EXCLUSIVE DISTRIBUTION AGREEMENT
CONFIDENTIAL
TREATMENT REQUESTED: Certain portions of this document have been omitted
pursuant to a request for confidential treatment and, where applicable, have
been marked with an asterisk (“[****]”)
to
denote where omissions have been made. Note that eight pages of this exhibit
contain omitted material pursuant to this request. The confidential material
has
been filed separately with the Securities and Exchange
Commission.
This
Exclusive Distribution Agreement (“Agreement”) is made as of April 1, 2002 (the
“Effective Date”), between Alliance Pharmaceutical Corp., a New York
corporation, having its principal place of business at 0000 Xxxxxxx Xxxx
Xxxx,
Xxx Xxxxx, Xxxxxxxxxx 00000 (“Client”), and CORD Logistics, Inc., an Ohio
corporation, having its principal place of business at 00 Xxxxxx Xxxxxxxxx,
XxXxxxxx, Xxxxxxxxx 00000 (“CORD”).
A. Client
is, among other things, in the business of developing and marketing
pharmaceutical products in the United States, the District of Columbia and
Puerto Rico (the “Territory”).
B. CORD
is,
among other things, in the business of distributing pharmaceutical products
to
wholesalers, specialty distributors, physicians, clinics, hospitals, pharmacies,
and other health care providers in the Territory, and of providing Information
Systems and other services that support its customers’ use of its distribution
capabilities.
C. Client
desires to engage CORD as its exclusive distribution agent for commercial
sales
of lmagent™ in all formulations (collectively, the “Product”), and such other
pharmaceutical products agreed to by the parties in the Territory and to
perform
certain other services described in this Agreement, all upon the terms and
conditions set forth in this Agreement.
THEREFORE,
in consideration of the mutual conditions and covenants set forth herein,
CORD
and Client (collectively referred to as “Party” or “Parties”) agree as
follows:
1. Appointment/Authorization.
1.1 Upon
the
terms and conditions set forth in this Agreement, Client appoints CORD as
its
exclusive distribution agent of Product in the Territory to Client’s customers,
including, but not limited to, wholesalers, specialty distributors, physicians,
clinics, hospitals, pharmacies and other health care providers in the Territory
(collectively, “Customers”).
1.2 Subject
to the terms and conditions set forth in this Agreement, CORD accepts the
appointment to represent Client as its authorized exclusive distribution
agent
of Product to Customers in the Territory.
1.3 Client
shall provide CORD with a right of first negotiation with respect to the
distribution of new imaging agents or other pharmaceutical products acquired
or
promoted by Client in the Territory after the Effective Date. Client shall
grant
CORD an exclusive right of negotiation with respect to the distribution of
such
new product for a period of sixty (60) days after Client’s notice to CORD that
such new product will be available for distribution. If the parties have
not
reached an agreement with respect to the distribution of the new product
within
sixty (60) days from the date of Client’s
notice,
and entered into a definitive agreement within sixty (60) days thereafter,
or if
Cord notifies Client in writing at any point during such negotiation period
that
it is not interested or unable to distribute such new product(s), then Client
shall have no further obligation with respect to that new product under this
Section 1.3.
[****]
Represents material which has been redacted pursuant to a request for
confidential treatment pursuant to Rule 24B-2 under the Securities
Exchange Act
of 1934, as amended. The confidential materials have been filed separately
with
the SEC.
2. Services.
2.1 CORD
shall provide the services set forth in the Operating Guidelines, which include,
without limitation, storage, distribution, returns, customer support, financial
support, EDI and system access support (“Services”). A copy of the Operating
Guidelines is attached hereto as Exhibit A and incorporated by
reference.
2.2 The
Operating Guidelines may be amended from time to time upon the mutual written
agreement of the Parties; provided, however, that any change, modification
or
amendment to the Operating Guidelines may result in an increase in the fees
charged by CORD in Section 5.
2.3 CORD’s
services shall comply with the Operating Guidelines, provided Client’s shipment
of Products to CORD are within [****]
of its
Forecast (as hereinafter defined).
2.4 All
Product Returns shall be processed and handled by CORD in accordance with
the
Operating Guidelines; and, any customization or additional return services
requested by Client shall be performed at an additional fee as agreed by
the
Parties.
2.5 Client
is
solely responsible for all Product recalls. In the event Product is subject
to
recall, or Client, on its own initiative, recalls any Product, CORD shall
provide assistance to Client as set forth in the Operating Guidelines, provided
that Client shall pay to CORD an amount equal to CORD’s actual costs incurred
with any, such recall services. Such cost shall be in addition to the Service
Fees described in Section 5 below.
3. Product
Supply/Client Responsibilities.
3.1 Client
shall deliver Product to CORD at CORD’s facility located at 00 Xxxxxx Xxxxxxxxx,
Xxxxx 000, Xx Xxxxxx, XX 00000, or to such other distribution facility as
may be
designated by CORD to Client in writing (“Facility”).
3.2 Client
shall be responsible for delivery of Product to the Facility, including all
costs, expenses and risk of loss associated with such delivery. Title to
Product
shall remain with Client at all times, even when Product is stored or warehoused
at the Facility. Client shall at all times insure the Product for damage,
loss,
destruction, theft or any such other property damage (“Loss”) as further set
forth in Section 17 below. Except for Loss resulting solely from the gross
negligence or willful misconduct of CORD, Client shall bear all risk of loss
or
damage with respect to the Product stored or warehoused at the
Facility.
3.3 Client
shall provide CORD with a forecast of the volume of Product to be handled
by
CORD under this Agreement, not less often than [****]
(“Forecast”). Upon execution of this Agreement, Client shall deliver to CORD a
customer list, which sets forth the Product prices (the “Customer Price List”).
Client shall notify CORD of any change in the Customer Price List not less
than
[****]
prior to
the effective date of any such change. CORD shall use commercially reasonably
efforts to implement such price change in accordance with Client’s
instruction.
3.4 CORD
shall visually inspect each shipment of Product for external damage or loss
in
transit and notify Client of any such damage or loss within a commercially
reasonable period of time following discovery.
2
[****]
Represents material which has been redacted pursuant to a request for
confidential treatment pursuant to Rule 24B-2 under the Securities
Exchange Act
of 1934, as amended. The confidential materials have been filed separately
with
the SEC.
4. Information
System Access.
4.1 CORD
shall provide Client access to an Operating System Base, which consists of
the
software used by CORD to support the services provided to Client, including
the
server and other components needed to execute the software and certain support
services associated therewith, as further set forth in the Operating Guidelines
(collectively, the “System”), upon the terms and conditions set forth in the
System Access Agreement. A copy of the System Access Agreement is attached
as
Exhibit C and incorporated herein by reference. The software releases are
(1)
EliteSeries 6.1.2, as modified by CORD, supplied by Tecsys, Inc., a Montreal,
Quebec, Canadian company, and any upgrades, maintenance releases or
modifications implemented by CORD to support distribution services provided
by
CORD; (2)
BACCS
3.0 as modified by CORD and any upgrades implemented by CORD to support
financial services provided by CORD; and (3)
Impromptu 6.0, supplied by Cognos Inc., a Canadian company, and any upgrades,
maintenance releases or modifications implemented by CORD to support reporting
services provided by CORD.
4.2 The
System shall be made available to Client at the fees set forth in the Fee
Schedule, except that any custom enhancements requested by Client shall be
billed separately based on an hourly rate set forth in the Fee Schedule (as
defined in Section 5).
4.3 In
addition to the terms set forth in the System Access Agreement, Client shall
maintain (4)
a local
area network sufficient to support Client’s terminals and personal computers
that have access to the System, all such personal computers shall meet the
minimum specifications necessary to support software needed to access the
system; (5)
a
centralized server sufficient for data storage, if data export requirements
exist; and (6)
a
connection to the internet sufficient to support system access. Client shall
also assign knowledgeable and qualified employees or representatives to
facilitate access to the System.
5. Fees.
5.1 As
compensation for the Services, Client shall pay to CORD the fees (the “Fees”)
set forth on Exhibit B (the “Fee Schedule”).
5.2 CORD
shall issue an invoice to Client for the Services rendered under this Agreement
or for any other amounts due on a [****]
basis.
Payment is due within [****]
days of
the invoice date. If the Invoice is not paid within such [****]
day
period, a service charge on the unpaid amount calculated at the rate of
[****]
per
month (or the maximum rate permitted by law if such rate is less than
[****]
per
month) shall be imposed until such amount is paid in full.
