Exhibit 10.1

 

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PHARMACY DISTRIBUTION AND SERVICES AGREEMENT

 

THIS PHARMACY DISTRIBUTION AND SERVICES AGREEMENT (“Agreement”) is made
effective as of the 1st day of July, 2017 (“Effective Date”) between:

 

CELGENE CORPORATION

86 Morris Avenue

Summit, New Jersey 07901

 

(together with its subsidiaries and affiliates hereinafter collectively,
“Celgene”),

 

and

 

DIPLOMAT PHARMACY, INC. d/b/a

DIPLOMAT SPECIALTY PHARMACY

4100 South Saginaw Street

Flint, MI 48507

 

(hereinafter, “Pharmacy”).

 

WHEREAS, Celgene is authorized to market and sell REVLIMID® (lenalidomide),
POMALYST® (pomalidomide), and THALOMID® (thalidomide) in the United States of
America and its territories; and

 

WHEREAS, Celgene and Pharmacy wish to enter into this Agreement under which
Pharmacy, registered under REVLIMID REMS®, POMALYST REMS®, and THALOMID
REMS(1) (as defined below), will provide data reporting and other services to
Celgene.

 

NOW THEREFORE, in consideration of the promises and mutual covenants herein
contained in this Agreement, the parties hereby agree as follows:

 

1.                                      DEFINITIONS

 

For purposes of this Agreement the following terms shall have the following
meanings:

 

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1.1                               “Adverse Drug Experience” or “ADE” shall have
the meaning set forth in 21 CFR 314.80 as well as any occurrence of an elevated
Beta HCG or positive urine pregnancy tests, or a pregnancy or a possible
exposure of a pregnant woman, whether involving a Customer or partner of a male
Customer or a pregnant female who comes into contact with the Product while
dispensing.  Furthermore:

 

(a)                                 the term “Adverse Drug Experience” or “ADE”
shall also include cases of special situations, as required by Guidelines on
good pharmacovigilance practices: Module VI - Management and reporting of
adverse reactions to medicinal products, which requires companies with marketed
products centrally authorized by the EMA to report situations such as, by way of
example only, outcome of use of medicinal product during pregnancy, adverse
reaction during breastfeeding, use of product in children, reports of lack of
efficacy, suspected transmission of infectious agents, reports of overdose,
abuse, misuse, medication error, and reports from compassionate/named-patient
use; and,

 

(b)                                 the term “suspected to be associated with
the use of” shall mean the causal relationship between the medicinal product and
the adverse drug experience is considered at least a reasonable possibility.

 

1.2                               “Affiliates” shall mean, with respect to a
given party, any corporation, firm, partnership or other entity that directly or
indirectly controls or is controlled by or is under common control with such
party.  For purposes of this Section 1.2, “control” shall mean direct or
indirect ownership of greater than fifty percent (50%) of the equity having the
power to vote on or direct the affairs of the entity.

 

1.3                               “Certified Counselor” shall mean a licensed
healthcare professional certified by Celgene as a counselor for REVLIMID REMS®,
POMALYST REMS®, and THALOMID REMS® program(s) and who is either a: Doctor of
Osteopathy (“D.O.”); Licensed Practical Nurse (“LPN”); Pharmacist (“R.Ph.”);
Pharmacy Intern; Physician (“M.D.”); Physician Assistant (“P.A.”); Nurse
Practitioner (“N.P.”); or Registered Nurse (“RN”).

 

1.4                               “Certified Pharmacist” shall mean a Pharmacist
certified by Celgene as a Pharmacist for REVLIMID REMS®, POMALYST REMS®, and
THALOMID REMS® program(s) to dispense REVLIMID®, POMALYST®, and THALOMID®, or
counsel patients.

 

1.5                               “Certified Prescriber” shall mean a licensed
healthcare professional who is licensed to prescribe medication and certified in
the REVLIMID REMS®, POMALYST REMS®, and THALOMID REMS® program(s).

 

1.6                               “Customers” shall mean persons who are
prescribed Product by a Certified Prescriber.

 

1.7                               “Database” shall have the meaning set forth in
Section 5.2.

 

1.8                               “Dispensing” shall mean a prescription for
Product was filled at the certified Dispensing Site, counseling for the patient
to receive Product was completed and a confirmation number obtained, and the
prescription for Product was either shipped (for greater clarity, to mean the
prescribed Product has physically left the Dispensing Site or provided to the

 

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patient or the patient’s authorized representative who has picked up the
prescribed Product from the Dispensing Site.)

 

1.9                               “Dispensing Site” shall mean Pharmacy’s
facility(ies) that fill and ship prescriptions, listed on Schedule 1.8, attached
hereto, as may be amended from time to time by upon mutual agreement of the
parties, after being properly certified in REVLIMID REMS°, POMALYST REMS®, and
THALOMID REMS®.  In the case of physician networks who are dispensing, it shall
be responsible for placing and receiving orders of Product, administration, and
record keeping, as well as certifying itself and any of its other Dispensing
Sites and implementing REVLIMID REMS (8), POMALYST REMS®, and THALOMID REMSR.

 

1.10                        “EMA” shall mean the European Medicines Agency.

 

1.11                        “FDA” shall mean the United States Food and Drug
Administration.

 

1.12                        “High Risk Deviation” shall mean any action taken by
the Pharmacy that is inconsistent or non-compliant with any provision, or part
thereof, of REVLIMID REMS®, POMALYST REMS ®, and THALOMID REMS® which or which
may: (i) increases the risk of fetal exposure; or (ii) occurs on a consistent
basis which evidences a negligent or willful disregard by the Pharmacy to the
requirements of REVLIMID REMS ®, POMALYST REMS®, and THALOMID REMS®.  Any High
Risk Deviation by Pharmacy shall be considered a material breach of the terms of
this Agreement.

 

1.13                        “Pharmacist” shall mean an individual who is
currently licensed by the state in which he/she is practicing to engage in the
practice of preparing, preserving, compounding and dispensing medical drugs.

 

1.14                        “Pharmacy” shall be the corporate entity(ies) at
Pharmacy responsible for placing and receiving orders of Product,
administration, and record keeping, as well as certifying-itself and all of its
Dispensing Sites and implementing REVLIMID REMS®, POMALYST REMS®, and THALOMID
REMS® program(s).  Pharmacy may also fill and ship prescriptions.

 

1.15                        “Pharmacy Intern” shall mean an individual who
engages in the practice of pharmacy while under the personal supervision of a
Pharmacist and is enrolled in a professional degree program of an accredited
school or college of pharmacy and is satisfactorily progressing towards meeting
requirements for licensure as a Pharmacist.

 

1.16                        “REVLIMID REMS®, POMALYST REMS® and THALOMID REMS®”
shall mean the controlled distribution program and component of the Risk
Evaluation Mitigation Strategies (“REMS”) program specifically tailored to the
sale and distribution of the Product(s) REVLIMID®, POMALYST®, and THALOMID® as
described in Section 3 and in the Requirements document (“Requirements
Document”), attached as Schedule 1.17, which may be updated from time to time by
Celgene, at its sole discretion.  In the event the Requirements Document is
updated, Celgene shall inform Pharmacy within ten (10) business days, and allow
Pharmacy thirty (30) days to meet requirements

 

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of the updated Requirements Document, unless a shorter time frame is necessary
to meet Regulatory Authority requirements.

 

1.17                        “Product” shall mean Celgene’s REVLIMID
(lenalidomide), or POMALYST® (pomalidomide), or THALOMIW (thalidomide), and
“Products” shall mean any two or more of REVLIMID® (lenalidomide) and/or
POMALYST® (pomalidomide) and/or THALOMID® (thalidomide).

 

1.18                        “Regulatory Authority” shall mean any governmental
authority, agency or other instrumentality having regulatory responsibility,
control or oversight over the manufacture, use, labeling, packaging, shipping,
distribution, dispensing or destruction of the Product.

 

1.19                        “SOP” shall mean the written standard operating
procedures, specifications and instructions, mutually agreed upon by the
parties, which may be updated from time to time, upon the sole discretion of the
party who the owns the SOP.

 

1.20                        “Territory” shall mean the United States of America
and its territories.

 

2.                                      PRODUCT ORDERS, SHIPMENT, AND HANDLING

 

2.1                               Orders.  The parties hereto agree that, during
the Term, as defined below, Pharmacy shall purchase REVLIMID®, POMALYST®, and/or
THALOMID® directly and exclusively from Celgene at the commercial prices in
effect at the time of order, and, subject to the right of Celgene to allocate
supplies of Product under Section 2.6, Celgene shall supply Product to Pharmacy,
for sale and distribution to Customers.  Pharmacy shall order Product by phone,
email, or EDI from Celgene in such quantities as are necessary to meet the
demand for Product from Customers.  All orders shall be firm, and Pharmacy may
not change or cancel an order without the prior written approval from Celgene. 
All purchases of Product by Pharmacy shall be on the terms and conditions set
forth in this Agreement.  No purchase order, invoice or other form shall be
deemed to vary the terms of this Agreement.

 

2.2                               Shipment by Celgene.  Celgene shall ship
Product to Pharmacy by means of transportation (commercial truck or better)
determined by Celgene and at Celgene’s cost.  While Celgene shall use reasonable
efforts to avoid any delay in delivering Product on the delivery dates agreed
upon by the parties, Celgene shall not be liable to Pharmacy for late delivery.

 

2.3                               Storage; Handling of Product; Inventory
Accountability.  Pharmacy shall unload each shipment of Product immediately upon
receipt from Celgene in accordance with the applicable Pharmacy SOP.  Pharmacy
may transport Product to a Dispensing Site for storage and distribution;
however, there shall be no transfer of Product between Dispensing Sites. 
Pharmacy shall use storage facilities and storage conditions for Product in
compliance with applicable Celgene SOPs.  Pharmacy shall at all times handle,
store and distribute Product in accordance with applicable Celgene SOPs which
shall incorporate by this reference the handling and storage provisions in the
package labeling for Product.  Pharmacy shall keep an inventory log of the
Product, by strength,

 

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reflecting its on-hand inventory, at all times.  Pharmacy shall provide Celgene
inventory reporting for all Products pharmacy is actively enrolled in a REMS
program, to dispense REVLIMID”, POMALYST®, and/or THALOMID.  Inventory reports
will be sent to Celgene within five (5) days after the Date of Count (the “Date
of Count” means the last business day of the quarter).  Electronic counts will
be provided at the end of Q1 and Q3, physical inventory counts will be provided
at the end of Q2 and Q4.  The inventory report template is detailed in Schedule
2.3.  Pharmacy shall be responsible for all costs associated with storage,
handling and shipment of Product from the Pharmacy/Dispensing Site to the
Customer.

 

2.4                               Inspection of Product; Remedies and Procedures
for Defects.  Pharmacy shall carefully examine Product upon delivery and shall
notify Celgene within ten (10) business days of any non-delivery of a portion of
a shipment or any defect in any Product that is reasonably discoverable upon
visual inspection of the Product, without unloading individual shipping units. 
Along with notice of any defect, Pharmacy shall furnish to Celgene a detailed
description of the nature of the defect.  Upon receipt of notice of any defect
or non-delivery, Celgene, at its option, shall (a) replace any defective
Product, (b) issue Pharmacy a credit in the amount of the purchase price paid
for any defective Product, or (c) replace, or issue Pharmacy a credit in the
amount of purchase price paid for, any undelivered Product.  Except as set forth
in Section 14, the preceding sentence sets forth Celgene’s sole liability with
respect to non-delivery of a portion of a shipment and Product defects
reasonably discoverable upon visual inspection of the Product without unloading
individual shipping units.  Section 7.1 sets forth Celgene’s sole liability with
respect to other Product returns, and except as set forth in this Section 2.4,
and Sections 7.1 and 14, Celgene shall not be otherwise liable to Pharmacy for
any Product delivery failures or Product defects.  In the absence of written
notice from Pharmacy to Celgene in accordance with the terms of this
Section 2.4, a shipment of Product shall be deemed to have been delivered and
accepted by Pharmacy as complete and in satisfactory condition.  Pharmacy shall,
at Celgene’s request and expense, follow Celgene’s instructions to return to
Celgene or Celgene’s third party disposal company any Product delivered to
Pharmacy, which are not in compliance with the documentation provided by
Celgene.  Pharmacy shall cooperate with Celgene in investigating the cause of
any defect in Product.

 

2.5                               Title and Risk of Loss.  Title to Product and
risk of loss of Product shall transfer to Pharmacy upon delivery of Product to
the Pharmacy or Dispensing Site.

 

2.6                               Shortages.  Notwithstanding anything in this
Agreement to the contrary, in the event of a shortage of the Product, Celgene
reserves the right to allocate available supplies of the Product in its sole
discretion, however, Celgene shall not allocate available supplies in a manner
which intentionally disadvantages Pharmacy.

 

3.                                      PHARMACY ORDERS AND DELIVERY

 

3.1                               Acceptance of Prescriptions.  Pharmacy shall
only accept prescriptions with an authorization number generated by Celgene’s
REMS system and patient risk category documented on the prescription.  The
authorization number on prescriptions for Females

 

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of Reproductive Potential (FRP) are only valid for seven (7) days from the date
of the last pregnancy test, the authorization number on prescriptions for all
other Customers are valid for thirty (30) days, from the date the authorization
number is obtained.  Pharmacy shall not accept or otherwise fill any
prescription for Product over the telephone or without a valid authorization
number.  Each unique authorization number on every prescription will require
that a confirmation number must be obtained from Celgene Customer Care Center by
way of: telephone; automated IVR system; or Celgene Web portal, prior to
dispensing Product.

 

3.2                               Counseling.  Prior to obtaining a confirmation
number related to each unique authorization number on each prescription,
Pharmacy will contact Customers.  Only Certified Counselors and/or Certified
Pharmacists shall contact Customers and provide counseling, which contact shall
be in accordance with the instructions set forth in this Section 3.1, and the
Requirements Document.  Pharmacy shall ensure there is a Certified Counselor
available during normal business hours.  Pharmacy shall educate Customers on the
risks associated with the use of the Product, in accordance with the
Requirements Document.  Pharmacy must ensure that the Certified Counselors
and/or Certified Pharmacists who will perform the counseling have been properly
identified upon Pharmacy’s registration of the Pharmacy/Dispensing Site and upon
staffing changes.  Certified Counselors and/or Certified Pharmacists will be
required to be recertified annually, or more frequently, as may be required by
Celgene.  Pharmacy shall inform Celgene of Certified Counselors and/or Certified
Pharmacists who will no longer be counseling or dispensing for Celgene REMS
products (example: employee no longer works there or has changed roles) when it
occurs, and as directed on monthly or annual basis by Account Executive or
Celgene Customer Care team.  In the event that there are no Certified
Counselors/Certified Pharmacists at a Pharmacy that have met their annual
recertification obligation, the Pharmacy will be suspended from dispensing until
such time as they have met their recertification obligations.  Each pharmacy
must have at least one Certified Counselor/Certified Pharmacist who is certified
to dispense/counsel for REVLIMID®, POMALYST®, and/or THALOMID®.  Pharmacy will
not ship the Product to a Customer unless it has contacted Celgene to obtain a
confirmation number and received a completed prescription from the Certified
Prescriber (by facsimile or e-prescribed, or otherwise), which must indicate the
authorization number and patient risk category, and has completed the additional
Customer counseling, as outlined in the Requirements Document.  Pharmacy shall
fill valid prescriptions for Product in accordance with all applicable laws and
regulations.  For each subsequent Customer prescription, Pharmacy shall repeat
counseling for such Customer upon receipt of additional Product prescriptions. 
Subsequent Customer prescriptions will only be allowed if fewer than seven
(7) days of Product dosage remains on the previous prescription with respect to
such Customer.  In addition to those Customers that have not previously been
prescribed Product, any Customer who has not received Product in the prior
twelve (12) months will also be considered a “new Customer” and will have to
re-enroll in POMALYST REMS®, REVLIMID REMS® and THALOMID REMS® program(s).

