of the Product. For the avoidance of doubt, Fill/Finish shall not include any activities included in the definition of Labeling and Packaging.
“FINAL PRODUCT” shall mean PRODUCT produced entirely by FIOCRUZ at the FACILITIES from the CELL BANK.
“FINISHED PACKAGED PRODUCT” means the PRODUCT that has undergone FILL/FINISH and LABELING AND PACKAGING to be supplied by PROTALIX to FIOCRUZ until the registration of PRODUCT 2 by ANVISA in PROTALIX's or FIOCRUZ's name.
“FORCE MAJEURE EVENT” shall have the meaning ascribed to such term in Article 20.1.
“FORECAST” shall have the meaning ascribed to such term in Article 6.2.1.
“GOOD MANUFACTURING PRACTICES” or “GMP” means all applicable Good Manufacturing Practices including, (a) the applicable part of quality assurance to ensure that products are consistently produced and controlled in accordance with the quality standards appropriate for their intended use, as defined in ANVISA RDC 17 and RDC 66-07 laying down the principals and guidelines of good manufacturing practice, (b) WHO GMP guidelines, and (c) the equivalent Laws in any relevant country or other sovereign entity in which PRODUCT is marketed, manufactured, distributed, offered for sale, sold or imported by or on behalf of FIOCRUZ, each as may be amended and applicable from time to time.
“GOVERNMENTAL AUTHORITY” means any court, agency, department, authority or other instrumentality of any national, state, country, city or other political subdivision.
“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.
“GOVERNMENT OFFICIAL” shall have the meaning ascribed to such term in Article 17.2(f).
“IMPROVEMENT” means any enhancements to the Protalix Technology enabling superior productivity, therapeutic activity, feasibility, profitability and/or improvement of the production processes included in the Protalix Technology.
“INDEMNIFIED PARTY” shall have the meaning ascribed to such term in Article 16.3.
“INDEMNIFYING PARTY” shall have the meaning ascribed to such term in Article 16.3.
"INITIAL FORECAST" shall have the meaning ascribed to such term in Article 6.2.1.
“INPI” means the Brazilian National Institute of Industrial Property.
“LABELING AND PACKAGING” means the final product labeling and packaging of the Product as intended for commercial distribution and sale of such PRODUCT to THIRD PARTIES in the TERRITORY, including insertion of materials such as patient inserts, patient medication guides, professional inserts and any other written, printed or graphic materials accompanying the Product.
“LAWS” means all laws, statutes, rules, regulations, codes, administrative or judicial orders, judgments, decrees, injunctions and/or ordinances of any Governmental Authority, and other legal requirements of any kind, whether currently in existence or hereafter promulgated, enacted, adopted or amended.
“LOSSES” means any and all damages (including all incidental, consequential, statutory and treble damages), awards, deficiencies, settlement amounts, defaults, assessments, fines, dues, penalties, costs, fees (including reasonable attorney fees), liabilities, obligations, taxes, liens, losses and expenses, including those incurred by or awarded to Third PARTIES with respect to a Third PARTY Claim by reason of any judgment, order, decree, stipulation or injunction, or any settlement entered into, and all other documented costs and expenses incurred in investigating, preparing or defending any Third PARTY Claim litigation or proceeding, commenced or threatened, or in complying with any judgments, orders, decrees, stipulations and injunctions (including court costs, interest and reasonable fees of attorneys, accountants and other experts).