Exhibit 10.24

 

DISTRIBUTION AND SERVICES AGREEMENT

 

This Distribution and Services Agreement is entered into and made effective as
of this 7th day of August, 2013 (“Effective Date”) by and between
PHARMACYCLICS, INC. with principal offices located at 995 E. Argues Avenue,
Sunnyvale, CA 94085 (“Pharmacyclics”), and DIPLOMAT PHARMACY, INC. with offices
located at 4100 S. Saginaw St., Flint, MI 48507 (“Distributor”).

 

WHEREAS, soon after the U.S. Food and Drug Administration (FDA) grants a
marketing authorization on the New Drug Application (“NDA”) of Pharmacyclics for
the drug ibrutinib, Pharmacyclics wishes to commercialize such drug;

 

WHEREAS, in preparation for such commercialization, Pharmacyclics is in the
process of establishing and/or restructuring a distribution network for the sale
of the drug;

 

WHEREAS, Distributor, as a mail order pharmacy, has the facilities and expertise
to distribute the drug to Participants, to provide reimbursement assistance and
other customer services to its Participants and to provide data reporting and
other services to Pharmacyclics;

 

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

 

1.                                      DEFINITIONS

 

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

 

1.1                               “Adverse Event” shall have the meaning set
forth in 21 CFR Section 600.80.

 

1.2                               “Affiliates” shall mean, with respect to a
given party, any corporation, firm, partnership or other entity which 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 thirty percent (30%) or greater of the equity having the
power to vote on or direct the affairs of the entity.

 

1.3                               “Dataset” shall have the meaning set forth in
Section 6.1.

 

1.4                               “Eligible Pharmacies” means the pharmacies
owned by Distributor or an Affiliate of Distributor and listed on Schedule D
attached hereto.

 

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

 

1.6                               “Participants” shall mean out-patients in the
Territory who are referred by their treating physician or provider.

 

1.7                               “Product” shall mean the pharmaceutical
products sold by Pharmacyclics and listed in Schedule A hereto, including such
products in any package size or strength listed in Schedule A or approved by the
FDA during the term of this Agreement.

 

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1.8                               “Territory” shall mean the United States of
America and the United States Territories.

 

1.9                               “Wholesale Acquisition Cost” or “WAC” means
the wholesale acquisition cost for a Product as determined by Pharmacyclics and
published by First Data Bank and/or Medispan, as selected by Distributor, and in
effect as of the time of order.

 

2.                                      ORDERS, DELIVERY

 

2.1                               The parties hereto agree that, in the event of
a commercial launch of Product in the United States by Pharmacyclics (the
“Product Launch”), which Product Launch will or will not occur as determined in
the sole discretion of Pharmacyclics, commencing on the date of the Product
Launch, which date shall be determined in the sole discretion of Pharmacyclics
(the “Product Launch Date”), and continuing during the term of this Agreement,
Distributor shall purchase Product from Pharmacyclics at the prices set forth in
Schedule A and Pharmacyclics shall supply Product to Distributor, for sale and
distribution to Participants as specified above.  Distributor shall order
Product from Pharmacyclics in such quantities as are necessary to meet the
demand for Product from Distributor’s Participants, as determined by Distributor
in its sole discretion.  All orders shall be subject to acceptance by
Pharmacyclics in its sole discretion.  All purchases of Product by Distributor
shall be on the terms and conditions set forth in this Agreement.

 

2.2                               Pharmacyclics shall ship Product to
Distributor FOB Destination (Incoterms 2000).  Pharmacyclics shall ship Product
to Distributor by means of three (3) day ground transportation via commercial
truck (or better), provided that such means of transportation shall be
determined by Pharmacyclics and at Pharmacyclics’ cost.  Distributor will prepay
all freight costs incurred to deliver Product to Participants.  Title to and
risk of loss of Product shall transfer to Distributor upon its delivery to
Distributor’s facility.  Pharmacyclics will notify Distributor in writing prior
to back-ordering any Product, whereupon Distributor will have the right to
cancel the order upon written notice to Pharmacyclics.  If Pharmacyclics is
unable to timely fulfill Distributor’s orders, Distributor may purchase products
from other sources.

 

2.3                               Distributor shall unload each shipment of
Product upon receipt.  Within two (2) business days of delivery of any shipment
of Product, Distributor shall (i) notify Pharmacyclics of any nondelivery 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; and (ii) furnish to Pharmacyclics a detailed description of the
nature of the defect.  Upon receipt of notice of any defect or nondelivery,
Pharmacyclics, at its option, shall (i) in the case of any defective Product,
replace or repair any defective Product or issue Distributor a credit in the
amount of the then current purchase price for the defective Product and (ii) in
the case of any nondelivery of Product, replace or issue Distributor a credit in
the amount of then current purchase price for the undelivered Product.  In the
absence of Pharmacyclics’ receipt of written notice from Distributor in
accordance with the terms of this Section 2.3, a shipment of Products shall be
deemed to have been delivered and accepted by Distributor as complete and in
satisfactory condition as to defects discoverable upon visual inspection. 
Distributor shall, at Pharmacyclics’ expense, follow Pharmacyclics’ instructions
to permit Pharmacyclics’ inspection of,

 

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return to Pharmacyclics or send to Pharmacyclics’ third-party disposal company
any Products delivered to Distributor that Distributor has deemed defective. 
Distributor shall use commercially reasonable efforts to cooperate with
Pharmacyclics in investigating the cause of any defect in Product.

 

2.4                               Distributor shall not alter Product packaging
without Pharmacyclics’ consent (except to remove Product from the shipping
containers) and shall not alter Product labeling except to add a prescription
label to Product, as permitted by applicable law.  Distributor shall at all
times comply with the information and recommendations communicated by
Pharmacyclics in writing with respect to the storage, handling and shipment of
Products, provided that if such information and recommendations are materially
different than those otherwise set forth in this Agreement and result in an
increase in the costs incurred by Distributor in performing its obligations
under this Agreement, the parties shall negotiate in good faith an adjustment to
the price set forth in Schedule A.  Distributor shall be responsible for all
costs associated with storage, handling and shipment of Product from the
Eligible Pharmacies.

 

3.                                      PARTICIPANT ORDERS AND IN-OFFICE
DELIVERY

 

3.1                               Pharmacyclics will provide such marketing,
sales and Participant/physician education materials as shall be deemed necessary
by Pharmacyclics to adequately promote Product for its FDA-approved uses.

 

3.2                               In accordance with a physician’s prescription,
Distributor shall provide Product to Participants as designated by Participant. 
Distributor shall use commercially reasonable efforts to provide Products such
that Product having the earliest expiration date is dispensed first from
available inventory.

 

3.3                               Distributor will investigate the Participant’s
ability to pay for the Product and will make its own determinations as to those
Participants to whom Distributor is willing to provide Product.  Distributor
will obtain an assignment of benefits from the Participant and will bill the
Participant/insurance company/governmental program/other third party payor in
Distributor’s name.  Distributor shall use reasonable efforts to obtain
reimbursement clearance, if necessary, for anticipated subsequent orders from a
Participant prior to actual receipt of the subsequent order.

 

3.4                               Distributor assignment of benefits (“AOB”)
services directly related to Product will include the following:

 

A.                                    Reimbursement services

 

1.                                      Accepting Participant referrals from a
toll free phone call or fax.  Referrals will primarily be in the form of
statements of medical necessity received with the support of Sonexus Health, a
third party vendor serving as a hub for the administration of Pharmacyclics’
program of patient support services.

 

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2.                                      Verification of Participant’s third
party benefits for Product, including in each instance determinations of both
Medical Benefit eligibility and Pharmacy Benefit eligibility.

 

3.                                      Use reasonable efforts to obtain prior
authorization for therapy and other supporting documentation, including the
continued application of such efforts in those cases that are denied “first
pass” prior authorization.

 

4.                                      Explaining to the appropriate party the
Participant’s insurance benefits and his/her financial responsibility.

 

5.                                      Accepting the Participant’s assignment
of benefits, including the Participant’s consent for therapy, release of medical
records, and acknowledgment of financial responsibility.

 

6.                                      Filing insurance claims for the Product
on the Participant’s behalf.

 

7.                                      Use reasonable efforts to collect the
Participant’s co-payments and deductibles.

 

8.                                      Coordination of benefits with
Participant’s secondary insurance.

 

9.                                      Receive and handle each Statement of
Medical Necessity for the Product as specified in Schedule E attached hereto.

 

10.                               Dedicating and identifying by name at least
one individual who is available on a weekly basis for discussion of the status
of cases with Pharmacyclics’ personnel responsible for reimbursement issues. 
The individual’s availability must be at mutually convenient times and must
allow for discussions of reasonable duration.

 

11.                               Pharmacyclics hereby represents and warrants
to Distributor that Pharmacyclics shall require its hub provider (a third party
vendor serving as a hub for the administration of Pharmacyclics’ program of
patient support services) to reverse any test claim adjudicated using
Distributor’s NCPDP# in conducting any benefit investigation activities for the
Products, if authorized by Distributor.  Pharmacyclics acknowledges that any
violation of this Section exposes Distributor to risk and that it will indemnify
Distributor for any breaches of this Section in accordance with Section 15 of
this Agreement.

 

B.                                    Pharmacy services

 

1.                                      Verify the prescription.

 

2.                                      Filling the prescription and labeling
medications in compliance with state pharmacy laws.

 

3.                                      Use commercially reasonable efforts to
computerize next shipment scheduling capability for follow up doses.

 

4.                                      Coordinating planned delivery times with
the Participant/caregiver so that medication is available on a continuous basis.

 

5.                                      Delivering medication to the designated
delivery address.

 

6.                                      Use commercially reasonable efforts to
make follow-up calls to arrange next delivery.

 

3.5                               Distributor shall be responsible for all
billing and collection in connection with its sales of Product.

 

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3.6                               Distributor shall be responsible for all costs
associated with distribution and delivery of Products to its Participants.

 

4.                                      INVENTORY CONTROL

 

4.1                               Maximum Product Inventory.  With the exception
of each of the first two full calendar months following the Effective Date, at
the end of any given full calendar month during the term of this Agreement,
Distributor shall not have remaining inventory of any Product in excess of the
average biweekly sales of such Product (any such average biweekly sales of such
Product, the “Maximum Product Inventory”), determined as follows: (I) calculate
the number of stock-keeping units of such Product dispensed to Participants by
Distributor during such full calendar month and the preceding two (2) full
calendar months; (II) divide by six (6) the number obtained from clause (I) of
this sentence; and (III) if the number obtained from clause (II) of this
sentence is not a whole number, round up to the next whole number.  If
Distributor believes that demand for a Product warrants such action, Distributor
may submit a written request to Pharmacyclics for a specific increase in the
Maximum Product Inventory for a specific Product for a specific full calendar
month.  Pharmacyclics may, in Pharmacyclics’ sole discretion, provide
Distributor with Pharmacyclics’ written authorization for such increase in the
Maximum Product Inventory for such Product for such full calendar month.  Unless
otherwise expressly stated in Pharmacyclics’ written authorization, the increase
shall not apply to the Maximum Product Inventory for such Product in any
subsequent month.

