This is an accessible guide to the legal and practical issues arising from complex outsourcing deals with a particular emphasis on the UK and the US. This book covers the discrete legal issues involved, and also the management of the relationship between vendor and purchaser of outsourcing services, in a practical and comprehensive way.

Outsourcing remains a global growth industry. New technologies and approaches have transformed the way in which services can be delivered with ever better service quality and lower cost, with robotic process automation (RPA) significantly reducing the numbers of supplier personnel required to deliver such projects, and the application of artificial intelligence tools dramatically improving some of the service outputs and outcomes. Now that the world is facing up to the impact of Covid-19 in terms of pressures on cost bases and the realisation that far more roles than previously understood can be effectively undertaken remotely, we can anticipate that there will be a further step change in the use of outsourcing as a core business strategy.This book is the fully updated second edition of the key text on outsourcing written by the market-leading global technology and sourcing team at DLA Piper, one of the world's largest law firms. Writing from both a legal and commercial perspective, it considers the complete lifecycle of an outsourcing contract and the variety of legal and contractual issues that can arise in connection with such a project, from the initial genesis of the proposal to outsource all the way through the procurement process and onto post-contract signature contract management. In so doing, it also breaks down the core outsourcing contract into its constituent parts, explains the rationale for the relevant provisions (from both a customer and service provider perspective), and provides guidance as to current market practice, options and trends, including individual nuances relevant to particular jurisdictions.The second edition also features new coverage of: *The use of cloud 'backbones';*New technologies such as RPA/artificial intelligence;*Digital transformation;*Data privacy; and *Outsourcing in heavily regulated sectors.Whether you are a user of outsourced services, an adviser on outsourcing projects or working with a service provider engaged in the provision of the outsourced services itself, this publication will provide you with an end-to-end guide to the outsourcing contracting process and the detailed terms to be considered and carefully negotiated.

Outsourcing has increased and developed immensely in scope, sophistication and ambition over the last twenty years - and continues to evolve. Information technology outsourcing is potentially highly complex and risk-laden, especially for the fast growing areas of business process and transformational outsourcing, and where whole departments or business areas are outsourced. Decisions taken by the customer at the outset have long term ramifications: they need to ensure that the processes are flexible enough to deal with change, maintain necessary levels of security, avoid abandoning management of key resources and prevent costs spiralling out of control. It is essential to have a good contract to meet such challenges. All these issues and others, such as intellectual property arrangements, the complexities of transferring staff, property and other assets, tendering procedures and performance monitoring, must not be ignored and are addressed in the second edition of Rachel Burnett's successful Outsourcing IT. Whether you are a supplier or a customer, it is vital to have a properly negotiated formal contract if you are entering into an outsourcing arrangement. A good contract needs careful planning and this book provides a comprehensive guide to the whole process. Well-planned and well-structured outsourcing arrangements, by well-informed and well-advised customers, are far more likely to work for both customer and supplier alike and Outsourcing IT - The Legal Aspects: Planning, Contracting, Managing and the Law is the perfect place to start.

Taking advantage of liberal regulations under the current world trade regime that permit the separation of manufacturing from marketing, many pharmaceutical companies (like other companies) outsource the actual manufacture of their products. However, because the quality of medicines is crucial to public health, the pharmaceutical industry is perhaps the most regulated of all industries. In most countries medicines are controlled prior to their marketing, and their manufacture is carried out under strict supervision. Necessarily, numerous international initiatives have led to elaboration of standards relating to the manufacture and marketing of medicines. These standards impose stringent rules on all parties to pharmaceutical manufacturing contracts. This very useful book provides a comprehensive global guide to the legal issues and procedures involved in outsourcing the manufacture of medicines. It describes the legal requirements relating to the manufacture and distribution of medicines, emphasising the impact of regulatory supervision on the rights and obligations of persons who outsource manufacturing of medicines and on those who provide the manufacturing services. The author provides detailed coverage of such pertinent topics as the following: and• definition of and‘medicineand’ in different jurisdictions; and• categories of medicines; and• manufacturing and importation regulation in numerous jurisdictions worldwide; and• inspection regimes; and• good manufacturing practice (GMP); and• marketing authorization; and• manufacturing documentation; and• complaints and product recall; and• liability insurance; and• protection of trade secrets; and• data exclusivity and data protection; and• deficiencies and delays; and and• recognition and enforcement of judgements. A significant part of the book is devoted to cross-border problems arising from such matters as conflict of laws or taxation. Indispensable to counsel for pharmaceutical companies of any size, Contract Manufacturing of Medicines will also be of great value to practitioners and academics concerned with international trade for its precise, in-depth delineation of the inner workings of a complex and highly significant trade regime.

"A Practical Guide to Intellectual Property Issues in the Pharmaceutical Industry guides the reader through the major IP issues pharmaceutical companies encounter when bringing new products to the market and post-commercialisation. It discusses the value of IP within the pharmaceutical industry. It gives an overview of the regulatory environment from a national and international perspective. This book takes a look at the EU competition and US and Canadian anti-trust regimes and explains how international treaty obligations impact national and global markets."--BOOK JACKET.

This book is the fully updated second edition of the key text on outsourcing written by the market-leading global technology and sourcing team at DLA Piper, one of the world's largest law firms.

The trend of outsourcing to India for research and development is catching on fast. Over the last decade, worldwide pharmaceutical and biotechnology companies have made India their choice for a research destination. Initially R&D was inclined more towards developing products for the Indian market within the country. This led to several multinational companies opening up production plants in India, primarily due to the globalization of the Indian economy and offshoring jobs to India. Alongside, several global pharma-biotech majors ascertained large market requirements within the country and capitalized on the advantage of serving Indian customers. Strategies were devised to optimize operational expenses with the setting up of on-site R&D to develop products for local requirements. In view of this, this book seeks to explore various nuances of the outsourcing sector with respect to biopharma in India. - Constitutes the first ever comprehensive insight on the Indian biopharma sector - Provides a perspective based on practical hands-on legal experience - Simply structured, clearly presented and free from excessive legal jargon