Pharmaceutical and Biomedical Due Diligence Checklist

Transcription

1 Pharmaceutical and Biomedical Due Diligence Checklist

2 Pharmaceutical and Biomedical Due Diligence Checklist 2 This due diligence checklist template includes many of the key items that are required in M&A transactions involving pharamaceutical and biomedical companies. A. Pharmaceutical and Biologics Products I. List of all intellectual property including products currently being marketed and under development. II. List of products under development and their regulatory statuses. III. List of filed/approved marketing applications in the U.S. or abroad. IV. List of drug master files (DMFs) filed by the company. V. Catalogs of the following: DMF deficiency letters, DMF annual update reports, companies authorized to reference DMFs, and FDA correspondences regarding the DMFs. VI. Any of the following documentation surrounding preclinical testing of existing/pending products: a. Documentation and correspondence regarding FDA Good Laboratory Practices. b. Accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care and/or compliance with regulations on Care and use of Laboratory animals. c. Compliance with Good Clinical Practice regulations. d. Assurances that services have not been provided by persons debarred, convicted of a felony, or for exhibiting bad conduct/ violating any NDA, ANDA, PLA, ELA, or BLA regulations.

3 Pharmaceutical and Biomedical Due Diligence Checklist 3 VII. Records of Investigational New Drug (IND) applications, including but not limited to IND numbers, deficiency letters from the FDA, and other correspondence regarding acceptances or denials of approval of IND applications. VIII. List of statuses of foreign and domestic marketing applications, including NDAs, ANDAs, PLAs, and BLAs. IX. Compilations of correspondence with governing agencies related to marketing applications, records of compliance in filing the applications, records of compliance with the Prescription Drug User Fee Act, records of compliance with reporting requirements for marketing applications in the U.S. and abroad, and records of compliance with any postmarket or Phase IV study obligations. X. The following documents regarding manufacturing processes (if they exist): FDA Good Manufacturing Practices (GMP) contractor agreements, records of compliance with GMP requirements, records of FDA inspections, GMP manual(s), Standard Operating Procedures, FDA ELAs, correspondence with the FDA regarding GMP compliance. XI. Adverse Experience Reports and/or documentation of Complaint Procedures. XII. Marketing Materials, including press releases, labeling, brochures, and abstracts. XIII. Documentation regarding MSL training, SOPs, products covered by Risk- MAPs or REMs. XIV. List of any Over-the-counter drugs manufactured, and any applications, complaints/resolutions, correspondence, and/or marketing materials associated with the OTC drugs. XV. Any remaining FDA documents or correspondence regarding potential violations by the company and the associated resolution/response documents.

4 Pharmaceutical and Biomedical Due Diligence Checklist 4 B. Organization and Good Standing. I. The Company s Articles of Incorporation, and all amendments. II. The Company s Bylaws, and all amendments. III. The Company s minute book, including all minutes and resolutions of executive committees, shareholders and directors, and other governing groups. IV. The Company s organizational chart. V. The Company s list of shareholders and number of shares held by each. VI. Copies of agreements relating to options, voting trusts, warrants, puts, calls, subscriptions, and convertible securities. VII. A Certificate of Good Standing from the Secretary of State of the state where the Company was incorporated. VIII. Copies of active status reports in the state of incorporation for the three years. IX. A list of all states where the Company is authorized to do business and annual reports for the last three years. X. A list of all states, provinces, or countries where the Company owns or leases property, maintains employees, or conducts business. XI. A list of all of the Company s assumed legal names and copies of registrations.

5 Pharmaceutical and Biomedical Due Diligence Checklist 5 C. Financial Information. I. Audited financial statements for three years, provided with Auditor s Reports. II. The most recent unaudited statements, with comparable statements to the previous year. III. Auditor s letters and replies for the past five years. IV. The Company s credit report, if available. V. Any projections, capital budgets and strategic plans. VI. A schedule of all indebtedness and contingent liabilities. VII. A schedule of inventory. VIII. A schedule of accounts receivable. IX. A schedule of accounts payable. X. A description of depreciation and amortization methods and changes in accounting methods over the past five years. XI. Any analysis of fixed and variable expenses. XII. Analysis of company gross margins. XIII. The Company s general ledger. XIV. Description of the Company s internal control procedures.

6 Pharmaceutical and Biomedical Due Diligence Checklist 6 D. Physical Assets. I. A schedule of fixed assets and their locations. II. All U.C.C. filings. III. All equipment leases. IV. A schedule of sales and purchases of major capital equipment during the last three years. E. Real Estate. I. A list of the Company s business locations. II. Copies of all real estate leases, deeds, mortgages, title policies, surveys, zoning approvals, variances or use permits. F. Intellectual Property. I. A list of domestic and foreign patents and patent applications. II. A list of trademark and trade names. III. A list of any copyrights. IV. A description of important technical know how. V. A description of methods used to protect trade secrets and know-how. VI. Any work for hire agreements. VII. A schedule and copies of all consulting agreements, agreements regarding inventions, and licenses or assignments of intellectual property to or from the Company.

