MSc Pharmaceutical Industrial Advanced Training (PIAT) / Course details

Year of entry: 2020

Course unit details:
Legal Issues in Business Development Contracts (PLG 4)

Unit code PHAR71430
Credit rating 15
Unit level FHEQ level 7 – master's degree or fourth year of an integrated master's degree
Teaching period(s) Variable teaching patterns
Offered by Pharmacy
Available as a free choice unit? No

Overview

This unit covers the key legal aspects required to support the negotiation and conclusion of agreements in business development. The unit will cover all types of agreements, as well as fundamental issues such as product development, marketing, performance, competition law and product liability. 

Aims

  • To provide a background to law and legal processes and an insight into applicable legislation.
  • To understand the different types of agreements used in the industry.
  • To provide an appreciation of the basic legal concepts relevant to English and European legislation.
  • To develop an understanding of the basic legal concepts with emphasis on application in a pharmaceutical and biotechnology business development and licensing context. 
  • To develop an understanding of the legal principles to differentiate different types of licensing and business development deals.
  • To develop a practical capability to undertake a review and recommendation of different types of business development deals.
  • To provide an appreciation of trends in deal types.

Learning outcomes

  • To recognise the key components of legal agreements and distinguish between their functions role and relevance in protecting businesses and business arrangements.
  • Understand a number of critical ‘deal’ terms and evaluate their importance to an overall business ‘deal’ from the viewpoint of both the buyer/licensee and the seller/licensor and communicate the information to a required audience in an appropriate manner.
  • Interpret  the key clauses in an agreement and to communicate the information in an appropriate manner.
  • Demonstrate ability to understand and summarise the key information in order to critically appraise the strengths and weaknesses of a given contract, including its business impact.
  • To develop a practical capability to undertake basic drafting of terms sheets for different types of business development agreements.

Syllabus

Unit 1:

 

Understanding the Law, provides a basic introduction to law and legal processes. It considers the origins of the law in Europe in relation to how this may apply to the business development environment.

Unit 2:

 

Tort. This Unit focuses on the concepts of the law of tort, negligence, product liability and the law of confidence.  These principles are fundamental and essential as a basis for forming the contractual relationships that are required to operate in business development. 

Unit 3:

 

Contract.  This unit addresses the Contract – the formation and drafting of contracts, the interpretation and management of breach of contract.  

Unit 4:

 

Preliminary and Ancillary Documents, Due Diligence.  In business development, there are a range of ancillary agreements which are entered into ahead of formal negotiations for major transactions such as license agreements.   This Unit underpins the legal rationale and reviews these basic contracts in the business development context.

Unit 5:

 

Collaboration Agreements, addresses the key issues in concluding research alliance agreements.  For example, the ownership and access to intellectual property rights which emanate from such collaborations.  It reviews the contentious issues between parties, in particular at the industry academia interface.

Unit 6:

 

Option Agreements, Pre Agreement Documents, Contract Research & outsourcing.  Building on the knowledge gained in the earlier Units, Unit 6 moves on to consider the management of risk by the use of Option Agreements which are frequently a precursor to major transactions.  

Unit 7:

 

Pharmaceutical Licensing Agreements, addresses all of the key components of a standard licence agreement and provides a legal perspective on the terms that have to be considered in this business arrangement.   

Unit 8:

 

Alternative Arrangements for Marketing, Promotion and Exploitation of Pharmaceutical Products.  This Unit addresses the key elements of marketing alliance agreements i.e. those agreements that govern marketing as opposed to R&D alliances.

Unit 9:

 

Supply and Distribution Agreements, looks at the standard legal provisions of a supply agreement and highlights the differences between a licence and distribution arrangement.

Unit 10:

 

Successful Contract Drafting and Negotiation. This Unit reviews some non legal aspects which are essential during the conduct of the negotiation in order to reach a fair and equitable settlement.

Unit 11:

Background Legal Issues in Business Development and Licensing Agreements, provides some more details on some of the key ancillary areas that are relevant to business development agreements.   So although for each of these specialised fields, it is most important to consult one's legal advisor, this gives a business person's insight into these key topics.

Assessment methods

Method Weight
Written assignment (inc essay) 100%

Assessed by 1 x 6000 word essay

Feedback methods

Provisional marks and feedback for coursework returned within 15 working days.

Exam marks and final marks returned after ratification at exam board. 

Study hours

Independent study hours
Independent study 150

Teaching staff

Staff member Role
Matthew Shaw Unit coordinator

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