STATE OF FLORIDA OFFICE OF THE ATTORNEY GENERAL CHARLES J. CRIST, JR. ATTORNEY GENERAL Medicaid Fraud Control Unit Investigative Subpoena Duces Tecum To: Geneva Pharmaceuticals, Inc. c/o Sandoz, Inc. 2555 West Midway Boulevard Broomfield, CO 80020 You are hereby directed to appear at: Office of The Attorney General Medicaid Fraud Control Unit 107 West Gaines Street Tallahassee, Florida 32399 on the 16 th day of August, 2004, at 10:00 A.M., and to have with you at that time and place the following: SEE ATTACHMENT A You may comply with this subpoena by providing legible copies of the items to be produced to the Medicaid Fraud Control Unit on or before the scheduled date of production. You may mail or deliver the copies and, with the consent of the Office of the Attorney General, eliminate your need to appear personally at the time and place specified. In lieu of a personal appearance please contact Assistant Attorney General, Mary S. Miller at (850) 414-3600. This Investigative Subpoena is issued pursuant to Section 409.920(8)(b), Florida Statutes. This subpoena is issued as part of an ongoing civil investigation. WITNESS, The Office of the Attorney General, Medicaid Fraud Control Unit, at Tallahassee, Fl., this day of July, 2004. Personally served this day of, 2004, upon by MARY S. MILLER Assistant Attorney General
SUBPOENA ADDENDUM DEFINITIONS As used herein, the following terms are defined as indicated: (a) You, your or your company means the person or entity responding to these requests. (b) Person means, without limitation, any natural person, corporation, partnership, proprietorship, joint venture, association, government entity, any group, or any other form of public or private business or legal entity. (c) Communication means, without limitation, oral or written communications of all kinds, including correspondence, any exchange of written or recorded information, face-to-face meetings, or electronic, facsimile or telephone transmissions. (d) Meeting means, without limitation, any assembly, convocation, encounter or contemporaneous presence of two or more persons for any purpose, physically or through electronic audio and/or video, contact whether planned, arranged, scheduled or not. (e) Employee means, without limitation, current and former officers, directors, executives, managers, sales personnel, administrative staff, secretaries, clerical staff, messengers, or any other person employed by defendants. (f) Competitor(s) means, without limitation, any person or entity who competes with you in the development, production, manufacture, distribution, marketing, promotion, or pricing of any prescription drug. (g) Document means, without limitation, the original (or identical duplicate when the original is not available) and all non-identical copies (whether non-identical because of notes made on copies or attached comments, annotations, marks, transmission notation or highlighting of any kind) of all writing, whether handwritten, typed, printed or otherwise produced, which writings or other documents may consist of letters, correspondence, memoranda, legal pleadings, notes, reports, agreements, calendars, diaries, travel or expense records, summaries, records, messages or logs of telephone calls, conversations or interviews, telegrams, mailgrams, facsimile transmissions (including cover sheets and confirmations), electronic mail, minutes or records of meeting, compilations, notebooks, laboratory notebooks, work papers, books, pamphlets, brochures, circulars, manuals, instructions, sales literature,
advertising or promotional literature or materials, ledgers, graphs, charts, blue prints, drawings (including, without limitation, engineering, assembly and detail drawings), sketches, photographs, film and sound reproductions, tape recordings, digital files, phone mail messages, sales literature, advertising literature, promotional literature, or any other tangible materials on which there is any recording or writing of any sort. The term also includes the file, folder tabs, containers and labels appended to or associated with any physical storage device for each original, copy and draft of a document. In addition, the term document includes electronic data, which means the original and any non-identical copies and drafts of mechanical, facsimile, electronic, magnetic, digital, or other programs (whether private, commercial, or work-in-progress), programming notes, instructions, comments or remarks, program change logs and activity listings of electronic mail receipts and/or transmittals, output resulting from the use of any software program, including word processing documents, spreadsheets, database files, charts, graphs and outlines, electronic mail, drive mirroring systems, back-up tapes, batch files, ASCII files, and any and all active file or files (readily readable by one or more computer application or forensics software); any deleted but recoverable electronic files on said media; and shall include all file, record, and field format definitions and instructions, codes, or information necessary to retrieve the data. Electronic data includes any and all items stored on computer memories or computer chips, including, but not limited to, floppy disks, CD-ROM, DVD, Zip Disk, magnetic tape of all types, microfiche, any other vehicle for digital date storage and/or transmittal. The term electronic data also includes the file, folder tabs, and/or containers and labels appended to or associated with, any physical storage device associated with each original and/or copy. All electronic data must be provided on one of the following media: Zip Disk, CD-ROM, or DVD. (h) Referring to, relating to, reflecting, regarding or with respect to may mean, depending on the context, pertaining to, dealing with, concerning, reflecting, recording, reporting, constituting, containing, mentioning, describing, discussing, analyzing, evaluating, estimating, studying, surveying, projecting, assessing, supporting, modifying, contradicting, criticizing, summarizing, commenting, or otherwise involving, in whole or in part.
