Biotechnology Due Diligence Checklist

Proper due diligence requires the ability to recognize issues and complications as they arise. Biotech company acquisitions often host a great number of challenges, making the due diligence process that much more important.

Biotech Due Diligence Template

Biotech company acquisitions create a host of unique issues and complications. Proper due diligence requires the ability to recognize issues as they arise. It also requires that one adequately address those issues so they don’t come back to haunt you after the acquisition.

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Biotech Due Diligence Template

Biotech company acquisitions create a host of unique issues and complications. Proper due diligence requires the ability to recognize issues as they arise. It also requires that one adequately address those issues so they don’t come back to haunt you after the acquisition.

Biotechnology Due Diligence Checklist

Proper due diligence requires the ability to recognize issues and complications as they arise. Biotech company acquisitions often host a great number of challenges, making the due diligence process that much more important.

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Biotech Due Diligence Template

Biotech company acquisitions create a host of unique issues and complications. Proper due diligence requires the ability to recognize issues as they arise. It also requires that one adequately address those issues so they don’t come back to haunt you after the acquisition.

What Tasks does the 

Biotechnology Due Diligence Checklist

 Include

Legal

The legal structure of a company is always of primary concern to a buyer. A seller should always know and be prepared to discuss the legal underpinnings of the company being sold.

Collect all information about the company’s structure, including:

  • An organizational chart
  • Governing and constitutional documents of the corporation
  • A list of jurisdictions in which the business is permitted to do business
  • Minutes of any board, shareholder, and managerial meetings
  • List all related party transactions
  • Include the firm’s policies with respect to related party transactions
  • Compile the CVs for all board members, managers, and vital employees
  • Compile all information about the capital structure of the company that is not included on the Statement of Shareholder Equity
  • Compile a list of all of the firm’s permits, licenses, and authorizations
  • Describe the firm’s compliance policies and provide any related documentation
  • Disclose if any officers or persons holding substantial numbers of shares qualify as Bad Actors
  • Disclose if the firm is currently restricted from doing business under any regulatory or legal provision
  • Collect any communications with a regulatory agency
  • Include a list of all previous product recalls and significant warranty claims

Valuation

More than anything else, a well-supported valuation by a reputable business valuation firm will provide a foundation for your offer price and negotiating position. Try to obtain this reasonably early and make sure that the valuation firm isn’t erring on the fanciful side when it comes to arriving at their final number.

  • Obtain a current, “as-is” valuation of the firm

Compliance

Compliance issues, most frequently with the pharmaceutical or biologic sales force, frequently arise. Acquirers should conduct a deep dive on the practices of the sales team, and all other employees and contractors, with an eye towards compliance with regulatory and legal requirements.

  • Look for inaccurate or misleading government or claim forms
  • Investigate the payment of any improper kickbacks, bribes, or benefits to healthcare providers
  • Investigate possible violations of the Foreign Corrupt Practices Act
  • Investigate all instances of impermissible, “off-label” promotion of pharmaceuticals and biologics
  • Examine whether the firm provides any incentives for any compliance-related violations
  • Review all policies and procedures involving employees and contractors of the firm with an eye towards its sales force
  • Review all compliance functions and personnel
  • Review any past instances of non-compliant conduct and the firm’s response thereto
  • Consider the Physicians Payments Sunshine Act and compliance of the firm therewith
  • Examine the firm’s treatment of “protected health information” and compliance with HIPAA
  • Review compliance with, and results of, FDA inspections

Marketing

  • Confirm all marketing materials comply with FDA regulations
  • Confirm if any products are covered by restricted distribution programs or a Risk Evaluation and Mitigation Strategy
  • Confirm if the target analyzes marketing metrics?
  • Confirm that any direct-to-consumer marketing is associated with an FDA advisory review request

Manufacturing Protocols

  • Confirm all contracts with manufacturers accord with FDA Good Manufacturing Practices
  • Confirm Good Manufacturing Process manual accords with FDA requirements on the subject
  • Review the target’s Adverse Experience Reports
  • Confirm that adverse experience trends were analyzed and reported on

Investigational Research

  • Confirm adequate in vitro and in vivo research for pending or approved products has been conducted by target or by contracted labs

Confirm compliance with:

  • Good Laboratory Practices regulation
  • Care and Use of Laboratory Animals regulation
  • Good Clinical Practice regulation

With respect to all Investigational New Drug applications, confirm:

  • The identities of all sponsors
  • Institutional Review Board approval
  • Investigator statements and research agreements have been signed
  • Informed consent forms meet regulatory guidelines
  • All annual reports have been filed
  • Any amended protocols have been forwarded to the FDA
  • Any deficiency letters from the FDA have been satisfactorily resolved
  • If any are considered inactive
  • Any treatment INDs have adequate reports and records
  • Confirm if any clinical research has been terminated or withdrawn
  • Confirm if any Special Protocol Assessments have been submitted to the FDA
  • Confirm if any trials are being conducted in foreign countries
  • Confirm all clinical monitoring is being conducted in accordance with FDA regulations

Tax & Finance

Taxation problems arise frequently after acquisitions when the due diligence process has been defective. Additionally, virtually any buyer of a business is going to want detailed information about any outstanding tax information. This includes information about tax policies within the company (with respect to employees and transfer pricing) and to pending tax liabilities owed to the state.

