Due Diligence Strategy for In-house Counsel Jen Sieczkiewicz, Ph.D., J.D. Research & Business Development Counsel

DISCLAIMER These materials have been prepared solely for educational purposes and reflect only the personal views of the author and not of her real employer Biogen Inc. Further, the presentation of these materials does not establish any form of attorney- client relationship with the author, nor does it constitute individualized legal advice. 2

Viewpoint on IP Acquisition Provide robust diligence to secure defendable assets Evaluate exclusivity (IP strength) and freedom-to- operate Examine ownership, derivation (details in CLE paper) Approach: How will a generic/biosimilar invalidate? Outcome of diligence will impact terms of license Separate risks that money can solve, and those it cannot Manage risks and expectations vs. need for speed and budget 3

4 DEAL IDEA “First Look” IP Diligence TERM SHEET CLOSING Formal Due Diligence DEAL ENDS No Yes  Gather information early o Size of transaction o Timing o Degree of comfort needed and when o Understand product, market, technology, etc o Get IP landscape from licensor; discuss with them  Prepare “assumed LOE” based on composition per se or method of treatment patents and RDP o Use info from licensor, free or library-paid patent databases  Form preliminary assessment of technology /competitive landscape o IPD Analytics, Thomson Cortellis o Google  Perform brief prelim. FTO o (USPTO, PCT, Espacenet, Thomson)  Summarize using “first look” template  Continue gathering information re: timing, progress, what is needed. o Engage outside counsel for formal patent, FTO search  Leverage what you know from “first look”  Send checklist to other party:  Update results using formal template

How to Summarize Results? The following slides represent an output inside counsel might use in presenting the results of diligence 5

Due Diligence Readout This readout is based on the information provided to us by the Target Company/Licensor and by our legal analysis of the same. We have based our analysis on our current understanding of the applicable laws, which are subject to change over time. This readout should thus be relied upon only as of the date of this slide deck. 6

Projected LOE Date – Summary Patent Brief description of key types IP (composition, method) on which LOE is based and then LOE date (noting if applicable that up to 5 years of extension could be available) Regulatory List current RDP terms unless launch date known; US – 12 years from launch if biosimilar, 5 years if generic 7 All slides should have date stamp and “CONFIDENTIAL – ATTORNEY/CLIENT PRIVILEGED – DO NOT DISTRIBUTE

Projected LOE Date Alternative Approach 8 20XX 2025 Generic (ANDA) Challenge possible (if s.m.) 20XX 30-mo stay Extendable up to 7.5 yrs from approval 20XX Patent expires (w/o Ext) XX App, if granted, expires 2028 Earliest date for generic entry Patent expires (w/ Ext) All slides should have date stamp and “CONFIDENTIAL – ATTORNEY/CLIENT PRIVILEGED – DO NOT DISTRIBUTE

Detailed summaries of key patents in key jurisdictions. Focus on why they provide meaningful exclusivity (or why they do not, e.g., they claim a formulation that likely can be ‘invented around, an indication that could be ‘skinny labeled,’ etc.). 9 Details of Key Patents/Patent Applications All slides should have date stamp and “CONFIDENTIAL – ATTORNEY/CLIENT PRIVILEGED – DO NOT DISTRIBUTE

Opportunities to Strengthen our Position Summarize any opportunities to improve the existing filings, and the potential for new IP to be generated in the future. 10 All slides should have date stamp and “CONFIDENTIAL – ATTORNEY/CLIENT PRIVILEGED – DO NOT DISTRIBUTE

Landscape Analysis Freedom-to-Operate (FTO) – key jurisdictions  Composition cleared?  Manufacturing cleared?  Risks? Competitors and Competitive Technologies 11 All slides should have date stamp and “CONFIDENTIAL – ATTORNEY/CLIENT PRIVILEGED – DO NOT DISTRIBUTE

Conclusions 12 Statement on whether the quality of exclusivity is sufficient to continue with deal Supporting points (brief –examples below – may put on separate slide) All slides should have date stamp and “CONFIDENTIAL – ATTORNEY/CLIENT PRIVILEGED – DO NOT DISTRIBUTE Good or Excellent Aspects Poor or Missing Aspects Potential Implications of Poor or Missing Aspects Composition of matter claims until 2059 RDP expected to be available until X assuming launch of Y. Manufacturing process may be covered by Company X patents Company Y is producing a prodrug that may not be covered by composition claims. Ownership chain has break Third party IP may have to license, increasing royalty stack. May need to delay launch until expiry. Similar therapeutic may be available by 2020 that we cannot block with current IP. Need to obtain assignments from potentially missing people.