(i) Or is used in its inclusive sense and shall be construed so as to require the broadest possible response. If, for example, a request calls for information about A or B, you should produce all information about A and all information about B as well as all information about A and B. In other words, or should be read as and/or. (j) The singular form of a noun or pronoun shall be considered to include within its meaning the plural form of the noun or pronoun so used, and vice versa; the use of the masculine form of a pronoun shall be considered to include also within its meaning the feminine form of the pronoun so used, and vice versa; and the use of any tense of any verb shall be considered to include also within its meaning all other tenses of the verb so used. (k) Price, prices and/or pricing mean any actual, proposed, suggested or recommended price, as well as price increases or decreases, price quotations, price lists, price announcements, as well as any discounts, rebates, credit terms, profit margins, freight rates and/or charges specifically indicated as such, and any changes and/or proposed changes in the above. (l) Policy means any practice, procedure or directive, whether written or unwritten, formal or informal, which was recognized, adopted, issued or followed by you. (m) The Subject Drugs means the products listed by National Drug Code number designation in Exhibit A to this subpoena. (n) AHCA refers to Florida s Agency for Health Care Administration, and includes any of its employees, agents, divisions, affiliates, and includes any entity acting on behalf of AHCA in any capacity. (o) Government Entity means, without limitation, any federal agency, legislative or investigative body or representative, including the Federal Trade Commission, the Food and Drug Administration, the United States Department of Justice, the United States Department of Health and Human Services, the Centers for Medicare and Medicaid Services, any federal grand jury, any Congressional committee, or other political subdivision, including a state or local grand jury, the Florida Agency for Health Care Administration, or any foreign investigatory body.
(p) AWP refers to average wholesale price which is reported in or by pharmaceutical industry publications such as the Red Book, Blue Book, First DataBank, and Medi-Span. (q) LCA refers to the Least Costly Alternative, the program for reimbursement instituted by Medicare in certain states, including Florida. (r) WAC refers to the wholesaler acquisition cost or cost to the wholesaler, which is reported in or by pharmaceutical industry publication sources such as the Red Book, Blue Book, First DataBank, and Medi-Span. (s) ASP refers to the average sale price which is the average of all final sales prices charged by you for the products identified in Attachment A in the United States to all purchasers, excluding those sales exempt from inclusion in calculation of Best Price for Medicaid Drug Rebate purposes, pursuant to 42 U.S.C. 1396r-8, and excluding identifiable direct sales to hospitals. The prices identified in the calculation of Average Sale Price should be net of all the following: volume discounts; prompt pay discounts; cash discounts; chargebacks; short-dated product discounts; free goods; rebates (excluding payments made by you to the States pursuant to the Medicaid Drug Rebate Program, 42 U.S.C. 1396r-8); and all other price concessions provided by you to any purchaser that result in a reduction of the ultimate cost to the purchaser. The Average Sale Price does not include the value of bona fide charity care or bona fide grants. (t) AMP refers to the Average Manufacturer Price pursuant to 42 U.S.C. 1396r-8. ADDITIONAL INSTRUCTIONS 1. In producing documents and other materials, you are to furnish all documents or things in your possession, custody or control, regardless of the physical location of the documents or whether such documents or materials are possessed directly by you or your directors, officers, agents, employees, representatives, subsidiaries, managing agents, affiliates, investigators, or by your attorneys or their agents, employees, representatives or investigators. 2. In producing documents, you are requested to produce the original of each document requested, together with all non-identical copies and drafts of such document. If the
original of any document cannot be located, a copy shall be produced in lieu thereof, and shall be legible and bound or stapled in the same manner as the original. 3. If any requested document or thing cannot be produced in full, you are to produce it to the extent possible, indicating which document, or portion of such document, is being withheld, and the reason that document is being withheld. 4. Documents not otherwise responsive to this subpoena shall be produced if such documents mention, discuss, refer to, or explain the documents that are called for by this subpoena, or if such documents are attached to documents called for by this subpoena and including routing slips, transmittal memoranda, letters, cover sheets, comments, evaluations or similar materials. 5. All documents shall be produced in the same order as they are kept or maintained by you in the ordinary course of your business. If maintained in files or folders, copies of said files or folders or other such identifying information shall also be produced. If any documents have been removed from the files in which they were found for purposes of producing them in response to these requests, indicate for each document the file(s) from which the document(s) was (were) originally located. 6. Documents shall be produced in such fashion as to identify the department, branch or office in whose possession they were located and, where applicable, the natural person in whose possession they were found and the business address of each document s custodian(s). 7. Documents attached to each other should not be separated, including, but not limited to, e-mail attachments. 8. If a document once existed and has subsequently been lost, destroyed, or is otherwise missing, please provide sufficient information to identify the document and state the details concerning its loss. 9. In responding to this subpoena you are to include documents (a) obtained from witnesses who gave information to any Government Entity; (b) that constitute, or refer or relate to, summaries of testimony or other statements in connection with any Government Entity proceedings or investigations; or (c) obtained on your behalf by representatives including counsel, in preparing for testimony or interviews before any Government Entity.
