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PPACT: Page 1835, Patient Protection and Affordable Care Act of 2009

1835
HR 3590 EAS/PP
``(1) C
ONFIDENTIAL ACCESS TO SUBSECTION
(k)
1
APPLICATION
.--
2
``(A) A
PPLICATION OF PARAGRAPH
.--Unless
3
otherwise agreed to by a person that submits an
4
application under subsection (k) (referred to in
5
this subsection as the `subsection (k) applicant')
6
and the sponsor of the application for the ref-
7
erence product (referred to in this subsection as
8
the `reference product sponsor'), the provisions of
9
this paragraph shall apply to the exchange of in-
10
formation described in this subsection.
11
``(B) I
N GENERAL
.--
12
``(i) P
ROVISION OF CONFIDENTIAL IN
-
13
FORMATION
.--When a subsection (k) appli-
14
cant submits an application under sub-
15
section (k), such applicant shall provide to
16
the persons described in clause (ii), subject
17
to the terms of this paragraph, confidential
18
access to the information required to be pro-
19
duced pursuant to paragraph (2) and any
20
other information that the subsection (k)
21
applicant determines, in its sole discretion,
22
to be appropriate (referred to in this sub-
23
section as the `confidential information').
24

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