Kevin Foley Email & Phone Number

Cambridge, Ma, Us

Chief legal counsel for strategic alliances and partnerships, which includes the management of a diverse portfolio of all key collaboration agreements, joint ventures, and licensing deals essential to our organizations commercial business growth and pipeline development. I lead the negotiation, drafting, and review of complex agreements related to alliances and partnerships, ensuring alignment with our company’s objectives, regulatory requirements, and operational goals.I work closely with colleagues across our organization to provide legal guidance on intellectual property rights, licensing, and technology transfer, supporting innovation and R&D efforts that drive our business forward. Additionally, I have primary responsibility for all legal aspects of acquisition integration and divestitures, which includes coordinating with cross-functional teams to ensure a seamless incorporation of acquired entities, assets, and intellectual property, as well as the smooth transition of divested assets.I frequently partner with teams in R&D, business development, commercial operations, and regulatory affairs to ensure the effective execution of alliance and acquisition agreements. I also develop and implement strategies to mitigate risks and resolve disputes, particularly within the context of collaborative ventures and acquisition transitions.In support of corporate governance, I ensure that our operations adhere to regulatory standards, including those set by the FDA, EMA, and other global biotech authorities providing executive leadership with guidance on legal risks, opportunities, and best practices for managing partnerships, alliances, and post-acquisition integration, helping to safeguard and strengthen the company’s strategic objectives.

Cambridge, Ma, Us

As the Head of Legal for the Intercontinental Region, I lead a team of senior attorneys and legal professionals who support Biogen's commercial businesses and operations in Asia-Pacific, Latin America, Middle East, Africa, Russia, and geographically associated partner/distributor markets. As a member of the Intercontinental Leadership Team, I provide critical leadership and guidance to ensure that our legal strategies and risk management initiatives and business objectives are aligned.Focus on driving compliance with laws and regulations in a complex and dynamic legal/regulatory environment, providing cross-functional leadership to the marketing, medical affairs, and value & access functions on matters related to applicable industry codes and regulations on promotion and stakeholder engagement. I also serve as the primary liaison for global and regional Compliance, Audit, and Investigation functions on critical matters such as distributor diligence, management resolution, and investigation matters.Through effective prioritization and management of my team's workload, we ensure timely and pragmatic legal engagement that aligns with business priorities. Overall, my contributions as the Head of Legal for the Intercontinental Region support Biogen's continued growth and success in a highly competitive and evolving global landscape.

Cambridge, Ma, Us

Lead Lawyer for the Worldwide Medical Organization, provided primary strategic legal advice to the global medical affairs organization and its leadership team. This included advising on activities related to developing medical research and communicating relevant scientific knowledge to healthcare professionals and payors. As part of the role, I served as a member of various leadership teams and key committees, providing legal guidance and insight to the medical affairs organization on matters across the business spectrum.Responsibilities also included providing advice, education, training, and legal direction on healthcare fraud and abuse laws, antitrust, privacy, and other laws impacting medical operations. Reviewed relevant policies, SOPs, and business practices to ensure compliance with all applicable laws and regulations. Worked closely with regional and affiliate Legal and other functions to provide effective legal advice across the medical affairs organizations and ensure consistency and alignment with the company's global strategy.Overall, my contributions as the Lead Lawyer for the Worldwide Medical Organization were instrumental in providing critical legal advice and ensuring compliance with relevant laws and regulations. My efforts also contributed to the success of the company's medical affairs organization by supporting the development of effective policies, practices, and strategies.

Cambridge, Ma, Us

Global leadership team member, responsible for establishing legal strategy and providing counsel to the global pharmaceutical operations and technology (PO&T) organization, which encompassed various functions such as Engineering & Technology, Asset Development and Program Management, Quality, Reg. CMC, Global Manufacturing, Global Supply Chain, and Corporate Partnerships. Led executive and cross-organizational engagement to ensure integration and execution of PO&T and corporate goals within the PO&T legal organization.Prioritized and managed staff workload, ensuring timely and pragmatic legal engagement aligned with business priorities. Managed external counsel engagement to support business needs. Spearheaded negotiation and resolution of business development transactions, including a multibillion-dollar deal critical to securing a global network for Alzheimer's program launch, development and licensing agreements critical for gene therapy drug delivery technologies, and a novel development and collaboration framework to leverage the company's industry-leading development and manufacturing capabilities.Provided strategic advice on partnership responsibilities and dispute resolution, trade compliance regulations, sanctions, and other legislation relevant to the pharmaceutical industry, with a focus on those related to manufacture, quality, and global delivery of pharmaceuticals. Addressed regulatory and GxP issues and ensured compliance with all applicable laws and regulations.Contributions as a lead global team member were instrumental in establishing and implementing effective legal strategies, ensuring business alignment, and contributing to the success of the company's global pharmaceutical operations and technology organization.