 

3.3                               Filling Prescriptions.  When filling
prescriptions for Females of Reproductive Potential, Pharmacy/Dispensing Site
shall ship Product to Customer on the same day of obtaining

 

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the confirmation number by United Parcel Service or Federal Express, standard
overnight delivery, or another similar carrier as agreed by the parties in
writing, and in any case, such delivery shall require signature for delivery. 
For all other prescriptions Pharmacy/Dispensing Site shall ship Product to
Customer within twenty four (24) hours of receipt of the confirmation number. 
Pharmacy/Dispensing Site shall package Products for shipment in accordance with
its applicable SOP.  Pharmacy/Dispensing Site shall use its best efforts to ship
Product having the earliest expiration date first from available inventory. 
Each shipment of the Product shall be tracked and Pharmacy will maintain records
of the disposition of all shipments, whether sent by Pharmacy or its Dispensing
Site.  Pharmacy/Dispensing Sites will require its shippers to receive written
confirmation of delivery of Product, or to provide written notice of the
non-delivery of a shipment of the Product within twenty four (24) hours of
shipping.  If the intended Customer does not receive a shipment of the Product,
Pharmacy shall use reasonable efforts to track and retrieve the missing
shipment, and shall inform Celgene of the missing shipment if it is not
retrieved.  In the event Customer will pick up the Product directly from
Pharmacy/Dispensing Site, such pickup must occur within twenty four (24) hours
of obtaining the confirmation number.

 

3.4                               New Customers.  In addition to Pharmacy
meeting all of its obligations under this Agreement and POMALYST REMS®, REVLIMID
REMS® and THALOMID REMS® program(s) for “new Customers” (for purposes of this
Section 3.4 and for greater clarity, the term “new Customers” shall mean those
customers that have not received Product in the prior twelve (12) months and/or
those Customers that have not previously been prescribed Product), Pharmacy
shall: (A) upon receipt of a prescription for Product immediately time-stamp
such prescription, (B) fulfill obligations under the REVLIMID REMS®, POMALYST
REMS®, and THALOMID REMS® Program requirements and dispense Product to such new
Customers as quickly as possible and consistent with good clinical practice.

 

4.                                      CORE SERVICES

 

4.1                               Core Services.  Pharmacy typically provides a
wide array of services to patients and their caregivers for which Pharmacy does
not receive any payment from manufacturers or vendors.  Specifically, depending
on the particular disease state, these core pharmacy activities include, but are
not limited to, the following:

 

(a)                                 Patient Intake: Initial patient processing,
insurance eligibility and benefits verification, and scheduling of initial
specialty medication order;

 

(b)                                 Pharmacy Dispensing: Standard dispensing of
specialty medications pursuant to a prescription in accordance with applicable
law, the deposit of such specialty medications with a third party carrier (e.g.,
Federal Express) to facilitate the delivery of same as per the patient’s or
prescribing physician’s instructions, and the provision of certain nominal
ancillary supplies (e.g., syringes, needles, and alcohol swabs) and certain
related items in connection with the specialty medication that may be necessary
or useful to the patient in connection with the administration of the specialty
medication; and

 

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(c)                                  Ongoing Clinical and Specialty Pharmacy
Support: Standard patient education (no product marketing), patient assessment,
and related clinical patient management activities and programs all of which are
clinically objective; physician consultations; provision of information to
prescribing physicians to facilitate patient coverage appeals; standard refill
reminder follow-up calls; managing ongoing medication orders and shipment
scheduling, and insurance follow-up and related ongoing delivery coordination.

 

4.2                               No Payment for Core Services.  Pharmacy
represents and warrants that it intends to make the core pharmacy activities
described in this Section 4 available to all Customers that are accepted by
Pharmacy, and Pharmacy is not seeking any compensation from Celgene for these
core pharmacy activities.  Celgene shall not pay Pharmacy any fees for these
core pharmacy activities.

 

5.                                      ENHANCED SERVICES

 

5.1                               Enhanced Services.  Pharmacy agrees to
provide, and Celgene agrees to purchase from Pharmacy, the enhanced pharmacy and
data reporting services performed under the REVLIMID REMS®, POMALYST REMS®, and
THALOMID REMSTM, as further detailed in Section 3 and the Requirements Document
(Schedule 1.17); and the services described in Sections 5.2, 5.3, and 5.4
(collectively, the “Enhanced Services”).

 

5.2                               Data.  Pharmacy shall maintain a
Celgene-specific data management system (the “Database”) from which reports can
be generated and provided to Celgene and that contains information as required
herein.  In addition, and subject to Pharmacy obtaining appropriate Customer
consent, Pharmacy shall maintain in the Database Customer-specific information
as set forth herein.  Pharmacy shall regularly update the Database with Product
and Customer information set forth in Schedule 5.1, attached hereto.  Celgene
and Pharmacy may amend the information requested in Schedule 5.1, upon request
by Celgene and mutual agreement of the parties.  Celgene shall be the sole owner
of the information compiled in the data reports, provided, however, that
Pharmacy shall have full access to the Database in order to fulfill its
obligations under this Agreement and to comply with all applicable laws and
regulations.  Celgene must authorize any release of the data to third parties,
including but not limited to, sales data, or prescriptions filled.

 

5.3                               Reports.  Pharmacy shall generate and furnish
data listed herein and in the format outlined in Schedule 5.1, for Vidaza®,
Abraxane® and Istodax®.  Pharmacy shall continue to provide this report on a
monthly, basis, and periodic reporting as Celgene may reasonably request. 
Reports will include, but not be limited to the following information:

 

(a)                                 Pharmacy site address

 

(b)                                 Pharmacy site city

 

(c)                                  Pharmacy site state

 

(d)                                 Pharmacy site zip

 

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(e)                                  Date Dispensed

 

(f)                                   Customer ID (specific to this customer)

 

(g)                                  Prescriber First Name

 

(h)                                 Prescriber Last Name

 

(i)                                     Prescriber Address ID (if available)

 

(j)                                    Prescriber Address

 

(k)                                 Prescriber City

 

(l)                                     (1)                                
Prescriber State

 

(m)                             Prescriber Zip

 

(n)                                 DEA (prescriber)

 

(o)                                 NPI (prescriber)

 

(p)                                 NDC

 

(q)                                 Product

 

(r)                                    QTY in vials

 

Report should be generated and received by Celgene no later than ten
(10) business days following the close of each month.  If no products were
dispensed, report should reflect this.  Report should be sent to
salesoperations@celgene.com

 

Data Reports may be further defined or amended by Schedule 5.1.  At Celgene’s
request, Pharmacy will deliver the reports specified under this
Section electronically through a secure connection in the format identified in
Schedule 5.1.

 

5.4                               Materials.  Pharmacy shall maintain an
inventory of current educational materials developed and provided by Celgene. 
Pharmacy shall include in shipments of Product any required material supplied
and designated by Celgene for inclusion in Product shipments.

 

6.                                      PAYMENT

 

6.1                               Service Fee.  Celgene shall pay Pharmacy a
service fee for the Enhanced Services, based on the achievement of performance
metrics set forth in Schedule 6.1 (“Service Fee”).  The performance metrics are
intended to encourage prompt compliance with the REMS and timely patient access
to the Products.  Celgene shall have the right to withhold or deny payment of
the Service Fee in the event Pharmacy does not provide the Enhanced Services, or
is in any way in breach of any of its obligations under this Agreement.

 

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6.2                               Service Fee Calculation.  The Service Fee will
be calculated and paid quarterly based on Celgene’s evaluation of Pharmacy’s
achievement of performance metrics, as specified above.

 

6.3                               Payment Due for Product Orders; Late Fee.

 

(a)                                 All amounts due hereunder to Celgene for
Product orders shall be payable by check or EFT to Celgene.  Celgene shall
invoice Pharmacy for all amounts due to Celgene hereunder, as adjusted to take
into account credits due to Pharmacy, and Pharmacy shall pay all invoiced
amounts when due.  Any amounts remaining unpaid for more than thirty-five (35)
days after date of invoice shall be subject to interest thereon equal to one and
one half percent (1.5%) per month.

 

(b)                                 Without limiting the generality of
Section 6.3(a) and subject to Pharmacy being at all times in full compliance
with all of the terms and conditions of this Agreement, Pharmacy shall be
entitled to a two percent (2.0%) prompt payment cash discount off the invoice
price if Celgene receives payment within thirty (30) days of the invoice date,
net thirty one (31) (the “Prompt Pay Discount”).

 

(c)                                  The parties agree that they have structured
Prompt Pay Discount in a manner consistent with the statutory discount exception
(42 U.S.C. § 1320a-7b(b)(3)(A)) and the discount safe harbor (42 C.F.R. §
1001.952(h)).  The terms pursuant to which the Prompt Pay Discount is paid are
fixed and set forth in this Agreement.  This discount is not dependent on, and
does not operate in conjunction with, (either explicitly or implicitly) any
other arrangement or agreement between Celgene and Pharmacy.  To the extent
required under applicable law, Pharmacy will report the discounts to appropriate
Federal health care programs, and will, upon the request of a governmental
agency, (including the Secretary of Health and Human Services or a state
healthcare agency), disclose information regarding the discounts to the
requesting agency.  Without limitation of the foregoing, all Prompt Pay
Discounts and any other information that must be disclosed under applicable law,
shall be disclosed to the Centers for Medicare and Medicaid Services (“CMS”) in
accordance with: (1) CMS guidance (as it may be revised from time to time);
(2) any contractual obligations with third parties; and (3) any other disclosure
or reporting obligations or requirements imposed by federal or state laws,
regulations, or guidance.  Confidential treatment shall be requested for any
disclosures made to CMS and Medicare Part D Plans to the extent permitted by
law.

 

6.4                               Costs and Expenses.  Except as otherwise
expressly set forth herein, Pharmacy shall be responsible for all costs and
expenses associated with fulfilling its obligations under this Agreement.

 

6.5                               Taxes.  All prices are exclusive of federal,
state and local excise, sales, use and other taxes levied or imposed on the
sale, shipment, delivery, ownership, possession or resale of Product or any
other activities contemplated under this Agreement.  Except for taxes on
Celgene’s income, Pharmacy shall be liable for and pay all taxes imposed in
connection with the activities contemplated hereunder.

 

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6.6                               Financial Condition.  At any time, when in
Celgene’s reasonable opinion, the financial condition of Pharmacy or its parent
company so warrants, or if Pharmacy consistently fails to make payments when due
or otherwise defaults under this Agreement, Celgene may alter terms of payment
(including but not limited to requiring full or partial payment in advance of
delivery, eliminating the Prompt Pay Discount), suspend credit, delay or cancel
shipping, request quarterly financial statements or other financial information
on an ongoing basis, or pursue any remedies available at law or under this
Agreement.

 

7.                                      RETURN GOODS POLICY

 

7.1                               Return Goods Policy.  The current form of
Celgene’s return goods policy is attached as Schedule 7.1 (the “Return Goods
Policy”).  Celgene may, if it deems necessary or desirable, update the Return
Goods Policy from time to time.  In the event Celgene updates the Return Goods
Policy, Celgene shall provide Pharmacy with advance written notice of any
changes to its Return Goods Policy.

 

7.2                               Returns by Pharmacy.  In the event Pharmacy
returns or requests to return a Product, for any reason, Pharmacy shall promptly
notify Celgene, and Celgene shall, upon receipt of Product, give Pharmacy a
credit amount in accordance with the current Celgene Return Goods Policy,
provided that the reason for the return of the Product does not arise from
(i) the negligence or intentional misconduct of Pharmacy or any of its agents or
employees, (ii) failure of Pharmacy to follow applicable SOPs or to otherwise
comply with the terms of this Agreement or (iii) mis-delivery or loss of Product
by a carrier used by Pharmacy.  For any return of Product authorized by Celgene,
Pharmacy shall send the Product, or shall instruct Customer to send the Product,
to Celgene or Celgene’s designated disposal company as specified and in the
manner described in the then current Return Goods Policy.

 

8.                                      ADVERSE DRUG EXPERIENCE AND CUSTOMER
COMPLAINTS

 

8.1                               Adverse Drug Experience.  Consistent with its
internal SOPs, Pharmacy will promptly inform Celgene’s Drug Safety Group of any
information regarding adverse drug experiences suspected to be associated with
the use of Product and all cases of special situations it receives, with the
appropriate information, as set forth in more detail on Schedule 8.1, to the
address set forth therein.

 

8.2                               Other Customer Complaints.  Pharmacy shall
give notice by email or phone to Celgene’s Customer Service Department at
orderprocessing@celgene.com or 888-423-5436 within ten (10) business days of
receipt of any Customer complaint related to Product and/or services, other than
Adverse Drug Events, and any labeling and package insert issues, specifying in
detail the nature of the complaint or issue.  Pharmacy shall provide Customer
Complaints in a form substantially similar to the form attached as Schedule 8.2.

 

8.3                               Cooperation.  Pharmacy shall cooperate with
Celgene in responding to or investigating any Customer complaints and Adverse
Drug Events.

 

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9.                                      SUSPENSION OF DISTRIBUTION AND RECALLS

 

9.1                               Suspension of Distribution.  Pharmacy shall
suspend distribution of Product if: (a) requested by Celgene as the result of a
problem with Product quality or a directive from the FDA; (b) Celgene has
determined, in Celgene’s sole and absolute discretion, Pharmacy to have deviated
from, or otherwise be in non-compliance with, the requirements of REVLIMID
REMS®, POMALYST REMS®, and THALOMID REMS® program(s); or (c) Pharmacy has
engaged in High Risk Deviations.  If multiple instances of deviations or
noncompliance are uncovered, Celgene reserves the right to immediately and
permanently suspend Pharmacy from dispensing any Product under a risk management
program.  Without otherwise limiting or waiving any other right or remedy
available to Celgene under law or equity, certain specific consequences of
Pharmacy deviations or non-compliance are as set forth in detail in the
Requirements Documents.  Any deviation from, or noncompliance with, REVLIMID
REMS®, POMALYST REMS®, and THALOMID REMS® program(s), as determined by Celgene
in Celgene’s sole and absolute discretion, shall be considered a breach of the
terms and conditions herein.  Any occurrence of a High Risk Deviation shall be
considered a material breach of the terms of this Agreement.

 

9.2                               Recalls.  Celgene shall promptly notify
Pharmacy of any recalls initiated by Celgene or requested by the FDA.  Upon
receipt of notice of a recall from Celgene, Pharmacy shall immediately notify
the affected Customers.  Celgene shall provide Pharmacy with the form of letter
to be used in connection with notice of any recall which shall contain the
appropriate instructions as to whether Customers should return or dispose of the
affected Product.  Celgene shall be responsible for the mailing, shipping and
reasonable administrative expenses incurred by Pharmacy in connection with the
recall as well as the cost of replacement Product for Customers, provided that
the reason for the recall does not arise from (i) the negligence or intentional
misconduct of Pharmacy or any of its agents or employees or (ii) failure of
Pharmacy to follow applicable SOPs or to otherwise comply with the terms of this
Agreement.  Pharmacy shall cooperate in any recalls by providing relevant
Product tracking information to Celgene.

 

9.3                               Records.  Pharmacy shall maintain during the
Term and for three (3) years thereafter such information as may be reasonably
required by Celgene to effect a Product recall, and shall make such information
available to Celgene, at Celgene’s request, in the event of such a recall.

 

9.4                               Cooperation.  Pharmacy shall cooperate with
Celgene in investigating any Product failure which resulted in the need for a
recall.

 

10.                               REPRESENTATIONS, WARRANTIES AND COVENANTS OF
PHARMACY

 

10.1                        Compliance.  In performing its obligations under
this Agreement, Pharmacy represents and warrants that it shall comply with all
applicable federal, state and local laws, regulations and ordinances, including
without limitation (a) the Social Security Act; (b) the Health Insurance
Portability and Accountability Act, (c) federal and state health care anti-fraud
and abuse laws; (d) state drug product selection, dispensing, pharmacy

 

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practice, biohazard disposal, privacy, and consumer protection laws; and
(e) rules and regulations of the FDA, the Center for Medicare and Medicaid
Services and any other Regulatory Authority by which Pharmacy may be governed. 
Pharmacy also shall comply with all applicable professional and industry
standards and good business practices.

