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This checklist was developed by our firm as a tool and guide to necessary and optional elements to consider in preparing to negotiate and document the principal agreement or deal document in an international or cross-border joint venture (JV) between a U.S. party or parties and one or more non-U.S. parties; it has been adapted for use specifically for cross-border JVs in the pharmaceuticals, chemicals, telecommunications, and satellite sectors. Following the checklist are “Deal Points,” which address the broader structure of the JV.
BIOTECHNOLOGY, PHARMACEUTICAL, AND CHEMICALS MASTER DISTRIBUTION AGREEMENT SAMPLE TERM SHEET: DEAL POINTS
This sample Term Sheet is derived from several prepared by our firm to negotiate and document Master Distribution Agreements (MDAs) in the Biotechnology, Pharmaceutical and Chemicals sectors. These are sample terms only to give an idea of the parameters of negotiation; any of them may be negotiated. Following the sample Term Sheet are “Deal Points” on broader considerations of an MDA transaction.
Raising Capital through Private Placements: Deal Points compares in detail Regulations D, A, and S and other principal U.S. Securities Act sections, rules, and regulations that may be used for registration-exempt offers and sales of securities for the purpose of raising capital and discusses their respective uses, requirements, advantages, and disadvantages. Appendix 1 at the end presents a condensed version of the same information in chart form. Following the discussion are Deal Points to aid the capital raising process: what to do, and what at all costs not to do.
Recent Department of Health and Human Services Office of Civil Rights (HHS OCR) resolution settlements (in lieu of fines) for a total of over $15 million confirm that wide-spread noncompliance with the HIPAA Business Associate Agreement requirement is now front and center in HHS OCR enforcement actions. OCR also recently announced a $650,000 settlement against the Catholic Health Care Services of the Archdiocese of Philadelphia, the first ever against a Business Associate directly. In all, last year OCR settled/fined violations of over $23 million, more than half the total amount levied since HIPAA was enacted; the Business Associate Agreement-related settlements constitute more than one quarter of all HIPAA settlements/fines ever levied.
It is a facial violation of HIPAA for a Covered Entity to transmit, and for a Business Associate to receive, patient Protected Health Information without a written, compliant Business Associate Agreement in place. In other words, if there is no written, compliant Business Associate Agreement in place, the Covered Entity had no right to transmit, and the Business Associate had no right to receive, the PHI in the first place.
The attached advisory, “HIPAA Business Associate Agreement Best Practices,” updated for 2017, analyzes the issues and offers a practical and cost-effective compliance solution for HIPAA-regulated entities for avoiding HIPAA civil and criminal enforcement penalties based on the Business Associate Agreement requirement.
Kurtin PLLC offers a range of flat-fee legal services for the formation, organization, financing, and operations of U.S. subsidiaries and affiliates of non-U.S.-based companies and U.S. startups. The services offered cover any legal or regulatory requirement a new enterprise is likely to face, while the flat-fee menu of basic and additional services allows both a la carte selection of services needed and predictability of costs.
A SWISS PRINCIPAL MODEL CASE STUDY: Restructuring a Multinational Corporation to Optimize Profitability and Efficiency
Owen D. Kurtin represented a public industrial technology company as lead outside counsel in staged four-year, thirty-plus country, Swiss Principal Model restructuring of worldwide governance and operations, including multiple mergers, acquisitions, issuances of new equity securities, stock transfers, recapitalizations, consolidations and conversions of domestic and non-U.S. subsidiaries and affiliates; engagement of, supervision of and collaboration with local counsel, accountants and consulting firms in each non-U.S. jurisdiction; development of inter-company and supply chain commercial protocols and agreements. The new structure will greatly enhance the company’s profitability and efficiency.
Kurtin PLLC is a New York City-based law firm founded in 2008 by Owen D. Kurtin, an attorney in practice since 1984. The firm’s practice focuses on corporate, commercial, and regulatory representation for both mature and early stage companies, investors and lenders in the Biotechnology & Life Sciences, Communications & Media, Information Technologies and Satellites & Space sectors. We have additional experience in the Energy and Financial Services sectors, and in Constitutional and civil rights issues arising in the Communications, Media, Technology and Arts sectors.
We advise on a wide range of M&A and private equity transactions, including buyouts, divestitures and roll-ups; cross-border joint ventures and strategic alliances; securities offerings and private placements; and financial and strategic investments. We also counsel company boards and officers on their fiduciary obligations and other governance issues and shareholders and creditors on their rights. We also have experience in the implementation of Swiss Principal and related corporate governance structures for multinational enterprises and structuring of investment trusts and other investment vehicles.
Kurtin PLLC also advises on complex commercial arrangements such as the development, financing, manufacture, outsourcing, distribution and deployment of: terrestrial, satellite and submarine broadband telecommunications and media networks; telecommunications, aerospace, energy, IT, health IT, data privacy and cybersecurity services, software and equipment; biotechnology and life sciences products; and digital media content and other intellectual property rights.
Our practice is international. We have in-country transactional experience throughout North America; Western and Eastern Europe; the Middle East and Persian Gulf; and Central, South and East Asia.
We recognize that our clients seek new ways to achieve their business goals and expect legal services to be as innovative and goal-responsive as they must be. We also recognize that while our clients seek a closer alignment of the attorney-client relationship with their business needs and risks, they also expect and require objective and disinterested legal advice from that relationship. The balance of that alignment and objectivity is key to the service we seek to provide.
To those ends, we offer alternative billing arrangements, which may include success- or partial success-based fees for transactional matters such as mergers and acquisitions and financings; tiered flat fee billing arrangements for corporate, commercial and regulatory matters; and retainers for recurring or continuing baskets of services. As part of this effort, Kurtin PLLC offers a package of flat-fee services for the formation, organization, financing and operations of U.S. subsidiaries and affiliates of non-U.S.-based companies and for U.S. startups. The breadth of services offered cover any legal or regulatory requirement a new enterprise is likely to face, while the menu of basic and additional services allows both a la carte selection of services needed and predictability of costs (for more information, click on Inbound and Startup Services).
We also engage in carefully selected pro bono and public service work. Past projects have included assistance to children’s rights and relief organizations, obtaining political asylum for persecuted African and Asian refugees, representation of performing and graphic artists and filmmakers in producing their work and protecting their rights, and assistance to the digital communications infrastructure of a major metropolitan performing arts center.
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