Cambridge, Ma, Us

As the primary attorney for the neurology franchise, responsible for overseeing all legal matters related to the MS and dementia portfolios. This included being a key member of a cross-functional team that provided counsel to executive leadership on a range of topics such as label development and negotiation, clinical and lifecycle management, external communications, regulatory exclusivity, regulatory interactions, and safety events.Primary legal support for neurology and immunology alliances and partnerships, including dispute resolution, agreement restructuring, compliance audits, and licensing. Drafted and implemented company-wide policies and practices, including material reviews, responsible communications, and label development.As part of my role, I liaised with global colleagues to ensure the uniform application of laws and regulations on patient privacy, data privacy, and reporting compliance. Served as the lead attorney for Global Clinical Operations, where I provided negotiation support for Clinical Trial Agreements, Investigator Initiated Trial Agreements, Informed Consent Forms, Clinical Service Agreements, Clinical Service Agreements, and government CRADAs.

Boston, Massachusetts, Us

Senior corporate lawyer for a publicly traded development stage biotech company, in a wide-ranging role with responsibility for all corporate legal work, including corporate governance and reporting, clinical trial engagements, label development, launch readiness, and technical operations.As Lead attorney for Technical Operations, I was responsible for drafting and negotiating strategic CMO and supply chain agreements for both clinical and commercial supply. Additionally, I provided counsel on all clinical and clinical development activities, including the drafting and negotiation of clinical trial agreements, informed consents, IST's, and CRA/CRO agreements.Lead the development and implementation of new company-wide policies and practices, including Data Privacy and Anti-Corruption/FCPA Policies. Designed and implemented functional training to ensure compliance with applicable laws and regulations.Responsible for all real estate transactions, where I established and implemented template strategic terms related to securing and building long-term office and lab space for a rapidly growing organization.Furthermore, I supported the organization’s corporate SEC reporting and filing activities, including the filing of SEC Forms 3, 4, and 5 and assisted in the drafting and review of corporate filings, including 8K, 10Q, 10K, Annual Shareholder Meeting materials, and Proxy Statements

Cambridge, Ma, Us

Responsible for drafting and negotiating various types of agreements related to process development, supply chain, property leases, and manufacturing activities. I provided legal support for litigation, quality, customs compliance, and regulatory matters. I also supported the Quality organization in regulatory agency inspections and the qualification of LSM facilities.Lead the structuring and negotiating collaboration, product acquisition, licensing, drug development, and other business development transactions. Additionally, I was the lead attorney for all US-based real estate transactions, ensuring all transactions were legally compliant and beneficial for the company.

Cambridge, Ma, Us

Provided legal support to various organizations including Corporate Development, R&D, IT, and Finance. This involved advising on a wide range of legal matters such as contract negotiation, corporate governance, and regulatory compliance.In addition, I assisted in drafting and filing reports required under U.S. securities laws, including Form 10-Q, Form 10-K, Proxy Statements, Registration Statements, and Forms 3, 4, and 5.Negotiated agreements for Logistics and Managed Markets groups related to drug product distribution, rebates/discounts, and therapy persistence, including the drafting and negotiating of contracts with third-party logistics providers, wholesalers, and pharmacies.Provided support for the formation and management of domestic and foreign business entities. This involved advising on legal structure, regulatory compliance, and governance matters, as well as drafting and negotiating formation and operating agreements.

Doctor Of Law - Jd, Banking, Corporate, Finance, And Securities Law

Bachelor Of Arts - Ba, Political Science And Government (Major), Business Administration (Minor), History (Minor)