Exhibit 10.18
DISTRIBUTION AND PRODUCT SERVICES AGREEMENT*
Dated as of May 15, 1998
Between
INTEGRATED COMMERCIALIZATION SOLUTIONS, INC.
and
IMMUNOMEDICS, INC.
--------
* Confidential portions omitted and filed separately with the Securities and
Exchange Commission.
DISTRIBUTION AND PRODUCT
SERVICES AGREEMENT
This Distribution and Product Services Agreement ("Agreement") made as
of this 15th day of May, 1998 by and between INTEGRATED COMMERCIALIZATION
SOLUTIONS, INC. ("ICS") and IMMUNOMEDICS, INC. ("IMMU").
RECITALS
A. IMMU, a Delaware corporation, is a biopharmaceutical Company that
manufactures and sells pharmaceutical products including CEA-Scan(r) (the
"Product") which has U.S.F.D.A. approval for human use.
B. ICS, a California corporation and a wholly-owned subsidiary of
Bergen Xxxxxxxx Specialty Company, a California corporation, which is a major
operating division of Bergen Xxxxxxxx Corporation, is in the business of
providing distribution and product support services to drug manufacturers and
other sectors of the healthcare industry.
C. IMMU desires to engage ICS to provide product support services
including Customer Account Set-up, Customer Service/Order Management,
Warehousing/Distribution, Invoicing/Accounts Receivable Management and
Credit/Collection Services for the Product and such other IMMU products as the
parties may agree from time to time to add by addendum hereto.
NOW THEREFORE, for good and valuable consideration, the receipt and
sufficiency of which is hereby acknowledged, the parties hereto agree as
follows:
1. Appointment
1.1. IMMU hereby appoints ICS as its non-exclusive agent to
provide product support services for the Product in the U.S.A. and the U.S.
territories. ICS represents and warrants that it has the facilities and
personnel necessary to satisfactorily and timely perform the services to be
provided by it under this Agreement.
1.2. IMMU hereby engages ICS to provide the services described
in this Agreement for the fees listed in Schedule "A" attached hereto and by
this reference made a part hereof.
2. Services
For the fees listed in Schedule "A", ICS will provide the
following services:
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2.1. Customer Account Set-up
ICS will establish, maintain and update a customer
data base to support IMMU and perform the following activities.
2.1.1. Obtain all necessary documentation to
establish new customer accounts, including, without limitation, a credit
application and the appropriate current radioactive materials handling license
as issued by the Nuclear Regulatory Commission or other governmental agency
having jurisdiction; and
2.1.2. Perform the necessary procedures to verify
extension of credit to customers. The cost of third party verification (TRW,
D&B, etc.) shall be borne by IMMU.
2.2. Customer Service/Order Management.
ICS will provide customer service representatives to
perform the following order process management activities.
2.2.1. Staffing during normal customer service hours
(8:00 a.m. CT to 6:00 p.m. CT) including a live operator greeting;
2.2.2. Management of inbound telephone calls, faxes
and EDI transmissions relating to ordering, marketing and distribution;
2.2.3. New account processing, including credit
verification; and
2.2.4. Coordinating inquiries regarding technical,
clinical and medical issues and referring directly to IMMU to assure an
appropriate response by IMMU.
2.3. Warehousing/Distribution.
ICS will provide the following warehousing and
distribution services:
2.3.1. Warehouse and inventory the Product at the
ICS distribution facility at [*]. Product that has met all regulatory product
release requirements will be received and placed in inventory for distribution.
ICS and IMMU will comply with all FDA regulations including product lot record
retention.
2.3.2. Maintain inventory under appropriate
conditions as specified by IMMU.
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2.3.3. Provide continuous inventory maintenance,
security and control.
2.3.4. Package (including packaging and shipping
materials) and ship designated q uantities pursuant to customer requirements and
IMMU guidelines.
2.3.5. Shipment/handling of outdated/damaged
products in accordance with FDA regulations and IMMU direction.
