TypeOnline Course
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Price$180 / Rs. 8500
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Introduction

Who should attend

Course Content

Course Deliverables

Course Code: KPE-C-061

Course Name: KPE’s Certificate Course in In-Licensing and Out-Licensing in Pharmaceutical Industry

This course is designed to provide participants with an detailed practical orientation about Drug R&D licensing  – In-licensing and Out-Licensing ,

Licensing, as is understood in plain terms, is the transfer of rights to a third party (the Licensee) to use the Intellectual Property owned by a party (the Licensor) for a fixed duration of time and under defined terms and conditions. The said terms and conditions may be, for ex., manufacturing and/or marketing rights in select geography, etc. Depending from whose perspective you see it, a licensing deal can be called an Out-Licensing deal or an In-Licensing deal. Out-Licensing means that the Licensor is ‘out’ – licensing his Intellectual Property to a third party. For the third party, the Licensee, who takes ‘In’ the Intellectual Property, it becomes an In-Licensing deal.

Coming to the Pharma domain, smaller size innovators companies are traditionally been an out-Licensing entity. They develop a drug molecule up to a certain level (generally till they identify a drug candidate from hundreds of potential ones) and then they out-license this molecule to a Big Pharma player for this molecule and then receive royalties on future sales if the drug candidate is finally marketed after passing all the regulatory steps. This benefits the Indian Pharma in two-ways: a) they do not have to invest into the high-risk business of developing a drug and b) they get a substantial amount from the one time payment they receive, which they can invest in further R&D etc.

This e-learning course provide comprehensive idea about the following:

  • Pharma R&D
  • Portfolio Analysis 
  • Strategies to strengthen Portfolio
  • Current scenario of Licensing in Pharma R&D
  • Detailed fundamental training regarding In-Licensing and Out-Licensing
  • Real Life Case Analysis in pharmaceutical, bio-pharmaceuticals and medical devices licensing
  • Terminologies regarding licensing
  • Pharma licensing deal structures
  • Confidential Disclosure Agreements (CDAs) and Materials Transfer Agreements (MTAs).
  • Practical understanding in Deal Valuation and Return Analysis
  • Detailed understanding how cross functional licensing team works in Large Innovator Companies, SMEs and Generic Drug Companies

The Pharmaceutical In and Out-licensing Course is designed for those likely to be involved in the in or out-licensing projects :
• Senior managers and scientists in companies developing or planning to develop products for out-licensing.
• Junior to mid-level managers, including scientists, commercial and legal managers.
• Business development managers, IPR teams with no formal training in licensing and staff joining the business development and licensing functions.

Introduction to Drug R&D Process
Overview of the Drug Regulations .
Introduction to Strategic Initiatives in Drug R&D
Overview of the In & out-licensing process.
In & out-licensing – Why? When? How?
Detailed understanding to different types of the deal with real life practical simulations
Deal Outcome – Co-promotion, Co-marketing
Typical Commercial Deal Structures – Milestone Payment, Royalities, Deal Incentives etc.
Deal Terminologies Analysis- Exclusivity, Sub-licenses, Field and Territory, Milestones, Royalties and Royalty stacking, Termination, Warranties and Jurisdiction.
Confidential Disclosure Agreements (CDAs) and Materials Transfer Agreements (MTAs).
Deal Valuation – Key factors affecting deal valuation
Setting Up licensing department in Pharma R&D – Cross Functional Team, Job Descriptions. How Licensing team works.
Finding Potential Partner – how to find the partner? Developing target list. Evaluations to refine the list.
Deal Announcement – PR issues

  • Upon admission you will be providing the user id and password to access all the content online.
  • You will also be receiving the soft copy of the e-module (which you can download from your dashboard).

 

Section 1Licensing: Introduction
Lecture 1Licensing in Pharma - Introduction
Lecture 2Discovery research to Commercialization: Basic Understanding
Lecture 3Patents Vs. exclusivity
Lecture 4Introduction to Portfolio Analysis
Lecture 5Evergreening -Strategic Session
Lecture 6Learning from New Drug Approvals
Lecture 7Understanding of Important Terminologies
Section 2Licensing Strategies for Big Pharma
Lecture 8Drug Pipeline and In / Outlicensing
Lecture 9License Agreement
Lecture 10Term or duration of a license
Lecture 11Are improvements licensed?
Lecture 12financial terms of a license and its total deal value
Lecture 13Milestone payments
Lecture 14How are royalties structured in a license?
Lecture 15Accounts, inspection and audit provisions are in a license
Lecture 16How is patenting dealt with in a license?
Lecture 17What warranties are in a license?
Lecture 18What competition law issues are there in licensing?
Section 3STRATEGIC ALLIANCES: CO-DEVELOPMENT AND CO-MARKETING AGREEMENTS
Lecture 19Step By Step In-Licensing Process
Lecture 20Drug Repurposing
Lecture 21Strategic Case - Pay For Delay
Lecture 22Case Study: Exclusivity
Lecture 23Compulsory Licensing
Lecture 24Technology Licensing
Lecture 25Due Diligence
Section 4Drafting of Legal Agreement
Lecture 26Overview of Licensing and Technology Transfer
Lecture 27Contractual Agreement in Technology Transfer
Lecture 28Confidentiality Agreements
Lecture 29Key Terms in License Agreements
Lecture 30Deeds of Assignments