5.3 The
Fees
shall be held firm for the [****].
Thereafter, CORD shall adjust the price not more often than once per contract
year by the increase in the Producer Price Index - All Commodities published
by
the United States Department of Labor, Bureau of Statistics, as amended from
time to time. In the case of a decrease in the Producer Price Index — All
Commodities referenced above, Client’s pricing shall remain unchanged from the
immediately preceding contract year. For purposes of sub-Section (i), the
base
point shall be the index level on the first day of the contract
year.
5.4 Notwithstanding
the terms set forth above in Section 5.3, if CORD can reasonably demonstrate
that the costs for providing the Services have materially increased, or are
likely to materially increase in the coming year due to the adoption of any
applicable law or regulation (or any material change in the interpretation
or
administration thereof), or due to unforeseen circumstances beyond CORD’s
reasonable control, then upon notice from CORD, the Parties agree to meet
in
good faith and negotiate a mutually acceptable adjustment to the
Fees.
3
[****]
Represents material which has been redacted pursuant to a request for
confidential treatment pursuant to Rule 24B-2 under the Securities
Exchange Act
of 1934, as amended. The confidential materials have been filed separately
with
the SEC.
6. Term
and Termination.
6.1 The
initial term of this Agreement shall begin on the Effective Date and shall
continue for a period of [****] years
(the “Initial Term”), unless terminated earlier pursuant to this Agreement.
Thereafter, this Agreement shall automatically renew for additional terms
of
[****]
each,
unless written notice of termination is given by either Party at least ninety
(90) days prior to the end of the Initial Term, or such other term, in which
case this Agreement shall terminate at the end of the then current
term.
6.2 Either
Party shall have the right to terminate this Agreement:
(a) upon
one
hundred eighty (180) days prior written notice to the other Party, provided
that
in the event Client terminates this Agreement, without cause, prior to the
end
of the Initial Term, such termination shall be effective only upon payment
to
CORD of six (6) months of the System Access Fees set forth on the Fee
Schedule;
(b) upon
the
breach by the other Party of a material provision of this Agreement and that
Party’s failure to cure such breach within thirty (30) days following written
notice thereof from the non-breaching Party, provided that, with respect
to any
failure to make any payment when due under this Agreement, such period to
cure
shall be reduced to ten (10) days; or
(c) immediately
upon notice to the other Party following the commencement of any bankruptcy
or
insolvency proceeding (whether voluntary or involuntary) with respect to
such
other Party or its assets, which in the event of an involuntary proceeding,
is
not dismissed within sixty (60) days, the general assignment for the benefit
of
creditors by such other Party, or the appointment of a receiver, trustee
or
liquidator by or for such other Party.
6.3 Termination
or expiration of this Agreement shall not relieve either Party from any
liability or obligation that accrued prior to such termination or expiration.
Upon termination or expiration of this Agreement, all Product shall be returned
to Client or a designee of Client, at Client’s sole cost and expense. Sections
13 and 14 shall survive termination or expiration of this
Agreement.
7. Audits.
No more
than twice per calendar year, Client or its designee shall have the right
during
normal business hours (i.e., 8:00 a.m. to 5:00 p.m. local time), upon fifteen
(15) business days prior written notice to CORD, to: ii)
conduct
a physical audit of such parties of the Facility that relate solely to Product
stored and warehoused at the Facility under this Agreement; and iii)
review
and audit records that relate solely to the storage and distribution of the
Product. Notwithstanding the foregoing, Client or its designee may, from
time to
time and subject to CORD’s prior consent, perform additional physical audits of
the Product located at the Facility in the event of a reasonable, documented
concern related to the state of such Product. Such additional audits shall
be
conducted during normal business hours (i.e., 8:00 a.m. to 5:00 p.m. local
time).
4
8. Compliance
With Laws.
Each
Party shall conduct its activities in connection with this Agreement in
compliance with all applicable laws, rules, regulations, and orders of
governmental entities.
9. Representations
and Warranties.
9.1 Each
Party represents and warrants to the other that:
(a) it
has
full power and authority to enter into this Agreement and perform all
obligations and conditions to be performed by it under this Agreement without
any restriction by any other Agreement or otherwise;
(b) the
execution, delivery and performance of this Agreement have been duly authorized
by all necessary corporate action of that Party; and
(c) this
Agreement constitutes the legal, valid and binding obligation of that
Party.
9.2 Client
further represents and warrants to CORD that the Product:
(a) is
and
shall be manufactured in conformity with the Food, Drug and Cosmetic Act,
as
amended from time to time, and all other applicable laws, rules, regulations
and
orders of governmental entities relating to the manufacture, promotion, sale
or
distribution of the Product;
(b) does
not
violate or infringe any patent, trademark, tradename or other interest of
any
person or entity.
10. Taxes.
Client
shall pay when due all sales, use, gross receipts, excise, personal property
taxes associated with the Product (excluding any personal property tax
associated with CORD’s equipment used in connection with the Services), and
other taxes now or hereafter imposed as a result of the transactions
contemplated by this Agreement (other than taxes based on CORD’s net income),
none of which have been included in the fees payable to CORD under this
Agreement; provided that the amounts payable by Client under this section
shall
not include taxes based on the net income of CORD.
11. Trademarks.
Neither
Party shall have the right to use the name of the other Party or any Affiliate
of the other Party, or the other Party’s or such Affiliates’ trademarks, service
marks, logos, or other similar marks in any manner except with the prior
written
approval of that Party; provided that the foregoing shall not prohibit CORD’s
use of Client names or marks in connection with the performance of the Services
in a manner consistent with this Agreement. “Affiliate,” as used in this
Agreement, means any legal entity which, during the Term hereof, controls,
is
controlled by, or is under common control with, such Party. For purposes
of this
definition, an entity shall be deemed to control another entity if it owns
or
controls, directly or indirectly, at least fifty percent (50%) of the voting
interest of all equity interests of the other entity (or other such comparable
ownership interest for an entity other than a corporation).
5
12. Confidentiality.
12.1 Each
Party acknowledges that as a result of this Agreement it may learn and have
access to trade secrets and other confidential and proprietary information
of
the other Party through employees, representatives and/or agents acting on
behalf of or subcontracted to either Party (collectively the “Representatives”),
including without limitation, financial information, information regarding
business practices and techniques, customer lists and systems and technology
information, or any information identified as confidential in writing by
either
Party (the “Confidential Information”). For purposes of this Agreement,
Confidential Information shall not include information disclosed by one Party
to
the other Party to the extent that such information can be proven by written
evidence: b)
to be in
the public domain or generally available in the industry in which the disclosing
Party engages in business without any violation of this Agreement by the
other
Party; c)
is
already legally known to the other Party or any of its Affiliates at the
time of
its disclosure by the disclosing Party; d)
becomes
known to the other Party or any of its Affiliates from a third party without
any
obligation of confidentiality or limitation on use; or e)
is
independently developed by the other Party or any of its Affiliates prior
to the
date of its disclosure. The specific material terms of this Agreement shall
be
deemed to be the Confidential Information of each Party. Confidential
Information shall not be deemed to be in the public domain or publicly known
or
in the receiving Party’s possession because it is embraced by more general
information in the receiving Party’s possession or because it is embraced in
general terms in publications.
12.2 Neither
Party shall, directly or indirectly, at any time: f)
disclose
to any third person or entity any Confidential Information of the other Party
(whether learned before or after the date of this Agreement), or g)
use, or
permit or assist any third person or entity to use, any such Confidential
Information, excepting only: (1)
disclosures required by law, rule, regulation or order, as reasonably determined
by the disclosing Party or its legal counsel, and (2)
disclosures on a confidential basis to directors, officers, employees, and
agents of that Party or its Affiliates who have a reasonable need to know
such
Confidential Information in the normal course of business of that Party or
any
of that Party’s Affiliates.
12.3 The
obligations of confidentiality hereunder shall survive the termination of
this
Agreement for a period of three (3) years. Upon termination of this Agreement
(for any reason) each Party shall promptly: (3)
return
to the other Party all documentation and other materials (including copies
of
original documentation or other materials) containing any Confidential
Information of the other Party; or (4)
with the
other Party’s consent, which consent will not be unreasonably withheld, certify
to the other Party, pursuant to a certificate in form and substance reasonably
satisfactory to the other Party, as to the destruction of all such documentation
and other materials.
