Kasan Insight :: 과학, 기술 그리고 법

- 제약/화학/바이오 분야의 실용적 법률정보와 해결방안

KASAN_독점라이선스 국제계약서에서 계약종료 시 라이센시의 보상청구 관련 주요내용, 분쟁사례, 판결 및 중재판정 요지 및 실무적 포인트 몇 가지.pdf

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4.1. Compliance with Legal Requirements.

Licensee shall conduct, and shall ensure that its Affiliates, Sublicensees and Subcontractors, conduct, all activities hereunder, including all Development and Commercialization of the Product, in compliance with all Applicable Laws.

In addition, Licensee hereby certifies that (i) to its reasonably knowledge or belief, neither Licensee nor its Affiliates has been, prior to the Effective Date debarred under United States law, including Section 21 U.S.C. 335a (or any foreign equivalent thereof), and (ii) neither Licensee nor its Affiliates will, from and after the Effective Date, employ or otherwise use in any capacity, the services of any Person, who to the knowledge or belief of Licensee or any of its Affiliates is, debarred under United States law, including Section 21 U.S.C. 335a (or any foreign equivalent thereof) to perform any portion of the activities hereunder, including any Development and Commercialization of the Product.

Licensee shall notify Sub-Licensor in writing promptly upon becoming aware of any such debarment of any such Person, and shall, upon becoming so aware, promptly remove such Person from performing any such activities and from any function or capacity related to any such activities.

4.2. Compliance with Ethical Business Practices.

(a) Compliance with Laws and Policies.

Licensee shall conduct the activities contemplated herein, and shall ensure that its Affiliates, Sublicensees and Subcontractors, conduct the activities contemplated herein, in a manner which is consistent with all Applicable Laws in Korea including, as applicable, Good Clinical Practices, Good Laboratory Practices, the U.S. Foreign Corrupt Practices Act which generally prohibits the promise, payment or giving of anything of value either directly or indirectly to any Official for the purpose of obtaining or retaining business or any improper advantage, and the UK Bribery Act of 2010 which additionally includes the prohibition on the making of any bribe to a foreign public official with the intention of influencing such person in order to obtain or retain business or an advantage in the conduct of business, and good business ethics.

(b) Governments and International Public Organizations.

Licensee warrants that, in connection with this Agreement and Licensee’s business relating thereto, Licensee, its directors, employees, officers, and anyone acting on Licensee’s behalf or with Licensee’s knowledge, shall not offer, make or promise any payment, and shall ensure that its Affiliates, Sublicensees and Subcontractors, do not offer, make or promise any payment (either directly or indirectly, of money or other assets) to any government officials (including any government-owned or controlled commercial enterprise), or political party officials, officials of international public organizations, candidates for public office, or representatives of other businesses or persons acting on behalf of any of the foregoing (hereinafter collectively referred as “Officials”) where such payment (either directly or indirectly of money or other assets) would constitute a violation of any Applicable Law.

In addition, Licensee shall make no payment (either directly or indirectly of money or other assets), and shall ensure that its Affiliates, Sublicensees and Subcontractors, make no payment in connection with this Agreement or Licensee’s business relating thereto, either directly or indirectly to Officials if such payment (either directly or indirectly of money or other assets) is for the purpose of (i) influencing decisions or actions with respect to the subject matter of this Agreement or any other aspect of either Party’s business; (ii) inducing such Official to do or omit to do any action in violation of the lawful duty of such Official; (iii) securing any improper advantage; or (iv) inducing such Official to use his/her position to affect or influence any decisions or actions of government or any legislative, administrative, public agency or other public body with respect to any activities undertaken relating to this Agreement.

Additionally, Licensee will make reasonable efforts to comply with requests for information, including answering questionnaires and narrowly tailored audit inquiries, to the extent they relate to the subject of this Agreement, to enable Licensor to ensure compliance with any applicable anti-corruption laws.

(c) Disclosure.

Where Licensor requests reasonable information regarding disclosure of any officers, employees, owners, or persons directly or indirectly retained by Licensee who are Officials or relatives of Officials of any governmental authority with oversight over the performance of Licensee’s obligations under this Agreement or any Regulatory Documentation, if such persons are engaged to perform Licensee’s obligations under this Agreement, Licensee shall provide complete and accurate information and documentation to Licensor with respect thereto. Licensee shall update such disclosures upon request of Licensor from time to time as necessary to ensure the information provided remains complete and accurate for the Term of this Agreement.

(d) Books and Records.

Licensee represents, warrants and covenants that all books, records, invoices and other documents relating to payments and expenses under this Agreement are and shall be complete and accurate and reflect in reasonable detail the character and amount of transactions and expenditures. Licensee further represents, warrants and agrees that no “off the books” or similar funds will be maintained or used in connection with this Agreement.

(e) Compliance Training.

Licensee agrees to ensure that all of Licensee’s employees involved in performing the obligations under this Agreement are made specifically aware of the compliance requirements under Sections 4.2(a), (b), (d), (e) and (f).

(f) Exclusions Lists.

Licensee shall not use (and shall cause its Affiliates not to use) any Person (including any employee, officer, director, Sublicensee or Third Party contractor) who is (or has been) on the Exclusions List, or who is (or has been) in Violation, in the performance of any activities hereunder. Licensee certifies to Sub-Licensor that as of the Effective Date, Licensee has screened itself, and its officers and directors (and its Affiliates, Sublicensees and Third Party contractors and their respective officers and directors) against the Exclusions Lists and that it has informed Licensor whether Licensee, or any of its officers or directors (or any of its Affiliates, Sublicensees or Third Party contractors or any of their respective officers and directors) has been in Violation. After the Effective Date, Licensee shall notify Licensor in writing immediately if any such Violation occurs or comes to its attention.

(g) Obligation to Notify.

Licensee shall promptly notify Licensor upon becoming aware of any violation of any anti-corruption laws by Licensee or its Affiliate or those acting on Licensee’s behalf in connection with the matters that are the subject of this Agreement and the performance by Licensee of its obligations hereunder.

(h) Compliance Audits.

Licensee shall maintain books and records that are complete and accurate in all material respects relating to its compliance by Licensee and its Affiliates that is engaged in carrying out activities in connection with this Agreement with anti-corruption laws and with respect to its obligations under this Agreement (collectively, the “Compliance Records”) for a period of two (2) years after the period to which such records relate or such longer period as required by Applicable Laws, which Compliance Records shall include: (a) its policies and procedures including those of Licensee and its Affiliates concerning compliance with anti-corruption laws with respect to its obligations under this Agreement, (b) records of any investigations and remedial and disciplinary actions undertaken to address material violations of anti-corruption laws with respect to its obligations under this Agreement and (c) records of any payments made by it or Licensee and its Affiliates in connection with this Agreement. Upon reasonable advance written notice to Licensee, Licensor shall be entitled, at its cost and expense, to have access to and audit the Compliance Records of Licensee and any of its Affiliates (to the extent such Compliance Records are not subject to attorney-client privilege) for a period of two (2) years after the period to which such records relate or such longer period as required by applicable anti-corruption laws. Licensor may not exercise this audit right more frequently than once during any twelve (12)-month period; provided, however, that if any audit by Licensor under this Section 4.2(h) reveals that Licensee or any of its Affiliates is or was not in material compliance with applicable anti-corruption laws in relation to the performance of its obligations under this Agreement, Licensor shall have the right to conduct such additional audits (for clarity, such additional audits shall apply only to the applicable Licensee and its Affiliates which was so determined during the initial audit in such twelve (12)-month period to not be in material compliance) during such twelve (12)-month period as may be reasonably required to determine whether Sub-Licensee and its Affiliates have appropriately remedied such non-compliance.

4.3. Termination for Non-Compliance.

Any uncured violation by Licensee or any of its Affiliates of any applicable anti-corruption laws in connection with its obligations under this Agreement shall be a material breach of this Agreement entitling Sub-Licensor to terminate this Agreement pursuant to Section 11.2(c).

4.4. Responsibility for Compliance.

Licensee acknowledges and agrees that neither Licensor, nor or any of its Affiliates or Licensor’s or its Affiliates’ officers, directors, employees, agents and representatives is authorized to waive compliance with the provisions of Section 4.3 and/or to give any direction, either written or oral, relating to the making of any commitment by Licensee or its agents to any Third Party in violation of the terms of this ARTICLE 4, and that Sub-Licensee shall be solely responsible for its compliance with all applicable anti-corruption laws irrespective of any act or omission of Merck or any of Merck’s Affiliates or Merck’s or its Affiliates’ officers, directors, employees, agents and representatives.

KASAN_기술이전, 라이선스, 특허실시, 공동연구개발 등 국제계약서, 영문계약서에서 미국법 FCPA, Anti-Corruption, Compliance 관련 계약조항 샘플.pdf

제 1 조 (공정의무)

 1) 양 당사자(그 임직원을 포함)는 본 계약의 체결, 이행 및 유지에 있어 거래의 공정성에 대한 확보가 중요한 전제 조건임을 인식하고, 타방 당사자(그와 동일시 할 수 있는 친인척 등 관계자 포함) 또는 본 계약과 관련한 제3자(이하 “거래 상대방”이라 한다)에 대하여 거래의 공정성을 해할 수 있는 행위(이하 "비위행위”라 한다)를 하여서는 아니 된다. "비위행위"의 예는 다음 각 호에 열거되어 있는 바와 같으며, 이에 한하지 아니한다.

① 금전을 제공하는 행위

② 사회통념수준을 초과하는 선물 또는 식사를 제공하는 행위

③ 불건전 업소, 오락, 골프, 스키 등의 향응 및 접대를 하는 행위

④ 출장지원, 개인 휴가 지원, 사무실 비품 제공, 협찬/찬조 등의 편의를 제공하는 행위

⑤ 차용/매입/매도, 부채상환, 보증, 금전대차 등 금전 또는 부동산 관련 모든 거래행위

⑥ 공동투자 및 공동재산의 취득 기회를 제공하거나, 합작투자 또는 “거래 상대방”의 회사에 겸직하도록 하는 행위

⑦ “거래 상대방”의 주식이나 기타 관련업체의 주식을 제공 또는 투자하도록 하거나 기타 재산을 공동 투자 또는 취득하도록 하는 행위

⑧ 고용보장, 취업알선의 약속 등 미래에 대한 보장을 하는 행위

⑨ 기타 타방 당사자의 정도경영 준수사항을 위반하거나, “거래 상대방”이 공정하게 업무를 수행하는 데 지장을 초래하는 행위

2) 양 당사자는 거래 공정성 확보를 위해 다음 각 호의 사항을 협조하도록 한다.

① 타방 당사자의 임직원을 상대로 일방 당사자의 임직원 등에 의해 이루어진 “비위행위”가 발견되거나 “비위행위”에 대한 의혹이 있는 경우, 양 당사자는 그와 관련된 자료의 제출 또는 열람을 상대방 당사자에게 요구할 수 있으며, 이 경우 양 당사자는 해당 요구에 적극 협조하여야 한다.

② 일방 당사자는 타방 당사자의 임직원으로부터 본 조 제1항 각 호의 행위를 제의받거나, 이러한 사실을 인지한 때에는 타방 당사자의 관련 부서에 즉각 신고토록 한다.

③ 양 당사자는 본 계약 외에 상대 당사자의 정도경영 실천에 적극 협조한다.

3) 본 조는 본 계약의 종료(만료, 해지 또는 해제 포함) 후에도 유효하다.

4) 본 계약의 일방 당사자가 본 조항의 공정의무를 위반한 경우 그 상대방은 본 계약을 즉시 해지할 수 있다.

KASAN_기술이전, 라이선스, 특허실시, 공동연구개발 등 국문계약서에서 공정의무, 반부패의무, 비위행위금지, Anti-Corruption, Compliance 관련 계약조항 샘플.pdf

KASAN_국제계약, 영문계약에서 Anti-Corruption, Compliance 쟁점, 미국법 FCPA 관련 주요내용, 최근 제재사례 및 실무적 포인트 몇 가지.pdf

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17. TERM AND TERMINATION. 

17.1 Termination Prior to the Closing Date.

This Agreement may be terminated at any time prior to the Closing Date (with respect to Sections 17.1(b) and 17.1(c) below, by written notice by the terminating Party to the other Party): (a) by mutual written agreement of the Parties;

(b) by Licensor or Licensee, if a court of competent jurisdiction or other Governmental Authority shall have issued a non-appealable final order, decree or ruling or taken any other non-appealable final action, in each case, having the effect of permanently restraining, enjoining or otherwise prohibiting the transactions contemplated by this Agreement; provided, however, that the right to terminate this Agreement under this Section 17.1(b) shall not be available to any Party whose failure to fulfill any obligation under this Agreement has been the primary cause of, or materially contributed to, such action; or

(c) by Licensee, if Licensor has breached any representation, warranty, covenant or agreement of Licensor set forth in this Agreement which (i) would result in a failure of a condition set forth in Section 13.2 and (ii) is not cured within thirty (30) calendar days after written notice thereof.   

17.2 Term.

Except as provided in Section 17.1, this Agreement shall continue until the date of expiration of the Royalty Term, unless earlier terminated in accordance with this Article 17 (the “Term”).  

17.3 Termination of the Agreement After the Closing Date.  

(a) Termination by Licensee. 

Licensee may terminate this Agreement in its entirety or in part (including, for example, on a country-by-country basis) for any reason (a) upon at least ninety (90) days prior written notice to Licensor if such notice is delivered prior to the First Commercial Sale of a Licensed Product anywhere in the Territory or (b) upon at least one hundred eighty (180) days prior written notice to Licensor if such notice is delivered after the First Commercial Sale of a Licensed Product anywhere in the Territory.  In the event of any significant adverse clinical events or the termination of a Clinical Trial for safety reasons and Licensee terminates this Agreement under this Section 17.3(a), the foregoing notice periods in clauses (a) and (b) shall be reduced to forty-five (45) days and ninety (90) days, respectively.

(b) Termination for Material Breach. 

If either Party believes the other is in material breach of its obligations under this Agreement, it may give notice of such breach to the other Party, which Party shall have sixty (60) days in which to remedy such breach, or thirty (30) days in the case of material breach of any payment obligation hereunder.

Such sixty (60) day period shall be extended in the case of a breach not capable of being remedied in such sixty (60) day period so long as the breaching Party uses diligent efforts to remedy such breach and is pursuing a course of action that, if successful, will effect such a remedy; provided, however, that such cure period shall not be extended more than sixty (60) additional days. 

