Brian Donnelly Email and Phone Number
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Nationally recognized corporate attorney with extensive experience as counsel and General Counsel for bio-pharma, med device, tech, software and life science companies.
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Head Of LegalLife Molecular ImagingPhiladelphia, Pa, Us -
General CounselOnix Nov 2024 - PresentNew York, Ny, Us -
Deputy General CounselHealthtrackrx May 2024 - Nov 2024Denton, Tx, Us• Advise the company’s CEO, CFO and executive leaders on mergers, acquisitions, divestitures, alliances, joint ventures, partnerships, and other complex corporate transactions. Manage legal and regulatory aspects (including engagement of external counsel) of related negotiations and financings, in conjunction with the General Counsel and the company’s Finance, Investment and Treasury functions.• Coordinate annual filings and oversee and manage entities’ corporate status in good standing and licenses to operate. • Serve as a collaborative partner and advisor to the General Counsel and Chief Compliance Officer on all strategic matters related to legal, compliance, and regulatory matters. With the concurrence of the General Counsel, advise and provides guidance to Chief Compliance Officer on compliance-related issues focusing on Anti-Kickback, Stark Laws and False Claims Act compliance. Assist CCO in conducting internal investigations as necessary.• Negotiate all commercial contracts on as well as complex corporate transactions including Research Collaboration Agreements, Lab Servicing Agreements, Joint Ventures, and Development and Management Agreements.• Provide oversight and leadership to support the provision of legal advice supporting payor/payee oversight and audit response, data protection, cybersecurity, and privacy.• Provide legal advice and assist with licensing and permitting applications and certification filings with state and federal regulators.. Monitor legislative and regulatory developments that may impact company operations. • Manage the legal strategy and spend for litigation and regulatory actions across various jurisdictions and matters including breach of contracts, employment, competition and solicitation, and commercial disputes. -
Managing Assistant General CounselNovo Nordisk May 2023 - Apr 2024Bagsværd, Dk• Reporting to VP, Deputy Counsel and General Counsel. Responsible for US corporate governance matters, including entity management and board of director matters for entities generating revenues exceeding $10 billion USD and dividends exceeding $1 billion USD. Serve on boards as Assistant Corporate Secretary for 14 U.S. affiliates. Prepare notices, board materials, agendas, resolutions, consents and minutes for corporate governance. Maintain by-laws and provide support to chairperson, board of directors and officers. Oversee and manage all corporate legal functions for U.S. Affiliates in 50 states. Coordinate annual filings and oversee and manage all entities’ corporate status in good standing and ability to operate.• Serve as NNI legal expert for U.S. Securities compliance including 1934 Act and SOX, investor relations, export controls/sanctions, insider trading and anti-trust matters.• Provide primary legal support for US corporate/business development activity. Conduct pre-closing due diligence, negotiation and post-closing integration. Draft, negotiate and review term sheets. • Lead Contract Management Team consisting of 5 attorneys and one paralegal. Overall responsibility for legal supplier/buy-side contracting function. Developed contracting operations.• Partner cross-functionally with brand teams to provide legal advice on Commercial, Market Access, and Medical Affairs matters on medical devices. Participate in promotional review board for medical devices including reviewing all promotional materials and concepts. Negotiate complex business transactions, partnerships and collaborations including those in digital health/technology, medical devices, SAMD, innovation and future business strategy. Negotiate multi-million-dollar agreements with App developers for design and launch of joint applications, data purchases data overlays and third-party access, market research, real world evidence and HEOR strategies. -