The purpose of financial due diligence is to create a complete and compelling financial story for the buyer. They should be able to understand, based on your due diligence alone, what the past, current, and future financial state of the firm was, is, and is likely to be.

Tax

  • Identify any deferred tax liabilities or assets and valuation allowances
  • Outline all transfer pricing policies
  • Outline all tax sharing or allocation agreements
  • Justify and provide a written explanation of the classification of employees and contractors
  • Include all tax audits conducted in recent history (up to five years prior)
  • Include any loss surrenders made in exchange for research and development credits
  • Describe property taxes paid by the firm in recent history (up to five years prior)
  • Describe any overseas activity
  • Describe any sale and leaseback transactions
  • Disclose any matters related to the firm under investigation by any tax authority
  • Disclose the tax base of any asset when it differs from its original cost
  • Explain the firm’s current approach to tax planning and strategy

Finance

  • Identify and highlight all recent capital expenditures and their likely impact on future cash flows
  • Identify capital expenditures likely to be required in the near future and their likely impact on future cash flows
  • Identify any seasonal or cyclical cash flow trends (in order to avoid under- or over-pricing the business, depending on the time of year)

Describe your sales patterns:

  • Identify your largest and most important clients and products/services
  • Identify any significant sales prospects
  • Identify any significant new products
  • Identify any significant discontinuances or potential losses of clients
  • Collect all complete and current financial statements
  • Specify and list any departures from GAAP and IFRS used during the preparation of the financial statements
  • Collect all budgets and financial projections
  • Include all Management Representation letters and any other communications regarding accounting controls

Current Agreements

All current agreements need to be explained and described in full. This includes not just written agreements, but verbal and “handshake” agreements as well. The purpose of this exercise is to paint for the buyer a clear picture of the firm’s rights and obligations pursuant to all current agreements.

Identify all current contract obligations, including:

  • Written contracts
  • Verbal contracts
  • “Handshake agreements”
  • Joint venture or partnership agreements
  • Any contracts terminable upon a change of control of the firm
  • Indemnification agreements
  • All real estate contracts and contracts involving real property or for the insurance thereof
  • Employment, independent contractor, consulting, compensation, and severance agreements

Describe all current obligations, including:

  • Assignability
  • Financial terms
  • Length of commitment

Identify any contracts to be entered into in the near future, including:

  • Letters of intent
  • Ongoing negotiations
  • Identify any crucial relationships with vendors, distributors, etc.
  • Examine all agreements with manufacturers and suppliers

Identify any licensing and collaboration agreements that involve:

  • The allocation of rights
  • The imposition of diligence requirements on the target
  • Non-compete limitations
  • Change of control provisions
  • Identify any contract research organizations currently used by the target and examine their confidentiality and IP provisions and practices

Intellectual Property (IP)

In some industries, intellectual property is the biggest contributor to a firm’s final valuation. Extensive due diligence with respect to IP is essential to ensuring a firm legal and contractual basis for ownership of that resource.

  • Compile a summary of all of the firm’s trademarks, patents, copyrights, and web domains and sites
  • Examine the basis and substance of all trade secrets currently held by the firm
  • Determine the ability of the firm to protect and keep secure and confidential its trade secrets
  • List all agreements and contracts under which the firm is granted the use of a third party’s intellectual property
  • Determine whether the firm is using IP for which the assignment of rights is incomplete or defective
  • Determine whether the firm is using IP developed in collaboration with, or acquired from, a third party. If so, examine the agreements that allow for use of that IP
  • List all agreements and contracts under which a third party is granted the use of the firm’s intellectual property
  • List all intellectual property used by the firm that is not solely owned by the firm
  • Create a summary of all intellectual property litigation involving the firm that is either concluded, ongoing, or reasonably foreseeable
  • List all instances in which a third party has infringed on the firm’s intellectual property (even if it did not result in litigation)
  • Describe the company’s process for developing and protecting its intellectual property
  • List all subsisting patents and their remaining terms
  • Compile a list of all pending patent applications and determine their likelihood of success
  • Determine likely ability of the firm to protect the IP of all pending patents’ should a patent be granted
  • Determine the eligibility of any patents for term extension
  • Determine the market exclusivity terms attaching to each of the firm’s products and whether those terms can be extended
  • For each biologic and pharmaceutical product, determine its stage in the FDA approval process and, for those products not yet approved, the likelihood of their eventual approval
  • Consider the likely timing and impact of the introduction of generic and biosimilar drugs on the firm’s market share and profitability

FAQ

What Is Due Diligence?