If such alleged breach is not remedied or is not capable of being remedied within the period set forth above, the non-breaching Party shall be entitled, without prejudice to any of its other rights conferred on it by this Agreement, and in addition to any other remedies available to it by law or in equity, to terminate this Agreement upon written notice to the other Party.  In the event of a dispute regarding any payments due and owing hereunder, all undisputed amounts shall be paid when due and the balance, if any, shall be paid promptly after settlement of the dispute including any accrued interest thereon.  

(c) Consequences of Termination. 

In the event that either Party terminates this Agreement, then as of the effective date of such termination, the following terms and conditions shall apply:

(i) Termination by Licensor for Licensee’s Material Breach. 

In the event of termination of this Agreement by Licensor pursuant to Section 17.3(b) for Licensee’s uncured material breach, and except for each Party’s rights and obligations that survive termination as set forth in Section 17.5:

(A) all licenses and rights granted by either Party under this Agreement shall terminate with the exception, subject to Section 19.1, of the license granted to Licensor by Licensee under the Licensee Inventions relating to formulations or methods of manufacturing formulations derived from the Licensed Intellectual Property pursuant to Section 9.2(c) which shall become perpetual, worldwide and fully paid; 

(B) Licensee shall pay Licensor any and all payments that have accrued prior to the effective date of such termination; 

(C) Licensee shall transfer to Licensor all materials, results, analyses, reports, websites, marketing materials, technology, know-how and other Information in whatever form received by Licensee from Licensor as of the effective date of such termination; 

(D) Licensee shall transfer to Licensor (A) all Regulatory Approvals in the Territory in effect as of the date of such termination and/or (B) any and all Information pertaining to the Development and Commercialization of the Licensed Products in the Territory, including but not limited to any and all Clinical Trial data pertaining to the Territory. 

(ii) Termination by Licensee. 

Subject to Section 17.3(c)(ii)(E), in the event of termination of this Agreement by Licensee pursuant to Section 17.3(a), and except for each Party’s rights and obligations that survive termination as set forth in Section 17.5:  

(A) all licenses and rights granted by either Party under this Agreement shall terminate, with the exception, subject to Section 19.1, of the license granted to Licensor by Licensee under the Licensee Inventions relating to formulations or methods of manufacturing formulations derived from the Licensed Intellectual Property pursuant to Section 9.2(c), which shall become worldwide, subject to Licensor’s obligations under subsection (E) below;  

(B) Licensee shall pay Licensor any and all payments that have accrued prior to the effective date of such termination; 

(C) Licensee shall transfer to Licensor all materials, results, analyses, reports, websites, marketing materials, technology, know-how and other Information in whatever form received by Licensee from Licensor as of the effective date of such termination;  

(D) Licensee shall, upon receipt of reasonable consideration from Licensor based on an actual cost basis, transfer to Licensor (A) all Regulatory Approvals in the Territory in effect as of the date of such termination and/or (B) any and all Information pertaining to the Development and Commercialization of the Licensed Products in the Territory, including but not limited to any and all Clinical Trial data pertaining to the Territory; and 

(E) in partial consideration for (A) Licensee’s costs of obtaining and maintaining such Regulatory Approvals and Commercializing Licensed Products in the Territory prior to the date of such termination, and/or (B) subject to Section 19.1, the license granted under the Licensee Inventions, Licensor shall pay to Licensee following the effective date of such termination, on a product-by-product and country-by-country basis, a commercially reasonable royalty to be negotiated in good faith by the Parties, on all sales by Licensor, its Affiliates and Sublicensees, of products that would have been Licensed Products, had they been sold by Licensee prior to the effective date of such termination. 

(iii) Termination by Licensee for Licensor’s Material Breach.  

In the event that Licensee has the right to terminate this Agreement for Licensor’s uncured material breach pursuant to Section 17.3(b), Licensee may terminate this Agreement or, in lieu of such termination, by written notice to Licensor after a determination that such breach was a material breach and was not cured before the expiration of the cure period set forth in Section 17.3(b), elect to retain all of the rights and licenses granted to Licensee hereunder for the remainder of the Term. Following such an election by Licensee:

(A) Licensee may request that damages be awarded to Licensee for Licensor’s uncured material breach by final and binding arbitration conducted in accordance with Section 19.12. In determining whether damages should be awarded to Licensee, the arbitrators shall consider the nature of Licensor’s uncured material breach and the impact of such uncured material breach on Licensee and the transactions contemplated by this Agreement. 

In the event that such final and binding arbitration determines that Licensee should be awarded damages, Licensee shall be entitled to deduct the amount of such damages from milestone and royalty payments to be paid to Licensor under Sections 8.2 and 8.3;

(B) the limitations applicable to Licensor’s activities as set forth in Sections 2.3(a) and 2.4 shall continue to apply; and

(C) the license granted by Licensee to Licensor under Section 9.2(c) shall terminate.    

17.4 Surviving Obligations. 

Upon termination of this Agreement, the Parties shall remain obligated to make all payments which have accrued under this Agreement prior to the date of termination, when and as they become due and payable.  In addition, the provisions in Articles 1, 9, 10, 14, 15, 16, 18 and 19, and Sections 2.6, 5.2, 5.7, 7.6, 8.3(h), 8.7 (with respect to payment accruing prior to the effective date of termination), 8.8, 8.9, 17.3(c), 17.4 and 17.5 of this Agreement shall survive termination of this Agreement for any reason.  

17.5 Accrued Rights. 

Termination or expiration of this Agreement shall not relieve either Party from obligations that are expressly indicated to survive termination or expiration of the Agreement.  Termination by a Party shall not be an exclusive remedy and all other remedies will be available to the terminating Party, in equity and at law.

KASAN_국제계약, 영문계약, 특허실시, 영업비밀, 기술이전 라이선스 계약서에서 계약종료, 계약해지, TERMINATION 영문조항 샘플.pdf

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ARTICLE 2 - TECHNICAL ASSISTANCE

2.1   TECHNICAL DOCUMENTATION

           (a) Licensor shall furnish to Licensee, in accordance with the time schedule to be agreed upon between the Parties, one (1) set of hard copies of the Technical Documentation. If Licensee discovers that any of the documents are missing or illegible or damaged, Licensee shall inform Licensor in writing and Licensor shall make such documents available for Licensee within twenty (20) days of receiving such notice.

           (b) The foregoing Technical Documentation to be furnished under paragraph 2.1 (a) above shall be delivered to Licensee and shall be the latest version as of the time it is delivered or sent.

           (c) Licensee shall pay Licensor for any additional copies of the Technical Documentation requested by Licensee at the rates agreed upon in writing by both Parties prior to sending.

           (d) Nothing in this Agreement shall be construed to require that Licensor furnish Licensee with any technical information on any products other than Licensed Product or any technical information which may not be furnished because of a government contract, act, regulation or restriction or the proprietary interest of a third party.

           (e) Errors in Technical Documentation. Each Party shall promptly advise the other of any significant error it may discover in the Technical Documentation. In that event, Licensor shall correct any error in the Technical Documentation and shall furnish such corrected Technical Documentation to Licensee without charge.

(f) Strict Compliance with Technical Documentation. In order to maintain the quality of the Licensed Products manufactured and assembled by Licensee pursuant to this Agreement, Licensee shall manufacture and/or assemble the Licensed Products in strict accordance with the standards and specifications stated in the Technical Documentation provided by Licensor and as otherwise specified by Licensor. Licensee shall exercise the utmost care in the selection of the materials and parts to be used and incorporated into the Licensed Products.

2.2      ASSISTANCE BY LICENSOR

Licensor shall provide reasonable assistance in the use of the Technical Documentation to the extent such assistance is reasonably necessary for Licensee to make use of the Technical Documentation to manufacture the Licensed Product. Such assistance may include, but will not be limited to, technical assistance, training, testing and limited application engineering services.

- 라이센서의 조력의무를 선언적으로 규정한 조항임. 제조에 필요한 기술정보 활용을 가능케 하도록 조력의무를 규정하고 있어 상당히 포괄적임.

- 이하에서 구제적인 비용을 규정할 경우 라이센서의 수입원이 되지만, 그렇지 않을 경우 부담조항이 될 수 있음.

2.3   TECHNICAL ASSISTANCE

      (a) At the request of Licensee, Licensor shall, at times agreed upon by the Parties, dispatch its engineers to Licensee to provide technical assistance on matters concerning the use of the Technical Documentation during the Technical Cooperation Period. All costs and expenses of such Licensor's personnel dispatched to Licensee shall be borne, or reimbursed to Licensor, by Licensee and shall include:

            (i)   round trip economic air fare between Korea and China;

            (ii)  suitable accommodations, meals, traveling and transportation expenses in China and other reasonable charges in connection with the performance of their duties hereunder;

            (iii) wage and daily allowance, payable to Licensor, on its demand, amounting to U$500 per Man Day for Licensor's personnel;

      (b) Licensee shall take appropriate steps necessary to protect and ensure the safety of Licensor's personnel and their property, including without limitation, against war, war-like operation, terror, revolution, civil commotion, catastrophe and acts of public enemies. Licensor reserves the right to  instruct any or all of its dispatched personnel to return to Korea, or such other place as it may designate, at Licensee's expense  when, in Licensor's sole judgment , one of the above-mentioned situations arises which may endanger the safety and well-being of such personnel.

- 기술자 파견에 따른 안전보장은 실시자 부담임

      (c) Licensee is responsible for obtaining any permits or authorizations required for Licensor's personnel to enter China to provide services hereunder, and to bring any related materials required by Licensor.

- 기술자 파견에 따른 출입국 보장은 실시자 부담

    (d) The number of such personnel, the period of their stay at Licensee's plant and other terms and conditions not set forth herein shall be agreed upon between the Parties on a case by case basis.

2.4   TRAINING

At the request of Licensee, Licensor will, during the Technical Cooperation Period, provide training on the use of the Technical Documentation for Licensee's employees (the "Trainees") at Licensor's place or other places designated by Licensor, subject to the following terms and conditions:

      (i) Licensor and Licensee shall agree on the most efficient training program for the Trainees;

      (ii) Licensee shall bear all the cost and expenses relating to the Trainees, including but not limited to their salaries, round trip airfare between China and Korea, lodgings and meals of Trainees in Korea, transportation and insurance;

      (iii) Licensor shall provide working lunches for the trainees during working days and transportation for the trainees between dormitory and training site.

      (iv) Licensee shall pay to Licensor as training fee, payable upon demand, US$300 per Trainee per day, as the compensation of training services provided by Licensor;

      (v) Licensee shall instruct the Trainees to observe and abide by all rules and regulations of Licensor and the laws of Korea during their training period;

      (vi) All Trainees shall be insured at the expense of Licensee by an internationally recognized accident compensation insurance during the entire training period between their departure from and return to China;

      (vii) Licensee shall indemnify and hold harmless Licensor against any loss, damage, claim, liabilities, cost or expense arising out of any act of a Trainee or any injury or death of the Trainee or any damage to his/her property.

2.5   SUPPORT OF TESTS

Pursuant to the terms of a purchase order, sale agreement or other document to be separately agreed by the Parties or Licensee and Delphi, Licensor will support the necessary manufacturing Part Production Approval Process validation tests for the Licensed Products.

2.6   SAMPLE TEST AND VERIFICATION

Before distribution and sale of any of the Licensed Product manufactured or assembled hereunder, Licensee shall submit, at its expense, samples of the Licensed Product for approval by Licensor. Licensor shall promptly conduct appropriate tests on such samples and advise Licensee of the results thereof. The costs of any tests on the samples shall be responsibility of Licensee, and Licensor shall advise Licensee of the test fees in advance.

KASAN_국제계약, 영문계약, 특허실시, 영업비밀, 기술이전 라이선스 계약서에서 기술지원 TECHNICAL ASSISTANCE 조항 샘플.pdf

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11. REPRESENTATIONS AND WARRANTIES.

11.1 The Parties ’Representations and Warranties.

Each Party hereby represents, warrants and covenants to the other Party, as of the Effective Date (or as of the Closing Date in the case of Section 11.1(h)), that:

(a) such Party (i) is a corporation duly organized and validly existing under the laws of its jurisdiction of organization, and (ii) has full power and authority and the 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;

(b) such Party has sufficient legal and/or beneficial title under its intellectual property rights necessary for the purposes contemplated under this Agreement and to grant the licenses contained in this Agreement;

(c) such Party is not aware of any pending or threatened litigation, nor has it received any notice of claim, alleging that it has violated or would violate, through the manufacture, import and/or sale of Licensed Products hereunder, or by conducting its obligations as currently proposed under this Agreement, any intellectual property or other rights of any Third Party;

(d) to such Party’s knowledge, all of its employees, officers, independent contractors, consultants and agents have executed agreements requiring assignment to such Party of all inventions made during the course of and as a result of their association with such Party and obligating the individual to maintain as confidential the Confidential Information of such Party;

(e) such Party has the power, authority and legal right, and is free to enter into this Agreement and, in so doing, will not violate any other agreement to which such Party is a party as of the Effective Date and such Party has maintained and will maintain and keep in full force and effect all agreements and regulatory filings necessary to perform its obligations under the Agreement and, during the Term, such Party shall not enter into any agreement with a Third Party that will conflict with the rights granted to the other Party under this Agreement;

(f) this Agreement has been duly executed and delivered on behalf of such Party and constitutes a legal, valid and binding obligation of such 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;

(g) such Party has taken all corporate action necessary to authorize the execution, delivery and performance of this Agreement;

(h) such Party has obtained all consents, approvals and authorizations of all Regulatory Authorities and other Third Parties reasonably deemed necessary by such Party to be obtained in connection with the execution and delivery of this Agreement and the performance of its obligations hereunder;

(i) the execution and delivery of this Agreement and the performance of such Party’s obligations hereunder: (i) do not conflict with or violate any provision of the certificate of incorporation, bylaws, limited partnership agreement or any similar instrument of such Party, as applicable, in any material way; (ii) to such Party’s knowledge, do not conflict with, violate or breach or constitute a default or require any consent under any indenture, mortgage, contract or instrument to which it is party or by which it is bound; and (iii) to such Party’s knowledge, do not conflict with, violate, or breach or constitute a default or require any consent under, any requirement of Applicable Laws or court or administrative order by which such Party is bound;

(j) except in connection with or related to the settlement between Licensee A and the United States Department of Justice, announced on September 1, 2010, neither such Party, nor any of such Party’s employees, officers, independent contractors, consultants or agents who will render services relating to Licensed Products: (i) has ever been debarred or is subject to 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. If during the Term a Party has reason to believe that it or any of its employees, officers, independent contractors, consultants or agents rendering services relating to Licensed Products: (x) is or will be debarred or convicted of a crime under 21 U.S.C. Section 335a; or (y) is or will be under indictment under said Section 335a, then such Party shall immediately notify the other Party of same in writing; and

(k) such Party currently has no research or development project, or agreement with any Third Party, that, in such Party’s reasonable scientific or business judgement, (i) requires or is likely to require changes to the Development Plan attached hereto as Exhibit 4.1, or (ii) is likely to interfere with such Party’s ability to enter into and perform its obligations under this Agreement.