 

4.2                               Audit.  Upon providing Distributor with at
least seventy-two (72) hours’ written notice, at any time Pharmacyclics may,
during Distributor’s normal business hours, conduct an on-site audit of
Distributor’s records and/or Distributor’s physical inventory of any Product at
Distributor’s facility or facilities for the purpose of assessing Distributor’s
compliance with the inventory restriction set forth in this Section 4.  No audit
initiated under this Section 4.2 may encompass a period of time longer than the
twelve (12) months preceding the initiation of such audit.  In the event any
audit initiated under this Section 4.2 identifies any given full calendar month,
excluding any month(s) subjected to a previous audit, at the end of which full
calendar month Distributor holds or held in inventory a total number of
stock-keeping units of any Product that is at least ten percent (10%) greater
than the applicable Maximum Product Inventory, Distributor shall reimburse
Pharmacyclics for all of Pharmacyclics’ reasonable costs and expenses incurred
in connection with the conduct of such audit.  In the event any audit initiated
under this Section 4.2 identifies no full calendar month, excluding any
month(s) subjected to a previous audit, at the end of which full calendar month
Distributor holds or held in inventory a total number of stock-keeping units of
any Product that is at least ten percent (10%) greater than the applicable
Maximum Product Inventory, Pharmacyclics shall bear all of Pharmacyclics’ costs
and expenses incurred in connection with the conduct of such audit.

 

5.                                      OTHER SERVICES

 

5.1                               Distributor shall ensure that a licensed
pharmacist, who is properly trained to answer Product-related questions or
requests for emergency supplies of Product, is available by

 

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telephone (i) from 8:00a.m. to 5:00 p.m. local time Monday through Friday,
except Distributor holidays, for routine calls and (ii) twenty-four hours (24)
per day for emergency calls.  Distributor will not handle requests for clinical
information outside of the scope of Distributor’s usual pharmacist counseling
which will be limited to information covered in the package insert.  Distributor
shall be responsible for all costs associated with the services provided
pursuant to this Section 5.1.

 

6.                                      DATA AND REPORTS

 

6.1                               As permitted by law, and at a frequency
mutually agreed upon by the parties and as specified in Schedule B, Distributor
shall generate and furnish to each of two third party data aggregators
designated by Pharmacyclics (collectively, “Data Aggregators,” and each
individually, a “Data Aggregator”), a Business Partner (as that term is defined
in this Section 6.1 below) designated by Pharmacyclics (the “Designated Business
Partner”), and Pharmacyclics data in the form of a dataset (the “Dataset”)
(which Dataset shall be owned by Distributor and de-identified in accordance
with Section 6.2) containing the information specified in Schedule B for each
Participant and each order.  All Datasets shall be furnished by Distributor to
Data Aggregators, Designated Business Partner and Pharmacyclics via and in
accordance with standard secure files transfer protocol (“FTP”).  Either one of
the Data Aggregators shall, on behalf of Pharmacyclics, perform all acts and
take all steps necessary to ensure adequate quality control and validation of
the data in the Datasets furnished by Distributor.  In the event Data Aggregator
identifies any issue with respect to the quality or validation of data in the
Datasets, Data Aggregator will, on behalf of Pharmacyclics, work directly with
Distributor to resolve such issue in a timely manner.  If Data Aggregator or
Pharmacyclics notifies Distributor of any error in any report that Distributor
provided to Data Aggregator or of any report that Distributor failed to provide
to Data Aggregator under this Section 6.1, Distributor shall, within fifteen
(15) days of such notice (any such notice period, a “Reporting Cure Period”),
provide to Data Aggregators, Designated Business Partner and Pharmacyclics a
revised report that corrects any such error in the original report or provide to
Data Aggregators, Designated Business Partner and Pharmacyclics the report that
Distributor failed to provide earlier.  The Datasets shall not be used by Data
Aggregators to improve or enhance any service or database of Data Aggregators. 
Data Aggregators may use the Datasets solely for purposes of integrating data
therefrom into the data streams (“Data Streams”) that Data Aggregators provide
to Pharmacyclics or any of Pharmacyclics’ business partners, including without
limitation Janssen Biotech, Inc. and its affiliates (any such business partner,
a “Business Partner”).  For the avoidance of doubt, Pharmacyclics and its
Business Partners may use data from the Data Streams for business planning
purposes.

 

6.2                               A Data Aggregator designated by Pharmacyclics
(the “Designated Data Aggregator”) will, on behalf of Pharmacyclics, provide
Distributor with a patient-identifiable health information (“PHI”)
de-identification service (the “PHI De-Identification Service”) for the blinding
of PHI in the data to be furnished by Distributor hereunder, which PHI
De-Identification Service shall be fully compliant with and certified under the
Health Insurance Portability and Accountability Act of 1996 (HIPAA).  The
Designated Data Aggregator and Distributor shall enter into a Business Associate
Agreement (as defined

 

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under HIPAA) under which Designated Data Aggregator shall receive PHI for the
sole purpose of performing the Patient De-Identification Service using PHI
De-Identification Software installed on the Designated Data Aggregator’s
computer network servers.

 

6.3                               In consideration of the data reporting
furnished to Pharmacyclics by Distributor in accordance with Schedule B and the
provisions of Section 6.1 above (“Data Reporting”), Pharmacyclics shall pay to
Distributor (a) a one-time fee (to defray the set-up cost for the commencement
of data reporting) in the amount of [*](1) (the “Set-Up Fee”) and (b) a
recurring fee to defray the ongoing cost of data reporting) in the amount of [*]
per calendar month (the “Data Fee”).  The Set-Up Fee shall be due and payable to
Distributor within thirty (30) days of the Effective Date and Pharmacyclics’
receipt of an invoice therefor.  The Data Fee corresponding to the Data
Reporting for any given calendar month shall be due and payable to Distributor
within thirty (30) days of Pharmacyclics’ receipt of all of such Data Reporting
for such calendar month and an invoice reflecting the Data Fee therefor.  All
past due accounts may be charged 1.5% interest per month.  Notwithstanding the
foregoing, (i) if any of the Data Reporting for a given calendar month is not
accurate or complete in keeping with the requirements of Schedule B,
Pharmacyclics shall not be obligated to pay the Data Fee for the Data Reporting
for such calendar month until such time as Pharmacyclics receives from
Distributor the complete and accurate Data Reporting for such calendar month and
an invoice reflecting the Data Fee therefor, and (ii) if Pharmacyclics receives
fewer than [*] of the installments of the Data Reporting for a given calendar
month prior to the expiration of a grace period of five (5) days commencing, for
any such installment, on the due date specified in Schedule B, Pharmacyclics
shall not be obligated to pay more than [*] of the Data Fee for the Data
Reporting for such calendar month.

 

6.4                               Notwithstanding anything stated herein to the
contrary, Distributor and Pharmacyclics each agree that to the extent that it
receives, in the performance of services hereunder, PHI, such PHI shall be used
or disclosed by it only as permitted by applicable state and federal laws,
including without limitation applicable Administrative Simplification provisions
of HIPAA, as the same may be amended from time-to-time.

 

7.                                      PRODUCT PRICING

 

7.1                               Distributor shall purchase Product from
Pharmacyclics at a price per unit as specified in Schedule A.  Distributor shall
have sole responsibility and authority for determining the price at which it
will sell Product to its Participants.

 

7.2                               All amounts due under Section 7.1 above are
payable by check to Pharmacyclics in U.S. currency.  Pharmacyclics shall invoice
Distributor for all amounts due hereunder.  Distributor shall pay all such
invoices in accordance with the due dates specified therein, under which (i) the
payment owed shall be net of a [*] discount applied against the invoiced amount
if (A) in the case of any invoice issued within ninety (90) days of the

 

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* 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.

 

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Product Launch Date, such payment is received by Pharmacyclics within forty-five
(45) days of the issue date of the invoice (B) in the case of any invoice issued
after the expiration of ninety (90) days following the Product Launch Date, such
payment is received by Pharmacyclics within thirty (30) days of the issue date
of the invoice and (C) Data Aggregator receives by the due date(s) specified in
Exhibit B complete and accurate Data Reporting for the month preceding the
issuance of the invoice (such achievement, a “Full Performance Data Reporting
Month”), and (ii) the payment owed shall be the full amount invoiced if (D) in
the case of any invoice issued within ninety (90) days of the Product Launch
Date, such payment is received by Pharmacyclics forty-six (46) or more days
after the issue date of the invoice (E) in the case of any invoice issued after
the expiration of ninety (90) days following the Product Launch Date, such
payment is received by Pharmacyclics thirty-one (31) or more days after the
issue date of the invoice or (F) Distributor did not achieve a Full Performance
Data Reporting Month for the month preceding the issuance of the invoice.  In
the event that an invoice payment due date falls on a Saturday, Sunday or a
federal holiday, Distributor may make payment on the next business day and still
satisfy the prompt payment requirement which, in combination with the
achievement of a Full Performance Data Reporting Month for the month preceding
the issuance of the invoice, is needed to earn the prompt payment discount for
the invoice.  All past due accounts may be charged 1.5% interest per month.

 

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

 

7.4                               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
Pharmacyclics’ income, Distributor shall be liable for and pay all taxes imposed
in connection with the activities of Distributor contemplated hereunder.

 

8.                                      REPLACEMENTS AND RETURNS

 

In the event Distributor or a Distributor Participant returns or requests to
return a Product, Distributor shall promptly notify Pharmacyclics and
Pharmacyclics shall, upon return of Product, give Distributor a credit in the
amount of the purchase price paid by Distributor for the returned Product,
provided that the (i) Product is either returnable and returned under
Pharmacyclics’ then-current Return Goods Policy for Product purchases, or
(ii) Pharmacyclics has nevertheless authorized the return; and provided that the
reason for the return of the Product does not arise from (x) the negligence or
intentional misconduct of Distributor or any of its agents or employees,
(y) failure of Distributor to comply with the terms of this Agreement or
(z) misdelivery or loss of Product by a carrier used by Distributor.  For any
return of Product authorized by Pharmacyclics, Distributor shall send the
Product, or shall instruct Participants to send the Product, to Pharmacyclics or
Pharmacyclics’ designated disposal company as specified and in the manner
described in the then current Return Goods Policy for Product.  Unless
Distributor receives notice to the contrary from Pharmacyclics in accordance
herewith, the Return Goods Policy for Product set forth in Schedule C will take
effect on the Product Launch Date.  Pharmacyclics may modify or restate the
Return Goods Policy for Product at any time by

 

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providing Distributor with advance written notice of such modification or
restatement in accordance with the notice provisions of Section 19.3, which
modified or restated Return Goods Policy for Product shall become effective upon
the date of delivery of the associated notice as specified in Section 19.3.

