-- 미국 FDA 허가 단계에서 License, Collaboration Agreement Termination 관련 Payment --

 

의약개발을 끝내고 FDA 허가 직전에 license 계약을 termination한 흥미로운 내용이라 소개합니다. 대상 신약은 Gabapentin은 오래 전부터 알려져 있는데, 그 적응증을 대상포진 신경통 postherpetic neuralgia 치료제로 확대한 프로젝트입니다.

 

2008. 11. 19. Dopomed에서 Gabapentinpost-herpetic neuralgia (PHN) 치료용도에 대해 SolvayExclusive License Agreement 체결한 후 2010 Solvay를 인수 합병한 Abbott에서 그 프로젝트를 재검토하여 2011년 개발중단을 선언한 것입니다.

 

이와 같이 장기간 진행되는 신약개발 도중에 M&A 등 다양한 이유로 change of control 발생으로 해당 프로젝트와 license의 운명이 완전히 바뀌는 사례가 종종 있습니다. 처음부터 이와 같은 변화를 염두에 둔 장기적 전략과 포석이 반드시 필요합니다. 아무리 애써도 쉽지 않은 일이지만 처음부터 그와 같은 가능성을 고려한 라이선스 구조인지 아닌지에 따라 당사자에게 상당히 다른 결과를 초래한다고 생각합니다.

 

첨부한 license 계약서의 Exhibit A에 표시된 milestone payment 조건은 FDA 허가신청 접수 시 1천만불, 허가성공 시 35백만불입니다. 본 건은 허가신청을 한 후 심사 중, 허가를 받기 전에 termination한 것입니다. 그렇지만, Abbott에서 신약에 대한 권리포기와 총 4천만불( 4백억원)을 지급하는 것으로 합의하였습니다.

 

참고로 허가신청 제출 milestone payment 1천만불이 포함된 것은 아닐 것입니다. 다만, NDA Approval 임박시점에 termination한 사정이 반영된 것으로 짐작됩니다.

 

참고자료로 미국 SEC 파일로 공개된 termination 합의서와 license 계약서를 첨부해 드립니다.

 

첨부: 1. Termination

Termination by Abbott.docx

 

첨부: 2. License  

  Exclusive License Agreement.docx

 

작성일시 : 2015.11.11 11:00
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-- 일본 Daiichi Sankyo에서 신약개발회사 Amgen, ArQule과 각 체결한 License, Co-Development and Co-Commercialization Agreement 중 허가신청 data access 관련 조항 --

 

미국 SEC에 제출되어 공개된 장문의 계약서를 참고로 첨부해 드립니다. 핵심부분은 삭제되었지만, 신약개발과정을 거쳐 미국 FDA 허가신청까지 진행된 계약서로 실무자용 참고자료라고 생각합니다.

 

수많은 조항 중에서 미국 FDA 허가신청 과정에서 필요한 data access에 관한 규정은 흔히 보기 어려운 내용입니다. 그대로 인용하면 다음과 같습니다.

 

4.8 Sharing of Regulatory Filings. Each of the Parties will disclose to the other a draft copy of any Regulatory Filing in the Territory in the original language no less than thirty (30) days prior to filing it with a Governmental Authority. Each Party will consider in good faith any comments made by the other Party with respect to such filings. Each Party shall, no less frequently than quarterly, and more often as reasonably requested by the other Party, provide to the other Party (in such format as reasonably requested) all material preclinical and clinical data arising out of or relating to Dmab in trials thereof in the Territory (and outside the Territory, for Amgen) (or such subset of such data as the Parties may agree). Each of the Parties shall maintain a database which contains all clinical trial data accumulated from all clinical trials of Dmab in the Territory (in a computer readable format reasonably requested by Amgen). Upon the request of either Party, the other Party shall provide a right of reference to any requested Regulatory Filings or Regulatory Approvals in the Territory, and Amgen shall provide the same such right of reference to Collaborator with respect to such Regulatory Filings and Regulatory Approvals outside the Territory, in each case as reasonably necessary for the requesting Party’s development or commercialization of Dmab as permitted hereunder (or, with respect to Amgen, manufacture of Dmab). Notwithstanding the foregoing, Amgen shall not be required to provide to Collaborator nor to allow Collaborator to access (but shall provide a right of reference as set forth in Section 4.15.3 (Amgen Cooperation) to the extent necessary) Amgen’s manufacturing information with respect to Dmab or any sections of any such Regulatory Filing related thereto and neither Party shall have an obligation to provide information relating to any product other than Dmab.

 

3.10.3 Right of Access. Each Party shall provide the other Party with access to all clinical project plans and clinical data, results and information derived from or relating to all Clinical Trials conducted, and all Regulatory Filings prepared, with respect to Collaboration Compounds and/or Licensed Products (collectively, “Product-Related Data”) in English and at no additional cost or expense. Notwithstanding anything to the contrary in this Agreement, ARQULE (a) may use, and provide to its Third Party licensees and collaborators, such Product-Related Data; provided, that, (i) ARQULE shall only have the right to share such Product-Related Data to its Third Party collaborators and licensees that have granted ARQULE the reciprocal right to share with DS clinical data, results and information, and information derived from or related to Regulatory Filings controlled by such Third Party collaborators and licensees for use with Licensed Products under this Agreement and (ii) ARQULE shall, upon DS’s request, use Commercially Reasonable Efforts to coordinate a global clinical trial targeting both within the Territory and the Asian Territory involving its Third Party collaborators and DS; (b) may use such Product-Related Data for the performance of its obligations and exercise of its rights under this Agreement; and (c) shall have a right of access, a right of reference and a right to use and incorporate all such Product-Related Data in any Regulatory Filings and Drug Approval Applications it makes with respect to Licensed Products. The Parties shall cooperate so that such Product-Related Data is transferred to ARQULE as expeditiously as possible.

 

 

신약허가에 필요한 임상시험 데이터를 얻는데 막대한 비용과 시간이 필요하기 때문에 상대방을 적극적으로 지원하여 허가를 받을 수 있도록 한다는 취지입니다. 신약개발의 어려움과 진정한 partnership이 필요한 현실을 반영한 계약조항으로 생각됩니다.

 

*첨부파일:

1. Collaboration Agreement between Amgen and Daiichi Sankyo 2007

1. Collaboration Agreement between Amgen and Daiichi Sankyo 2007

2. License, Co-Development and Co-Commercialization Agreement between ArQule and Daiichi Sankyo 2008

2. License, Co-Development and Co-Commercialization Agreement be

 

작성일시 : 2015.11.10 17:30
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