2.3.6. Maintain a database required to facilitate a
recall in accordance with FDA guidelines and requirements should that ever
become necessary.
2.4. Invoicing/Accounts Receivable Management
2.4.1. ICS will invoice customers in the name of IMMU, on IMMU
invoices.
2.4.2. Product pricing will be determined by IMMU and
communicated to ICS. Price changes will be communicated in writing to ICS.
2.4.3. Special handling charges (including drop shipments)
will be invoiced to the customers for non-standard shipments, as agreed with
IMMU.
2.4.4. ICS will maintain appropriate accounts receivable data
(including detailed aged trial balances) to facilitate customer account
management and collections.
2.4.5. Payments will be directed to be made to a lockbox at a
bank selected by IMMU. IMMU shall cause remittance advices to be forwarded to
ICS on a timely basis for cash application.
2.4.6. ICS will be responsible for dispute resolution,
deduction management, etc.
2.5. Credit/Collection
2.5.1. ICS will verify and establish credit within the broad
guidelines established by IMMU.
2.5.2. Credit holds will be placed on any account which is
sixty (60) days past due. Release of credit hold must be authorized by IMMU.
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2.5.3. ICS will establish the capability of accepting credit
card payments and IMMU will accept orders for payment via credit card.
2.5.4. All credits to be issued to customers, other than
clerical, recording or invoicing errors, require pre-approval of IMMU.
2.5.5. IMMU shall bear the ultimate credit risk for the IMMU
accounts.
2.6. Other
2.6.1. IMMU will pay all costs, expenses, insurance, and
import duties, if any, for delivery of all Product to the ICS facility. ICS will
visually inspect each shipment of Product for external container or package
damage or loss in transit (based upon records provided to ICS from IMMU).
Contingent upon ICS receiving the appropriate records to enable batch
verification, ICS shall notify IMMU when damage or loss has occurred within
three business days of receipt of Product by ICS. ICS will store and ship all
Product in compliance with good manufacturing practice guidelines and other FDA
requirements. ICS will store Product at 2 (degree) to 8 (degree) centigrade at
all times.
2.6.2. Upon receipt of the order transmission from customer
service Product will be shipped in regulatory compliant refrigerated shippers
(which will be directed to maintain the required temperature). Orders received
by [*] will be shipped [*]. ICS will make every reasonable effort to process
orders received after [*]. in the event of an emergency. Products will be
distributed on an FEFO (first expired, first out) basis.
2.6.3. Emergency Deliveries. In emergencies Product will be
shipped same day if necessary and costs will be passed through to the customer.
3. Data Management and Reporting (Key Program Activity and
Management Reports)
The following types of reports will be available to IMMU for
the fees listed in Schedule "A" attached hereto:
3.1. transmission of daily sales by unit and dollars
3.2. sales reports by territory/region
3.3. inventory reports
3.4. credits
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3.5. new accounts
3.6. chargeback, rebate data
IMMU and ICS will jointly determine the types of
reports, data elements and formats, and the frequency of reports that will be
required to provide key management and program oversight information. IMMU shall
receive up to [*] of the above standard reports without additional charge. There
will be additional charges for any further reports requested, based upon
programming charges.
It is intended that IMMU will have the ability and
the right to access via electronic media the data maintained by ICS on behalf
of IMMU for reporting purposes.
4. Recalls
4.1. In the event that it becomes necessary to conduct a
recall, market withdrawal or field correction (a "Recall") of any Product, IMMU
shall conduct the Recall and shall have primary responsibility therefor, and ICS
shall cooperate with IMMU in recalling any affected Product. If the Recall was
due to the acts or omissions of IMMU, then IMMU shall pay or reimburse, as the
case may be, all of ICS's direct out-of-pocket expenses, including but not
limited to any reasonable attorney's fees and expenses, incurred by ICS in
connection with performing any such Recall. If the Recall was due to the acts or
omissions of ICS, then ICS shall pay or reimburse, as the case may be, all of
IMMU's direct out-of-pocket expenses, including but not limited to any
reasonable attorneys fees or expenses, incurred by IMMU in connection with
performing any such Recall. Each of the parties shall use its reasonable best
efforts to minimize the expenses of Recall when it occurs. IMMU shall inform ICS
of the proposed Recall within forty-eight (48) hours of the initiation of the
Recall. IMMU and ICS will jointly develop Recall standard operating procedures.
