Life Sciences

Moses & Singer’s Life Sciences Practice is comprised of regulatory, corporate, health care, intellectual property, privacy and technology attorneys, whose comprehensive and collaborative approach sets us apart from other law firms. While each Life Sciences Practice attorney possesses particular expertise, they are all versed in the other life sciences practice areas and take into account the myriad of issues and disciplines when counseling life sciences clients.

Moses & Singer works closely with organizations to help guide their growth into successful and highly regarded leaders in the life sciences community. We address immediate, specific legal issues, while working with clients to strategically implement long-term goals.

We advise our clients on cutting-edge issues with respect to genomics, translational research, regenerative medicine, vaccine therapy, ancillary research, genetic privacy, tissue banking, data repositories and research data via the cloud, social media & applications. Our clients represent a range of life sciences organizations including biotechnology and pharmaceutical companies, academic medical centers, research foundations, IRBs, biorepositories, medical device companies and scientific research consortia.

For more information please contact us.

Prior results do not guarantee a similar outcome.

Representative Matters

  • Counseled client in creating and executing the first consortium to bring together leading academic medical centers solely dedicated to Phase I and Phase II clinical trials.
  • Designed complex privacy program for national non-profit disease-specific patient advocacy group. 
  • Structured and negotiated a strategic joint venture which created a research and development consortium comprised of pharmaceutical/biotechnology companies and research institutions.
  • Structured and implemented GLP-compliant biobank that integrates patient tissue samples with corresponding laboratory and clinical data.
  • Represented client in launching landmark personalized medicine study to focus on disease progression and response to treatment based on patients’ genomic or molecular profiles.
  • Developed and implemented privacy policies and procedures for international medical device company.

 

Overview

Moses & Singer’s Life Sciences Practice is comprised of regulatory, corporate, health care, intellectual property, privacy and technology attorneys, whose comprehensive and collaborative approach sets us apart from other law firms. While each Life Sciences Practice attorney possesses particular expertise, they are all versed in the other life sciences practice areas and take into account the myriad of issues and disciplines when counseling life sciences clients.

Moses & Singer works closely with organizations to help guide their growth into successful and highly regarded leaders in the life sciences community. We address immediate, specific legal issues, while working with clients to strategically implement long-term goals.

We advise our clients on cutting-edge issues with respect to genomics, translational research, regenerative medicine, vaccine therapy, ancillary research, genetic privacy, tissue banking, data repositories and research data via the cloud, social media & applications. Our clients represent a range of life sciences organizations including biotechnology and pharmaceutical companies, academic medical centers, research foundations, IRBs, biorepositories, medical device companies and scientific research consortia.

Biomedical Research

Our experience representing life sciences organizations reflects the depth and breadth of expertise and commitment attorneys in our Life Sciences Practice bring to bear for organizations involved in research. Our broad range of experience in the health, technology and non-profit fields makes us uniquely qualified to assist life sciences organizations in both the design and implementation of their research models.

Moses & Singer assists life sciences organizations in identifying legal, regulatory and business risk areas related to research and developing strategies, structures, procedures, agreements and processes to mitigate such risks.  In addition to our legal experience, we have relationships with many institutions, pharmaceutical and biotechnology companies, research organizations, and other counsel that enable us to remain informed and up-to-date about scientific, business and legal issues that are relevant to the conduct of research.

Research Agreements

Moses & Singer has substantial expertise structuring and negotiating documents related to pre-clinical research and clinical trials including sponsor- and investigator-initiated clinical trial agreements, Data Use Agreements, Informed Consent Forms and HIPAA Authorizations.  We counsel on issues arising from data ownership, scope of data use, publication rights, intellectual property, subject injury and indemnification provisions and the informed consent process. We work closely with life sciences organizations and their researchers to understand the complexity of the research and structure agreements to best protect their interests.  In representing life sciences organizations, Moses & Singer attorneys have negotiated with a variety of entities and are familiar with industry clinical research contract provisions and negotiation techniques. We can anticipate likely areas of contention and advise our clients of potential pitfalls and protective language that they should be including in their research agreements.

Data Rights and Ownership

The data created and collected during clinical research is of tremendous value to all stakeholders, as well as third parties. We advise clients how to acquire and secure intellectual property rights developed in the course of research.  Our attorneys have experience in structuring intellectual property and technology agreements and can advise our clients as to the various options they have in order to achieve its goals in these matters.  In addition to advising clients how to monetize and otherwise license and exploit their intellectual property, we also assist in assessing the risks associated with such use as well as the use of third party intellectual property.