11.2 Representations and Warranties of Licensor M.

Licensor M hereby represents, and warrants and covenants to Licensee A, as of the Effective Date, that:

(a) Licensor M is the sole and exclusive owner of all right, title and interest, in, to and under the Licensed Intellectual Property in the Territory;

(b) M is the sole and exclusive owner of all right, title and interest, in, to under the Licensed Intellectual Property necessary or useful in the Manufacture of Licensed Products;

(c) M has sufficient rights to grant the rights and licenses granted herein, free and clear of any security interests, claims, encumbrances or charges of any kind that would conflict in any material respect with the rights and licenses granted hereunder;

(d) M has not assigned or granted to any Third Party any rights under the Licensed Intellectual Property that cover Licensed Products in the Territory except as granted to independent contractors in the ordinary course of business in connection with M's research, Development and Manufacturing of Licensed Products, and consistent with the terms and intent of this Agreement;

(e) (i) M has not received any written notice from any Third Party asserting or alleging that any Development, Manufacturing, or Commercialization of the Licensed Products has infringed or misappropriated any Patent or intellectual property right of such Third Party, (ii) to the knowledge of M, the manufacture, use, offer for sale, sale or importation of Licensed Products in the Territory has not infringed and, as of the Effective Date, will not infringe, any Patent of any Third Party or misappropriate any technology of any Third Party, and (iii) there are no pending, and, to the knowledge of M, no threatened, adverse actions, suits, arbitrations, litigations, or proceedings of any nature, civil, criminal, regulatory or otherwise, in law or in equity, against M or any of its Affiliates alleging that the Development, Manufacture, Commercialization or other exploitation of Licensed Products has infringed any Patent, or misappropriated any intellectual property right of any Third Party;

(f) to Licensor M’s knowledge, the issued Patents within the M Patent Rights in the Territory are valid and enforceable;

(g) all applicable maintenance and renewal fees with respect to the M Patent Rights in the Territory have been paid and all documents, and certificates required to be filed for the purpose of maintaining such M Patent Rights have been filed;

(h) to Licensor M’s knowledge, no Third Party has asserted that any Licensed Intellectual Property is invalid or not enforceable;

(i) (i) other than as disclosed by M in writing to A prior to the Effective Date, none of the M Patent Rights, were developed with federal or state funding from any Governmental Authority, (ii) no Governmental Authority has any march in rights or other rights to use the Licensed Intellectual Property in the Territory, and (iii) neither the execution and delivery of this Agreement nor the performance hereof by M will result in the breach of, or give rise to, any right of termination, rescission, renegotiation or acceleration under, or trigger any other rights under, any agreement or contract to which M is a party, or to which it may be subject, that relates to the Licensed Products;

(j) no written communication has been received by M from any Third Party that alleges, and there is no pending litigation that alleges, that (i) any issued M Patent is invalid or unenforceable as of the Effective Date, or (ii) any patent application included in the M Patents, if issued, would be, invalid or unenforceable;

(k) to the knowledge of Licensor M, no Third Party (i) is infringing any M Patent Rights or has misappropriated any M Know-How, or (ii) has challenged the ownership, scope, duration, validity, enforceability, priority or right to use any M Patent Rights (including, by way of example, through the institution of or written threat of institution of interference, re-examination, review, supplemental examination, derivation proceeding, protest, opposition, nullity or similar invalidity proceeding before the U.S. Patent and Trademark Office or any analogous foreign entity) or any M Know-How;

(l) the Licensed Intellectual Property licensed to Licensee A hereunder constitutes all of the intellectual property rights Controlled by M that are necessary for A to Commercialize Licensed Products in the Territory;

(m) to Licensor M’s knowledge, M has complied in all material respects with all Applicable Laws in the prosecution and maintenance of the M Patent Rights in the Territory;

(n) all of Licensor M’s and its Affiliates’ employees, officers, and consultants/contractors involved in the research, Manufacture or Development of Licensed Products are and have been obligated to assign to M or such Affiliate, as the case may be, all Inventions claimed in the M Patent Rights and to maintain as confidential the Confidential Information of M or such Affiliate, as applicable; and

(o) all inventors of any Inventions included within the M Patent Rights and M Know-How have assigned their entire right, title, and interest in and to such Inventions and the corresponding Patents and Information to M and have been listed in the M Patent Rights as inventors.

KASAN_특허기술, 영업비밀 실시허락, 기술이전, 라이선스 영문계약서에서 진술 및 보증조항 REPRESENTATIONS AND WARRANTIES 샘플.pdf

KASAN_특허실시, 기술이전, 공동연구개발, 라이선스 등 국제계약에서 분쟁해결수단 중재조항 관련된 분쟁사례 및 실무적 포인트 몇 가지.pdf

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조정 정의

조정(Mediation)은 분쟁 당사자가 조정인의 도움을 받아 당사자 사이의 대화와 상호양해를 통하여 조리(條理)를 바탕으로 분쟁을 실정에 맞게 자율적으로 해결하는 제도입니다. 중립적인 제3자인 조정인이 분쟁 당사자간의 합의를 통해 분쟁을 해결하도록 도와주는 ADR 제도 중의 하나가 조정(調停)입니다.

분쟁을 조정에 의하여 해결하기로 하는 합의를 조정합의(調停合意)라고 합니다. 대한상사중재원의 조정을 이용하기 위해서는 분쟁 당사자간에 체결한 계약서나 합의서 등에 '대한상사중재원의 조정규칙에 의한 조정 또는 대한상사중재원의 조정에 따라 해결하기로 합의한 경우' 즉 조정합의가 있는 경우에 해당하여야 합니다.

조정합의는 사전 합의(조정 조항)나 사후 조정합의 형식으로 할 수 있습니다.

당사자간에 조정합의가 없는 경우나 사후 조정합의가 곤란한 경우 일방 당사자(신청인)는 중재원에 조정참여 권유요청을 할 수 있습니다. 이 경우 중재원은 타방 당사자(피신청인)에게 조정참여 권유요청을 하고, 피신청인이 동의하면 조정절차를 진행하게 됩니다.

조정인의 역할

조정인은 당사자들이 분쟁을 우호적으로 해결하도록 협조하여야 합니다. 조정인은 당사자간의 거래관행 및 분쟁과 관련된 제반 상황 등을 고려하여 공정하고 객관적이며, 형평과 선의 원칙에 따라 분쟁을 조정하여야 합니다. 조정인은 언제든지 구두 또는 서면으로 당사자들에게 조정안을 제시할 수 있습니다.

조정인의 의무

조정인은 조정에 관하여 공정성과 독립성을 유지하여야 합니다. 조정인은 그 자신의 공정성 또는 독립성에 관하여 정당한 의문을 야기시킬 수 있는 사유가 있을 때에는 지체없이 이를 사무국에 고지하여야 합니다. 사무국은 조정인으로부터 그러한 고지를 받으면 즉시 당사자들에게 통지합니다.

조정절차 개요

KASAN_대한상사중재원의 조정 (Mediation) 개요 설명 – 중재(Arbitration)와 엄격하게 구별.pdf

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제3조(정의) 이 법에서 사용하는 용어의 뜻은 다음과 같다.

1. "중재"란 당사자 간의 합의로 재산권상의 분쟁 및 당사자가 화해에 의하여 해결할 수 있는 비재산권상의 분쟁을 법원의 재판에 의하지 아니하고 중재인의 판정에 의하여 해결하는 절차를 말한다.

2. "중재합의"란 계약상의 분쟁인지 여부에 관계없이 일정한 법률관계에 관하여 당사자 간에 이미 발생하였거나 앞으로 발생할 수 있는 분쟁의 전부 또는 일부를 중재에 의하여 해결하도록 하는 당사자 간의 합의를 말한다.

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

③ 다음 각 호의 어느 하나에 해당하는 경우는 서면에 의한 중재합의로 본다.

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

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

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

④ 계약이 중재조항을 포함한 문서를 인용하고 있는 경우에는 중재합의가 있는 것으로 본다. 다만, 중재조항을 그 계약의 일부로 하고 있는 경우로 한정한다.

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

제35조(중재판정의 효력) 중재판정은 양쪽 당사자 간에 법원의 확정판결과 동일한 효력을 가진다. 다만, 제38조에 따라 승인 또는 집행이 거절되는 경우에는 그러하지 아니하다.

제36조(중재판정 취소의 소) ① 중재판정에 대한 불복은 법원에 중재판정 취소의 소를 제기하는 방법으로만 할 수 있다.

② 법원은 다음 각 호의 어느 하나에 해당하는 경우에만 중재판정을 취소할 수 있다.

1. 중재판정의 취소를 구하는 당사자가 다음 각 목의 어느 하나에 해당하는 사실을 증명하는 경우

가. 중재합의의 당사자가 해당 준거법에 따라 중재합의 당시 무능력자였던 사실 또는 중재합의가 당사자들이 지정한 법에 따라 무효이거나 그러한 지정이 없는 경우에는 대한민국의 법에 따라 무효인 사실

나. 중재판정의 취소를 구하는 당사자가 중재인의 선정 또는 중재절차에 관하여 적절한 통지를 받지 못하였거나 그 밖의 사유로 변론을 할 수 없었던 사실

다. 중재판정이 중재합의의 대상이 아닌 분쟁을 다룬 사실 또는 중재판정이 중재합의의 범위를 벗어난 사항을 다룬 사실. 다만, 중재판정이 중재합의의 대상에 관한 부분과 대상이 아닌 부분으로 분리될 수 있는 경우에는 대상이 아닌 중재판정 부분만을 취소할 수 있다.

라. 중재판정부의 구성 또는 중재절차가 이 법의 강행규정에 반하지 아니하는 당사자 간의 합의에 따르지 아니하였거나 그러한 합의가 없는 경우에는 이 법에 따르지 아니하였다는 사실

2. 법원이 직권으로 다음 각 목의 어느 하나에 해당하는 사유가 있다고 인정하는 경우

가. 중재판정의 대상이 된 분쟁이 대한민국의 법에 따라 중재로 해결될 수 없는 경우

나. 중재판정의 승인 또는 집행이 대한민국의 선량한 풍속이나 그 밖의 사회질서에 위배되는 경우

③ 중재판정 취소의 소는 중재판정의 취소를 구하는 당사자가 중재판정의 정본을 받은 날부터 또는 제34조에 따른 정정ㆍ해석 또는 추가 판정의 정본을 받은 날부터 3개월 이내에 제기하여야 한다. ④ 해당 중재판정에 관하여 대한민국의 법원에서 내려진 승인 또는 집행 결정이 확정된 후에는 중재판정 취소의 소를 제기할 수 없다.

제37조(중재판정의 승인과 집행) ① 중재판정은 제38조 또는 제39조에 따른 승인 거부사유가 없으면 승인된다. 다만, 당사자의 신청이 있는 경우에는 법원은 중재판정을 승인하는 결정을 할 수 있다. ② 중재판정에 기초한 집행은 당사자의 신청에 따라 법원에서 집행결정으로 이를 허가하여야 할 수 있다. ③ 중재판정의 승인 또는 집행을 신청하는 당사자는 중재판정의 정본이나 사본을 제출하여야 한다. 다만, 중재판정이 외국어로 작성되어 있는 경우에는 한국어 번역문을 첨부하여야 한다. ④ 제1항 단서 또는 제2항의 신청이 있는 때에는 법원은 변론기일 또는 당사자 쌍방이 참여할 수 있는 심문기일을 정하고 당사자에게 이를 통지하여야 한다. ⑤ 제1항 단서 또는 제2항에 따른 결정은 이유를 적어야 한다. 다만, 변론을 거치지 아니한 경우에는 이유의 요지만을 적을 수 있다. ⑥ 제1항 단서 또는 제2항에 따른 결정에 대해서는 즉시항고를 할 수 있다. ⑦ 제6항의 즉시항고는 집행정지의 효력을 가지지 아니한다. 다만, 항고법원(재판기록이 원심법원에 남아 있을 때에는 원심법원을 말한다)은 즉시항고에 대한 결정이 있을 때까지 담보를 제공하게 하거나 담보를 제공하게 하지 아니하고 원심재판의 집행을 정지하거나 집행절차의 전부 또는 일부를 정지하도록 명할 수 있으며, 담보를 제공하게 하고 그 집행을 계속하도록 명할 수 있다. ⑧ 제7항 단서에 따른 결정에 대해서는 불복할 수 없다.

KASAN_중재법 주요조항 정리.pdf

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당연 위법 사항 - per se illegal

► price fixing, ► output restraint, ► market division, ► group boycott, ► resale price maintenance

경쟁제한성과 합리성 판단 사항 - Rule of Reason 적용대상

Safeguards against the anticompetitive concerns 

► horizontal restraints

► tying arrangements (package licensing)

► exclusive dealing (territory, field of use, components, alternatives, etc.)

► cross-licensing and pooling arrangements

           . fair, reasonable and non-discriminatory terms and conditions

           . limiting to technically essential patents, not including alternatives

            . free to be licensed individually or in a package

            . worldwide non-exclusive

            . royalties on actual use of the patents

  . free to develop and use alternatives

           . grant back under non-exclusive, non-discriminatory licenses

  . no joint defense

► grant-back

► acquisition (exclusive licensing) of IPR

판단요소

1. Whether the restraint is likely to have anticompetitive effects?

2. Whether, under the relevant market context, the restraint is reasonably necessary to achieve pro-competitive efficiencies that outweigh anticompetitive effects?