4.2. FDA Correspondence and Inspections
Each of the parties shall provide the other with a
copy of any correspondence or notices received by such party from FDA
specifically relating to distribution of the Product within three (3) days of
receipt. Each party shall also provide the other copies of any responses to any
such correspondence or notices within three (3)days of making the response. ICS
shall notify IMMU of any FDA inspections of ICS's facilities specifically
relating to any of the Product and, if reasonably possible, shall afford IMMU
the opportunity to be present at such inspection.
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5. Delivery of Product/Risk
5.1. IMMU shall deliver, and ICS shall accept, such quantities
of the Product as shall be necessary for ICS to fill orders for the Product. All
Product delivered to ICS will be held by ICS as agent for IMMU and will remain
at all times under and subject to the ownership, direction and control of IMMU
until sold through ICS to IMMU's customers. Pricing shall be established by
IMMU. Title to the Product held by ICS will pass directly from IMMU to the IMMU
customers who purchase the Product through ICS. IMMU shall bear the risk of loss
of the Product not yet delivered by ICS to a customer, whether by fire, theft or
other casualty; provided, however, that ICS shall indemnify IMMU for Product
which is lost or damaged as a result of ICS's negligence. During the term of
this Agreement, ICS will store Product at its facility in [*].
5.2. ICS shall accept returns from customers only with prior
written approval of IMMU. ICS shall forward unusable Product to IMMU for final
disposition in accordance with applicable regulations.
6. Certain Obligations of the Parties
6.1. IMMU and ICS will jointly develop standard operating
procedures ("SOP's") as may be required from time to time in accordance with
IMMU directives and consistent with FDA regulations.
6.2. IMMU will deliver Product in boxes containing one (1)
vial per box.
6.3. IMMU will provide package inserts for all single vial and
other quantities.
6.4. IMMU warrants and represents to ICS that the execution
and performance of this Agreement will not breach any existing contracts or
arrangements that IMMU has entered into with any third parties.
6.5. IMMU will assist ICS in training ICS customer support
personnel concerning CEA-Scan.
7. Term And Termination
7.1. Initial Term
This Agreement shall be effective as of May 15, 1998,
and shall continue in full force and effect thereafter for a period of [*]
from such effective date unless sooner terminated as provided herein. This
Agreement shall automatically renew for successive [*] periods unless terminated
as provided herein.
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7.2. Termination Without Cause
This Agreement may be terminated by either party
without cause on one hundred eighty (180) days written notice to the other.
7.3. A party may terminate this Agreement immediately upon
written notice for the following causes:
7.3.1. the commencement of a voluntary case or other
proceeding seeking liquidation, reorganization or other relief with respect to
the other party of its debts under any bankruptcy, insolvency, corporation or
other similar law now or hereafter in effect; or (ii) the other party's making a
general assignment for the benefit of creditors, or the other party's becoming
insolvent, or the other party taking any corporate action to authorize any of
the foregoing;
7.3.2. the other party's failure to pay any amount
that is due to the non-breaching party under this Agreement and such failure
continues for seven (7)days after the other party receives notice of such breach
from the non-breaching party;
7.3.3. the other party's failure to perform any of
its material obligations under this Agreement, and such failure continues for
thirty (30) days after the other party receives notice of such breach from the
non-breaching party; provided, however, if the other party has commenced to cure
such breach within such thirty (30) days, but such cure is not completed within
said thirty (30)days, the other party shall be afforded the amount of additional
time reasonably necessary to complete said cure, provided that the other party
diligently pursues curing the breach until completion; and
7.3.4. the other party's failure to perform the
services as described in Section 2 for a period of more than thirty (30) days as
a result of a force majeure event specified in Section 22.