Assoc. General Counsel, Tech Development And OperationsSpark Therapeutics, Inc. Jul 2021 - May 2023Philadelphia, Pa, Us• Member of the Chief Legal Officer’s leadership team reporting to Chief Legal Officer. Advise leadership team and collaborate with the CLO and the leadership team on strategies that mitigate legal risks.• Collaborate and works cross functionally with the CLO’s leadership team, CEO Chief of Staff and company’s leadership team to establish and refine budgets, contract management, third party oversight, and procurement capabilities. • Draft, negotiate and advise on partnering agreements that support Business Development business objectives, including but not limited to: research collaborations, global licensing agreements, leases and land acquisitions, licenses, and option agreements with values exceeding $800mm. Advise cross-functional teams on legal risk while still facilitating innovation. Coordinate and negotiate financing and loan activities. Coordinate with intellectual property counsel to protect company intellectual property when engaging in licensing, promotion and collaboration agreements. • Negotiate and coordinate inter-company affiliate, partnership and licensing agreements within the Roche Group for global operation and commercialization of pipeline candidates. Support client group in government authority-initiated audits and investigations. • Support Technical Operations and Strategy, Manufacturing, Real Estate and Corporate Facilities, Quality Assurance, Research and Development and Business Development functions. Negotiate numerous multi-million-dollar land, real property, leases simultaneously.Close transactions with values of US$1 billion. • Prepare and assist in prosecution of contractual matters and defense of litigation matters including negotiation and settlement. • Retain and seek the guidance and advice from AMLAW 100 external counsel as needed. Evaluate performance and cost expectations of external counsel and manage external counsel to ensure that such guidance and advice is provided effectively and efficiently. -
Director, Cyber Security & Technology CounselStryker Dec 2020 - Aug 2021Kalamazoo, Mi, Us• Director for Stryker advising on Medical Device Product Security including related Industry Standards and guidance documents with respect to product cybersecurity to Stryker's R&D, IT, and Digital Cloud (Stryker Health Cloud). • Negotiate outbound multi-million-dollar revenue generating Product Agreements, Information Security Agreements, Data Processing Agreements, Technology Licenses and similar agreements with major hospital systems and Group Purchasing Organizations.• Interact and provide legal and strategic guidance to senior management and C-Suite organizational leadership.• Collaborate with cross-functional global teams including Division and Regional Counsels, Global Privacy, Regulatory Law Global Security, Product Security, Regulatory, and R&D and business clients across company on complex technology and product security legal regulatory issues.• Subject Matter Expert and counsel on changes in technology and cybersecurity related laws and regulations that impact the regulation of product offerings. • Support the development and communication of product strategies regarding product technology features and security safeguards to empower business stakeholders to communicate internally and externally.• Direct the work of outside counsel, defined project objectives and manage projects to ensure the work, strategy and costs meet Stryker’s expectations. -
Digital Pharma & Innovations CounselGsk Mar 2019 - Dec 2020Brentford, Middlesex, GbCreate, draft and negotiate complex global digital SaaS and platform legal agreements in coordination with business development teams with nations as well as the largest companies in the world including Microsoft and Google for national and international business clients. • Provide creative and proactive counseling on a broad range of complex legal and regulatory issues including drug promotion, advertising, data privacy, security and intellectual property within digital environments. • Draft and negotiate proof of concept and collaboration agreements for development and sharing of digital intellectual property assets, AI, bots and machine learning. • Work with key stakeholders across multiple lines of business and partner with practice groups including vaccines, pharmaceuticals and consumer healthcare to manage digital assets, data lakes, data infrastructure, and internal assets for compliance, coding, creation and open source projects. • Stay current and train and advise R&D and marketing teams on emerging technologies and brief and develop best practices for centers of excellence and company in the digital, privacy and data analytics spaces -