13. Indemnification.
Each
Party shall indemnify and hold harmless the other Party and its parent and
Affiliates, and each of their directors, officers, employees, agents, and
representatives from and against all claims, liabilities, losses, damages,
costs, and expenses, including, without limitation, reasonable attorneys’ fees
(“Liability”) to a third party or property arising directly or indirectly out of
any failure of that Party to perform fully all obligations and conditions
to be
performed by that Party pursuant to this Agreement or any breach of any warranty
made by that Party in this Agreement. Client further agrees to indemnify
and
hold harmless CORD, its parent and Affiliates and each of their directors,
officers, employees, agents and representatives from any and all Liability
arising directly or indirectly out of injury or death to person or property
alleged to have been caused by Client’s Product.
6
14. Limitation
of Liability.
NOTWITHSTANDING THE FOREGOING PROVISIONS OF SECTION 13, OR ANY OTHER PROVISION
OF THIS AGREEMENT TO THE CONTRARY, NEITHER PARTY SHALL BE LIABLE TO THE OTHER
PARTY FOR ANY CONSEQUENTIAL (SPECIFICALLY EXCEPTING THOSE CONSEQUENTIAL DAMAGES
ARISING FROM EACH PARTY’S OBLIGATION TO INDEMNIFY THE OTHER FOR LIABILITY
ARISING OUT OF OR RELATING TO THIRD PARTY CLAIMS IN ACCORDANCE WITH SECTION
13
ABOVE), INCIDENTAL, INDIRECT, SPECIAL, OR OTHER SIMILAR DAMAGES ARISING OUT
OF
OR IN CONNECTION WITH THIS AGREEMENT.
15. Insurance.
During
the term of this Agreement and for as long thereafter as necessary to cover
claims resulting from this Agreement, Client shall maintain: (5)
product
liability and commercial general liability insurance having a limit of not
less
than $5 million; and (6)
property
damage insurance at replacement value for the Product located at the CORD
Facility or in transit to or from the CORD Facility, pursuant to one or more
insurance policies with reputable insurance carriers. Cardinal Health, Inc.
and
its subsidiaries shall be designated as “additional insureds” under the product
liability and commercial general liability insurance policy(ies) and under
the
property damage insurance policy(ies). Prior to the Commencement Date, Client
shall deliver to CORD certificates evidencing such insurance. Client shall
not
cause or permit such insurance to be canceled or modified to materially reduce
its scope or limits of coverage during the term of this Agreement or thereafter
as provided above. Except for any losses resulting solely from the gross
negligence or intentional misconduct of CORD, Client shall bear all risk
of loss
or damage with respect to the Product, whether located at the Facility or
otherwise.
16. Dispute
Resolution.
The
Parties agree to use good faith efforts to resolve all disputes within ninety
(90) days of written notice that such a dispute exists. If dispute under
this
Agreement cannot be resolved by the Parties within such sixty (60) day period,
the Parties agree to refer the matter to one executive from each Party not
directly involved in the dispute for review and resolution. A copy of the
terms
of this Agreement, agreed upon facts and areas of disagreement, and a concise
summary of the basis for each side’s contentions will be provided to both
executives who shall review the same, confer, and attempt to reach a mutual
resolution of the issue within forty-five (45) days after receipt of the
materials referenced above. If the matter has not been resolved within such
forty-five (45) day period, either or both Parties may pursue resolution
of the
matter through litigation or other process available under law or
equity.
17. Miscellaneous.
17.1 Relationship
of the Parties.
The
relationship among the Parties is that of independent contractors, and this
Agreement does not establish or create a partnership, joint venture, or other
agency relationship among the Parties.
7
17.2 Notices.
Any
notice or other communication required or desired to be given to any Party
under
this Agreement shall be in writing and shall be deemed given: ii)
three
business days after such notice is deposited in the United States mail,
first-class postage prepaid, and addressed to that Party at the address for
such
Party set forth at the end of this Agreement; iii)
one
business day after delivered to Federal Express, Airborne, or any other similar
express delivery service for delivery to that Party at that address; or
iv)
when
sent by facsimile transmission, with electronic confirmation, to that Party
at
its facsimile number set forth at the end of this Agreement. Any notice
delivered by facsimile transmission will be deemed delivered upon electronic
confirmation provided the notice is also deposited in the U.S. mail, first-class
postage prepaid. Any Party may change its address or facsimile number for
notices under this Agreement by giving the other Parties notice of such
change.
17.3 Governing
Law.
This
Agreement shall be construed under the laws of the State of Tennessee, without
regard to its conflicts of laws provisions.
17.4 Severability.
If any
term of this Agreement is declared invalid or unenforceable by a court or
other
body of competent jurisdiction, the remaining terms of this Agreement will
continue in full force and effect.
17.5 Non-Waiver.
No
failure by either Party to insist upon strict compliance with any term of
this
Agreement, to enforce any right, or to seek any remedy upon any default of
the
other Party shall affect, or constitute a waiver of, the first Party’s right to
insist upon strict compliance, to exercise that option, to enforce that right,
or to seek that remedy with respect to that default or any prior,
contemporaneous, or subsequent default. No custom or practice of the Parties
at
variance with any provision of this Agreement shall affect, or constitute
a
waiver of, that Party’s right to demand strict compliance with all provisions of
this Agreement.
17.6 Force
Majeure.
If the
performance of any part of this Agreement by either Party shall be prevented,
restricted, interfered with or affected for any length of time by fire or
other
casualty, government restrictions, war, riots, strikes or labor disputes,
lock
out, transportation delays, acts of God, or any other causes which are beyond
the reasonable control of such Party, such Party shall not be responsible
for
delay or failure of performance of this Agreement for such length of time,
provided, however, that the obligation of one Party to pay amounts due to
the
other Party shall not be subject to the provisions of this Section.
17.7 Complete
Agreement.
This
Agreement constitutes the entire understanding between the Parties and
supersedes any contracts, agreements or understanding (oral or written) of
the
Parties with respect to the subject matter hereof. No term of this Agreement
may
be amended except upon written agreement of both Parties, unless provided
otherwise in this Agreement.
17.8 Assignment.
Except
as set forth herein, neither Party shall have the right to assign this
Agreement, or any of such Party’s rights or obligations under this Agreement,
without the prior written consent of the other Party, provided, however,
that
CORD may assign its rights under this Agreement to any parent, subsidiary
or
affiliate without obtaining such consent. This Agreement shall be binding
upon,
inure to the benefit of, and be enforceable by and against the respective
successors and assigns of the Parties.
17.9 Independent
Contractor.
The
relationship of the Parties is that of independent contractors, and neither
Party shall incur any debts or make any commitments for the other Party except
to the extent expressly provided in this Agreement. Nothing in this Agreement
is
intended to create or shall be construed as creating between the Parties
the
relationship of joint ventures, co-partners, employer, employee or principal
and
agent.
8
IN
WITNESS WHEREOF, the undersigned acknowledge and accept the terms of this
Agreement and have duly executed this Agreement.
CORD
LOGISTICS, INC.
By:
/s/ Xxxxx
X.
Xxxxxxxx
Xxxxx
X. Xxxxxxxx
Vice
President and General Manager
00
Xxxxxx Xxxxxxxxx
XxXxxxxx,
XX 00000
Facsimile
No. (000) 000-0000
|
ALLIANCE
PHARMACEUTICAL CORP.
By:
/s/
Xxxx
XxXxxxxx
B.
Xxxx XxXxxxxx
Vice
President, Marketing &
Business Development
0000
Xxxxxxx Xxxx Xxxx
Xxx
Xxxxx, XX 00000
Facsimile
No.: (000) 000-0000
|
9
Exhibits
Exhibit
A Operating
Guidelines
Exhibit
B Fee
Schedule
Exhibit
C System
Access Agreement
Alliance
Pharmaceuticals / CORD Logistics, Inc.
Exhibit
A
Operating
Guidelines
In
performing its obligations under the Distribution Services Agreement
(“Agreement”), CORD Logistics, Inc. (“CORD”) will follow the Operating
Guidelines as developed jointly with Alliance Pharmaceuticals Corp Inc.
(“Client”). These Operating Guidelines are in addition to CORD Standard
Operating Procedures (“SOPs”). Copies of these documents are maintained by both
parties and will be reviewed, and updated if necessary, from time to time
as
mutually agreed, but not less than once per calendar year.