10. Whenever a document is not produced in full or is produced in redacted form, so indicate on the document and state with particularity the reason or reasons it is not being produced in full and describe to the best of your knowledge, information and belief, and with as much particularity as possible, those portions of the document which are not being produced. 11. Unless a different time period is specified, the relevant time period is July 1, 1994 through the present. DOCUMENTS REQUESTED 1. Any promotional documents and public statements, announcements, disclosures, or press releases issued by you or any of your competitors referring or relating to the price, distribution, marketing or sale of the Subject Drugs, including any media files maintained by you. 2. All documents relating to discounts, rebates, credits, or any other reduction from listed prices or announced prices offered by you or any other company relating to the sale of the Subject Drugs that was in any manner offered to, provided, or presented to any purchaser of your drugs. 3. All sales materials for the Subject Drugs and all reports, memoranda, circulars, letters, bulletins, instructions or other documents sent to or provided to sales staff, marketing staff, service representatives, customers, distributors or other persons relating to the Subject Drugs. 4. All marketing and/or promotional documents issued by you to wholesalers doing business in Florida and, retailers, hospitals, nursing homes, home health care agencies, assisted care facilities, assisted living facilities, or other health care providers doing business in Florida.
STATE OF FLORIDA OFFICE OF THE ATTORNEY GENERAL CHARLES J. CRIST, JR. ATTORNEY GENERAL Medicaid Fraud Control Unit Investigative Subpoena Duces Tecum To: IVAX Pharmaceuticals, Inc. c/o Steven Rubinn Registered Agent 4400 Biscayne Blvd. Miami, FL 33137 You are hereby directed to appear at: Office of The Attorney General Medicaid Fraud Control Unit 107 West Gaines Street Tallahassee, Florida 32399 on the 16 th day of August, 2004, at 10:00 A.M., and to have with you at that time and place the following: SEE ATTACHMENT A You may comply with this subpoena by providing legible copies of the items to be produced to the Medicaid Fraud Control Unit on or before the scheduled date of production. You may mail or deliver the copies and, with the consent of the Office of the Attorney General, eliminate your need to appear personally at the time and place specified. In lieu of a personal appearance please contact Assistant Attorney General, Mary S. Miller at (850) 414-3600. This Investigative Subpoena is issued pursuant to Section 409.920(8)(b), Florida Statutes. This subpoena is issued as part of an ongoing civil investigation. WITNESS, The Office of the Attorney General, Medicaid Fraud Control Unit, at Tallahassee, Fl., this day of July, 2004. MARY S. MILLER Assistant Attorney General Personally served this day of, 2004, upon by
SUBPOENA ADDENDUM DEFINITIONS As used herein, the following terms are defined as indicated: (a) You, your or your company means the person or entity responding to these requests. (b) Person means, without limitation, any natural person, corporation, partnership, proprietorship, joint venture, association, government entity, any group, or any other form of public or private business or legal entity. (c) Communication means, without limitation, oral or written communications of all kinds, including correspondence, any exchange of written or recorded information, face-to-face meetings, or electronic, facsimile or telephone transmissions. (d) Meeting means, without limitation, any assembly, convocation, encounter or contemporaneous presence of two or more persons for any purpose, physically or through electronic audio and/or video, contact whether planned, arranged, scheduled or not. (e) Employee means, without limitation, current and former officers, directors, executives, managers, sales personnel, administrative staff, secretaries, clerical staff, messengers, or any other person employed by defendants. (f) Competitor(s) means, without limitation, any person or entity who competes with you in the development, production, manufacture, distribution, marketing, promotion, or pricing of any prescription drug. (g) Document means, without limitation, the original (or identical duplicate when the original is not available) and all non-identical copies (whether non-identical because of notes made on copies or attached comments, annotations, marks, transmission notation or highlighting of any kind) of all writing, whether handwritten, typed, printed or otherwise produced, which writings or other documents may consist of letters, correspondence, memoranda, legal pleadings, notes, reports, agreements, calendars, diaries, travel or expense records, summaries, records, messages or logs of telephone calls, conversations or interviews, telegrams, mailgrams, facsimile transmissions (including cover sheets and confirmations), electronic mail, minutes or records of meeting, compilations, notebooks, laboratory notebooks, work papers, books, pamphlets, brochures, circulars, manuals, instructions, sales literature,
advertising or promotional literature or materials, ledgers, graphs, charts, blue prints, drawings (including, without limitation, engineering, assembly and detail drawings), sketches, photographs, film and sound reproductions, tape recordings, digital files, phone mail messages, sales literature, advertising literature, promotional literature, or any other tangible materials on which there is any recording or writing of any sort. The term also includes the file, folder tabs, containers and labels appended to or associated with any physical storage device for each original, copy and draft of a document. In addition, the term document includes electronic data, which means the original and any non-identical copies and drafts of mechanical, facsimile, electronic, magnetic, digital, or other programs (whether private, commercial, or work-in-progress), programming notes, instructions, comments or remarks, program change logs and activity listings of electronic mail receipts and/or transmittals, output resulting from the use of any software program, including word processing documents, spreadsheets, database files, charts, graphs and outlines, electronic mail, drive mirroring systems, back-up tapes, batch files, ASCII files, and any and all active file or files (readily readable by one or more computer application or forensics software); any deleted but recoverable electronic files on said media; and shall include all file, record, and field format definitions and instructions, codes, or information necessary to retrieve the data. Electronic data includes any and all items stored on computer memories or computer chips, including, but not limited to, floppy disks, CD-ROM, DVD, Zip Disk, magnetic tape of all types, microfiche, any other vehicle for digital date storage and/or transmittal. The term electronic data also includes the file, folder tabs, and/or containers and labels appended to or associated with, any physical storage device associated with each original and/or copy. All electronic data must be provided on one of the following media: Zip Disk, CD-ROM, or DVD. (h) Referring to, relating to, reflecting, regarding or with respect to may mean, depending on the context, pertaining to, dealing with, concerning, reflecting, recording, reporting, constituting, containing, mentioning, describing, discussing, analyzing, evaluating, estimating, studying, surveying, projecting, assessing, supporting, modifying, contradicting, criticizing, summarizing, commenting, or otherwise involving, in whole or in part.
