MATERIAL CONTRACTS 22 22.2 application, GenSight has reconsidered its partnership with IN-LICENSE AGREEMENTS Novasep Henogen, and has decided to move on with Brammer Bio. Brammer Bio acquired in 2017 additional facilities dedicated Agreements Relating to GS010 to Phase I I I and commercial production for Gene Therapy. These • License agreement relating to patents used in connection with facilities are currently under qualification and should be licensed GS010 with Inserm Transfert S.A. and the Company dated in 2019, which would allow the manufacture of the consistency October 12, 2012. lots for our product candidate GS010. On October 12, 2012, we entered into a license agreement Hence, on October 10, 2017, we entered into a master services with Inserm Transfert S.A. (acting as delegae of Inserm. Fort ) agreement with Brammer Bio for the manufacturing and control more details, see Section 11.5, “Intel lectual Property” of this of our product candidate GS010. The performance of the Registration Document. services under the agreement is split into two work statements. • License agreement relating to scientific data used in connection The first work statement (WS1) has been contracted for the with GS010 with Association Française contre les Myopathies, process transfer and establishment at Brammer Bio (part A) and Inserm Transfert S.A. and the Company dated December 2, the process characterization (part B), with completion timeframes 2013. ranging from 6 months to 10 months. The second work statement (WS2) will be contracted for the process performance On December 2, 2013, we entered into a license agreement qualification (PPQ) which includes the manufacture of 3-PPQ for use of scientific data with the AFM, Genethon and Inserm batches (part C) eligible to market. Each work statement wil l Transfert, acting as a delegate of Inserm and on behalf of the terminate upon completion of the delivrables. UPMC. For more details, see Section 11.5, “Intellectual Property” of this Registration Document. • Services agreement with Lonza dated February 10, 2014. Agreements Relating to GS030 GenSight has conducted for its second lead product GS030 a process development program with Lonza (8066 El Rio St- • License agreement relating to patents used in connection with Houston-TX 77054-USA) on a scale that will support non-clinical GS030 with Adverum Biotechnologies (formerly Avalanche safety evaluation, clinical trials and potentially commercial needs Biotechnologies) and the Company dated February 23, 2014. with full GMP compliance. Lonza is an established supplier to the On February 23, 2014, we entered into a non-exclusive license pharmaceutical industry with global manufacturing expertise agreement with Adverum. For more details, see Section 11.5, in viral-based therapeutics. Lonza facility in Houston is FDA- “Intellectual Property” of this Registration Document. inspected and the personnel has a broad experience in the manufacture and release of batches of Phase I through Phase I I I Massachusetts Institute of Technology clinical trial materials for use in the US, Europe and Japan. In the • License agreement relating to patents used in connection with frame of several Statement Of Work (SOWs) agreed between GS030. 2015 and 2017, Lonza has executed the development of the On January 6, 2016, we entered into a license agreement with manufacturing process up to 100L batch-scale, as wel l as the M.I.T., upon exercising an option right granted under the patent manufacture and the control of the GS030-product required for option agreement between M.I.T. and us, dated January 9, 2015. preclinical and Phase I/I I clinical studies. This license agreement has been amended in April 2017, whereby By the end 2017, Lonza has completed the construction of a the Company will provide the M.I.T. with a written research and new Biotech facility in Pearland (Kirby Drive-Pearland-TX) development plan no later than July 1, 2018. For more details, see dedicated to the production of clinical and commercial Cell and Section 11.5, “Intellectual Property” of this Registration Document. Gene Therapy products. The facility is designed to accommodate process development unit, quality control laboratories, USP/DSP manufacturing suite and fully segregated fill-and-finish suite and 22.3 is expected to double the company’s current capacity for the MANUFACTURING AGREEMENT production of vectors for virally modified therapeutics. GenSight is considering further partnership with Lonza in Pearland for • Services agreement with Brammer Bio dated October 10, process scale-up to 250L and manufacture of the GS030- 2017. product required for the Phase I I I clinical studies. In order to secure the commercial grade manufacturing when GenSight will be ready for submitting the marketing authorization GENSIGHT BIOLOGICS – 2017 Registration Document– 233