 무효심판을 청구하더라도 무효심결이 확정되기까지는 상당한 시간과 비용이 소요된다.

이러한 이유로 특허권에 대한 실시권을 설정받지 않고 실시하고 싶은 사람이라도 우선 특허권자로부터 실시권을 설정받아 특허발명을 실시하고 그 무효 여부에 대한 다툼을 추후로 미루어 둘 수 있으므로, 실시권을 설정받았다는 이유로 특허의 무효 여부를 다투지 않겠다는 의사를 표시하였다고 단정할 수도 없다.”

KASAN_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 2.pdf

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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 된다면 ‘실제의 분쟁’이 발생한 것이라고 볼 수 있다고 보았습니다.

우리나라 공정위 특허라이선스 계약 관련 심사지침 - ‘무효인 특허의 존속 등을 위하여 부당하게 실시권자가 관련 특허의 효력을 다투는 것을 금지하는 행위’는 공정거래법 위반 소지 있음, 해당 계약조항의 효력 불인정 소지 있음, 해당 사안에 대한 판결 없음

대법원 2019. 2. 21. 선고 2017후2819 전원합의체 판결: 실시권자 Licensee의 특허권자 Licensor 상대로 대상특허에 대한 무효심판청구 가능 - 특허무효의 경우 계약상 실시료 Royalty 지급의무 범위 소멸:

“특허권의 실시권자에게는 실시료 지급이나 실시 범위 등 여러 제한 사항이 부가되는 것이 일반적이므로, 실시권자는 무효심판을 통해 특허에 대한 무효심결을 받음으로써 이러한 제약에서 벗어날 수 있다.

그리고 특허에 무효사유가 존재하더라도 그에 대한 무효심결이 확정되기까지는 그 특허권은 유효하게 존속하고 함부로 그 존재를 부정할 수 없으며, 무효심판을 청구하더라도 무효심결이 확정되기까지는 상당한 시간과 비용이 소요된다.

이러한 이유로 특허권에 대한 실시권을 설정받지 않고 실시하고 싶은 사람이라도 우선 특허권자로부터 실시권을 설정받아 특허발명을 실시하고 그 무효 여부에 대한 다툼을 추후로 미루어 둘 수 있으므로, 실시권을 설정받았다는 이유로 특허의 무효 여부를 다투지 않겠다는 의사를 표시하였다고 단정할 수도 없다.”

Licensor 이익을 위한 부쟁조항 예문 Example

라이센시의 특별한 상황에서는 인정한 미연방대법원 MedImmune 판결이 나온 지 벌써 10년이 지났습니다. 현재에도 Licensee의 부쟁의무 조항에 대해 정답을 명확하게 말할 수 없을 정도로 매우 어려운 쟁점사항(issue)입니다. 최근 본 미국 블로그 내용 중에서 라이선스 실무자에게 참고자료로 도움될 것 같은 계약문구 examples을 간략하게 인용합니다.

Examples of Patent Challenge Definition Clause

Example 1: “if licensee or its affiliate under a license commences an action in which it challenges the validity, enforceability or scope of any of the patent rights under, then [a remedy will be triggered, such as termination of the license, doubling of the royalty rate, or some other event].”

Example 2: “in the event any licensee (or sublicensee or any entity or person acting on its behalf) initiates any proceeding or otherwise asserts any claim challenging the validity or enforceability of any licensed patent right in any court, administrative agency or other forum, then [a remedy will be triggered].”

Example 3: “any legal or administrative challenge to the validity, patentability, enforceability and/or non-infringement of any of the licensed patent or otherwise opposing the licensed patent.”

