Some Examples* of How Randy's Innovative, Outside the Box Thinking Has Helped or Is Helping Clients °
Litigation: Hatch Waxman (HW) , IP, PL, antitrust, employment, contract & general commercial litigations for numerous corporate clients, including:
- successful 1st chair/support/management of jury/bench/administrative trials/matters
- summary judgment in wrongful discharge, whistleblower, Product Liability (PL) & contract matters
- Innovative/Ground-breaking/Company Transforming HW, PL & other strategies, solutions & settlements re core client products
- Landmark FDA preemption/jurisdictional ruling; motions in limine re recalls/defects
- document management strategies to drastically reduce overhead/increase efficiency
Regulatory/LCM: Creative ideas securing transformational product results, including:
- Citizen Petitions securing exclusivity years past patent expiry; pediatric extensions
- product portfolio maximization through new/follow-on/combo product ideas
- deterrence of illicit generics
- design/securing of lead product NDA/PI with enhanced IP/market exclusivities
- significant experience re: drugs, devices, advertising/labeling, recalls, cGMP CROs,
REMS, managing diversion/AEs/PCs/crises/cGxPs/facility inspections
Compliance/Government Inspection/Crisis Management: Effective risk control through:
- conduct of Compliance Gap Analysis
- design/implementation/training of Codes of Conduct & significant policies
- defending vs. DEA/DOJ/EEOC/FDA/FTC Audits/Inspections/Investigations
- leading Crisis Management Teams to avoid PR/PL/Regulatory fallout
- managing FTC Decision & Order merger compliance; AT issues
Employment: Managing/coordinating HR legal advice/services/resources:
- employment counseling/discipline/PIPs/terminations/RIFs
- suits, EEOC & State Agency Claims won, dismissed or favorably settled
- summary judgment re $ multi-million wrongful discharge/whistleblower suits
- FMLA/STD/Workers Compensation/Leave policies & RTW Accommodations/IMEs
- policy design re Civil Treatment, Secrecy/Invention & Employee Handbooks
- award winning Company-Wide Harmonization re HR Investigations & Discipline
Business Development/Due Diligence: Gap Analysis & Diligence tools to help:
- assess where Companies are/should be/devise plan to align vision/practices
- recognize if current practices miss/worsen risks and/or impede opportunities
- make Business Development decisions with the long view in mind
- enable Business Teams to leverage issues to commercial advantage
- interest investors in companies/assess potential acquisition candidate value
Contract/Transactional: protective, business-focused and business- friendly:
- agreement negotiation/drafting/review including re acquisition, divestiture,
partnership, licensing, development, manufacture, quality, packaging, supply,
distribution, pricing, goods & services, vendors, lease & construction - forms/SOPS to enable employees to contract re repeat low risk transactions
- management of press releases to minimize legal, regulatory & compliance risk
- Legal Operations management; corporate secretarial function
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° Any information contained on this website with respect to results obtained by IngeNEWity Legal Consultants, LLC is not meant to indicate that the same or
similar results can or will be obtained in other cases or situations. Results will vary depending on the facts and circumstances of each individual matter. Prior
results do not predict, warrant, or guarantee a similar outcome with respect to any future matter that we or any lawyer may be retained to handle. See
link to the Legal Notices, Disclaimers and Terms of Use and Privacy below.