1.0
WAREHOUSING,
1.1
|
CORD
will maintain its warehouse facility in accordance and comply with
all
federal, state and local laws, rules and regulations, including
the
Prescription Drug Marketing Act and current Good Manufacturing
Practices
(“cGMP”) as promulgated under the
FDA.
|
1.2
|
CORD
will maintain Standard Operating Procedures appropriate for a
pharmaceutical distribution center operating
environment.
|
1.3
|
CORD
will maintain documented training
programs.
|
1.4
|
CORD
will comply with storage, handling and shipping conditions designated
by
Client for the “Products”.
|
1.5
|
Products
with specific storage requirements must be identified by Client
and the
storage requirements must be expressly communicated by Client to
CORD. The
specific requirements must be identified on the package label in
accordance with NWDA bar coding standards. Product so identified
by Client
will be stored in areas designed, continuously monitored and periodically
validated for the temperature range specified for each product.
CORD will
maintain daily temperature recordings. CORD will provide such records
to
Client upon written request.
|
1.5.1
|
Frozen
— minus 20 degrees Celsius
|
1.5.2
|
Refrigerated
— 2 degrees to 8 degrees Celsius
|
1.5.3
|
Controlled
ambient — 15 degrees to 25 degrees
Celsius
|
1.5.4
|
Controlled
ambient — 15 degrees to 30 degrees
Celsius
|
1.6
|
CORD
will report temperature excursions to Client within two (2) business
days
of occurrence.
|
1.7
|
Products
will be stored in an area with secured access, accessible only
to
authorized CORD personnel as agreed to by Client and
CORD.
|
2.0
RECEIVING
2.1
|
Client
or Client’s contract manufacturing agent will arrange transportation
services to transfer the product to CORD. Client will notify CORD
of the
specific delivery schedule.
|
Page
1
2.2
|
Client’s
carrier will contact CORD to arrange a delivery
appointment.
|
2.3
|
Client
retains title to the goods at all times. CORD signature on the
xxxxxxx’x
xxxx of lading is an acknowledgement only of CORD’s receipt of
product.
|
2.4
|
Client
will provide CORD with Material Safety Data Sheets for each product
stored
at CORD.
|
2.5
|
Client’s
product must meet the following standards for carton identification,
documentation, palletization, and
uniformity:
|
2.5.1
|
Each
shipping carton and inner packaging of Client’s product must be labeled to
meet NWDA standards for bar coding and human readable
markings.
|
2.5.2
|
Client
will provide the xxxx of lading, certificate of analysis and other
documentation necessary. CORD and Client will mutually agree upon
the
receiving process.
|
2.5.3
|
Pallets
will meet GMA standards for 40” x 48” dimensions with four-way entry; will
be free of broken boards, treated for pests, and
clean.
|
2.5.4
|
Receipt
of product on non-standard pallets may require restacking onto
conforming
pallets at Client’s expense.
|
2.5.5
|
Palletized
product must be uniform and consistent with specifications set
up in the
product master for the number of cartons and
xxxxxx.
|
2.6
|
CORD
will receive each shipment into a secure Receiving
area.
|
2.7
|
CORD
will count and inspect the exterior packaging of the product, noting
any
shortages, overages or damage on the xxxxxxx xxxx of lading. CORD
will
obtain the carrier’s signature on the xxxx of lading acknowledging the
condition of the product upon receipt by
CORD.
|
2.8
|
CORD
will compare the Client documentation to CORD’s receiving report.
Discrepancies will be noted. CORD Quality Assurance will investigate
and
report all discrepancies to Client within 24 hours of receipt.
Client and
CORD will determine corrective actions, if
any.
|
2.9
|
CORD
will post receipts in the computer inventory system within one
business
day of delivery unless count discrepancies, missing paperwork,
damage
investigation, and other receiving anomalies interfere with efficient
receiving and documentation. CORD will use commercially reasonable
efforts
to receive product accurately and
efficiently.
|
2.10
|
CORD
reserves the right to assess a fee for services required to hold
non-conforming product in receiving, and to investigate, reconcile
and
report discrepancies to Client. Fees for receiving services are
listed in
the Fee Schedule, Exhibit C.
|
2.11
|
CORD
will return partial case quantities -- defined as less than a saleable
quantity - to Client at Client’s
expense.
|
2.12
|
Client
product in unapproved or quarantine status will be physically segregated
and CORD’s computer system will be flagged accordingly to prevent
unapproved product from entering approved picking areas of the
warehouse.
Client will provide written documentation to CORD to change quarantine
product to approved status.
|
Page
2
[****]
Represents material which has been redacted pursuant to a request for
confidential treatment pursuant to Rule 24B-2 under the Securities Exchange
Act
of 1934, as amended. The confidential materials have been filed separately
with
the SEC.
2.13
|
CORD
will move product from the Receiving area to bulk storage following
CORD
SOPs.
|
3.0
INVENTORY
3.1
|
Inventory
will be received, tracked and controlled on CORD’s computerized inventory
system by item number, lot number, expiration date, quantity, and
status.
CORD’s system will meet all cGMP requirements for lot traceability and
accountability, from receipt of product at CORD to shipment of
product to
Client’s customer.
|
3.2
|
Quarantined
product will be physically segregated and appropriately labeled.
Quarantined Product will be released from quarantine status in
CORD’s
inventory system upon written authorization by
Client.
|
3.3
|
CORD
will assign unique locations for each product and lot in
storage.
|
3.4
|
Inventory
will be routinely verified by CORD through periodic cycle counts.
CORD
will use its best efforts to maintain accurate and timely inventory
records.
|
3.5
|
Inventory
deviations will be investigated by CORD and reported to Client.
Corrective
actions will be determined jointly by CORD and
Client.
|
3.6
|
Client
may conduct a complete physical inventory once per calendar year,
upon at
least thirty-(30) days advance written notice prior to the start
of a
physical inventory.
|
3.7
|
CORD
will notify Client of all expired or short dated Product (as specified
by
Client to be “X” number of months prior to expiry
date).
|
3.8
|
Disposition
of returned, rejected or expired Product will be handled according
to
Client’s specific written
direction.
|
4.0
DISTRIBUTION
4.0
|
Orders
approved and available for processing (pick & pack) by 2:00 p.m.
Central Time will be shipped before the close of business the same
day,
Monday through Friday. Orders received by EDI and approved for
inventory
allocation by 12:00 noon will be shipped by close of business the
same
day. Orders received and processed after the cutoff times will
be shipped
the following business day.
|
4.1
|
Recognizing
that order volume may fluctuate from time to time, CORD will staff
to meet
[****]
of
the rolling average number of Client orders processed over the
previous
[****]
calendar months. CORD will use commercially reasonable efforts
to meet the
shipping schedule outlined herein when order or unit volume exceeds
[****]
of
the rolling average number of orders or units; provided, however,
that
CORD cannot guarantee daily on-time shipping standards will be
achieved
during such increased activity
periods.
|
4.2
|
CORD
will measure the timeliness of shipments and will report this attribute
periodically according to Section 19 of the Operating
Guidelines.
|
4.3
|
Emergency
shipments and other exceptions will be authorized in writing by
Client.
