코로나19, COVID-19 대상으로 하는 DNA 백신 후보 INO-4800의 임상시험 뉴스와 더불어 한국의 관련회사 진원생명과학에 대한 백신공급계약(Supply Agreement) 관련 소송제기 뉴스가 있습니다.

 

구글을 찾아보니 Inovio vs GeneOne 사이 2007년 체결한 Supply Agreement는 계약서가 공개되어 있지 않습니다. 아마도 오래 전 체결된 계약서라서 미국법상 Inovio 공시대상이 아닌 것으로 보입니다. 참고로 최근 위 계약분쟁 소송에 관한 미국 SEC 공시내용은 다음과 같습니다. 

 

On June 3, 2020, Inovio Pharmaceuticals, Inc. (the “Company”) filed a complaint in the Court of Common Pleas of Montgomery County, Pennsylvania seeking, among other requests for emergency relief, to compel VGXI, Inc. and GeneOne Life Science, Inc. (together, “VGXI”) to facilitate the transfer of manufacturing methods, using VGXI’s technology, under the parties’ existing supply agreement (the “Supply Agreement”).

 

The technology transfer, which the Company has requested as permitted under the Supply Agreement, will allow for the large-scale manufacture of the Company’s product candidate INO-4800, a new vaccine candidate against the disease, known as COVID-19, caused by the outbreak strain of the coronavirus SARS-CoV-2.

 

As described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission on March 12, 2020, the Company and VGXI entered into the Supply Agreement in 2008.

 

Under the Supply Agreement, VGXI produces and supplies the DNA plasmids for the Company’s research and early clinical trials for its product candidates. There are no purchase commitments by the Company under the Supply Agreement; rather, terms of purchase are determined on an individual purchase order basis. Under the Supply Agreement, the Company has agreed to treat VGXI as its most favored supplier for DNA plasmids, and VGXI has agreed to treat the Company as its most favored customer.

 

In January 2020, the Company began preclinical studies of INO-4800 in an effort to develop a potential vaccine for an urgent public health need. In April 2020, the Company received approval from the U.S. Food and Drug Administration (the “FDA”) to begin a Phase 1 clinical trial of INO-4800. If the initial safety and immunogenicity data from the Phase 1 trial are acceptable, the Company plans to advance the development of INO-4800 into later-stage efficacy trials in the second half of 2020, subject to further regulatory guidance from the FDA. The Company has a goal of producing one million doses of INO-4800 by the end of 2020, with its existing capacity and contract resources, for further clinical trials or emergency use.

 

VGXI informed the Company that it did not have the capacity to manufacture the Company’s full order of DNA plasmids on the requested timeline, nor would it be able to manufacture plasmids for the commercial sale of INO-4800, if it were to be approved for sale.

 

The Company began discussions with other third-party contract manufacturers, as permitted by the Supply Agreement. As previously announced, in March and April 2020, the Company engaged Ology Bioservices Inc. and Richter-Helm BioLogics GmbH & Co. KG to support large-scale manufacturing of INO-4800. Richter-Helm BioLogics has manufactured the Company’s DNA medicine candidate VGX-3100, currently in Phase 3 trials as a potential treatment for precancerous cervical dysplasia, since 2015 using a process technology that was transferred by VGXI at that time. The Company intends to engage additional contract manufacturers for the production of INO-4800.

 

Following notification of VGXI’s insufficient capacity, the Company requested that VGXI provide the necessary technology transfer materials in order to allow its engaged contract manufacturers to proceed with the manufacture of INO-4800, as required by the Supply Agreement. In May 2020, following further discussions between the parties, VGXI notified the Company of its refusal to undertake the Company’s request, leading the Company to initiate legal proceedings as an emergency action to compel the technology transfer required of VGXI by the Supply Agreement for the planned large-scale manufacture of the Company’s COVID-19 vaccine candidate.

 

참고자료로 Inovio vs Apollo 사이 2017년 체결한 HPV 대상 DNA 백신후보 VGX-3100 백신공동개발 및 공급계약 라이선스 계약서를 첨부합니다. 타사의 표준, 샘플 계약서가 언제나 통용될 수 있는 것이 아니지만, 백신개발 분야의 실무자에게 유용한 참고자료가 될 것입니다.

 

첨부: Inovio – Apollo License Agreement 영문계약서

Inovio-Apollo License Agreement .docx

KASAN_코로나19, COVID-19 백신개발 미국바이오회사 INOVIO – 중국바이오회사 Apollo 사이 20

 

[질문 또는 상담신청 입력하기]

 

 

작성일시 : 2020. 6. 8. 11:10
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