IN THE MATTER OF: CASE NO.

2017-
1892

Merck Sharp & Dohme Corp.

License
Steven W. No. 01-2217150
Schierholt,
Executive Director
Esq. c/o William Halm
OHIO
STATE OF John R.
Ga

SETTLEMENT AGREEMENT WITH THE STATE OF OHIO

BOARD OF PHARMACY BOARD OF PHARMACY

This Settlement Agreement (Agreement) is entered into by the State of Ohio

Board of Pharmacy (Board) and Merck Sharp & Dohme Corp., for the purpose
of resolving all issues between the parties relating to the Board investigation of
IN THE
their MATTER
failure OF: sample distribution to OARRS. Together, the Board
to report and NO. 2017-
CASE
Merck Sharp & Dohme Corp. are referred to hereinafter as "the parties."
1892

Merck Sharp & Dohme Corp. JURISDICTION

1. Pursuant
License to Section
No. 01-2217150 4729.57Halm
c/o William of the Ohio Revised Code and the rules
adopted thereunder, the Board has the authority to suspend, revoke,
or refuse to grant AGREEMENT
SETTLEMENT or renew any license
WITH THEissued pursuant
STATE OF OHIO to Section
BOARD OF
4729.54 of the Ohio Revised PHARMACY
Code.

This2.Settlement
Merck Sharp Agreement
& Dohme (Agreement)
Corp. is a is enteredDistributor
licensed into by the of
State of Ohio
Dangerous
Board of Pharmacy
Drugs (Board)
entitled and Merck
to distribute Sharp drugs
dangerous & Dohme Corp., for
at wholesale the purpose
under license
number
of resolving all 01-2217150.
issues between the parties relating to the Board investigation of
their failure to report sample distribution to OARRS. Together, the Board and
Merck Sharp & Dohme Corp. are referred FACTSto hereinafter as "the parties."

1. On or about July 6, 2017, JURISDICTION

in response to self-disclosure by Merck
regarding inadvertent reporting violations, the Board initiated an
1. Pursuant to Section
investigation 4729.57
of Merck Sharp &of Dohme
the Ohio Revised
Corp, Code and
Distributor the rules
of Dangerous
adopted thereunder,
Drugs entitled the Board
to distribute has the authority
dangerous drugs attowholesale
suspend, revoke,
license
or refuse
number to grant orrelated
01-2217150, renew to
any license
Merck issued
Sharp pursuant
& Dohme to Section
Corp.'s shipping
4729.54
ScheduleofIV,thenon-opioid
Ohio Revised Code. substance samples into Ohio, without
controlled
reporting to OARRS.
2. Merck Sharp & Dohme Corp. is a licensed Distributor of Dangerous
Merck Sharp & Dohme
DrugsCorp. Case No.
entitled to distribute 2017-1892drugs at wholesale under license
dangerous 1
number 01-2217150.
T; 465 4143 1 F: .C14; 7:0 48 1
. 6 I contact@pharmacy.ohio.gov I www.pharmacy.ohio.go

FACTS

1. On or about July 6, 2017, in response to self-disclosure by Merck

regarding inadvertent reporting violations, the Board initiated an
investigation of Merck Sharp & Dohme Corp, Distributor of Dangerous
Drugs entitled to distribute dangerous drugs at wholesale license
number 01-2217150, related to Merck Sharp & Dohme Corp.'s shipping
Schedule IV, non-opioid controlled substance samples into Ohio, without
reporting to OARRS.

Merck Sharp & Dohme Corp. Case No. 2017-1892 1

T; 461:14143 1 F: 7:0 48% I contact@pharmacy.ohio.gov I www.pharmacy.ohio.go

 WHEREFORE, the parties desire to resolve the issues relating to the above-
referenced findings without resorting to further administrative or judicial
proceedings.

TERMS

NOW 2. THEREFORE, in consideration

On or about April 3, 2018, theofBoard
the mutual
sent apromises herein
Notice of expressed,
Opportunity for
the parties knowingly and voluntarily agree as follows:
Hearing to Merck Sharp & Dohme Corp., which outlined the allegations
and provided notice of its right to a hearing, its rights in such hearing,
and its right to submit contentions in writing. On or about April 17,
1. The recitals set forth above are incorporated in this Settlement Agreement as though fully set
2018, the Board sent a revised Notice of Opportunity for Hearing, which
forth herein.
clarified the scope of the proposed action.
2. Merck Sharp & Dohme Corp. neither admits nor denies the allegations stated in the Notice of
WHEREFORE, the parties desire to resolve the issues relating to the above-
Opportunity for Hearing letter dated April 3, 2018; however, the Board has evidence
referenced findings without resorting to further administrative or judicial
sufficient to sustain the allegations, finds them to violate Ohio's pharmacy law as set forth in
proceedings.
the Notice, and hereby adjudicates the same.