CORD will separately invoice Client for emergency shipments, which
are
defined as shipments occurring on weekends, holidays, and non-standard
hours, as defined in the Fee Schedule, Exhibit
C.
|
Page
3
4.4
|
CORD’s
inventory system will comply with First-to-Expire, First-Out (FEFO)
inventory allocation. Any exceptions from FEFO must be approved
by Client
in writing prior to shipment.
|
4.5
|
CORD
will provide the system, equipment and procedures, along with trained
personnel and supervision to services related to picking product
for
Client’s customer orders.
|
4.6
|
CORD
will perform quality verification on all Client shipments by an
individual
other than the employee who picked the order. CORD will use commercially
reasonable efforts to pick, check and ship accurately all Client
customer
orders.
|
4.7
|
CORD
and Client will mutually determine and agree in writing on the
packaging
requirements for shipping Client’s finished product(s). CORD’s Quality
Assurance will assist Client and CORD will issue appropriate guidelines
and training to the Distribution department to assure compliance
with
Client specifications.
|
4.8
|
Client
and CORD will mutually determine and agree on special shipping
conditions,
such as for refrigerated product, which may be limited to Monday
through
Thursday shipping, or as otherwise instructed by the
Client.
|
4.9
|
CORD
will provide shipment confirmation information to Client through
CORD’s
information system on the same business day on which the shipment
occurs.
|
4.10
|
CORD
will manage shipping supplies - including vendor selection, ordering,
inventory record keeping, and storage. CORD will invoice Client
for all
shipping materials — corrugated cartons, insulated coolers (if specified),
address labels, inner packing — as may be required by Client’s packing
specifications, per CORD’s
proposal.
|
4.11
|
All
Products will be shipped utilizing packaging and shipping carton(s)
as per
Client’s packaging instructions, or as deemed appropriate by CORD in the
absence of Client specifications. Unless instructed otherwise by
Client,
shipping will occur based on the shipping procedures provided by
Client.
|
4.12
|
CORD
personnel will be available for emergency product shipments, via
phone
request, 24 hours per day, 365 days per year. For emergency shipments
called in after the carrier’s cutoff time (approximately 8:00 p.m. for
overnight airfreight), CORD will ship the product the following
day,
except Sunday, unless otherwise directed by the Client. CORD’s fees for
emergency shipments are set forth in the Fee Schedule, Exhibit
C.
|
5.0
TRANSPORTATION
5.1
|
CORD
and Client will mutually agree upon a common carrier (s) based
on shipment
size, destination, freight rates, availability of standard and
special
services, reliability of delivery, and claim history among other
requirements.
|
5.2
|
CORD
shall provide, if Client agrees, carriers under contract with
Cardinal-Allegiance for discounted rates. Client and CORD will
share the
savings according to a formula acceptable to both parties, or ,
if Client
so chooses and CORD agrees, CORD shall charge a freight management
fee
according to the Fee Schedule, Exhibit
C.
|
Page
4
5.3
|
Shipping
charges, including all special charges for insurance, proof of
delivery,
hazardous materials, service upgrades, and so forth, will be billed
directly to CORD’s account with the carrier and passed through to Client
per terms of the Distribution Agreement, inclusive of CORD’s
transportation management fees as defined in the Fee Schedule,
Exhibit
C.
|
5.4
|
Freight
terms will be F.O.B. Origin, Freight Prepaid where title passes
to the
customer when the shipment is tendered to the common
carrier.
|
5.5
|
CORD,
at the request of the Client, will provide proof of delivery for
specific
customer shipments. Fees charged by carriers for proofs of delivery,
if
any, will be passed directly to
Client.
|
5.6
|
Client
will approve payment of all credits to Client customers for overage,
shortage and damage claims related to transportation. CORD, if
handling
Accounts Receivable for Client, will issue a credit to Client’s customer
accordingly, or CORD will provide freight claim documentation to
Client
when Client is responsible for the Accounts
Receivable.
|
6.0
CUSTOMER
SERVICE
6.1
|
CORD
will provide a dedicated inbound phone line (or lines) for Client’s
customers to phone in purchase orders, for inquiries, and for general
information.
|
6.2
|
CORD
will staff the Client Customer Service inbound phone line from
7:00 a.m.-
6:00 p.m. central standard time, Monday through Friday, except
for the
following holidays: Christmas Day, New Year’s Day, Memorial Day,
Independence Day, Labor Day, Thanksgiving
Day.
|
6.3
|
CORD
will be responsible for the training of the customer service
representative and backup representative(s). Client will provide
company
and product specific information for training of the customer service
representatives assigned to Client.
|
6.4
|
CORD
will be responsible for initial set up and on-going maintenance
of
customer master files. The initial customer master file will be
approved
and signed by Client. Client may add customers by completing the
customer
profile form and forwarding to CORD for system
entry.
|
6.5
|
CORD
will accept customer orders by electronic data interchange (EDI),
phone,
mail or fax.
|
6.6
|
CORD
will use commercially reasonable efforts to answer inbound phone
calls
within the first thirty (30) seconds, and enter orders
accurately.
|
6.7
|
Orders
received by phone, mail or fax that are entered and approved for
shipment
by 2:00 p.m. Central Time will be shipped the same day. Orders
received by
EDI and approved for inventory allocation by 12:00 noon will be
shipped
the same day. Orders received and processed after the cutoff times
will be
shipped the following business day.
|
6.8
|
As
a backup to the customer service representatives, a voice mail
system will
be maintained to accept telephone orders and to collect messages
from
customers.
|
Page
5
[****]
Represents material which has been redacted pursuant to a request for
confidential treatment pursuant to Rule 24B-2 under the Securities Exchange
Act
of 1934, as amended. The confidential materials have been filed separately
with
the SEC.
6.9
|
CORD’s
dedicated customer service line for Client will incorporate programming
to
forward calls to a Client designated clinical service phone number
if
calls of a clinical nature are received outside of regular customer
service hours.
|
7.0
ORDER
ENTRY
7.1
|
Client
will determine minimum order and order line quantity and CORD will
enter
orders accordingly.
|
7.2
|
Client
will instruct its customers and trading partners to place orders
based on
the Client’s Distribution
Agreement.
|
7.3
|
Client
will determine when customers shall pay for premium freight, special
handling, and emergency order
processing.
|
7.4
|
Client
reserves the right to limit quantities, to hold or to refuse orders.
These
decisions will be executed by CORD.
|
7.5
|
CORD
will use commercially reasonable effort to enter orders accurately.
CORD
measures the accuracy of orders entered and will report this attribute
periodically according to the conditions set forth in Section 19
of the
Operating Guidelines.
|
8.0
CUSTOMER
CREDIT
8.1
|
Client
will determine the customers to whom it will sell on a direct basis
and
will assign each to a customer class, sales territory, and other
sort
classifications, as applicable, based on definitions mutually acceptable
to Client and CORD.
|
8.2
|
Client
will establish credit limits for each customer or groups of
customers.
|
8.3
|
CORD’s
system will monitor orders and outstanding account receivable against
the
customer’s credit limit and hold orders where credit limits are
exceeded.
|
8.4
|
Client
may elect to place a customer’s account on credit hold so that all orders
are reviewed prior to shipment.
|
8.5
|
Client
will review and approve all customer orders held for credit limits
prior
to shipment.
|
9.0
PRICING
AND TERMS
9.1
|
Client
will publish terms and conditions of sale to wholesalers and warehouse
chains. Standard terms are [****]
days, net [****]
days. Contracted customers may have non-standard
terms.
|
9.2
|
Client
will publish list prices for wholesalers and warehouses chains
and are
subject to change from time to time at the sole discretion of
Client.
|
9.3
|
Client
will determine contract prices on a contract by contract basis.
Client
will notify CORD of such price changes with seven-(7) days notice
for
update of the CORD system files. Client will develop and forward
customer
notifications to CORD and CORD will provide printing and mailing
services
on behalf of Client.
|
Page
6
9.4
|
CORD
will perform system maintenance of pricing and terms. Client will
provide
to CORD in writing any changes to prices or terms. CORD will be
responsible for updating the CORD system within 48 hours of receipt
of
such notice or as Client may otherwise
instruct.
|
9.5
|
CORD
employees are bound by the confidentiality provisions of the Agreement
between CORD and Client and as such, shall not disclose Client
sales data
or pricing information outside the specific CORD employees who
have a need
to know of this information in the course of performing their routine
job
responsibilities.
|
9.6
|
CORD
will provide the necessary reports within stipulated time frames
to ensure
Client can comply with the reporting requirements of Medicaid (OBRA),
Veterans HealthCare Act, PHS Covered Entities, and state rebate
programs.
Client will define reporting requirements against which CORD will
produce
the required reports.
|
10.0
INVOICING
10.1
|
CORD
Customer Service will use commercially reasonable efforts to mail
invoices
the morning following shipment of product, or transmit by electronic
data
interchange (EDT), where installed, the same say of shipment of
product,
to customer’s billing address.
|
10.2
|
For
any order shipped after the close of business, the invoice will
be
prepared and mailed the following business
day.
|
10.3
|
CORD
will make its best effort to process invoices as timely and accurately
as
possible. CORD measures invoice accuracy and processing timeliness
and
will report this attribute periodically according to the conditions
set
forth in Section 19 of the Operating
Guidelines.
|
11.0
CHARGEBACKS
11.1
|
Client
may enter into prime vendor arrangements for select contract or
government
mandated pricing arrangements.
|
11.2
|
Client
will select a wholesaler with full EDI capabilities, including
but not
limited to purchase orders chargeback submission, chargeback
reconciliation and credit, invoicing and bid award
notification.
|
11.3
|
CORD,
on behalf of Client, will process chargebacks daily with reconciliation
of
chargeback discrepancies within 5 working days. CORD’s chargeback SOP will
define the parameters available to CORD to resolve discrepancies
between
Client’ contract terms and conditions and the chargeback submitted by
the
wholesaler.
|
11.4
|
All
chargebacks will be processed according to the chargeback policy
for
Client.
|
11.5
|
All
validated chargeback submissions will be settled via credit invoice.
