AFFIDAVIT
`State of Maryland, Montgomery County
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`I, Marlene S. Bobka, under oath, hereby depose and state as follows:
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`1.
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`I am the president of F.O.I., Inc. d/b/a FOI Services, Inc. (“FOI Services”).
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`2. FOI Services is a privately-held corporation organized and operating under the laws of the State of
`Maryland, with its principal mailing address at 23219 Stringtown Road, Suite 240, Clarksburg, MD
`Maryland 20871, U.S.A.
`
`3. FOI Services specializes in United States Food & Drug Administration (“FDA”) information and
`maintains a private library of over 150,000 FDA documents obtained under the Freedom of
`Information Act (“FOIA”) in all categories of products regulated by FDA, including drugs, biologics,
`veterinary products, foods and medical devices. These documents are sold individually; the copies we
`maintain and sell are faithful reproductions of the original documents supplied to us by FDA and,
`except for cover sheets, are not altered in any way. Many U.S. courts have accepted our documents as
`true copies of official FDA documents.
`
`4. The document attached as Exhibit A is FOI Services’ Document 5223777G, which contains the
`Clinical Pharmacology & Biopharmaceutics Review portion of the drug approval package for NDA
`21450, Zomig Nasal Spray. This document is a selected portion of Document 5211576A, which
`contains the complete approval package for NDA 21450, Zomig Nasal Spray. Document 5211576A
`was available to the public no later than April 22, 2005 via www.foiservices.com, as this is the date of
`FOI Services’s first record of this document being ordered through our website.
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`5. Document 5211576A was, as of April 22, 2005, searchable and locatable via an electronic keyword
`search on www.foiservices.com, where such keywords included the drug brand name (Zomig®) and
`active ingredient generic name (zolmitritptan). The document attached as Exhibit A includes a true and
`correct copy of the materials FOI Services received from FDA in response to FOI Services’ request.
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`6. The record attached as Exhibit A was kept in the course of our regularly conducted business activity.
`Making the record was a regular practice of my job duties and our business activities.
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`7.
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`8.
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` I have prepared this affidavit as part of my duties at FOI Services. I have not been retained as an
`outside consultant by any party in this action. FOI Services has been compensated for this affidavit at
`its usual rate of $300 per affidavit, and no part of that compensation is dependent on the outcome of
`this action.
`
`I hereby declare that all statements made herein of my own knowledge are true and correct. I further
`declare that all of my statements are made with the knowledge that willful false statements and the like
`so made are punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of the United
`States Code.
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`State of Maryland, Montgomery County
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`I, Marlene S. Bobka, under oath, hereby depose and state as follows:
`
`1.
`
`I am the president of F.O.I., Inc. d/b/a FOI Services, Inc. (“FOI Services”).
`
`2. FOI Services is a privately-held corporation organized and operating under the laws of the State of
`Maryland, with its principal mailing address at 23219 Stringtown Road, Suite 240, Clarksburg, MD
`Maryland 20871, U.S.A.
`
`3. FOI Services specializes in United States Food & Drug Administration (“FDA”) information and
`maintains a private library of over 150,000 FDA documents obtained under the Freedom of
`Information Act (“FOIA”) in all categories of products regulated by FDA, including drugs, biologics,
`veterinary products, foods and medical devices. These documents are sold individually; the copies we
`maintain and sell are faithful reproductions of the original documents supplied to us by FDA and,
`except for cover sheets, are not altered in any way. Many U.S. courts have accepted our documents as
`true copies of official FDA documents.
`
`4. The document attached as Exhibit A is FOI Services’ Document 5223777G, which contains the
`Clinical Pharmacology & Biopharmaceutics Review portion of the drug approval package for NDA
`21450, Zomig Nasal Spray. This document is a selected portion of Document 5211576A, which
`contains the complete approval package for NDA 21450, Zomig Nasal Spray. Document 5211576A
`was available to the public no later than April 22, 2005 via www.foiservices.com, as this is the date of
`FOI Services’s first record of this document being ordered through our website.
`
`5. Document 5211576A was, as of April 22, 2005, searchable and locatable via an electronic keyword
`search on www.foiservices.com, where such keywords included the drug brand name (Zomig®) and
`active ingredient generic name (zolmitritptan). The document attached as Exhibit A includes a true and
`correct copy of the materials FOI Services received from FDA in response to FOI Services’ request.
`
`6. The record attached as Exhibit A was kept in the course of our regularly conducted business activity.
`Making the record was a regular practice of my job duties and our business activities.
`
`7.
`
`8.
`
` I have prepared this affidavit as part of my duties at FOI Services. I have not been retained as an
`outside consultant by any party in this action. FOI Services has been compensated for this affidavit at
`its usual rate of $300 per affidavit, and no part of that compensation is dependent on the outcome of
`this action.
`
`I hereby declare that all statements made herein of my own knowledge are true and correct. I further
`declare that all of my statements are made with the knowledge that willful false statements and the like
`so made are punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of the United
`States Code.
`
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`EXHIBIT A
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