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

 

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

 

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

 

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

 

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

 

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

 

9.1

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

 

9.2

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

 

9.3

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

 

9.4

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

 

9.5

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

 

9.6

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

 

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

 

11.1

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

 

11.2

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

 

11.3

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

 

11.4

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

 

11.5

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

 

11.6

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

 

11.7

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

 

11.8

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

 

11.10

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

 

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

 

12.1

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

 

12.2

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

 

12.3

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

 

12.4

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

 

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

 

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

 

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작성일시 : 2020. 5. 18. 09:07
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KASAN_공동연구개발계약에서 개량발명 쟁점 - 특허실시, 기술이전 라이선스 시 후속 연구개발 결과물, 개량발명 관

 

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작성일시 : 2020. 5. 15. 13:00
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1. 공동연구계약 당사자 벤처기업 공동연구결과의 개량발명 및 공동소유 주장

   

 

2. 대기업 주장요지 - 공동연구계약 범위에 포함되지 않음

 

 

 

3. 청구취지 특허발명의 권리귀속 확인 판결 청구

 

 

 

4. 공동연구개발계약서 조항

 

9.1 Ownership of Inventions.

 

9.1.1 Disclosure of Inventions. Each Party shall promptly disclose to the other Party, including without limitation at the joint meetings provided in Section 5.2, the making, conception or reduction to practice of any inventions directly arising out of activities conducted under this Agreement (“Program Inventions”).

 

9.1.2 Ownership of Program Inventions. All right, title and interest in all Program Inventions that are discovered, made or conceived as part of the activities conducted under this Agreement shall be owned as follows:

 

(a) [***] shall own all Program Inventions that (i) are invented solely by one or more employees, agents or consultants of [***] and do not primarily relate to the [***] or (ii) are invented solely or jointly by employees, agents or consultants of [***] and/or [***] and primarily relate to the [***]. To the extent that any such Program Inventions relating primarily to the [***] shall have been invented by [***] and are owned by [***], [***] hereby assigns all of its right, title and interest therein to [***];

 

(b) [***] shall own all Program Inventions that (i) are invented solely by one or more employees, agents or consultants of [***] and do not primarily relate to the [***] or (ii) are invented solely or jointly by employees, agents or consultants of [***] and/or [***] and primarily relate to the [***]. To the extent that any Program Inventions relating primarily to Drug Conjugation Technology shall have been invented by [***] and are owned by [***], Licensee hereby assigns all of its right, title and interest therein to [***]; and

 

(c) Except as set forth in Sections 9.1.2(a) and 9.1.2(b), Licensee and SGI shall jointly own all other Program Inventions. For purposes of clarification and notwithstanding anything to the contrary set forth herein, all Program Inventions that relate primarily to ADCs, including without limitation, patents or patent applications claiming compositions of matter or methods of use of Licensed Products, shall be jointly owned.

 

(d) Inventorship, for purposes of this Agreement, shall be determined in accordance with applicable national patent laws. To the extent permissible under applicable national patent laws, each Party will cause each employee and contractor conducting work on such Party’s behalf under this Agreement to be subject to a contract that (a) compels prompt disclosure to the Party of all inventions and other intellectual property conceived, created or reduced to practice by such employee or contractor during his or her performance under the Research Program and (b) assigns to such Party all right, title and interest in and to all such inventions and other intellectual property and all related Patents. Each Party will require each employee and contractor conducting work on such Party’s behalf under this Agreement to maintain records in sufficient detail and in a good scientific manner appropriate for patent purposes to properly reflect all work done. To the extent any royalties are owed to an employee or contractor of a Party relating to an invention, that Party shall be solely responsible for such royalties.

 

첨부: 미국소장

 

KASAN_바이오벤처 미국회사 SGI, Licensor vs 대기업 일본회사 Daiichi-Sankyo, Licen

미국소장_complaint.pdf

 

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ARTICLE 2 - RESEARCH PROGRAM

2.1 Objective and Conduct of the Research Program. Licensee intends to conduct a Research Program, with SGI’s support, to evaluate ADCs for research, development and commercialization under this Agreement. Licensee acknowledges that, in addition to the licenses to the SGI Patents granted hereunder, the SGI Know-How transferred to Licensee during the Research Program contains valuable information that is critical to Licensee’s development of ADCs hereunder. All research work performed by Licensee and SGI hereunder shall be performed in a good scientific manner and in compliance with all applicable laws.

 

2.2 Term of the Research Program. The term of the Research Program shall initially be for a period of two (2) years after the Effective Date (the “Research Program Term”), unless terminated earlier in accordance with Article 13. Licensee shall have a one-time right to extend the Research Program Term for an additional year by providing written notice to SGI not less than [***] prior to the expiration of the initial Research Program Term. SGI shall submit, within [***] from the expiration of the Research Program Term (in the case that the Research Program Term is extended by Licensee as set forth above, within [***] from the expiration of such extended term), a written report to Licensee which describes the research activities conducted by SGI during such Research Program Term.