 

9.                                      ADVERSE EVENT REPORTING AND PARTICIPANT
COMPLAINTS

 

Distributor will comply with applicable state and federal laws, regulations, and
policies and instructions concerning serious adverse events in accordance with
Distributor’s policies and procedures.  Distributor will report to Pharmacyclics
any product problems such as defective or mislabeled product, as soon as
possible, but no later than two (2) business days after becoming aware of such
an issue.

 

10.                               SUSPENSION OF DISTRIBUTION AND RECALLS

 

Upon written notification and request by Pharmacyclics to suspend distribution
of Product, Distributor shall use commercially reasonable efforts to suspend its
distribution of Product.  If the suspension continues for more than six
(6) weeks, Pharmacyclics will repurchase the Product held in inventory by
Distributor at the price paid for such Product by Distributor, and Distributor
shall have the right to terminate this Agreement for material breach under
Section 13.3 excluding the thirty (30) day cure period.  All repurchased Product
shall be returned to Pharmacyclics at Pharmacyclics’ expense.

 

10.1                        Pharmacyclics shall promptly notify Distributor of
any recalls initiated by Pharmacyclics or required by the FDA.  Upon receipt of
notice of a recall from Pharmacyclics, Distributor shall promptly notify the
affected Participants in accordance with Distributor’s standard recall
guidelines.  Pharmacyclics shall provide Distributor with a form letter to be
used in connection with notice of any recall, subject to Distributor’s review
and prior written approval of the form letter, which approval shall not
unreasonably withheld.  Pharmacyclics shall be responsible for the mailing,
shipping and reasonable administrative expenses incurred by Distributor in
connection with the recall as well as the cost of replacement Product for
Distributor’s Participants, except to the extent that the reason for the recall
arises from (i) the negligence or intentional misconduct of Distributor or any
of its agents or employees or (ii) failure of Distributor to comply with the
terms of this Agreement.  Distributor shall cooperate in any recalls by
providing relevant Product information to Pharmacyclics.

 

10.2                        Distributor shall maintain for two (2) years after
termination or expiration of this Agreement such information as reasonably
required in the event of a Product recall after termination or expiration of
this Agreement, and shall make such information available to Pharmacyclics at
Pharmacyclics’ expense in the event of such a recall.

 

10.3                        Distributor shall use its commercially reasonable
efforts to cooperate with Pharmacyclics in investigating any Product failure
which resulted in the need for a recall.

 

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11.                               REPRESENTATIONS AND WARRANTIES OF DISTRIBUTOR

 

11.1                        In performing its obligations under this Agreement,
Distributor shall comply with all applicable laws and regulations, including
without limitation (A) federal and state pharmacy laws and regulations, laws and
regulations relating to the dispensing and/or disposal of pharmaceutical
products and hazardous wastes (to the extent disposal of Product is
Distributor’s responsibility under this Agreement); (B) laws and regulations
relating to the prohibition of off-label promotion; and (C) the Social Security
Act, and as applicable, the federal healthcare anti-kickback statute at
Section 1128(B)(b) and its implementing regulations (42 C.F.R.
Section 1001.952(h)), in furtherance but not limitation of which Distributor
agrees that it will fully and accurately account for, and report, any discounts
received in accordance with the terms of this Agreement in compliance with all
applicable federal, state and local laws and regulations, and Distributor shall
comply with all applicable professional and industry standards and good business
practices.

 

11.2                        Distributor shall not take any action which would
reasonably be anticipated to materially adversely affect its standing or that of
Pharmacyclics in the industry or with respect to Product Participant base or
which would undermine the image of Product.

 

11.3                        Distributor represents and warrants that it now has
and shall maintain in full force during the term of this Agreement all federal
and state pharmacy, wholesaler and other licenses or approvals required for
Distributor to fulfill its obligations under this Agreement, except that
Distributor shall not be required to maintain its licenses in any state which
amends its laws and regulations to require an in-state pharmacy presence as a
requirement for licensing if the new requirement would materially increase the
costs incurred by Distributor in performing its obligations under this
Agreement.

 

11.4                        Distributor shall not use the trademarks or
tradenames of Pharmacyclics except to the extent contained in Product literature
provided by Pharmacyclics and on Product labels or as otherwise approved in
writing by Pharmacyclics.

 

11.5                        Distributor represents that it has the authority to
enter into this Agreement and that its execution of this Agreement and its
performance of its obligations hereunder will not conflict with and is not
prohibited by any other agreement to which Distributor is a party.

 

12.                               REPRESENTATIONS AND WARRANTIES OF
PHARMACYCLICS

 

12.1                        Pharmacyclics represents and warrants that as of
date of shipment the Products: (i) are free from defect in design, material and
workmanship; (ii) comply with all applicable laws, regulations, directives and
requirements of the FDA, including those related to the adulteration or
misbranding of products within the meaning of Sections 501 and 502 of the Food
Drug and Cosmetics Act (“FDCA”); (iii) are not articles which may not be
introduced into interstate commerce pursuant to the requirements of Sections
505, 514, 514, 516 or 520 of the FDCA; (iv) have been manufactured in accordance
with current FDA Good Manufacturing Practices as required by 21 C.F.R. §§ 210
and 820; (v) to its knowledge are not infringing upon the valid and enforceable
patents or trademarks of any third party; and (vi) have been approved by the FDA
pursuant to Section 505 of the FDCA.

 

10

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

 

12.2                        Pharmacyclics shall not use the trademark or
tradenames of Distributor or any Affiliate except to the extent necessary for
activities contemplated under this Agreement or as otherwise approved in writing
by Distributor.  For the avoidance of doubt, Pharmacyclics shall be allowed to
make reference to the corporate name of Distributor in marketing materials or
communications relating to the Product or in the context of Product information
on websites hosted by Pharmacyclics.

 

12.3                        In performing its obligations under this Agreement,
Pharmacyclics shall comply with all applicable laws and regulations, including
without limitation federal and state pharmacy laws and regulations, laws and
regulations relating to the disposal of pharmaceutical products and hazardous
wastes (to the extent disposal of Product is Pharmacyclics’ responsibility under
this Agreement), laws and regulations relating to the prohibition of off-label
promotion, and all applicable professional and industry standards and good
business practices.

 

12.4                        Pharmacyclics shall not take any action which would
reasonably be anticipated to materially adversely affect its standing or that of
Distributor in the industry or with respect to Product Participant base or which
would undermine the image of Product.

 

12.5                        Pharmacyclics represents that it has the authority
to enter into this Agreement and that its execution of this Agreement and its
performance of its obligations hereunder will not conflict with and is not
prohibited by any other Agreement to which Pharmacyclics is a party.

 

12.6                        Pharmacyclics represents and warrants that neither
it nor any of its employees or representatives has been or is debarred pursuant
to the FDCA or has been or is excluded from participating in a federal health
care program, including without limitation the Medicare and Medicaid programs. 
Moreover, Pharmacyclics covenants that in the event it or any of its employees
or representatives are subsequently debarred under the FDCA or excluded from a
federal health care program during the term hereof, Pharmacyclics shall
immediately notify Distributor of such action.

 

13.                               TERM AND TERMINATION

 

13.1                        The initial term of this Agreement shall commence on
the Effective Date and shall continue thereafter for a period of one (1) year,
unless earlier terminated as provided herein.  The term shall be extended
automatically at the end of the initial term and any renewal term thereafter for
an additional one (1) year period unless terminated by either party upon written
notice to the other party of non-renewal at least ninety (90) days prior to the
expiration of the initial term or any renewal term thereafter.

 

13.2                        Either party may terminate this Agreement for any
reason, at any time upon ninety (90) days prior written notice to the other
party.

 

13.3                        Either party may terminate this Agreement (i) for a
material breach by the other party upon thirty (30) days’ prior written notice
unless the breaching party cures the breach within forty-five (45) days or
(ii) in the event of any proceedings, voluntary or

 

11

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involuntary, in bankruptcy or insolvency, by or against the other party, or the
appointment with or without the other parties’ consent of a receiver for such
party.

 

13.4                        Upon receipt or delivery of a termination notice,
the parties shall cooperate to transition distribution of Product for
Distributor’s Participants to a party to be designated by Pharmacyclics. 
Transition of distribution under this Section shall mean the following:

 

(i)            At Pharmacyclics’ request, Distributor shall provide notice to
all of Distributor’s Participants of the change in distributors.

 

(ii)           Distributor shall provide the necessary information from the
Dataset, as allowable and in accordance with the law and all confidentiality
requirements set forth in this Agreement, to the designated distributor.

 

(iii)          Distributor’s obligation to order additional product shall cease
and Pharmacyclics shall repurchase any Product held in inventory by Distributor
on the day of termination at the price paid for the Product by Distributor.  All
such inventory shall be returned to Pharmacyclics at Pharmacyclics’ cost.

 

13.5                        Sections 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18
and 19 shall survive termination or expiration of this Agreement.

 

14.                               REGULATORY, INSPECTIONS, AUDITS

 

14.1                        During the term of this Agreement and for a period
of one (1) year thereafter, each party may perform an audit relating to the
other party’s compliance with the requirements of this Agreement.  The foregoing
notwithstanding, neither party shall be required to disclose any PHI or any
information it is barred from disclosing by a confidentiality agreement to a
third party.  Each party shall be limited to a single audit per year, whether
conducted during the term of this Agreement or the one year period thereafter,
provided that a party’s limit of a single audit per year shall not apply to any
audit initiated for cause by such party.  Any audit initiated under this
Section 14.1 shall be conducted during normal business hours and upon at least
thirty (30) days prior written notice (which notice shall specify the purpose of
the audit and the time period to be audited).  No audit may review data
pertaining to time periods more than twelve (12) months prior to the notice of
audit.  Audits will be performed by either a party’s personnel or by a third
party auditor approved by both parties (“Third Party Auditor”).  The Third Party
Auditor must sign a confidentiality agreement with each party before performing
an audit.  Each party will be responsible for all costs incurred in the
performance of any audit it requests, and will reimburse the audited party for
photocopying and computer processing costs (including reasonable charges for any
requested computer programming and/or retrieval of archived records) incurred in
connection with such audit.  Each party will provide to the audited party a
complete copy of any audit report generated pursuant to this Section 14.1.  In
addition to the above requirements and limitations, any audit desired by a party
shall be conducted as follows: (i) Within fifteen (15) days of receipt of an
audit notice, the party being audited shall deliver a confidentiality agreement
to the requesting party or the Third Party Auditor, as applicable, and
(ii) within forty-five (45) days of the

 

12

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execution of an audit confidentiality agreement between the parties, the party
being audited shall schedule an on-site review and audit of the relevant data.

