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) With holding 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_라이센스, 기술이전, License, 제조판매 계약서에서 Royalty Payment 관련 영문계약 조항 샘플.pdf

18. LICENSE AND EXCLUSIVITY COMPENSATION.

18.1 Payments; Extension of Exclusivity Period.

(a) Upfront License Fee and Prepayment. Hospira shall within [*] after the Effective Date (and in any event, before December 30, 2011) pay to CyDex a non-refundable upfront license fee of $500,000, in consideration of the rights granted Hospira under this Agreement. In addition, Hospira shall within [*] after the Effective Date (and in any event, before December 30, 2011) pay to CyDex $2,500,000 by wire transfer as a one-time materials purchase prepayment usable only as a cumulative $2,500,000 credit toward future purchases of Captisol hereunder. Such credit shall be applied to the first $2,500,000 of Captisol purchased hereunder, until exhausted. In the event that this Agreement is terminated, then to the extent so provided in Section 11.4 CyDex shall immediately make a payment to Hospira in the amount of any such remaining prepayment credit.

(b) Extension of Exclusivity Period. To retain the benefits of having the Exclusivity Period remain in force for additional time, Hospira shall have the option to extend one or more times the expiration date of the Exclusivity Period. Not more than [*] before and not less than [*] before the Exclusivity Period would otherwise expire (taking into account any previous proper extension or extensions of the Exclusivity Period pursuant to this Section 4.1(b)), CyDex shall deliver to Hospira written notice that the Exclusivity Period is set to expire. Hospira may, in its sole discretion, extend the Exclusivity Period by making a non-refundable payment, by wire transfer, of $[*] to CyDex within [*] after the receipt of CyDex’s notice. Each such extension shall extend the erstwhile expiration date of the Exclusivity Period for [*] beyond when it would otherwise have expired. For avoidance of doubt: (i) such option to extend can be exercised in compliance with this Section 4.1(b) multiple times, but no extension can extend the Exclusivity Period beyond the end of the Term, (ii) if CyDex does not provide notice to Hospira at least [*] before the end of the then current term of the Exclusivity Period, the Exclusivity Period will automatically extend for [*] after Hospira’s receipt of any such notice and Hospira shall have the right to further extend the Exclusivity Period as set forth above by making the required payment within [*] after receipt of CyDex’s notice, and (iii) the Exclusivity Period cannot be resuscitated after it has expired or terminated.

18.3 Taxes. All amounts due hereunder exclude all applicable sales, use, and other taxes and duties, and Hospira will be responsible for payment of all such taxes (other than taxes based on CyDex’s income), arising from the payment of amounts due under this Agreement. The parties agree to cooperate with one another and use reasonable efforts to avoid or reduce tax withholding or similar obligations in respect of payments made by Hospira to CyDex under this Agreement. To the extent Hospira is required to deduct and withhold taxes on any payment to CyDex, Hospira shall pay the amounts of such taxes to the proper governmental authority in a timely manner and promptly transmit to CyDex official receipts issued by the appropriate taxing authority and/or an official tax certificate, or such other evidence as CyDex may reasonably request, to establish that such taxes have been paid. CyDex shall provide Hospira any tax forms that may be reasonably necessary in order for Hospira to not withhold tax or to withhold tax at a reduced rate under an applicable bilateral income tax treaty. CyDex shall use reasonable efforts to provide any such tax forms to Hospira at least [***] before the due date for any payment for which CyDex desires that Hospira apply a reduced withholding rate. Each party shall provide the other with reasonable assistance to enable the recovery, as permitted by applicable law, of withholding taxes, value added taxes, or similar obligations resulting from payments made under this Agreement, such recovery to be for the benefit of the party bearing such withholding tax or value added tax.

19. RECORDS; AUDIT.

19.1 Records and Reports.

(a) Records. During the Term and for a period of [*], Hospira shall, and shall require its Affiliates to, maintain accurate records relating to Net Sales of the Finished Product.

(b) Reports. During the Term, Hospira shall provide CyDex with written a report that identifies whether each respective Section 4.1(c) milestone has been achieved.

19.2 Audit. Upon reasonable prior notice, such Section 5.1 records shall be available during regular business hours for examination and audit at the expense of CyDex by an independent certified public accountant selected by CyDex and reasonably acceptable to Hospira, for the sole purpose of verifying Net Sales. CyDex shall [*]. Such records may not be audited more often than [*] and the records for any period may not be audited more than once. During any audit, the scope of such audit shall only include, with respect to those items of deduction for which Hospira, under its then-current system, calculates using a fixed allocation system, a review of actual allocated deductions thereunder unless and until such time as Hospira has changed its system to reflect actual deductions for such category of deductions. In the event that Hospira begins tracking actual costs and deductions on a product by product basis generally (which it has no obligation to do hereunder), Hospira will implement such actual tracking for purposes of this Agreement in lieu of fixed allocation percentages and the calculation of such actual costs and deductions shall thereafter become subject to audit pursuant to this Section 5.2. All information learned in the course of any audit or inspection under this Section 5.2 shall be deemed to be Confidential Information of Hospira, subject to the terms and provisions of Section 7 below.

KASAN_라이선스, 기술이전, License 계약서에서 Royalty Payment 관련 영문계약 조항 샘플 – 독점권 대가 고정액 구조.pdf

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 등

● 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?

(예) “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_라이센스, 기술이전, 국제계약 단계별 계약서의 형식, 구성, 필수사항, 체크포인트 등 실무적 포인트 몇 가지.pdf

[​질문 또는 상담신청 입력하기]

Types of Royalties :

Lump Sum, 분할불

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

Running Royalties

정율 (%)

정액 ($ per unit)

Sliding scale

Minimum Royalty vs Maximum Royalty

Gross Sales Price vs Net Sales Price

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

Royalty Bearing Product

Tax

Report & Audit

4.1 License Fees. On or before the Effective Date, the Licensee Kite shall pay to the Licensor Cabaret a one-time upfront license fee of twenty-five thousand United States dollars (US$25,000). On or before each anniversary of the Effective Date until First Commercial Sale of the first Licensed Product, Kite shall pay to Cabaret an annual license fee of thirty thousand dollars (US$30,000).

4.3 Royalties.

4.3.1 Royalty Rate. During the applicable Royalty Term for a Licensed Product, subject to the terms and conditions of this Agreement, Kite shall pay to Cabaret royalties, with respect to each Licensed Product, equal to [*] percent ([*]%) of Net Sales of such Licensed Product by the Licensee Kite, its sublicensees and their respective Affiliates; provided, however, if the Licensed Product is made, used, or sold in such country where such Licensed Product would not infringe a Valid Claim, then the applicable royalty rate for such Licensed Product in such country shall be reduced to [*] percent ([*]%) of Net Sales of such Licensed Product. Only one royalty shall be owing for a Licensed Product regardless of how many Valid Claims cover such Licensed Product.