Regulatory

Moses & Singer regularly counsels clients on how best to develop effective compliance programs to ensure that their audit and compliance functions encompass relevant research risk areas. We work with clients in developing comprehensive risk assessment and risk management processes that include compliance with FDA, OHRP and state human subject research protection laws; HIPAA privacy and security laws; Anti-Kickback and Stark Laws; Sunshine Act and state conflict of interest laws; Medicare and Medicaid reimbursement laws and the False Claims Act:

Biorepositories

One of the key issues facing biorepositories is the complex network of regulations governing the collection and use of biospecimens generated during clinical trials. With heightened regulatory and privacy compliance necessitated by Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs), 21 CFR Part 11, the Health Insurance Portability and Accountability Act (HIPAA), the Health Information Technology Economic and Clinical Health Act (HITECH) and IRB requirements, biorepositories must develop thorough policies and procedures which accurately track patient consent, HIPAA Authorizations and the use of biospecimens. In addition, as researchers recognize the value of utilizing samples for pharmacogenomics and pharmacoproteomics, the biorepository must be able to easily store, locate, and access biospecimens along with critical genomic, proteomic, and phenotypic data.

Moses & Singer can assist in structuring the biorepository to maximize data capture, tissue tracking and release of the biospecimens in compliance with GLPs & GCPs, HIPAA and other privacy laws.

Transactional

Our attorneys regularly structure, negotiate and draft a range of transactional agreements, ranging from basic non-disclosure agreements and materials transfer agreements to complex multi-party clinical research agreements, joint ventures and other novel collaborative agreements for cutting-edge arrangements with respect to research, ownership of intellectual property and disclosure of data.

Attorneys in our Life Sciences group represent both users and providers of outsourced life sciences services and have assisted life sciences clients in the procurement process, including evaluating RFP responses and negotiating the resulting agreements, including the subject service level agreements.

Privacy & Security

Privacy

Healthcare privacy laws on both the state and federal levels are constantly evolving and life sciences organizations will need to be informed of potential privacy issues surrounding the disclosure and use of identifiable health information. Moses & Singer helps keep our clients abreast of changes and applicability of such privacy laws.

Moses & Singer attorneys are expert in dealing with privacy issues under federal, state, and local privacy laws.  We have closely monitored and extensively commented on the HIPAA and HITECH rules, particularly the privacy rule. Our attorneys have devoted significant time and effort into developing comprehensive expertise in privacy issues under the HIPAA rules.  Attorneys in the healthcare department speak nationally on subjects specific to HIPAA, HITECH and medical record privacy.

Moses & Singer also provides strategic advice to a variety of life sciences clients on complex privacy and security issues related to electronic data management including genetic privacy; data mining, open source, mobile applications, health information exchanges, electronic health record development and implementation; deployment of electronic health record systems, outsourcing and technology deals, affiliations and joint ventures between healthcare providers and vendors who service providers. Moses & Singer counsels clients on how to preserve, protect and recover electronic data as well as how to address potential and actual data security breaches and vulnerabilities.

Our knowledge of the array of state security breach notification laws gives us expertise in determining best practices regarding security breach policy development.  We stay at the forefront of this rapidly expanding area of law, keeping up to date with changes in state law and proposed federal legislation.

Cybersecurity and Data Protection

Moses & Singer’s Privacy and Cybersecurity Group advises healthcare entities on issues relevant to the collection, storage and authorized use of personally identifiable information. We regularly provide legal counsel on all matters relating to the protection of health information.  We perform compliance audits, structure transactions and draft agreements to protect clients and, when needed, represent clients in related litigation.

Our lawyers are frequently called upon to counsel clients in developing, implementing and managing their privacy and security policies.  The team routinely advises clients on applicable regulatory requirements, including HIPAA, HITECH and FTC provisions.  We also offer advice on existing and pending legislation that could affect our client’s business practices, such as the Children's Online Privacy Protection Act (COPPA) and the FTC's enforcement activities regarding adherence by companies to their own privacy policies.

Transfer of Personal Data Across U.S. Borders

In many instances, life sciences organizations engage in the transfer of personal data across borders.  We have worked with organizations regarding compliance with the EU Data Protection Directive transmission of personal data into the U.S.  We can assist life sciences organizations in staying current regarding new developments in this context.

Patient/Consumer Relationship Marketing

Moses & Singer counsels clients on legal issues related to patient or consumer relationship marketing to assist them in making decisions about how to effectively yet prudently market their services.  We work with our life sciences clients to develop a "best practices" approach to compliance regarding such matters.  We provide advice regarding specific problems relating to the permissibility of certain types of advertising materials and help clients craft policies and procedures governing consumer marketing practices. 