 

15.                               INDEMNIFICATION

 

15.1                        Pharmacyclics shall at all times during the term of
this Agreement and thereafter defend, indemnify and hold Distributor and its
Affiliates, officers, directors, agents and employees harmless from and against
any and all claims, demands, actions, causes of action, losses, judgments,
lawsuits, damages, liabilities, costs and expenses (including, but not limited
to, court costs and costs of settlement, and reasonable attorneys’ fees), (each,
a “Loss”) that Distributor may suffer or incur in connection with any
third-party claim arising out of: (i) the death of, or bodily injury to, any
person on account of the use of any Product, (ii) any recall, quarantine,
warning, or withdrawal of any Product, or (iii) any breach by Pharmacyclics of
any of its representations, warranties, covenants or agreements contained in
this Agreement; provided however, that the foregoing obligation of
indemnification shall not apply to the extent any such Loss arises from (i) the
negligence or intentional misconduct or violation of applicable law on the part
of Distributor or its Affiliates, or any of its officers, directors, agents or
employees or (ii) breach by Distributor of any of the terms of this Agreement.

 

15.2                        Distributor shall at all times during the term of
this Agreement and thereafter defend, indemnify and hold Pharmacyclics and its
Affiliates, officers, directors, agents and employees harmless from and against
any Loss that they may suffer or incur in connection with any third-party claim
arising out of (i) the negligence or intentional misconduct of Distributor or
any of its Affiliates, officers, directors, agents or employees, or (ii) any
breach by Distributor of any of its representations, warranties, covenants or
agreements contained in this Agreement; provided however, that the foregoing
obligation of indemnification shall not apply to the extent any such Loss arises
from (i) the negligence or intentional misconduct or violation of applicable law
on the part of Pharmacyclics or its Affiliates, or any of its officers,
directors, agents or employees or (ii) breach by Pharmacyclics of any of the
terms of this Agreement.

 

15.3                        A party seeking indemnification under this section
shall give written notice to the other party within five (5) business days of
the indemnified party’s first knowledge of the third party claim giving rise to
an indemnity obligation hereunder, provided that a delay in providing such
notice will not relieve the indemnifying party of its indemnification
obligations hereunder unless the indemnifying party has been materially
prejudiced by such delay.  Provided that the indemnifying party is not
contesting the indemnity obligation, the indemnified party shall permit the
indemnifying party to control any litigation relating to such claim, including
without limitation control over the retention of counsel and control over the
settlement or other disposition of any such claim, provided that the
indemnifying party shall act reasonably and in good faith with respect to all
matters relating to the defense, settlement or disposition of such claim as the
defense, settlement or disposition relates to the party/ies being indemnified
under this Section.  The indemnified party shall cooperate with the indemnifying
party in its defense of any claim for which indemnification is sought
hereunder.  If the indemnifying party fails to defend the claim within a
reasonable time, the indemnified party may assume the defense

 

13

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thereof, and the indemnifying party will reimburse the indemnified party for all
expenses incurred in connection with such defense (including reasonable
attorney’s fees, settlement payments, and payments of judgments) until the
indemnifying party assumes such defense.  All rights of the indemnified party
against any third party with respect to which a claim of indemnity was paid
hereunder shall be subrogated to the indemnifying party.

 

15.4                        In no event shall either party be liable for loss of
profit or any other incidental or consequential damages of the other party.

 

16.                               CONFIDENTIALITY

 

16.1                        Distributor and Pharmacyclics each shall maintain
the confidentiality of any confidential and/or proprietary information of the
other party and the terms of this Agreement (“Confidential Information”).  Such
Confidential Information shall not be disclosed to either party’s employees or
representatives or to any third party, or used by or for the benefit of such
party or any third party, directly or indirectly, except as may be necessary to
carry out or enforce this Agreement.  Neither party shall use the name of the
other party, including any tradename or trademark, in any advertising or
promotional materials or in any communication without prior written consent of
such other party; provided, however, that Distributor may reference
Pharmacyclics in product informational communications.  The foregoing
notwithstanding, the restrictions of this Section shall not apply to
information: (A) which is required to be disclosed by law; (B) which the
receiving party can show was known to it prior to the disclosure by the
disclosing party; (C) which is or becomes public knowledge through no fault of
the receiving party; (D) which is lawfully disclosed to the receiving party by a
third party; or (E) which a client or its agent or representative on behalf of
the client, reviews in connection with an audit of its agreement with
Distributor and disclosure of the terms and conditions of this Agreement is
reasonably necessary in such context; provided, the client or its agent or
representative (as appropriate) has agreed to hold such documents in confidence
prior to receipt of any such Confidential Information.  In addition, nothing in
this Section 16 shall prevent Pharmacyclics from disclosing Confidential
Information to any Business Partner for Business Partner’s use in connection
with any product or program of Pharmacyclics, provided that the Business Partner
is subject to non-use and non-disclosure obligations at least as stringent as
those imposed on Pharmacyclics hereunder and any breach thereof by Business
Partner shall be deemed a breach of such obligations by Pharmacyclics hereunder.

 

16.2                        Immediately upon the expiration or termination of
this Agreement, Distributor and Pharmacyclics shall cease use of and deliver to
the other party all Confidential Information of the other party that such party
may have in its possession or control; provided that one copy may be kept for
archival purposes (subject to the confidentiality requirements of this
Agreement).

 

16.3                        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.

 

14

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16.4                        Notwithstanding anything to the contrary contained
herein, Distributor shall be permitted to disclose to potential and existing
Participants of Distributor that Distributor distributes Product under an
agreement with Pharmacyclics, and shall be permitted to disclose to potential
purchasers of stock or assets of Distributor or other potential sources of
capital (i) that Distributor distributes Product under an agreement with
Pharmacyclics and (ii) the general nature of the relationship with
Pharmacyclics.  Distributor shall also be permitted to make such public
statements regarding its relationship with Pharmacyclics as may be required by
law, regulation or by obligations pursuant to any listing agreement with any
securities exchange.

 

16.5                        The obligations of the parties under this Section 16
shall continue during the term of this Agreement and for a period ending five
(5) years after termination or expiration of this Agreement.

 

17.                               INSURANCE

 

During the term of this Agreement and thereafter as may be necessary to cover
claims associated with Product purchased by Distributor (whether such claims are
made during or after such term), (i) Pharmacyclics shall obtain, pay for, and
keep in full force and effect policies of Commercial General Liability and
Product Liability Insurance; and (ii) Distributor shall obtain, pay for, and
keep in full force and effect policies of Commercial General Liability, Product
Liability and Professional Liability Insurance; provided that in each case such
insurance, together with the policy holding party’s liability umbrella policies,
if any, shall, by virtue of either the limit of a single policy or the combined
limits of a plurality of policies, have minimum per occurrence/per claim limits
of at least five million dollars ($5,000,000), and which policies shall be
carried by one or more insurance carriers with an AM Best Rating of at least A-,
VII or its equivalent.  In the event that any such insurance policy is written
on a claims-made basis, then the policy shall be maintained during the entire
period of this Agreement and for a period of not less than three (3) years
following the termination or expiration of this Agreement.  Each party shall
(i) either effect an endorsement(s) of its subject insurance policy(ies)
designating the other party as an additional insured thereof or carry its
subject insurance policy(ies) with specific policy language granting such
additional insured coverage; and (ii) upon request provide the other party with
a Certificate(s) of Insurance reflecting such endorsement(s) or evidence of
specific policy language granting such coverage.  A new certificate(s) shall be
provided to the other party each time any such insurance policy(ies) is/are
renewed.

 

18.                               DISPUTE RESOLUTION

 

18.1                        By Representatives and Officers.  Pharmacyclics and
Distributor each shall designate an individual as the primary point of contact
for the purpose of administering such party’s obligations under this Agreement. 
If a dispute arises out of or relates to this Agreement, or any party’s
performance under or breach of this Agreement (a “Dispute”), Distributor’s and
Pharmacyclics’ respective representatives shall first attempt to resolve any
such Disputes for up to thirty (30) days, after which time any unresolved
Disputes shall be submitted for resolution by the General Counsel of
Pharmacyclics and the legal

 

15

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

 

representative of Distributor.  If such executives cannot resolve any such
Disputes within thirty (30) days of such submission, then Distributor or
Pharmacyclics may submit such Disputes for resolution by arbitration under
Section 18.2 below.

 

18.2                        Binding Arbitration.  If any Dispute is not resolved
pursuant to Section 18.1, then Distributor or Pharmacyclics may submit such
Dispute for binding arbitration.  Such arbitration shall be conducted by, and in
accordance with the then-applicable rules of, JAMS and shall be held in the
state in which the party not electing to bring suit has its principal business
site.  The award rendered shall be final and binding upon the parties.

 

18.3                        Costs.  The party against whom the arbitrator
rules shall reimburse the prevailing party for all reasonable attorneys fees
incurred by the prevailing party in such proceeding.

 

18.4                        Injunctive Relief.   Nothing in this Agreement shall
be deemed as preventing Distributor or Pharmacyclics from seeking injunctive
relief (or any other provisional remedy) from any court having jurisdiction over
the parties and the subject matter of the dispute as necessary to protect any
party’s name, proprietary information, trade secrets, know-how or any other
proprietary rights.  Judgment upon the arbitrator’s award may be entered in any
court having jurisdiction, or application may be made to such court for judicial
acceptance of the award and/or an order of enforcement as the case may be.

 

19.                               MISCELLANEOUS

 

19.1                        This Agreement shall be binding upon and shall inure
to the benefit of the parties hereto and their respective successors and
assigns, provided that neither party shall have the right to assign this
Agreement or its rights and obligations hereunder without the prior written
consent of the other party, which consent shall not be unreasonably withheld,
except that either party may assign this Agreement or its rights and obligations
hereunder to its Affiliates or successors in business who assume and agree to be
bound by the terms hereof provided the entity has demonstrated financial ability
to carry out the party’s obligations hereunder.

 

19.2                        This Agreement constitutes the entire and only
agreement between the parties relating to the subject matter hereof, and all
prior negotiations, representations, agreements and understandings are
superseded hereby.  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.

 

19.3                        Any notice required by this Agreement shall be given
by prepaid, first class, certified mail, return receipt requested, or by air
courier, hand delivery or facsimile, to the parties at the following addresses:

 

If to Pharmacyclics:

Pharmacyclics, Inc.