Qualcomm 퀄컴 특허라이선스 계약의 불공정사항 수정 명령 - 미국법원 FTC v. Qualcomm 사건 2019. 5. 21. 선고 1심 판결 내용

(1) Qualcomm must not condition the supply of modem chips on a customer’s patent license status and Qualcomm must negotiate or renegotiate license terms with customers in good faith under conditions free from the threat of lack of access to or discriminatory provision of modem chip supply or associated technical support or access to software.

(2) Qualcomm must make exhaustive SEP licenses available to modem-chip suppliers on fair, reasonable, and non-discriminatory ("FRAND") terms and to submit, as necessary, to arbitral or judicial dispute resolution to determine such terms.

(3) Qualcomm may not enter express or de facto exclusive dealing agreements for the supply of modem chips.

(4) Qualcomm may not interfere with the ability of any customer to communicate with a government agency about a potential law enforcement or regulatory matter.

KASAN_기술이전, 특허라이선스 계약에서 공정거래법, Anti-trust & Fair Competition Law 관련 실무적 개요.pdf

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실무적 포인트

·         진술 및 보증 조항 Rep. & Warranty

Ø  소유권/license허여권 보증 (○)

Ø  계약대상 IP의 권리 유효성 보증 (적법 등록유지 ○, 절대적 유효성 ×)

Ø  제3자의 지재권 비침해 보증 (고의침해 ○, 기타 △)

·         면책 Indemnification

Ø  지재권 침해 claim시 면책규정은 license, 공동연구발 계약협상에서 쟁점이 많은 규정

Ø  특허를 제외한 copyright등 기타 권리에 대해서는 indemnification을 대부분 수용하는 편이나, 특허에 대해서는 면책보장의 수용이 어려운 경우가 많음. 

Ø  전세계 특허의 사전조사는 현실적으로 불가능하고, 고의적으로 copy한 경우가 아니더라도 유사성이 존재하는 한 침해를 구성  

Ø  반면, 저작권 등의 경우는 제3자의 저작물을 copy한 경우가 아니라면, 독자개발에 의해 발명/발견된 경우는 유사성이 존재하더라도 침해를 구성치 않음.  

Ø  고의침해 경우(punitive damage대상이 됨) - 무제한 배상 보장 가능

Ø  기타 지재권 침해 claim경우 - 지불금액 총액 한도내에서 합의가 합리적  

Ø  제외: - 허여 용도 외 사용, 제공기술/제품의 임의 수정, 제공 외 기술/제품과 결합, 합성 등으로 인해 침해가 발생한 경우         

계약조항 영문 샘플

23. INDEMNIFICATION; INSURANCE; LIMITATION OF LIABILITY. 

23.1 General Indemnification by Licensor. Licensor CyDex shall defend, indemnify and hold Licensee 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 Licensee. Licensee Hospira shall defend, indemnify and hold Licensor 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_특허실시, 기술이전, 라이선스 영문계약서에서 진술보증, 면책조항 관련 실무적 포인트 몇 가지 면책조항 INDEMNIFICATION, INSURANCE, LIMITATION OF LIABILITY 계약조항 샘플.pdf

KASAN_특허실시, 기술이전 라이선스, 공동연구개발계약에서 추가 연구개발 결과물, 개량발명 관련 계약조항 샘플, 법적 쟁점 및 실무적 대응방안 몇 가지.pdf

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기술사용료 vs 기술지원 용역비 구분

로열티 지급과 세금 원천징수

원천소득이란 당해 소득의 원천이 되는 소재지 등이 국내인 소득을 말하며 이를 근거로 각국이 외국법인에 대해서도 과세할 수 있습니다. 우리나라 세법은 국내 원천소득을 열거하고 있고 규정되지 않은 사항은 과세 대상이 아닙니다. 원천징수란 국내사업장이 없는 외국법인에 특허사용료를 지급하는 경우와 같이 외국법인이 국내에서 올린 소득에 대하여 세금을 낼 것을 기대하기 어려운 경우 그 소득을 지급하는 자가 미리 일정액을 떼어 우리 국세청에 납부하도록 하는 제도를 말합니다.  

그런데, 같은 기간 동안 동일소득에 대하여 2개국에서 중복 과세한다면 부당하기 때문에, 대부분 이중과세를 방지하기 위한 조약을 체결하고 있습니다. 이중과세 방지는 (1) 특정소득에 대하여 당해 소득의 원천지국에서 세금을 면제하여 주고 거주지국에서만 과세하도록 하는 방법, (2) 원천지 국가에서 과세하고 그 소득에 대해 거주지 국가에서 공제해주는 방법을 활용합니다. 그 중 원천징수를 하지 않는 경우 원천지국가의 조세수입을 감소시키는 측면이 있어서 통상 두 번째 내용의 조세조약으로 해결합니다. 따라서, 특별한 경우가 아닌 한 지급하는 기술료에 대해 원천징수하는 것이 원칙입니다. 

그러나, 당사국 사이 조세조약에 따라 우리나라에 과세권이 없는 경우라면 국내기업이 원천징수를 할 수 없습니다. 예를 들어 특허권자 법인이 아일랜드 소재 기업인 경우 한국 아일랜드 조세협약에 따라 우리나라에서 원천징수를 할 수 없습니다. 이와 같은 이유로 애플, 화이자 등 많은 다국적 거대기업들이 아일랜드에 설립한 법인에 다수의 특허권을 양도하고, 기술 로열티를 아일랜드 법인 귀속으로 하는 경우가 많습니다. 

만약, 국내기업이 외국법인에게 특허 사용료를 지급하면서 세금을 원천 징수하여야 함에도 잘못하여 이를 하지 않는 경우에는 국내기업이 그 해당부분에 대한 원천세를 부과받을 위험이 있습니다. 따라서, 원천징수 여부를 정확하게 확인해야만 이와 같은 부담을 피할 수 있습니다. 

예를 들어, 아일랜드 법인이 세금 회피 목적으로 설립된 실체가 없는 Paper Company인 경우 국세청은 그 아일랜드 법인의 실체를 부인하고 그 소득의 실질 귀속자(그 법인의 투자자 등)를 찾아 한국과 그 실질 귀속자들의 거주국간의 조세조약에 따라 과세할 수 있습니다. 즉, 소득의 실질 귀속자의 국가 세율에 따라 원천징수한 것으로 보고 그 소득에 대한 법인세를 부과할 수 있습니다. 따라서, 국내기업 입장에서는 기술거래 또는 라이선스의 실질적 당사자와 다른 형식적으로 조세회피 목적으로 설립된 paper company에 불과하다는 의문이 든다면 이를 반드시 확인해야 합니다. 상대방이 조세조약을 이유로 기술 로열티에 대한 원천징수를 거부하는 경우라면 그 단계에서 반드시 조세 전문가의 검토 및 확인을 거쳐 적절한 내용으로 계약을 체결하는 것이 바람직합니다. 일단 기술로열티를 모두 지급한 후 상당 기간이 경과하였다면 추후 부과된 세금부담을 해결하기 쉽지 않을 수 있습니다. 

KASAN_기술이전, 라이선스 계약에서 특허기술 사용대가 로열티 vs 기술지원 비용 로열티 구분 로열티 지급과 원천징수 문제.pdf

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미국연방대법원 판결

-      Licensor 상표등록권자 Tempnology vs Licensee 상표사용권자 Mission Product

-      의류 분야 등록상표의 사용허락 라이선스 계약 기간 중 Licensor 상표등록권자 Tempnology 도산 상황 발생 – 미국법원에 소위 Chapter 11 파산신청 접수

-      미국 파산법에 따라 채무자(debtor)는 이행해야 할 계약상 채무의 이행을 거절하는 부인권(rejection) 행사할 수 있음

-      본 상표사용하락 라이선스 계약에서는 Licensor 상표권자가 채무자로 상대방 채권자, licensee에 대해 라이선스 계약상 채무이행을 거절하는 부인권 행사함.

-      라이센서의 채무는 대상 상표사용을 허여하는 내용이므로 위 부인권 행사로 licensee의 상표사용권한이 소멸되는지 쟁점

-      라이센서의 부인권 행사 후 라이센시가 상표사용을 계속하는 경우 상표권침해에 해당하는지 여부가 쟁점

-      미국연방대법원 – 라이센시 계속 상표사용권한 인정함

미국판결 요지 – 부정, 라이센시는 대상 상표를 계속 사용할 수 있음

KASAN_미국연방대법원 2019. 5. 20. 선고 Mission Product vs Tempnology 판결 - 라이선스 계약서에서 계약해지 (termination) 사유 - 파산, bankruptcy 사유 발생 시 라이선스 계약의 종료 관련 라이센시의 권리 .pdf

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10. TERMINATION 

10.1 Expiration. Subject to this Section 10 below, this Agreement shall expire, on a Licensed Product-by-Licensed Product and country-by-country basis, on the date on which Kite, its Affiliates and sublicensees permanently cease to research, develop, sell and commercialize the Licensed Product in such country (the “Term”).

10.2 Termination for Convenience. The Licensee Kite may terminate this Agreement, in its sole discretion, upon thirty (30) days prior written notice to the Licensor Cabaret and Dr. Eshhar.

10.3 Termination for Cause. Except as otherwise provided in Section 12, each party may terminate this Agreement upon or after the breach of any material provision of this Agreement by the other party if the other party has not cured such breach within sixty (60) days (or such longer period as such party may reasonably agree if said breach is incapable of cure within such sixty (60) days) after receipt of express written notice thereof by such party.

10.4 Insolvency. This Agreement may be terminated by the Licensor Cabaret in the event of an Insolvency Event occurring in relation to the Licensee Kite, by giving a notice of termination to Kite. The termination shall take effect upon delivery of the notice of termination by Cabaret. “Insolvency Event” shall mean that, with respect to Kite, any of the following occurs: (i) Kite makes any arrangement or composition with or any assignment for the benefit of its creditors generally; (ii) a petition is presented that is not dismissed within 120 days or a court order is made or a resolution is passed for the winding up of Kite or for the making of an administration order or for the appointment of a provisional liquidator or a judicial factor or similar officer in relation to Kite; (iii) an encumbrancer takes possession of or a trustee, receiver, liquidator, provisional liquidator, administrator, manager ad interim, administrative receiver, judicial factor or similar officer is appointed, in each case for all or substantially all of Kite’s intellectual property rights and such appointment materially prejudices Cabaret’s rights under this Agreement; or (iv) Kite does, or suffers to be done in relation to it, any analogous action or proceeding in any jurisdiction anywhere in the world (including without limitation any actions or proceedings relating to bankruptcy law of any nature in the United States of America).

10.5 Effect of Expiration or Termination. Expiration or termination of this Agreement shall not relieve the parties of any obligation accruing prior to such expiration or termination, and the provisions of Sections 5.2, 8, 10.5, 10.6, 11 and 13 shall survive the expiration or termination of this Agreement. Upon any termination of this Agreement, all licenses granted herein shall terminate, nevertheless, Cabaret shall grant a direct license to any Sublicensee of Kite hereunder having the same scope as such sublicense and on terms and conditions no less favorable to such Sublicensee than the terms and conditions of this Agreement, provided that such Sublicensee is not in default of any applicable obligations under this Agreement and agrees in writing to be bound by the terms and conditions of such direct license.

10.6 Termination Fee. In the event that Kite terminates this Agreement termination for convenience under Section 10.2 prior to the third (3rd) anniversary of the Effective Date, Kite shall pay to Cabaret a termination fee in an amount equal to US$500,000 within thirty (30) days of such termination.

KASAN_특허실시, 기술이전, 라이선스 계약서에서 TERMINATION 조항 – 라이센시 파산 등 일반사유 및 양 당사자의 계약위반으로 인한 계약종료, 계약종료 후 처리 등 계약조항 샘플.pdf

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계약실무 관행 및 실무적 쟁점

- 실무상 통상적으로 계약해지 Termination 사유로 당사자 부도, 압류, 파산 등을 규정함

- 그러나 국가마다 차이가 있지만 실제 파산 발생 시 termination 조항의 상대방의 계약 해제권 조항은 무효가 되어 아무런 의미가 없는 경우가 많다는 점을 유의해야 함

- 강행법규인 파산법에 따른 파산재산관리/분배규정에 따라, 계약이행상 상당한 변경이 발생할 수 있음

- 미국연방파산법에서는 원칙적으로 미이행계약에 대해서는 파산신청 즉시 automatic stay (자동정지) 발효

- 채무자의 계약상대방은 계약상 허여된 모든 권리 행사는 물론, (금전적 손해배상 청구 외에는) 채무자를 상대로 한 어떤 claim이나 소송도 금지

- 파산관재인은 스스로의 business judgment에 따라, 해당 계약을 거부할 수 있음은 물론(채무자는 계약이행의무가 면제됨), ‘Ipso facto’ 규정 [bankruptcy 발생 시 상대방의 계약 해제권 또는 특정 option 행사권(escrow상 금액/자료 등 인출권한) 발동조항 등]은 무효가 됨

- Licensor의 bankruptcy 경우에는 해당 license계약상 명시적인 non- assignment 규정이 있는 경우에도, 관재인은 해당 license 계약을 제3자에게 양도할 수 있는 반면,

- (특허 및 저작권법상 IP owner의 동의 없이는 licensee가 해당 license의 양도를 제3자에게 양도하는 것을 금하고 있는 것으로 해석되는 바) licensee가 bankruptcy에 처한 경우에는 licensor의 동의 없이는 해당 license를 제3자에게 양도, 승계할 수 없다.

- 프랑스, 독일에서는 파산관재인은 라이센스 계약을 미이행 계약으로서 해제할 수 있고, 이것에 대해서 특별한 Licensee 보호 제도는 마련되어 있지 않다.

- 단, 미국에서는 파산관재인은 미이행 계약인 특허, 저작권, 영업비밀 라이선스 계약(상표/서비스/상호는 제외)의 이행 또는 거절을 선택할 수 있지만,

- 파산관재인이 라이선스 계약의 거절을 선택했을 경우에는 licensee는 라이선스의 유지를 선택할 수 있고, 이 경우 기존 라이센스의 범위 내(단, licensor의 특정이행 의무 등의 부수적인 의무는 제외)에서 보호된다.

