Corporate Strategy

Corporate Law Firm having Offices in Boston, Los Angeles, Orange County, and San Diego

Torrey Pines Law Group has substantial, meaningful experience with life sciences and healthcare businesses to visualize paths toward your goals, and to identify risks for the unwary. We reduce your corporate vision to actionable items, and help you implement your strategies for success -- however you may define it.

Specifically, each of our transactional team members have the following exceptional qualities:

Scientific and Business Acumen: A deep understanding of the scientific and technical concepts behind drug development, clinical trial processes, high technology, and the commercialization landscape of the life sciences, healthcare, and tech industries.
Strategic Thinking: The ability to analyze complex situations, identify potential legal and regulatory hurdles, and develop creative solutions to achieve our client's business objectives.
Communication and Collaboration: Strong communication skills to collaborate effectively with scientists, R&D teams, business development departments, and senior management.
Client Focus: A client-centric approach, understanding our client's goals and challenges, and providing tailored legal advice that supports overall business strategies.

Our firm also works with experienced outside counsel to help clients with international business formation, tax strategy, US Securities Act, and US Exchange Act matters. Working with both US co-counsel and foreign associates, we have helped clients establish foreign subsidiaries, and engage in cross-border supply, manufacturing, and distribution agreements for software, cleared medical devices, and approved drugs worldwide. We work seamlessly within our vetted network of experienced tax, securities, and foreign attorneys to help with developing the proper structure of business transactions, and thereby minimize the risk of complex ventures.

Business Transactions

Our attorneys have successfully handled a number of both "day-to-day" and complex business transactions including, but not limited to:

Research and Development (R&D) Agreements:

Joint Research Agreements (JRAs): Collaboration between two or more parties to conduct research on a specific technology, drug or therapeutic target. Defines ownership of intellectual property (IP) generated, cost-sharing, and publication rights.
Sponsored Research Agreements (SRAs): A technology company funds research conducted by a university or research institution. Outlines research goals, deliverables, ownership of IP, and publication rights.
Clinical Trial Agreements (CTAs): Outlines the terms for conducting clinical trials on a new drug candidate or medical device. Specifies responsibilities of the sponsor (e.g., a pharmaceutical company), investigator (doctor or research institution), and regulatory requirements.

Examples of license agreements include:

Licensing Agreements:

In-licensing Agreements: Technology company acquires the rights to develop, manufacture, and commercialize a technology, drug candidate already discovered by another party. Defines license fees, royalties, milestones, and potential co-development arrangements.
Out-licensing Agreements: Technology, pharmaceutical, biotech, or medical device company grants another party the rights to develop, manufacture, and/or commercialize its existing technology, drug or device. Defines license fees, royalties, territories covered, and quality control measures.

Manufacturing and supply agreements we have experience with include:

Manufacturing and Supply Agreements:

Manufacturing Agreements: Technology, pharmaceutical, or device company outsources the manufacturing of its technology to a Contract Manufacturing Organization (CMO). Defines quality standards, production timelines, costs, and intellectual property ownership.
Supply Agreements: Technology, pharmaceutical, or device company secures a reliable source for software, raw materials or specific components needed for manufacturing. Defines quantities, pricing, delivery schedules, and quality control procedures.

Commercialization agreements we have experience with include:

Commercialization Agreements:

Co-Promotion Agreements: Two technology, pharmaceutical, or device companies collaborate to market and sell a technology or drug, sharing marketing costs and profits. Defines brand strategy, marketing activities, and profit-sharing mechanisms.
Distribution Agreements: Technology, pharmaceutical, or device company grants a distributor the right to sell its technology, drug, or device in a specific territory. Defines pricing, sales targets, marketing restrictions, and quality control responsibilities.

Other agreements related to life sciences and health care clients we have experience with include:

Other Agreements Related to Life Sciences and Health Care Clients:

Material Transfer Agreements (MTAs): Outlines the terms for sharing biological materials (e.g., cell lines, tissues) between research institutions or companies. Defines ownership rights, usage restrictions, and publication considerations.
Non-Disclosure Agreements (NDAs): Ensures confidentiality of sensitive information shared during collaborations, such as trade secrets or early-stage research data.

We also help our clients ensure that a variety of protections are in place so that they are compliant with US and International laws and regulations. This includes a focus on intellectual property protection, regulatory affairs and compliance experience, and risk management and corporate governance.