995 E. Argues Avenue

Sunnyvale, CA 94085

Attn: Commercial Operations

Fax: 408-215-3684

 

16

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With copy to:

 

995 E. Argues Avenue

Sunnyvale, CA 94085

Attn: General Counsel

Fax: (408) 774-0340

 

If to Distributor:

 

Diplomat Specialty Pharmacy

4100 S. Saginaw St.

Flint, MI 48507

Attn: General Counsel

Fax:

 

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 courier or
hand delivery.

 

19.4                        Neither party shall be liable for any failure or
delay caused by fires, flood, earthquakes, peril of the sea, 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 (not due to the acts or omissions of the non-performing party),
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.

 

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

 

19.6                        For purposes of this Agreement, the parties and
their employees and agents shall not be deemed agents, servants, partners, joint
ventures or employees of the other party.  Thus, they do not have the authority
to take action on a party’s behalf or to bind the other party without the other
party’s prior written consent.  The parties, its employees and agents are acting
in the capacity of independent contractors.  The parties are not responsible for
withholding, and shall not withhold, FICA or taxes of any kind from any payments
it owes to the other party.  Each party is responsible to provide any and all
compensation, benefits and/or insurance to its employees and agents.  It is also
understood and expressly acknowledged that the party’s employees and agents are
not eligible to participate in, nor are they eligible for coverage under, any of
the other party’s benefit plans, programs, employment policies, procedures or
workers’ compensation insurance.

 

19.7                        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

 

17

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Agreement, except if the principal intent of the Agreement is frustrated by such
reformation or deletion, in which case this Agreement shall terminate.

 

19.8                        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.

 

19.9                        This Agreement shall be construed and enforced in
accordance with the laws of the State of California, excluding choice of law
rules.

 

19.10                 Construction.  Titles, headings and other captions are for
convenience only and are not to be used for interpreting this Agreement. 
Ambiguities, if any, in this Agreement shall not be construed against any party,
irrespective of which party may be deemed to have drafted the Agreement or
authorized the ambiguous provision.

 

19.11                 Exclusion of Extrinsic Evidence.  It is the express intent
of the parties to exclude, and the parties hereby agree to exclude, in any
litigation or legal proceeding relating to this Agreement, any and all evidence
of oral or other communications between the parties concerning the meaning or
interpretation of this Agreement, regardless of whether any such communications
were made before or after the execution of this Agreement (any and all such
evidence, “Extrinsic Evidence”).  The parties hereby mutually agree, covenant
and pledge (i) not to offer into evidence any Extrinsic Evidence in connection
with the meaning or interpretation of this Agreement in any litigation or legal
proceeding relating to this Agreement, and (ii) solely as and to the extent any
material parol evidence is in dispute with respect to an issue not governed by
the terms and conditions of this Agreement or made subject thereto by virtue of
the merger and integration provision set forth in Section 19.2 above, and solely
in any litigation or legal proceeding between the parties not subject to the
binding arbitration procedures set forth in Section 18 above, to accept and
stipulate, and hereby so accept and stipulate, to the disposition by special
verdict of any and all factual issues in connection with which the disputed
material parol evidence is offered, prior to any decision or judgment rendered
in the matter by a court having jurisdiction thereof, as permitted under Medical
Operations Management, Inc. v. National Health Laboratories, Inc., 176 Cal. App.
3d 886 (1986) and City of Hope National Medical Center v. Genentech, Inc.,
No. 129463, 2008 WL 1820916 (Cal. Apr. 24, 2008).

 

IN WITNESS WHEREOF, the parties have executed this Agreement on the date first
above written.

 

DIPOLMAT PHARMACY, INC.

PHARMACYCLICS, INC.

(DISTRIBUTOR)

 

 

 

By:

 

/s/ Ryan E. Ruzziconi

 

By:

 

/s/ Richard B. Love

 

Name:

 

Ryan E. Ruzziconi

 

Name:

 

Richard B. Love

 

Title:

 

VP and General Counsel

 

Title:

 

VP and General Counsel

 

 

 

 

 

 

 

 

 

Date:

 

August 13, 2013

 

Date:

 

August 9, 2013

 

 

18

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SCHEDULE A

 

Product

 

NDC#

 

Strength

 

Package Size

 

Price*

 

 

 

 

 

 

 

 

 

ibrutinib

 

57962-140-09

 

140mg

 

90 capsule bottle

 

[*]

 

 

 

 

 

 

 

 

 

ibrutinib

 

57962-140-12

 

140mg

 

120 capsule bottle

 

[*]

 

[*]

 

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

* 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.

 

19

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SCHEDULE B

 

DISPENSING REPORT

 

Ibrutinib Product

 

Distributor shall provide the Dispensing Report on a daily basis (such
Dispensing Report, the “Daily Dispensing Report”) to Pharmacyclics, the
Designated Business Partner, and the Data Aggregator who is selected by
Pharmacyclics to receive the Daily Dispensing Report (the “Daily Data
Aggregator”).  The requirements of the Daily Dispensing Report are described in
paragraphs I-III under the heading “Daily Dispensing Report Requirements” below.

 

Distributor shall provide the Dispensing Report on a weekly basis (such
Dispensing Report, the “Weekly Dispensing Report”) to the Data Aggregator who is
selected by Pharmacyclics to receive the Weekly Dispensing Report (the “Weekly
Data Aggregator”).  The requirements of the Weekly Dispensing Report are
described in paragraphs IV-VI under the heading “Weekly Dispensing Report
Requirements” below.

 

Daily Dispensing Report Requirements

 

I.             Data Record General Requirements:

 

·                                          Record delimiter - Cartridge return
(ASCII value 13) + Line feed (ASCII value 10)

 

·                                          Field delimiter - Pipe (“I”)

 

II.            The Daily Dispensing Report must be in an electronic format,
include the data records/files specified in the table below and cover the period
commencing on the opening of business on a given day of the week (including
Saturdays and Sundays) through the close of business on such day (each such
period, a “Day”).  The Daily Dispensing Report layout must comply with the
requirements of this Schedule B, including the specifications set forth in the
table below.

 

III.          The Distributor shall transmit the Daily Dispensing Report to the
Daily Data Aggregator, the Designated Business Partner, and Pharmacyclics no
later than 12 p.m. (noon) EST each day for the previous Day’s dispensing
activity.  If the day the Daily Dispensing Report is due falls on a Saturday,
Sunday or nationally recognized holiday, Distributor shall submit the Report on
the next business day.

 

Weekly Dispensing Report Requirements

 

IV.          Data Record General Requirements:

 

·                                          Record delimiter - Cartridge return
(ASCII value 13) + Line feed (ASCII value 10)

 

·                                          Field delimiter - Pipe (“I”)

 

20

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V.            The Weekly Dispensing Report must be in an electronic format,
include the data records/files specified in the table below and cover the period
commencing on a given Saturday through and including the close of business on
Friday (each such consecutive 7-day period, a “Week”) The Weekly Dispensing
Report layout must comply with the requirements of this Schedule B, including
the specifications set forth in the table below.

 

VI.          The Distributor shall transmit the Weekly Dispensing Report to the
Weekly Data Aggregator no later than 12 p.m. (noon) EST each Monday for the
previous Week’s dispensing activity.  If the day the Weekly Dispensing Report is
due falls on a nationally recognized holiday, Distributor shall submit the
Report on the next business day.

 

21

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Report Type - Dispensing Report

 

Field #

 

Data
Category

 

Data
Element

 

Description

 

Identified
Required

 

Notes/ Coding
Instructions

 

Field
Length

 

Format

 

Example

 

Comment

1

 

Patient

 

Record
Code

 

Required for patient de- identification process

 

Yes

 

Must be populated with ‘PAT’

 

 

 

Alpha
Num

 

 

 

If encryption is done at the SPP, this field needs to be populated with
encryption key. Else, SPP send non-encrypted data to data integrator for
encryption.

2

 

Transaction

 

Record
Type

 

Indicates type of record being submitted

 

Yes

 

STATUS, DISPENS E, REFERRA L, etc.

 

 

 

Alpha

 

 

 

 

3

 

Transaction

 

HUB Pharmacy site indentifier

 

Unique code designating pharmacy submitting the record

 

Yes

 

DIP, BLG, TLC, ONC, AVE

 

 

 

Alpha

 

i.e. Diplomat code = DIP, etc. Will provide full list

 

 

4

 

Patient

 

Patient
HUB ID

 

HUB ID of the Patient

 

If available

 

Submit as D999999 for Deidentified

 

 

 

Alpha
Num

 

 

 

 

5

 

Patient

 

Specialty Pharmacy Patient or Case ID

 

Patient ID will uniquely identify each patient. This would be an alphanumeric ID
(Record ID)

 

Yes

 

Must be HIPAA compliant

 

 

 

Alpha
Num

 

HJ2011203

 

 

6

 

Patient

 

Site of Care

 

Site where care was provided to the patient

 

Yes

 

 

 

 

 

Alpha
Num

 

Home administered = H or HCP office= HCP or other = 0

 

 

7

 

Patient

 

Patient Enrollment Form (“PEF”)

 

This field indicates whether the Service Provider, has received the Patient
Enrollment Form, which includes the Patient’s Authorization to disclose the
PHI/IIHI, including the PHI/IIHI set forth in data fields “Year of Birth” and
“Gender”

 

If available

 

 

 

 

 

Alpha

 

Y = Received; N = Not Received

 

 

8

 

Patient

 

Executed
Patient
Authorization PEF

 

This field indicates
whether the Service Provider has received a fully executed PEF (including a
Patient Authorization that was executed/ signed by the Patient authorizing the
disclosure of the Patient PHI/IIHI) if indicated with an “N”, data fields “Year
of Birth” and “Gender” should not be submitted.