4.3.2 Third Party Royalties. If the Licensee Kite, its Affiliate or Sublicensee is required to pay royalties in consideration for a license to such Third Party IP to any Third Party in order to exercise its rights hereunder to make, have made, use, sell, offer to sale or import any Licensed Product, then Kite shall have the right to credit [*] percent ([*]%) of such Third Party IP royalty payments against the royalties owing to Cabaret under Section 4.3.1 with respect to sales of such Licensed Product in such country; provided, however, that Kite shall not reduce the amount of the royalties paid to Cabaret under Section 4.3.1 by reason of this Section 4.3.2, with respect to sales of such Licensed Product in such country, to less than [*] percent ([*]%) of Net Sales of such Licensed Product in such country.

4.3.3 Generic Product. On a country-by-country and Licensed Product-by-Licensed Product basis, if at any time during the applicable Royalty Term, one or more Generic Products are commercially launched by a Third Party (other than a Third Party sublicensee) in a country, then the applicable royalty rate for such Licensed Product in such country shall be reduced to [*] percent ([*]%) of Net Sales of such Licensed Product beginning from the launch of such Generic Product and continuing so long as such Generic Product is being sold in such country. Notwithstanding anything to the contrary set forth in this Agreement, to the extent that Kite has entered into a Sublicense Agreement pursuant to which Kite is not entitled to receive royalties in a country in which a Generic Product has been commercially launched, Kite shall have no obligation to pay, and Cabaret shall have no right to receive, royalties with respect to sales of Licensed Product in such country.

4.3.4 Combination Products. If a Licensed Product either (a) is sold together with another active ingredient product or device product which is not covered by a Valid Claim for a single price, or (b) consists of components that are covered by a Valid Claim and an active ingredient or device component that is not covered by a Valid Claim, then (except in the case where (i) the other active ingredient or device product or component which is not covered by Valid Claim also is not covered by any other valid patent claim, and (ii) a sublicensee pays to Kite a royalty which is not subject to an adjustment for such other active ingredient or device product or component) for purposes of the royalty payments under Section 4.3 for Net Sales of such Licensed Products, such Net Sales, prior to the royalty calculation set forth in Section 4.3, first shall be multiplied by the fraction A/(A+B), where A is [*], and B is [*]. If the parties cannot reach an agreement as to the Value of each of the products or components then a Third Party arbitrator who is an industry expert shall be appointed to provide such determination which shall be binding on the parties. The parties shall equally share all costs associated which such determination. Until such determination is made Kite shall make payment under Section 4.3 to Cabaret in accordance with its own determination and if following the Third Party arbitrator’s decision an increase in payments is required Kite shall make such adjustment payments retroactively.

KASAN_라이선스, 기술이전 계약서에서 대가지급, Royalty 구성, 산정기준 등 판단기준, 미국판결 사항, 체크포인트, 계약조항 샘플 등 실무적 포인트 몇 가지.pdf

10. REPRESENTATIONS, WARRANTIES, AND COVENANTS. 

10.1 Mutual Representations and Warranties. Licensor and Licensee (each, a “Representing Party”) each hereby represents and warrants to each other, as of the Effective Date and except as otherwise set forth in Schedule 10.2 (in the case of Licensor) and Schedule 10.3 (the case of Licensee), that:  

(a) such Representing Party is a corporation or limited liability company, as applicable, duly organized and subsisting under the laws of its jurisdiction of organization; 

(b) such Representing Party has the power, authority, and legal right, and is free, to enter into this Agreement on behalf of itself and its Affiliates and to perform its respective obligations hereunder and to cause its Affiliates to perform their respective obligations hereunder; 

(c) such Representing Party has the power, authority, and legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as it is contemplated to be conducted by this Agreement; 

(d) this Agreement constitutes a legal, valid, and binding obligation of such Representing Party and is enforceable against it in accordance with its terms, subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered a proceeding at law or equity; 

(e) the execution and delivery of this Agreement and the performance of such Representing Party’s and its Affiliates’ obligations hereunder (i) have been duly authorized and approved by all necessary action by such Representing Party, and all necessary consents, approvals, and authorizations of all Regulatory Authorities and other Third Parties required to be obtained by such Representing Party in connection with the execution and delivery of this Agreement and the performance of its obligations hereunder have been obtained; (ii) do not conflict with or violate any requirement of Applicable Laws or any provision of the articles of incorporation, bylaws, limited partnership agreement, or any similar instrument of such Representing Party, as applicable, in any material way; and (iii) do not, and will not, conflict with or otherwise interfere with in such a manner as to result in a violation, breach, or default under or require any consent that has not been obtained under any contract between such Representing Party and any Third Party; 

(f) there are no, and shall be no, liens, conveyances, mortgages, assignments, encumbrances, or other agreements that would prevent or impair such Representing Party’s or any of its Affiliates’ full and complete exercise of the terms and conditions of the Agreement; 

(g) such Representing Party and its Affiliates shall at all times comply with all Applicable Laws relating or pertaining to their obligations under the Agreement; 

(h) with respect to the services provided hereunder to the other Party, its Affiliates, and their respective employees, officers, contractors and agents who perform such services have the experience, capability, and resources to efficiently and skillfully perform the services, and shall perform, where applicable, all such services in a professional and workmanlike manner and in accordance with the generally accepted then-current standards, forms, procedures, and techniques established from time to time by the industry; 

(i) all of such Representing Party’s employees, officers, contractors, and consultants have executed agreements requiring assignment to such Representing Party of all inventions created by such persons in the course of their employment by such Representing Party and obligating each such employee, officer, contractor, and consultant to maintain and safeguard the confidentiality of (i) any information that is confidential to such Representing Party or (ii) any information that is confidential to any other Person and that such Representing Party is obligated to maintain and safeguard as confidential; and

(j) neither such Representing Party, nor any of its employees, officers, subcontractors, or consultants who have rendered or will render services relating to the Product: (i) has ever been debarred or is subject or debarment or convicted of a crime for which an entity or person could be debarred under 21 U.S.C. Section 335a or (ii) has ever been under indictment for a crime for which a person or entity could be debarred under said Section 335a. 

10.2 Additional Representations, Warranties, and Covenants of Licensor. Licensor hereby represents, warrants, and covenants to Licensee, as of the Effective Date and except as otherwise set forth in Schedule 10.2, that: 

(a) Licensor is entitled to grant the rights and licenses purported to be granted to Licensee under this Agreement, and to assign the rights purported to be assigned to Licensee under this Agreement, and is not currently bound by any agreement with any Third Party, or by any outstanding order, judgment, or decree of any court or administrative agency, that restricts it from granting to Licensee the rights, licenses and sublicenses purported to be so granted in this Agreement; 

(b) Licensor is the sole and exclusive owner of all right, title, and interest, in, to, and under the Licensed Rights and has the right under the Licensed CPEX Patent Rights and the Licensed Reprise Patent Rights to grant the sublicenses thereunder in accordance with Section 2.2; 

(c) the Licensed Rights are free and clear of any liens, charges, encumbrances, or judgments, and Licensor has sufficient rights to grant the licenses and rights purported to be granted herein, free and clear of any security interests, claims, encumbrances, or charges of any kind; 

(d) Licensor has not granted, and will not grant during the term of this Agreement, any right, option, license, or interest in or to any of the Licensed Rights that is in conflict with the rights assigned or granted to Licensee under this Agreement; 