Managing Member Outside General CounselDonnelly Llc Sep 2007 - Feb 2019Principal of AV Preeminent Rated firm concentrating practice in business and corporate counseling and litigation including, business formation, business sales and acquisitions, transactional drafting and negotiation, corporate governance, partnership dissolutions, employee contracts, and commercial contract and collection disputes. • Outside counsel to West Pharmaceutical Services. Draft and negotiate MSAs, Consulting Agreements, Supply Agreements, Technology, GDPR, Distribution Agreements and Production Agreements. Outside counsel to UL Compliance to Performance (previously UL Eduneering), a subsidiary of Underwriters Laboratories Inc., which develops and maintains a cloud-based platform for online regulatory and compliance training services for the world's largest companies and governments. Develop terms and conditions for sales and license agreements with particular emphasis on SaaS, data center, cloud and web service agreements and data acquisitions. Review and negotiate privacy and security agreements, including EU modal clause data transfers. Outside General Counsel to Cobblestone Systems, a leading contract management software company with over 100 employees and a heavy focus on software, software as a service, cloud based applications and application integration.Outside General Counsel to Service Engine BPO, an Inc. 5000 Company that specializes in interactive marketing, quality assurance, software web development, digital advertising operations and risk compliance for the digital advertising industry.• Draft and negotiate on a daily basis corporate transactional documents, including software agreements, Cloud Agreements and SAAS Agreements, privacy policy, GDPR, terms of use, end user agreements, licensing agreements, statements of Work, Master Service Agreements, non-disclosure agreements, service and vendor agreements, consulting agreements, teaming agreements, commercial leases, franchise disclosure documents
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General CounselPierre Fabre Group Mar 2014 - Oct 2018Toulouse, Occitanie, Fr• Outside General Counsel to second largest dermo-cosmetics laboratory in the world and one of Europe's largest Pharmaceutical companies with sales exceeding 900 million Euros. • Draft and negotiate MSAs, Consulting Agreements, Tech Transfers, Logistics Agreements, Quality Control, HIPAA, Privacy Policies, Research Study Agreements, CTAs, Rebate Agreements, Resale Agreements, Development and Supply Agreements, Distribution and Wholesale Agreements, Promotional Agreements, Joint Ventures and Production Agreements. • Draft Employee Agreements, Employee Handbooks, Confidentiality and Non-Disclosure Agreements , consultant agreements , and work regularly with Human Resource Director on compliance training and employee issues. • Draft and negotiate License acquisitions for generic pharmaceuticals and bio-similiars.• Interface with Director, Digital on e-commerce platform, website, GDPR, Privacy Policy, Consents, Terms of Use and social media and marketing campaigns.• Interface with CFO and International Group General Counsel on all legal issues pertaining to company including consumer complaints, FDA and Stark, Laws, taxes, international agreements and maintain company tax registration, licensing and business registration across all states.• Collaborate with Pharmacovigilance officer to review promotional materials, respond to product complaints and evaluate potential risk and provide counsel for e-commerce and promotional events.• Partner with Group Counsel and Directors on Supply Chain and Operations to mitigate and resolve pre-litigation contractual disputes with quality control and production issues, suppliers, landlords, vendors and other third parties. Interface and negotiate with AMLAW 100 firms. -
Cpt D153Rd Lso 2002 - 2008JAG
Brian Donnelly Skills
Brian Donnelly Education Details
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Massachusetts Institute Of TechnologyCertificate Blockchain Technology -
Temple University - James E. Beasley School Of LawTaxation -
Rutgers Law SchoolLaw -
University Of MarylandCriminology And Criminal Justice -
Dhs -
Dhs -
Rutgers Law SchoolDoctor Of Law - Jd -
Rutgers Law School -
Rutgers Law SchoolJuris Doctor -
Temple University - James E. Beasley School Of LawTax Law/Taxation
Frequently Asked Questions about Brian Donnelly
What company does Brian Donnelly work for?
Brian Donnelly works for Life Molecular Imaging
What is Brian Donnelly's role at the current company?
Brian Donnelly's current role is Head of Legal.
What is Brian Donnelly's email address?
Brian Donnelly's email address is br****@****ker.com
What is Brian Donnelly's direct phone number?
Brian Donnelly's direct phone number is +185648*****
What schools did Brian Donnelly attend?
Brian Donnelly attended Massachusetts Institute Of Technology, Temple University - James E. Beasley School Of Law, Rutgers Law School, University Of Maryland, Dhs, Dhs, Rutgers Law School, Rutgers Law School, Rutgers Law School, Temple University - James E. Beasley School Of Law.
What skills is Brian Donnelly known for?
Brian Donnelly has skills like Litigation, Legal Research, Legal Writing, Powers Of Attorney, Commercial Litigation, Estate Administration, Wills, Trusts, Civil Litigation, Tax Law, Guardianship, Mediation.
Who are Brian Donnelly's colleagues?
Brian Donnelly's colleagues are Donna Felker, Iris Hardewig, Ingo Horn, Lysian Niering, Chris Bentley, Sara Smith, Ms, Rt(N)(Ct), Vanina Andrea Lucifora.
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