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    Health (Bio-Tech)

 

  • Management of domestic and international bio-tech issues, including: advertising; affiliates; agreements; bankruptcy; class actions; claims management in class action lawsuit; compliance; contracts; corporate structures; distribution; distributorships; franchises; government interaction; insurance; internal and external investigations; internal review committees; domestic and international life sciences distribution agreements; managing document review, due diligence, ediscovery, records management and records retention; managing domestic and international outside law firms; managing internal law teams; managing litigation budgets; master agreements (MAs); master services agreements (MSAs); mergers and acquisitions; multi-district litigation; pharmacovigilance; providing success estimates for litigations; regulatory; retaining subject matter experts (SMEs); reputational risk management; risk management; settlement coordination.

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  • Compliance with Federal administrative agencies, frameworks, guidelines, recommendations, regulations, rules and statutes, such as the: 21st Century Cures Act (Cures Act); Anti-Kickback Statute (AKS); Biologics Price Competition and Innovation Act (BPCIA); Biotechnology Patent Protection Act (BPPA) – covering specialized patents utilized in bio-tech industries; Centers for Medicare & Medicaid Services (CMS); Civil Monetary Penalties Law (CMPL); Controlled Substances Act (CSA); Coordinated Framework for Regulation of Biotechnology (CFRB); Environmental Protection Agency (EPA); Export Administration Regulations (EAR); False Claims Act (FCA); Food and Drug Administration (FDA); FDA Office of International Programs (OIPs); Food, Drug, and Cosmetic Act (FD&C Act); fraud & abuse statutes; Health Insurance Portability and Accountability Act (HIPAA); International Traffic in Arms Regulations (ITAR); Office of Science and Technology Policy (OSTP); Orphan Drug Act (ODA); Physician Self-Referral Law (Stark law); Plant Protection Act (PPA); Plant Variety Protection Act (PVPA); Public Health Service Act (PHSA); US Department of Agriculture (USDA); US Department of Health and Human Services (HHS) Office of Inspector General (OIG) Exclusion Authorities (EA).

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  • Negotiation and drafting of agreements, contracts, documents and templates, such as for: acquisitions; asset purchase; biotechnology license; business associates; clinical research; clinical trials; co-branding; co-development and option; co-marketing; co-promotion; collaborative research; confidentiality; consulting; contract research and development; contract research organization (CRO) collaborations; cooperation; deferred compensation plan; development; development and license; development, promotion, distribution and supply; distribution; divestitures; employee stock purchase plan; engagement letter; equipment leasing commitment; financing; group purchasing organizations (GPOs); framework partnership; incentive stock option plan; integrated facilities management services; international co-development; intellectual property (IP) and technology transfer; IP rights; joint ventures; lease; master services; manufacturing; material transfer (MTA); mergers; multi-year international research and development (R&D) collaborations; non-compete (NCA); non-disclosure (NDA); non-employee directors' stock option plan; non-qualified stock option plan; non-solicitation (NSA); offer to purchase; outsourcing; partnering; patent rights purchase; plan of merger; preferred stock purchase; private label; purchase and sale; research and license; reverse mergers; royalties; sales representative; securities exchange; services; share option; share purchase; shareholder voting; sourcing; sourcing and supply; sponsored research; stock option plan; stockholder; strategic alliances; subject matter expert (SME); sublease; supply chain; supply of material; technology rights; tender and support; term sheet; underwriting; university licensing; voting.

 

  • Familiarity with various bio-tech industries and practices, such as: aesthetic biotechnology; agricultural biotechnology; animal genetics; biochemistry; bioethics; biofuels; bioinformatics; biologics; biomedical ethics; biosimilars; biotechnology licensing; catalysts; cell biology; combinatorial chemistry; cosmetic biotechnology; critical care technologies; cytogenetics; diagnostic assays; diagnostics; drug discovery; electronic health records; enzymes; gene therapies; genomics; immunology; diagnostics (IVD); laboratories; life sciences; medical devices; medical imaging; microbiology; molecular biology; nanotechnology; neurobiology; nextgen sequencing; oncology; peptides; personalized medicine; pharmaceuticals; pharmacogenomics; plant genetics; proteomics; radiation therapies; small molecule therapeutics; stem cell technologies; transgenic animal and plant technologies; white bio-tech.

 

  • Management of complex domestic and international litigation related to bio-tech issues, including: bankruptcy; class actions; claims management in class action lawsuit; internal and external investigations; managing document review, due diligence, ediscovery, records management and records retention efforts; managing domestic and international outside law firms; managing internal law teams; managing litigation budgets; multi-district litigation; providing estimates of success or failure for potential litigations; retaining subject matter experts (SMEs); settlement coordination in class action lawsuit.