(e) there is no legal, administrative, arbitration, or other proceeding, suit, claim, or action of any nature, judgment, decree, decision, injunction, writ, or order pending, or to Licensor’s knowledge threatened by, against or involving Licensor, regarding the Licensed Rights, whether at law or in equity, before or by any Third Party, and Licensor has not received any written communications alleging that it has violated, through the manufacture, Development, import, or other exploitation of the Product, any intellectual property rights of any Third Party; 

(f) to Licensor’s knowledge: 

(i) the patents in the issued Licensed Serenity Patent Rights, the Licensed CPEX Patent Rights, and the Licensed Reprise Patent Rights are valid and enforceable; and

(ii) no Third Party has asserted that any of the Licensed Rights or the Sublicensed Rights is invalid or unenforceable; 

(g) all applications, registrations, maintenance and renewal fees due in respect of any of the Licensed Serenity Patent Rights and, to Licensor’s knowledge, the Licensed Reprise Patent Rights and the Licensed CPEX Patent Rights, have been paid and all documents and certificates required to be filed with the relevant agencies for the purpose of maintaining such Licensed Serenity Patent Rights, and to Licensor’s knowledge, the Licensed Reprise Patent Rights and Licensed CPEX Patent Rights have been filed; 

(h) none of the Licensed Serenity Patent Rights, the Licensed Serenity Know-How and, to Licensor’s knowledge, none of the Licensed CPEX Patent Rights and the Licensed Reprise Patent Rights were developed with funding from any Governmental Authority such that any Governmental Authority has any march in rights or other rights to use the Licensed Serenity Patent Rights, the License Serenity Know-How, the Licensed Reprise Patent Rights, or the Licensed CPEX Patent Rights; 

(i) to Licensor’s knowledge, no Third Party has infringed or misappropriated any of the Licensed Rights or the Sublicensed Rights; 

(j) all inventors of any inventions included within the Licensed Serenity Patent Rights and, to the knowledge of Licensor, the Licensed CPEX Patent Rights and the Licensed Reprise Patent Rights have assigned their entire right, title, and interest in and to such inventions and the corresponding patents and patent applications to Licensor, Reprise, or CPEX, as applicable, and have been listed as inventors in the Licensed Serenity Patent Rights, the Licensed CPEX Patent Rights, and the Licensed Reprise Patent Rights, as applicable; 

(k) no agreements that Licensor or its Affiliates may have with any Third Party provide such Third Party with any rights of first offer, rights of first refusal, or any other rights to make, have made, use, conduct Clinical Studies for, sell, offer for sale, have sold, import, export, or otherwise Exploit the Product in the Field in the Territory or the right to use the Licensed Rights or the Sublicensed Rights in connection with the Exploitation of the Product in the Field in the Territory; and Licensor has received no notice from a Third Party of any suit, action, proceeding, or arbitration pending or threatened against it that the proposed terms and conditions of this Agreement, and the Parties’ performance in accordance therewith, do or shall conflict or interfere with in a manner resulting in a breach or default under, or other violation of, any agreements that Licensor or its Affiliates may have with any Third Party; 

to Licensor’s knowledge, (i) each of the CPEX License Agreement and the Reprise License Agreement is valid and enforceable in accordance with its terms, is in full force and effect, and there are no approvals or consents required to make it effective, (ii) Licensor has supplied Licensee with a true and correct copy of the CPEX License Agreement and the Reprise License Agreement , together with all amendments, waivers, or other changes thereto, (iii) Licensor has performed all material obligations required to be performed by it in connection with the CPEX License Agreement and the Reprise License Agreement, (iv) Licensor shall not materially breach and is not in material breach of the CPEX License Agreement or the Reprise License Agreement, (v) Licensor is not in receipt of any claim of default, cure notice, or show cause notice under the CPEX License Agreement or the Reprise License Agreement, and (vi) there is no current material breach or anticipated material breach by any other party to the CPEX License Agreement or the Reprise License Agreement; 

(m)

 (i) Licensor is the named sponsor of the First Approved NDA for the Product; and (ii) with respect to all Regulatory Documentation to obtain Regulatory Approvals for the Product in the Field: (A) the data, information and/or all other documents in Licensor’s or its Affiliates submissions were, are and shall be free from fraud or material falsity, and neither Licensor nor its Affiliates has made any material misrepresentation or omission in connection with such data; (B) the Regulatory Approvals have not been and will not be obtained either through bribery or the payment of illegal gratuities by Licensor; (C) the data, information and/or all other documents in Licensor’s or its Affiliates’ submissions are, were and shall be accurate and reliable for purposes of supporting approval of the submissions; and (D) the Regulatory Approvals shall be obtained without illegal or unethical behavior of any kind by Licensor or its Affiliates; provided that Licensor shall not be deemed to be in breach of this Section 10.2(m) if the violation of this Section 10.2(m) results from the action or omission of Licensee of Licensee’s Affiliates, Sublicensees, or contractors (other than Licensor); 

(n) Licensor believes in good faith, based on the information set forth in Schedule 10.2(n), that FDA will consider amending or supplementing the First Approved NDA (or the related IND) in the manner described in Schedule 10.2(n); provided, however, that Licensor cannot assure that FDA will approve such amendment or supplement. 

(o) except as expressly permitted hereunder, Licensor agrees not to, and agrees to cause its Affiliates and Sublicensees not to (i) assign, transfer, convey or otherwise encumber any right, title or interest in or to the Licensed Rights, the Sublicensed Rights, or any Regulatory Approvals and Documentation in respect of the Product, (ii) grant in any manner any license or other right, title or interest in or to any of the Licensed Rights, the Sublicensed Rights, or the Regulatory Approvals and Documentation in respect of the Product, or (iii) agree to or otherwise become bound by any covenant not to sue for any infringement, misuse or other action or inaction with respect to any of the Licensed Rights, the Sublicensed Rights, or the Regulatory Approvals and Documentation in respect of the Product; and

(p) other than the CPEX License Agreement, the Reprise License Agreement, the Renaissance Supply Agreements, and the other Third Party Supply Agreements, Licensor and/or its Affiliates have not entered into any agreements with any Third Party, pursuant to which any Third Party has granted to Licensor, or Licensor has granted to any Third Party, any rights to licenses to, in or under any of the Licensed Rights or the Sublicensed Rights or other intellectual property rights that relate to the Product, or relating to the manufacture of the Product.