7.4. All accrued payment obligations of the parties under this
Agreement, and Sections 11 through 15, inclusive, of this Agreement shall
survive the termination of this Agreement and, except as provided elsewhere in
this Agreement, no termination of this Agreement shall affect any obligations or
liabilities arising, or based upon acts or omissions occurring, prior to the
date of such termination. All fees shall be non-refundable. Within thirty (30)
days of termination, ICS shall return to IMMU or destroy, in accordance with
IMMU's instructions and at IMMU's cost, all inventory of Product previously
delivered to ICS and not sold to customers. If ICS shall have terminated this
Agreement without cause, or if IMMU shall have terminated for cause, ICS shall
pay the freight costs to deliver such inventory to IMMU. If this
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Agreement shall have terminated for any other reason, IMMU shall pay the
reasonable freight costs to deliver such inventory to IMMU.
8. Disaster Recovery
ICS and IMMU shall cooperate to develop a disaster recovery
service specific to IMMU's needs during the implementation process. This shall
be drafted as a standard operating procedure ("SOP").
9. Compensation - Fees for Services
9.1. Consignment Distribution Fee
IMMU shall pay fees to ICS as detailed in Schedule
"A". ICS shall invoice IMMU within [*] of the previous calendar month end. IMMU
shall pay all invoices within [*] of the invoice date.
9.2. Hourly Fees
In addition to the fees for services detailed in
Sections 1, 2 and 3, the following services will be provided by ICS on an as
required basis and shall be billed at the rate of [*] per hour as listed in
Schedule "A":
The provision of custom sales reports requested by
IMMU for specific territories and/or time periods. The creation of software
designed to produce such custom sales reports and all other services required
by IMMU for the provision of custom management report set-up. A reasonable
estimate of such charge shall be provided in advance.
9.3. Travel Costs
IMMU will pay to ICS all reasonable costs incurred
while traveling for and on behalf of IMMU at IMMU's request. A reasonable
estimate of such charge shall be provided in advance.
9.4. Auditing Rights
ICS shall keep records relating to the transactions
covered by this Agreement, which records shall be available for inspection by
IMMU to confirm that the correct amounts have been paid under this Agreement.
Such inspections shall take place not more than once per year at ICS's offices
and on no less than thirty (30) days notice and during normal business hours.
10. Compliance with Laws
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10.1. During the term of this Agreement, each party shall
conduct its activities in connection with this Agreement in compliance with all
applicable laws. Specifically, ICS shall comply with all applicable Requirements
of Law related to the storage, handling and distribution of Product, and IMMU
shall comply with all applicable Requirements of Law related to the importation,
manufacture, distribution, labeling, storage, sale and handling of Product. IMMU
shall have the right, not more than once per year and on no less than thirty
(30) days notice and during normal business hours, to inspect ICS's facilities
to confirm compliance with all applicable Requirements of Law related to the
storage, handling and distribution of Product, provided that IMMU acknowledges
that such inspection shall be limited to such extent required to comply with
laws and to maintain the confidentiality of ICS's other customers and clients.
10.2. IMMU agrees and does hereby represent and warrant to ICS
during the term of this Agreement that (1) all Product, and each shipment of
each, or other delivery now and hereafter made by IMMU to or on the order of
ICS, will not be, at the time of shipment or delivery, adulterated, misbranded
or otherwise prohibited within the meaning of the Act or within the meaning of
any applicable state or municipal law and (2) the Product is not, at the time of
shipment or delivery to ICS, merchandise which may not be introduced or
delivered for introduction into interstate commerce under the provisions of
Sections 404 or 405 of the Act, and (3) all such Product will be the subject of
a duly approved BLA and may be legally transported or sold under applicable
Requirements of Law and IMMU guarantees that only those chemicals or sprays, and
the amounts of such chemicals or sprays, approved by Governmental Authority,
have been used in any of the Product, and (4) ail Product have been duly
approved by all Governmental Authority for commercial sale and shipment within
the United States.