7 Pharmaceutical and Biomedical Due Diligence Checklist 7 VIII. Any patent clearance documents. IX. A schedule and summary of any claims or threatened claims by or against the Company regarding intellectual property. G. Employees and Employee Benefits. I. A list of employees including positions, current salaries, salaries and bonuses paid during last three years, and years of service. II. All employment, consulting, nondisclosure, nonsolicitation or noncompetition agreements between the Company and any of its employees. III. Resumés of key employees. IV. The Company s personnel handbook and a schedule of all employee benefits and holiday/vacation/sick leave policies. V. Summary plan descriptions of qualified and non-qualified retirement plans. VI. Copies of any collective bargaining agreements. VII. A description of all employee issues within the last three years, including alleged wrongful termination, harassment, and discrimination. VIII. A description of any labor disputes, requests for arbitration, or grievance procedures currently pending or settled within the last three years. IX. A list and description of benefits of all employee health and welfare insurance policies or self-funded arrangements. X. A description of worker s compensation claim history. XI. A description of unemployment insurance claims history. XII. Copies of all stock option and stock purchase plans and schedule of grants.

8 Pharmaceutical and Biomedical Due Diligence Checklist 8 H. Licenses and Permits. I. Copies of any governmental licenses, permits or consents. II. Any correspondence or documents relating to any proceedings of any regulatory agency. I. Environmental Issues. I. Environmental audits, if any, for each property leased by the Company. II. A listing of hazardous substances used in the Company s daily operations. III. A description of the Company s disposal methods for hazardous substances. IV. A list of environmental licenses and permits. V. Copies of all correspondence, notices and files related to EPA, state, or local regulatory agencies. VI. A list identifying and describing any environmental litigation or investigations. VII. A list identifying and describing any contingent environmental liabilities or continuing indemnification obligations. J. Taxes. I. Federal, state, local, and foreign income tax returns for the last three years. II. State sales tax returns for the previous three years. III. Any audit and revenue agency reports.

9 Pharmaceutical and Biomedical Due Diligence Checklist 9 IV. Any tax settlement documents for the previous three years. V. Employment tax filings for three years. VI. Excise tax filings for three years. VII. Tax liens, if any. K. Material Contracts. I. A schedule of all subsidiary, partnership, or joint venture relationships and obligations, with copies of all related agreements. II. Copies of all contracts between the Company and any officers, directors, 5% shareholders or affiliates. III. All loan agreements, bank financing arrangements, line of credit, or promissory notes to which the Company is a party. IV. All security agreements, mortgages, indentures, collateral pledges, and similar agreements. V. All guaranties to which the Company is a party. VI. Any installment sale agreements. VII. Any distribution agreements, sales representative agreements, marketing agreements, and supply agreements. VIII. Any letters of intent, contracts, and closing transcripts from any mergers, acquisitions, or divestitures within the past five years. IX. Any options and stock purchase agreements involving interests in external companies.

10 Pharmaceutical and Biomedical Due Diligence Checklist 10 X. The Company s standard quote, purchase order, invoice and warranty forms. XI. All nondisclosure or noncompetition agreements to which the Company is a party. XII. Any other material contracts. L. Product or Service Lines. I. A list of all existing products or services and products or services currently being developed. II. Copies of all correspondence and reports related to any regulatory approvals or disapprovals of any Company s products or services. III. A summary of all complaints or warranty claims. IV. A summary of results of all tests, evaluations, surveys, and other data regarding existing products or services and products or services currently being developed. M. Customer Information. I. A list of the Company s twelve largest customers in terms of sales and a description of sales over a period of two years. II. Any supply or service agreements. III. A description or copy of the Company s purchasing policies. IV. A description or copy of the Company s credit policy. V. A list of unfilled orders. VI. A list and explanation for any major customers lost over the last two years.

11 Pharmaceutical and Biomedical Due Diligence Checklist 11 VII. All surveys and market research reports relevant to the Company or its products or services. VIII. The Company s current advertising programs, marketing plans and budgets, and printed marketing materials. IX. A description of the Company s major competitors. N. Litigation. I. A schedule of all pending litigation. II. A description of any threatened litigation. III. Copies of insurance policies possibly providing coverage as to pending or threatened litigation. IV. Documents relating to any injunctions, consent decrees, or settlements to which the Company is a party. O. Insurance Coverage. I. A schedule and copies of the Company s general liability, personal and real property, product liability, errors and omissions, directors and officers, worker s compensation, and other insurance. II. A schedule of the Company s insurance claims history for past three years.

12 Pharmaceutical and Biomedical Due Diligence Checklist 12 P. Professionals. I. A schedule of all accounting firms, law firms, consulting firms, and similar professionals engaged by the Company during the past five years. Q. Articles and Publicity. I. Copies of all articles and press releases relating to the Company for the past three years. Need a workspace to manage all your due diligence documents? Learn how CapLinked can speed up this process and keep you organized. Talk with a CapLinked representative today DISCLAIMER This Due Diligence Checklist is solely for informational purposes and intended only as a description and model; it is not intended to be a complete list of all necessary Due Diligence activities. It is not an offering of services or a description of services, by either CapLinked or any Member of CapLinked. CapLinked will not be liable for any errors or omissions in this information nor for the availability of this information. CapLinked will not be liable for any losses, injuries, or damages from display or use of this information.