10.3 Additional Representations, Warranties, and Covenants of Licensee. Licensee hereby represents, warrants, and covenants to Licensor, as of the Effective Date and except as otherwise stated in Schedule 10.3, that: 

(a) if, during the term of this Agreement Licensee has reason to believe that it or any of its employees, officers, subcontractors, or consultants rendering services relating to the Product: (i) is or will be debarred or convicted of a crime under 21 U.S.C. Section 335a, or (ii) is or will be under indictment under said Section 335a, then Licensee shall immediately notify Licensor in writing; 

 (b) as of the Effective Date, there is no legal, administrative, arbitration, or other proceeding, suit, claim, or action of any nature, judgment, decree, decision, injunction, writ, or order pending or, to the knowledge of Licensee’s senior management, threatened by, against Licensee regarding this Agreement, whether at law or in equity, before or by any Third Party; and Licensee shall provide notice of any of the foregoing to the extent it affects Licensee’s performance of its obligations under this Agreement; 

(c) except for information provided by Licensor, its Affiliates or Sublicensees: (i) the data and information in Licensee’s submissions and modifications of Regulatory Documentation relating to the Product shall be free from fraud or material falsity; (ii) Regulatory Approvals for the Product hereafter obtained will not be obtained either through bribery or the payment of illegal gratuities by Licensee; (iii) the data and information in Licensee’s submissions and modifications of any Regulatory Documentation shall be accurate and reliable; and (iv) any such the Regulatory Approvals will be obtained without illegal or unethical behavior of any kind by Licensee; provided that Licensee shall not be deemed to be in breach of this Section 10.3(c) if the violation of this Section 10.3(c) results from the action or omission of Licensor or its Affiliates, Sublicensees (other than Licensee), or contractors; and

(d) except as expressly permitted hereunder, Licensee agrees not to, and agrees to cause its Affiliates and Sublicensees not to (i) assign, transfer, convey or otherwise encumber any right, title or interest in or to the Licensed Rights, the Sublicensed Rights, or any Regulatory Approvals and Documentation in respect of the Product, (ii) grant in any manner any license or other right, title or interest in or to any of the Licensed Rights, the Sublicensed Rights, or the Regulatory Approvals and Documentation in respect of the Product, (iii) agree to or otherwise become bound by any covenant not to sue for any infringement, misuse or other action or inaction with respect to any of the Licensed Rights, the Sublicensed Rights, or the Regulatory Approvals and Documentation in respect of the Product, or (iv) bring any action or proceeding or otherwise assert any claim under any Applicable Law in the event any licensee (or sublicensee or any entity or person acting on its behalf) initiates any proceeding or otherwise assert any claim in any court, administrative agency, or other forum with jurisdiction over such proceeding or claim, that any of the Licensed Rights or Sublicensed Rights are invalid, unenforceable, or not infringed, violated, or misappropriated. In the event that Licensee or any Affiliate or Sublicensee of Licensee initiates any proceeding or otherwise asserts any claim in violation of clause (iv) of this Section 10.3, and the result thereof is a final decision, ruling, holding, award, or other disposition to the effect that any of the Licensed Rights or Sublicensed Rights are valid, enforceable, or infringed, violated, or misappropriated, then each of the royalty rates set forth in the table in Section 8.3(a) will each be increased by [***] and the party initiating such proceeding or otherwise asserting such claim shall pay the attorneys’ fees and expenses incurred by Licensor in defending against such proceeding or claim.

10.4 Inaccuracies. Without limiting either Party’s rights and remedies at law, in equity or under this Agreement, if, at any point in time (not just at the times when the warranties are deemed granted), either Party becomes aware of any inaccuracies in the foregoing warranties and representations, such Party shall promptly notify the other Party of such inaccuracies, with a detailed written explanation.

KASAN_기술이전, 특허 라이선스 계약서에서 진술 및 보증조항 REPRESENTATIONS AND WARRANTIES 계약조항 샘플.pdf

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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.pdf

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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, WARRANTIES AND COVEANTS – 권리진술 및 독점권 보장의무 등 상세한 내용을 매우 구체적으로 기재하는 방식의 .pdf

1. 진술 및 보증조항 관련 분쟁

정유회사의 M&A 주식양수도계약서에서 '양도인은 양수인에게 주식양수도계약 체결일 및 양수도 실행일에 일체의 행정법규를 위반한 사실이 없고, 이와 관련하여 행정기관으로부터 조사를 받고 있거나 협의를 진행하는 것은 없다’는 내용의 진술 및 보증조항, 나아가 '양수도 실행일 이후 보증 위반사항이 발견된 경우나 약속사항 위반으로 손해가 발생할 경우 500억원을 초과하지 않는 범위 내에서 배상하기로 한다'는 책임조항이 포함되어 있었습니다.

그런데, 양도인 회사는 군용유류 구매입찰에서 담합행위 등 공정거래법을 위반했다는 이유로 거액의 과징금 납부명령을 받았고 거액의 손해배상청구소송까지 제기 받았습니다. 이에 양수인이 진술 및 보증조항 위반을 이유로 책임조항을 적용하여 양도인에 대한 손해배상청구 소송을 제기하였습니다.

2. 항소심 서울고등법원 2008나19678 판결

항소심 법원은 양수인도 진술 및 보증위반 사항을 알면서도 계약을 체결했다는 이유로 양도인의 책임을 인정하지 않았습니다. 판결문 중 핵심부분을 인용하면 다음과 같습니다. "양수인도 이 사건 담합행위에 직접 참여했던 탓에 주식양수도계약 체결 당시에 이미 이 사건 진술 및 보증 조항의 위반사실을 알고 있었고, 계약협상 및 가격산정에 반영할 수 있었음에도 방치하였다가 이후 위반사실이 존재한다는 사정을 들어 양도인 피고에게 책임을 묻는 것은 공평의 이념 및 신의칙상 허용될 수 없으므로, 양도인 피고는 위와 같은 악의의 주식양수인인 원고에 대하여 이 사건 진술 및 보증 조항의 위반에 따른 책임을 부담하지 않는다."

3. 대법원 2012다64253 판결

원심판결을 파기 환송하였습니다. "이 사건 주식양수도계약의 양수도 실행일 이후에 이 사건 진술 및 보증 조항의 위반사항이 발견되고 그로 인하여 손해가 발생하면, 원고가 그 위반사항을 계약체결 당시 알았는지 여부와 관계없이, 피고들이 원고에게 그 위반사항과 상당인과관계 있는 손해를 배상하기로 하는 합의를 한 것으로 봄이 상당하다.

양수인 원고가 이 사건 진술 및 보증조항과 관련된 이 사건 담합행위를 알고 있었고 이 사건 담합행위로 인한 공정거래위원회의 제재 가능성 등을 이 사건 주식양수도대금 산정에 반영할 기회를 가지고 있었다고 하더라도 그러한 점만으로 원고의 손해배상청구가 공평의 이념 및 신의칙에 반한다고 볼 수 없다."

4. 실무적 함의

대법원 판결은 계약서 문언이 가장 중요하다는 원칙을 다시 한번 확인하였습니다. 비록 계약체결 당시 당사자가 진술 및 보증 조항의 위반사실을 알고 있었다고 해도 계약서 효력을 함부로 부정할 수 없다고 명확하게 판결하였습니다.

처분문서인 계약서의 계약문언이 그 객관적 의미가 명확하다면 특별한 사정이 없는 한 문언대로의 의사표시의 존재와 내용을 인정하여야 합니다. 설령 공평의 이념이나 신의칙을 적용해야 할 사정이 있다고 하더라도, 이과 같은 일반원칙에 근거하여 계약의 효력을 부정하거나 계약상 책임을 제한하는 것은 사적 자치의 원칙이나 법적 안정성에 대한 중대한 위협이 될 수 있으므로 신중을 기하여 극히 예외적으로 인정하여야 한다는 입장입니다.