11. Corporate Authority
During the term of this Agreement, each party continually
represents and warrants to the other that: (a) it has full power and authority
to enter into this Agreement and perform and observe all obligations and
conditions to be performed or observed 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, (c) this Agreement constitutes the legal, valid
and binding obligation of that Party, (d) no approvals, consents, orders or
authorizations of or designation, registration, declaration or filing with any
Governmental Authority (within, as a part of, or constituting the United States
of America) is required for the sale and distribution of the Product other than
any approvals previously obtained from the FDA, (e) there is no action,
proceeding, or investigation pending or, so far as each party knows, threatened,
which questions the validity of this Agreement, the patents and licenses related
to and for the Product, any actions taken or to be taken pursuant to this
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Agreement, and (f) the Product, or any part thereof, has not been materially
adversely affected in any way as a result of any legislative or regulatory
change, or any revocation of license or right to manufacture, distribute,
handle, store, sell or market any of the Product.
12. Trade Marks/Data
Neither Party shall have the right to use the name of the
other Party or the other Party's trademarks, service marks, logos, other similar
marks or data and information in any manner except to the extent necessary to
allow each party hereto to carry out their respective obligations as
contemplated herein, without the prior written approval of the other Party. Data
and information which shall be deemed to belong to IMMU will be its proprietary
information and data relating to the Product, the identity of Product customers,
prescribing physician data and the identity of payor coverage and reimbursement
policy data related to Product. Data and information which shall be deemed to
belong to ICS shall be the data and information related to services offered and
sold by ICS and all data and information relating to any of ICS's customers and
their respective profiles.
13. Confidentiality
13.1. Each Party acknowledges that as a result of this
Agreement, that each Party shall learn Confidential Information of the other
Party. Each party shall treat Confidential Information furnished by the other
party as if it were its own proprietary information, and neither Party shall
disclose any Confidential Information of the other Party to any person or
entity, or use, or permit any person or entity to use, any of such Confidential
Information, excepting only: (a) disclosures on a confidential basis to and use
by the directors, officers, employees, and agents of that Party, or its
affiliates, who have a reasonable need to know such information in connection
with that Party's performance of this Agreement and who agree to keep such
information confidential, and (b) disclosures which are required by law, or
legal process, as reasonably determined by that Party or its legal counsel, or
are made on a confidential basis to that Party's attorneys, accountants, and
other professional advisors in connection with matters relating to this
Agreement. The specific material terms of this Agreement shall be deemed to be
Confidential Information of each Party.
13.2. The obligation of confidentiality hereunder shall
survive the termination of this Agreement for a period of five (5) years.
13.3. Disclosure Required by Law. In the event that IMMU or
ICS shall be required to make disclosure of the other's Confidential Information
as a result of the issuance of a court order or other government process, the
party subject to such requirement promptly, but in no event more than
forty-eight (48) hours after learning
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of such court order or other government process, shall notify, by personal
delivery, mail, express delivery service, or facsimile, all pursuant to Section
16.0 hereof, the other party and, at the other party's expense, the party
subject to such requirements shall: (a) take all reasonably necessary steps
requested by the other party to defend against the enforcement of such court
order or other government process, and (b) permit the other party to intervene
and participate with counsel of its choice in any proceeding relating to the
enforcement thereof.
13.4. Advertising and Publicity. Except for such disclosures
as are deemed necessary in IMMU's or ICS's, as the case may be, reasonable
judgment to comply with applicable law (such as, by way of example but not
limitation, the securities laws of the United States), each of IMMU and ICS
agrees that neither it nor anyone acting on its behalf will make any publicly
disseminated oral or written disclosure relating to or referring to, or use any
advertising or publicity which relates or makes reference to, the other party,
this Agreement or the terms hereof, without in each case the other party's prior
approval (which approval will not be unreasonably withheld or delayed); each
party agrees to respond promptly to a disclosure request, but in any event not
later than five (5) business days from receipt of such a request.