 

10.2                        Services.

 

(a)                                 Pharmacy represents and warrants:
(1) Celgene has engaged Pharmacy to perform bona fide, legitimate, reasonable,
and necessary Enhanced Services; (2) the Enhanced Services are not intended to
serve, either directly or indirectly, as a means of marketing the Product;
(3) the Enhanced Services are not intended to diminish the objectivity or
professional judgment of Pharmacy or to interfere with the objectivity or
professional discretion of any prescriber; (4) the Enhanced Services do not
involve the counseling or promotion of any off-label use of the Products or a
business arrangement or other activity that violates any state or federal law;
(5) the Service Fees do not constitute a discount off the purchase price of the
Product; (6) the Service Fees are not intended in any way as remuneration for
referrals or for other business generated; (7) the Service Fees represent fair
market value for the compensated services based on arms-length negotiations; and
(8) the Service Fees are not intended in any way as a payment related to a drug
formulary or drug formulary activities and have not been negotiated or discussed
between the parties in connection with any such drug formulary or formulary
activities.

 

(b)                                 Pharmacy further represents and warrants:
(1) no Enhanced Services shall be provided with respect to any Customer unless
Pharmacy has received a prescription from the Customer’s prescribing physician;
(2) Enhanced Services for which any Service Fees are to be paid hereunder are in
addition to the services that Pharmacy typically performs for patients;
(3) Pharmacy does not perform the Enhanced Services on behalf of any
pharmaceutical manufacturer or other third party without being paid fair market
value service fees for each such service; (4) the clinical judgment of the
Customer’s treating physician (or other healthcare provider) shall not be
undermined or otherwise usurped in the performance of the Enhanced Services;
(5) Pharmacy shall not offer physicians or any other healthcare professionals
any financial inducement to prescribe or switch patients to any Product; and
(6) Pharmacy will not bill, and is not obligated by law or contract with, any
third party for the performance of the Enhanced Services to be performed under
this Agreement.

 

10.3                        Federal Programs.  Pharmacy represents and warrants
that neither it nor any director, officer, employee, independent contractor,
agent or other representative of Pharmacy (referred to collectively in this
section as “Representative”) has been debarred pursuant to the Federal Food,
Drug and Cosmetic Act or is currently excluded, debarred, suspended, or
otherwise ineligible to participate in any Federal health care program (as
defined in Section 1128B(f) of the Social Security Act (“Government Program”) or
in Federal procurement or non-procurement programs.  Pharmacy shall notify
Celgene immediately if Pharmacy or any of its Representatives who are concerned
with the performance of this

 

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Agreement becomes debarred, excluded, suspended or ineligible, or is convicted
of a criminal offense that falls within the ambit of the Federal statute
providing for mandatory exclusion from participation in any Government Program,
but has not yet been excluded, debarred, suspended, or otherwise declared
ineligible to participate in those programs.

 

10.4                        Quality of Employees and Monitoring.  Pharmacy
represents and warrants that it shall use a well-trained, knowledgeable team of
employees to handle Product and to perform the services to be performed by
Pharmacy under this Agreement.  Pharmacy employees who will be providing the
services will be required to be certified by Celgene in REVLIMID REMS®, POMALYST
REMS®, and THALOMID REMS® program(s) and any other training required by
Celgene.  Pharmacy’s ability to maintain its certification, and its right to
dispense Product is contingent upon completion of any such training required by
Celgene, including compliance with recertification.  Subject to applicable
privacy laws, Celgene shall have the right, from time to time, to have a Celgene
employee monitor Pharmacy’s responses during telephone calls transferred from
Celgene’s customer support line, and Pharmacy shall cooperate with Celgene to
enable such monitoring activities.  Customer shall be notified at the beginning
of a call to be monitored that monitoring for quality assurance purposes is to
occur.

 

10.5                        Medicaid Provider Status.  Pharmacy represents and
warrants that it is currently eligible to participate as a provider in the
Medicaid program in each state in the Territory except those states listed on
Schedule 10.3 (for avoidance of doubt, the list of those states to be provided
by Pharmacy) attached hereto, and agrees to maintain such eligibility during the
Term.  Upon notice to Celgene, Pharmacy may amend Schedule 10.3 in its sole
discretion to add additional states and shall provide Celgene with prompt notice
of any such amendment, provided that Pharmacy shall not add any state to
Schedule 10.3 unless the state has changed its laws to require an in-state
pharmacy presence for eligibility in its Medicaid program.  Pharmacy shall
remove a state from Schedule 10.3 (and shall provide notice to Celgene of such
removal) when the state no longer requires an in-state pharmacy presence for
eligibility in the state’s Medicaid program.

 

10.6                        Actions.  Pharmacy shall not take any action which
would materially adversely affect its standing or that of Celgene in the
industry or with respect to Product customer base or which would undermine the
image of Product.

 

10.7                        Quality Reviews.  Pharmacy shall periodically, but
not less frequently than once per year, perform written quality reviews of
Pharmacy’s performance in fulfilling its obligations under this Agreement, and
shall provide Celgene with copies of such reviews.  Pharmacy shall administer a
validation checklist to each employee performing services related to Product
upon completion of such employee’s initial training and annually thereafter, and
shall provide Celgene with copies of such checklists.  Pharmacy shall fully
cooperate with Celgene in fulfilling all of its obligations under this
Agreement, including, but not limited to, quality reviews.

 

10.8                        Licenses.  Pharmacy represents and warrants that it
now has and shall maintain in full force during the Term all federal and state
pharmacy, wholesaler and other licenses or approvals required by Pharmacy to
fulfill its obligations under this Agreement.

 

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Pharmacy shall provide Celgene with notice of any communications with pharmacy
licensing boards or the FDA which relate to potential problems with facilities,
operations or procedures used by Pharmacy in its distribution of Product that
may affect Pharmacy’s performance of its obligations under this Agreement,
including notices of inquiries, investigations or inspections and resulting
findings.

 

10.9                        Limitation on Promotion.  Pharmacy shall not make
any performance claims or engage in any promotional activities with respect to
Product except for the distribution of required Product literature prepared by
Celgene and any other activities directly related to the services to be provided
by Pharmacy hereunder, in each case as expressly approved in writing by Celgene.

 

10.10                 Use of Trademarks.  Pharmacy shall not use the trademarks,
trade names, trade dress or logos of Celgene except to the extent contained in
Product literature provided by Celgene, on Product labels or as otherwise
approved by Celgene in writing.

 

10.11                 Authority.  Pharmacy represents and warrants that (a) it
has all requisite corporate power and authority to execute, deliver and perform
this Agreement and any other agreements contemplated hereby and (b) it is not
currently obligated nor will it assume any future obligation under any contract
(including without limitation any commitment of any nature) or other agreement,
instrument or arrangement that conflicts with its obligations under this
Agreement.

 

10.12                 Limitation of Liability.  Except for its obligations of
indemnification, or breach of its obligations of confidentiality, in no event
shall Pharmacy be liable for any consequential, exemplary, punitive, incidental,
indirect or special damages or costs, including without limitation, lost
profits, of Celgene, whether or not Pharmacy has been advised of the possibility
of such damages or costs.

 

10.13                 Celgene Information.  Pharmacy shall use information about
Customers to whom Product has been dispensed, including any list of such
Customers, and other Celgene Information (as defined below) solely to perform
its obligations under this Agreement and to dispense Product to such Customers. 
Pharmacy shall not make such information (or any portion thereof) available to,
or use such information for the benefit of, any third party other than an
insurance provider and/or other third party payor (with respect to its covered
persons).  Notwithstanding the foregoing, Pharmacy may disclose information on
or about Customers to whom Product has been dispensed, including any list of
such Customers, as authorized under the Health Insurance Portability and
Accountability Act and to Regulatory Authority(ies) and Pharmacy’s auditors,
legal counsel and lenders, provided that each such party to whom such
information is disclosed is obligated to preserve the confidentiality of such
information.

 

11.                               REPRESENTATIONS, WARRANTIES AND COVENANTS OF
CELGENE

 

11.1                        Compliance with Law.  Celgene shall be responsible
for testing Product and ensuring that Product complies, when shipped to
Pharmacy, with all applicable laws, regulations, directives and requirements of
the FDA, including without limitation, packaging and

 

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labeling requirements, product warning requirements, product design and safety
requirements and advertising requirements.

 

11.2                        Services.  Celgene represents and warrants:
(1) Celgene has engaged Pharmacy to perform bona fide, legitimate, reasonable,
and necessary Enhanced Services; (2) the Enhanced Services are not intended to
serve, either directly or indirectly, as a means of marketing the Product;
(3) the Enhanced Services are not intended to diminish the objectivity or
professional judgment of Pharmacy or to interfere with the objectivity or
professional discretion of any prescriber; (4) the Enhanced Services do not
involve the counseling or promotion of any off-label use of the Products or a
business arrangement or other activity that violates any state or federal law;
(5) the Service Fees do not constitute a discount off the purchase price of the
Product; (6) the Service Fees are not intended in any way as remuneration for
referrals or for other business generated; (7) the Service Fees represent fair
market value for the Enhanced Services based on arms-length negotiations; and
(8) the Service Fees are not intended in any way as a payment related to a drug
formulary or drug formulary activities and have not been negotiated or discussed
between the parties in connection with any such drug formulary or formulary
activities.

 

11.3                        Federal Programs.  Celgene represents and warrants
that neither it nor any director, officer, employee, independent contractor,
agent or other representative of Celgene (referred to collectively in this
section as “Representative”) has been debarred pursuant to the Federal Food,
Drug and Cosmetic Act or is currently excluded, debarred, suspended, or
otherwise ineligible to participate in any Government Program or in Federal
procurement or non-procurement programs.  Celgene shall notify Pharmacy
immediately if Celgene or any of its Representatives who are concerned with the
performance of this Agreement becomes debarred, excluded, suspended or
ineligible, or is convicted of a criminal offense that falls within the ambit of
the Federal statute providing for mandatory exclusion from participation in any
Government Program, but has not yet been excluded, debarred, suspended, or
otherwise declared ineligible to participate in those programs.

 

11.4                        Use of Trademarks.  Celgene shall not use the
trademarks, trade names, trade dress or logos of Pharmacy except to the extent
necessary for activities contemplated under this Agreement.

 

11.5                        Warranty.  Celgene represents and warrants that,
upon the date of shipment to Pharmacy, Product will not be adulterated or
misbranded within the meaning of the Federal Food, Drug and Cosmetic Act (the
“Act”) and will not be articles which may not, under the provisions of the Act,
be introduced into interstate commerce.  THE EXPRESS WARRANTIES CONTAINED IN
THIS SECTION 11 ARE IN LIEU OF ALL OTHER REPRESENTATIONS AND WARRANTIES WITH
RESPECT TO PRODUCT.  CELGENE DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING WITHOUT LIMITATION ALL WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.  Except as otherwise set forth in Section 14, Celgene’s sole
liability and Pharmacy’s sole remedy for breach of warranty under this Agreement
shall be for Celgene to replace the defective Product or to credit Pharmacy’s
account in accordance with Section 2.4 and Section 7.1.  Except for its
obligations of indemnification, or breach of its obligations of

 

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confidentiality, in no event shall Celgene be liable for any consequential,
exemplary, punitive, incidental, indirect or special damages or costs, including
without limitation, lost profits, of Pharmacy, whether or not Celgene has been
advised of the possibility of such damages or costs.

 

11.6                        License.  Celgene represents and warrants to
Pharmacy that Celgene has a valid and existing license from the FDA to market
and sell Product in the Territory.

 

11.7                        Authority.  Celgene represents and warrants that
(i) it has all requisite corporate power and authority to execute, deliver and
perform this Agreement and any other agreements contemplated hereby and (ii) it
is not currently obligated nor will it assume any future obligation under any
contract (including without limitation any commitment of any nature) or other
agreement, instrument or arrangement that conflicts with its obligations under
this Agreement.

 

11.8                        No Adverse Actions.  Celgene shall not take any
action which would adversely affect its standing or that of Pharmacy in the
pharmaceutical and/or health care industry; provided that nothing in this
Section 11.8 shall prevent Celgene from entering into agreements with other
specialty distributors of Product within the Territory, terminating this
Agreement pursuant to Section 12.2 or 12.3 or enforcing its rights under this
Agreement.

 

12.                               TERM AND TERMINATION

 

12.1                        Term.  This Agreement shall become effective on the
Effective Date and, unless earlier terminated in accordance with this
Section 12, shall continue in effect for an initial term ending on June 30,
2019.

 

12.2                        Voluntary Termination.  Either party may terminate
this Agreement for convenience at any time upon at least ninety (90) days’ prior
written notice to the other party.

 

12.3                        Termination for Breach.  Either party may terminate
this Agreement (i) for a material breach by the other party upon fifteen (15)
days’ prior written notice unless the breaching party cures the breach within
such fifteen (15) day period or (ii) in the event of any proceedings, voluntary
or involuntary, in bankruptcy or insolvency, by or against the other party, or
the appointment, with or without such other party’s consent, of a receiver for
such other party.

 

12.4                        Transition.  Upon the expiration or earlier
termination of this Agreement, as applicable, the parties shall begin to
transition distribution of Product for Pharmacy’s Customers to a party to be
designated by Celgene.  Transition of distribution under this Section 12.4 shall
mean the following:

 

(a)                                 Celgene shall as soon as practicable begin
referring Pharmacy Customers who contact Celgene’s Customer Service Department
to a new designated distributor.

 

(b)                                 At Celgene’s request, Pharmacy shall provide
notice to all of Pharmacy Customers of the change in distributors.

 

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(c)                                  Pharmacy shall complete any Product
shipments then underway, but otherwise shall refer Customers to the
Celgene-designated distributor.

 

(d)                                 Pharmacy shall transfer a copy of the
Database and Customer information, including prescription files, to the
Celgene-designated distributor, provided that if applicable patient
confidentiality laws prohibit transfer of Customers’ names to such distributor,
Pharmacy shall transfer the Database and Customer information using Customer
numbers instead of names, and shall notify Customers of their respective
numbers.

 

(e)                                  Pharmacy’s obligation to order additional
Product when its inventory falls to a one (1) week supply shall cease and
Celgene shall repurchase any Product held in inventory by Pharmacy on the date
of termination at the price paid for the Product by Pharmacy.

 

After (a) expiration of this Agreement or (b) upon the sending or receiving of
any termination notice by Pharmacy in accordance with the terms hereof and
(c) for a period of six (6) months after the event described in (a) or (b), as
applicable, Pharmacy shall use commercially reasonable efforts to cooperate with
Celgene in ensuring the smooth transition of the services provided by Pharmacy
under this Agreement to any other distributor(s) designated by Celgene, provided
that after the expiration or the effective date of any termination of this
Agreement, as applicable, Celgene shall reimburse Pharmacy for its reasonable
out-of-pocket, non-personnel-related expenses associated with such cooperation.

 

12.5                        Survival.  Sections 6 , 7, 8, 9, 10.3, 10.8, 10.9,
10.10, 10.12, 10.13, 11.1, 11.4, 11.5, 11.8, 12.4, 12.5, 13, 14, 15 and 17 shall
survive termination or expiration of this Agreement for as long as necessary to
permit their full discharge.

 

13.                               REGULATORY INSPECTIONS, INVESTIGATIONS, AUDITS

 

13.1                        Regulatory Inspections.  Pharmacy shall provide to
the applicable Regulatory Authority or, at Celgene’s request, shall provide to
Celgene all available documents and information requested by any Regulatory
Authority or by Celgene in support of its regulatory filings.  Copies of all
documents to be provided to the applicable Regulatory Authority shall be
provided to Celgene in advance, if practicable, or otherwise within two
(2) business days of delivery to Regulatory Authority.  Pharmacy shall notify
Celgene immediately upon receipt of notice of any inspection by any Regulatory
Authority directed specifically toward Product, and Celgene shall have the right
to have an employee(s) and/or agent(s) present at any such inspection, if
allowed by law.  Pharmacy shall notify Celgene immediately of any notices,
requests for information or other communications related to Product from the
U.S. Department of Health and Human Services or any other Regulatory Authority
or any state healthcare program or other state agency and, to the extent
permitted under applicable law, shall promptly give Celgene copies of such
communications.

 

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13.2                        Recalls, Returns or Investigations.  Pharmacy shall
provide Celgene, at Celgene’s request, any information reasonably required in
connection with Celgene investigations relating to recalled or returned Product
or any requests or investigations by or filings with any applicable Regulatory
Authority, including without limitation the FDA, or in support of Celgene’s
applications to the FDA.  Pharmacy shall respond within two (2) business days to
any reasonable request for information by Celgene.