즉, 무엇보다 계약서 문언을 가장 중시하고 신의칙이나 공평이념 등을 아주 예외적으로 극히 신중하게 적용하라는 취지입니다. 가능성을 완전히 배제하는 것은 아니지만 현실적으로 실제 사례에서 그와 같은 특별한 경우는 인정되기 어렵다는 의미입니다.

5. 진술 및 보증 조항 위반과 손해배상책임 범위: 대법원 2018. 7. 20. 선고 2015다207044 판결

(1) M&A 계약에서 진술 및 보증 조항을 둔 목적은, 계약 종결과 이행 이후 진술 및 보증하였던 내용과 다른 사실이 발견되어 일방 당사자에게 손해가 발생한 경우에 상대방에게 그 손해를 배상하게 함으로써, 불확실한 상황에 관한 경제적 위험을 배분하고 사후에 현실화된 손해를 감안하여 매매대금을 조정할 수 있게 하기 위한 것이다.

(2) M&A 대상회사에 대한 소송이나 분쟁의 존재는 우발채무에 따른 손실로 이어질 가능성이 있어 진술 및 보증의 대상으로 삼는 것이다.

(3) 매도인이 대상회사에 대한 소송이나 분쟁을 고지하지 않았고 이후 대상회사에 실제로 우발채무가 발생한 경우 언제나 그 전부가 손해배상의 범위에 포함된다고 볼 수는 없다. 제3자가 대상회사를 상대로 터무니없는 소송을 제기하였음에도 매도인이 이를 알리지 않은 상태에서 M&A 계약이 종결, 이행되었는데, 매도인에게 책임을 물을 수 있으므로 매수인으로서는 실질적 피해가 없다는 이유로 대상회사로 하여금 별다른 다툼 없이 거액의 합의금을 지급하도록 하는 경우와 같이, 매도인에게 과도한 책임을 지우는 결과를 초래할 수 있기 때문이다.

(4) 그러나 소송 또는 분쟁으로부터 직접 그리고 자연스럽게 도출되거나 합리적으로 예상가능한 범위의 손해에 관하여는 매도인이 그에 관한 배상책임을 부담하여야 한다.

(5) 매수인이 거래 종결 후 대상회사 주식을 매각하는 경우 대부분 매수인은 후속 매수인에게 진술 및 보증을 하고 그 위반으로 인한 책임을 부담하게 된다.

(6) 만약 매도인의 진술 및 보증 조항 위반으로 매수인의 주식 매각 이후 대상회사에 손실이 발생하고, 그로 인해 매수인이 새로운 매수인에 대하여 책임을 부담하게 되었음에도, 매수인이 주식을 매각하여 주주의 지위에 있지 않다는 이유로 당초의 매도인에게 책임을 물을 수 없는 결과에 이른다면 경제적 위험의 적정한 배분이라는 진술 및 보증 조항의 목적에 반하게 된다.

(7) 따라서 당사자들 사이에 특별한 합의가 없다면 매수인이 대상회사의 주식을 처분하더라도 손해배상청구 및 액수 산정에 별다른 영향을 미치지 않는다.

KASAN_진술보증 조항 REPRESENTATIONS AND WARRANTIES 관련 분쟁 - M&A 계약서 중 진술 및 보증조항 위반 및 손해배상책임 범위.pdf

[질문 또는 상담신청 입력하기]

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, Collaboration Agreement 당사자의 M&A 등 경영권 변경사유, change of control 발생 상황에 대비한 계약조항.pdf

23. INDEMNIFICATION; INSURANCE; LIMITATION OF LIABILITY. 

23.1 General Indemnification by CyDex. CyDex shall defend, indemnify and hold Hospira and its Affiliates and Sublicensees, and each of their respective directors, officers, agents and employees, harmless from and against any and all losses, judgments, damages, liabilities, settlements, penalties, fines, costs and expenses (including the reasonable costs and expenses of attorneys and other professionals) (collectively “Losses”) incurred as a result of any claim, demand, action or other proceeding (each, a “Claim”) by a Third Party, to the extent such Losses arise out of: (a) the manufacture, use, handling, promotion, marketing, distribution, importation, sale or offering for sale of Captisol by CyDex, its Affiliates or any of their agents, or (b) CyDex’s breach of this Agreement, including without limitation any of its representations and warranties set forth in Section 8, or (c) any negligent or willful misconduct by CyDex or its Affiliates or any of their respective distributors, officers, directors employees or agents, in each case to the extent that such Losses are not due to Hospira’s or any of its Affiliates’ or Sublicensees’, or any of their respective directors’, officers’, agents’ or employees’ breach of this Agreement or negligence or willful misconduct.

23.2 General Indemnification by Hospira. Hospira shall defend, indemnify and hold CyDex and its Affiliates, and each of their respective directors, officers, agents and employees, harmless from and against any and all Losses incurred as a result of any Claim by a Third Party, to the extent such Losses arise out of: (a) the manufacture, use, handling, promotion, marketing, distribution, importation, sale or offering for sale of the Finished Product by Hospira, its Affiliates and Sublicensees, or (b) Hospira’s breach of this Agreement, including without limitation any of its representations and warranties set forth in Section 8, or (c) any negligent or willful misconduct by Hospira or its Affiliates or any of their respective distributors, officers, directors employees or agents, in each case to the extent that such Losses are not due to CyDex’s or any of its Affiliates’ or any of their respective directors’, officers’, agents’ or employees’ breach of this Agreement or negligence or willful misconduct.

23.4 Procedure.

(a) The person intending to claim indemnification under Section 9 (an “Indemnified Party”) shall promptly notify the other party (the “Indemnifying Party”) of any Claim in respect of which the Indemnified Party intends to claim such indemnification, and a reasonable explanation of the basis for the Claim and the amount of alleged Losses to the extent of the facts then known by the Indemnified Party. (Notwithstanding the foregoing, no delay or deficiency on the part of the Indemnified Party in so notifying the Indemnifying Party will relieve the Indemnifying Party of any liability or obligation under this Agreement except to the extent the Indemnifying Party has suffered actual prejudice directly caused by the delay or other deficiency.) The Indemnifying Party shall assume the defense thereof; provided, however, that if the Indemnifying Party assumes the defense, the Indemnified Party shall have the right to employ counsel separate from counsel employed by the Indemnifying Party in any such action and to participate in the defense thereof, but the fees and expenses of such counsel employed by the Indemnified Party shall be at the sole cost and expense of the Indemnified Party unless the Indemnifying Party consents to the retention of such counsel or unless the named parties to any action or proceeding include both the Indemnifying Party and the Indemnified Party and a representation of both the Indemnifying Party and the Indemnified Party by the same counsel would be inappropriate due to the actual or potential differing interests between them. And provided further that, if the Indemnifying Party shall fail to assume the defense of and reasonably defend such Claim, the Indemnified Party shall have the right to retain or assume control of such defense and the Indemnifying Party shall pay (as incurred and on demand) the fees and expenses of counsel retained by the Indemnified Party.