(i) Or is used in its inclusive sense and shall be construed so as to require the broadest possible response. If, for example, a request calls for information about A or B, you should produce all information about A and all information about B as well as all information about A and B. In other words, or should be read as and/or. (j) The singular form of a noun or pronoun shall be considered to include within its meaning the plural form of the noun or pronoun so used, and vice versa; the use of the masculine form of a pronoun shall be considered to include also within its meaning the feminine form of the pronoun so used, and vice versa; and the use of any tense of any verb shall be considered to include also within its meaning all other tenses of the verb so used. (k) Price, prices and/or pricing mean any actual, proposed, suggested or recommended price, as well as price increases or decreases, price quotations, price lists, price announcements, as well as any discounts, rebates, credit terms, profit margins, freight rates and/or charges specifically indicated as such, and any changes and/or proposed changes in the above. (l) Policy means any practice, procedure or directive, whether written or unwritten, formal or informal, which was recognized, adopted, issued or followed by you. (m) The Subject Drugs means the products listed by National Drug Code number designation in Exhibit A to this subpoena. (n) AHCA refers to Florida s Agency for Health Care Administration, and includes any of its employees, agents, divisions, affiliates, and includes any entity acting on behalf of AHCA in any capacity. (o) Government Entity means, without limitation, any federal agency, legislative or investigative body or representative, including the Federal Trade Commission, the Food and Drug Administration, the United States Department of Justice, the United States Department of Health and Human Services, the Centers for Medicare and Medicaid Services, any federal grand jury, any Congressional committee, or other political subdivision, including a state or local grand jury, the Florida Agency for Health Care Administration, or any foreign investigatory body.
(p) AWP refers to average wholesale price which is reported in or by pharmaceutical industry publications such as the Red Book, Blue Book, First DataBank, and Medi-Span. (q) LCA refers to the Least Costly Alternative, the program for reimbursement instituted by Medicare in certain states, including Florida. (r) WAC refers to the wholesaler acquisition cost or cost to the wholesaler, which is reported in or by pharmaceutical industry publication sources such as the Red Book, Blue Book, First DataBank, and Medi-Span. (s) ASP refers to the average sale price which is the average of all final sales prices charged by you for the products identified in Attachment A in the United States to all purchasers, excluding those sales exempt from inclusion in calculation of Best Price for Medicaid Drug Rebate purposes, pursuant to 42 U.S.C. 1396r-8, and excluding identifiable direct sales to hospitals. The prices identified in the calculation of Average Sale Price should be net of all the following: volume discounts; prompt pay discounts; cash discounts; chargebacks; short-dated product discounts; free goods; rebates (excluding payments made by you to the States pursuant to the Medicaid Drug Rebate Program, 42 U.S.C. 1396r-8); and all other price concessions provided by you to any purchaser that result in a reduction of the ultimate cost to the purchaser. The Average Sale Price does not include the value of bona fide charity care or bona fide grants. (t) AMP refers to the Average Manufacturer Price pursuant to 42 U.S.C. 1396r-8. ADDITIONAL INSTRUCTIONS 1. In producing documents and other materials, you are to furnish all documents or things in your possession, custody or control, regardless of the physical location of the documents or whether such documents or materials are possessed directly by you or your directors, officers, agents, employees, representatives, subsidiaries, managing agents, affiliates, investigators, or by your attorneys or their agents, employees, representatives or investigators. 2. In producing documents, you are requested to produce the original of each document requested, together with all non-identical copies and drafts of such document. If the
original of any document cannot be located, a copy shall be produced in lieu thereof, and shall be legible and bound or stapled in the same manner as the original. 3. If any requested document or thing cannot be produced in full, you are to produce it to the extent possible, indicating which document, or portion of such document, is being withheld, and the reason that document is being withheld. 4. Documents not otherwise responsive to this subpoena shall be produced if such documents mention, discuss, refer to, or explain the documents that are called for by this subpoena, or if such documents are attached to documents called for by this subpoena and including routing slips, transmittal memoranda, letters, cover sheets, comments, evaluations or similar materials. 5. All documents shall be produced in the same order as they are kept or maintained by you in the ordinary course of your business. If maintained in files or folders, copies of said files or folders or other such identifying information shall also be produced. If any documents have been removed from the files in which they were found for purposes of producing them in response to these requests, indicate for each document the file(s) from which the document(s) was (were) originally located. 6. Documents shall be produced in such fashion as to identify the department, branch or office in whose possession they were located and, where applicable, the natural person in whose possession they were found and the business address of each document s custodian(s). 7. Documents attached to each other should not be separated, including, but not limited to, e-mail attachments. 8. If a document once existed and has subsequently been lost, destroyed, or is otherwise missing, please provide sufficient information to identify the document and state the details concerning its loss. 9. In responding to this subpoena you are to include documents (a) obtained from witnesses who gave information to any Government Entity; (b) that constitute, or refer or relate to, summaries of testimony or other statements in connection with any Government Entity proceedings or investigations; or (c) obtained on your behalf by representatives including counsel, in preparing for testimony or interviews before any Government Entity.