 

13.3                        Celgene Right to Audit.  Throughout the Term and for
a period of three (3) years following expiration or earlier termination of this
Agreement, Pharmacy shall maintain complete and accurate records consistent with
requirements of the REVLIMID REMS®, POMALYST REMS®, and THALOMID REMS ®
program(s) and sales of Product.  First audits will occur within 3 months of a
Pharmacy’s first dispense of REVLIMID®, POMALYST®, and THALOMID®, then an annual
risk-based audit thereafter.

 

13.4                        Inspection.  Applicable records shall be made
available for inspection at Pharmacy for three (3) years from the date of the
initial Product receipt.  Celgene and its representatives will not be required
to sign additional non-disclosure or confidentiality agreements.  Celgene and
its representatives shall have the right to periodically visit Pharmacy and its
Dispensing Sites during regular business hours, during the Term and for a period
of three (3) years thereafter, upon reasonable prior notice to
Pharmacy/Dispensing Site.  During any such visit, Celgene and its
representatives will have the right to (i) examine the books, ledgers and
records, including inventory levels, of Pharmacy related to Celgene Product
sales, (ii) audit quality control/assurance procedures, registrations, shipping
records, supplements and regulatory correspondence to ensure that
Pharmacy/Dispensing Site is in compliance with the SOPs and with applicable
regulations, the Requirements Document or other procedures required by Celgene. 
The audit shall also include Celgene’s ability to interview Pharmacy’s Certified
Counselors/Certified Pharmacists, monitor the Enhanced Services being provided,
as well as access Pharmacy’s computer systems used to provide Enhanced Services
for Celgene pursuant to this Agreement; provided that such access to Pharmacy’s
computer systems used to provide Enhanced Service shall be limited in a manner
to prevent the auditor from accessing Protected Health Information (as defined
under the Health Insurance Portability and Accountability Act).  Pharmacy shall
take a course of action and resolution acceptable to Celgene in the event that
Celgene finds any contractual or regulatory deficiencies during such audits. 
Each party shall bear its own costs of such examinations.

 

14.                               INDEMNIFICATION

 

14.1                        Celgene Indemnification of Pharmacy.  Celgene shall
at all times during the Term and thereafter defend, indemnify and hold Pharmacy
and its officers, directors, agents and employees harmless from and against any
and all claims, suits, damages, liabilities, costs and expenses, including but
not limited to court costs and reasonable attorneys’ fees (collectively,
“Claims”), incurred in connection with any third-party claim arising out of the
use of any Product by a Customer, except to the extent caused by (i) the
negligence or intentional misconduct of Pharmacy or any of its officers,
directors, agents or employees or (ii) breach by Pharmacy of any of the terms of
this Agreement or (iii) acts of Pharmacy

 

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or any of its officers, directors, agents or employees which are outside the
scope of this Agreement.

 

14.2                        Pharmacy Indemnification of Celgene.  Pharmacy shall
at all times during the Term and thereafter defend, indemnify and hold Celgene
and its officers, directors, agents and employees harmless from and against any
and all Claims incurred in connection with any third-party claim arising out of
(i) the negligence or intentional misconduct of Pharmacy or any of its officers,
directors, agents or employees, (ii) breach by Pharmacy of any of the terms of
this Agreement, or (iii) acts of Pharmacy or any of its officers, directors,
agents or employees which are outside the scope of this Agreement.

 

14.3                        Procedures.  A party that intends to seek
indemnification under this Section 14 (the “indemnitee”) shall notify the other
party (the “indemnitor”) promptly in writing of any Claim in respect of which
the indemnitee believes it is entitled to claim indemnification, provided that
the failure to give timely notice to the indemnitor shall not release the
indemnitor from any liability to the indemnitee, except to the extent the
indemnitor is prejudiced thereby.  The indemnitor shall have the right, by
notice to the indemnitee, to assume the defense of any such Claim within ten
(10) days after the indemnitor’s receipt of notice of any Claim with counsel of
the indemnitor’s choice and at the sole cost of the indemnitor.  If the
indemnitor so assumes such defense, the indemnitee may participate therein
through counsel of its choice, but at the sole cost of the indemnitee; provided,
however, that the indemnitor shall be obligated to pay fees and expenses of such
indemnitee’s counsel if representation of the indemnitee by the counsel retained
by the indemnitor would be inappropriate due to actual or potential conflicting
interests between the indemnitee and any other party represented by such counsel
in the investigation and defense of any such Claim.  The party not assuming the
defense of any such Claim shall render all reasonable assistance to the party
assuming such defense, and all reasonable out-of-pocket costs of such assistance
shall be for the account of the indemnitor.  No such Claim shall be settled
other than by the party defending the same, and then only with the consent of
the other party which shall not be unreasonably withheld; provided that the
indemnitee shall have no obligation to consent to any settlement of any such
Claim which imposes on the indemnitee any liability or obligation which cannot
be assumed and performed in full by the indemnitor, and the indemnitee shall
have no right to withhold its consent to any settlement of any such Claim if the
settlement involves only the payment of money by the indemnitor or its insurer.

 

15.                               CONFIDENTIALITY

 

15.1                        Pharmacy Obligation.  Pharmacy agrees to treat any
confidential or proprietary information obtained from Celgene and any
confidential or proprietary information generated by Pharmacy in performing its
obligations under this Agreement, including Customer lists, information
regarding Celgene’s pricing policies, information regarding reimbursement for
the Product, information regarding the cost of providing services to Celgene and
the information in the Database, and anything derived therefrom, (collectively,
the “Celgene Information”) as the confidential and exclusive property of
Celgene, and agrees not to disclose any of the Celgene Information to any third
party without first obtaining the written consent of Celgene.  Pharmacy agrees
that it will use the Celgene Information

 

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only for purposes of performing its obligations hereunder and for no other
purpose without the prior written consent of Celgene.  Pharmacy further agrees
to take all practicable steps necessary to ensure that the Celgene Information
(i) will be maintained in strict confidence, (ii) will not be disclosed to any
third party except as expressly permitted herein, and (iii) will not be
disclosed to or used by its directors, officers, employees or agents except
pursuant to a written agreement with terms no less strict than those terms of
confidentiality as aforesaid, set forth in this Section 15 and will be kept
confidential by them.

 

The above provisions of confidentiality shall not apply to that part of the
Celgene Information which Pharmacy is able to demonstrate by competent
documentary evidence:

 

(a)                                 was in Pharmacy’s possession prior to
receipt from Celgene and prior to being generated under this Agreement;

 

(b)                                 was in the public domain at the time of
receipt from Celgene;

 

(c)                                  became part of the public domain through no
fault of Pharmacy, its directors, officers, employees or agents;

 

(d)                                 was lawfully received by Pharmacy from a
third party not disclosing the
information on behalf of Celgene and having a right of further disclosure; or

 

(e)                                  is required to be disclosed by law or
regulation applicable to Pharmacy, provided that Pharmacy gives prompt notice to
Celgene that it is required to make such disclosure so that Celgene can take
steps to limit the scope of the Celgene Information disclosed or otherwise to
protect the Celgene Information, and provided further that Pharmacy limits such
disclosure of the Celgene Information to the maximum extent practicable.

 

Specific aspects or details of the Celgene Information shall not be deemed to be
within the public domain or in the possession of Pharmacy merely because the
Celgene Information is embraced by general disclosures in the public domain or
in the possession of Pharmacy.  In addition, any combination of Celgene
Information shall not be considered in the public domain or in the possession of
Pharmacy merely because individual elements thereof are in the public domain or
in the possession of Pharmacy unless the combination and its principles are in
the public domain or in the possession of Pharmacy.

 

Pharmacy agrees that, at Celgene’s request, it shall return to Celgene all parts
of the Celgene Information existing in documentary form, not including Pharmacy
records, and will, at Celgene’s request, return or destroy any copies thereof
made by Pharmacy, its directors, officers, employees or agents, except that
Pharmacy shall retain a copy of the Database subject to the ongoing obligations
of confidentiality set forth in this Section 15.  Pharmacy shall not dispose of
the information in the Database without first offering in writing, given at
least five (5) business days prior to such disposal, to deliver such information
to Celgene, at Celgene’s expense, without additional consideration.

 

21

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15.2                        Celgene Obligation.  Celgene agrees to treat any
confidential or proprietary information obtained from Pharmacy, (not including
the Database and information about insurers’ reimbursement policies with respect
to Product) and anything derived therefrom, (collectively, the “Pharmacy
Information”) as the confidential and exclusive property of Pharmacy, and
Celgene agrees not to disclose any of the Pharmacy Information to any third
party without first obtaining the written consent of Pharmacy, provided that
Celgene may disclose Pharmacy Information to any third party providing
reimbursement-related services to Celgene as long as the third party is
obligated to Pharmacy to keep such information confidential.  Celgene agrees
that it will use any Pharmacy Information only for purposes of activities
contemplated hereunder and for no other purpose without the prior written
consent of Pharmacy.  Celgene further agrees to take all practicable steps
necessary to ensure that the Pharmacy Information (i) will be maintained in
strict confidence, (ii) will not be disclosed to any third party except as
expressly permitted herein, and (iii) will not be disclosed to or used by its
directors, officers, employees or agents except pursuant to a written agreement
with terms no less strict than those set forth in this Section 15.

 

The above provisions of confidentiality shall not apply to that part of the
Pharmacy Information which Celgene is able to demonstrate by competent
documentary evidence:

 

(a)                                 was in Celgene’s possession prior to receipt
from Pharmacy;

 

(b)                                 was in the public domain at the time of
receipt from Pharmacy;

 

(c)                                  became part of the public domain through no
fault of Celgene, its directors, officers, employees or agents;

 

(d)                                 was lawfully received by Celgene from a
third party not disclosing the information on behalf of Pharmacy and having a
right of further disclosure; or

 

(e)                                  is required to be disclosed by law or
regulation applicable to Celgene provided that Celgene gives prompt notice to
Pharmacy that it is required to make such disclosure so that Pharmacy can take
steps to limit the scope of the Pharmacy Information disclosed or otherwise to
protect the Pharmacy Information, and provided further that Celgene limits such
disclosure of the Pharmacy Information to the maximum extent practicable.

 

Specific aspects or details of the Pharmacy Information shall not be deemed to
be within the public domain or in the possession of Celgene merely because the
Pharmacy Information is embraced by general disclosures in the public domain or
in the possession of Celgene.  In addition, any combination of Pharmacy
Information shall not be considered in the public domain or in the possession of
Celgene merely because individual elements thereof are in the public domain or
in the possession of Celgene unless the combination and its principles are in
the public domain or in the possession of Celgene.

 

Celgene agrees that, at Pharmacy’s request, it shall return to Pharmacy all
parts of the Pharmacy Information existing in documentary form and will, at
Pharmacy’s request,

 

22

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return or destroy any copies thereof made by Celgene, its directors, officers or
employees.

 

15.3                        No Implied Licenses.  Nothing contained herein shall
be deemed to grant to either party any rights or licenses under any patent
applications or patents or to any know-how, technology, inventions or other
intellectual property rights of the other party.

 

15.4                        Publicity.  Each party shall be permitted to make
such public statements regarding its relationship with the other party as may be
required by law or regulation or by obligations pursuant to any listing
agreement with any securities exchange.  Pharmacy shall not disclose the terms
of this Agreement to any third party or, except as expressly set forth in this
Section 15, make any public announcement of the existence of its relationship
with Celgene without the prior written consent of Celgene except to its auditors
and lawyers or as required by law.

 

15.5                        Length of Obligation.  The obligations of the
parties under this Section 15 shall continue during the Term and for a period
ending five (5) years after the expiration or earlier termination thereof.

 

16.                               INSURANCE

 

Pharmacy agrees (i) to obtain and maintain, while this Agreement is in effect,
(a) commercial general liability insurance, including product liability
insurance, and Pharmacists professional liability insurance, each with coverage
limits of not less than $1,000,000 per occurrence and $3,000,000 in the
aggregate, and (ii) not to cancel the insurance or reduce the coverage without
giving at least thirty (30) days’ prior written notice to Celgene.  Pharmacy
shall cause Celgene to be provided notice on each insurance policy such that
Celgene shall receive notice of any cancellation or change in the policy.  At
the request of Celgene, Pharmacy shall provide Celgene with a copy of a
certificate of insurance to verify that insurance with the required coverage is
in effect.  All policies should be placed with an insurer with financial ratings
of at least A- or better.

 

17.                               MISCELLANEOUS

 

17.1                        Notices.  Any notice required by this Agreement
shall be given by prepaid, first class, certified mail, return receipt
requested, or by air or other overnight courier, hand delivery or facsimile, or
email provided that an original printed copy is also transmitted by any one of
the methods prescribed in this sentence, to the parties at the addresses set
forth below (or at such other address as either party may from time to time
notify the other party in writing), provided, however, that updates and/or
notice of updates to the Requirements Document or REMS may be communicated by
Celgene to Pharmacy by email without requiring any subsequent provision of a
printed notice.  Notices:

 

if to Celgene:
                                                                                                                      
Celgene Corporation

86 Morris Avenue

Summit, NJ 07901

Attention: Greg Walls

 

23

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with a copy to:
                                                                                                             
Celgene Corporation

86 Morris Avenue

Summit, NJ 07901

Attention: Legal Department

 

if to Pharmacy:
                                                                                                         
DIPLOMAT PHARMACY, INC. d/b/a

DIPLOMAT SPECIALTY PHARMACY

4100 South Saginaw Street

Flint, MI 48507

Attention: General Counsel

 

With a copy to:
                                                                                                          
DIPLOMAT PHARMACY, INC. d/b/a

DIPLOMAT SPECIALTY PHARMACY

4100 South Saginaw Street

Flint, MI 48507

Attention: Corporate Services, Contract Management

 

Any notice sent under this Section shall be deemed delivered within five
(5) days if sent by mail and within twenty-four (24) hours if sent by fax,
courier or hand delivery.  In the event that any Section or subsection of this
Agreement requires the notice contemplated therein to be sent to a different
notice party and/or address, then that notice and/or address shall apply in lieu
of the notice party and/or address in this Section, but the remainder of this
Section shall apply.

 

17.2                        Force Majeure.  In the event a party (the “Affected
Party”) shall be delayed or hindered in or prevented from the performance of any
act required under this Agreement by reasons of fires, flood, earthquakes,
accidents, explosions, sabotage, strikes, or other labor disturbances
(regardless of the reasonableness of the demands of labor), civil commotions,
riots, invasions, wars, acts, restraints, requisitions, regulations, or
directions of governmental authorities, shortages of labor, fuel, power, or raw
material, inability to obtain equipment or supplies, inability to obtain or
delays in transportation, acts of God, or any other cause beyond its reasonable
control (“Force Majeure”), then upon notice to the other party (the “Other
Party”) performance of such act shall be excused for the period of such delay. 
Notice of the start and stop of any such Force Majeure and the nature and
expected duration thereof shall be provided to the other party promptly
following the occurrence thereof.  The Affected Party shall use all commercially
reasonable efforts to perform its obligations under this Agreement.  In the
event Force Majeure renders the Affected Party unable to perform its obligations
under this Agreement for a period of ten (10) consecutive days or the aggregate
of thirty (30) days in any twelve (12) month period, the Other Party may
terminate this Agreement without penalty immediately upon written notice of
termination to the Affected Party.

 

17.3                        Binding Effect / No Amendments Unless in Writing. 
This Agreement shall be binding upon and shall inure to the benefit of the
parties hereto and their permitted successors and permitted assigns.  No
agreements amending, altering or supplementing the terms hereof may be made
except by means of a written document signed by the duly authorized
representatives of both parties.

 

24

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17.4                        No Assignment/No Transfer Without Celgene’s
Consent.  This Agreement shall be personal to Pharmacy.  Pharmacy shall not
assign, sell, or otherwise transfer any of its rights and obligations
(including, but not limited to, by operation-of-law, mergers, transfer of
assets, change-of-ownership, or change-of-control) under this Agreement without
the prior written consent of Celgene, which Celgene may grant or deny in its
sole and absolute discretion.  In the event Pharmacy attempts or otherwise
enters into any agreement to assign, sell, or otherwise transfer this Agreement
or any of its rights or obligations under this Agreement by way of any agreement
or transaction which may involve any merger, transfer of assets,
change-of-ownership, change-of-control or the like, Celgene shall have the right
to immediately terminate this Agreement.

