CONFIDENTIAL
guidelines of good manufacturing practice in respect of Medicinal Products for human use and investigational Medicinal Products for human use, (ii) Directive 2001/83/EC laying down the principles and guidelines of good manufacturing practice for Medicinal Products; (iii) further guidance as published by the European Commission in Volume 4 (Good Manufacturing Practice) of “The Rules Governing Medical Products in the European Union” and (iv) ICH Q7 Guideline “Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients”.
1.30 “Government Authority” means any national, international, federal, state, provincial, or local government, or political subdivision thereof, or any multinational organization, or any authority, agency, or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory, or taxing authority or power, or any court or tribunal (or any department, bureau or division thereof).
1.31 “Know-How” means any and all data, inventions, methods, proprietary information, processes, trade secrets, techniques and technology, whether patentable or not, but which are not known to the public, including discoveries, formulae, materials (including chemicals), biological materials (including expression constructs, nucleic acid sequences, amino acid sequences, and cell lines), practices, test data (including pharmacological, toxicological, pre-clinical and clinical information and test data), analytical and assay information, procedures, designs for experiments and tests, technology, instrumentation, devices, regulatory filings, constructs, compounds, plans, diagrams, drawings, manufacturing practices, methods, models, knowledge, technology, and data (including formulation data), quality control data (including drug stability data), and descriptions, and any other type of information, in any form whatsoever.
1.32 “Pandemic” means the COVID-19 pandemic as declared by the World Health Organization.
1.33 “Patents” means any and all: (a) patents and patent applications (with the term patent being deemed to include an inventor’s certificate and application therefor, and utility model and design model patents and applications), (b) any foreign counterparts thereof, (c) all divisionals, continuations, continuations in part thereof, (d) all patents issuing on any of the foregoing, and any foreign counterparts thereof, and (e) all registrations, reissues, re-examinations (including resulting post-grant amendments to a granted patent), renewals, supplemental protection certificates, substitutions, revalidations, and extensions, supplementary protection certificates, and foreign equivalents of any of the foregoing.
1.34 “Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture, or other similar entity or organization, including a government or political subdivision, department, or agency of a government.
1.35 “Product” means any pharmaceutical product containing or comprising [***].
1.36 “Purchase Order” means each purchase order submitted by Purchaser for Doses of CpG Material.
1.37 “Quality Agreement” has the meaning set forth in Section 4.1.
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