 

If available

 

 

 

 

 

Alpha

 

Y = Received; N = Not Received

 

 

9

 

Patient

 

Patient Last Name

 

Patient Last Name

 

Yes

 

 

 

 

 

Alpha
Num

 

 

 

Only provide if data is not encrypted onsite

10

 

Patient

 

Patient First Name

 

Patient First Name

 

Yes

 

 

 

 

 

Alpha
Num

 

 

 

Only provide if data is not encrypted onsite

11

 

Patient

 

Patient Middle Name

 

Patient Middle Name

 

Yes

 

 

 

 

 

Alpha
Num

 

 

 

Only provide if data is not encrypted onsite

12

 

Patient

 

Patient Address 1

 

Patient’s primary correspondence address line 1

 

Yes

 

 

 

 

 

Alpha
Num

 

22 Benson Turnpike

 

Only provide if data is not encrypted onsite

 

22

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

 

Report Type - Dispensing Report

 

Field #

 

Data
Category

 

Data
Element

 

Description

 

Identified
Required

 

Notes/ Coding
Instructions

 

Field
Length

 

Format

 

Example

 

Comment

13

 

Patient

 

Patient Address 2

 

Patient’s primary correspondence address line 2

 

If available

 

 

 

 

 

Alpha
Num

 

Ste 567

 

Only provide if data is not encrypted onsite

14

 

Patient

 

Patient City

 

Patient’s primary correspondence city

 

Yes

 

 

 

 

 

Alpha
Num

 

 

 

Only provide if data is not encrypted onsite

15

 

Patient

 

Patient
State

 

Patient’s primary correspondence state

 

Yes

 

 

 

 

 

Alpha
Num

 

 

 

Only provide if data is not encrypted onsite

16

 

Patient

 

Patient
Zip

 

Patient’s primary correspondence zip

 

Yes

 

5 digits

 

 

 

Numeric

 

17034

 

Only provide if data is not encrypted onsite

17

 

Patient

 

Patient Primary Contact Phone #

 

Patient’s primary correspondence phone

 

Yes

 

 

 

 

 

Numeric

 

3032328569

 

Only provide if data is not encrypted onsite

18

 

Patient

 

Patient Birth Date

 

Need full and true/actual date of birth. Needed to be able to de-identify the
patient and maintain longitudinally

 

Yes

 

MM/DD/
YYYY

 

10

 

Date

 

 

 

Only provide if data is not encrypted onsite

19

 

Patient

 

Patient Gender

 

Patient
Gender
(M/F)

 

Yes

 

M - Male, F - Female

 

1

 

Alpha
Num

 

 

 

 

20

 

Patient

 

Patient Weight

 

Patient
Weight

 

If available

 

 

 

 

 

Numeric

 

Rounded up to whole Lbs

 

 

21

 

Patient

 

ICD - 9 - Primary

 

Numeric ICD-9 Code

 

Yes

 

 

 

 

 

Alpha
Num

 

40.01

 

 

22

 

Patient

 

ICD - 9 - Secondary

 

Numeric ICD-9 Code

 

No

 

if available

 

 

 

Alpha
Num

 

 

 

 

23

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

 

 

[*]

 

[*]

 

 

24

 

Patient

 

Patient
Status

 

Indicates if a patient’s therapy is active, on- hold or discontinued. Values
depend on SP’s Case Management System

 

Yes

 

Actual value or empty if not supplied

 

 

 

Alpha
Num

 

Select from drop down list

 

 

25

 

Patient

 

Patient Sub Status

 

This field should be populated only if Patient Shipment has been suspended. DCxx
where xx indicates the reason for the therapy being discontinued for this
patient. CCxx where xx indicates the reason for the therapy being cancelled.
OHxx where xx indicates the reason for the therapy being On Hold PDxx where xx
indicates the reason for the therapy being pending Values depend on SP’s Case
Management System

 

Yes, if status is not active

 

Actual value or empty if not supplied When this field is populated, the product
dispensing fields should be empty or zero.

 

 

 

Alpha
Num

 

Select from drop down list

 

 

26

 

Patient

 

Patient Status Date

 

Date the current patient status was set

 

Yes

 

MM/DD/
YYYY

 

10

 

 

 

 

 

 

 

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

* 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.

 

23

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

 

27

 

Patient

 

Referral Source

 

Indicates original source of the patient

 

If available

 

Actual value or empty if not supplied

 

 

 

 

 

Direct, Hub, Retail

 

 

28

 

Patient

 

Referral
date

 

Date patient referral is received

 

Yes

 

MM/DD/
YYYY

 

10

 

 

 

 

 

 

29

 

Physician - Prescriber

 

Prescribing Physician NPI #

 

Prescribing NPI #

 

Yes

 

Actual value or ‘Restricted’ if legislative restriction

 

 

 

Alpha
Num

 

2313036901

 

 

30

 

Physician - Prescriber

 

Prescribing Physician
DEA #

 

Prescribing DEA #

 

If available

 

Actual value or ‘Restricted’ if legislative restriction

 

 

 

Alpha
Num

 

AB2374658

 

 

31

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

[*]

 

[*]

 

 

32

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

 

 

 

 

 

 

 

33

 

Physician - Prescriber

 

Prescribing
Physician
First Name

 

Prescribing
Physician
First Name

 

Yes

 

Actual value or ‘Restricted’ if
legislative restriction

 

 

 

Alpha
Num

 

Julie

 

 

34

 

Physician - Prescriber

 

Prescribing
Physician
Last Name

 

Prescribing
Physician
Last Name

 

Yes

 

Actual value or ‘Restricted’ if
legislative restriction

 

 

 

Alpha
Num

 

Marsh

 

 

35

 

Physician - Prescriber

 

Prescribing Physician Middle Initial

 

Prescribing Physician Middle Initial

 

No

 

Actual value or ‘Restricted’ if legislative restriction

 

 

 

Alpha
Num

 

 

 

 

36

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

[*]

 

[*]

 

 

 

 

37

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

[*]

 

 

 

 

 

 

38

 

Physician - Prescriber

 

Prescriber Specialty

 

Prescriber Specialty

 

If available

 

 

 

50

 

 

 

 

 

 

39

 

Physician - Prescriber

 

Prescribing Physician Address 1

 

Prescribing Physician Address 1

 

Yes

 

Actual value or ‘Restricted’
If legislative restriction

 

 

 

Alpha
Num

 

610 Main St.

 

 

40

 

Physician - Prescriber

 

Prescribing
Physician
Address 2

 

Prescribing Physician Address 2

 

No

 

Actual value or ‘Restricted’ if legislative restriction

 

 

 

Alpha
Num

 

Bldg 200

 

 

41

 

Physician - Prescriber

 

Prescribing Physician City

 

Prescribing Physician City

 

Yes

 

Actual value or ‘Restricted’ if legislative restriction

 

 

 

Alpha

 

New Orleans

 

 

42

 

Physician - Prescriber

 

Prescribing Physician State

 

Prescribing Physician State

 

Yes

 

Actual value or ‘Restricted’ if legislative restriction

 

 

 

Alpha

 

LA

 

 

43

 

Physician - Prescriber

 

Prescribing Physician Zip

 

Prescribing Physician Zip

 

Yes

 

5 digits or first 3 if legislative restriction

 

 

 

Numeric

 

17034

 

 

44

 

Physician - Prescriber

 

Prescribing Physician Phone Number

 

Prescribing Physician Phone Number

 

Yes

 

10 digits, no dashes, or empty

 

 

 

Numeric

 

3032328569

 

 

45

 

Physician - Prescriber

 

Prescribing Physician Fax Number

 

Prescribing Physician Fax Number

 

Yes

 

10 digits, no dashes, or empty

 

 

 

Numeric

 

3032328569

 

 

46

 

Drug

 

Product
NDC

 

National Drug Code — always send 11 digit NDC

 

Yes

 

Actual value or empty if not supplied, no dashes

 

11

 

Numeric

 

55555222200

 

 

47

 

Drug

 

Product
Form

 

Product
Form

 

If available

 

Actual value or empty if not supplied

 

 

 

Alpha

 

 

 

 

 

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

* 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.

 

24

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

 

48

 

Drug

 

Drug Name

 

Drug name

 

Yes

 

Actual value or
empty if not
supplied

 

 

 

Alpha
Num

 

 

 

 

49

 

Drug

 

Dosage

 

Dosage

 

If available

 

Actual value or empty if not supplied

 

 

 

Alpha
Num

 

2x per week

 

 

50

 

Drug

 

Dispensing unit of measure

 

This file will be the unit of measure quantified by the quantity shipped field.
Such as tab for tablets, vials for vials, mls for milliliters.

 

Yes, if
dispensed

 

Actual value or empty if not supplied

 

 

 

Alpha

 

tablets

 

 

51

 

Drug

 

Dispense Date

 

Date
dispense
occurred

 

Yes, if
dispensed

 

 

 

10

 

Date

 

MM/DD/YYYY

 

 

52

 

Drug

 

Dispense
Quantity

 

Quantity of Medication Dispensed

 

Yes, if
dispensed

 

 

 

 

 

Numeric

 

 

 

 

53

 

Drug

 

Days
Supply

 

# of days supply

 

Yes, if
dispensed

 

Actual
value or
empty if
not
supplied

 

 

 

Numeric

 

28

 

 

54

 

Rx

 

Rx Number/ Order
Number

 

The number the pharmacy assigns to the prescription

 

Yes, if
dispensed

 

Actual
value or
empty

 

 

 

Numeric

 

50023691020 3

 

 

55

 

Rx

 

Rx Date

 

Date Rx was written

 

Yes, if
dispensed

 

MM/DD/
YYYY

 

10

 

Numeric

 

20120425

 

 

56

 

Rx

 

# of Refills Prescribed

 

The number of refills included in the initial prescription

 

If available

 

Actual
value or
empty

 

 

 

Numeric

 

01 to 99

 

 

57

 

Rx

 

# of Refills Remaining

 

The number of refills that patient has remaining

 

If available

 

Actual
value or
empty

 

 

 

Numeric

 

00 to 99

 

 

58

 

Rx

 

Fill Number

 

Fill number of
prescription

 

Yes, if dispensed

 

Actual value or empty

 

2

 

Numeric

 

00, 01, etc.

 

 

59

 

Rx

 

Fill Status

 

Filled, Rejected, Returned

 

If available

 

Actual value or empty

 

 

 

Alpha

 

Select from drop down list

 

 

60

 

Rx

 

Fill Type

 

New or Refill

 

Yes, if dispensed

 

N - new,
R - refill

 

 

 

Alpha

 

Select from drop down list

 

Data integrator required this data

61

 

Payor - Primary

 

Primary Specialty Pharmacy Primary Payor ID

 

Unique ID designated by Specialty Pharmacy for Primary Payor ID

 

If available

 

 

 

 

 

Alpha

 

 

 

 

62

 

Payor - Primary

 

Primary
Payor
Name

 

Patient’s insurance carrier

 

If available

 

Actual value or empty if not supplied

 

 

 

Alpha
Num

 

Aetna

 

 

63

 

Payor - Primary

 

Primary Payor Type

 

Indicates type of Payor

 

If available

 

Actual value or empty if not supplied

 

 

 

Alpha
Num

 

Select from drop down list

 

 

64

 

Payor - Primary

 

Primary
Plan Name

 

Plan name for patient’s insurance

 

If available

 

Actual value or empty if not supplied

 

 

 

Alpha
Num

 

Aetna of NJ

 

 

65

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

[*]

 

[*]

 

 

66

 

Payor - Primary

 

Primary
Plan ID

 

Patient’s ID for the payor

 

Yes

 

 

 

 

 

Alpha
Num

 

 

 

 

67

 

Payor - Primary

 

Primary Group
Code

 

Group Number. Group Code, BIN Code and PCN are used to match the IMS managed
care customer master

 

If available

 

 

 

 

 

Alpha
Num

 

329175146

 

 

68

 

Payor - Primary

 

Primary Plan address 1

 

Specialty Pharmacy Plan address 1

 

If available

 

or PBM if plan unavailable

 

 

 

Alpha

 

 

 

 

69

 

Payor - Primary

 

Primary Plan address 2

 

Specialty Pharmacy Plan address
2

 

If available

 

 

 

 

 

Alpha

 

 

 

 

 

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

* 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.