 

  • Legal support for copyright issues, patent issues (such as the preparation, filing, and prosecution of patent applications to obtain the broadest possible protection), trademark issues, and also for all activities of external patent lawyers, such as: brand protection strategies; dispute resolution; due diligence; enabling innovative IP protection strategies; FDA regulatory activities; freedom-to-operate analysis; Hatch-Waxman Paragraph IV certification and litigation; identifying key IP opportunities; integrating with R&D teams; inter partes reviews (IPRs) before the Patent Trial and Appeal Board; licensing; literature searches; non-infringement review; opposition proceedings; patent infringement litigation; patent invalidity review; patentability review; patent prosecution; prior art searches; risk evaluations; technology transfers; trade secret protection; trademark acquisition; trademark enforcement; trademark registration; Uniform Domain-Name Dispute-Resolution Policy (UDRP) issues; utilization of non-patent literature databases and patent databases.

 

  • Legal support for the filing of typical bio-tech-related patents, such as: design patent (14-year term, for a new, original, and ornamental design embodied into or applied onto some manufactured item); drug patent (20-year term and subsequent extensions of exclusivity, for an active compound that is not a previously-approved composition or a modification of a previously approved compound promoted for a new use in terms of the dosage amount or form, formulation, indicators, method of administration, patient population or strength); plant patent (20-year term, for new and distinct, invented or discovered asexually-reproduced plant); and, utility patent (20-year term, for the invention of a new and useful composition of matter, machine, manufacture or process, or improvement thereof).

 

  • Management of patent portfolios covering diverse and various products, including: animal feed additives; anti-microbial compounds; gene-silencing compounds; nutraceutical products; probiotic beverages, foods and supplements; synthetic lethality medicines; targeted cancer therapeutics; topical applications.

 

  • Experience with typical ancillary financial issues related to biotech practice, such as: alternative public offerings (APOs); angel financing; asset and stock purchases and sales; biological licensure application (BLA); bridge loans; capital markets; confidentially-marketed public offering; convertible debt; debt financing; emerging companies; follow-on offerings; healthcare reimbursement; licensing; Medicaid; Medicare; private equity investments; registered direct offering; representation in startup lifecycle from incorporation through initial public offering (IPO); sale of royalties stream for a product licensed to a private bio-tech company; securities; Securities and Exchange Commission (SEC) Form 10 (General Form for Registration of Securities); seed financings; Series A through C venture capital financing initiatives; spin-offs; synthetic royalty financing; transfer pricing

 

  • Experience with typical ancillary miscellaneous issues related to biotech practice, such as: abbreviated new animal drug applications (ANADAs); abbreviated new drug applications (ANDAs); adulteration; assistance for interdiction of fraudulent products produced in non-FDA-certified foreign facilities; change-of-control transactions; combination products; complex torts; cosmetics labeling; cross-border licensing; coordination with US Customs and Border Protection (CBP); corporate governance; corporate policies, procedures and protocols; crisis management; country of origin issues; current good manufacturing practices (cGMPs); data exclusivity; data privacy; data security; dietary supplement labeling; drug master file (DMF); employment law; entity formation; FD&C Section 505(b)(2) applications; FD&C Section 510(k) premarket submissions; FD&C Section 520(l)(2) Premarket Approval of medical devices; FDA Form 483 observations; FDA warning letters; general wellness products; genetic variant detection; Health Economics and Outcomes Research (HEOR); healthcare fraud and abuse; intellectual property (IP); investigational new drug (IND) applications; investigations; licensing; market exclusivity; misbranding; nutraceuticals; new drug application (NDA) process; orphan drug exclusivity; personal use importation; Pharmaceutical Research and Manufacturers of America (PhRMA) code; pharmacy compounding; post-grant proceedings; products liability; strategic collaborations; strategic partnering; tariff classification of products; technology transfers between collaborating entities; utilization of the Orange Book Database for research.

 

  • Experience with various FDA regulation life cycle services, such as: advertising; approval pathways; clinical research; compliance; enforcement; product development; promotions.

 

  • Experience with US International Trade Commission (ITC) Section 337 exclusion orders, directing the Secretary of the Treasury to exclude certain goods scheduled for entry into the US, after the ITC determines that such goods violate Section 337 of the 1930 Tariff Act (TA).

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  • Bio-Tech (or biotech or biotechnology) is the general name for the application of scientific processes to any biological entity (such as in agriculture, agronomy, animal breeding, fish farming, genetic research, horticulture, medical research, scientific research, and the like) for the purpose of improving the human condition through the process of moving genes from one living organism into another using advanced recombinant deoxyribonucleic acid (DNA) technology, where the organism could be an animal, plant, or microbe, or the transfer of genes into a synthetic compound, and the United Nations Convention on Biological Diversity defines biotechnology as "...any technological process that utilizes living organisms, biological systems, or their components..." for the improvement of human living conditions.

 

  • Examples of bio-tech may be the creation of new biological compounds to clean and treat water for the purpose of increasing the available potable water supply for all persons on the planet, or the manipulation of the genes in a plant for the purpose of increasing yearly yield, or the use of stem cells for the purpose of creating new medicines or curing specific medical conditions.

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    Last updated 210509_1344

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