Medicamentos, the Brazilian interministerial chamber that approves prices of drug
products in Brazil.
means any confidential or proprietary information of a Party disclosed to the other Party or generated in the course of this Agreement, including inventions, know-how, works of authorship, software, data, software tools, designs, schematics, plans or other information relating to any work in process, future development, engineering, manufacturing, marketing or business plan, or financial or personnel matters relating to either Party, its present or future
products, sales, suppliers, customers, employees, investors or business.
1.6“Current Good Manufacturing Practice”
means the methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the regulatory requirements of the United States Food and Drug Administration and as further defined in 21 C.F.R. Parts 210 and 211 and the guidance of the
Center for Drug Evaluation and Research (“
CDER”) and the
Center for Biologics Evaluation and Research (“
CBER”), and the
European Commission Directive 2003/94/
EC of October 8, 2003.
1.7 “Definitive Product Registration”
means ANVISA’s formal approval (i.e., that is not on an emergency use basis) of the Product for treating any indications in humans, together with CMED´s price approval. for the Product.
1.8“Authorization For Emergency Use” or “Authorization”
means the authorization granted by ANVISA for emergency use of the Product intended for COVID-19 treatment, in order to immediately make available certain pharmaceutical drugs that are able to control de current public health emergency arising from the pandemic.
1.9 “Distribution Price” [*]
1.10“FDA” means the United States Food and Drug Administration.
1.11“Intellectual Property Rights” means any and all rights in and to discoveries, concepts, ideas, technical information, developments, specifications, methods, drawings, designs, flow charts, diagrams, models, formulae, procedures, processes, schematics, specifications, algorithms, apparatus, inventions, ideas, know-how, materials, techniques, methodologies, modifications, improvements, works of authorship and data (whether or not protectable under patent, copyright, trade secrecy or similar laws), including patents, utility models, and registered and unregistered designs, including mask works, copyrights, trade secrets, design history, manufacturing documentation, and any other form of protection afforded by law to inventions, models, designs, works of authorship, databases or technical information and applications and registrations with respect thereto.
means all necessary
approvals issued by ANVISA for Territory required to develop, market, sell or have sold the Product in the Territory but excluding any CMED’s pricing