Intellectual Property

In the field of intellectual property law, we counsel life sciences organizations on how to structure, negotiate and implement collaborative and licensing transactions that will have a significant and strategic impact on their business. Our Intellectual Property attorneys bring a high degree of judgment, sophistication and experience to bear on the legal and business issues confronting life sciences companies and tailor the process to fit a client’s needs and the type and size of the transaction.

The Intellectual Property Group works closely with the Corporate, Healthcare and Litigation practice groups to provide comprehensive representation for a broad range of intellectual property issues for our life sciences clients.

Technology

The life science field increasingly involves many types of technology and licensing arrangements, professional services and software development agreements. We advise and represent both technology providers and purchasers in development, procurement, maintenance, outsourcing, hosting, collocation, ASP (hybrid-cloud) and consulting agreements. 

We are able to leverage experience from prior transactions with major vendors to understand what strategic position to take when acquiring or developing technology, and to assist in negotiating and implementing unique and creative solutions. 

We negotiate complex IP, infrastructure, application development, mobile, help desk, call center, claims processing, telecommunications, and other regulated and non-regulated outsourcing agreements.  We assist clients with both their physical and online presence and advise on the architecture, look and feel, compatibility and most enforceable methods to ensure a positive user experience, while securing data consents through carefully crafted click through, terms of use and privacy policies. We advise on Internet, website, branding, advertising, promotion and other online presence agreements.

We also advise on risk management and mitigation procedures, compatibility of different licenses and contractual obligations, and related compliance issues.  In addition, we advise on risk issues relating to warranty, limitation of liability and indemnification with respect to all such acquired or developed technology.  We understand the complicated issues faced in the development of a platform and complex software, how the numerous pieces fit together and how to mitigate the risks through contractual and technological protection and solutions. We can assist in the development and implementation of software and development policies, procedures and assist with strategies to insure technology and data rights are preserved and protected through both contractual and technology applications.

Emerging Companies

We offer a range of legal services for life sciences entrepreneurs and emerging companies.  Our network of industry contacts enables our clients to build relationships with service partners and potential collaborators. We help guide growth through proof-of-concept to establishment in the life sciences industry. We offer counseling on strategic and alternative funding models, IP protection and partnering arrangements, outsourcing, employment issues, duties of investor appointed directors, exit strategies.

Working closely with the founders of life sciences companies in structuring and negotiating initial and early stage financing, including seed financing, "angel" investments, venture capital and later stage equity and mezzanine financing, enables us to provide early input into our clients' business plans, suggest ways to avoid potential pitfalls, and assist emerging companies in raising the financing needed to capitalize on the opportunities arising in this fast-growing and rapidly changing industry.

Moses & Singer's services to early-stage ventures include the selection of appropriate business structures, tax planning, shareholders' and founder's agreements, confidentiality and consulting agreements and real estate and equipment leases. We work with clients in establishing employee stock option plans and employment policies to motivate and retain employees. We also draft and negotiate consulting and employment agreements.

Non-Profit/Tax Law

Non-profit life sciences organizations need to be particularly cognizant of potential tax implications from every aspect of their work and operations.  In addition to potentially incurring unrelated business taxable income, the organization must be careful not to jeopardize its tax-exempt status.  Our extensive experience in representing not-for-profit entities, both public charities and private foundations, in their corporate and tax matters will enable us to work with non-profit life sciences organizations relating to their operations. 

We represent and advise 501(c)(3) and other tax-exempt entities on a variety of issues, including unrelated business taxable income, and various transactions with business partners which might otherwise give rise to private inurement or a private benefit jeopardizing tax-exemption.  In addition, we also counsel on commercial co-venture relationships and regulatory compliance, and have extensive experience counseling not-for-profit clients with respect to matters such as filing requirements, fiduciary obligations of the directors/trustees, transactional matters and structuring relationships with for-profit and other not-for-profit entities.

For more information please contact us.

Prior results do not guarantee a similar outcome.

Representative Matters
  • Counseled client in creating and executing the first consortium to bring together leading academic medical centers solely dedicated to Phase I and Phase II clinical trials.
  • Designed complex privacy program for national non-profit disease-specific patient advocacy group. 
  • Structured and negotiated a strategic joint venture which created a research and development consortium comprised of pharmaceutical/biotechnology companies and research institutions.
  • Structured and implemented GLP-compliant biobank that integrates patient tissue samples with corresponding laboratory and clinical data.
  • Represented client in launching landmark personalized medicine study to focus on disease progression and response to treatment based on patients’ genomic or molecular profiles.
  • Developed and implemented privacy policies and procedures for international medical device company.