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ShareVault Presentation
Due Diligence Preparation
&
Document Sharing Options
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Steve Joseph
Vice President of Market Development
Mike Liccardo
Vice President of Corporate Development
ShareVault Presenters
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Due Diligence Preparation Process
Why is it necessary?
Planning for it
Document Sharing Options
Common methods
Pro’s & con’s
Data Rooms
Pro’s & con’s of Data Rooms vs. other document sharing options
Data Room features
Data Room checklist (differentiators)
Q&A
Topics To Be Covered
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Due Diligence Preparation
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Used to review & validate licensing/partnering and
other business opportunities (e.g. M&A, asset sales)
For the prospective licensee/receiving partner
Allows evaluation of the IP, science, testing, business opportunity
Uncovers any important issues & gaps
Helps to determine deal valuation
Validates fit with their business
For the licensor/sharing partner
Enables selection of the “best” licensee/partner
Helps to optimize deal terms
Ensures continuing development and/or marketing of the asset
Due Diligence Processes
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Allows time to identify/prioritize goals (already covered)
Allows time to identify potential licensees/partners
Allows time to develop and justify valuation
Helps uncover holes & issues ahead of time
Allows time to collect/organize relevant documents
Doing all of this prep work presents an “organized and ready”
image to the potential licensees/partners and can accelerate the
due diligence process and a successful outcome.
Due Diligence Advance Planning
Using a business development consultant
Knows the therapeutic area
Has relevant large pharma connections
Has experience in valuation & licensing/negotiations
Doing it internally
Using a database to identify prospective partners
Using a database to understand past deal terms
Using a network to get access to the partner
Using an experienced IP licensing attorney
Have this decided and set up well ahead of any opportunities.
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Identifying Licensees/Partners
Missing/qualified expertise?
IP attorneys
Business development experts
Regulatory advisors, CRO’s, CMO’s
Data & info to justify the valuation?
Pre-clinical & clinical results
Having comparables available
Agreements/contracts handled?
IP ownership
Key IP expertise
Ahead of time, avoid “glitches” and be armed to pre-empt concerns!8
Uncovering Holes/Issues
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Document Sharing
Ensure ease of document sharing & review
Important for licensor/sharing partner AND recipients
Speed of sharing & review affects the speed of the deal!
Plan desired level of document security/control
Protecting documents from getting to unintended recipients
Avoiding accidental or malicious breaches by intended recipients
Recognize activity monitoring importance/value
Identification of primary interested partner
Identification of primary areas of interest
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Document Sharing Considerations
Having essential supporting documents available
Collecting them from all parties and centralizing their storage
Identifying and finding missing ones
Identifying and updating outdated ones
Having an organizing structure - a checklist
Using one – from an attorney, prospective partner, colleague at another company
Adjusting the categories to fit the company’s business, therapeutic area, stage of development, etc.
Making it easy for licensees/partners to narrow down the areas of focus and assign their domain experts.
Your documents will be used to tell and validate your story!
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Document Sharing Preparation
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Document collection done well ahead of time
Know the volume of documents to be shared
Avoid the mad “scramble” to find documents
Avoid sharing wrong & outdated documents
Company is immediately ready for sharing
- when the timing is right OR when it’s approached
Present a “well- organized” impression
Deal opportunities can and do show up on a Friday afternoon. Would
you be ready on Monday to share information?
Document Sharing Preparation
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Setting up document sharing with the other parties
Deciding the method to be used for document sharing
Deciding who gets access to what information
Planning document sharing well in advance if approvals,
technology purchase or configuration, training required
Validating in advance that people only see what they are
supposed to see
Planning effective information presentation
Staging disclosure of information – “unfolding” it
Making sure there’s a smooth process for getting questions about
document content addressed quickly and fully
Document Sharing Preparation
Confidential Disclosure Agreements
Are standard practice
BUT
Don’t stop hackers
Don’t provide control of documents sent to intended recipients
Don’t provide user and activity monitoring
“You don’t really need a CDA with people you know and trust and for
everyone else, it doesn’t help.”
- Harvard IP attorney
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Is a CDA enough?
