A Guide To Creating Contracts For Outsourcing In The Pharmaceutical Industry

Dublin, Ireland - Research and Markets has announced the addition of Legal Aspects of Outsourcing in the Pharmaceutical Industry: A Practical Guide to their offering.

Paul Ranson's comprehensive report covers the contractual features of the outsourcing process from start to finish. This report includes information on the legal aspects of outsourcing services at all stages of product development, manufacturing and exploitation, including preclinical and clinical research, manufacture, logistics and sales.

By affording a background to the key legal issues in this field, this provides a manual for individuals new to outsourcing, as well as support for those familiar with the area. More than just an overview, this report is a practical guide to the process--the sections on drafting issues, documentation, negotiation and termination take readers step by step through the legal aspects of the outsourcing process.

The report includes an extensive selection of examples of the various types of outsourcing agreements. In addition there is a glossary of legal terms to assist the non-lawyer and information and specific considerations in different types of outsourcing to support contract development.

Key Questions Answered:

This report will provide a guide to creating contracts for outsourcing in the pharmaceutical industry:

-- Understand the term 'outsourcing'

-- Be aware of the key legal issues

-- Know what contracts should contain, both generally and in specific circumstances

The report contains a glossary and six example agreements.

Scope of report:

-- The scope of outsourcing

-- The key issues

-- Preparing the preliminary documentation

-- Drafting the contract

-- Service level terms and documents

-- Contract negotiation and managing disputes

-- Specific considerations in different types of agreements

-- Six agreement examples

This report is targeted at individuals responsible for and interested in:

-- Board and executive management

-- Marketing

-- Business development

-- Licensing/partnering

-- Deal making

-- Business strategy

-- Marketing and promotion

-- Distribution and manufacturing (including contract services)

-- Legal professionals new to pharmaceutical licensing and partnering

Chapters Include:

1. Introduction: The extent and nature of outsourcing and the procurement of services

2. Some key legal issues in outsourcing agreements

3. Selection and due diligence

4. Preliminary documentation

5. The outsourcing agreement:

General drafting issues

6. Service level terms and documents

7. Successful contract drafting and negotiation

8. Specific considerations in contract manufacture

9. Specific considerations in logistics

10. Clinical research

11. Contract Sales

12. Facilities Management

13. Managing disputes and exit routes

14. Appendices

Sources: Research and Markets