10. Whenever a document is not produced in full or is produced in redacted form, so indicate on the document and state with particularity the reason or reasons it is not being produced in full and describe to the best of your knowledge, information and belief, and with as much particularity as possible, those portions of the document which are not being produced. 11. Unless a different time period is specified, the relevant time period is July 1, 1994 through the present. DOCUMENTS REQUESTED 1. Any promotional documents and public statements, announcements, disclosures, or press releases issued by you or any of your competitors referring or relating to the price, distribution, marketing or sale of the Subject Drugs, including any media files maintained by you. 2. All documents relating to discounts, rebates, credits, or any other reduction from listed prices or announced prices offered by you or any other company relating to the sale of the Subject Drugs that was in any manner offered to, provided, or presented to any purchaser of your drugs. 3. All sales materials for the Subject Drugs and all reports, memoranda, circulars, letters, bulletins, instructions or other documents sent to or provided to sales staff, marketing staff, service representatives, customers, distributors or other persons relating to the Subject Drugs. 4. All marketing and/or promotional documents issued by you to wholesalers doing business in Florida and, retailers, hospitals, nursing homes, home health care agencies, assisted care facilities, assisted living facilities, or other health care providers doing business in Florida.
STATE OF FLORIDA OFFICE OF THE ATTORNEY GENERAL CHARLES J. CRIST, JR. ATTORNEY GENERAL Medicaid Fraud Control Unit Investigative Subpoena Duces Tecum To: Mylan Pharmaceuticals, Inc. 781 Chestnut Ridge Rd. P. O. Box 4310 Morgantown, WV 26504 You are hereby directed to appear at: Office of The Attorney General Medicaid Fraud Control Unit 107 West Gaines Street Tallahassee, Florida 32399 on the 16 th day of August, 2004, at 10:00 A.M., and to have with you at that time and place the following: SEE ATTACHMENT A You may comply with this subpoena by providing legible copies of the items to be produced to the Medicaid Fraud Control Unit on or before the scheduled date of production. You may mail or deliver the copies and, with the consent of the Office of the Attorney General, eliminate your need to appear personally at the time and place specified. In lieu of a personal appearance please contact Assistant Attorney General, Mary S. Miller at (850) 414-3600. This Investigative Subpoena is issued pursuant to Section 409.920(8)(b), Florida Statutes. This subpoena is issued as part of an ongoing civil investigation. WITNESS, The Office of the Attorney General, Medicaid Fraud Control Unit, at Tallahassee, Fl., this day of July, 2004. MARY S. MILLER Assistant Attorney General Personally served this day of, 2004, upon by
SUBPOENA ADDENDUM DEFINITIONS As used herein, the following terms are defined as indicated: (a) You, your or your company means the person or entity responding to these requests. (b) Person means, without limitation, any natural person, corporation, partnership, proprietorship, joint venture, association, government entity, any group, or any other form of public or private business or legal entity. (c) Communication means, without limitation, oral or written communications of all kinds, including correspondence, any exchange of written or recorded information, face-to-face meetings, or electronic, facsimile or telephone transmissions. (d) Meeting means, without limitation, any assembly, convocation, encounter or contemporaneous presence of two or more persons for any purpose, physically or through electronic audio and/or video, contact whether planned, arranged, scheduled or not. (e) Employee means, without limitation, current and former officers, directors, executives, managers, sales personnel, administrative staff, secretaries, clerical staff, messengers, or any other person employed by defendants. (f) Competitor(s) means, without limitation, any person or entity who competes with you in the development, production, manufacture, distribution, marketing, promotion, or pricing of any prescription drug. (g) Document means, without limitation, the original (or identical duplicate when the original is not available) and all non-identical copies (whether non-identical because of notes made on copies or attached comments, annotations, marks, transmission notation or highlighting of any kind) of all writing, whether handwritten, typed, printed or otherwise produced, which writings or other documents may consist of letters, correspondence, memoranda, legal pleadings, notes, reports, agreements, calendars, diaries, travel or expense records, summaries, records, messages or logs of telephone calls, conversations or interviews, telegrams, mailgrams, facsimile transmissions (including cover sheets and confirmations), electronic mail, minutes or records of meeting, compilations, notebooks, laboratory notebooks, work papers, books, pamphlets, brochures, circulars, manuals, instructions, sales literature,