TERMS
3. Merck Sharp & Dohme Corp. agrees to pay to the Board a monetary penalty in the amount of
$10,000.00. This fine will be attached to your license record and must be paid no later than 30
NOW THEREFORE, in consideration of the mutual promises herein expressed,
days from the effective date of this Order. To pay this fine you must login to
the parties knowingly and voluntarily agree as follows:
wvvw.elicense.o io.-ov and process the items in your cart.

1. Merck
4. Sharp
The recitals & forth
set Dohme Corp.
above areagrees to conduct
Incorporated in thisan internal audit
Settlement of its as
Agreement OARRS reporting
though fully set
activities on
forth herein. or before December 31, 2018.

Merck
2. The
5. Sharp
Board & Dohme
agrees Corp.Merck
to release neither admits
from any nor deniespenalties
additional the allegations stated inaction
or disciplinary the Notice
in of
Opportunitywith
connection for Hearing letteratdated
the conduct issueApril 3, 2018;
related however,
to OARRS the Board
reporting hasthe
through evidence
date of this
sufficient
Agreement. to sustain the allegations, finds them to violate Ohio's pharmacy law as set forth in
the Notice, and hereby adjudicates the same.
6. The Board further agrees that Merck remains fully eligible for renewal of its Ohio wholesale
Merck
3. drug Sharp & Dohme
distributor license. Corp. agrees to pay to the Board a monetary penalty in the amount of
$10,000.00. This fine will be attached to your license record and must be paid no later than 30
days Sharp
7. Merck from & the effective
Dohme date of
Corp. agrees andthis Order. To that
acknowledges paythis
this finedisciplinary
Board you must login
action to
must
www.elicense.ohio.Eov
be and process
disclosed to the proper licensingthe items inof
authority your
anycart.
state or jurisdiction, as required by any
such state or jurisdiction, in which it currently holds a professional license, including the Board
4. Merck Sharp
on renewal & Dohmeor
applications Corp. agrees for
applications to conduct an internal audit of its OARRS reporting
a newlicense.
activities on or before December 31, 2018.
Merck Sharp & Dohme Corp. Case No. 2017-1892 2
5. The Board agrees to release Merck from any additional penalties or disciplinary action in
connection with the conduct at issue related to OARRS reporting through the date of this
Agreement.

6. The Board further agrees that Merck remains fully eligible for renewal of its Ohio wholesale
drug distributor license.

7. Merck Sharp & Dohme Corp. agrees and acknowledges that this Board disciplinary action must
be disclosed to the proper licensing authority of any state or jurisdiction, as required by any
such state or jurisdiction, in which it currently holds a professional license, including the Board
on renewal applications or applications for a new license.

Merck Sharp & Dohme Corp. Case No. 2017-1892 2

 Merck Sharp & Dohme Corp. of the terms of one or more federal or state requirements may
constitute sufficient grounds for further enforcement action related to any licenses granted to
Merck Sharp & Dohme Corp. by the Board and will NOT discharge Merck Sharp & Dohme Corp.
from any obligation under the terms of this Agreement.

9. Merck Sharp & Dohme Corp. agrees to pay all reasonable costs associated with the collection of
any payment, and of the prosecution of any violation of this Agreement.
8. Merck Sharp & Dohme Corp. agrees to comply with all federal and state requirements related
10. to Terminal
Merck SharpDistributors of Dangerous
& Dohme Corp. Drugs,
understands thatincluding
it has the but not
right tolimited to, Ohio by
be represented Revised
counselCode
for
Chapter
review and4729. and the
execution Rules
of this adopted thereunder, Chapter 3719. and the Rules adopted
agreement.
thereunder, Chapter 3715. and the Rules adopted thereunder as well as the "Federal Food,
Drug,Agreement
11. This and Cosmetic Act," 52
is binding Stat.any
upon 1040
and(1938), 21 U.S.C.A.
all successors, 301 and
assigns, Chapterand
affiliates, 21,subsidiaries
Section 360ofof
the United States Code, and Section 207.20 of the Code of Federal Regulations.
the parties or any other corporation through whom or with whom Merck Sharp & Dohme Corp. Any violation by
Merck Sharp & Dohme Corp. of the terms of one or more federal or state requirements may
will operate.
constitute sufficient grounds for further enforcement action related to any licenses granted to
Merck Sharp & Dohme Corp. by the Board and will NOT discharge Merck Sharp & Dohme Corp.
12. Merck Sharp & Dohme Corp. waives its right to a hearing and an opportunity to be heard
from any obligation under the terms of this Agreement.
pursuant to Chapter 119. of the Ohio Revised Code and waives any right to an appeal.