계약실무상 대응방안

- 파산신청 전에 예견될 수 있는 일정 기준 이하의 재정부실, 이행 지연 등을 계약 해지사유로 규정

- 파산신청 전에 발생할 수 있는 Change of control 관련 사안을 해지사유로 규정 라이선스 계약을 미이행계약으로 해석되지 않는 구조로 설정

- 예: 로열티 지불의무 외에는 실질적인 미이행 의무가 존재치 않도록 규정하고, 다른 의무 (특허 유지/관리의무 등) 는 별도의 미이행계약으로 구성

- Source Code를 제3자 보관 또는 Escrow 위탁 의무가 발생하는 경우를 설정하고, 그 경우 보관/위탁된 source code가 관재인의 control 또는 파산재산 범위에 속하지 않도록 규정 해당 특허권에 대한 담보권 설정

미국판결 사안의 쟁점 및 판단 요지

- The question is whether the debtor-licensor’s rejection of that contract deprives the licensee of its rights to use the trademark. We hold it does not.

- 쟁점: 라이센서, 등록권자가 계약서 termination 조항의 사유 – 파산을 이유로 라이선스 계약을 종료하고 라이센시의 상표사용을 금지할 수 있는지 여부

- 미국대법원 판단요지 – 부정, 라이센시는 대상 상표를 계속 사용할 수 있음 \

- A rejection breaches a contract but does not rescind it. And that means all the rights that would ordinarily survive a contract breach, including those conveyed here, remain in place.

- 상표사용 허락 라이선스 거절은 계약위반에 해당함

첨부: 미국연방대법원 판결

KASAN_라이선스 계약서에서 계약해지 (termination) 사유 - 부도, 압류 등 파산, bankruptcy 관련 사유 발생 시 라이선스 계약의 법률관계 – 미국연방대법원 2019. 5. 20. 선고 Mission Product vs Tempnology 판.pdf

미국연방대법원 2019. 5. 20. 선고_Mission Product _vs_Tempnology_17-1657_판결.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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KASAN_[NDA분쟁] 비밀보호계약, 비밀유지약정, NDA, CDA에서 비밀보호대상 조항 위반여부 쟁점 미국소송 사례.pdf

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사안의 개요 및 쟁점

(1) 외국회사 특허권자 vs 국내회사 특허라이선스 체결

(2)  특허발명 – 방법발명, 특허권자로부터 통상실시권 획득

(3)  통상실시권자, 국내회사의 요청으로 특허발명의 전용품 마찰교반용접기를 제작하여 통상실시권자에게 납품한 행위

(4) 쟁점 - 특허권의 간접침해 해당여부

법원 판단 – 간접침해 해당하지 않음

대법원 2017다290095 판결요지

특허법 제127조 제2호는 특허가 방법의 발명인 경우 그 방법의 실시에만 사용하는 물건을 생산․양도․대여 또는 수입하거나 그 물건의 양도 또는 대여의 청약을 하는 행위를 업으로서 하는 경우에는 특허권 또는 전용실시권을 침해한 것으로 본다고 규정하고 있다. 이러한 간접침해 제도는 어디까지나 특허권이 부당하게 확장되지 아니하는 범위에서 그 실효성을 확보하고자 하는 것이다(대법원 2015. 7. 23. 선고 2014다42110 판결 등 참조).

방법의 발명(이하 ‘방법발명’이라고 한다)에 관한 특허권자로부터 허락을 받은 실시권자가 제3자에게 그 방법의 실시에만 사용하는 물건(이하 ‘전용품’이라고 한다)의 제작을 의뢰하여 그로부터 전용품을 공급받아 방법발명을 실시하는 경우에 있어서

그러한 제3자의 전용품 생산․양도 등의 행위를 특허권의 간접침해로 인정하면, 실시권자의 실시권에 부당한 제약을 가하게 되고, 특허권이 부당하게 확장되는 결과를 초래한다.

또한, 특허권자는 실시권을 설정할 때 제3자로부터 전용품을 공급받아 방법발명을 실시할 것까지 예상하여 실시료를 책정하는 등의 방법으로 당해 특허권의 가치에 상응하는 이윤을 회수할 수 있으므로, 실시권자가 제3자로부터 전용품을 공급받는다고 하여 특허권자의 독점적 이익이 새롭게 침해된다고 보기도 어렵다.

따라서 방법발명에 관한 특허권자로부터 허락을 받은 실시권자가 제3자에게 전용품의 제작을 의뢰하여 그로부터 전용품을 공급받아 방법발명을 실시하는 경우에 있어서 그러한 제3자의 전용품 생산, 양도 등의 행위는 특허권의 간접침해에 해당한다고 볼 수 없다.

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

[질문 또는 상담신청 입력하기]

15. MISCELLANEOUS.

15.1 Agency. Neither Party is, nor shall be deemed to be, an employee, agent, co-venturer, or legal representative of the other Party for any purpose, except as expressly set forth herein. No Party shall be entitled to enter into any contracts in the name of, or on behalf of the other Parties, nor shall either Party be entitled to pledge the credit of the other Parties in any way or hold itself out as having the authority to do so.

15.2 Assignment. Except as expressly provided in this Agreement, neither Party may assign any rights or delegate any duties under this Agreement to any Third Party without the prior written consent of the other Party; provided, however, that (a) Licensor may freely assign its right to receive any payments hereunder without such consent of Licensee, (b) in the case where either Party seeks to assign this Agreement as a whole to an Affiliate or to a Successor in connection with a Change of Control of such Party or of that part of such Party’s business to which this Agreement relates, such consent shall not be unreasonably withheld, delayed, or conditioned, provided that such Party provides written notice to the other Party of such Change of Control and such Successor agrees in writing to be bound as such Party hereunder. This Agreement shall be binding upon and inure to the successors and permitted assignees of the Parties and the name of a Party appearing herein shall be deemed to include the names of such Party’s Successors and permitted assigns to the extent necessary to carry out the intent of this Agreement. Any assignment or transfer not in accordance with this Section 15.2 shall be null and void.

15.3 Further Actions. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

15.4 Notices. All notices and other communications hereunder shall be in writing and shall be deemed to have been given: (a) when personally delivered or sent by confirmed facsimile or email (with hard copy to follow); (b) one (1) Business Day after sent by reputable overnight express courier (charges prepaid); or (c) five (5) Business Days following mailing by certified or registered mail, postage prepaid and return receipt requested. Unless another address is specified in writing, such notices to Licensor or Licensee shall be sent to the addresses indicated below:

15.5 Amendment. No amendment, modification, or supplement of any provision of this Agreement shall be valid or effective unless made in writing and signed by a duly authorized officer of each Party.

15.6 Waiver. No provision of this Agreement shall be waived by any act, omission or knowledge of a Party or its agents or employees except by an instrument in writing expressly waiving such provision and signed by a duly authorized officer of the waiving Party.

15.7 Counterparts; Electronic Delivery. This Agreement may be executed simultaneously in two counterparts, either of which need not contain the signature of more than one Party but both such counterparts taken together shall constitute one and the same agreement. Signatures to this Agreement transmitted by facsimile, by email in “portable document format” (“.pdf”), or by any other electronic means intended to preserve the original graphic and pictorial appearance of this Agreement shall have the same effect as physical delivery of the paper document bearing original signature.

15.8 Governing Law; Dispute Resolution.

(a) This Agreement shall be governed by and interpreted in accordance with the substantive laws of the State of New York, U.S.A. without regard to its or any other jurisdiction’s choice of law rules that would result in the application of the laws of any jurisdiction other than the State of New York, U.S.A.

(b) Except as otherwise provided in this Agreement, in the event of any dispute, controversy, or claim (“Dispute”) between the Parties in connection with this Agreement, the construction hereof, or the rights, duties or liabilities of either Party under this Agreement, the Parties shall first attempt in good faith to resolve such Dispute by negotiation and consultation between themselves. In the event that such Dispute is not resolved on an informal basis within ten (10) Business Days after one Party provides notice to the other Party of such Dispute, either Party providing such notice may, by written notice to the other Party refer such Dispute to the other Party for attempted resolution by good faith negotiation by the Chief Executive Officers or President of Licensor and the Chief Executive Officer, President or an Executive Vice President within thirty (30) days after such notice is received. In the event that any such Dispute is not resolved under the foregoing provisions, each Party may, at its sole discretion, seek resolution of such Dispute in accordance with Section 15.8(c). Any Disputes of the type described in Section 3.2(i) shall first be subject to the dispute resolution mechanism set forth in Section 3.2(i) before being subject to this Section 15.8.

(c) In the event such officers of the Parties are not able to resolve any such Dispute, either Party may at any time after such thirty (30) day period submit such Dispute to be finally settled by arbitration administered in accordance with the Commercial Arbitration Rules of the American Arbitration Association (“AAA”) in effect at the time of submission. The arbitration shall be heard and determined by three (3) arbitrators. Each such Party shall each appoint one arbitrator and the third arbitrator shall be selected by the two Party-appointed arbitrators, or, failing agreement within thirty (30) days following the date of receipt by the respondent of the claim, by the AAA. Such arbitration shall take place in New York, NY. The arbitration award so given shall be a final and binding determination of the dispute, shall be fully enforceable in any court of competent jurisdiction, and shall not include any damages expressly prohibited by Section 12.1. The Parties agree that all applicable statutes of limitation and time-based defenses (such as estoppel and laches) shall be tolled while the dispute resolution procedures set forth in this Section 15.8(c) are pending.

(d) Notwithstanding anything herein to the contrary, nothing in this Section 15.8 shall preclude either Party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction or other interim equitable relief concerning a Dispute, including in a court of law, if necessary to protect the interests of such Party. This Section 15.8 shall be specifically enforceable.

(e) Notwithstanding the foregoing, any disputes regarding the validity, scope or enforceability of Patent Rights or trademarks shall be submitted to a court of competent jurisdiction in the territory in which such rights apply.

15.10 Severability. Whenever possible, each provision of this Agreement shall be interpreted in such manner as to be effective and valid under Applicable Laws, but if any provision of this Agreement is held to be prohibited by or invalid under Applicable Laws, such provision shall be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of this Agreement. In the event of such invalidity, the Parties shall seek to agree on an alternative enforceable provision that preserves the original purpose of this Agreement.

15.11 Compliance with Applicable Laws. Each Party will comply with all Applicable Laws in performing its obligations and exercising its rights hereunder.

15.12 Remedies. The exercise of any remedies hereunder shall be cumulative and in addition to and not in limitation of any other remedies available to such Party at law or in equity.

15.13 Force Majeure. Neither Party shall be liable for delay or failure in the performance of any of its obligations hereunder if such delay or failure is due to causes beyond its reasonable control, including, without limitation, acts of nature, fires, earthquakes, strikes and labor disputes, acts of war, terrorism, or civil unrest (“Force Majeure”); provided that the affected Party promptly notifies the other Party and further provided that the affected Party shall use its commercially reasonable efforts to avoid or remove such causes of non-performance and to mitigate the effect of such occurrence, and shall continue performance with the utmost dispatch whenever such causes are removed. In the event any such Force Majeure event continues for three (3) months or more, the unaffected Party shall have the right to terminate this Agreement, effective as of the date of delivery of notice, which notice shall not be delivered prior to the end of such three (3) month period.

15.14 Interpretation. Each Party represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting hereof. In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption will apply against the Party which drafted such terms and provisions.

15.15 Construction. In construing this Agreement, unless expressly specified otherwise: (a) unless otherwise specifically provided, any references to Articles, Sections, Exhibits, Schedules, and Appendices are to articles in, sections of, and exhibits, schedules and appendices to, this Agreement; (b) except where the context otherwise requires, use of either gender includes the other gender and use of the singular includes the plural and vice versa; (c) headings and titles are for convenience only and do not affect the construction or interpretation of this Agreement; (d) any list or examples following the word “including” shall be interpreted without limitation to the generality of the preceding words; (e) the words “herein”, “hereof” and “hereunder”, and words of similar import, shall be construed to refer to this Agreement in its entirety and not to any particular provision hereof; (f) except where the context otherwise requires, the word “or” is used in the inclusive sense; (g) all references to “dollars” or “$” herein shall mean US Dollars; (h) any definition of or reference to any agreement, instrument or other document herein shall be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein or therein), (i) any reference to any Applicable Laws herein shall be construed as referring to such Applicable Laws as from time to time enacted, repealed or amended, and (j) any reference herein to any person or entity shall be construed to include the person’s or entity’s successors and assigns.

15.16 Entire Agreement of the Parties. This Agreement and the exhibits attached hereto constitute and contain the complete, final, and exclusive understanding and agreement of the Parties, and cancel and supersede any and all prior and contemporaneous negotiations, correspondence, understandings, and agreements, whether oral or written, between the Parties respecting the subject matter hereof, including without limitation the Confidentiality Agreement, and neither Party shall be liable or bound to any other Party in any manner by any representations, warranties, covenants, or agreements except as specifically set forth herein or therein. Nothing in this Agreement, express or implied, is intended to confer upon either Party, other than the Parties and their respective successors and assigns, any rights, remedies, obligations, or liabilities under or by reason of this Agreement, except as expressly provided herein. To the extent that anything set forth in an exhibit attached hereto conflicts with the terms of this Agreement, the terms of this Agreement shall control.

KASAN_기술이전, 라이선스 등 영문계약서에 사용되는 일반조항 GENERAL PROVISIONS 계약조항 샘플.pdf

3. JOINT STEERING COMMITTEE AND ALLIANCE MANAGERS.

3.1 Generally.

(a) Joint Steering Committee. Licensor and Licensee shall form the Joint Steering Committee. The JSC will have only such powers as are specifically delegated to it in this Agreement, and such powers shall be subject to the terms and conditions set forth in this Agreement.

(b) JSC Subcommittees. The JSC is hereby authorized to appoint one or more JSC Subcommittees to which the JSC may assign responsibility for specific matters (including, without limitation, matters arising with respect to Development, Commercialization, and Manufacturing. Each JSC Subcommittee will have only such powers as are specifically delegated to it by the JSC, and the delegation of any such powers to any JSC Subcommittee shall be subject to the terms and conditions set forth in this Agreement.

(c) Limitation of Power of JSC and JSC Subcommittees. Without limiting the generality of Sections 3(a) and 3(b), neither the JSC nor any JSC Subcommittee shall have any power to amend this Agreement or bind or incur liability on behalf of either Party without such Party’s express prior written authorization.

(d) Compliance with JSC and JSC Subcommittee Decisions. Each Party will comply with the decisions of the JSC and any JSC Subcommittee to the extent such decisions arise from the JSC or such JSC Subcommittee, as applicable, carrying out its powers and responsibilities as set forth in this Agreement and not otherwise inconsistent with the terms and conditions of this Agreement. Notwithstanding the foregoing, and is expressly set forth herein, Licensee shall have the sole and absolute right and discretion to decide matters related to the Commercialization, Manufacturing, or Development of the Product.