advertising or promotional literature or materials, ledgers, graphs, charts, blue prints, drawings (including, without limitation, engineering, assembly and detail drawings), sketches, photographs, film and sound reproductions, tape recordings, digital files, phone mail messages, sales literature, advertising literature, promotional literature, or any other tangible materials on which there is any recording or writing of any sort. The term also includes the file, folder tabs, containers and labels appended to or associated with any physical storage device for each original, copy and draft of a document. In addition, the term document includes electronic data, which means the original and any non-identical copies and drafts of mechanical, facsimile, electronic, magnetic, digital, or other programs (whether private, commercial, or work-in-progress), programming notes, instructions, comments or remarks, program change logs and activity listings of electronic mail receipts and/or transmittals, output resulting from the use of any software program, including word processing documents, spreadsheets, database files, charts, graphs and outlines, electronic mail, drive mirroring systems, back-up tapes, batch files, ASCII files, and any and all active file or files (readily readable by one or more computer application or forensics software); any deleted but recoverable electronic files on said media; and shall include all file, record, and field format definitions and instructions, codes, or information necessary to retrieve the data. Electronic data includes any and all items stored on computer memories or computer chips, including, but not limited to, floppy disks, CD-ROM, DVD, Zip Disk, magnetic tape of all types, microfiche, any other vehicle for digital date storage and/or transmittal. The term electronic data also includes the file, folder tabs, and/or containers and labels appended to or associated with, any physical storage device associated with each original and/or copy. All electronic data must be provided on one of the following media: Zip Disk, CD-ROM, or DVD. (h) Referring to, relating to, reflecting, regarding or with respect to may mean, depending on the context, pertaining to, dealing with, concerning, reflecting, recording, reporting, constituting, containing, mentioning, describing, discussing, analyzing, evaluating, estimating, studying, surveying, projecting, assessing, supporting, modifying, contradicting, criticizing, summarizing, commenting, or otherwise involving, in whole or in part.
(i) Or is used in its inclusive sense and shall be construed so as to require the broadest possible response. If, for example, a request calls for information about A or B, you should produce all information about A and all information about B as well as all information about A and B. In other words, or should be read as and/or. (j) The singular form of a noun or pronoun shall be considered to include within its meaning the plural form of the noun or pronoun so used, and vice versa; the use of the masculine form of a pronoun shall be considered to include also within its meaning the feminine form of the pronoun so used, and vice versa; and the use of any tense of any verb shall be considered to include also within its meaning all other tenses of the verb so used. (k) Price, prices and/or pricing mean any actual, proposed, suggested or recommended price, as well as price increases or decreases, price quotations, price lists, price announcements, as well as any discounts, rebates, credit terms, profit margins, freight rates and/or charges specifically indicated as such, and any changes and/or proposed changes in the above. (l) Policy means any practice, procedure or directive, whether written or unwritten, formal or informal, which was recognized, adopted, issued or followed by you. (m) The Subject Drugs means the products listed by National Drug Code number designation in Exhibit A to this subpoena. (n) AHCA refers to Florida s Agency for Health Care Administration, and includes any of its employees, agents, divisions, affiliates, and includes any entity acting on behalf of AHCA in any capacity. (o) Government Entity means, without limitation, any federal agency, legislative or investigative body or representative, including the Federal Trade Commission, the Food and Drug Administration, the United States Department of Justice, the United States Department of Health and Human Services, the Centers for Medicare and Medicaid Services, any federal grand jury, any Congressional committee, or other political subdivision, including a state or local grand jury, the Florida Agency for Health Care Administration, or any foreign investigatory body.