9. Merck Sharp & Dohme Corp. agrees to pay all reasonable costs associated with the collection of
13. This Agreement
any payment, andmay be prosecution
of the executed in counterparts or facsimiles,
of any violation each of which shall be deemed
of thisAgreement.
an original, but all of which shall constitute one and the same instrument.
10. Merck Sharp & Dohme Corp. understands that it has the right to be represented by counsel for
review
14. All and to
parties execution of this agreement.
this Agreement understand that this document is a public record pursuant to Ohio
Revised Code Section 149.43.
11. This Agreement is binding upon any and all successors, assigns, affiliates, and subsidiaries of
the parties or any other corporation through whom or with whom Merck Sharp & Dohme Corp.
15. This Agreement contains the entire agreement between the parties, there being no other
will operate.
agreement of any kind, verbal or otherwise, which varies the terms of this Agreement.

12. Merck Sharp & Dohme Corp. waives its right to a hearing and an opportunity to be heard
16. This Agreement shall become effective upon the date of the Board President's signature below.
pursuant to Chapter 119. of the Ohio Revised Code and waives any right to an appeal.
(SIGNATURE PAGE FOLLOWS)
13. This Agreement may be executed in counterparts or facsimiles, each of which shall be deemed
an original, but all of which shall constitute one and the same instrument.

14. All parties to this Agreement understand that this document is a public record pursuant to Ohio
Revised Code Section 149.43.

15. This Agreement contains the entire agreement between the parties, there being no other
Merck Sharp & Dohme Corp. Case No. 2017-1892 3
agreement of any kind, verbal or otherwise, which varies the terms of this Agreement.

16. This Agreement shall become effective upon the date of the Board President's signature below.

[SIGNATURE PAGE FOLLOWS]

Merck Sharp & Dohme Corp. Case No. 2017-1892 3

 ..---- 9/4C1/7-0/3
irke D. Weaver, on behalf of, Date of Signature
Merck Sharp & Dohme Corp., Respondent

6//26/zo/ a'
Michael S. Labson, Attorney for Respondent Date of Signature

IN WITNESS WHEREOF, the parties to this Agreement have executed It and/or cause It to be executed
by their 1.6
duly authorized
421€7 representatives.
40ce...1__ 49-- 2---P-
Fred M. 7aver, RPh, President Date of Signature
Approved by: Board of Pharmacy
State of Ohio

CIP—
/ip ighice_ 1-02--- 9/0/a•Ci
Date
/7-Clii 23
b--/-0
irke D. Weaver, on behalf of,
Yvdine Tertel, Ohio Assistant Attorney General Date of
of Signature
Signature
Merck Sharp & Dohme Corp., Respondent

Michael S. Labson, Attorney for Respondent Date of Signature

2
7, 142, -4-'
Fred M. eaver, RPh, President
2---./.
.03-
Date of Signature
State of Ohio Board of Pharmacy

vcrfne Tertel, Ohio Assistant Attorney General Date of Signature

Merck Sharp & Dohme Corp. Case No. 2017-1892 i

Merck Sharp & Dohme Corp. Case No. 2017-1892 i

 Restricted Den very? Service Type

(Extra Fee) Yes CERTIFIED

7-1-itliz Article 14 um De r
C—)
7 -
1(1) cn
c•
L

r)\ 411111 I
'41 IN II III iii 1111
9414 7118 9956 0700 3683 10

Article Addressed
D. Addressee's Address is Fr..1From AG6,133 Uoad by &podgy) .66-
Merck Sharp & Dohme Corp.
Secondary Address r Suite :Apl : Floor (Reese Print Clearly)
c/o William Halm
770 Sumneytown Pike
Delivery Address West Point PA 19486

:Ay Z9•4Cods
 First-Class Mail
"I"DiRqt?ifUlfr,9Vtig6FirF ili,..1111, 11
NI Li it Postage & Fees Paid
USPS
Permit No. G-10

/USACMF-u7609/ 17
RETURN TO-

PS FURM 34 11, 2.R.4

STATE OF OHIO BOARD OF PHARMACY
77 S HIGH ST RM 1702
COLUMBUS, OH 43215