Client will not make advance payments or authorize advance deductions
of
chargebacks.
|
11.6
|
Prime
vendors will be instructed to report all returns from Client’s contract
customers as a reverse chargeback.
|
Page
7
11.7
|
CORD
will make its best effort to process chargebacks as timely and
accurately
as possible. CORD measures the chargeback discrepancy rate and
timeliness
of chargebacks processed and will report this attribute periodically
according to the conditions set forth in Section 19 of the Operating
Guidelines.
|
12.0
ACCOUNTS
RECEIVABLE
12.1
|
Client
will open and maintain a bank lockbox. The bank will receive customer
remittances invoice information on behalf of
Client.
|
12.2
|
Client’
bank will forward information about lockbox deposits along with
the
customer’s remittance information to
CORD.
|
12.3
|
CORD
will reconcile and apply the cash receipt to the outstanding account
receivable within 24 hours of receipt from the
bank.
|
12.4
|
To
aid the cash application process, Client will authorize accounts
receivable payment terms of one day past published terms. This
grace
period will not be communicated to
customers.
|
12.5
|
CORD
will disallow discounts for payments received beyond the payment
terms
grace period, as indicated by the postmark. CORD will handle the
amount of
the discount as a balance due on the Accounts Receivable
account.
|
12.6
|
CORD’s
standard for past due payment collection
activity:
|
12.6.1
|
Notify
by phone all customers with payments that have reached 10 days
past due.
|
12.6.2
|
Initiate
second collection call at 17 to 20 days past
due.
|
12.6.3
|
Send
letter to customer at ten (10) days past due with Client’s approval.
|
12.6.4
|
Forward
to an outside agency for collection with approval of
Client.
|
12.7
|
CORD
will maintain notes related to collection activities in a Accounts
Receivable system file that will be accessible to Client’ authorized
personnel.
|
12.8
|
CORD
will use commercially reasonable effort to process accounts receivable
as
timely and accurately as possible. CORD, at Client’s option, may measure
accounts receivable and collections activity report these attribute
periodically according to the conditions to be defined and mutually
agreed
upon by CORD and Client.
|
13.0
GOVERNMENT
REPORTING
13.1
|
CORD
personnel will provide the following Government reports to Client
by the
fifth business day following the close of a business
quarter.
|
13.1.1
|
IFF
Direct Sales Report
|
13.1.2
|
IFF
Indirect Sales Report
|
13.1.3
|
AMP
Report
|
13.1.4
|
Non
FAMP Report
|
Page
8
13.1.5
|
Best
Price Report
|
13.1.6
|
Most
Favored Price Report
|
13.2
|
CORD
will also provide supporting schedules and source documents to
be used by
Client to perform verification of the Government
reports.
|
14.0
MONTH-END
CLOSE
14.1
|
CORD
will comply with month-end reporting requirements as specified
by
Client.
|
14.2
|
Client
will complete its close by the 5th
working day after the last day of the month being
closed.
|
15.0
RETURN
GOODS
15.1
|
Returns
will be processed according to the Return Procedures defined by
Client.
|
15.2
|
CORD
will complete the processing of all returns and issue credits within
5
business days of receipt of the
return.
|
15.3
|
CORD
will use commercially reasonable efforts to process return goods
as timely
and accurately as possible.
|
16.0
RECALL
ASSISTANCE
16.1
|
Client
is responsible for management of a recall event, including but
not limited
to preparation of the letter of notification to customers, coordination
and reporting with FDA, tracking of recalled product by customer,
follow
up letters to customers, and final disposition of
product.
|
16.2
|
CORD
will provide the necessary recall reports within two hours of notification
by Client. Reports will contain, but not be limited to, the following
information for each recalled product and lot number: all customer
shipments by date, item number, quantity, lot number, and ship
to
address.
|
16.3
|
CORD
will provide a secure area for the receipt of recalled product.
CORD will
assist Client with inventory
reconciliation.
|
16.4
|
CORD
will provide destruction services for recalled product as may be
required
by Client.
|
17.0
SYSTEMS
17.1
|
Client
retains ownership to all data in the CORD system related to Client’
business.
|
17.2
|
CORD
will maintain security of the Client’s data in files segregated and
inaccessible to other CORD Client, to CORD’s parent organization Cardinal
Health, or to any other entity as determined by the
Client.
|
Page
9
17.3
|
CORD
will provide Client with on-line access to sales information,
inventory
records, lot tracking, customer profiles, item maintenance, pricing
and
terms, and other business critical data as defined in CORD’s standard
reports output.
|
17.4
|
Reporting
and interfaces will be defined by Client and jointly agreed upon
with
CORD.
|
17.5
|
CORD
will maintain all systems within the change control
SOPs.
|
17.6
|
CORD’s
system will be accessible by Client 7:30 a.m. - 7:30 p.m. Central
Time,
Monday through Friday except for routine, scheduled
maintenance.
|
17.7
|
Unscheduled
system downtime per calendar quarter shall not exceed 2% of the
normally
accessible access hours. CORD will immediately notify Client of
any system
problem that might affect services and an estimated time for restoration
of system access.
|
17.8
|
Full
system backups will be generated on a nightly basis in conjunction
with
SOP IS-005 ‘Backup and Recovery’. These backup tapes will be sorted either
off-site or in a
fireproof cabinet as indicated by the
SOP.
|
18.0
AUDITS
/ INVENTORIES
18.1
|
Upon
not less than ten (10) days prior written notice, Client personnel
and
their representatives will have access to CORD facilities for review
and
audit of CORD’s facility and records to assure compliance with cGMP’s,
standard operating procedures, guidelines, and Client specific
agreements.
|
18.2
|
Client
may request one complete physical inventory of Client products
every 12
months.
|
18.3
|
CORD
will assist Client with inspections/audits ordered by the Federal
Food
& Drug Administration or other governmental or official
agencies.
|
18.4
|
CORD
will notify Client immediately of any inspection activity by FDA,
DEA or
other government agency, as applicable to the Client or Client’s
product.
|
19.0
QUALITY
COUNCIL REPORT
19.1
|
CORD
will provide Client with a periodic report on measurable attributes,
as
identified in preceding sections, to be used to track and benchmark
performance. The frequency of the report will be determined jointly
by
CORD and Client.
|
19.2
|
Client
and CORD will agree to meet periodically to review performance
and to
develop methods, policies, practices, and procedures that may improve
the
quality and efficiency of the CORD - Client
relationship.
|
19.3
|
CORD
will use its best efforts to meet or exceed the Client’s expectation for
performance based on the measured
attributes.
|
Page
10
[****]
Represents material which has been redacted pursuant to a request for
confidential treatment pursuant to Rule 24B-2 under the Securities Exchange
Act
of 1934, as amended. The confidential materials have been filed separately
with
the SEC.
19.4
|
Measured
attributes and standards:
|
Section
|
Performance
Attribute
|
Performance
Standard
|
Reporting
Frequency
|
1.0
|
Temperature
excursions
|
[****]
excursion -free
|
Upon
occurrence
|
2.0
|
On-time
receipts and data entry
|
[****]
within [****]
business hours for all conforming receipts
|
Monthly
|
3.0
|
Cycle
count accuracy
|
[****]
|
Monthly
|
4.0
|
On-time
shipping
|
[****]
same day for orders received
by
the standard cut-off time
|
Monthly
|
4.0
|
Picking
/ shipping accuracy
|
[****] for
all orders processed with carton markings meeting NWDA bar code
standards
|
Monthly
|
6.0
|
Answer
inbound phone calls within thirty (30)
seconds
|
[****]
answered within [****] seconds
|
Monthly
|
7.0
|
Order
entry accuracy
|
[****]
|
Monthly
|
10.0
|
Invoicing
accuracy and timeliness
|
[****]
|
Monthly
|
11.0
|
Chargeback
processing time
|
[****]
processed in [****]
days or less from receipt of chargeback from wholesaler
|
Monthly
|
11.0
|
Chargeback
discrepancy rate
|
[****]
or
Less
|
Monthly
|
12.0
|
Accounts
receivable
|
Based
on Client specifications; standard TBD.
|
TBD
|
14.0
|
Return
goods processing cycle time
|
[****]
processed in [****]
business days
or
less
|
Monthly
|
17.0
|
System
availability
|
>[****]
of
normal accessible hours
|
Upon
occurrence
|
Page
11
[****]
Represents material which has been redacted pursuant to a request for
confidential treatment pursuant to Rule 24B-2 under the Securities Exchange
Act
of 1934, as amended. The confidential materials have been filed separately
with
the SEC.