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Document Sharing Methods
Physical Options
Conference & hotel rooms
Physical media
Electronic Options
Point-to-point file sharing tools
Cloud-based file sharing tools
“Data rooms”
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Document Sharing Methods
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Document Sharing: “Rooms”
Pro’s
Face to face conversations
Due diligence team is captive in one place
Quick answers to questions
Highly secure
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Document Sharing: “Rooms”
Con’s
Travel may be required – licensee expense & inconvenience
Constant room “management” required
Single party at a time review
Difficult to find information – no “search”
Limited ability to determine licensee interest
Complexity of handling documents for licensee’s multiple experts
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Document Sharing: Media
Pro’s
Easy to use & inexpensive
Quick access
Can handle larger volumes of documents
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Document Sharing: Media
Con’s
No control of documents or licensee use of documents
No activity monitoring – no ability to determine true interest
Inefficient for providing document updates
Difficult to manage and track when multiple licensees involved
No easy search
No ability to “obsolete” outdated documents
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Security Breach Example
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Document Sharing: eMail
Pro’s
Easy to use & inexpensive
Quick access
Efficient for small documents and document volumes
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Document Sharing: eMail
Con’s
Email hacking potential
No control of documents or licensee use of documents
No activity monitoring – no ability to determine true interest
Unusable for large documents & document volumes
Difficult to manage and track when multiple licensees involved
No ability to “obsolete” outdated documents
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Security Breach Example
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Document Sharing: Point-to-Point
Pro’s
Proven legacy systems
Secure (VPN & sFTP)
Handles large files
Simple for handling small document volumes
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Document Sharing: Point-to-Point
Con’s
Slow & frequent access challenges due to firewalls
No control of documents or licensee use of documents
No activity monitoring – no ability to determine true interest
Very limited for large documents & document volumes
Difficult to manage and track when multiple licensees involved
No ability to “obsolete” outdated documents
Requires extensive IT involvement
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Security Breach Example
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Document Sharing: Cloud Services
Con’s
Varying degrees of security & past breaches
No control of documents or licensee use of documents
Limited activity monitoring – no ability to determine true interest
Often blocked by large companies
PDF and other hyperlinks don’t work
May not have content level searching
Harder to do staged sharing of documents
No ability to “obsolete” outdated documents
Pro’s
Free or inexpensive
Can handle large volumes of documents
Easy access from anywhere (unless blocked)
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Document Sharing: Cloud Services
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Security Breach Examples
Lak of
Security
Limited Control
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Data Rooms
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Document Sharing: Data Rooms
Cloud-based platform
with bank-grade security
allowing organizations to
securely control & monitor
highly confidential documents
being shared with outside parties
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Data Room Definition
“Deal Room”
“e-Room”
“Virtual Data Room”
“VDR”
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Data Rooms – Other Names
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Document Sharing: Data Rooms
Pro’s
Usually have bank-grade security
Significant control of user access
Significant control of documents
Monitoring of document & user activity (= business intelligence)
Can handle large volumes of documents
Usually accessible from anywhere
Easier to handle multiple parties
Often required by large pharma, i-bankers, attorneys
Audit trail can mitigate “you didn’t disclose that” claims
Con’s More expensive than other options (relatively speaking)
Takes time to set up
User access can be an issue with severe firewalls36
Document Sharing: Data Rooms
Types of documents to be shared – non-confidential Overview slide decks
Elevator pitches
Patents
Can use watermarks to “mark” the document source
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Data Room Documents
Types of documents to be shared – confidential Prior art
Pre-patent IP
Pre-clinical info
Clinical info
Regulatory submissions
Comparative analyses
Contracts/agreements with other IP owners
CRO, CMO & other partner relationships & communications
Ease of use
Document handling
Document uploading
Document protection
Reports/Audit trails
Industry-specific needs
System configurations
Connections to other platforms
Support & training
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Data Room Considerations
Intuitive
Easily usable by administrators with minimal or no training
Easily usable by document recipients with no training
Speed
Fast scrolling of document pages
Responsive search engine
Minimal steps to accomplish tasks
International support
Interface for users available in multiple languages
Search support for documents in other languages &
character sets
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Data Rooms: Ease of Use
Size limitations
Ability to upload/search/display large documents (>1,000 pages)
Ability to store large volumes of documents (>100,000 pages) with
no performance degradation
Search engine
Content level search engine (or just file name)
Tags
Allowing single document to appear in 1 or more folders without
requiring document copies
Intra-document hyperlinks
Preservation of hyperlinking ability
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Data Rooms: Document Handling
Ease of uploading
Support for “drag & drop” uploading
Ability to reliably upload large volumes of documents (>2 GB)
Ability to automatically upload and unpack zip files
Ability for “users” to upload documents
Due diligence index creation
Ability to create data room folder structure from uploaded folders
Document formats
Ability to upload many different document types (not just PDF’s)
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Data Rooms: Document Uploading
Controlled access by users
Allow different levels of access by different users
Hide folders from viewing until appropriate time
Document controls
Dynamic watermarks that include email addresses,
date/time (to deter screen photos/capture)
“View only” option for documents
Ability to revoke access to downloaded documents
Ability to detect and block screen captures
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Data Rooms: Document Protection
Reports
Real-time reporting
Ability to review reports within the data room (spreadsheet
export not required)
Activity metrics
Ability to differentiate user interest level and interest focus
Audit trail
Ability to view and filter user and administrator activity
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Data Rooms: Reports/Audit Trails
BioPharma
Preservation of hyperlinks between PDF’s in regulatory
submissions
Support for sharing data analytics files
Life Sciences
Ability to support an organization’s HIPAA & 21 CFR Part 11
compliance requirements
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Data Rooms: Industry Requirements
Devices
Support for PC’s, Mac’s & mobile devices
Browsers
Support for all major browsers
Compatibility with older and newer versions
Configurability
Customization with company name & logo
System security
Compliant with industry security standards
Documents encrypted during storage AND during transfer
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Data Rooms: System Requirements
Data room features comparison checklist
(Handout provided)
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Checklist
Corporate governance
Sharing documents with Board members, attorneys,
auditors
Partners, vendors and distributors
Sharing contracts, price lists/quotes, customers lists, …
Service providers
Communicating with CRO’s, CMO’s, regulatory advisors
Centralized corporate archive
Critical company documents secured, backed up,
accessible from any location
Enables reduced IT support
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Data Rooms: Other Applications
Conclusion
Our thanks to BIO, Joe & Lesley for enabling ShareVault’s
sponsorship of this course and to all attendees for your
attention!
If you have questions or would like additional information,
please contact:
Steve Joseph: [email protected] or +1 408-596-5603
Mike Liccardo: [email protected] or +1 408-596-5587
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