Protecting Intellectual Property (IP):

Patent Strategy: Collaborate with research and development (R&D) teams to identify patentable inventions and develop comprehensive patent filing strategies for new drugs, formulations, and technologies.
Patent Portfolio Management: Manage the company's patent portfolio, ensuring timely renewals, maintenance fees are paid, and potential challenges or infringement issues are addressed proactively.
Licensing Agreements: Draft, negotiate, and review in-licensing and out-licensing agreements for intellectual property related to drugs, technologies, or research tools.

In addition, we assist our clients with ensuring regulatory compliance:

Regulatory Affairs and Compliance:

FDA Compliance: Ensure all activities comply with Food and Drug Administration (FDA) regulations throughout the drug development process, from pre-clinical trials to clinical studies and post-market surveillance.
Global Regulatory Landscape: Navigate the complexities of international regulations for drug development and marketing, working with partner law firms in different countries to ensure compliance.
Adverse Event Reporting: Advise on procedures for identifying, investigating, and reporting adverse events associated with the company's drugs to regulatory agencies.

Additionally, we provide counsel with respect to risk management and corporate governance:

Risk Management and Corporate Governance:

Contract Review: Review and negotiate various contracts entered into by the company, mitigating potential legal and financial risks associated with collaborations, vendor agreements, or service contracts.
Corporate Governance: Advise on and ensure adherence to corporate governance best practices, including board of directors' responsibilities, shareholder rights, and compliance with anti-bribery and anti-corruption laws.
Data Privacy and Security: Develop and implement policies and procedures to comply with data privacy regulations and safeguard sensitive patient information collected during clinical trials or drug use.
Internal Investigations: Conduct internal investigations into potential legal or ethical violations within the company, ensuring fair and impartial processes.

Contracts, Shareholder & Operating Agreements

Our firm also drafts and negotiates documents related to:

Corporate formation (C-corp, S-corp, LLC, etc.)
Shareholders Agreements
Operating Agreements
Executive Compensation Agreements
Separation Agreements

Entity Formation

Our attorneys substantial experience in the formation of business entities. We form corporations (both C-corporations and S-corporations) in any state (through our third-party vendors), including providing registered agent services. Entity formation includes the preparation oand filing of Articles of Incorporation, Bylaws, Minutes, and Corporate Books, and Seals where required.

We also assist with the formation of:

Limited Liability Companies (LLCs),
Limited Partnerships,
Limited Liability Partnerships, and
General Partnerships.

For information on these and other legal, regulatory, and business matters, please contact us.

Torrey Pines Law Group, PC serves technology innovators with protecting intellectual property, obtaining regulatory approvals and clearances, and making deals and closing technology transactions throughout the U.S., including in major technology hubs such as San Diego, San Francisco, Palo Alto, San Jose, Silicon Valley, Boston, Cambridge, Chicago, Minneapolis, Houston, Dallas, Atlanta, Denver, Seattle, Portland, Boulder, Orlando, the Research Triangle (Raleigh, Durham, and Chapel Hill), the Mid-Atlantic (New Jersey, New York, Philadelphia, Maryland, Virginia, and Washington, DC), Pittsburgh, Cleveland, Ann Arbor, and throughout Southern California in Los Angeles, Orange County, Irvine, Torrey Pines, Sorrento Valley, and La Jolla.

We have experience with international intellectual property, regulatory and transactional matters pending in Beijing, Shanghai, Shenzhen, and Guangzhou China; Tokyo, Japan; Berlin, Munich and Frankfurt Germany; Tel Aviv Israel; Mumbai, Bengaluru, and New Delhi India; London and Edinburgh United Kingdom; Vancouver, Toronto, Calgary and Montreal Canada; Dublin, Ireland; Cape Town, South Africa; Mexico City and Tijuana Mexico; Brussels, Belgium; Copenhagen, Denmark; Paris, France; Madrid and Barcelona Spain; Moscow, Russia; Santiago, Chile; Montevideo, Uruguay; Buenos Aires, Argentina; Sao Paulo and Rio de Janeiro Brazil; Seoul, South Korea; Taipei, Taiwan; Hong Kong; Hanoi, Vietnam; Bangkok, Thailand; Kuala Lumpur, Malaysia; Milan, Italy; Singapore; Sydney, Melbourne, Perth and Adelaide Australia; Auckland, New Zealand; Oslo, Norway; Stockholm, Sweden; Helsinki, Finland; Kiev, Ukraine; Budapest, Hungary; Vienna, Austria; Prague, Czechia; Geneva and Lausanne Switzerland; Bahrain; Doha, Qatar; Abu Dhabi and Dubai UAE; and Jeddah, Saudi Arabia.

IP Agreement Drafting and Negotiation - Inbound and Outbound Technology Licensing Transactions - Intellectual Property Transactions Counseling - IP Enforcement Agreements