AFFIDAVIT
`
`State of Maryland, Montgomery County
`
`I, Marlene S. Bobka, under oath, hereby depose and state as follows:
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`I.
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`I am the president ofF.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 place of business at 704 Quince Orchard Road, Suite 275, Gaithersburg,
`Maryland 20878-1770, 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, FOI Services' Document Number 143374 A, titled "[N20622]
`Copaxone (Teva Pharm): Approval Letter, Review & Evaluation of Clinical Data, Statistical Review,
`Pharmacology & Toxicology, Chemistry, FONSI, Environmental Assesment, Microbiology" was publicly
`available,
`incorporated into the FOI Services publicly available files, and was provided to a third party at
`least as early as April 8, 2005.
`
`5.
`
`FOI Services provided the document attached as Exhibit A to Mylan Pharmaceuticals
`
`Inc. on July 17, 2007.
`
`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.
`
`I further declare
`I hereby declare that all statements made herein of my own knowledge are true and correct.
`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.
`
`~~
`Marlene S. Bobka
`
`December 9,2014
`Date
`
`"'"
`
`~,'.,\
`~
`'..
`,"...:
`
`-;
`
`. -'. ~..,
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`, "'
`'-" .",:,.
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`
`SUBSCRIBED AND SWORN before me on December 9,2014.
`
`&dkr
`
`Notary Public
`
`My commission expires:
`
`'7{2d20/7
`_
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