3.2 Membership and Governance of JSC and JSC Subcommittees.

(a) Membership.

(i) The JSC will be comprised of six (6) members who, except as otherwise provided in clause (iii) of this Section 3.2(a), are employees of the Parties (each a “JSC Member”), with three (3) JSC Members designated by Licensor and three (3) JSC Members designated by Licensee.

(ii) Each JSC Subcommittee will be comprised of the total number of members (each a “JSC Subcommittee Member”) as is designated by the JSC in forming such JSC Subcommittee, with the number of JSC Subcommittee Members appointed to such JSC Subcommittee from each Party to be designated by the JSC in forming such JSC Subcommittee. In determining the number of JSC Subcommittee Members to serve on any JSC Subcommittee formed by the JSC, the JSC will provide that the number of such JSC Subcommittee Members to be designated by each Party will be reasonable with respect to the experience and expertise of the human resources of each such Party in respect of the matters for which such JSC Subcommittee is responsible.

(iii) Each of Licensor and Licensee, upon prior written notice to the other Party, may (i) replace each person such Party has designated as a JSC Member or a JSC Subcommittee Member for any reason at any time, upon prior written notice to the other Party, (ii) designate a substitute for each person such Party has designated as a JSC Member or JSC Subcommittee Member, and (iii) appoint non-employees of such Party as JSC Members and JSC Subcommittee Members only upon the prior consent and approval of the other Party.

(b) Decision-Making. While the JSC and each JSC Subcommittee will seek to decide matters under their respective consideration by consensus of all of its members, Licensee reserves the right to decide each such matter in its sole and absolute discretion.

(c) Meetings. The JSC and each JSC Subcommittee will meet as agreed upon by the JSC Members or the applicable JSC Subcommittee Members, respectively, in person or by teleconference or video-teleconference; provided that the first meeting of the JSC Committee or such JSC Subcommittee, as applicable, will be within ninety (90) days after the Effective Date.

(d) Observers. Except for matters in respect of which the JSC or any JSC Subcommittee needs to meet in executive session, the meetings of the JSC and any JSC Subcommittee may be attended by non-Member observers at the invitation of an executive officer of either Party (the “Inviting Party”), provided that (i) the Inviting Party provides reasonable prior notice of such invitation to the other Party, (ii) the other Party has consented to such invitation in advance of the applicable meeting, which such consent shall not be unreasonably withheld, delayed or conditioned and (iii) any such observer has agreed in writing to obligations to safeguard the confidentiality and restrictions on use of Confidential Information that are no less restrictive than the obligations in Section 13.2.

(e) Chairperson.

(i) Of JSC. At the first meeting of the JSC following the Effective Date and at the first meeting of the JSC in each calendar year beginning after the Effective Date, the JSC Members will select a chairperson to serve until such person’s successor has been designated in accordance herewith. The chairperson of the JSC shall rotate annually between JSC Members designated by Licensor and those designated by Licensee. The first chairperson of the JSC shall be selected from the JSC Members designated by the Licensee.

(ii) Of Each JSC Subcommittee. Each JSC Subcommittee shall have a chairperson appointed in accordance with the directions of the JSC in establishing such JSC Subcommittee.

(f) Secretary.

(i) Of JSC. The chairperson of the JSC shall designate a secretary of the JSC who will be responsible for calling meetings, preparing and circulating an agenda in advance of each meeting, and preparing and circulating minutes within thirty (30) days after each meeting of such committee setting forth, among other things, a description, in reasonable detail, of the discussions at the meeting and a list of any actions, decisions or determinations approved by the JSC. Such minutes shall be effective only after being approved by both Parties. Definitive minutes of all committee meetings shall be finalized no later than sixty (60) days after the meeting to which the minutes pertain.

(ii) Of Each JSC Subcommittee. Each JSC Subcommittee shall have a secretary appointed in accordance with the directions of the JSC in establishing such JSC Subcommittee.

(g) Term of JSC and JSC Subcommittees.

(i) The JSC shall continue to exist for the Term of this Agreement or upon its termination upon mutual agreement of the Parties.

(ii) Each JSC Subcommittee shall continue to exist for the term to be set forth by the JSC in establishing such JSC Subcommittee, but in no event for a period extending beyond the Term of this Agreement

(h) Alliance Managers.

(i) Each of Licensor and Licensee shall appoint an Alliance Manager, who shall be an individual authorized to act as such Party’s point of contact for communications between and among the Parties relating to the Commercialization, Manufacturing and Supply, and any Development Activities contemplated by this Agreement. Each Party may change its designated Alliance Manager from time to time upon written notice to the other Party. The Alliance Manager of a Party may designate a substitute to temporarily perform the functions of that Alliance Manager by written notice to the other Party.

(ii) Each Alliance Manager shall be charged with creating and maintaining a collaborative work environment between and among the Parties and within the JSC and each JSC Subcommittee.

(iii) Each Alliance Manager will also: (i) be the point of first referral in all matters of conflict resolution; (ii) identify and bring disputes to the attention of the JSC or the relevant JSC Subcommittee, as applicable, in a timely manner; (iii) plan and coordinate cooperative efforts and internal and external communications; and (iv) take responsibility for ensuring that governance activities, such as the conduct of required JSC and JSC Subcommittee meetings and production of meeting minutes occur as set forth in this Agreement, and that relevant action items resulting from such meetings are appropriately carried out or otherwise addressed

(i) Dispute Resolution.

(i) In the event that any dispute arises with respect to matters falling within the scope of the role and the powers and responsibilities of the JSC or any JSC Subcommittee as set forth in or contemplated by this Article 3 or elsewhere in this Agreement, then either Licensor or Licensee or any of the Members of such Committee may notify the Alliance Managers of such disputed matter.

(ii) The Alliance Managers shall discuss in good faith any such disputed matter referred to them in accordance with Section 3.2(i)(i). If the Alliance Managers are unable to resolve any such matter, either Licensor or Licensee may refer the matter to the Chief Executive Officer or President of Licensor and the Chief Executive Officer, President, or an Executive Vice President of Licensee, which such two individuals shall meet at an agreed location or by telephone to resolve the matter within twenty (20) days after the meeting at which such matter arose.

(iii) If such two officers of the Parties are unable to resolve the disputed matter so referred to them in accordance with Section 3.2(i)(ii) within an additional thirty (30) day period, then the following procedures shall apply:

(A) in the case of matters with respect to which Licensee is authorized hereunder to decide in its sole and absolute discretion, including, without limitation, any Commercialization or Manufacturing and Supply matter, Licensee shall have final decision-making rights with respect thereto and shall promptly provide written notice to Licensor of its final position regarding such matter and Licensor will comply with the position taken by Licensee on such matter unless compliance with such position would result in the incurrence of a direct material financial expenditure or imposition of some other non-financial burdensome obligation upon Licensor that would be greater than would have been the case absent compliance with such position, which in such case shall be referred for dispute resolution under Section 15.8 and

(B) in the case of matters with respect to which Licensee is not authorized hereunder to decide such matters in its sole and absolute discretion, such matters shall be referred for dispute resolution under Section 15.8.

3.3 Committee Oversight of Commercialization Activities.

(a) Role. The JSC and any JSC Subcommittee established for the purpose of oversight of Commercialization Activities, will monitor, assess, and make recommendations to Licensee in respect of the Commercialization of the Product contemplated in Article 4 of this Agreement.

(b) Powers and Responsibilities. With respect to Product Commercialization Activities, the powers and responsibilities of the JSC and any JSC Subcommittee established for the purpose of oversight of such Commercialization Activities are limited to the matters set forth in this Section 3.3 and Article 4. Neither the JSC nor any JSC Subcommittee shall have the power to amend, modify, or waive compliance with this Agreement with respect to Commercialization Activities required to be undertaken by Licensee under this Agreement, including, without limitation, the Commercialization Plans for the Product and any Indications. Notwithstanding the foregoing, Licensee reserves the right to decide each such Commercialization matter in its sole and absolute discretion, including amending or modifying any Commercialization Plan.

(c) Annual Review of Commercialization Plan. On an annual basis, beginning in the first full Calendar Year following the Effective Date, no later than sixty (60) days before the end of such Calendar Year, the JSC or any JSC Subcommittee responsible for oversight of Commercialization Activities will review, analyze, and comment on the Annual Commercialization Plan then in effect and any revisions thereto proposed by Licensee or Licensor, which such review, analysis, and comment will include, without limitation:

(i) an assessment of whether the Commercialization Activities contemplated by the Annual Commercialization Plan for the then current Calendar Year have been successfully undertaken and have achieved or are achieving the strategic objectives set forth in the Commercialization Plan;

(ii) an assessment of whether the strategic objectives set forth in the Annual Commercialization Plan, together with any revisions then proposed by Licensee or Licensor, continue to reflect the best interests of the Parties;

(iii) the submission to Licensee of any recommended revisions to the Annual Commercialization Plan then in effect and any revisions then proposed by Licensee or Licensor, in order to reflect the aforementioned assessments.

(d) Regulatory Exclusivity. The JSC and any JSC Subcommittee responsible for oversight of Commercialization Activities shall monitor the process of applying for and securing Regulatory Exclusivity that may be available under the applicable Law of countries in the Territory, including, without limitation, any data or market exclusivity periods such as those periods listed in the FDA’s Orange Book. Each of Licensor and Licensee shall use Commercially Reasonable Efforts to cooperate with each other and to take such reasonable actions to obtain such Regulatory Exclusivity in each country in the Territory.

3.4 Oversight of Manufacturing and Supply Activities.

(a) Role. The JSC and any JSC Subcommittee responsible for oversight of Manufacturing and Supply Activities will monitor, assess, and make recommendations to Licensee in respect of the manufacture and supply of the Product as contemplated in Article 5 for purposes of Commercializing the Product for any Indications that are the subject of Regulatory Approvals and any Development Activities in respect of the Product for the PNE Indication, any Additional Indications and the Nocturia Indication throughout the Territory.

(b) Powers and Responsibilities. With respect to Product Manufacturing Activities, the powers and responsibilities of the JSC and any JSC Subcommittee responsible for oversight of such Manufacturing Activities are limited to the matters set forth in this Section 3.4 and Article 5. Neither the JSC nor any JSC Subcommittee shall have the power to amend, modify or waive compliance with this Agreement with respect to Manufacturing Activities required to be undertaken by Licensee under this Agreement, including, without limitation, the Manufacturing and Supply Plan for the Product. Notwithstanding the foregoing, Licensee reserves the right to decide each such manufacturing and supply matter in its sole and absolute discretion, including amending or modifying any Manufacturing and Supply Plan.

(c) Annual Review of Manufacturing and Supply Plan. On an annual basis, beginning in the first full Calendar Year following the Effective Date, no later than sixty (60) days before the end of such Calendar Year, the JSC or any JSC Subcommittee responsible for oversight of Manufacturing Activities will review, analyze, and comment on the Manufacturing and Supply Plan then in effect, and any revisions thereto proposed by Licensee or Licensor, which such review, analysis, and comment will include, without limitation:

(i) an assessment of whether the Manufacturing Activities contemplated by the Manufacturing and Supply Plan for the then current Calendar Year have been successfully undertaken and have achieved or are achieving the strategic objectives set forth in the Manufacturing and Supply Plan; and

(ii) an assessment of whether the strategic objectives set forth in the Manufacturing and Supply Plan, together with any revisions then proposed by Licensee or Licensor, continue to reflect the best interests of the Parties.

3.5 Oversight of Development Activities.

(a) Role. The JSC and any JSC Subcommittee responsible for oversight of any Development Activities contemplated in Article 6 of this Agreement will monitor such Development Activities. In this role the JSC or such JSC Subcommittee, as applicable, will (i) assist Licensee in overseeing any Development of, Clinical Studies for, and preparation and submission of Regulatory Documentation for obtaining Regulatory Approval of the Product contemplated by any Development Plan, including, without limitation, review of any relevant Regulatory Documents and Regulatory Documentation and (ii) provide a forum for sharing advice, progress, and results and documents, including, without limitation, relevant Clinical Study designs, protocols, study reports, and any other material information with respect to any such Development Activities.

(b) Powers and Responsibilities. With respect to any Product Development Activities, the powers and responsibilities of the JSC and any JSC Subcommittee responsible for oversight of such Development Activities are limited to the matters set forth in this Section 3.5 and Article 6. Neither the JSC nor any JSC Subcommittee shall have the power to amend, modify or waive compliance with this Agreement with respect to Development Activities, including, without limitation, any Development Plan in effect from time to time. Notwithstanding the foregoing, Licensee reserves the right to decide each such Development matter in its sole and absolute discretion, including amending or modifying any Development Plan.

(c) Annual Review of Development Plan. If Licensee determines to engage in any Product Development Activities in accordance with Article 6, on an annual basis, beginning in the first full Calendar Year following the Effective Date, no later than sixty (60) days before the end of such Calendar Year, the JSC and any JSC Committee responsible for oversight of Development Activities that Licensee may so determine to undertake in accordance with Article 6 will review, analyze, and comment on the Development Plan then in effect, and any revisions thereto proposed by Licensee or Licensor, which such review, analysis, and comment will include, without limitation:

(A) an assessment of whether the Development Activities contemplated by the Development Plan for the then current Calendar Year have been successfully undertaken and have achieved or are achieving the strategic objectives set forth in the Development Plan;

(B) an assessment of whether the strategic objectives set forth in the Development Plan, together with any revisions then proposed by Licensee or Licensor, continue to reflect the best interests of the Parties;

(C) the submission to Licensee of any recommended revisions to the Development Plan then in effect and any revisions then proposed by Licensee or Licensor, in order to reflect the aforementioned assessments.

KASAN_제약회사의 기술이전, 독점 라이선스, API 공급, 완제품 생산위탁, 완제품구매 계약서에서 개발, 생산, 판매 활동에 관한 JSC 관련 계약조항 영문 샘플.pdf

[질문 또는 상담신청 입력하기]

7. REGULATORY MATTERS.

7.1 Ownership of Product Regulatory Approvals and Documentation. Licensee shall own all Product Regulatory Approvals and Documentation in respect of each country in the Territory.

