Successes and Achievements on Behalf of Our Clients:

Intellectual Property:

• We are experts in patent preparation and prosecution with a focus on patenting the commercial embodiments of your inventions, and able to withstand validity challenges worldwide. Our team has helped major universities including the University of California, Stanford University, University of Chicago, Washington University in St. Louis, and many others with protecting basic research innovations with an eye on follow-on commercialization. Our team has helped major biopharmaceutical and electronics companies such as Pfizer, Novartis, Covidien, Mallinckrodt, Teva, Sony, and Sun Microsystems with patenting and challenging core "composition of matter" and product patents.

• Each member of our patent team has prepared and prosecuted hundreds of cutting-edge patents throughout the world related to biotechnology, pharmaceutical, medical device, artificial intelligence, convergence technologies, and chemistry and chemical engineering.
• Our team has helped extend the patent term for multiple Active Pharmaceutical Ingredients (APIs) through complex pharmaceutical lifecycle management strategies.
• Obtained patents on several "Orange Book listable" technologies to extend the patent term and FDA exclusivity of a small molecule pharmaceutical.
• Secured several exclusive license agreements of both small and large molecule candidates, including sub-licenses for international manufacturing.
• Protected trade secrets and know-how through licenses and other forms of value-created and securitized transactions.
• Filed international trademark applications related to biotechnology, pharmaceutical, medical device, and other innovative company branding.

• Obtained significant patent protection for Guardant Health related to multiple bioinformatics platform technologies that help pharmaceutical companies develop next-generation cancer therapies. The patent were granted in one of the most difficult art units within the US Patent & Trademark Office.
• Obtained 10+ US patents (and additional international patents) for Dermala related to its novel microbiome balancing dermal technologies. The technology validated investments by Johnson & Johnson and several VC funds.
• Obtained early patent protection for Singulex, under which its patent portfolio was acquired by Millipore in 2015 and incorporated into Millipore's SMCxPRO System for Single Molecule Counting.
• Created a substantial patent portfolio which underpinned the IPO of Galera Therapeutics (NASDAQ: GRTX).
• Obtained early patent protection for an acclaimed US private research institute, then licensed to Epic Sciences as a basis for its liquid biopsy platform.
• Created a substantial patent portfolio for Isto Technologies which which was later acquired by Zimmer, and now used in its DeNovo NT Graft cartilage restoration products.
• Created a novel patent portfolio for Abcore which provided significant value in its acquisition by Fortis Life Sciences.
• Obtained 10+ US patents (and additional international patents) for CB Therapeutics related to its precision synthetic biology platform, and ultimately resulting in significant follow on investments.
• Created a substantial patent portfolio which was licensed to MediBeacon for the commercialization of kidney function detection platform.
• Obtained early patent protection for ProteoPlex, an antibody microarray company which was acquired by EMD Biosciences.

Business Deals:

We have exceptional experience with drafting and negotiating contracts and agreements, and specifically with *closing* business transactions, including investment funding, commercial, corporate, and myriad other contractual matters that affect your bottom line.

• On behalf of a Berkeley-based synthetic biology company, we advised on the closing of a complex international license agreement having a component in-licensed from a prominent university; all patent applications related to the deal are drafted and prosecuted by our attorneys.
• On behalf of a California artificial intelligence-powered Avatar app developer, we advised on the legal de-risking of the platform by drafting comprehensive Privacy Policies, Terms of Service, and other legal documents that take a novel approach to copyright, copyleft, public domain, rights of publicity, and other legal doctrines.
• On behalf of a Carlsbad, San Diego-based biotechnology company, we advised on the creation of a joint venture with a multi-billion dollar publicly traded European biotech, and conducted all related due diligence.
• On behalf of a major international specialty chemical manufacturer and distributor, we drafted legal opinions to block assertions of patent infringement, either direct or contributory, under theories of patent validity/invalidity, non-patent exclusivities, data exclusivities, and other legal theories.

• On behalf of a leading generic drug manufacturer, we led a team of IP, corporate, and tax attorneys in nine-figure acquisition of pharmaceutical manufacturer for Fortune 500® company.
• On behalf of a major US Active Pharmaceutical Ingrediant (API) manufacturer, we created a legal strategy for the company to avoid significant liabilities under the license of the API manufacturing process.
• On behalf of a Fortune 500® ANDA applicant, we provided pharmaceutical product clearance and successfully condluded due diligence.
• We have created numerous entities for clients including limited liability companies (LLCs) in a variety of states including California, Delaware, Wyoming, Arizona and Nevada; Delaware corporations; California corporations including C-corps., S-corps., and partnerships; and non-profit corporations including 501(c)(3) and 501(c)(5) corporations.
• On behalf of numerous clients, we have drafted and negotiated international technology license agreements with counterparts in China, Japan, Korea, Taiwan, Europe, Canada, Mexico, and Brazil, among other nations and jurisdictions.
• We have helped countless company founders with identifying and obtaining private and non-dilutive government funding for biotech, pharmaceutical, and medical device startups, including SBIR, STTR, and TABA funding.

FDA Regulatory:

• We have very deep experience with obtaining FDA approvals and clearances, obtaining reimbursement codes, and guiding that processes including with dossier submissions, quality compliance, labeling, advertising and promotion, and health economics studies. Our team works hand-in-hand with R&D teams, CMC teams, CROs and CMOs, clinical trials specialists, and our clients' executive teams to expertly drive a drug, medical device, or diagnostic to market.

• On behalf of our client, Imeka, we helped obtain a 510(K) clearance for "Automated Radiological Image Processing Software" in conjunction with our collaborators, EVERSANA. The software was cleared to provide automated radiological image processing and analysis tools.
• On behalf of our client, CureMetrix, we helped the company obtain 510(k) clearance for "Radiological Computer-Assisted Prioritization Software For Lesions." The radiological computer-assisted prioritization software for lesions is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images. The device offers high sensitivity and specificity >95% AUC.

• Members of our IP and FDA Regulatory teams assisted a biopharmaceutical company with the Japenese drug approval of HIYASTA® (tucidinostat 10 mg tablets) in Japan's Pharmeceuticals and Medical Devices Agency (PMDA) through Japan's Orphan Drug designation. The drug is a new active ingredient indicated for the treatment of relapsed or refractory adult T-cell leukemia-lymphoma.
• Assisted with the clearance of medical devices under 510(K), 510(K) de novo, and Pre-Market Authorization regulatory pathways.
• Identified Orange Book listable innovations and protected the same with patent application submissions.
• Helped identify reimbursement stragegies and CPT code procurements.
• Identified Risk Evaluation and Mitigation Strategies (REMS) before the US FDA.
• Members of our team have assisted with the preparation of Investigational New Drug and New Drug Applications in the US, China and Japan.