(p) AWP refers to average wholesale price which is reported in or by pharmaceutical industry publications such as the Red Book, Blue Book, First DataBank, and Medi-Span. (q) LCA refers to the Least Costly Alternative, the program for reimbursement instituted by Medicare in certain states, including Florida. (r) WAC refers to the wholesaler acquisition cost or cost to the wholesaler, which is reported in or by pharmaceutical industry publication sources such as the Red Book, Blue Book, First DataBank, and Medi-Span. (s) ASP refers to the average sale price which is the average of all final sales prices charged by you for the products identified in Attachment A in the United States to all purchasers, excluding those sales exempt from inclusion in calculation of Best Price for Medicaid Drug Rebate purposes, pursuant to 42 U.S.C. 1396r-8, and excluding identifiable direct sales to hospitals. The prices identified in the calculation of Average Sale Price should be net of all the following: volume discounts; prompt pay discounts; cash discounts; chargebacks; short-dated product discounts; free goods; rebates (excluding payments made by you to the States pursuant to the Medicaid Drug Rebate Program, 42 U.S.C. 1396r-8); and all other price concessions provided by you to any purchaser that result in a reduction of the ultimate cost to the purchaser. The Average Sale Price does not include the value of bona fide charity care or bona fide grants. (t) AMP refers to the Average Manufacturer Price pursuant to 42 U.S.C. 1396r-8. ADDITIONAL INSTRUCTIONS 1. In producing documents and other materials, you are to furnish all documents or things in your possession, custody or control, regardless of the physical location of the documents or whether such documents or materials are possessed directly by you or your directors, officers, agents, employees, representatives, subsidiaries, managing agents, affiliates, investigators, or by your attorneys or their agents, employees, representatives or investigators. 2. In producing documents, you are requested to produce the original of each document requested, together with all non-identical copies and drafts of such document. If the
original of any document cannot be located, a copy shall be produced in lieu thereof, and shall be legible and bound or stapled in the same manner as the original. 3. If any requested document or thing cannot be produced in full, you are to produce it to the extent possible, indicating which document, or portion of such document, is being withheld, and the reason that document is being withheld. 4. Documents not otherwise responsive to this subpoena shall be produced if such documents mention, discuss, refer to, or explain the documents that are called for by this subpoena, or if such documents are attached to documents called for by this subpoena and including routing slips, transmittal memoranda, letters, cover sheets, comments, evaluations or similar materials. 5. All documents shall be produced in the same order as they are kept or maintained by you in the ordinary course of your business. If maintained in files or folders, copies of said files or folders or other such identifying information shall also be produced. If any documents have been removed from the files in which they were found for purposes of producing them in response to these requests, indicate for each document the file(s) from which the document(s) was (were) originally located. 6. Documents shall be produced in such fashion as to identify the department, branch or office in whose possession they were located and, where applicable, the natural person in whose possession they were found and the business address of each document s custodian(s). 7. Documents attached to each other should not be separated, including, but not limited to, e-mail attachments. 8. If a document once existed and has subsequently been lost, destroyed, or is otherwise missing, please provide sufficient information to identify the document and state the details concerning its loss. 9. In responding to this subpoena you are to include documents (a) obtained from witnesses who gave information to any Government Entity; (b) that constitute, or refer or relate to, summaries of testimony or other statements in connection with any Government Entity proceedings or investigations; or (c) obtained on your behalf by representatives including counsel, in preparing for testimony or interviews before any Government Entity.
10. Whenever a document is not produced in full or is produced in redacted form, so indicate on the document and state with particularity the reason or reasons it is not being produced in full and describe to the best of your knowledge, information and belief, and with as much particularity as possible, those portions of the document which are not being produced. 11. Unless a different time period is specified, the relevant time period is July 1, 1994 through the present. DOCUMENTS REQUESTED 1. Any promotional documents and public statements, announcements, disclosures, or press releases issued by you or any of your competitors referring or relating to the price, distribution, marketing or sale of the Subject Drugs, including any media files maintained by you. 2. All documents relating to discounts, rebates, credits, or any other reduction from listed prices or announced prices offered by you or any other company relating to the sale of the Subject Drugs that was in any manner offered to, provided, or presented to any purchaser of your drugs. 3. All sales materials for the Subject Drugs and all reports, memoranda, circulars, letters, bulletins, instructions or other documents sent to or provided to sales staff, marketing staff, service representatives, customers, distributors or other persons relating to the Subject Drugs. 4. All marketing and/or promotional documents issued by you to wholesalers doing business in Florida and, retailers, hospitals, nursing homes, home health care agencies, assisted care facilities, assisted living facilities, or other health care providers doing business in Florida.
STATE OF FLORIDA OFFICE OF THE ATTORNEY GENERAL CHARLES J. CRIST, JR. ATTORNEY GENERAL Medicaid Fraud Control Unit Investigative Subpoena Duces Tecum To: Purepac Pharmaceutical Co. Division of Faulding, Inc. 200 Elmora Ave Elizabeth, NJ 07207 You are hereby directed to appear at: Office of The Attorney General Medicaid Fraud Control Unit 107 West Gaines Street Tallahassee, Florida 32399 on the 16 th day of August, 2004, at 10:00 A.M., and to have with you at that time and place the following: SEE ATTACHMENT A You may comply with this subpoena by providing legible copies of the items to be produced to the Medicaid Fraud Control Unit on or before the scheduled date of production. You may mail or deliver the copies and, with the consent of the Office of the Attorney General, eliminate your need to appear personally at the time and place specified. In lieu of a personal appearance please contact Assistant Attorney General, Mary S. Miller at (850) 414-3600. This Investigative Subpoena is issued pursuant to Section 409.920(8)(b), Florida Statutes. This subpoena is issued as part of an ongoing civil investigation. WITNESS, The Office of the Attorney General, Medicaid Fraud Control Unit, at Tallahassee, Fl., this day of July, 2004. MARY S. MILLER Assistant Attorney General Personally served this day of, 2004, upon by