Alliance
Pharmaceutical
ESTIMATED
SCHEDULE
Exhibit
B
|
||
Program
implementation
|
||
One
Time Start-up Fee(2)
|
$[****]
|
|
Distribution
Services
|
||
Monthly
per pallet ambient storage(5)
|
$[****]
|
|
Ambient
product pick/pack/stage - first full case picked(1)
|
$[****]
|
|
Ambient
product pick/pack/stage-each add’l case picked(1)
|
$[****]
|
|
Surcharge
for loose case pick orders less than shelf pack of less than
5
|
$[****]
|
|
Per
case sample product pick/pack/stage - (1)
|
$[****]
|
|
Monthly
distribution system access and use(1)
|
$[****]
|
|
Monthly
account management fee (6)
|
$[****]
|
|
Emergency/International
Orders
|
$[****]
|
|
Packing
/Shipping Supplies(3)
(includes
ordering, receiving, storage)
|
Cost
plus [****]
handling fee
|
|
Shipping
charges (4)
|
Cost
plus [****]
handling fee
|
|
Customer
Service
|
||
Monthly
fixed fee
|
$[****]
|
|
Per
order fee
|
$[****]
|
|
Per
credit memo
|
$[****]
|
|
Financial
Services
|
||
Monthly
fixed fee Accounts Receivable Management
|
$[****]
|
|
Per
order fee Accounts Receivable Management
|
$[****]
|
|
Monthly
fixed fee Chargeback Management
|
$[****]
|
|
Per
submission Chargeback Processing & Government
Reporting
|
$[****]
|
Note
(1):
|
This
proposal is based on the distribution services of Imavist for
Alliance as
outlined in the RFI received on August 21, 2001. This proposal
assumes
that there are four vials per case and a minimum of [****] case
will be shipped. If the actual average units shipped exceeds
[****] percent,
additional charges may be assessed. Other products requiring
distribution
services, or modified distribution channels, will be quoted separately.
If
the assumptions change from those presented in the RFI, either
partner
will have the right to renegotiate the fees and the basis used
for quoting
these services.
|
Note (2): | System access fee includes licenses for two concurrent users. Additional licenses required by Alliance will increase the monthly fee by [****] per concurrent user. |
Note (3): | The implementation fee is to be paid in [****] installments; the [****] after the implementation meeting and the [****] after the launch. Any additional procedures required for connectivity will be charged accordingly ®[****] (i.e. - Alliance must have a Registered IP address and Local Area Network (LAN)). |
Note (4): | Supplies include boxes, tape, labels, bubble pack, etc (approx. [****] per shipment), pallets if necessary ([****] per pallet), and any other Alliance requirements. |
Note (5): | A one pound package shipped UPS ground five zones will cost approximately $2.25. |
Note (5): | The pallet fee is based on a [****] month Inventory on hand. Pallet storage greater than [****] months on hand will be assessed an additional charge of twice the standard fee. |
Note (7): | The account management fee covers the following services: logistics management, inventory management, regulatory affairs and quality assurance, receiving discrepancy resolution, standard operating procedures, validation management, supply control, process set-ups, and process scheduling. |
Page
1
EXHIBIT
C
SYSTEM
ACCESS AGREEMENT
This
System Access Agreement (“Agreement”) is made as of April 1, 2002 between CORD
Logistics, Inc., an Ohio corporation (“Licensor”), and Alliance Pharmaceutical
Corp., a New York corporation (“Licensee”), who hereby agree as
follows:
1. Exclusive
Distribution Agreement.
Licensor
and Licensee have entered into a Distribution Services Agreement (“Distribution
Agreement”) of even date with this Agreement, the terms of which are
incorporated by reference.
2. System
Access: Maintenance Obligations.
Licensor
hereby grants to Licensee a nonexclusive, nontransferable limited license
(the
“License”) to utilize Licensor’s Operating
System Base Package, consisting of the computer hardware (as set forth below),
software, and other components described in the Distribution Agreement as
well
as future upgrades and maintenance of the base package (collectively, the
“System”), for the information processing needs of Licensee in connection with
the Services to be provided by Licensor under the Distribution Agreement.
Licensee shall maintain during the term of this Agreement the local area
network
(including without limitation centralized server) and desktop processing
requirements for the System as further described in the Distribution Agreement
or the Operating Guidelines, a copy of which are attached to the Distribution
Agreement as Exhibit A.
During
the term of this Agreement, Licensor shall employ reasonable security
measures and
policies designed to safeguard the integrity, accessibility, and confidentiality
of all of Licensee’s data resident on the System and establish and maintain
reasonable disaster and emergency recovery plans designed to minimize disruption
from System operation interruptions. Licensee shall have the right to review
the
operation of the System from time to time during regular business hours,
upon
reasonable prior notice and at a time mutually agreeable by the parties;
provided that such reviews shall be conducted in a manner to avoid disruption
of
Licensor’s business operations.
3. Lease
of Hardware.
Licensee
shall have the right to lease a router (“Hardware”) from Licensor during the
term of this Agreement, at no additional cost to Licensee, other than the
Fee
set forth in the Distribution Agreement. The Hardware shall be kept by Licensee
(a) subject to inspection by Licensor during regular business hours, upon
reasonable prior notice and at a time mutually agreeable by the parties;
(b) at
Licensee’s address, as stated at the end of this Agreement, which Hardware shall
not be relocated without the prior written consent of Licensor, which consent
shall not be unreasonably withheld; (c) free of all security interests if
any
kind whatsoever, liens, encumbrances and other claims; (d) marked with
Licensor’s identification marks or numbers and if requested by Licensor,
conspicuously labeled “supplied by Licensor”; and (e) maintained in good and
efficient working order, condition and repair, reasonable wear and tear
excepted.
Licensee
shall use the equipment with due care to prevent injury thereto, and to any
person or property and in conformity with all applicable laws, ordinances,
rules, regulations and other requirements of any insurer or governmental
bonding
and with all requirements of the manufacturer with respect to use, maintenance
and operation of the Hardware. Licensee shall not modify any hardware without
the prior written consent of Licensor, which may be granted or withheld in
its
sole discretion. It is the intention
and understanding of both Licensor and Licensee that the Hardware shall be,
and
at all times remain, separately identifiable personal property of Licensor.
Licensee shall not permit any Hardware to be installed in or used, stored
or
maintained with, any of Licensee’s personal property in such manner or under
such circumstances that such Hardware might be or become an accession to
or
confused with such other personal property. Licensee shall not permit such
Hardware to be installed in or used, stored or maintained with, any real
property in such manner or under such circumstances that any person might
acquire any rights in such Hardware paramount to the rights of the Licensor
by
reason of such Hardware being deemed to be real property or a fixture
thereon.
Licensee
shall at all times during the term of this Agreement and until the Hardware
has
been returned to Licensor, at its own expense, maintain physical damage
insurance in the amount of not less than the replacement value of the Hardware.
All insurance so maintained shall provide for a thirty (30) day prior written
notice to Licensor or its assignees of any cancellation or reduction of
coverages; (ii) an option in Licensor or its assignees to prevent cancellation
by payment of premiums, (iii) cover the interest of the Licensor and (iv)
provide that all insurance proceeds shall be payable to the Licensee and
Licensor, as their respective interests may appear at the time of any such
payment. Licensor shall be named as an additional insured on any public
liability insurance policy so maintained. Upon the request of Licensor, Licensee
shall furnish to Licensor satisfactory evidence of any insurance so
maintained.
4. Proprietary
Rights.
Licensee
shall have the right to use the System during the term of this Agreement
as
expressly provided in paragraphs 1 and 2 of this Agreement, but not otherwise.