Examples of Licensor’s Remedies

-      Right to Terminate the License

-      Increase in Royalty Rates

-      Liquidated Damages

-      Reimbursement of Legal Fees

KASAN_특허발명 실시허여, 기술이전, 라이센스 계약서에서 Licensee의 특허유효성 도전 제한, 부쟁의무 계약조항의 효력, 쟁점, 영문 계약조항 샘플.pdf

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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 사이 바이오신약 후보물질 특허기술 라이선스 계약서에서 라이센시의 임상시험 수행 등 개발의무 관.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 Biosciences에 nonexclusive license를 허여하는 계약을 체결하였고, Neurocrine는 10여년간의 연구개발 끝에 2010년경 대기업 Abbott(현재 AbbVie)와 신약연구개발 성과(신약후보 물질 Elagolix 등)에 대한 exclusive license 계약을 체결하였습니다.

최초 라이선스 계약서 중 sublicense 허용조항은 다음과 같습니다. – The Licensee Neurocrine may "grant sublicenses under the License only with the prior written consent" of the Licensor Mt. Sinai.

Neurocrine에서 AbbVie와 라이선스 계약을 체결하면서 Mt. Sinai 의과대학의 사전동의를 받지 않았습니다. 그것이 라이선스 계약위반에 해당하는지, 손해배상책임 여부가 문제됩니다.

한편, Elagolix는 현재 FDA 허가심사 중인데, Mt. Sinai 의과대학에서 향후 신약에 대한 Royalty를 받을 수 있는지 등이 중대한 문제입니다.

2. 특허라이선스와 Licensee의 특허무효 부쟁의무   

원칙적으로 licensee 입장에서 대상특허의 무효항변을 제기하는 것은 허용됩니다. 미국연방대법원 Lear v. Adkins (1969) 판결: a licensee cannot be estopped from challenging the validity of a patent merely because it benefitted from the license agreement.

그러나, 라이선스 계약위반으로 이미 성립된 책임을 회피하기 위해 사후적으로 제기하는 특허무효주장은 허용되지 않는다는 것이 미국법원 판결입니다. Studiengesellshaft Kohle v. Shell Oil (CAFC 1997) 판결: Lear does not apply where a licensee seeks to avoid contractual obligations already owed at the time of the suit. It "must prevent the injustice of allowing a licensee to exploit the protection of the contract and patent rights and then later to abandon conveniently its obligations under those same rights."

3. 미국법원의 Licensee Neurocrine의 대상특허 무효 항변 배척 판결 

미국법원은 sublicense 허용조건으로 licensor의 사전동의를 받도록 한 계약조항을 위반한 행위에 대한 손해배상을 구하는 범위내에서 licensee의 특허무효 항변이 허용되지 않는다고 판결하였습니다.

다만, 사안을 구별하여, 특허권자가 특허기술 사용에 대한 장래 royalty를 청구하는 경우는 licensee의 특허무효 항변이 허용될 수 있다는 취지의 판결입니다. 이 부분에 대한 라이선스 계약위반 사항은 없기 때문입니다.

참고로 licensee는 특허비침해 주장도 하였지만, 미국법원은 위 사안에서 라이선스 계약위반에 대한 항변으로 허용될 수 없다고 명확하게 판결하였습니다.

대학의 특허발명에 출발하여 벤처기업에서 10여년간 연구개발한 성과를 다시 대규모 제약회사에 라이선스하여 최종적으로 신약허가신청까지 성공한 사례입니다. 여기서 최초 대학과 체결한 라이선스 계약에 관한 분쟁으로 라이선스 실무자들에게 흥미로운 사건입니다.

중도 합의로 종결되어 최종 손해배상금액까지 결정한 최종 판결이 나오지 않을 가능성이 높지만 비록 중간판결일지라도 모니터링해볼 흥미로운 사례라고 생각합니다.

미국법원 사건 정보 Case: Icahn School of Medicine at Mount Sinai v. Neurocrine Biosciences, Inc., No. 15 Civ. 9414, S.D.N.Y.

KASAN_대학소유 특허의 기술이전, 라이선스 계약에서 재실시허용 조건 위반 사례 - 특허권자 Licensor 미국대학 vs Licensee 벤처회사 Sub-licensee 대기업 AbbVie 라이선스 계약분쟁 중 라이센시 특허.pdf

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