Course Outline

MODULE 1: PREPARING THE GROUND

At the end of this module, you should understand how licensing processes are normally undertaken and the general strategic issues relating to inward and outward licensing activities.

• An overview of the licensing process
• Strategic issues – Reasons for licensing
• Preparing A licensing strategy
• Resources
• Product champions
• Licensing organization
• Relationships with potential partners

MODULE 2: DEAL STRUCTURE

The second module reviews the overall types and structures of deals that are commonly used in the pharmaceutical industry and looks at how to construct the commercial elements, including an overview of standard payment terms.

• Deal types
• Intellectual property to be licensed
• Levels of exclusivity
• Areas covered by the agreement
• Types of income
• Duration

MODULE 3: LEGAL AGREEMENTS

This module explains some of the legal elements of licensing in more detail, including the purpose and implications of all the main clauses covered in an agreement. The module also considers how to set up confidentiality and material transfer agreements, when and how to seek exclusive discussions, the difference between termsheets and ‘heads of agreement’ and the importance of competition law.

• An overview of the legal negotiations
• Confidentiality
• Samples and material transfer agreements
• Exclusive discussions and option agreements
• Termsheet
• Clauses for inclusion in a licensing agreement
• Competition law issue

MODULE 4: INWARD LICENSING

This module deals with the practicalities of inward licensing and considers how to define the type of product to seek, how to set out a competitive profile that is attractive to potential partners and, last but not least, how to make contact.

• Overview of the in-licensing process
• Action List for In-Licensing Activities
• Confirming the team
• Defining search criteria
• Identifying in-license partners
• Targeting potential opportunities
• What do you offer a potential partner?
• Making contact

MODULE 5: OUTWARD LICENSING

This module is all about the crucial parts of preparing a product for out-licensing. You will learn how to arrange successful confidential and non-confidential brochures, how to make sure approaches have maximum impact, and how to target and approach potential partners.

• Deciding when and how to out-license
• Licensing action plan and the licensing team
• Presentational material for products in development
• Presentational material for marketed products
• Other in-house preparations
• Identifying out-licensing partners

MODULE 6: MANAGING CONTACTS WITH OTHER COMPANIES

This module shows you to manage contacts with other companies. In addition to planning and making contacts, the module deals with the presentation of successful corporate presentation to maximize the chances of identifying potential opportunities, including a worked example, and finishes with a discussion on the key factors leading to successful negotiations.

• Establishing initial contacts
• Planning company visits
• Corporate presentational material
• Corporate presentation
• Data transfer and record-keeping
• Confidentiality
• Samples and materials transfer agreements
• Negotiating techniques

MODULE 7: EVALUATING OPPORTUNITIES

When opportunities are identified, they must be evaluated and Module 7 looks at how to manage evaluation resources efficiently using a step-wise process. The module reviews what is meant by ‘due diligence’ and considers some of the most common technical and commercial issues to look out for when undertaking an evaluation.

• Outline approach
• Licensing review
• Preliminary evaluation
• Full evaluation
• Final evaluation and decision

MODULE 8: FINANCIAL FACTORS

This module reviews the general dynamics of valuing a licensing deal, including a look at current trends in the industry, and how the characteristics of the product and a potential partner can influence the value of the deal. The module also considers how to model prospective deals to optimize the various payment terms and how the parameters can be varied to reach a win-win deal.

• Reviewing sales trends
• Why sales of marketed products need to be doubled by a licensee
• Using split royalties to enhance the value of marketed product licenses
• Putting a value on a deal examples of deal values
• Modelling your product

MODULE 9: SPECIAL CASES

Signing a deal is not the end of the process – it’s the beginning! This module deals with implementation. Starting with a review of what needs to be thought about before signature to assure success, the module goes on to consider the resource implications of entering a deal and how to use task-forces to manage partnerships. You will also learn how to manage any problems that arise.

• Platform technologies
• Universities and other academic and medical institutions
• Joint ventures
• Co-promotion
• Royalty stacking
• Sub-contracted work

MODULE 10: AFTER THE DEAL

The final module deals with some special cases that may be encountered in the course of licensing activities, including platform technologies, working with universities and other academic institutions, and when and how best to structure joint-venture agreements, co-marketing and co-promotion deals.

• Issues to be resolved before signature
• Internal management issues
• Building a team
• What to do if it all goes wrong
• Learn from the experience