7.2 Conduct and Management of Regulatory Activities. Licensee will use its Commercially Reasonable Efforts:

(a) to maintain the First Approved NDA in the United States;

(b) to obtain Regulatory Approval for the Product for the Nocturia Indication in each other country in the Territory in accordance with the Development Plan;

and

(c) to obtain Regulatory Approval for the Product for the PNE Indication in each country in the Territory in accordance with the Development Plan.

Any breach by Licensee of its obligations under Section 7.2(a) shall be deemed to be a material breach of this Agreement for purposes of Article 14.

7.3 Transfer to Licensee of Product Regulatory Approvals and Documentation. Following the transfer to Licensee of ownership of the Product Regulatory Approvals and Documentation in each such country in the Territory pursuant to Section 2.3(b),

(a) Licensee or its designee shall be the owner of any and all Product Regulatory Approvals and Documentation in each such country in the Territory, subject to the Right of Reference or Use hereby granted by Licensee to Licensor in Section 2.5(c) for purposes of Development and Commercialization of Products outside the Territory;

(b) Except for the Development and Commercialization of Products by Licensor in the Territory pursuant to Section 6.3, Licensee shall have the responsibility, at its expense, for all regulatory activities (including, without limitation, Development Activities undertaken to support obtaining or maintaining Regulatory Approvals) and interactions relating to the Product in each country in the Territory, including without limitation preparing, obtaining, and maintaining Regulatory Approvals in each country in the Territory and all substantive interactions with such Regulatory Authorities relating thereto; and

(c) Licensee shall determine, in its sole discretion, the content of all such submissions and of all correspondence with Regulatory Authorities relating to the Product in the Territory.

(d) To the extent Licensor has not undertaken any Product Development Activities in the Territory under Section 2.5(c), Section 2.6, Section 6.1 and/or Article 14, Licensor hereby grants to Licensee a Right of Reference or Use in all Regulatory Approvals and Regulatory Documentation in respect of the Compound and any Products in respect of which Licensor is the sponsor for purposes of Licensee’s Development and Commercialization of Products in the Field and in the Territory. In consideration of such grant, Licensee will make one or more payments to Licensor determined in accordance with the same provisions set forth in clauses (ii) and (iii) in Section 2.5(c) in respect of Licensee’s grant of the Right of Reference or Use set forth in clause (i) of Section 2.5(c).

7.4 Regulatory Documentation for Generic Products.

(a) Each Party shall deliver written notice to the other Party of any notice it receives as to the submission, filing, or approval of an application, including, without limitation, an Abbreviated New Drug Application in the United States or the equivalent thereof in any other country in the Territory, in respect of a Generic Product within three (3) days after receipt or such notice thereof.

(b) Licensee shall have the sole right to respond to each such application, provided that Licensee shall consult with Licensor regarding any such application and the response thereto.

7.5 Audits. Licensor will have the continuing right during the Term of this Agreement, upon reasonable prior written notice to Licensee, to inspect, audit, and investigate any facilities, equipment, record-keeping procedures, and records utilized by Licensee and its subcontractors in connection with the Manufacture and Commercialization of the Product and any Development (including, without limitation, the conduct of Clinical Studies) of the Product.

7.6 Regulatory Authority Communications Received by a Party.

(a) Each Party shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection, or communication by or from any Person, including, without limitation, any Regulatory Authority in any country in the Territory, that may affect the safety or efficacy claims of the Product, have a material adverse effect on the Commercialization of the Product, or that otherwise suggests the Product may be in violation of Applicable Laws in such country.

(b) Upon receipt of such information described in Section 7.7(a), the Parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for Licensee to take at Licensee’s expense.

(c) Each Party shall keep the other Party informed, in a timely manner consistent with the reporting requirements of Regulatory Authorities, of notification of any action by any Regulatory Authority, or notification or other information that the Party receives (directly or indirectly) from any such Regulatory Authority, and provide to such other Party copies of all documents, if any, it received from such Regulatory Authority.

(d) Each Party will provide the other Party in a timely manner with a copy of all correspondence received from a Regulatory Authority specifically regarding the matters referred to in this Section 7.7.

7.7 Adverse Event Reporting and Safety Data Exchange.

(a) Licensee shall be responsible, at Licensee’s expense, in each country in the Territory for the monitoring of all clinical experiences, post-marketing experiences, and filing of all required reports with respect to the Product.

(b) Licensor shall transfer to Licensee the patient database, including without limitation the databases, in their entirety, containing pharmacokinetic, pharmacodynamic, efficacy, and safety information, developed in connection with the conduct of Clinical Studies for the Product under U.S. IND 076667, and all information relating thereto, in the format requested by Licensee. Licensor shall have the right to retain a copy of any and all such information transferred to Licensee.

(c) Each Party shall (i) notify the other Party immediately, but in no event later than three (3) Business Days, after becoming aware of any information concerning any complaint involving the possible failure of Product to meet any requirement of Applicable Laws, and any Unexpected Adverse Drug Experience or other serious or unexpected side effect, injury, toxicity, or sensitivity reaction or any unexpected incidents associated with the distribution or use of the Product and (ii) with respect to adverse events, comply with the provisions of this Section 7.7, and the applicable agreements described herein. Specific details regarding the exchange and management of information relating to adverse events related to the use of the Product shall be delineated and product labeling personnel of each Party shall work in good faith together during such time to negotiate an agreement that:

(i) identifies which safety information shall be exchanged, which shall include without limitation all adverse events for any Indication or condition;

(ii) identifies when such information shall be exchanged (which SAE information shall be provided within two (2) Business Days after notification of such SAE);

(iii) provides that Licensee shall (i) have regulatory reporting responsibilities, (ii) manage the global safety database, (iii) be obligated to obtain follow-up information on incomplete safety reports, (iv) review the literature for safety report information, and (v) prepare required periodic safety updates;

(iv) sets forth the roles and responsibilities of the Parties related to review and approval of safety information for inclusion in the Product labeling; provided that Licensee shall have the final decision-making authority with respect to any disputes regarding such activities with respect to Product in accordance with the terms and conditions hereof;

(v) identifies any other details required to appropriately manage safety information for the Product; and

(vi) as soon as reasonably practicable following the Effective Date, but in no event later than sixty (60) days thereafter Licensor and Licensee will agree upon the terms and conditions of the Pharmacovigilance Agreement and will thereupon execute and deliver to the other Party a copy of such Agreement.

7.8 Remedial Actions.

(a) Each Party will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that the Product in the Field may be subject to a Remedial Action.

(b) The Parties will assist each other in gathering and evaluating such information as is required to determine the necessity of conducting a Remedial Action with respect to the Product in the Field in the Territory; provided, however, that Licensee shall have sole responsibility for collecting information from its customers in the Territory, including, without limitation, customer complaints, in accordance with the terms and conditions hereof.

(c) Each Party will maintain adequate records to permit the Parties to trace the manufacture of the Product in the Field and the distribution and use of the Product in the Field. In the event Licensee determines that any Remedial Action with respect to the Product in the Field in the Territory should be commenced or Remedial Action is required by any Governmental Authority having jurisdiction over the matter, Licensee will control and coordinate all efforts necessary to conduct such Remedial Action, provided that Licensee shall consult with Licensor or its designee regarding any such Remedial Action.

(d) The cost and expense of a Remedial Action (including the Parties’ reasonable costs and expenses in conducting such Remedial Action, but excluding claims described in Article 10) shall be allocated as follows:

(i) If such Remedial Action is due to Licensee’s gross negligence or willful misconduct, material breach of this Agreement, or material violation of or substantial noncompliance with any Law, but only to the extent such Remedial Action is due thereto, such costs and expenses shall be borne and paid by Licensee;

(ii) if and to the extent that such Remedial Action is due to Licensor’s gross negligence or willful misconduct, Licensor’s material breach of this Agreement, or Licensor’s material breach of or substantial noncompliance with any Law, but only to the extent such Remedial Action is due thereto, such costs and expenses shall be borne and paid by Licensor; and

(iii) if and to the extent that such Remedial Action is due to reasons other than as set forth in Sections 7.8(d)(i) and (ii), then: (A) Licensor shall bear and pay the costs and expenses incurred by the Parties in connection with a Remedial Action with respect to any lots of the Product subject to such Remedial Action that were manufactured by or for Licensor, as Licensor’s predecessor in interest; and (B) except for the Development and Commercialization of Product in the Territory by Licensor pursuant to Section 6.3, Licensee shall bear and pay the costs and expenses incurred by the Parties in connection with a Remedial Action with respect to any lots of the Product subject to such Remedial Action that were manufactured by or for Licensee and its contractors; provided, however, that nothing in this Section 7.8(d)(iii) is intended to limit or supersede any obligation that Renaissance may have in respect of any such lots of the Product subject to such Remedial Action.

KASAN_제약회사의 API 공급, 완제품 생산위탁, 완제품구매 계약서에서 정부의 제조품목허가 관련 계약조항 영문 샘플.pdf

미국 Cook Inc.과 Boston Scientific Corp.은 의료기기 stent 분야의 경쟁업체입니다. 양사는 1997년 stent에 항암제 paclitaxel을 코팅한 stent (paclitaxel-coated stent) 제품개발을 진행하였습니다. Angiotech사는 paclitaxel 특허권을 보유하고 있었습니다.

양사 모두 exclusive license를 체결하여, 각자 Exclusive right 보유한 licensee입니다. 공존의 의미로 co-exclusive로 표현하기도 합니다. 우리나라 특허법상 전용실시권 공유와 유사한 것으로 이해됩니다.

1. 분쟁대상 계약조항

Licensee Cook & Boston Scientific에 대한 GRANT 조항은 "use, manufacture, have manufactured, distribute and sell, and to grant sublicenses to its Affiliates to use, manufacture, have manufactured, distribute and sell, the Angiotech Technology ... for use in the Licensed Applications."입니다.

한편, "none of the parties could assign their rights or obligations under the agreement without the prior written consent of the other two."과 같은 명시적 제한 조항이 포함되어 있습니다.

2. Cook사의 계약위반 쟁점 행위

Cook사는 2001년 일방적으로 Advanced Cardiovascular Systems, Inc. ("ACS")와 다음과 같은 일련의 계약 5건을 체결하였습니다. (1) a Paclitaxel Coated Stent ("PCS") Distribution Agreement, (2) a Component Supply Agreement, (3) a PCS Development Agreement, (4) a Stent Delivery System Distribution Agreement, (5) a Cross-License Agreement

Cook사는 위 라이선스에서 허용한 판매행위는 최종 소비자에 대한 판매뿐만 아니라 판매를 사업으로 하는 도매상 등 중간상인에 대한 판매도 포함한다는 입장입니다. 판매범위에 특별한 제한을 둘 수 없다고 주장합니다.

허락된 생산행위도 직접 생산뿐만 아니라 제3자에게 대한 위탁생산도 포함된다는 입장입니다. 특히 계약 문언에 "have manufactured"도 포함되어 있습니다.

3. 계약위반 분쟁 및 쟁점

Cook과 Boston Scientific는 경쟁업체로 동일한 exclusive licensee이기 때문에 라이선스 계약범위에 관한 첨예하게 이해관계가 대립됩니다. Cook의 행위에 대해 Boston Scientific에서는 계약상 권리양도금지 조항을 위반하는 사실상 계약이전(de facto assignment)에 해당한다고 주장하였습니다.

반면, Cook사는 ACS는 Angiotech 특허기술에 대한 access도 없고 직접 권리를 획득하지도 않는다는 점을 강조하면서, Angiotech사와 라이선스 계약으로 허용된 권리행사에 불과하다고 주장합니다.

4. 미국법원 1,2심 판결 요지

미국법원은 Cook/ACS 계약을 “a transparent attempt to draft around the limitations clearly expressed within the Angiotech Agreement”로 보았습니다. 오직 Cook사와 Boston Scientific사만 라이선스 독점권의 공유자로서 Angiotech Technology 사용권을 갖는다는 범위제한을 내포하고 있다고 판시하였습니다.

양사에 독점권을 공동으로 부여한 계약에서 당사자들의 진정한 의사는 당사자 2개사 이외에 제3자 타사에 대한 위탁생산 또는 위탁판매를 예정하지 않았다고 보았습니다. 만약 그렇게 된다면 licensee 중 상대방에게 심대한 이해관계를 미치기 때문입니다.

제3자의 위수탁 생산, 판매행위는 계약문언상 포함된 것으로 해석될 수도 있었습니다. 그러나, 당사자의 진정한 의사와 합리적 상식을 고려하여 계약상 허용범위에서 배제한 사례입니다.

KASAN_특허실시, 기술이전, 라이선스 계약서에서 계약제품의 외주생산 허용범위 해석분쟁 판결 - 의료기기 Drug Elution Stent (DES) 관련 Exclusive License 분쟁 – 위수탁 생산, 판매행위와 assign 및 sub-l.pdf

17. MANUFACTURE AND SUPPLY OF CAPTISOL.

17.1 Supply.

(a) Subject to the terms and conditions of this Agreement, CyDex agrees to supply to Hospira those quantities of Captisol ordered by Hospira in accordance with Section 3.2 of this Agreement. So long as CyDex is able to deliver Captisol in accordance with the terms of this Agreement, except as provided in Section 3.11 (c) below, Hospira agrees that Hospira and its Affiliates shall during the Term order from CyDex no less than 90% of Hospira and its Affiliates aggregate requirements for Captisol for use in the formulation of Finished Product to be sold in the Major-Market countries.

(b) The parties hereby agree that [*] is CyDex’s Third-Party manufacturer of Captisol as of the Effective Date of this Agreement.

17.2 Purchase Orders. Hospira shall periodically submit firm purchase orders for Captisol to CyDex, which purchase orders shall set forth the specific quantities needed, the grade of Captisol required, delivery date and shipping instructions. Such purchase orders shall be submitted to CyDex at least [*] but not more than [*] prior to the required delivery date specified therein. If any purchase order or other document submitted by Hospira hereunder or any other document passing between the parties contains terms or conditions in addition to or inconsistent with the terms of this Agreement, the terms of this Agreement shall control and prevail and the parties hereby agree that such additional or inconsistent terms shall simply be ignored and deemed not to exist, unless they are expressly identified as being additional to or inconsistent with this Section 3.2 and are signed by officers of both parties.