13.5. Upon termination of this Agreement (for any reason) each
Party shall promptly: (i) return to the other Party or destroy all documentation
and other materials (including copies of original documentation or other
materials) containing any Confidential Information of the other Party; or (ii)
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.
14. Indemnification
14.1. Each Party shall indemnify, defend and hold harmless the
other and their respective Related Parties as defined in Appendix A attached
hereto and by this reference incorporated herein, from and against all claims,
liabilities, losses, damages, costs and expenses (including without limitation
reasonable attorneys' fees) arising directly or indirectly out of any act or
omission of that Party or any failure of that Party to perform and observe fully
all obligations and conditions to be performed or observed by that Party
pursuant to this Agreement or any breach of any warranty made by that Party in
this Agreement. Further, IMMU does hereby protect, indemnify and hold harmless
ICS and its related parties from and against all claims, liabilities, losses,
damages, costs and expenses (including without limitation, reasonable attorneys'
fees and expenses) imposed upon or incurred by or asserted against ICS related
to or arising from (1 ) any claim of patent or copyright infringement relating
to the subject matter of this Agreement, and (2) any loss of or damage to
property, accident, injury to or death of a person or persons occurring or
arising from the use, demonstration, consumption, ingestion, digestion,
manufacture, production and assembly, of the Product and its transportation to
ICS, excepting only for claims
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arising out of the act, negligence or omission of ICS or its Related Parties.
Further, ICS does hereby agree to protect, indemnify and hold harmless IMMU and
its Related Parties from and against all claims, liabilities, losses, damages,
costs and expenses (including without limitation, attorneys' fees and expenses)
imposed upon or incurred by or asserted against IMMU related to or arising from
any loss of or damage to property, accident, injury to or death of a person or
persons occurring or arising from the negligence of ICS (or its Related
Parties), excepting herefrom, any act, negligence or omission of IMMU or its
Related Parties. NOTWITHSTANDING THE FOREGOING OR ANY OTHER PROVISION TO THE
CONTRARY CONTAINED IN THIS AGREEMENT, NEITHER PARTY SHALL BE LIABLE TO THE OTHER
PARTY FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, OR OTHER SIMILAR
DAMAGES ARISING OUT OF OR IN CONNECTION WITH A BREACH OF THIS AGREEMENT OR,
EXCEPT AS SET FORTH IN SECTION 7, ANY EXPENSES, CHARGES, COSTS OR LIABILITIES,
WHETHER FORESEEN OR UNFORESEEN, ARISING FROM OR RELATED TO THE ACT OF
TERMINATING THIS AGREEMENT.
14.2. Each party shall give the other prompt notice of any
potential claim for indemnification hereunder, and promptly after receipt by a
party claiming indemnification under this Section 14.2 of notice of the
commencement of any action, such indemnified party will notify the indemnifying
party of the commencement of the action and generally summarize such action. The
indemnifying party shall have the right to participate in and to assume the
defense of such action with counsel of its choosing. An indemnifying party shall
not have the right to direct the defense in such an action of an indemnified
party if counsel to such indemnified party has reasonably concluded that there
may be defenses available to it that are different from or additional to those
available to the indemnifying party; provided, however, that in such event, the
indemnifying party shall bear the reasonable fees and expenses of separate
counsel reasonably satisfactory to the indemnifying party. The failure to notify
an indemnifying party promptly of the commencement of any such action, if
prejudicial to the ability to defend such action, shall relieve such
indemnifying party of any liability to the indemnified party under this Section
14.2. No settlement of any claim or action may be made without the consent of
the indemnifying party (which shall not be unreasonably withheld or delayed).