Licensee shall not assign or otherwise transfer, disclose, copy, modify,
re-engineer, sell, license, disassemble, or decompile the System or disclose
or
permit access to the System or related documentation to any other person
or
entity. The System and all parts thereof, in all of their tangible and
intangible manifestations, all existing or new enhancements, developments,
derivative works, and other adaptions or modifications to the System (or
any
part thereof), and all related proprietary rights, are and shall remain the
exclusive property of Licensor. Except for the License and the lease provided
by
Section 3, Licensee shall have no right, title, or interest in or to the
System
or any part thereof. Upon termination of this Agreement, Licensee shall promptly
return to Licensor all portions of the System then in Licensee’s possession or
under its control in accordance with the term set forth in Section 6
below.
5. Warranties.
Licensee
acknowledges that it has had adequate opportunity to review the System and
its
features and operation, and Licensee accepts the System “AS IS” for its use as
contemplated in the Distribution Agreement. LICENSOR
MAKES NO REPRESENTATIONS OR WARRANTIES, AND HEREBY EXPRESSLY DISCLAIMS ALL
REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, RELATING DIRECTLY OR
INDIRECTLY TO THE SYSTEM OR ANY PART THEREOF, INCLUDING WITHOUT LIMITATION
ANY
WARRANTIES OF QUALITY, PERFORMANCE, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR
PURPOSE.
6. Limitation
On Liability. LICENSOR
SHALL NOT BE LIABLE FOR ANY CONSEQUENTIAL, INDIRECT, SPECIAL, OR OTHER SIMILAR
DAMAGES ARISING DIRECTLY OR INDIRECTLY OUT OF THE USE OR INABILITY TO USE
THE
SYSTEM OR ANY PART THEREOF, EVEN IF INFORMED OF THE POSSIBILITY OF SUCH DAMAGES,
WHETHER CLAIMED UNDER CONTRACT, TORT, OR ANY OTHER LEGAL
THEORY.
IF
ANY OF THE LIMITATIONS ON THE LIABILITY OF LICENSOR CONTAINED IN THIS AGREEMENT
ARE FOUND TO BE INVALID OR UNENFORCEABLE FOR ANY REASON, THEN LICENSOR AND
LICENSEE EXPRESSLY AGREE THAT THE MAXIMUM AGGREGATE LIABILITY OF LICENSOR
FOR
ALL CLAIMS RELATING TO THE SYSTEM SHALL NOT EXCEED 100% OF THE AGGREGATE
BASE
PACKAGE FEES PAID BY LICENSEE TO LICENSOR FOR LICENSEE’S USE OF THE SYSTEM UNDER
THE DISTRIBUTION AGREEMENT.
7. Taxes.
Licensee
shall pay when due all sales, use, gross receipts, excise, property, and
other
taxes (other than taxes based upon Licensee’s net income) now or hereafter
imposed as a result of the transactions contemplated by this
Agreement.
8. System
Availability.
The
System shall be available for access twenty-four (24) hours a day, seven
(7)
days a week, except for scheduled maintenance periods.
9. Term.
The
term of this Agreement shall begin upon Licensee’s initial use of the System as
evidenced by the first entry of inventory into the System (which may be a
date
earlier than the Commencement Date specified for the Distribution Agreement)
and
shall end: (a) automatically upon the termination of the Distribution Agreement
(for any reason), or (b) on any earlier date specified by Licensee in notice
to
Licensor given not less than ninety (90) days prior to the specified termination
date; provided that: (i) paragraphs 4 through 10 inclusive shall survive
the
termination of this Agreement, and (ii) no termination of this Agreement
shall
affect any liabilities arising from, or based upon, acts or omissions occurring
prior to such termination.
10. Expiration/Termination.
Licensee
shall continue to have access to the System for a reasonable period of time
(not
be exceed ninety (90) days) following termination of this Agreement solely
for
purposes of retrieving and transferring to a separate system Licensee’s data
relating to its pre-termination operations, and Licensor shall reasonably
cooperate with Licensee to preserve the integrity and accessibility of
Licensee’s data during such period; provided that, during such period, Licensee
shall continue to pay the full Base Package and other fees payable by Licensee
under the Distribution Agreement and comply with all other requirements imposed
upon Licensee under this Agreement.
Upon
the
expiration of this Agreement, Licensee shall return the Hardware to Licensor
in
the same condition and configuration as received, reasonable wear and tear
excepted.
11. Notices.
Any
notice or other communication required or desired to be given to either Party
under this Agreement shall be in writing and shall be deemed given: (a) five
(5)
days after mailing, if deposited in the United States mail, first-class postage
prepaid, and addressed to that Party at its address set forth at the end
of this
Agreement; (b) when received if delivered to Federal Express or any other
similar overnight delivery service for delivery to that Party at that address;
or (c) when sent by facsimile transmission, with electronic confirmation,
to
that Party at its facsimile number set forth at the end of this Agreement.
Either Party may change its address or facsimile number for notices under
this
Agreement by giving the other Party notice of such change.
12. Remedies.
Licensee
shall indemnify Licensor and its affiliates, directors, officers, employees,
agents, and representatives against all claims, liabilities, losses, damages,
costs, and expenses (including without limitation reasonable attorneys’ fees)
arising directly or indirectly out of any failure of Licensee to perform
fully
all obligations and conditions to be performed by Licensee pursuant to this
Agreement. Licensee acknowledges that in the event of any violation by it
of any
of the provisions of paragraph 2 (Proprietary Rights) of this Agreement,
Licensor would suffer irreparable harm and its remedies at law would be
inadequate. Accordingly, in the event of any violation or attempted violation
of
any such provisions by Licensee, Licensor shall be entitled, in addition
to any
other rights or remedies which may be available to Licensor, to a temporary
restraining order, temporary and/or permanent injunctions, specific performance,
and other equitable relief, without the showing of irreparable harm, injury,
damage or the inadequacy of damages, and without the necessity of the posting
of
any bond.
13. Force
Majeure.
Notwithstanding any other provisions of this Agreement or the Distribution
Agreement to the contrary, each Party’s obligations under this Agreement
(exclusive of payment obligations) shall be excused if and to the extent
that
any delay or failure to perform such obligations is due to fire or other
casualty, government restrictions, war, riot, strikes or labor disputes,
acts of
God, or other causes beyond the reasonable control of that Party; provided,
however, that any party hindered by such condition beyond its reasonable
control
must employ reasonable efforts to overcome such hindrance as promptly as
practicable.
14. Successors.
Licensee
shall not assign or otherwise transfer this Agreement or any of its rights
or
obligations under this Agreement without the prior written consent of Licensor,
which consent shall not be unreasonably withheld. Subject to the preceding
sentence, this Agreement shall be binding upon, inure to the benefit of,
and be
enforceable by and against the respective successors and assigns of each
Party.
15. Interpretation.
This
Agreement shall be governed by and construed in accordance with the laws
of the
State of Ohio. If and to the extent that any court of competent jurisdiction
determines that it is impossible to construe any provision of this Agreement
consistently with any law or public policy and consequently holds that provision
to be invalid, such holding shall in no way affect the
validity of the other provisions of this Agreement, which shall remain in
full
force and effect.
16. Complete
Agreement.
This
Agreement (together with the Distribution Agreement, which is hereby
incorporated herein by reference) constitutes the entire Agreement between
the
Parties with respect to the subject matter of this Agreement and supersedes
all
prior or contemporaneous discussions, negotiations, representations, warranties,
or Agreements relating to the subject matter of this Agreement. This Agreement
may not be amended or otherwise modified except by a written instrument signed
by each Party.
IN
WITNESS WHEREOF, the undersigned acknowledge and accept the terms of this
Agreement and have duly executed this Agreement.
CORD LOGISTICS, INC.
By: /s/
Xxxxx X.
Xxxxxxxx
Xxxxx X.
Xxxxxxxx
Vice President
and General Manager
00 Xxxxxx
Xxxxxxxxx
XxXxxxxx, XX
00000
Facsimile No.
(000) 000-0000
|
ALLIANCE PHARMACEUTICAL CORP.
By: /s/
Xxxx
XxXxxxxx
Xxxx
XxXxxxxx
Vice
President, Marketing & Business Development
0000
Xxxxxxx Xxxx Xxxx
Xxx
Xxxxx, XX 00000
Facsimile
No.: (000) 000-0000
|