Health (Pharmaceuticals - Contracts)
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Negotiating and drafting all the documents required to facilitate a new product launch, such as agreements and contracts for advertising, banker engagement, business development, clinical call centers, co-branding, co-promotion, collaboration, collateral, compliance services, confidential disclosure (CDA), customer purchasing, data usage, direct distribution, discounts, fee-for-service, formularies, franchise, joint venture, implementing chargeback programs for Section 340B participation, law firm retainer, license, managed markets, marketing, mergers and acquisitions (M&A)-related (such as asset and stock purchase or sale, definitive purchase), non-compete, non-disclosure (NDA), non-solicit, patient assistance programs, payer rebates, pharmacy and therapeutics (P&T) coverage, prescription drug list (PDL), privacy, promotions, rebates, reimbursement hubs, risk evaluation and mitigation strategy (REMS) programs – including Elements to Assure Safe Use (ETASU), sales, venture capital, Veterans Health Administration (VHA) programs, wholesale distribution.
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Negotiating and drafting of manufacturing, supply and distribution (MSD) agreements.
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Negotiating and drafting of various types of licensing agreements related to pharmaceutical manufacturing, such as pre-FDA-drug-licensing (all agreements and certifications required in order to provide the FDA with all information and samples for the FDA drug licensing approval process), pre-FDA-facility-licensing (all agreements and certifications required in order to receive a license for a drug manufacturing facility from the FDA and from any state agencies), in-licensing (in which an investor firm provides development and launch capital so a small pharmaceutical startup may initiate production of a new drug), out-licensing (in which a partnership of legal, lobbying, marketing and media firms assist a drug manufacturer in finding a target market for a new drug).
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Negotiating and drafting of Federal government health-related procurement, involving the Federal Employees Health Benefit Program (FEHBP), Federal Supply Service (FSS), General Services Administration (GSA), Multiple Award Schedules and Veterans Administration (VA) procurement practices.
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Familiarity with government-wide acquisition contracts (GWACS) and other multiple-award indefinite delivery/indefinite quantity (ID/IQ) contracts.
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Consultation for government prime contractors procuring from subcontracting firms, or for subcontractor firms selling to government prime contractors.
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Implemented internal controls compliance protocols and systems to conform to the requirements for various government procurement contract frameworks.
Last updated 210509_1520