Protalix – Fiocruz, Gaucher Disease Therapy Technology Transfer and Supply Agreement

Intellectual property | Ownership of IP

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This Technology Transfer and Supply Agreement is between Protalix, Ltd and Fundação Oswaldo Cruz (“Fiocruz“), a foundation affiliated with the Ministry of Health of the Brazilian Government with a manufacturing unit known as Bio-Manguinhos. Under the Agreement, Protalix agrees to provide Fiocruz with rights, technical assistance and materials to enable Fiocruz to manufacture and supply finished forms of plant cell expressed recombinant Glucocerebrosidase (“Product“) for enzyme replacement therapy for the treatment of Gaucher Disease (“Field“) in Brazil (“Territory“).

Fiocruz receives a license to use Protalix Technology and Patent Rights for the purposes of manufacturing and commercialization of the Product in the Field and Territory. The license for commercialization is exclusive provided that Fiocruz is able to meet demand for the Products, and complies with the conditions of the license grant and requirements for diligent commercialization.

The Agreement provides for technology transfer in several stages, and Fiocruz will purchase materials exclusively from Protalix as required depending on the stage of technology transfer. Fiocruz will reimburse Protalix for the costs of providing training and technical assistance, and royalties will be due to Protalix upon completion of a Phase III clinical trial and approval from the Brazilian regulatory authority for manufacture of the final product by Fiocruz. Fiocruz must also ensure that manufacturing processes are in compliance with GMP, Brazilian law and the specifications set by Protalix. Protalix will have the right to inspect Fiocruz’s facilities to verify compliance with quality control standards, and to conduct quality control testing on production batches.

Provision Language

ARTICLE 10. OWNERSHIP OF ENHANCEMENTS

10.1 Any invention made, conceived or reduced to practice by PROTALIX in connection with the performance of the obligations of this AGREEMENT relating to: (i) a pharmaceutical product with the same chemical composition as the PRODUCT or (ii) an IMPROVEMENT to the PRODUCT or (iii) an IMPROVEMENT to the process or specifications provided by PROTALIX to FIOCRUZ, shall be the exclusive property of PROTALIX. PROTALIX, in its sole discretion, may file for patent protection in its own name for any such invention. PROTALIX shall, and hereby does, grant to FIOCRUZ a non-exclusive, irrevocable, perpetual, worldwide, royalty-free license to use, sublicense, practice and otherwise exploit in any manner any such invention and any patent or other intellectual property or proprietary rights therein throughout the world.

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Protalix – Fiocruz, Gaucher Disease Therapy Technology Transfer and Supply Agreement

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