17.3 Forecasts and Excess Demand. No later than the First Commercial Sale date, Hospira shall provide to CyDex a [*] forecast of its requirements for Captisol, with the first [*] of such forecast constituting a binding commitment upon Hospira to purchase such quantities under firm purchase orders submitted for the respective applicable [*] in accordance with Section 3.2. The balance of the forecast shall merely represent reasonable good-faith estimates for planning purposes only and shall not obligate Hospira to purchase any such amounts. On a [***] basis, Hospira shall update the forecast. If Hospira fails to provide any updated forecast in accordance with this Section 3.3, the forecast last provided by Hospira shall be deemed to be resubmitted as Hospira’s binding forecast for the next succeeding [*] period, and with the same quantity and timing as had been forecasted (or deemed to be forecasted) for the [*] of the prior forecast being repeated as the forecasted quantity and timing for the forecast’s [*]. CyDex shall notify Hospira as soon as possible, but in any event within [*] of the receipt of any forecast, if CyDex will be unable to deliver Captisol in accordance with such forecast. CyDex’s providing of such notification shall not be interpreted in any manner as relieving CyDex of its obligations under this Agreement, nor shall it prevent Hospira from pursuing any and all rights and remedies Hospira may have based on CyDex’s failure to be able to deliver Captisol in accordance with the terms of this Agreement. If any purchase order includes an Excess Demand, then (a) CyDex shall supply the quantity of Captisol which does not constitute an Excess Demand to Hospira in accordance with Section 3.2, and (b) CyDex shall use commercially reasonable efforts to supply the Excess Demand quantities of Captisol requested by Hospira in its purchase orders as soon as commercially possible.

17.4 Delivery Terms.

(a) CyDex agrees to deliver Captisol to Hospira’s carrier at a continental United States factory or warehouse designated by CyDex, in accordance with the purchase orders submitted by Hospira in accordance with Section 3.2 (each such delivery to be accompanied by a copy of the purchase order submitted by Hospira that corresponds to such delivery). All Captisol shall be delivered to Hospira using the carrier and in accordance with the delivery schedule specified by Hospira in its purchase orders. Captisol shall be delivered by CyDex to Hospira. CyDex will provide the carrier with proper instructions regarding how to transport the Captisol in conditions which will not adversely affect the Captisol, including ensuring that the shipment is temperature monitored and the Captisol is kept at an appropriate temperature throughout shipment.

(b) If CyDex is unable to deliver the Captisol on the date specified by Hospira, CyDex shall notify Hospira as soon as possible, but in any event within [***] of receipt of the purchase order. CyDex’s providing of such notification shall not be interpreted in any manner as relieving CyDex of its obligations under this Agreement, nor shall it prevent Hospira from pursuing any and all rights and remedies Hospira may have based on CyDex’s failure to deliver the Captisol in accordance with the terms of this Agreement.

(c) With each shipment of Captisol, CyDex shall, if so requested, provide by reference or otherwise all documentation as is reasonably required by any [*] from time to time in connection with Hospira’s research, development, modification, manufacture, importation, exportation, use, promotion, marketing, distribution, packaging, offering for sale, selling, and otherwise commercially exploitation, as applicable, of Captisol or the Finished Product. If such documentation is not supplied Hospira may reject the Captisol.

17.5 Safety Stock. Within [*] of CyDex’s receipt of the first purchase order from Hospira, CyDex shall establish and maintain a safety stock of at least [*] of Captisol available to Hospira based on Hospira’s latest forecast provided under Section 3.3. CyDex shall keep Hospira reasonably informed of the level of inventory identified as the safety stock and shall notify Hospira in the event any deliveries to Hospira deplete the current safety stock levels.

17.6 Failure to Supply.

(a) CyDex shall maintain sufficient capacity to manufacture Hospira’s projected needs for Captisol during the Term. If CyDex fails to deliver or anticipates that it will be unable to deliver any quantity of Captisol ordered pursuant to the terms of this Agreement for [*], CyDex will promptly notify Hospira. If CyDex fails to deliver any quantity of Captisol for [*], if such notice is received from CyDex, or if upon request by Hospira CyDex fails to provide adequate assurance of its ability to continue to deliver Captisol as required by the terms of this Agreement, then Hospira in its sole discretion and without impairing or limiting any other rights that Hospira may have under this Agreement or under applicable law, including, without limitation, its rights under Sections 2-609 and 2-610 of the Uniform Commercial Code, shall have the right to agree to a revised delivery date or Hospira may: [***] above, CyDex shall assist Hospira, if so requested by Hospira, by [*].

(d) Alternate Manufacturers. If CyDex fails to supply to Hospira, or if CyDex will be unable to supply Hospira with [***]% or more of the quantity of Captisol properly forecasted and ordered by Hospira in accordance with this Agreement, for a period of [*] then CyDex shall immediately provide written notice to Hospira of the [*]. In the event of a [*] in addition to any other rights and remedies Hospira may have under this Agreement, or in equity, or at law:

17.7 Inspection and Acceptance.

(a) CyDex shall test and inspect each lot of Captisol for compliance with Specifications prior to the release and shipment thereof to Hospira. CyDex will provide a Certificate of Analysis with each shipment of each lot of Captisol signed by the responsible quality official of CyDex. This Certificate of Analysis must include the results (whether numerical or otherwise) for each test performed that verifies that the Captisol is in compliance with the Specifications, as well as a statement that the subject lot was manufactured in accordance with the appropriate DMF/CEP. To the extent that any reference standard material is delivered to Hospira along with any shipment of Captisol as a result of Hospira’s request for such material pursuant to Section 3.2 of this Agreement, the Certificate of Analysis shall also include specifications on such material for each criterion listed in Exhibit B hereto, which specifications shall meet or exceed the Specifications.

(b) Hospira may test and inspect the Captisol after receipt and either accept or reject it. Captisol may be rejected if it does not comply with the Specifications or is otherwise defective. Hospira will be deemed to have accepted the Captisol, except as to latent defects which are not reasonably discoverable, if Hospira fails to give notice of rejection within [*] after receipt by Hospira of such Captisol. The written notice of rejection shall be given to CyDex and shall include identification of the lot number and description of the Specification failure or other defect.

(c) Following receipt of written notice of rejection of a particular lot of Captisol, in addition to any other rights or remedies Hospira may have under this Agreement, in equity, or at law, CyDex shall, at Hospira’s option, provide a credit, refund or prompt replacement of Captisol to Hospira; provided, however, that if CyDex does not agree with Hospira’s claim of noncompliance with Specifications or other defect, then the parties shall designate a mutually acceptable Third Party laboratory to make a determination on such matter from a sample obtained from the batch or other quantity shipped to Hospira. The decision of the Third Party laboratory shall be binding on all parties hereto and all expenses related to such Third Party investigation shall be borne by the party found to have been mistaken. Should such Third Party laboratory confirm Hospira’s claim, CyDex shall, at Hospira’s request, promptly provide Hospira with a credit, refund or prompt replacement of Captisol to Hospira.

(d) Hospira shall return any rejected Captisol to CyDex at CyDex’s expense to an address that CyDex may designate within [*] of CyDex receiving written notice of rejection; provided, however, that if CyDex does not agree with Hospira’s claim of noncompliance with Specifications or other defect, Hospira shall not be obligated to return the rejected Captisol to CyDex until [*] after a final determination is made by a Third Party laboratory that such Captisol does not comply with Specifications or is otherwise defective as provided in subparagraph (c) above. Absent such designation of address, Hospira will ship rejected Captisol to CyDex’s facility at [*], or such other address as CyDex may previously have given written notice of to Hospira as being the default address for return of rejected Captisol. All freight, insurance and other costs of such shipment along with any risk of loss shall be borne by CyDex, and shipment will be made from Hospira’s designated plant.

(e) Hospira’s rights of rejection, return, refund and replacement set forth in this Section 3.7 shall not apply to any Captisol that is non-conforming due to damage that occurs after delivery of such Captisol to Hospira’s carrier at the point of origin that is caused by Hospira, any of its Affiliates’ or their respective employees or agents’ negligence or willful misconduct, including but not limited to, misuse, neglect, improper storage, transportation or use beyond any dating provided.

17.8 Quality Agreement. The parties shall on the Effective Date enter into a separate Quality Agreement, in the form attached hereto as Exhibit D. The parties shall comply with the terms of the Quality Agreement, and any breach of the Quality Agreement shall be deemed a breach of this Agreement.

17.9 Quality Assurance. Each lot of Captisol to be supplied to Hospira hereunder shall be subject to a quality assurance inspection by CyDex in accordance with CyDex’s then current quality assurance standards and the Quality Agreement, which standards shall be designed to ensure that the Captisol meets the requirements of the Specifications and is manufactured per Good Manufacturing Practices.

17.10 Process Change Provisions and Procedure.

(a) General. To the extent pertaining to Captisol to be delivered pursuant to this Agreement, all modifications, changes, additions or deletions to the (i) Specifications; (ii) changes in the expiration period for Captisol; (iii) composition or source of any raw material for Captisol; (iv) method of producing, processing or testing Captisol; (v) change in subcontractors for producing, processing or testing Captisol; or (vi) site of manufacture for Captisol, which CyDex intends to carry out must be evaluated and documented by CyDex. [*], CyDex shall if so required amend its DMF/CEP through the appropriate notification to the FDA and any other applicable Regulatory Authorities. [*].

(b) Required Changes. Any changes relating to the Specifications or manufacturing processes for Captisol hereunder that are required by any applicable laws or other Regulatory Authority requirements in any Major Market, or by medical concerns related to the toxicity, safety and/or efficacy of Captisol shall hereinafter be referred to as “Required Changes”. The parties shall cooperate in making such changes promptly.

KASAN_제약회사의 API 공급, 완제품 생산위탁, 완제품구매 계약서에서 원료공급 및 생산 관련 계약조항 영문 샘플.pdf

[질문 또는 상담신청 입력하기]

“Net Sales” means, with respect to a given period of time, gross sales of the Product in such period to unrelated Third Parties in bona fide arm’s length transactions, (excluding sales or dispositions for use in Clinical Studies or other scientific testing or reasonable quantities of samples, in each case for which Licensee and any such Third Party Distributors receive no revenue), less the following deductions which are actually incurred, allowed, paid, accrued or specifically allocated to such gross sales amounts of the Product and not separately invoiced:

(a) credits or allowances actually granted for damaged Product, returns or rejections of Product, price adjustments, and billing errors;

(b) governmental and other rebates (or equivalents thereof) granted to: managed health care organizations; pharmacy benefit managers (or equivalents thereof); federal, state/provincial, local and other governments, their agencies and purchasers and payors, including, without limitation, any state or federal Medicare, Medicaid or similar program); or trade customers;

(c) normal and customary trade, cash and quantity discounts, allowances and credits actually allowed and taken specifically with respect to sales of other dispositions of the Product;

(d) distribution services agreement fees allowed or paid to Third Party distributors;

(e) transportation costs, including without limitation insurance, for outbound freight related to delivery of the Product to the extent included in the gross amount invoiced;

(f) excise and sales taxes, tariffs, duties, value added taxes, and other taxes applied to the sale of the Product imposed upon and paid directly with respect to such sales or (reduced by any refunds of such taxes deducted in the calculation of Net Sales for prior periods and, for the avoidance of doubt, no deduction shall be permitted for income, withholding, corporate or similar taxes); and

(g) any other items that reduce gross sales amounts as required by GAAP.

Transfers and sales of the Product between or among a Party and its Affiliates or Third Party Distributors shall be excluded from the computation of Net Sales, but the subsequent final sales of the Product to Third Parties by such Affiliates or Third Parties shall be included in the computation of Net Sales.

There shall be no double counting in determining the foregoing deductions from gross amounts invoiced to calculate Net Sales. The deductions set forth above in this definition of Net Sales shall be determined in accordance with GAAP, as consistently applied by Licensee and such Third Party Distributors across all of their products. The amounts set forth in clauses (a) through (g) above shall only be deducted from gross invoiced sales where gross invoiced sales before deductions are non-discounted gross sales amounts.

In the event Licensee or such Third Party Distributors sell the Product together with other products to Third Parties in a particular country in the Territory and the price attributable to the Product is less than the average price of “arm’s length” sales of the Product alone in the particular country for the reporting period in which such sales occur (such sales to be excluded from the calculation of the average price of “arm’s length“ sales of the Product alone), Net Sales for any such sales shall be the average price of “arm’s length” sales by Licensee or Third Party Distributors, as applicable, of the Product alone and in the country during the reporting period in which such sales occur. If the average price of “arm’s length” sale of the Product cannot be determined in any given country, the Net Sales will be determined by the value of the Product sold to similar customers in countries with similar pricing and reimbursement structures and for similar quantities. Any dispute as to the determination of fair market value that cannot be resolved through discussion between the Parties shall be determined in accordance with Section 3.2(i). Notwithstanding the foregoing, in the event the Product is sold as a Combination Product, for purposes of determining the royalties payable by Licensee to Licensor hereunder, Net Sales shall be calculated by the Net Sales for such Combination Product in a manner to be negotiated and agreed upon by Licensor and Licensee, reasonably and in good faith, prior to any sale of such Combination Product, which shall be based upon the respective fair market values of the active pharmaceutical ingredients in such Combination Product; provided that in no event shall the royalty rate payable by Licensee to Licensor for such Combination Product be greater than the royalty rate of the Product containing the Compound as the sole active ingredient.

KASAN_라이선스, 특허실시, 기술이전, License 계약에서 Running Royalty 산정기준 Net Sales 정의 영문계약 조항 샘플 – 상세하게 기재한 방식 사례.pdf

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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_특허라이선스, 기술이전 계약서에서 대가지급, Royalty 계약조항 샘플.pdf

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기술이전, 라이선스 협상 진행 단계 및 관련 계약서

단계별 계약서의 법적 구속력 유무 판단

계약이란: 법적 구속력 있는 합의 + 실무적 포인트 몇 가지

● 계약서의 표제를 근거로 판단하지 말 것

양해각서(MOU), 의향서(LOI), 합의서(LOA), 동의서(Letter Agreement), 계약조건 정리표(Term Sheet), 메모(Memo), 합의서(Agreement), 계약서(Contract), Work Plan, Terms & Conditions 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_특허실시, 기술이전, 라이선스 관련 업무진행 단계별 계약서 형식, 특허라이선스 계약서의 구성, 기본적 필수사항, 체크포인트 등 실무적 포인트 몇 가지.pdf

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18. LICENSE AND EXCLUSIVITY COMPENSATION. 

18.1 Payments; Extension of Exclusivity Period.

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

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

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

19. RECORDS; AUDIT. 

19.1 Records and Reports.

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

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

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

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

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