(b) The Indemnifying Party shall not be liable for the indemnification of any Claim settled (or resolved by consent to the entry of judgment) without the written consent of the Indemnifying Party (which shall not be unreasonably withheld or delayed). Also, if the Indemnifying Party shall control the defense of any such Claim, the Indemnifying Party shall have the right to settle such Claim; provided, that the Indemnifying Party shall obtain the prior written consent (which shall not be unreasonably withheld or delayed) of the Indemnified Party before entering into any settlement of (or resolving by consent to the entry of judgment upon) such Claim unless (A) there is no finding or admission of any violation of law or any violation of the rights of any Third Party by an Indemnified Party, no requirement that the Indemnified Party admit fault or culpability, and no adverse effect on any other claims that may be made by or against the Indemnified Party and (B) the sole relief provided is monetary damages that are paid in full by the Indemnifying Party and such settlement does not require the Indemnified Party to take (or refrain from taking) any action.

(c) Regardless of who controls the defense, the other party hereto shall reasonably cooperate in the defense as may be requested. Without limitation, the Indemnified Party, and its directors, officers, advisers, agents and employees, shall reasonably cooperate with the Indemnifying Party and its legal representatives in the investigations of any Claim.

23.5 Insurance. CyDex will procure and maintain, at its own expense, for the duration of the Agreement, and for [*] thereafter if written on a claims made or occurrence reported form, the types of insurance specified below with carriers rated [*]. Best or like rating agencies:

  a. Workers’ Compensation accordance with applicable statutory requirements and shall provide a waiver of subrogation in favor of Hospira; 

  b. Employer’s Liability with a limit of liability in an amount of not less than $[***]; 

  c. Commercial General Liability including premises operations, products & completed operations, blanket contractual liability, personal injury including fire legal liability for bodily injury and property damage in an amount not less than $[***]; 

  d. Commercial Automobile Liability for owned, hired and non-owned motor vehicles with a combined single limit in an amount not less than $[*]; 

  e. Excess Liability including product liability with a combined single limit in an amount of not less than $[*]; 

  f. Commercial Crime or Fidelity Bond in an amount of not less than $[*] including an endorsement for Third Party liability without the requirement of a conviction. 

  g. Cargo Legal Liability insurance covering all risks of physical loss or damage to cargo handled by CyDex. The limit of liability shall not be less than $[*]. 

23.6 Limitation of Liability. EXCEPT FOR (1) PERSONAL INJURY, INCLUDING DEATH, (2) TANGIBLE PROPERTY DAMAGE, (3) EACH PARTY’S INDEMNIFICATION OBLIGATIONS, (4) DAMAGES ARISING OUT OF AN INTENTIONAL BREACH OF THE CONFIDENTIALITY OBLIGATIONS HEREIN, (5) DAMAGES ARISING OUT OF CYDEX’S BREACH OF SECTION 2.4, AND (6) DAMAGES FOR WHICH CYDEX IS RESPONSIBLE PURSUANT SECTION 3.6, 3.7 OR 6.4.

KASAN_신제품 라이선스 및 생산공급 국제계약서 중에서 면책조항 INDEMNIFICATION, INSURANCE, LIMITATION OF LIABILITY 계약조항 샘플.pdf

22. REPRESENTATIONS AND WARRANTIES. 

22.1 Mutual Representations and Warranties. Each party represents and warrants to the other (as of the Effective Date) as follows:

(a) it is a corporation duly organized and validly existing under the laws of the state or country of its incorporation;

(b) it has the complete and unrestricted power and right to enter into this Agreement and to perform its obligations hereunder;

(c) this Agreement has been duly authorized, executed and delivered by such party and constitutes a legal, valid and binding obligation of such party enforceable against such party in accordance with its terms except as enforceability may be limited by applicable bankruptcy, insolvency, reorganization, receivership, moratorium, fraudulent transfer, or other similar laws affecting the rights and remedies of creditors generally and by general principles of equity;

(d) the execution, delivery and performance of this Agreement by such party does not conflict with any agreement, instrument or understanding, oral or written, to which such party is a party or by which such party may be bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having authority over such party; without limiting the warranties in this Section,

(e) all consents, approvals and authorizations from all governmental authorities or other third parties required to be obtained by such party in connection with the execution and delivery of this Agreement have been obtained;

(f) no person or entity has or will have, as a result of the transactions contemplated by this Agreement, any right, interest or valid claim against or upon such party for any commission, fee or other compensation as a finder or broker because of any act by such party or its agents; and

(g) it has not entered into any agreement with any Third Party that is in conflict with the rights granted to the other party pursuant to this Agreement;

(h) there are no suits, claims, or proceedings pending, or to its best knowledge and belief, after due inquiry, threatened against it or any of its Affiliates in any court or by or before any governmental body or agency which would affect its ability to perform its obligations under this Agreement.

22.2 Captisol Warranties. CyDex warrants that the Captisol delivered hereunder shall:

(a) at the time of delivery and until the applicable Captisol expiration date be in compliance with and meet any and all specifications as set out in the DMF/CEP as referenced in the Regulatory Filings and Regulatory Approvals and in compliance with Good Manufacturing Practices.

(b) at the time of delivery and until the applicable Captisol expiration date be free from defects in materials and manufacture and shall continue to conform to the Specifications.

(c) have been manufactured in accordance with the DMF/CEP and in accordance with all applicable statutes, ordinances and regulations of the FDA and any other then applicable Major-Market national, supra-national and United States Regulatory Authorities, including without limitation, the Act and Good Manufacturing Practices.

(d) not, when delivered, be adulterated or misbranded within the meaning of the Act or any similar laws or regulations of applicable Major-Market national, supra-national and United States Regulatory Authorities or be an article which may not, under provisions of any applicable Major-Market national, supra-national or United States law, be sold by CyDex to Hospira.

(e) at the time of delivery have at least [*]% of its original shelf life.

(f) at the time of delivery be free and clear of all liens, claims, charges and encumbrances and that CyDex shall have title to the Captisol.

22.4 Reference Standard Warranty. CyDex further warrants that any reference standard material delivered to Hospira pursuant to this Agreement shall meet the specifications outlined in the applicable Certificate of Analysis provided pursuant to Section 3.7.

22.6 No Debarred Service Providers. CyDex represents and warrants that to neither CyDex, nor any of its Affiliates, employees or agents working on Hospira’s behalf, has ever been, is currently, or is the subject of a proceeding that could lead to that party becoming, as applicable, a Debarred Entity or Individual. CyDex further covenants, represents and warrants that if, during the Term of this Agreement, it, or any of its Affiliates, employees or agents working on Hospira’s behalf, becomes or is the subject of any FDA investigation or debarment proceeding that could lead to that party becoming, as applicable, a Debarred Entity or Individual, CyDex shall immediately notify Hospira, and Hospira shall have the right to immediately terminate this Agreement. This provision shall survive termination or expiration of this Agreement. For purposes of this provision, the following definitions shall apply:

(a) A “Debarred Individual” is an individual who has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) from providing services in any capacity to a person that has an approved or pending drug Captisol application.

(b) A “Debarred Entity” is a corporation, partnership or association that has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) from submitting or assisting in the submission of any abbreviated drug application, or a subsidiary or Affiliate of a Debarred Entity.