 

2.3 Delivery of Drug Conjugation Materials. In support of the Research Program, during the Research Program Term, SGI will (a) deliver Drug Conjugation Materials to Licensee in accordance with the Research Plan; and (b) at Licensee’s request, provide Licensee with the [***] provided to the Licensee to enable [***]. All Drug Conjugation Materials and other information provided by SGI to Licensee hereunder will be deemed Confidential Information of SGI pursuant to Article 8.

 

2.4 SGI Preparation of ADCs. SGI will use reasonable commercial efforts to prepare ADCs using Antibodies supplied by Licensee to SGI which shall meet and satisfy specifications mutually agreed upon by SGI and Licensee, and shall deliver the resulting ADCs to Licensee in accordance with the Research Plan.

 

2.5 Payment. Licensee shall pay SGI the amounts set forth in Section 6.1.2 for any research efforts or other assistance provided by SGI.

 

2.6 Ownership of Data. Licensee shall own all right, title and interest in and to the data, research and results related specifically to ADCs arising out of activities conducted pursuant to the Research Program (“ADC Data”). SGI shall disclose to Licensee any ADC Data that are developed, conceived, or otherwise made, solely or jointly, by or on behalf of SGI in the course of, as a result of, or in connection with the Research Program, promptly after the same is developed, conceived or otherwise made. SGI hereby assigns to Licensee any and all right, title, and interest SGI may have in, to and under ADC Data; provided, that SGI may retain copies of, and use, all ADC Data for any purpose related to this Agreement, including but not limited to, patent prosecution and defense pursuant to [***].

 

2.7 Disclaimer. EXCEPT AS MAY BE OTHERWISE EXPRESSLY PROVIDED IN ARTICLE 12 OR THE RESEARCH PLAN, SGI MAKES NO REPRESENTATIONS AND GRANTS NO WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, REGARDING THE DRUG CONJUGATION MATERIALS OR ANY ADCs PREPARED BY SGI, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR USE OR PURPOSE.

 

ARTICLE 3 - EXCLUSIVE LICENSE

3.1 Exclusive License Grant.

3.1.1 Upon execution of this Agreement, subject to the terms and conditions of this Agreement, including payment of the ADC Access Fee set forth in Section 6.1.1, SGI shall be automatically deemed to grant to Licensee a worldwide, exclusive (even as to SGI), royalty-bearing license under the SGI Technology, with the right to sublicense as permitted in Section 3.2, to discover, research, develop, make, have made, import, export, use, offer for sale, and sell Licensed Products that bind selectively to the Designated Antigen within the Field in the Territory (the “Exclusive License”). The Exclusive License shall continue for the Royalty Term, unless earlier terminated pursuant to Article 13, subject to Licensee’s compliance with the terms and conditions of this Agreement, including payment of all applicable fees, milestones and royalties hereunder.

 

3.1.2 During the Term, SGI shall not carry out, by itself or in collaboration with any third parties, to discover, research, develop, make, have made, import, export, use, offer for sale, and sell any antibody-drug conjugate products that bind selectively to the Designated Antigen within the Field in the Territory.

 

3.2 Rights to Sublicense.

3.2.1 Licensee shall have the right to grant sublicenses of the rights granted to Licensee pursuant to this Agreement to any Affiliate or any Third Party, subject to the terms and [***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. conditions of the SGI In-Licenses listed on Schedule C. Licensee shall not have the right to sublicense the SGI Technology outside the scope of the license granted in Section 3.1, including to develop further Drug Conjugation Technology on a stand-alone basis or to create antibody-drug conjugates that include or are based upon any antibodies that bind selectively to an antigen other than the Designated Antigen.

 

3.2.2 Licensee agrees to contractually obligate any Sublicensee to make all payments due to SGI pursuant to this Agreement by reason of achievement of any fees, milestones and royalties set forth herein, as well as to comply with all terms of this Agreement applicable to Licensee (including all terms of this Agreement identified as applicable to Sublicensee). Licensee shall also require any such Sublicensee to agree in writing to keep books and records and permit SGI to review the information concerning such books and records in accordance with the terms of this Agreement.

 

3.2.3 Licensee shall notify SGI of each sublicense granted to Affiliates or Third Parties and shall provide SGI with the name and address of each Sublicensee and a description of the rights granted and the territory covered by each Sublicensee.

 

KASAN_항암제 바이오신약 ADC 관련 공동연구개발 계약서 - 미국 바이오벤처 SGI, Licensor vs 대기

 

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작성일시 : 2020. 5. 15. 12:00
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