Provision Language
Definitions
“GOVERNMENTAL APPROVAL” means the authorizations and approvals (including regulatory and pricing approvals) of a Governmental Authority that are necessary for the TECHNOLOGY TRANSFER, or the COMMERCIALIZATION, MANUFACTURE, use or exploitation of the SUPPLIED MATERIALS, COMPOUND, DRUG SUBSTANCE or PRODUCTS in the TERRITORY.
ARTICLE 5. TECHNOLOGY TRANSFER
5.1 General
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5.1.4 During all STAGES, FIOCRUZ shall, at its own cost and expense, be responsible for (a) obtaining all GOVERNMENTAL APPROVALS required to MANUFACTURE and COMMERCIALIZE the PRODUCTS MANUFACTURED in the FACILITY in the Territory in accordance with the applicable STAGE, and (b) the construction, validation, maintenance and operation of the FACILITIES (including the new lyophilization suite, bioreactor facility and purification suites). FIOCRUZ shall be permitted to conduct any clinical trials approved by ANVISA required to obtain GOVERNMENTAL APPROVALS in the TERRITORY for the PRODUCTS entirely MANUFACTURED by FIOCRUZ at the FACILITY for the FIELD; provided FIOCRUZ provides PROTALIX prior written notice thereof and reasonably consults with PROTALIX upon PROTALIX’s request.
5.1.5 Notwithstanding Article 5.1.4, and for the avoidance of doubt, (a) FIOCRUZ acknowledges and agrees that PROTALIX shall be permitted to obtain and maintain, and take all actions necessary to obtain and maintain its own GOVERNMENTAL APPROVALS for the PRODUCTS or similar pharmaceutical products in the TERRITORY, and (b) the PARTIES acknowledge and agree that until FIOCRUZ obtains its own GOVERNMENTAL APPROVAL for the Products, FIOCRUZ shall COMMERCIALIZE the FINISHED PACKAGED PRODUCT supplied by PROTALIX under the GOVERNMENTAL APPROVALS obtained prior to the Effective Date by PROTALIX for the Territory. […]
ARTICLE 18. PHARMACOVIGILANCE AGREEMENT/QUALITY AGREEMENT
18.1 The PARTIES agree to comply with the terms and conditions of the Pharmacovigilance Agreement set forth as Appendix VIII.
18.2 The PARTIES agree in good faith to establish mutually agreeable quality guidelines following the EXECUTION DATE and prior to distribution of PRODUCT by FIOCRUZ, which shall cover, amongst other matters, delivery and storage of PRODUCT by FIOCRUZ. The PARTIES agree to comply with such quality guidelines during the TERM.