 

17.5                        No Deemed Waiver.  Failure of either party to
enforce a right under this Agreement shall not act as a waiver of that right or
the ability to later assert that right relative to the particular situation
involved or to terminate this Agreement as a result of any subsequent default or
breach.

 

17.6                        No Publicity.  Except as required by law, neither
party shall use the name, logos, marks or trade names of the other party (or its
affiliates) of the other party or of any employee of the other party in
connection with any press release, public announcement or publicity without the
prior written approval of the other party.  The obligations in this section
shall survive expiration or termination of the Agreement.

 

17.7                        Severability.  If any provision of this Agreement
shall be found by a court to be void, invalid or unenforceable, the same shall
either be reformed to comply with applicable law or stricken if not so
conformable, so as not to affect the validity or enforceability of this
Agreement, except if the principal intent of the Agreement is frustrated by such
reformation or deletion in which case this Agreement shall terminate.

 

17.8                        Independent Parties.  The parties are, and shall be
deemed to be, independent contractors and not agents or employees of the other
party.  Neither party shall have authority to make any statements,
representations or commitments of any kind, or to take any action, which shall
be binding on the other party.

 

17.9                        Counterparts.  This Agreement may be executed in one
or more counterparts, which taken together will constitute the one and the same
Agreement, between the parties hereto.

 

17.10                 Headings.  Headings and section numbers included herein
are for convenience only, and shall not be used to construe this Agreement.

 

17.11                 Governing Law.  This Agreement shall be construed and
enforced in accordance with the laws of the state of New Jersey, without giving
effect to its conflicts of law principles.

 

17.12                 Schedules/Attachments.  As of the Effective Date of this
Agreement the following schedules, exhibits and/or attachments are attached to
this Agreement:

 

·                                          Schedule 1.8 — Pharmacy Dispensing
Site List

·                                          Schedule 1.17 — Requirements Document

 

25

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·                                          Schedule 2.3 — Sample Inventory

·                                          Schedule 5.1 — Data Reports

·                                          Schedule 6.1 — Performance Metrics

·                                          Schedule 7.1 — Return Goods Policy

·                                          Schedule 8.1 — Adverse Drug
Experience Reporting Form

·                                          Schedule 8.2 — Complaints Form

·                                          Schedule 10.3 — Medicaid Program List

 

17.13                 Entire Agreement.  This Agreement, together with the
attached schedules, exhibits and/or other attachments, constitutes the entire
and only agreement between the parties relating to the subject matter hereof. 
Any and all other prior or contemporaneous negotiations, discussions,
understandings, documents or agreements, are no longer of any force or effect,
and are superseded by this Agreement.  In the event of any conflict or
inconsistency between the terms and conditions of this Agreement and any other
document agreement concerning the subject matter hereof, the terms and
conditions of this Agreement shall control.

 

[REMAINDER OF THIS PAGE LEFT BLANK, EXECUTION PAGE FOLLOWS]

 

26

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[EXECUTION PAGE TO AGREEMENT]

 

THIS AGREEMENT WILL NOT BE CONSIDERED ACCEPTED, APPROVED, OR OTHERWISE EFFECTIVE
UNTIL THE SIGNATURE OF EACH PARTY IS AFFIXED IN THE SPACE PROVIDED BELOW.

 

A FULLY EXECUTED AGREEMENT MUST BE RETURNED TO, AND RECEIVED BY, CELGENE BY NO
LATER THAN MAY 31, 2017 OTHERWISE CELGENE RESERVES THE RIGHT TO RE-EVALUATE THE
TERMS AND CONDITIONS OF THE AGREEMENT, INCLUDING BUT NOT LIMITED TO DECLARING
THIS AGREEMENT NULL AND VOID.

 

IN WITNESS WHEREOF, the parties have executed and entered into this Agreement as
of the Effective Date first above written.

 

 

DIPLOMAT PHARMACY, INC. d/b/a

CELGENE CORPORATION

 

DIPLOMAT SPECIALTY PHARMACY

 

 

 

 

By:

/s/ James Kilgallon

 

By:

/s/ Gary Rice

 

 

 

 

 

Name:

James Kilgallon

 

Name:

Gary Rice

 

 

 

 

 

Title:

Exec. Dir. Pricing & Contracting

 

Title:

EVP, Operations

 

 

 

 

 

Date:

3/31/2017

 

Date:

3/8/2017

 

 

 

 

 

Legal:

rorlitta@celgene.com

 

 

 

 

2017.03.10 13:45:02 -05’00’

 

 

 

 

[g88651ki05i001.gif]

 

27

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SCHEDULE 1.8

 

PHARMACY DISPENSING SITE LIST

 

Diplomat Specialty Pharmacy- Michigan

NPI: 1427250448 NCPDP: 2369797 DEA: FD0286244

4100 South Saginaw Street, Suite D

Flint, MI 48507-2683

P: 810-768-9000 F: 810-281-0158

 

Diplomat Specialty Pharmacy- Michigan

NPI: 1558307462 NCPDP: 2321052 DEA: AD6448446

G-3320 Beecher Road,

Flint, MI 48532-3614

P: 810-732-8720 F: 810-732-2580

 

Diplomat Specialty Pharmacy- Florida

NPI: 1548375181 NCPDP: 1093929 DEA: FD0417825

500 SE 15th Street, Suite 102

Ft. Lauderdale, FL 33316-1952

P: 954-527-0440 F: 954-527-0940

 

Diplomat Specialty Pharmacy- Illinois

NPI: 1780605741 NCPDP: 1478189 DEA: BD9628542

1370 Busch Parkway,

Buffalo Grove, IL 60089-4505

P: 847-229-4141 F: 866-700-6500

 

Diplomat Specialty Pharmacy- California

NPI: 1659479632 NCPDP: 0574764 DEA: FD1746835

1809 Excise Ave. Suite 205-208

Ontario, CA 91761-8559

P: 909-881-1728 F: 877-336-7052

 

28

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SCHEDULE 1.17

 

REVLIMID®, POMALYST®, and THALOMID®

 

REQUIREMENTS DOCUMENT

 

1.                                      BACKGROUND

 

1.1.                            REVLIMID®

 

REVLIMID® is approved by the United States Food and Drug Administration (FDA).

 

REVLIMID® is a thalidomide analogue, a known teratogen that causes severe birth
defects or embryo-fetal death.

 

REVLIMID® is indicated for the treatment of patients with:

 

·                                          Multiple myeloma (MM), in combination
with dexamethasone.

·                                          Transfusion-dependent anemia due to
low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a
deletion 5q abnormality with or without additional cytogenetic abnormalities.

·                                          Mantle cell lymphoma (MCL) whose
disease has relapsed or progressed after two prior therapies, one of which
included bortezomib.

 

Limitations of Use:

REVLIMID® is not indicated and is not recommended for the treatment of patients
with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

 

MM: The recommended starting dose of REVLIMID® is 25 mg orally once daily on
Days 1-21 of repeated 28-day cycles in combination with dexamethasone.

 

MDS: The recommended starting dose is 10 mg daily.

 

MCL: The recommended starting dose of REVLIMID® is 25 mg/day orally on Days 1-21
of repeated 28-day cycles.

 

REVLIMID® is available in 2.5 mg (white and blue-green opaque), 5 mg (white
opaque), 10 mg (blue/green and pale yellow opaque), 15 mg (powder blue and white
opaque), 20 mg (powder blue and blue-green opaque), and 25 mg (white opaque)
capsules.

 

29

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2.                                      BACKGROUND

 

2.1.                            POMALYST®

 

POMALYST® is approved by the United States Food and Drug Administration (FDA).

 

POMALYST® is a thalidomide analogue, a known teratogen that causes severe birth
defects or embryo-fetal death.

 

POMALYST® is a thalidomide analogue indicated, in combination with
dexamethasone, for patients with multiple myeloma who have received at least two
prior therapies including lenalidomide and a proteasome inhibitor and have
demonstrated disease progression on or within 60 days of completion of the last
therapy.

 

The recommended starting dose of POMALYST® is 4 mg per day taken orally on Days
1-21 of repeated 28-day cycles until disease progression. POMALYST® should be
given in combination with dexamethasone.

 

POMALYST® is available in 1 mg (dark blue and yellow opaque), 2 mg (dark blue
and orange opaque), 3 mg (dark blue and green opaque), and 4 mg (dark blue and
blue opaque) capsules.

 

3.                                      BACKGROUND

 

3.1.                            THALOMID®

 

THALOMID® is approved by the United States Food and Drug Administration (FDA).

 

THALOMID® is a known teratogen that causes severe birth defects or embryo-fetal
death.

 

THALOMID® is indicated for the treatment of patients with:

 

·                                          THALOMID® in combination with
dexamethasone is indicated for the treatment of patients with newly diagnosed
multiple myeloma (MM).

·                                          THALOMID® is indicated for the acute
treatment of the cutaneous manifestations of moderate to severe erythema nodosum
leprosum (ENL).

·                                          THALOMID® is not indicated as
monotherapy for such ENL treatment in the presence of moderate to severe
neuritis.

·                                          THALOMID® is also indicated as
maintenance therapy for prevention and suppression of the cutaneous
manifestations of ENL recurrence.

 

MM: 200 mg orally once daily. The recommended dose of dexamethasone is 40 mg/day
on days 1-4, 9-12, and 17-20 every 28 days.

 

ENL: 100 to 300 mg/day for an episode of cutaneous ENL. Up to 400 mg/day for
severe cutaneous ENL.

 

THALOMID® is available in 50 mg (white opaque), 100 mg (tan), 150 mg capsules
(tan and blue), and 200 mg (blue) capsules.

 

30

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4.                                      RISK EVALUATION AND MITIGATION STRATEGY

 

4.1.                            OVERVIEW

 

REVLIMID®, POMALYST®, AND THALOMID® are contraindicated in pregnancy.
Thalidomide is a known teratogen that causes severe birth defects or
embryo-fetal death. REVLIMID® and POMALYST® are analogues of thalidomide.

 

Celgene addresses the risks of REVLIMID®, POMALYST®, AND THALOMID® therapy not
only through normal pharmacovigilance, but also through FDA-mandated Risk
Evaluation and Mitigation Strategies, which include, among other things, the
restricted distribution programs REVLIMID REMS®, POMALYST REMS®, and THALOMID
REMS®.

 

The REVLIMID REMS®, POMALYST REMS®, and THALOMID REMS® programs controls
distribution of REVLIMID®, POMALYST®, AND THALOMID® through certified
pharmacies. The REVLIMID REMS®, POMALYST REMS®, AND THALOMID REMS® programs
require education by telephone or in-person by trained, Certified Counselors who
are licensed healthcare professionals, such as Nurses (“RNs”), Nurse
Practitioners (“NPs”), Licensed Practical Nurses (“LPNs”), Pharmacists
(“R.Ph,”), Pharmacy Interns, Physicians (“M.D.”), Doctors of Osteopathy
(“D.O.”), and Physician Assistants (“P.A.”), before a prescription of REVLIMID®,
POMALYST®, and/or THALOMID® can be dispensed by direct-shipment to a patient or
the product is picked-up at the pharmacy. Education is the key component of the
REVLIMID REMS®, POMALYST REMS®, AND THALOMID REMS® programs.

 

4.2.                            DEFINITION

 

A Risk Evaluation and Mitigation Strategy (“REMS”) is a strategy to manage a
known or potential serious risk associated with a drug or biological product. A
REMS program can include a Medication Guide, Patient Package Insert, a
communication plan, elements to assure safe use, and an implementation system,
and must include a timetable for assessment of the REMS.

 

4.3.                            CURRENT GOALS

 

Consistent with Title IX of Subtitle A of the Food and Drug Administration
Amendments Act (“FDAAA”) Celgene Corporation has proposed the following REMS
goals for REVLIMID®, POMALYST®, AND THALOMID® in each of the REVLIMID REMS®,
POMALYST REMS®, AND THALOMID REMS® programs.

 

The goals of each of the REVLIMID®, POMALYST®, AND THALOMID® risk evaluation and
mitigation strategies are as follows:

 

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·                                          To prevent the risk of embryo-fetal
exposure to REVLIMID®, POMALYST®, and/or THALOMID®

 

·                                          To inform prescribers, patients, and
pharmacists on the serious risks and safe-use conditions for REVLIMID®,
POMALYST®, and/or THALOMID®

 

4.4.                            REVLIMID REMS®, POMALYST REMS®, AND THALOMID
REMS® PROGRAMS PATIENT RISK CATEGORIES

 

The REVLIMID REMS®, POMALYST REMS®, AND THALOMID REMS® programs categorize
patients into six patient risk categories:

 

Female (4); and Male (2)

 

·                                          Adult female of reproductive
potential

·                                          Adult female not of reproductive
potential

·                                          Female child of reproductive
potential

·                                          Female child not of reproductive
potential

·                                          Adult Male

·                                          Male Child

 

What is a Female of Reproductive Potential (“FRP”)? An FRP is a female that:

·                                          Is menstruating

·                                          Is amenorrheic from previous medical
treatments

·                                          Is under 50 years of age

·                                          Is perimenopausal

·                                          Does not qualify for the adult female
or female child not of reproductive potential category

 

4.5.                            REVLIMID REMS®, POMALYST REMS®, and THALOMID
REMS® PROGRAMS PHARMACY BUSINESS REQUIREMENTS

 

4.5.1                     Pharmacy Certification

 

Pharmacies must have executed a Pharmacy Distribution and Services Agreement
(“Agreement”) with Celgene; completed a REVLIMID REMS®, POMALYST REMS®, AND
THALOMID REMS® program Pharmacy Inclusion Form; and successfully completed the
REVLIMID REMS®, POMALYST REMS®, AND THALOMID REMS® program training and
certification, in order to be certified with REVLIMID REMS®, POMALYST REMS®, AND
THALOMID REMS® programs.

 

All pharmacy distribution sites must be certified with the REVLIMID REMS®,
POMALYST REMS®, AND THALOMID REMS® programs.

 

32

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4.5.2                     Training/Certification for Counselors and Staff

 

Pharmacy manager responsibilities

 

·                                          Educate all staff regarding
dispensing guidelines, including floater pharmacists, pharmacy technicians, or
anyone else handling the product

·                                          Make sure counselors are registered
and certified in Compliance Wire and advise Celgene of inactive counselors

·                                          Complete and return all documentation
that pertains to non-compliance

 

Certified Counselors and Certified Pharmacists involved in dispensing REVLIMIW,
POMALYST®, and THALOMID®

 

·                  For counselors to be certified they are required to be
licensed healthcare professionals (See section 3.1). Counselors must complete
Adverse Drug Reaction Reporting training modules, and REVLIMID REMS®, POMALYST
REMS®, AND THALOMID REMS® program training via onsite training (for newly
certified sites), along with web based training modules, as may be required, to
receive certification (Certified Counselor/Certified Pharmacist)). Additional
personnel added to the program by a certified pharmacy must perform the web
based training to receive certification prior to counseling patients. All
Pharmacists involved in dispensing REVLIMID®, POMALYST®, and THALOMID® must
complete the same training as a Certified Counselor.

 

·                  All Certified Counselors are required to take the Adverse
Drug Reaction Reporting training modules and the REVLIMID REMS®, POMALYST REMS®,
and THALOMID REMS® programs Certification Exam on an annual basis in order to
maintain their certification status as counselors. Additionally, revised
training or additional training, based upon enhanced REVLIMID REMS®, POMALYST
REMS®, and THALOMID REMS® training requirements, or in response to identified
regulatory issues, may be deployed using web based training and all Certified
Counselors must complete the training by its scheduled due date in order to
maintain their Certified Counselor status.

 

·                  A score of one hundred percent (100%) is required to pass the
REVLIMID REMS®, POMALYST REMS®, AND THALOMID REMS® programs exam. If a Counselor
fails the REVLIMID REMS®, POMALYST REMS®, AND THALOMID REMS® programs exam 4
times they will be locked out and be required to contact Celgene Customer Care
and speak to a Risk & Compliance Specialist to request one additional attempt.
The 5th attempt resulting in failure, will be reported to the Account Executive
to provide additional training as needed.

 

The following table (Table 1: Certified Counselor Objectives and Tools) provides
an overview of the objectives and tools for the Certified Counselor.

