Free Notice to Take Deposition - District Court of Delaware - Delaware

Case 1 :06-cv—00033-SLR Document 73-2 Filed 1 1/17/2006 Page 1 of 2
Schedule A
l. The identity of and organizational/reporting structure for all individuals involved in
the research, development, testing, product refinement, quality control, manufacture, distribution,
sale, marketing or licensing of "i`eva’s proposed lansoprazole delayed release capsules (15 and 30
mg), as described in Abbreviated New Drug Application ("A1\lDA") No. 77-255 (‘°ANDA
Products").
2. Teva’s decision to develop a generic lansoprazole product, including any
comparisons to other substituted benzimidazole products including, but not limited to,
omeprazole, esomeprazole, pantoprazole and/or rabeprazole, from a marketing, promotional,
sales, efficacy, toxicity, biological activity and/or preference standpoint.
3. Di\/[F N0. 1755i submitted to FDA by Teva for lansoprazole as manufactured in
Be’er Sheva, Israel.
4. ANDA No. 77-255, including, but not limited to, the chemistry, manufacturing and
control sections.
5. All correspondence between Teva and FDA regarding ANDA No. 77-255 and
DMF No. 1755l, including, but not limited to, Teva’s responses to FDA deficiency letters and
the status of ANDA No. 77-255.
6. Teva’s decision to prepare and tile ANDA No. 77-255, including, but not limited
to, the identification of all facts, documents, data, studies, investigations, opinions, and analyses
that were considered by Teva in making its decision.
7. Teva’s decision to amend ANDA No. 77-255 to include a certification under 21
U.S.C. § 355(j)(2)(A)(vii)(lV) (a "i’aragraph IV certitication") that, in "t`eva’s opinion, U.S.
Patent Nos. 4,628,098 ("the ‘098 patent"); 5,026,560 ("the ‘560 patent"); 5,045,321 ("the ‘32I
patent"); 5,093,132 ("the ‘i32 patent”) and 5,433,959 ("the ‘959 patent") (collectively “the
patents-in-suit") are invalid, unenforceable or will not be infringed by the commercial
manufacture, use or sale of Teva’s ANDA Products, including, but not limited to, the
identification of all facts, documents, data, studies, investigations, opinions, and analyses that
were considered by Teva in making its decision.
8. The identity and description of all facilities and equipment used to produce Teva’s
ANDA. Products.
9. The research, evaluation, studies, tests, and other data or information leading to the
development of 'l`eva’s ANDA Products.
E0. The development, scale-up, commercial manufacture and testing of Teva’s ANDA
Products, including, but not limited to, bioequivalence testing, dissolution testing, stability
studies, in vivo and in vitro tests, and test results and conclusions.
li. All studies, tests, data and information related to the stability, storage and handling
of'1`eva’s lansoprazole pellets used in 'l“eva’s ANDA Products.

Case 1 :06-cv—00033-SLR Document 73-2 Filed 1 1/17/2006 Page 2 of 2
12. The factual bases for and preparation of Teva’s Notice Letter dated December 5,
2005, sent to Plaintiffs pursuant to 21 U.S.C. § 355(j)(2)(B) of the Federal Food Drug and
Cosmetic Act, including, but not limited to, the identification of ali facts, documents, data,
studies, investigations, opinions, and analyses that were considered in preparing the Notice
Letter.
i3. The factuai bases for Teva’s contentions or beliefs that ”l`eva’s ANDA Products
have not infringed, are not infringing and will not infringe, either literally or under the doctrine
of equivalents, any vaiid and enforceable claim ofthe patents—in-suit, including, but not limited
to, the identification of all facts, documents, data, studies, investigations, opinions, and anaiyses
that support Teva’s contentions or beiiefs.
14. The factual bases for Teva’s contentions or `oeiiefs that the claims ofthe patents-in-
suit are invalid for failure to comply with the requirements of the patent laws of the United
States, including, without limitation, 35 U.S.C. §§ §01, 102, 103 and/or 112, including, but not
limited to, all facts, documents, data, studies, investigations, opinions, and analyses that support
Teva’s contentions or beliefs.
15. Teva’s patent application(s), whether filed in the U.S. under the Patent Cooperation
Treaty, or in any other country, relating to Teva’s ANDA Products.
16. Testing, calculations, anaiyses, statistical interpretation, and validation of stability
studies on any lansoprazole deiayed release capsule formulation considered by Teva, including,
but not limited to, any formulation abandoned, contemplated, discussed, or proposed by or for
Teva.
17. Formulation development reports, analyses, studies, and any other communication
or information related to Teva’s ANDA product or other lansoprazole delayed release capsule
formulation considered by Teva, including, but not iimited to, any formulation abandoned,
contemplated, discussed, or proposed by or for Teva.
18. Teva’s attempts to design around or not infringe the patents—in—suit.
19. Labeling for Teva’s ANDA Product, including, but not limited to, tire package
insert and packaging label.
20. Forecasts, models, analyses, evaluations, and projections concerning sales of
PREVAClD®, Teva’s ANDA Product or lansoprazoie deiayed release capsules (15 and 30 mg)
in the United States.
21. Any agreements between Teva and any third parties regarding the development,
manufacture, distribution, sales, or promotions of Teva’s ANDA Products.
22. Any agreements between Teva and third parties reiated to this litigation, Teva’s
ANDA Product, or Piaintiffs’ PREVAClD® products.
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