22.7 No-Conflict by CyDex. CyDex also represents and warrants that the execution, delivery and performance of this Agreement does not conflict with any of the [*]; and that CyDex has the right to grant Hospira the licenses set forth herein to all CyDex Intellectual Property, including, without limitation, the Licensed Patents.

22.8 Disclaimer. THE WARRANTIES SET FORTH IN THIS SECTION 8 ARE PROVIDED IN LIEU OF, AND EACH PARTY HEREBY DISCLAIMS, ALL OTHER WARRANTIES, EXPRESS AND IMPLIED, RELATING TO THE SUBJECT MATTER OF THIS AGREEMENT, CAPTISOL, THE LICENSED PATENTS OR THE CAPTISOL DATA PACKAGE, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NON-INFRINGEMENT OF THIRD PARTY RIGHTS.

KASAN_제약회사 라이선스 및 생산공급 계약서 중에서 진술 및 보증조항 REPRESENTATIONS AND WARRANTIES 계약조항 샘플.pdf

21. CONFIDENTIALITY. 

21.1 Definition. Hospira and CyDex each recognizes that, during the Term, it may be necessary for a party (the “Disclosing Party”) to provide Confidential Information (as defined herein) to the other party (the “Receiving Party”) that is highly valuable, the disclosure of which would be highly prejudicial to such party. The disclosure and use of Confidential Information will be governed by the provisions of this Section 7. Neither Hospira nor CyDex shall use the other’s Confidential Information except as expressly permitted in this Agreement. For purposes of this Agreement, “Confidential Information” means all information disclosed by the Disclosing Party to the Receiving Party in any form whatsoever, including but not limited to product specifications, data, know-how, formulations, product concepts, sample materials, business and technical information, financial data, batch records, trade secrets, processes, techniques, algorithms, programs, designs, drawings, and any other information related to a party’s present or future products, sales, suppliers, customers, employees, investors or business. Without limiting the generality of the foregoing, CyDex’s Confidential Information includes all materials provided as part of the Captisol Data Package.

21.2 Obligation. CyDex and Hospira agree that they will disclose the other’s Confidential Information to its (or its respective Affiliates’) own officers, employees, consultants and agents only if and to the extent reasonably necessary to carry out their respective responsibilities under this Agreement or in accordance with the exercise of their rights under this Agreement, and such disclosure shall be limited to the extent reasonably possible consistent with such responsibilities and rights. Except as provided in the previous sentence, neither party shall disclose Confidential Information of the other to any Third Party without the other’s prior written consent. Any disclosure to a Third Party shall be pursuant to the terms of a non-disclosure agreement substantially similar to the requirements of this Section 7. The party which disclosed Confidential Information of the other to any Third Party shall be responsible and liable for any disclosure or use by such Third Party (or its disclosees) which would have violated this Agreement if committed by the party itself. Neither party shall use Confidential Information of the other except as expressly allowed by and for the purposes of this Agreement. Each party shall take such action to preserve the confidentiality of each other’s Confidential Information as it would customarily take to preserve the confidentiality of its own Confidential Information (but in no event less than a reasonable standard of care). Unless otherwise specified in this Agreement and subject to terms and conditions in this Agreement, if so requested by the other party a party shall promptly return all relevant records and materials in its possession or control containing or embodying the other party’s Confidential Information (including all copies and extracts of documents); provided, however, that each party may retain one archival copy (and such electronic copies that exist as part of the party’s computer systems, network storage systems and electronic backup systems) of such records and materials solely to be able to monitor its obligations that survive under this Agreement.

21.3 Exceptions. The use and non-disclosure obligations set forth in this Section 7 shall not apply to any Confidential Information, or portion thereof, that the Receiving Party can demonstrate by appropriate documentation:

(a) at the time of disclosure is in the public domain;

(b) after disclosure, becomes part of the public domain, by publication or otherwise, through no fault of the Receiving Party or its disclosees;

(c) is independently developed by Receiving Party personnel with no reference or access to the Confidential Information; or

(d) is made available to the Receiving Party by an independent third party without obligation of confidentiality, provided, however, that to the Receiving Party’s knowledge, such information was not obtained by said third party, directly or indirectly, from the Disclosing Party hereunder.

In addition, the Receiving Party may disclose information to a court or ADR forum in the process of seeking to enforce through such court or ADR forum its own rights under this Agreement, and also may disclose information that is required to be disclosed by law, by a valid order of a court or by order or regulation of a governmental agency including but not limited to, regulations of the Securities and Exchange Commission, or in the course of litigation, provided that in all cases the Receiving Party shall give the other party prompt notice of the pending disclosure and make a reasonable effort to obtain, or to assist the Disclosing Party in obtaining, a protective order or confidential-treatment order preventing or limiting (to the greatest possible extent and for the longest possible period) the disclosure and/or requiring that the Confidential Information so disclosed be used only for the purposes for which the law or regulation required, or for which the order was issued.

21.4 Injunction. Each party agrees that should it breach or threaten to breach any provisions of this Section 7, the Disclosing Party will suffer irreparable damages and its remedy at law will be inadequate. Upon any breach or threatened breach by the Receiving Party of this Section 7, the Disclosing Party shall be entitled to seek from any court of competent jurisdiction temporary, preliminary and/or permanent injunctive relief in addition to any other remedy which it may have, without need to post any bond or security, in addition to any and all other legal and equitable rights and remedies available to the Disclosing Party.

21.5 Public Announcements. If a press release is required by law or the applicable rules of a national securities exchange to be issued upon execution of this Agreement or reasonably soon thereafter, the parties will mutually agree on such a press release. Neither party shall make any subsequent public announcement concerning this Agreement or the terms hereof not previously made public without the prior written approval of the other party with regard to the form, content, and precise timing of such announcement, except as may be required to be made by either party in order to comply with applicable law, regulations, court orders, or tax or securities filings. Such consent shall not be unreasonably withheld or delayed by such other party. Before any such public announcement, the party wishing to make the announcement will submit a draft of the proposed announcement to the other party in sufficient time to enable such other party to consider and comment thereon. The parties agree that a party may disclose this Agreement’s existence and terms, and material developments or material information generated under this Agreement, in (i) securities filings with the Securities and Exchange Commission (or equivalent foreign agency) to the extent required by law, or (ii) under conditions of confidentiality/nonuse in connection with investment and similar corporate transactions. Notwithstanding the above, once a public announcement has been made, either party shall be free to disclose to third parties any information contained in said public announcement.

KASAN_국제계약서 중 비밀보호계약, 비밀유지약정, NDA, CDA 조항 – 비밀정보 범위, 적용 배제대상, 비밀유지 의무, 위반시 조치 등 계약조항 샘플.pdf

[질문 또는 상담신청 입력하기]

26.1 Relationship of Parties. Each of the parties hereto is an independent contractor and nothing in this Agreement is intended or shall be deemed to constitute a partnership, agency, employer-employee or joint venture relationship between the parties. No party shall have the right to, and each party agrees not to purport to, incur any debts or make any commitments or contracts for the other.

26.2 Compliance with Law. Each of the parties shall comply with all applicable international, federal, state and local laws, rules and regulations, including, but not limited to, import/export restrictions, laws, rules and regulations governing product quality and safety and patent, copyright and trade secret protection.