 

[REMAINDER OF PAGE BLANK, TABLE 1 FOLLOWS]

 

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Table 1: Certified Counselor Objectives and Tools

 

Certified Counselor Objective

 

Tools

·             Completion of Celgene-sponsored training on REVLIMID®, POMALYST®,
and THALOMID® and REVLIMID REMS®, POMALYST REM®, and THALOMID REMS® programs to
be able to counsel on the safe and effective use of REVLIMID®, POMALYST®, and
THALOMID® annually

 

·             Warn and educate Females of Reproductive Potential and males that
REVLIMID®, POMALYST®, and/or THALOMID® can cause severe human birth defects and
embryo-fetal death. Females of Reproductive Potential must use 2 forms of
effective birth control at the same time or 4 weeks before, during, during dose
interruptions and 4 weeks after discontinuation of therapy. Male patients must
use a latex or synthetic condom as required in the REVLIMID REMS®, POMALYST
REM®, and/or THALOMID REMS® programs

 

·             Educate Females of Reproductive Potential of the requirements for
pregnancy testing as scheduled during therapy

 

·             Complete phone or in-person counseling with each patient, and
complete the REVLIMID REMS®, POMALYST REM®, and/or THALOMID REMS® programs
Education and Counseling Checklist prior to fulfillment of each prescription

 

·             Understand and counsel on the risks of deep venous thrombosis
(“DVT”) and pulmonary embolism (“PE”) with REVLIMID®, POMALYST®, and
THALOMID® treatment and myocardial infarction (“MI”) and stroke risk for
REVLIMID® and POMALYST®

 

·             Understand and counsel on the risk of neutropenia and
thrombocytopenia with REVLIMID® treatment

 

·             Specific training provided by Celgene to certified pharmacy

 

·             Pharmacy Guides to REVLIMID REMS®, POMALYST REM®, and THALOMID
REMS® programs

 

·             REVLIMID®, POMALYST®, and THALOMID® Prescribing Information

 

·             REVLIMID REMS®, POMALYST REM®, and THALOMID REMS® programs
Education and Counseling Checklists for Pharmacies

 

·             Adverse Drug Experience Reporting Procedure

 

·             Celgene Medical Information Services

 

34

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The physician and/or nurse and Certified Counselor/Certified Pharmacist will
work as a team to ensure that the patient is properly educated about the
potential risks associated with REVLIMID®, POMALYST® and/or THALOMID® treatment.

 

Training for pharmacy staff involved in dispensing REVLIMID®, POMALYST®, and
THALOMID®

 

·                                          Other Pharmacy staff involved in
dispensing REVLIMID®, POMALYST®, and THALOMID® under the REVLIMID REMS®,
POMALYST REMS®, AND THALOMID REMS® programs that are not Counselors or
Pharmacists must be educated on the dispensing guidelines and adverse event
reporting, and may be required to complete web based training as may be deemed
necessary by Celgene. These staff members must read the REVLIMID REMS®, POMALYST
REMS®, AND THALOMID REMS® programs pharmacy training and Adverse Drug Reaction
Reporting, and must sign and date the acknowledgment form (Please see: Figure 1)
indicating that that they have read and understand the trainings. A Certified
Counselor/Pharmacist or Diplomat training representative must also record and
either sign or have an electronic system to verify and acknowledge that they
reviewed the training staff member’s submitted training material to ensure the
staff member’s understanding and completion. Additionally, revised training or
additional training requirements, based on enhancements to training requirements
or in response to identified regulatory issues, may be required to read and
acknowledge.

 

4.5.3                     Guidelines for Dispensing REVLIMID®, POMALYST®, AND
THALOMID® (Please see Figure 2: Workflow for Dispensing REVLIMID®, POMALYST®,
and THALOMID®))

 

(1)                                 Fill valid prescriptions for REVLIMID®,
POMALYST®, and THALOMID® in accordance with REVLIMID REMS®, POMALYST REMS®, and
THALOMID REMS® programs and all applicable laws and regulations. Accept only
prescriptions with an authorization number and patient risk category. The
authorization number is a number issued by Celgene Customer Care to the
prescriber after the completion of patient counseling by the prescriber and the
prescriber survey.

 

(2)                                 Prescriptions with corresponding
authorization numbers are only valid for: (a) seven (7) days from the date of
the last pregnancy test for FRP; and, (b) thirty (30) days from the date issued
for all other patients. Prescriptions must be faxed, electronically transmitted
(state law permitting), or written prescriptions presented in person. Faxed and
written prescriptions must be signed and dated by the prescriber using ink.
Stamped signatures are not permitted. Telephone prescriptions are not permitted.
If a prescription does not have an authorization number and/or patient risk
category, the pharmacy can contact the prescriber or Celgene Customer Care,
obtain the authorization number and/or patient risk

 

35

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category over the phone and write it on the prescription or include in
electronic pharmacy records that can be linked to the original prescription, and
is easily retrievable during a Celgene audit or as requested by Celgene. If the
authorization number is available, but the patient risk category is missing, the
Celgene web portal (if available) can provide the patient risk category. The
pharmacist or designee will need to sign, date, and obtain name and title of
person who provided the information, document on the hard copy of the
prescription or in electronic pharmacy records that can be linked to the
original prescription.

 

(3)                                 Contact the patient through a Certified
Counselor to provide the required counseling and to verify the shipping address.
Before dispensing REVLIMID®, POMALYST®, or THALOMID®, a Certified Counselor will
be required to complete the REVLIMID REMS®, POMALYST REMS®, or THALOMID
REMS® programs Education and Counseling Checklist for Pharmacies (ECCP). (Please
see: Figure 3) Certified Counselors/Certified Pharmacists are expected to use
the most recently approved version of the ECCP when updates occur. Celgene will
communicate these updates to Certified Pharmacies.

 

(4)                                 Obtain confirmation number from Celgene by
calling Celgene Customer Care Center at 1-888-423-5436 to use the IVR system 24
hours a day, 7 days a week, or speak to a live representative during business
hours. Confirmation numbers can also be obtained through the Celgene web portal
(if available.) Provide the following information to obtain a confirmation
number:

 

(a)                                 NCPDP# or DEA#

 

(b)                                 Authorization number written on prescription

 

(c)                                  Milligram strength and number of capsules
being dispensed

 

(5)                                 Celgene Customer Care Center will provide a
confirmation number once the authorization number has been verified. Write the
confirmation number on the prescription and date it, or include in pharmacy
electronic records that can be linked to the original prescription. The
confirmation number is valid for 24-hours once it is obtained from Celgene.

 

(6)                                 Dispense no more than a 4-week (28-day)
supply with no refills, along with the FDA approved MEDICATION GUIDE. A new
prescription is required for subsequent dispenses.

 

(7)                                 Dispense subsequent prescriptions only if 7
days or less of therapy remaining on the current prescription.

 

36

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(8)                                 In the event that the patient cannot be
contacted or does not have access to a phone:

 

(a)                                 Contact the Certified Prescriber; and

 

(b)                                 Call and counsel patient in Certified
Prescriber’s office after prescription has been faxed.

 

(9)                                 Do not transfer REVLIMID®, POMALYST®, or
THALOMID® inventory to another Pharmacy without prior permission from Celgene.
Prescription transfers are allowed to be faxed to another pharmacy in the
REVLIMID REMS®, POMALYST REMS®, AND THALOMID REMS® programs network (state law
permitting) if the original pharmacy is not in the patient’s insurance network.

 

(10)                          Educate ALL STAFF involved in filling REVLIMID®,
POMALYST®, and THALOMID® prescriptions about the dispensing procedures and
document as per training requirements listed in Section 4.5.2 above.

 

(11)                          Keep a record of the prescription and REVLIMID
REMS®, POMALYST REMS®, and THALOMID REMS® programs Education and Counseling
Checklist with each REVLIMID®, POMALYST®, and THALOMID® prescription.
Alternatively, the checklist and prescription can be linked to each other
electronically in Pharmacy’s computer system. If Pharmacy uses an electronic
Education and Counseling Checklist, it must be identical to the paper version
(including all required elements from the paper form) provided by Celgene.

 

(12)                          The FDA approved MEDICATION GUIDE must be included
with EACH filled prescription.

 

4.5.4                     Shipping Requirements

 

·                                          To avoid delays in the start of
therapy, Product must be provided to patients as follows:

 

·                                          Females of Reproductive Potential
(High Risk) — Product must be shipped the same day the confirmation number is
obtained or picked-up within twenty four (24) hours of obtaining the
confirmation number.

 

·                                          All other risk categories — Product
must be shipped within twenty four (24) hours of obtaining the confirmation
number or picked-up within twenty four (24) hours of obtaining the confirmation
number.

 

·                                          Use appropriate packing materials to
protect the Product in transit

 

37

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·                                          Track each shipment to ensure on-time
delivery

 

·                                          Ship all packages for all patient
risk categories Monday through Friday utilizing next calendar day delivery
SIGNATURE REQUIRED.

 

·                                          All shipments for FRP are required to
ship for next calendar day delivery on the first attempt. For all FRP, all
shipments on Fridays must be shipped for Saturday delivery with SIGNATURE
REQUIRED.

 

·                                          For all Male patients and all non-FRP
female patients, all shipments on Fridays may be shipped for either Saturday
delivery with SIGNATURE REQUIRED or Monday delivery with SIGNATURE REQUIRED.

 

IN ADDITION TO THE FOREGOING, PHARMACY MUST CANCEL THE CONFIRMATION NUMBER IF
THE SHIPMENT IS “UNDELIVERABLE.” FOR PURPOSES OF THIS PARAGRAPH “UNDELIVERABLE”
SHALL MEAN DELIVERY HAS BEEN ATTEMPTED BY THE CARRIER (UPS, FEDEX, ETC.) AND
CARRIER WAS UNABLE TO DELIVER THE SHIPMENT AFTER 3 ATTEMPTS AT DELIVERY. THE
SHIPMENT SHALL BE RETURNED TO THE PHARMACY AS “UNDELIVERABLE”. ONCE THE SHIPMENT
IS RETURNED TO THE PHARMACY AS “UNDELIVERABLE”, PHARMACY MUST CONTACT CELGENE TO
CANCEL THE CONFIRMATION NUMBER.

 

By way of example only: A shipment (for any patient risk category) is shipped to
a patient on Friday, May 20, 2016 for Saturday delivery signature required. The
patient is not home when the carrier arrives to deliver the package. The
carrier’s next attempt to deliver is Monday, May 23, 2016. The patient is not
home again to receive the package. The carrier reattempts the delivery on
Tuesday, May 24, 2016 and the patient is not home once again. The carrier now
returns the package to the Pharmacy as undeliverable. At this point, the
Pharmacy must call Celgene the day they receive the undeliverable package to
cancel the confirmation number. If the package is returned to the pharmacy on a
Saturday or Sunday, the Pharmacy must call Celgene Customer Care first thing
Monday morning to obtain a cancellation number.

 

·                                          As a reminder, each prescription
requires a new confirmation number when ready to ship again (after the shipment
had been returned due to being undeliverable.). Record the confirmation number
and the date that the confirmation number was received from Celgene Customer
Care after you have counseled the patient, and prior to shipping product.

 

YOU MUST NOT DISPENSE OR SHIP REVLIMID®, POMALYST®, AND THALOMID® WITHOUT A
VALID AND CURRENT CONFIRMATION NUMBER.

 

38

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·                                          The Pharmacy shall not ship or
dispense REVLIMID®, POMALYST®, or THALOMID® to a patient until:

 

·                                          The authorization numbers and patient
risk category are recorded on the prescription, or REVLIMID®, POMALYST®, or
THALOMID® Patient Prescription form (Please see: Figure 4), by the Prescriber or
designee, or Pharmacy Certified Counselor or designee.

 

·                                          The Certified Counselor has counseled
the patient.

 

·                                          The Pharmacy, through the Certified
Counselor confirms by completing the Education and Counseling Checklist, that
the patient understands the risks of REVLIMID®, POMALYST®, and/or
THALOMID® therapy.

 

·                                          NOTE: Any patient who has not
received REVLIMID®, POMALYST®, or THALOMID® in the prior twelve (12) months will
be considered a “new” patient and will have to be re-enroll into the REVLIMID
REMS®, POMALYST REMS®, or THALOMID REMS® program.

 

·                                          Celgene Customer Care provides the
confirmation number to the Pharmacist or designee when the Pharmacist or
designee calls to verify the authorization number. The Pharmacist or designee
must write the confirmation number and date on the hard copy of the prescription
or document in the Pharmacy’s electronic records linked to that prescription.
The confirmation number obtained is valid for twenty four (24) hours. For
prescriptions filled for Females of Reproductive Potential (FRP), the Pharmacy
must ship the Product the same day that they receive the confirmation number or
provide the Product directly to the patient within twenty four (24) hours of
receipt of the confirmation number. For prescriptions for all other risk
categories, Pharmacy shall ship within twenty-four (24) hours of obtaining the
confirmation number.

 

·                                          If the prescription is not shipped or
provided to the patient in the proper timeframe, please call Celgene Customer
Care to cancel the confirmation number. Document the cancellation number and
date obtained on the prescription for auditing purposes.

 

DO NOT DISPENSE OR SHIP REVLIMID®, POMALYST®, OR THALOMID® IF:

 

(a)           THE PATIENT IS PREGNANT;

 

39

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(b)                                 A FEMALE OF REPRODUCTIVE POTENTIAL STATES
PREGNANCY TESTS WERE NOT CONDUCTED; OR

 

(c)                                  THE PATIENT STATED THAT THEY DID NOT USE
RECOMMENDED EFFECTIVE BIRTH CONTROL (UNLESS PRACTICING CONTINUOUS ABSTINENCE).
See Education and Counseling Checklist for Pharmacies (see Figure 3) for
acceptable birth control methods.

 

IF A, B, OR C OCCUR, CONTACT THE CERTIFIED PRESCRIBER AND CELGENE AT
1-888-423-5436, TO REPORT INDIVIDUAL INCIDENT(S).

 

4.5.5                     Pharmacy Deviations:

 

The Pharmacy will be required to investigate and correct conditions that lead to
deviations from the REVLIMID REMS®, POMALYST REMS®, and THALOMID REMS® programs.
Celgene is committed to work with the Pharmacy to assist in implementing
appropriate corrective actions, and establishing a timeframe for those actions.

 

These corrective action measures may include:

·                                          Re-education of the pharmacy manager
and staff by Celgene U.S. REMS and/or Account Executive

·                                          Documentation of investigation of
root cause and corrective action plan to prevent a future occurrence within the
requested timeframe.

·                                          Other risk mitigation measures or
other actions if deemed suitable.

 

High Risk Deviations:

·                                          In the event that Celgene deems any
dispensing situation to be High Risk, Celgene shall have the right in its sole
discretion to apply this provision and will contact the Pharmacy to advise that
the subject dispense is deemed High Risk. See definition of “High Risk
Deviation” on page 3 (1.12).

·                                          Next steps may include correction
action measures listed above, and will be considered for other risk mitigation
options including deactivation, implementation of risk mitigation measures, or
other actions as deemed suitable by Celgene.

·                                          For any additional occurrence of a
High Risk Deviation beyond 2 High Risk Deviations, the pharmacy may be
deactivated and no longer permitted to dispense product.

·                                          If the Pharmacy is deactivated, it
will be informed of the decision and will not be permitted to order or dispense
any Celgene Products.

 

Notwithstanding the foregoing, or anything to the contrary, if any corrective
action measures or other actions deemed suitable by Celgene are not undertaken
to Celgene’s satisfaction, Celgene has the right in its sole and absolute
discretion to immediately deactivate the Pharmacy.

 

40

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Request for reinstatement, following deactivation

 

·                                          The Pharmacy must submit a letter of
appeal directly to the CMO requesting reinstatement.

·                                          The letter must document how
circumstances have changed to ensure future compliance in the REMS Program(s).

·                                          The CMO shall evaluate the appeal and
determine whether the Pharmacy should be reactivated or remain deactivated.

·                                          The pharmacy will be contacted by
Celgene with the decision.

 

4.6.                            ADVERSE DRUG EXPERIENCE REPORTING

 

·                                          All Adverse Drug Experiences
suspected to be associated with the use of REVLIMID®, POMALYST®, or
THALOMID® and all cases of special situations received by the Pharmacy from
Prescribers or patients associated with the dispensing of REVLIMID®, POMALYST®,
or THALOMID® must be reported within twenty four (24) hours to Celgene so that
Celgene can meet all current health authority regulations and guidelines for
reporting of Adverse Drug Experiences relating to REVLIMID®, POMALYST®, and
THALOMID®.