 

25

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

 

70

 

Payor - Primary

 

Primary Plan City

 

Specialty
Pharmacy
Plan City

 

If available

 

·

 

 

 

Alpha

 

 

 

 

71

 

Payor - Primary

 

Primary Plan State

 

Specialty
Pharmacy
Plan State

 

If available

 

 

 

 

 

Alpha

 

 

 

 

72

 

Payor - Primary

 

Primary
Plan Zip
code

 

Specialty Pharmacy Plan Zip code

 

If available

 

 

 

 

 

Alpha

 

 

 

 

73

 

Payor - Primary

 

Primary Plan Phone #

 

Specialty Pharmacy Plan phone

 

If available

 

 

 

 

 

Numeric

 

3032328569

 

 

74

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

[*]

 

[*]

 

 

75

 

Payor - Primary

 

Primary BIN Code

 

Group Code, BIN Code and PCN are used to match the IMS managed care customer
master

 

Yes

 

Actual value or empty if not supplied

 

 

 

Numeric

 

512039

 

 

76

 

Payor - Primary

 

Primary
PCN

 

Processor Control Number. Group Code, BIN Code and PCN are used to match the IMS
managed care customer master.

 

Yes

 

Actual value or empty if not supplied

 

 

 

Alpha
Num

 

3049249482

 

 

77

 

Payor - Primary

 

Primary Copay Type

 

Formulary that defines the patient’s out of pocket cost (e.g. copay,
coinsurance)

 

If available

 

Actual value or empty if not supplied

 

 

 

Alpha
Num

 

Select from drop down list

 

PCYC required this information for key business purposes

78

 

Payor - Primary

 

Primary Copay amount

 

Amount the patient has to pay out of pocket for the drug

 

If available

 

Actual value or empty if not supplied

 

 

 

Alpha
Num

 

15.1

 

PCYC required this information for key business purposes

79

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

[*]

 

[*]

 

[*]

80

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

 

 

[*]

 

[*]

 

[*]

81

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

[*]

 

[*]

 

[*]

82

 

Payor - Primary

 

Primary PA Required

 

Indicates if a prior authorization was required for the Rx (YIN)

 

If available

 

Actual value or empty if not supplied

 

 

 

Alpha

 

Y

 

PCYC required this information for key business purposes

83

 

Payor - Primary

 

Primary Payor Reject Reason Code

 

Reason for denial by Payor. Values depend on SP’s Case Management System

 

If available

 

Values depend on Pharmacy system

 

 

 

 

 

 

 

PCYC required this information for key business purposes

84

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

 

 

[*]

 

 

85

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

 

 

 

86

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

[*]

 

[*]

 

[*]

87

 

Payor - Secondary

 

Secondary Specialty Pharmacy Primary Payor ID

 

Unique ID designated by Specialty Pharmacy for Primary Payor ID

 

Yes

 

 

 

 

 

Alpha

 

 

 

 

88

 

Payor - Secondary

 

Secondary Payor Name

 

Patient’s insurance carrier

 

If available

 

Actual value or empty if not supplied

 

 

 

Alpha Num

 

Aetna

 

 

89

 

Payor - Secondary

 

Secondary Payor Type

 

Indicates type of Payor

 

If available

 

Actual value or empty if not supplied

 

 

 

Alpha Num

 

Select from drop down list

 

 

90

 

Payor - Secondary

 

Secondary Plan Name

 

Plan name for patient’s insurance

 

If available

 

Actual value or empty if not supplied

 

 

 

 

 

Aetna of NJ

 

 

91

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

[*]

 

[*]

 

 

92

 

Payor - Secondary

 

Secondary Plan ID

 

Patient’s ID for the payor

 

Yes

 

 

 

 

 

Alpha Num

 

 

 

 

 

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

* 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.

 

26

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

 

93

 

Payor - Secondary

 

Secondary Group Code

 

Group Number. Group Code, BIN Code and PCN are used to match the IMS managed
care customer master

 

If available

 

Actual value or empty if not supplied

 

 

 

Alpha Num

 

329175146

 

 

94

 

Payor - Secondary

 

Secondary Plan address 1

 

Specialty Pharmacy Plan address 1

 

If available

 

or PBM if plan unavailabl e

 

 

 

Alpha

 

 

 

 

95

 

Payor - Secondary

 

Secondary Plan address 2

 

Specialty Pharmacy Plan address 2

 

If available

 

 

 

 

 

Alpha

 

 

 

 

96

 

Payor - Secondary

 

Secondary Plan City

 

Specialty Pharmacy Plan City

 

If available

 

 

 

 

 

Alpha

 

 

 

 

97

 

Payor - Secondary

 

Secondary Plan State

 

Specialty Pharmacy Plan State

 

If available

 

 

 

 

 

Alpha

 

 

 

 

98

 

Payor - Secondary

 

Secondary Plan Zip code

 

Specialty Pharmacy Plan Zip code

 

If available

 

 

 

 

 

Alpha

 

 

 

 

99

 

Payor - Secondary

 

Secondary Plan Phone #

 

Specialty Pharmacy Plan phone #

 

If available

 

 

 

 

 

Numeric

 

3032328569

 

 

100

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

[*]

 

[*]

 

 

101

 

Payor - Secondary

 

Secondary BIN Code

 

Group Code, BIN Code and PCN are used to match the IMS managed care customer
master

 

Yes

 

Actual value or empty if not supplied

 

 

 

Numeric

 

512039

 

 

102

 

Payor - Secondary

 

Secondary PCN

 

Processor Control Number. Helps us in auto matching to plan. Group Code, BIN
Code and PCN are used to match the IMS managed care customer master

 

Yes

 

Actual value or empty if not supplied

 

 

 

Alpha

 

 

 

 

103

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

[*]

 

[*]

 

[*]

104

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

[*]

 

[*]

 

 

105

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

[*]

 

[*]

 

 

106

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

 

 

[*]

 

[*]

 

[*]

107

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

[*]

 

[*]

 

[*]

108

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

[*]

 

[*]

 

 

109

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

[*]

 

[*]

 

 

110

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

 

 

[*]

 

 

111

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

 

 

 

112

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

[*]

 

[*]

 

 

113

 

Shipping

 

Transaction ID

 

SP Distributor’s unique ID

 

If available

 

Actual value or empty

 

 

 

Alpha
Num

 

J39340284

 

Leave in as filler, don’t populate if there is no data

114

 

Shipping

 

Site Control
Number

 

NCPDP or NPI

 

If available

 

Restrictions may apply if shipped to Patient

 

 

 

Alpha
Num

 

 

 

 

115

 

Shipping

 

Carrier

 

Carrier

 

No

 

Actual value or empty

 

 

 

Alpha
Num

 

FedEx

 

 

116

 

Shipping

 

Ship To

 

Represents party to whom drug is being shipped (Provider, Patient, Therapy Site,
Alternate Contact)

 

Yes

 

Actual value

 

 

 

Alpha
Num

 

Select from drop down list

 

Leave in as filler, don’t populate if there is no data

117

 

Shipping

 

Site Name

 

Site’s Name

 

If available

 

Restriction s may apply if shipped to Patient

 

 

 

Alpha
Num

 

 

 

Leave in as filler, don’t populate if there is no data

118

 

Shipping

 

Shipment Date

 

Date product is shipped

 

Yes

 

MM/DD/
YYYY

 

10

 

Numeric

 

20120427

 

Leave in as filler, don’t populate if there is no data

119

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

120

 

Shipping

 

Initial Ship Date

 

Date of the first shipment to patient

 

Yes

 

MM/DD/
YYYY

 

0

 

 

 

 

 

Leave in as filler, don’t populate if there is no data

 

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

* 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.

 

27

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

 

121

 

Shipping

 

Shipment
Status

 

Status (e.g. Shipped,
Rejected, Reshipped, Returned)

 

If available

 

Actual value
or empty

 

 

 

Alpha

 

Select from
drop down list

 

Leave in as filler, don’t populate if there is no data

122

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

123

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

[*]

124

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

125

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

[*]

126

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

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

* 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.

 

28

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

 

PATIENT STATUS REPORT

 

Ibrutinib Product

 

Distributor shall provide the Patient Status Report on a daily basis (such
Patient Status Report, the “Daily Patient Status Report”) to Pharmacyclics, the
Designated Business Partner, and the Daily Data Aggregator.  The requirements of
the Daily Patient Status Report are described in paragraphs I-IV under the
heading “Daily Patient Status Report Requirements” below.

 

Distributor shall provide the Patient Status Report on a weekly basis (such
Patient Status Report, the “Weekly Patient Status Report”) to the Weekly Data
Aggregator.  The requirements of the Weekly Patient Status Report are described
in paragraphs V-VIII under the heading “Weekly Patient Status Report
Requirements” below.

 

Daily Patient Status Report Requirements

 

I.             Data Record General Requirements:

 

·              Record delimiter - Cartridge return (ASCII value 13) + Line feed
(ASCII value 10)

·              Field delimiter - Pipe (“I”)

 

II.            The Daily Patient Status Report must be in an electronic format
and include the data records/files specified in the table below for all patients
referred to Distributor, including without limitation patients referred through
the Hub (as that term is defined in paragraph IV. below).  The Daily Patient
Status Report layout must comply with the requirements of this Schedule B,
including the specifications set forth in the table below.

 

III.          The Distributor shall transmit the Daily Patient Status Report to
the Daily Data Aggregator, the Designated Business Partner, and Pharmacyclics no
later than 3 p.m. EST on the day following the previous day’s activity.  If the
day the Daily Patient Status Report is due falls on a Saturday, Sunday or
nationally recognized holiday, Distributor shall submit the Report on the next
business day.

 

IV.          Distributor shall, via telephone, inform Sonexus Health or any
other third party vendor Pharmacyclics designates and authorizes to serve as a
hub for the administration of Pharmacyclics’ program of patient support services
(the “Hub”) of any discrepancies between any given fax cover sheet corresponding
to patient referral data (“Fax”) sent to Distributer by the Hub and the related
patient referral data, within one business day of Distributor’s receipt of the
Fax

 

Weekly Patient Status Report Requirements

 

V.            Data Record General Requirements:

 

·              Record delimiter - Cartridge return (ASCII value 13) + Line feed
(ASCII value 10)

 

29

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

 

·              Field delimiter - Pipe (“I”)

 

VI.          The Weekly Patient Status Report must be in an electronic format,
include the data records/files specified in the table below.  The Weekly Patient
Status Report layout must comply with the requirements of this Schedule B,
including the specifications set forth in the table below.