SUBPOENA ADDENDUM DEFINITIONS As used herein, the following terms are defined as indicated: (a) You, your or your company means the person or entity responding to these requests. (b) Person means, without limitation, any natural person, corporation, partnership, proprietorship, joint venture, association, government entity, any group, or any other form of public or private business or legal entity. (c) Communication means, without limitation, oral or written communications of all kinds, including correspondence, any exchange of written or recorded information, face-to-face meetings, or electronic, facsimile or telephone transmissions. (d) Meeting means, without limitation, any assembly, convocation, encounter or contemporaneous presence of two or more persons for any purpose, physically or through electronic audio and/or video, contact whether planned, arranged, scheduled or not. (e) Employee means, without limitation, current and former officers, directors, executives, managers, sales personnel, administrative staff, secretaries, clerical staff, messengers, or any other person employed by defendants. (f) Competitor(s) means, without limitation, any person or entity who competes with you in the development, production, manufacture, distribution, marketing, promotion, or pricing of any prescription drug. (g) Document means, without limitation, the original (or identical duplicate when the original is not available) and all non-identical copies (whether non-identical because of notes made on copies or attached comments, annotations, marks, transmission notation or highlighting of any kind) of all writing, whether handwritten, typed, printed or otherwise produced, which writings or other documents may consist of letters, correspondence, memoranda, legal pleadings, notes, reports, agreements, calendars, diaries, travel or expense records, summaries, records, messages or logs of telephone calls, conversations or interviews, telegrams, mailgrams, facsimile transmissions (including cover sheets and confirmations), electronic mail, minutes or records of meeting, compilations, notebooks, laboratory notebooks, work papers, books, pamphlets, brochures, circulars, manuals, instructions, sales literature,
advertising or promotional literature or materials, ledgers, graphs, charts, blue prints, drawings (including, without limitation, engineering, assembly and detail drawings), sketches, photographs, film and sound reproductions, tape recordings, digital files, phone mail messages, sales literature, advertising literature, promotional literature, or any other tangible materials on which there is any recording or writing of any sort. The term also includes the file, folder tabs, containers and labels appended to or associated with any physical storage device for each original, copy and draft of a document. In addition, the term document includes electronic data, which means the original and any non-identical copies and drafts of mechanical, facsimile, electronic, magnetic, digital, or other programs (whether private, commercial, or work-in-progress), programming notes, instructions, comments or remarks, program change logs and activity listings of electronic mail receipts and/or transmittals, output resulting from the use of any software program, including word processing documents, spreadsheets, database files, charts, graphs and outlines, electronic mail, drive mirroring systems, back-up tapes, batch files, ASCII files, and any and all active file or files (readily readable by one or more computer application or forensics software); any deleted but recoverable electronic files on said media; and shall include all file, record, and field format definitions and instructions, codes, or information necessary to retrieve the data. Electronic data includes any and all items stored on computer memories or computer chips, including, but not limited to, floppy disks, CD-ROM, DVD, Zip Disk, magnetic tape of all types, microfiche, any other vehicle for digital date storage and/or transmittal. The term electronic data also includes the file, folder tabs, and/or containers and labels appended to or associated with, any physical storage device associated with each original and/or copy. All electronic data must be provided on one of the following media: Zip Disk, CD-ROM, or DVD. (h) Referring to, relating to, reflecting, regarding or with respect to may mean, depending on the context, pertaining to, dealing with, concerning, reflecting, recording, reporting, constituting, containing, mentioning, describing, discussing, analyzing, evaluating, estimating, studying, surveying, projecting, assessing, supporting, modifying, contradicting, criticizing, summarizing, commenting, or otherwise involving, in whole or in part.
(i) Or is used in its inclusive sense and shall be construed so as to require the broadest possible response. If, for example, a request calls for information about A or B, you should produce all information about A and all information about B as well as all information about A and B. In other words, or should be read as and/or. (j) The singular form of a noun or pronoun shall be considered to include within its meaning the plural form of the noun or pronoun so used, and vice versa; the use of the masculine form of a pronoun shall be considered to include also within its meaning the feminine form of the pronoun so used, and vice versa; and the use of any tense of any verb shall be considered to include also within its meaning all other tenses of the verb so used. (k) Price, prices and/or pricing mean any actual, proposed, suggested or recommended price, as well as price increases or decreases, price quotations, price lists, price announcements, as well as any discounts, rebates, credit terms, profit margins, freight rates and/or charges specifically indicated as such, and any changes and/or proposed changes in the above. (l) Policy means any practice, procedure or directive, whether written or unwritten, formal or informal, which was recognized, adopted, issued or followed by you. (m) The Subject Drugs means the products listed by National Drug Code number designation in Exhibit A to this subpoena. (n) AHCA refers to Florida s Agency for Health Care Administration, and includes any of its employees, agents, divisions, affiliates, and includes any entity acting on behalf of AHCA in any capacity. (o) Government Entity means, without limitation, any federal agency, legislative or investigative body or representative, including the Federal Trade Commission, the Food and Drug Administration, the United States Department of Justice, the United States Department of Health and Human Services, the Centers for Medicare and Medicaid Services, any federal grand jury, any Congressional committee, or other political subdivision, including a state or local grand jury, the Florida Agency for Health Care Administration, or any foreign investigatory body.