·                                          All reports of suspected pregnancy
exposure must be reported immediately.

 

4.7.                            AUDIT

 

First audits will occur within 3 months of a Pharmacy’s first dispense of
REVLIMID®, POMALYST®, and/or THALOMID®, then an annual risk-based audit
thereafter.

 

41

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FIGURE 1: REVLIMID REMS®, POMALYST REMS® AND THALOMID REMS®
NON-COUNSELOR STAFF TRAINING ACKNOWLEDGMENT

 

[g88651ki09i001.jpg]

 

REVLIMID REMS® (formerly known as RevAssist®), POMALYST REMS® AND

THALOMID REMS® (formerly known as the S.T.E.P.S.® program)

NON COUNSELOR STAFF TRAINING ACKNOWLEDGMENT

 

REVLIMID REMS®, POMALYST REMS® AND THALOMID REMS® Training (REMS-GEN16777)

 

REMS ADVERSE DRUG REACTION REPORTING OVERVIEW PRESENTATION
(Version 7.0 January 2015 PPA)

 

REMS ADVERSE DRUG REACTION REPORTING FORM
(Version 6.0 March 2016)

 

REMS ADVERSE DRUG REACTION REPORTING FORM INSTRUCTIONS

(Instructions for ADR Report Form V4.1 February 2013_PPA)

 

REMS ADR REPORTING — IMPORTANT MEDICAL EVENTS LIST

(Version 7.1 March 01, 2018/ID/PPA)

 

I intend to assist in the dispensing of Celgene REMS products.  I certify that I
have read and understand the above listed REVLIMID REMS®, POMALYST REMS®, and
THALOMID REMS® training and Adverse Event Reporting training, instructions, and
reporting form.  I understand that if there is revised training or additional
training, based upon enhanced REVLIMID REMS®, POMALYST REMS®, or THALOMID REMS®
training requirements or in response to identified regulatory issues, I will be
required to complete additional training to ensure understanding, and I will
sign another training form at that time.

 

 

PRINTED NAME OF PHARMACY STAFF MEMBER

 

 

SIGNATURE OF PHARMACY STAFF MEMBER

 

 

DATE

 

I certify that I have assisted in training above pharmacy staff member on the
CELGENE REMS requirements.

 

 

PRINTED NAME OF CERTIFIED COUNSELOR/CERTIFIED PHARMACIST WITH CELGENE
REMS/CELGENE STAFF

 

 

SIGNATURE OF CERTIFIED COUNSELOR/CERTIFIED PHARMACIST WITH CELGENE REMS/CELGENE
STAFF

 

 

DATE

 

[g88651ki09i002.jpg]

 

42

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FIGURE 2: WORKFLOW FOR DISPENSING REVLIMID®, POMALYST®, AND THALOMID®

 

[g88651ki09i003.jpg]

 

43

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FIGURE 3: REVLIMID REMS® EDUCATION AND COUNSELING CHECKLIST FOR PHARMACIES;
POMALYST REMS® EDUCATION AND COUNSELING CHECKLIST FOR PHARMACIES; THALOMID REMS®
EDUCATION AND COUNSELING CHECKLIST FOR PHARMACIES

[g88651ki09i004.jpg]

 

44

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[g88651ki09i005.jpg]

 

45

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[g88651ki09i006.jpg]

46

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[g88651ki09i007.jpg]

47

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[g88651ki09i008.jpg]

 

48

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[g88651ki09i009.jpg]

 

49

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FIGURE 4: REVLIMID® PATIENT PRESCRIPTION FORM;

POMALYST® PATIENT PRESCRIPTION FORM;

THALOMID® PATIENT PRESCRIPTION FORM

 

REVLIMID® (lenalidomide) Patient Prescription Form

 

 

 

 

 

Today’s Date                  Date Rx Needed

Patient Last Name                    Patient First Name

Phone Number (     )

Shipping Address

City                          State                  Zip

Date of Birth                    Patient ID#

Language Preference: ¨ English        ¨ Spanish       ¨  Other

Best Time to Call Patient: ¨ AM                               ¨ PM

Patient Diagnosis

Patient Allergies

 

Other Current Medications

 

Prescriber Name

State License Number

Prescriber Phone Number (    )            Ext

Fax Number (    )

Prescriber Address

 

City               State              Zip

 

Patient Type From PPAF (Check one)

 

o Adult Female — NOT of Reproductive Potential

¨ Adult Female — Reproductive Potential

¨ Adult Male

¨ Female Child — Not of Reproductive Potential

¨ Female Child — Reproductive Potential

¨ Male Child

 

 

 

PRESCRIPTION INSURANCE INFORMATION

(Fill out entirely and fax a copy of patient’s insurance card, both sides)

 

Primary Insurance

 

Insured

Policy #

Group #

Phone #

Rx Drug Card #

 

Secondary Insurance

 

Insured

 

TAPE PRESCRIPTION HERE PRIOR TO FAXING

REFERRAL, OR COMPLETE THE FOLLOWING

 

Recommended Starting Dose:  See below for dosage

 

Myelodysplastic Syndromes.  The recommended starting dose of REVLIMID is 10
mg/day with water.  Dosing is continued or modified based upon clinical and
laboratory findings.

 

Multiple Myeloma and Mantle Cell Lymphoma:  The recommended starting dose of
REVLIMID is 25 mg/day orally for Days 1 – 21 of repeated 28-day cycles.  Dosing
is continued or modified based upon clinical and laboratory findings.

 

REVLIMID

 

Policy #

 

Dose

 

Quantity

 

Directions

 

 

 

 

 

 

 

 

 

Group #

 

¨  2.5 mg

 

 

 

 

 

Phone #

 

¨  5 mg

 

 

 

 

 

Rx Drug Card #

 

¨  10 mg

 

 

 

 

 

 

 

¨  15 mg

 

 

 

 

 

 

 

¨  20 mg

 

 

 

 

 

 

 

¨  25 mg

 

 

 

 

 

 

 

¨  Dispense as Written

 

¨ Substitution Permitted

 

 

 

 

 

 

 

 

 

NO REFILLS ALLOWED (Maximum Quantity = 28 days)

 

 

 

 

 

 

 

 

 

 

Prescriber Signature

 

 

Date

 

 

 

 

 

 

 

 

 

 

 

 

Authorization #

 

 

Date

 

 

 

 

(To be filled in by healthcare provider)

 

 

 

 

 

 

 

 

 

 

 

Pharmacy Confirmation #

 

 

Date

 

 

 

 

(To be filled in by pharmacy)

 

 

 

 

 

For further information on REVLIMID, please refer to the full Prescribing
Information

 

50

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How to Fill a REVLIMID® (lenalidomide) Prescription

 

1.              Healthcare Provider (HCP) instructs female patients to complete
initial patient survey

 

2.              HCP completes survey

 

3.              HCP completes patient prescription form

 

4.              HCP obtains REVLIMID REMS® (formerly known as the RevAssist®
program) authorization number

 

5.              HCP provides authorization number on patient prescription form

 

6.              HCP faxes form, including prescription, to one of the Celgene
Certified Pharmacy Network participants (see below)

 

7.              HCP advises patient that a representative from the certified
pharmacy will contact them

 

8.              Certified pharmacy conducts patient education

 

9.              Certified pharmacy obtains confirmation number

 

10.       Certified pharmacy ships REVLIMID to patient with MEDICATION GUIDE

 

Please see www.Celgene.com/PharmacyNetwork for the list of pharmacy participants

 

Information about REVLIMID and the REVLIMID REMS® program can be obtained by
calling the Celgene Customer Care Center toll-free at 1-888-423-5436, or at
www.CelgeneRiskManagement.com.

 

[g88651ki11i001.jpg]

 

[g88651ki11i002.jpg]

 

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POMALYST® (pomalidomide) Patient Prescription Form

 

 

 

 

 

Today’s Date                  Date Rx Needed

Patient Last Name                    Patient First Name

Phone Number (     )

Shipping Address

City                          State                  Zip

Date of Birth                    Patient ID#

Language Preference: ¨ English        ¨ Spanish       ¨  Other

Best Time to Call Patient: ¨ AM                   ¨ PM

Patient Diagnosis

Patient Allergies

 

Other Current Medications

 

Prescriber Name

State License Number

Prescriber Phone Number (    )       Ext

Fax Number (    )

Prescriber Address

 

City               State              Zip

 

Patient Type From PPAF (Check one)

 

¨ Adult Female — NOT of Reproductive Potential

¨ Adult Female — Reproductive Potential

¨ Adult Male

¨ Female Child — Not of Reproductive Potential

¨ Female Child — Reproductive Potential

¨ Male Child

 

 

 

PRESCRIPTION INSURANCE INFORMATION

(Fill out entirely and fax a copy of patient’s insurance card, both sides)

 

Primary Insurance

 

Insured

Policy #

Group #

Phone #

Rx Drug Card #

 

 

TAPE PRESCRIPTION HERE PRIOR TO FAXING

REFERRAL, OR COMPLETE THE FOLLOWING

Recommended Starting Dose:  See below for dosage

 

Multiple Myeloma:  The recommended starting dose of POMALYST is 4 mg/day orally
for Days 1 — 21 of repeated 28-day cycles.  POMALYST should be given in
combination with dexamethasone.  Dosing is continued or modified based upon
clinical and laboratory findings.

 

POMALYST

Secondary Insurance

 

Dose

 

Quantity

 

Directions

 

 

 

 

 

 

 

 

 

Insured

 

¨ 1 mg

 

 

 

 

 

Policy #

 

¨ 2 mg

 

 

 

 

 

Group #

 

¨ 3 mg

 

 

 

 

 

Phone #

 

¨ 4 mg

 

 

 

 

 

Rx Drug Card #

 

¨ Dispense as Written

 

¨ Substitution Permitted

 

 

 

 

 

 

 

 

 

NO REFILLS ALLOWED (Maximum Quantity = 28 days)

 

 

 

 

 

 

 

 

 

 

Prescriber Signature

 

 

Date

 

 

 

 

 

 

 

 

 

 

 

 

Authorization #

 

 

Date

 

 

 

 

(To be filled in by healthcare provider)

 

 

 

 

 

 

 

 

 

 

 

Pharmacy Confirmation #

 

 

Date

 

 

 

 

(To be filled in by pharmacy)

 

 

 

 

 

For further information on POMALYST, please refer to the full Prescribing
Information

 

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How to Fill a POMALYST® (pomalidomide) Prescription

 

1.              Healthcare Provider (HCP) instructs female patients to complete
initial patient survey

 

2.              HCP completes survey

 

3.              HCP completes patient prescription form

 

4.              HCP obtains POMALYST REMS® authorization number

 

5.              HCP provides authorization number on patient prescription form

 

6.              HCP faxes form, including prescription, to one of the Celgene
Certified Pharmacy Network participants (see below)

 

7.              HCP advises patient that a representative from the certified
pharmacy will contact them

 

8.              Certified pharmacy conducts patient education

 

9.              Certified pharmacy obtains confirmation number

 

10.       Certified pharmacy ships POMALYST to patient with MEDICATION GUIDE

 

Please see www.Celgene.com/PharmacyNetwork for the list of pharmacy participants

 

Information about POMALYST and the POMALYST REMS® program can be obtained by
calling the Celgene Customer Care Center toll-free at 1-888-423-5436, or at
www.CelgeneRiskManagement.com.

 

[g88651ki11i003.jpg]

 

[g88651ki11i004.jpg]

 

53

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THALOMID® (thalidomide) Patient Prescription Form

 

 

Today’s Date                  Date Rx Needed

Patient Last Name                    Patient First Name

Phone Number (     )

Shipping Address

City                          State                  Zip

Date of Birth                    Patient ID#

Language Preference: ¨ English        ¨ Spanish       ¨  Other

Best Time to Call Patient: ¨ AM                   ¨ PM

Patient Diagnosis

Patient Allergies

 

Other Current Medications

 

Prescriber Name

State License Number

Prescriber Phone Number (    )          Ext

Fax Number (    )

Prescriber Address

 

City               State              Zip

 

Patient Type From PPAF (Check one)

 

¨ Adult Female — NOT of Reproductive Potential

¨ Adult Female — Reproductive Potential

¨ Adult Male

¨ Female Child — Not of Reproductive Potential

¨ Female Child — Reproductive Potential

¨ Male Child

 

 

 

PRESCRIPTION INSURANCE INFORMATION

(Fill out entirely and fax a copy of patient’s insurance card, both sides)

 

Primary Insurance

 

Insured

Policy #

Group #

Phone #

Rx Drug Card #

 

Secondary Insurance

Insured

Policy #

Group #

 

TAPE PRESCRIPTION HERE PRIOR TO FAXING

REFERRAL, OR COMPLETE THE FOLLOWING

 

Recommended Starting Dose:  See below for dosage

 

Multiple Myeloma:  The recommended starting dose of THALOMID is 200 mg/day
orally with water for a 28-day treatment cycle.  Dosing is continued or modified
based upon clinical and laboratory findings.

 

Erytherna Nodosum Leprosum:  The recommended starting dose of THALOMID is 100 to
300 mg/day with water for an episode of cutaneous ENL.  Up to 400 mg/day for
severe cutaneous ENL.  Dosing is continued or modified based upon clinical and
laboratory findings.

 

THALOMID

 

 

 

Phone #

 

Dose

 

Quantity

 

Directions

 

 

 

 

 

 

 

 

 

Rx Drug Card #

 

¨ 50 mg

 

 

 

 

 

 

 

¨ 100 mg

 

 

 

 

 

 

 

¨ 150 mg

 

 

 

 

 

 

 

¨ 200 mg

 

 

 

 

 

 

 

¨ Dispense as Written

 

¨ Substitution Permitted

 

 

 

 

 

 

 

 

 

NO REFILLS ALLOWED (Maximum Quantity = 28 days)

 

 

 

 

 

 

 

 

 

 

Prescriber Signature

 

 

Date

 

 

 

 

 

 

 

 

 

 

 

 

Authorization #

 

 

Date

 

 

 

 

(To be filled in by healthcare provider)

 

 

 

 

 

 

 

 

 

 

 

Pharmacy Confirmation #

 

 

Date

 

 

 

 

(To be filled in by pharmacy)

 

 

 

 

 

For further information on THALOMID, please refer to the full Prescribing
Information

 

54

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How to Fill a THALOMID® (thalidomide) Prescription

 

1.              Healthcare Provider (HCP) instructs female patients to complete
initial patient survey

 

2.              HCP completes survey

 

3.              HCP completes patient prescription form

 

4.              HCP obtains THALOMID REMS® (formerly known as the S.T.E.P.S.®
program) authorization number

 

5.              HCP provides authorization number on patient prescription form

 

6.              HCP faxes form, including prescription, to one of the Celgene
Certified Pharmacy Network participants (see below)

 

7.              HCP advises patient that a representative from the certified
pharmacy will contact them

 

8.              Certified pharmacy conducts patient education

 

9.              Certified pharmacy obtains confirmation number

 

10.       Certified pharmacy ships THALOMID to patient with MEDICATION GUIDE

 

Please see www.Celgene.com/PharmacyNetwork for the list of pharmacy participants

 

Information about THALOMID and the THALOMID REMS® program can be obtained by
calling the Celgene Customer Care Center toll-free at 1-888-423-5436, or at
www.CelgeneRiskManagement.com.

 

[g88651ki11i005.jpg]

 

[g88651ki11i006.jpg]

 

 

 

 

FIGURE 1: REVLIMID REMS®, POMALYST REMS® AND THALOMID REMS® NON-COUNSELOR STAFF
TRAINING ACKNOWLEDGMENT

 

55

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SCHEDULE 2.3

 

SAMPLE INVENTORY REPORT

 

Quarterly Inventory Reporting Template

 

Required for all products pharmacy is actively enrolled in REMS to dispense
(Revlimid, Pomalyst, or Thalomid)

 

Date of inventory count will be the last business day of the quarter (4x per
year).

 

Electronic inventory count will be conducted at the end of Q1 and Q3, physical
inventory count will be conducted at the end of Q2 and Q4.

 

All inventory reports must be submitted within 5 business days of count.

