Steve Malaska Email & Phone Number

Redwood City, Ca, Us

General legal, employment, compliance, regulatory, governance, IP, transactions, privacy, securities, fundraising, etc.

Portland, Oregon, Us

General Counsel, reporting to the CEO, for rapidly growing, pre-IPO, machine learning, data science, biopharma and diagnostics company. Strategic partner to the board and senior leadership. Manage all legal matters including: identifying and implementing internal controls, employment law, manage commercial litigation and arbitration, ensure HIPAA, EKRA and anti-kickback statute compliance, regulatory compliance, marketing initative and sales training review, commercial transactions, conduct and manage internal investigations, intellectual property strategy and procurement, and business development. Managed the closing of a $30M tranche Series B round. Prepare board meeting minutes, board resolutions, negotiated long-term leases, subsidiary dissolution, coordinated IPO-preparedness activities, including: drafting S-1 business section, interviewed and selected a Big-4 auditor, assisted in audit; participated in investor pitches, prepared virtual data room. Created corporate Code of Ethics and Business Conduct including whistleblower hotline, created board committee charters, and guided management and board on IPO process. Manage stock option matters in Carta. Negotiated terms of Diligent Board portal.

STRATEGIC LAW & MANAGEMENT GROUP, PLLC – Seattle Area, WAManaging Member 03/2020 – PresentProvide strategic legal advice on general legal, intellectual property, transactions, and business development for emerging and established companies in the biotechnology, foodtech and diagnostic industries. Assist clients with IP procurement, due diligence and implementing strategic initiatives. Identify new IP opportunities, IP monetization strategies, IP for defense strategies, and build long term value through IP development and strategic transactions.

Bellevue, Wa, Us

Founded and led all activities to start-up a life science company using patented cell therapy platform technology. Developed strategic plans, negotiated and completed business transactions, worked collaboratively with cross-functional groups, assist in fund raising efforts and recruit scientific board members. Skilled at proactively finding creative solutions to seemingly intractable problems.

Bellevue, Wa, Us

Hired to lead first of its kind, highly innovative and productive $400M Invention Science Fund to oversee all aspects of biotech & life sciences patent protection and monetization. Expanded responsibilities to chief intellectual property strategist for life sciences portfolio, managing day-to-day patent operations and budget with a hands-on approach, supervising a team of 9 (including 7 JD/Ph.Ds.), and 25 indirect reports in a department of 55 professionals. Effectively managed external partners, including law firm, and database service providers.● Devised and led the patent portfolio in biological science, genomics, imaging, medical devices, bioinformatics, drug delivery, and diagnostics. Worked closely with corporate development management to monetize the assets.● Used time management and project management skills for efficient high-volume patent application drafting, filing and prosecution and maintenance in major world territories; manage docket of 1,500+ worldwide patent assets. ● Standardized internal patent appellate practice (PTAB), thereby improving appeal success by 50%. ● Served as internal expert on IP legislation and regulations; evaluated proposed intellectual property legislation and interacted with USPTO on behalf of Invention Science Fund.● Performed regular competitive intelligence in relevant markets.● Worked closely with senior business leaders to determine monetization path for each technology.● Used best practices and policies to drive continuous departmental improvement and customer service.● Conducted due diligence on potential partnering or in-licensing technologies.● Served as the primary point of contact for all HR matters relating to the legal department.

Us

Reporting to the President & CEO, hired to direct all legal affairs and business development functions. Provided counseling to the senior leadership team on all corporate, governance, financing, intellectual property, business transactions, real estate leases, product development, employee relations, and other policy & legal matters. ● Draft, file, and prosecute patent applications and claims, and prepare freedom-to-operate searches and opinions, regarding small molecule therapeutic global patent portfolio, including manufacturing, & process development.● Performed due diligence to support corporate development activities.● Managed external general legal and patent counsel. ● Responsible for overseeing legal budget.● Led negotiation with myriad multinational pharmaceutical companies for potential corporate alliances.● Built a collaborating partnership with R&D & project teams on IP matters, publication review, trade secrets, etc.

Us

[Acquired by Amgen in 2002] Asked to lead a newly formed IP Transactional Law group reporting to the General Counsel after 6 years in positions of increasing IP responsibility, including Director and Senior Director levels. Developed patent portfolio of key discoveries, and developed transaction and defensive strategy, including freedom-to-operate opinions, that maximized value and protection of products. ● Devised and executed the entire FDA Paragraph IV Certification ANDA strategy and managed successful patent litigation against Bristol Myers Squibb Co. for generic Taxol, followed by the sale of the product. ● Managed the drafting, prosecution, and licensing of patent portfolio for Enbrel, a $8 billion dollar/yr rheumatoid arthritis product, including patent interferences, European Oppositions, PTAB Appeals, etc. Headed trademark search, analysis, selection and maintenance of the Enbrel trademark and for two other products. Devised creative patent strategy for Enbrel that significantly contributed to acquisition of Immunex for $16B.● Demonstrated success in the negotiation and completion of myriad transactions including confidential disclosure agreements, material transfer, CRADA, license, collaboration, research & development, commercialization, copromotion, joint defense, and supply agreements. Involved in the details of the M&A with Amgen, and divestiture of Leukine to Schering AG.● Worked closely with product launch teams to ensure compliance with industry regulations, and IP strategy.● Assisted the General Counsel on sections of SEC filings relating to IP.● Built a collaborating partnership with R&D, project, manufacturing, & CMC teams on IP, publication review, trade secrets, etc.

Switzerland 🇨🇭 , Ch

Responsible for drafting and prosecuting patent applications in mechanical and chemistry areas.

Bs, Chemical Engineering

Jd, Law