Due diligence is a critical aspect of any deal that begins very early in the process and can continue right up until closing. During due diligence, the potential buyer asks questions and requests documentation from the seller that helps the buyer understand the target company and its business. These requests are usually general to start and become more specific as the buyer develops a greater understanding of the target. Buyers use the information provided by the seller to evaluate the opportunities and risks associated with the potential transaction. It is important for sellers to stay organized throughout the process. Buyers often submit thorough, detailed request lists that require input from numerous members of the seller’s deal team.

What is a due diligence checklist?

As the name implies, a due diligence request list is a list of questions and requests for information and documentation that a buyer submits to a seller in order to learn about the target company, its business and its operations. The initial diligence request list tends to be broad and typically includes an extensive list of questions covering a wide range of subjects. This allows the buyer to gain a broad understanding of the target company and identify key issues that can be investigated and considered more closely. Because every deal is different, due diligence request lists have to be tailored to meet the needs of the buyer and address the unique circumstances of your transaction.
However, there is a variety of fundamental requests that are relevant in most deals. These are the types of requests that our templates are designed to address.

What Questions Does the Master Due Diligence Questionnaire Include?

As the name implies, a due diligence request list is a list of questions and requests for information and documentation that a buyer submits to a seller in order to learn about the target company, its business and its operations. The initial diligence request list tends to be broad and typically includes an extensive list of questions covering a wide range of subjects. This allows the buyer to gain a broad understanding of the target company and identify key issues that can be investigated and considered more closely. Because every deal is different, due diligence request lists have to be tailored to meet the needs of the buyer and address the unique circumstances of your transaction.
However, there is a variety of fundamental requests that are relevant in most deals. These are the types of requests that our templates are designed to address.

Key considerations when using our m&a due diligence template

Our templates are drafted to provide an inclusive and wide-ranging list of initial due diligence requests. However, the templates, as well as the information contained therein, are not legal advice. They are not complete, and they are not specific to your transaction. The templates are designed to elicit general information from the seller that will provide the buyer with a broad overview of the target and it’s business and operations. You should review any template before using it, and it may need to be modified to ensure that it is suitable and relevant to your circumstances. Information provided by the seller will likely trigger additional questions that focus on specific aspects of the target’s business and issues identified during the due diligence process.

Are the requests in the template comprehensive?

No. Our Due Diligence Checklist is drafted to include typical requests that are relevant in most transactions. However, every deal and every target company is unique. Before utilizing any template, it is important that you review it with the help of your legal and other professional advisors to ensure that the requests are complete and tailored to the specific circumstances of your deal.

How to use the template with Dealroom

  • Start 14-day Free Trial of DealRoom and sign-up
  • Select a Master Due Diligence Template while creating a new room
  • Start assigning, adding to, and completing due diligence requests with needed documents by uploading them into the built-in virtual data room. The Requests tab is automatically populated with the requests from the due diligence template.

Can I change requests in this checklist or add new?

Every M&A process is different. Downloaders are urged to make these checklists their own by changing the providing information to better fit their needs.

Does this questionnaire provide all the necessary integration information?

This checklist was created by and for M&A professionals. It includes a comprehensive starting point for the integration process. However, every deal is different and may require additional requirements and tasks.

How to use this template with DealRoom?

  • Start 14-day Free Trial of DealRoom and sign-up
  • Select an Integration Template while creating a new workspace
  • Start planning, assigning, adding to, and completing integration tasks. The Requests tab is automatically populated with the tasks from the integration template.

Key considerations when using our m&a due diligence template

Our templates are drafted to provide an inclusive and wide-ranging list of initial due diligence requests. However, the templates, as well as the information contained therein, are not legal advice. They are not complete, and they are not specific to your transaction. The templates are designed to elicit general information from the seller that will provide the buyer with a broad overview of the target and it’s business and operations. You should review any template before using it, and it may need to be modified to ensure that it is suitable and relevant to your circumstances. Information provided by the seller will likely trigger additional questions that focus on specific aspects of the target’s business and issues identified during the due diligence process.

Are the requests in the template comprehensive?

No. Our Due Diligence Checklist is drafted to include typical requests that are relevant in most transactions. However, every deal and every target company is unique. Before utilizing any template, it is important that you review it with the help of your legal and other professional advisors to ensure that the requests are complete and tailored to the specific circumstances of your deal.

How to use the template with Dealroom

  • Start 14-day Free Trial of DealRoom and sign-up
  • Select a Master Due Diligence Template while creating a new room
  • Start assigning, adding to, and completing due diligence requests with needed documents by uploading them into the built-in virtual data room. The Requests tab is automatically populated with the requests from the due diligence template.

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