 

Pharmacy
DEA

 

Pharmacy
NABP

 

Pharmacy
Name

 

Pharmacy
Address

 

Pharmacy
City

 

Pharmacy
State

 

Pharmacy
Zip

 

NDC#:

 

Product
Name

 

Strength

 

Unit of
Measure

 

Units
per pack

 

Capsules on
hand at close
of business

 

Date of
count

BD1234567

 

1112223

 

Main Street Pharmacy

 

1 Main St

 

New York

 

NY

 

10001

 

59572-405-00

 

Revlimid

 

5MG

 

Capsule

 

100

 

106

 

3/31/2016

 

Submit Reports via e-mail to: Celgenelnventory@celgene.com

 

56

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SCHEDULE 5.1

 

DATA REPORTS

 

The table below outlines the fields, which are required for a report to be
considered “complete”.

 

Celgene Sample File Format — Microsoft Excel.

 

Field Name

 

Type

 

Format

 

Pharmacy site address

 

VARCHAR

 

 

 

Pharmacy site city

 

ALPHA

 

 

 

Pharmacy site state

 

ALPHA

 

 

 

Pharmacy site zip

 

NUMERIC

 

 

 

Date Dispensed

 

DATE

 

MM/DD/YYYY

 

Customer ID (specific to this prescriber)

 

VARCHAR

 

 

 

Prescriber First Name

 

ALPHA

 

 

 

Prescriber First Name

 

ALPHA

 

 

 

Prescriber Address ID (if available)

 

VARCHAR

 

 

 

Prescriber Address

 

VARCHAR

 

 

 

Prescriber City

 

ALPHA

 

 

 

Prescriber State

 

ALPHA

 

 

 

Prescriber Zip

 

NUMERIC

 

 

 

DEA (prescriber)

 

VARCHAR

 

 

 

NPI (prescriber)

 

NUMERIC

 

 

 

NDC

 

NUMERIC

 

XXXXX-XXXX-XX

 

Product

 

ALPHA

 

 

 

QTY in vials

 

NUMERIC

 

 

 

 

Submit Reports via e-mail to:  salesoperations@celgene.com

 

57

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SCHEDULE 6.1
PERFORMANCE METRICS

 

Pharmacy shall receive a Service Fee to pay for its performance of the Enhanced
Services in connection with the first dispense of a Product to a Customer, based
on the range in days between Pharmacy’s receipt of a prescription with a valid
authorization from a Certified Prescriber and the dispensing of the Product, in
an amount listed in the Time to First Dispense table for the Product. The
Service Fee paid for Enhanced Services performed in connection with each
subsequent dispense shall equal the applicable sum of the Time to Repeat
Dispense and Subsequent Dispense Count amounts for the Product. All payments are
subject to Section 6.2 of the Agreement.

 

[g88651ki11i007.jpg]

 

Time to First Dispense

 

 

 

Range
in Days

 

Payout in
$ per Rx

[*]

 

[*]

[*]

 

[*]

[*]

 

[*]

[*]

 

[*]

[*]

 

[*]

 

Time to Repeat Dispense

 

 

 

Range
in Days

 

Payout in
$ per Rx

[*]

 

[*]

[*]

 

[*]

[*]

 

[*]

 

 

 

Subsequent Dispense Count

 

 

 

Disp.
Count

 

Payout in
$ per Rx

[*]

 

[*]

[*]

 

[*]

[*]

 

[*]

 

--------------------------------------------------------------------------------

* Information redacted pursuant to a confidential treatment request by Diplomat
Pharmacy, Inc. under 5 U.S.C. §522(b)(4) and Rule 24b-2 under the Securities
Exchange Act of 1934 and submitted separately with the Securities and Exchange
Commission.

 

58

--------------------------------------------------------------------------------

 

Performance Metrics

 

[g88651ki11i008.jpg]

 

Revlimid Specialty Pharmacy Scorecard

 

Time to First Dispense

 

 

 

Range
in Days

 

Payout in
$ per Rx

[*]

 

[*]

[*]

 

[*]

[*]

 

[*]

[*]

 

[*]

[*]

 

[*]

 

Time to Repeat Dispense

 

 

 

Range
in Days

 

Payout in
$ per Rx

[*]

 

[*]

[*]

 

[*]

[*]

 

[*]

 

Subsequent Dispense Count

 

 

 

Disp.
Count

 

Payout in
$ per Rx

[*]

 

[*]

[*]

 

[*]

[*]

 

[*]

 

--------------------------------------------------------------------------------

* Information redacted pursuant to a confidential treatment request by Diplomat
Pharmacy, Inc. under 5 U.S.C. §522(b)(4) and Rule 24b-2 under the Securities
Exchange Act of 1934 and submitted separately with the Securities and Exchange
Commission.

 

59

--------------------------------------------------------------------------------

 

[g88651ki13i001.jpg]

 

Time to First Dispense

 

 

 

Range
in Days

 

Payout in
$ per Rx

[*]

 

[*]

[*]

 

[*]

[*]

 

[*]

[*]

 

[*]

[*]

 

[*]

 

Time to Repeat Dispense

 

 

 

Range
in Days

 

Payout in
$ per Rx

[*]

 

[*]

[*]

 

[*]

[*]

 

[*]

 

Subsequent Dispense Count

 

 

 

Disp.
Count

 

Payout in
$ per Rx

[*]

 

[*]

[*]

 

[*]

[*]

 

[*]

 

--------------------------------------------------------------------------------

* Information redacted pursuant to a confidential treatment request by Diplomat
Pharmacy, Inc. under 5 U.S.C. §522(b)(4) and Rule 24b-2 under the Securities
Exchange Act of 1934 and submitted separately with the Securities and Exchange
Commission.

 

60

--------------------------------------------------------------------------------

 

SCHEDULE 7.1

 

RETURN GOODS POLICY

 

[g88651ki13i002.jpg]

 

Return Goods Policy

 

Unless otherwise required by law, return of Celgene products will be handled in
accordance with this Return Policy effective July 1, 2013.

 

Return Authorization Requests

 

1              ALL returns require prior authorization from Celgene Corporation
by calling

 

·                                          1-888-423-5436 for All Celgene
products

 

2                                         The customer must provide the
following information for the products being returned in order to be considered
for authorization

 

·                                          Contact name

·                                          NABP number or DEA number

·                                          Lot number and quantity of each item
to be returned

·                                          Reason for return

·                                          Advise if the product has been
previously dispensed to a pattern (for Risk Managed Products)

 

3                                         Celgene Corporation reserves the right
to deny credit for product returned without the accompanying return
authorization documentation, or any product returned that falls outside of the
guidelines stated in this policy

 

4.                                      All products should be returned within
five (5) business days of receiving authorization from Celgene Corporation

 

Products Eligible for Credit

 

·                                          Products returned in ORIGINAL,
UNOPENED, INTACT, FULL trade cartons, blister packs, bottles or vials maybe
returned for credit unless Otib21,15, stated in the (-)Not Eligible for
Credit(-) section below

 

·                                          Products that are recalled or damaged
during original shipment from Celgene are eligible for credit only if the
customer reports any damages to the product within ten (10) business days of
receipt of product shipment

 

·                                          Products that are shipped in error by
Celgene are eligible for credit only if the customer reports any errors or
discrepancies in the order within ten (10) business days of receipt of product
shipment

 

·                                          All authorized products must be
received within 3 months prior to expiration or up to 6 months after expiration
date of the product to be eligible for credit

 

Celgene Corporation     86 Morris Avenue     Summit, NJ    07901    phone (888)
423-5436   fax (888) 432-9325

 

61

--------------------------------------------------------------------------------

 

·                  Handling fees apply

 

·                                          20% for products returned prior to 3
months expiration date

·                                          5% for products returned within 3
months prior expiration date or up to 6 months after expiration date

 

·                                          Celgene (NDC # 59572), Pharmion (NDC
# 67211) and Gloucester (NDC # 46026) Abraxis (NDC # 68817) trade dress product

 

Products NOT Eligible for Credit

 

·                                          Product for professional sample,
professional package, free goods, or with similar markings or special label

 

·                                          Merchandise obtained other than
through a Celgene authorized distributor of record or Celgene Corporation
directly

 

·                                          Product that has been used or
dispensed to a patient

 

·                                          Product obtained illegally or that
has been diverted or resold by an account pursuant to a special price

 

·                                          Product where the lot number or
expiration date is missing, covered or unreadable

 

·                                          When the intent of the customer is to
temporarily reduce inventory

 

·                                          Products involved in a bankruptcy
sale or proceeding

 

·                                          Product destroyed by the customer or
a third party without prior written authorization from Celgene

 

·                                          Product not manufactured by or on
behalf of Celgene for distribution in the United States

 

·                                          Expired product received by Celgene
more than 6 (six) months past its expiration date

 

·                                          Partial blister packs, bottles or
vials

 

·                                          Opened or unsealed commercial
packages

 

Products NOT Eligible for Credit (continued)

 

·                                          Products damaged by insurable
catastrophes such as fire, smoke, acts of terrorism, flood, etc.

 

·                                          Products sold, purchased or
distributed contrary to federal, state or local law

 

·                                          Product that is sold, purchased or
distributed contrary to Celgene’s REMS programs

 

·                                          BMS/Dupont trade dress product (NDC #
00056)

 

Terms of Return Policy

 

1.                                      Credit for returned product will be
determined by the return receipt date and upon review and inspection for
compliance with all aspects of Celgene’s Product Return Policy.

 

2.             A handling fee will be assessed on the original gross purchase
price of the product as follows:

 

Celgene Corporation     86 Morris Avenue     Summit, NJ     07901     phone
(888) 423-5436     fax (888) 432-9325

 

62

--------------------------------------------------------------------------------

 

a)                                     20% on in-date product returns, prior to
3 months before expiration unless otherwise agreed.

 

b)                                     5% on product returns up to 3 months
before expiration and up to 6 months past expiration

 

--------------------------------------------------------------------------------

*This fee does not apply to any product recalled, shipped damaged or shipped in
error by Celgene or that which is ineligible for credit

 

3.                                      Returns made in accordance with this
policy will be credited, to the direct purchaser from Celgene, for the actual
net price paid after any applicable handling fees, discounts, allowances or
adjustments (including but not limited to, prompt payment discounts, government
discounts, chargebacks or rebates)

 

4.                                      Deductions from payables may not be
taken until the credit memo is issued by Celgene Corporation. Unauthorized
deductions from payables for returns may result in held orders

 

5.                                      Credits will be processed through the
account directly invoiced by Celgene Corporation. Customers who have been
invoiced through a wholesaler or distributor should seek return credit from such
wholesaler or distributor

 

6.                                      No credit will be given for destroyed
merchandise. A Returned Goods Authorization Form must accompany all returned
product

 

7.                                      Celgene Corporation reserves the right
to destroy, without recourse, any returned product not eligible for credit

 

Shipping Information and Return Goods Addresses

 

1                                         All Authorized returns must be sent
to:

 

Celgene Product Returns

7339 Industrial Road

Allentown, PA 18106

 

2.                                      Shipping charges are the responsibility
of the customer, unless the return is of products shipped in error by Celgene
Corporation

 

3.                                      Shipping labels will be provided when a
pharmacy is returning product on behalf of a patient (returned product is
ineligible for credit)

 

4.                                      The return authorization number must be
referenced on the shipping label to be considered as valid proof of delivery

 

Celgene reserves the right to destroy, without notification, credit, exchange or
return to the customer, any merchandise that does not conform to the policy.

 

Celgene reserves the right to modify this policy in its discretion without
advance notice.

 

Celgene Corporation     86 Morris Avenue     Summit, NJ     07901     phone
(888) 423-5436     fax (888) 432-9325

 

63

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SCHEDULE 8.1

 

ADVERSE DRUG REACTION REPORTING

 

ADVERSE DRUG EXPERIENCES THAT ARE SUSPECTED TO BE ASSOCIATED WITH THE USE OF
REVLIMID®, POMALYST®, OR THALOMID®, ANY SUSPECTED PREGNANCY OCCURRING DURING THE
TREATMENT WITH REVLIMID®, POMALYST®, OR THALOMID®, AND ALL CASES OF SPECIAL
SITUATIONS MUST BE REPORTED TO CELGENE WITHIN 24 HOURS. ANY REPORTS OF PREGNANCY
EXPOSURE MUST BE REPORTED IMMEDIATELY.

 

Reporting to Celgene

 

Fill out Adverse Drug Reaction (ADR) Report Form as completely as possible (be
sure to include reporter’s name on each page), then:

 

·                                          Fax: 1-908-673-9115

 

·                                          E-mail: drugsafety@celgene.com

 

·                                          Toll Free: 1-800-640-7854 (Global
Drug Safety & Risk Management) 24 hours a day/7 days a week OR 1-888-423-5436
(Customer Care Center)

 

·                                          Other electronic exchange as agreed
upon by both parties.

 

If the report is of a possible exposure of a PREGNANT WOMAN, CALL Celgene Drug
Safety IMMEDIATELY then follow-up with the ADR report form.

 

Reporting Procedures: Essential Information

 

·                                          Reporter information

 

·                                          Full Name/Title

 

·                                          Address & Phone #

 

·                                          Patient information (Sufficient
information to enable Celgene to correspond with the treating physician)

 

·                                          Initials

 

·                                          Date of Birth, Age, Gender

 

·                                          Adverse Drug Reaction (ADR) including
causality assessment

 

·                                          As complete a description as possible
—Provide diagnosis and/or symptoms

 

64

--------------------------------------------------------------------------------

 

·                                          Key details —date started, date
resolved and outcome

 

·                                          Hospitalization or drug discontinued
.... Ask why?

 

·                                          Drug

 

·                                          Did patient receive drug?

 

·                                          If so, dose, frequency, dates of
therapy, indication

 

·                                          Lot # and expiration date

 

·                                          Physician’s full name, address, phone
number

 

Definitions: Cases of Special Situations

 

Market Authorization Holder (MAH) is responsible to report “Cases of Special
Situations” which may include, but not be limited to:

 

·                                          Outcomes of use of a medicinal
product during pregnancy

 

·                                          Adverse reactions during
breastfeeding

 

·                                          Use of product in pediatric or
elderly population

 

·                                          Reports of lack of therapeutic
efficacy

 

·                                          Reports in relation to overdose,
abuse, off-label use, misuse; medication errors or occupational exposure

 

·                                          Examples of Special Situations
include but are not limited to:

 

·                                          ADR in infant following exposure to
product from breastfeeding

 

·                                          Contamination of starting materials,
or during product manufacturing

 

·                                          Promotion of opportunist infections
due to contamination

 

·                                          Drug prescribed to a patient,
accidentally taken by their child

 

·                                          Patient took expired product or
incorrect prescription given whether or not an adverse reaction occurred

 

65

--------------------------------------------------------------------------------

 

[g88651ki13i003.jpg]

 

66

--------------------------------------------------------------------------------

 

[g88651ki13i004.jpg]

 

67

--------------------------------------------------------------------------------

 

SCHEDULE 8.2

 

COMPLAINT FORM

 

To:

 

Celgene Customer Care Center

 

Fax:

 

1-888-432-9325

 

 

 

 

 

 

 

Specialty Pharmacy Name:

 

 

 

Phone:

 

 

 

 

 

 

 

 

 

From:

 

 

 

 

 

 

 

 

 

 

 

 

 

Title:

 

 

 

 

 

 

 

 

 

 

 

 

 

Date of Call:

 

 

 

 

 

 

 

 

 

 

 

 

 

Complainant Name:

 

 

 

Address:

 

 

 

 

 

 

 

 

 

Home Phone:

 

 

 

 

 

 

 

 

 

 

 

 

 

Work Phone:

 

 

 

 

 

 

 

 

 

 

 

 

 

Product

 

 

 

Gender:

 

 

 

 

 

 

 

 

 

Lot Number:

 

 

 

Language:

 

 

 

 

 

 

 

 

 

Expiration Date:

 

 

 

Address:

 

 

 

 

 

 

 

 

 

Best Day to Call:

 

 

 

Best Time to Call:

 

 

 

 

 

 

 

 

 

Description of Problem:

 

 

 

 

 

 

 

68

--------------------------------------------------------------------------------

 

SCHEDULE 10.3

 

MEDICAID PROGRAM LIST BY STATE

 

[NOTE: Pharmacy to provide. To be attached/inserted here]

 

69

--------------------------------------------------------------------------------