 

VII.         The Distributor shall transmit the Weekly Patient Status Report to
the Weekly Data Aggregator no later than 3 p.m. EST on the Wednesday following
the previous week’s activity.  If the day the Weekly Patient Status Report is
due falls on a nationally recognized holiday, Distributor shall submit the
Report on the next business day.

 

VIII.       Distributor shall, via telephone, inform the Hub of any
discrepancies between any given Fax and the related patient referral data,
within one business day of its receipt of the Fax

 

Data Element

 

Description

 

Identified
Required

 

Deidentified
Required

 

Notes/
Coding
Instructions

 

Field
Length

 

Form
At

 

Example

Patient Status

 

Indicates if a patient’s therapy is active, on- hold or discontinued. Values
depend on SP’s Case Management System

 

Yes

 

Yes

 

Actual value or empty if not supplied

 

 

 

Alpha
Num

 

Select from drop down list

Patient Sub Status

 

This field should be populated only if Patient Shipment has been suspended. DCxx
where xx indicates the reason for the therapy being discontinued for this
patient. CCxx where xx indicates the reason for the therapy being cancelled.
OHxx where xx indicates the reason for the therapy being On Hold PDxx where xx
indicates the reason for the therapy being pending Values depend on SP’s Case
Management System

 

Yes, if status is not active

 

Yes, if status is not active

 

Actual value or empty if not supplied When this field is populated, the product
dispensing fields should be empty or zero.

 

 

 

Alpha
Num

 

Select from drop down list

Patient Status Date

 

Date the current patient status was set

 

Yes

 

Yes

 

MM/DD/
YYYY

 

10

 

 

 

 

Fill Status

 

Filled, Rejected, Returned

 

If available

 

If available

 

Actual value or empty

 

 

 

Alpha

 

Select from drop down list

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

 

 

[*]

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

 

Secondary
Reimbursement Status

 

Indicates the Payor’s status for reimbursement. Usual values indicate Approved,
Rejected, Or Pending

 

If available

 

If available

 

Values depend on Pharmacy system

 

 

 

 

 

Select from drop down list

Secondary
Reimbursement Status Date

 

The date the reimbursement status was set for the patient

 

If available

 

If available

 

MM/DD/
YYYY

 

10

 

 

 

 

Shipment
Status

 

Status (e.g. Shipped, Rejected, Reshipped, Returned)

 

If available

 

If available

 

Actual value or empty

 

 

 

Alpha

 

Select from drop down list

 

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

* 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.

 

30

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

 

PRODUCT INVENTORY REPORT
Ibrutinib Product

 

Distributor shall provide the Product Inventory Report on a daily basis (such
Product Inventory Report, the “Daily Product Inventory Report”) to
Pharmacyclics, the Designated Business Partner, and the Daily Data Aggregator. 
The requirements of the Daily Product Inventory Report are described in
paragraphs I-Ill under the heading “Daily Product Inventory Report Requirements”
below.

 

Distributor shall provide the Product Inventory Report on a weekly basis (such
Product Inventory Report, the “Weekly Product Inventory Report”) to the Weekly
Data Aggregator.  The requirements of the Weekly Product Inventory Report are
described in paragraphs IV-VI under the heading “Weekly Product Inventory Report
Requirements” below.

 

Daily Product Inventory Report Requirements:

 

I.             Data Record General Requirements:

 

·              Record delimiter - Cartridge return (ASCII value 13) + Line feed
(ASCII value 10)

·              Field delimiter - Pipe (“I”)

 

II.            The Daily Product Inventory Report must be in an electronic
format, include the data records/files specified in the table below and cover
the period commencing on the opening of business on a given day of the week
through the close of business on such day (each such consecutive period, a
“Day”).  The Daily Product Inventory Report layout must comply with the
requirements of this Schedule B, including the specifications set forth in the
table below.

 

III.          The Distributor shall transmit the Daily Product Inventory Report
to the Daily Data Aggregator, the Designated Business Partner, and Pharmacyclics
no later than 12 p.m. (noon) EST each day for the previous Day’s dispensing
activity.  If the day the Daily Product Inventory Report is due falls on a
Saturday, Sunday or nationally recognized holiday, Distributor shall submit the
Report on the next business day.

 

Weekly Product Inventory Report Requirements:

 

IV.          Data Record General Requirements:

 

·              Record delimiter - Cartridge return (ASCII value 13) + Line feed
(ASCII value 10)

·              Field delimiter - Pipe (“I”)

 

V.            The Weekly Product Inventory Report must be in an electronic
format, include the data records/files specified in the table below and cover
the period commencing on Saturday through and including the close of business on
Friday (each such consecutive 7-day period, a “Week”) The Weekly Product
Inventory Report layout must comply with the requirements of this Schedule B,
including the specifications set forth in the table below.

 

31

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

 

VI.          The Distributor shall transmit the Weekly Product Inventory Report
to the Weekly Data Aggregator no later than 12 p.m. (noon) EST each Monday for
the previous Week’s dispensing activity.  If the day the Weekly Product
Inventory Report is due falls on a nationally recognized holiday, Distributor
shall submit the Report on the next business day.

 

Report Type — Product Inventory Report

Data
Category

 

Field
Name

 

Definition

 

Required

 

Notes/
Coding
Instructions

 

Field
Length

 

Format

 

Example

 

CDFS
Comments

Record

 

Record Datestamp

 

Date report generated

 

Yes

 

date report generated, MM/DD/
YYYY

 

10

 

Date

 

 

 

 

Specialty
Pharmacy

 

Data hub vendor Specialty Pharmacy ID

 

Unique ID designated by data hub vendor

 

Yes

 

multiple locations/ pharmacies, want NPI number

 

 

 

Alpha

 

 

 

 

Specialty
Pharmacy

 

National Provider Identifier

 

National Unique ID that can identify Specialty Pharmacy by location

 

Yes

 

 

 

 

 

Alpha

 

 

 

 

Inventory

 

Product
Name

 

Product Name

 

Yes

 

 

 

 

 

Alpha

 

 

 

 

Inventory

 

NDC

 

Drug NDC, Unique identifier for each drug. One record for each NDC number.

 

Yes

 

Includes all 11 digits, without dashes.

 

 

 

Alpha

 

 

 

 

Inventory

 

Inventory Date Begin

 

Begin date for inventory period

 

Yes

 

 

 

 

 

Date

 

 

 

 

Inventory

 

Inventory Date End

 

End date for inventory period

 

Yes

 

 

 

 

 

Date

 

 

 

 

Inventory

 

QTY Begin

 

Beginning inventory units

 

Yes

 

 

 

 

 

Numeric

 

 

 

 

Inventory

 

QTY End

 

Ending inventory units

 

Yes

 

 

 

 

 

Numeric

 

 

 

 

[*]

 

[*]

 

[*]

 

[*]

 

 

 

 

 

[*]

 

[*]

 

 

 

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

* 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.

 

32

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

 

SCHEDULE C

 

Pharmacyclics Return Goods Policy

 

Policy Guidelines for Product bearing NDC #s:

57962-140-09 - 90 capsule bottle

57962-140-12 - 120 capsule bottle

 

Returnable Items

 

·                  Expired unopened product in its original package (single
units) within 3 months of expiration or 3 months after expiration.

 

·                       A valid Return Goods Authorization (RGA) Number must
accompany all returns for proper credit.

·                       RGA Numbers are valid for 45 days from issuance. 
Expired RGA Numbers will be considered invalid and no credit will be issued.

·                       Returned products will be verified by Pharmacyclics and
the final credit will be calculated based upon the Pharmacyclics count.

·                       For a RGA, contact Pharmacyclics Customer Service, phone
at:

 

·                                          Phone: 888-345-9915

·                                          Fax: 866-230-7960

·                                          Email: PCYCCS@rxcrossroads.com

 

·                  Product returned by a wholesaler/customer after having been
shipped in error.

·                  Recalled products (if returned within 6 months from date of
recall).

 

Transportation Charges

 

·                  Prepaid by customer, except if product is shipped in error by
Pharmacyclics, or damaged in transit prior to receipt by customer.  Such charges
will be paid by Pharmacyclics.

 

Non-Returnable Items

 

All product other than listed above shall be deemed not returnable. 
Non-returnable products include, without limitation:

 

·              Not in original package

·              Open or partial packages (unless required by law)

·              Package label has been removed

·              Purchased on a non-returnable basis (e.g., free goods,
short-dated product purchased at a discount)

·              Involved in a fire sale or bankruptcy sale

 

33

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

 

·                                          Deteriorated because of
characteristics beyond the control of manufacturer (e.g., due to improper
storage, heat, cold, water, smoke, fire, etc.)

·              Returned more than three (3) months prior to expiration or more
than three (3) months after the expiration date

·              Product damaged in transit in which case a claim should be
submitted to carrier

·              An unauthorized return

 

Terms of Return Policy

 

·                                          All returns are subject to review by
Pharmacyclics.  Issuance of RGA number does not guarantee credit.  Credit
issuance is dependent on confirmed receipt/review of return goods.  Unauthorized
return goods will be destroyed and credit will not be issued.

 

Procedure for Returning Items

 

All returnable products must be returned to Pharmacyclics’ approved return goods
service contractor, at the following address and in accordance with such
contractor’s procedures:

 

RxCrossroads

4500 Progress Blvd.

Louisville, KY 40218

 

Registered Office:

995 E. Argues Avenue

Sunnyvale, CA 94085-4521

 

34

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

 

SCHEDULE D

 

Eligible Pharmacies (drop-ship locations)

 

Diplomat Specialty Pharmacy

4100 S. Saginaw Street

Flint, MI 48507

 

Diplomat Specialty Pharmacy

G-3320 Beecher Rd.

Flint, MI 48532

 

Diplomat Specialty Pharmacy

1370 Busch Parkway

Buffalo Grove, IL 60089

 

Diplomat Specialty Pharmacy

500 SE 15th St. Suite 102

Ft. Lauderdale, FL 33316

 

Diplomat Specialty Pharmacy

214 E. Fulton St.

Grand Rapids, MI 49503

 

Diplomat Specialty Pharmacy

1809 Excise Ave., Suite 205-208

Ontario, CA 91761

 

35

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

 

SCHEDULE E

 

Statements of Medical Necessity for ibrutinib are primarily submitted to Sonexus
Health, or any other third party vendor Pharmacyclics designates and authorizes
to serve as a hub for the administration of Pharmacyclics’ program of patient
support services, (the “Hub”) directly by prescribers.  In such cases where the
Distributor receives the Statement of Medical Necessity direct, Distributor will
service said patient with ibrutinib Product and said patient will be accounted
for in the required data fields of the periodic reports.

 

36

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