26.3 Arbitration.

(a) Procedure. The parties recognize that bona fide disputes may arise which relate to the parties’ rights and obligations under this Agreement. The parties agree that except as provided in Section 7.4, any such dispute shall be resolved by alternative dispute resolution in accordance with the procedure set forth in Exhibit F.

(b) Confidentiality of Proceedings. All arbitration proceedings hereunder shall be confidential and the arbitrator(s) shall issue appropriate protective orders to safeguard each party’s Confidential Information. Except as required by law, no party shall make (or instruct the arbitrator(s) to make) any public announcement with respect to the proceedings or decision of the arbitrator(s) without prior written consent of the other party.

(c) Binding Effect. The provisions of this Section 12.3 shall survive any expiration or termination of this Agreement, and shall be severable and binding on the parties hereto, notwithstanding that any other provision of this Agreement may be held or declared to be invalid, illegal or unenforceable.

26.4 Force Majeure. Neither party shall be liable for failure to perform, or delay in the performance of, its obligations under this Agreement (other than payment obligations) when such failure or delay is caused by an event of force majeure. For purposes of this Agreement, an event of force majeure means any event or circumstance beyond the reasonable control of the affected party, including but not limited to, war, insurrection, riot, fire, flood or other unusual weather condition, explosion, act of God, peril of the sea, strike, lockout or other industrial disturbance, sabotage, embargo, act of governmental authority, compliance with governmental order or national defense requirements, or inability to obtain fuel, power, raw materials, labor or transportation facilities. A failure of supply by CyDex’s supplier shall only be deemed an event of force majeure affecting CyDex if caused by a force majeure event affecting such supplier. If, due to any event of force majeure, either party shall be unable to fulfill its obligations under this Agreement (other than payment obligations), the affected party shall immediately notify the other party of such inability and of the period during which such inability is expected to continue and the time for performance [*].

26.6 Notices. Any notice, request, or communication under this Agreement shall be effective only if it is in writing and personally delivered; sent by certified mail, postage pre-paid; facsimile with receipt confirmed; or by nationally recognized overnight courier with signature required, addressed to the parties at the addresses stated below or such other persons and/or addresses as shall be furnished in writing by any party in accordance with this Section 12.6. Unless otherwise provided, all notices shall be sent:

12.8 Use of Name; Publicity. No party shall use the name, trademark, trade name or logo of the other party, its Affiliates or their respective employee(s) in any publicity, promotion, news release or public disclosure relating to this Agreement or its subject matter, without the prior express written permission of the other party, except as may be required by law or the rules of NASDAQ or the New York Stock Exchange. In the event of a required public announcement, the party making such announcement shall provide the other party with a copy of the proposed text before such announcement sufficiently in advance of the scheduled release of such announcement to afford such other party a reasonable opportunity to review and comment upon the proposed text and the timing of such disclosure.

12.9 Governing Law. This Agreement shall be governed by and construed in accordance with the internal laws of the State of New York (without giving effect to any conflicts of law principles that require the application of the law of a different state). The United Nations Convention on the International Sale of Goods is hereby expressly excluded.

12.10 Entire Agreement; Amendment. This Agreement, together with the Quality Agreement, constitutes the entire agreement of the parties relating to the subject matter hereof and thereof and supersedes any and all prior or contemporaneous agreements, written or oral, between CyDex (and/or any of its Affiliates) and Hospira (and/or any of its Affiliates) relating to the subject matter hereof and thereof; provided, that any confidentiality/nonuse provisions of any prior agreement are not superseded and will remain in effect solely with respect to information provided under the terms of such prior agreement that is not subsequently provided to a Party under the terms of this Agreement. If the Quality Agreement contains terms or conditions inconsistent with the terms of this Agreement, the terms of the Quality Agreement will control and prevail solely with respect to quality issues, and the terms of this Agreement shall control and prevail for all other matters. This Agreement cannot be amended except by way of an express writing signed by both parties.

12.11 Binding Effect. This Agreement shall be binding upon, and the rights and obligations hereof shall apply to, CyDex and Hospira and any successor(s) and permitted assigns. The name of a party appearing herein shall be deemed to include the names of such party’s successors and permitted assigns to the extent necessary to carry out the intent of this Agreement.

12.12 Waiver. The rights of either party under this Agreement may be exercised from time to time, singularly or in combination, and the exercise of one or more such rights shall not be deemed to be a waiver of any one or more of the others. No waiver of any breach of a term, provision or condition of this Agreement shall be deemed to have been made by either party unless such waiver is addressed in writing and signed by an authorized representative of that party. The failure of either party to insist upon the strict performance of any of the terms, provisions or conditions of this Agreement, or to exercise any option contained in this Agreement, shall not be construed as a waiver or relinquishment for the future of any such term, provision, condition or option or the waiver or relinquishment of any other term, provision, condition or option.

12.13 Severability. If any provision of this Agreement is determined by a final and binding court or arbitration judgment to be invalid, illegal or unenforceable to any extent, such provision shall not be not affected or impaired up to the limits of such invalidity, illegality or unenforceability; the validity, legality and enforceability of the remaining provisions of this Agreement shall not be affected or impaired in any way; and the parties agree to negotiate in good faith to replace such invalid, illegal and unenforceable provision (or portion of provision) with a valid, legal and enforceable provision that achieves, to the greatest lawful extent under this Agreement, the economic, business and other purposes of such invalid, illegal or unenforceable provision (or portion of provision).

12.14 Assignment. Neither party may assign its rights or obligations under this Agreement without the prior written consent of the other party; provided, however, that either party may assign this Agreement, in whole or in part, without such consent, to an Affiliate of such party or to any Third Party successor by merger or acquisition or by divestiture or spin-off of substantially all of the business to which this Agreement relates, upon written notice to the other party of any such assignment and, in the case of an assignment to an Affiliate, such party hereby guarantees the performance of any such Affiliate, and, in the case of a Third Party assignment, such Third Party shall assume the obligations of the assigning party under this Agreement. No assignment shall relieve any party of responsibility for the performance of any obligation, which such party may have or incur hereunder.

12.15 Third Party Beneficiaries. The terms and provisions of this Agreement are intended solely for the benefit of each party hereto and their respective Affiliates, related Indemnified Parties (as set forth in Section 9), successors or permitted assigns and it is not the intention of the parties to confer third-party beneficiary rights upon any other person, including without limitation Sublicensees.

12.17 Headings. The descriptive headings of this Agreement are for convenience only, and shall be of no force or effect in construing or interpreting any of the provisions of this Agreement.

12.18 Interpretation. The language used in this Agreement is the language chosen by the parties to express their mutual intent, and no provision of this Agreement will be interpreted for or against any party because that party or its attorney drafted the provision.

12.19 Counterparts. This Agreement may be executed in counterparts, each of which shall constitute an original document, but both of which shall constitute one and the same instrument.

KASAN_국제계약서에 통상 들어가는 일반조항 GENERAL PROVISIONS 사례 – 제약회사 신제품 라이선스 및 생산공급 계약서 중 일반조항 샘플.pdf