The updated handbook provides a comprehensive collection of annotated sample contracts for all common regulatory areas related to a product’s life cycle, from development to clinical trial and approval to production, marketing and licensing.
What does the 2nd edition offer?
The first edition has proven its worth as a comprehensive work in the field of pharmaceuticals/life sciences. Since the field is highly regulated with constant changes, there was a need for an all-embracing revision of the first edition.
From the General Data Protection Regulation, to the Directive 2011/62/EU relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products through to the Medical Device Directive and numerous new regulations at national level, the legal and regulatory framework has changed considerably.
In Germany alone, the 4th amendment to the Medicinal Products Act and the Act to Strengthen the Supply of Medicinal Products and Aids or the Act for More Safety in the Supply of Medicinal Products (GSAV) have brought new complexities.
What is the special feature?
The updated and well thought-out templates provide a structured insight into all relevant constellations and conceivable contract types.
The manual provides the user with proven and at the same time up-to-date template contracts, which, on the one hand, take into account the new legal framework conditions and, on the other hand, also offers solutions for a variety of possible problems related to the different contractual constellations.
Despite its volume of more than 1,200 pages the work was conceived as a methodical reference guide. Once again, experts from all areas of the life science and pharmaceutical/healthcare industry have contributed to the various areas.
How is the manual structured?
In the various fields, experts from companies, specialized law firms, universities and associations use their expertise to comment on the respective contract models.
From non-disclosure agreements on MTAs, R&D and cooperation agreements, contracts for the acquisition of drug candidates and approvals, donations to members of the professional community and medical institutions, sales and compliance, acquisition of drug approvals, through to clinical trials, forms for tenders or agreements for M&A transactions in the pharmaceutical sector, all typical constellations are covered.
The manual is suitable for pharmaceutical and medical device manufacturers, healthcare institutions, specialized law firms as well as universities and research institutions in this field.
For each area of relevance, the potential issues are presented. This discussion is followed by a sample contract, partly in English, partly in German and then the explanations and comments dedicated to the practical handling of the contracts.
There is a general section concerning the general part of all of these contracts which discusses clauses that become relevant regardless of the type of contract, such as jurisdiction, termination or contractual penalties.
It is therefore a comprehensive manual, which is structured and written in an intuitive and easily understandable way.
Vertragshandbuch Pharma und Life Sciences
Handbook hardcover (in linen)
2nd, extended edition. 2021
Published by Dr. Marco Stief, LL.M., Attorney
and Dr. Boris Bromm, Attorney and In-House Counsel