15. Insurance
During the term of this Agreement, IMMU will maintain product
liability and commercial general liability insurance having a limit of not less
than [*], pursuant to one or more insurance policies with reputable insurance
carriers. IMMU shall designate ICS as an "additional insured" under all
insurance policies referenced in this paragraph. As a condition precedent to the
effectiveness of this Agreement, IMMU shall execute the Guarantee in the form
attached hereto as Schedule "B".
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ICS shall provide IMMU with a certificate of insurance showing
that ICS is a named insured covered by the commercial and general liability
policies of its parent company, Bergen Xxxxxxxx Corporation.
16. 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
duly made when: (a) delivered personally, (b) 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; (c) delivered to an
express delivery service for delivery to that Party at that address; or (d) sent
by facsimile transmission, with electronic confirmation, to that Party at its
facsimile numbers set forth at the end of this Agreement. Any notice or
communication shall be deemed given and received on the date delivered
personally, three business days after mailing, one business day after delivery
to an express delivery service and upon electronic confirmation during
recipients normal business hours (or the next business day, if received
thereafter), if communicated by facsimile transmission. Any Party may change its
address or facsimile number for notices under this Agreement by giving the other
Party notice of such change.
17. Remedies
With respect to the provisions of Section 13 of this
Agreement, each Party acknowledges that in the event of any violation by that
Party of any of the provisions of Section 13 of this Agreement, the other Party
may suffer irreparable harm and its remedies at law may be inadequate.
Accordingly, in the event of any violation or attempted violation of any such
provisions of Section 13 by either Party, the other Party shall be entitled to
petition for a temporary restraining order, temporary and permanent injunctions,
specific performance, and other equitable relief. The rights and remedies of
each Party under this Agreement shall be cumulative and in addition to any other
rights or remedies available to such Party, whether under any other agreement,
at law, or in equity.
18. Governing Law and Attorneys Fees
All questions concerning the validity or meaning of this
Agreement or relating to the rights and obligations of the Parties with respect
to performance under this Agreement shall be construed and resolved under the
laws of the State of New York excluding the body of law relating to conflicts of
laws. In the event that either party takes legal action to enforce its rights or
remedies under this Agreement, the prevailing party shall be entitled to recover
its costs and expenses, including reasonable attorneys' fees, incurred in such
action.
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19. Severability
The intention of the Parties is to comply fully with all laws
and public policies, and this Agreement shall be construed consistently with all
laws and public policies to the extent possible. 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.
20. Tax Provision
Each party shall bear all taxes imposed on it as a result of
the performance by such party under this Agreement including, but not limited
to, any sales tax and tax on or measured by any payment required to be made
hereunder, any registration tax, or any tax imposed with respect to the granting
of other rights hereunder. The parties shall cooperate fully with each other in
obtaining and filing all requisite certificates and documents with the
appropriate authorities and shall take such further action as may be reasonably
necessary to avoid the deduction of any withholding or similar taxes from any
remittance of funds by one party to the other hereunder.
21. Non-Waiver
No failure by either Party to insist upon strict compliance
with any term of this Agreement, to exercise any option, 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.
22. Force Majeure
If the performance of any part of this Agreement by either
Party shall be affected for any length of time by fire or other casualty,
government restrictions, war, riots, strikes or labor disputes, lock out,
transportation delays, electronic disruptions, telecommunication failures, and
acts of God, or any other causes which are beyond the control of the Parties
(financial inability excepted), 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 any other Party
shall not be subject to the provisions of this Section. Each party shall use
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its commercially reasonable efforts to minimize the impact on the other of any
force majeure event specified in this Section.
23. Captions
The captions of the various sections of this Agreement are not
part of the context of this Agreement, and are only labels to assist in locating
those sections, and shall be ignored in construing this Agreement.
24. Complete Agreement
This Agreement contains the entire agreement between the
Parties and supersedes all prior or contemporaneous discussions, negotiations,
representations, warranties, or agreements relating to the subject matter of
this Agreement. No changes to this Agreement shall be made or be binding on
either Party unless made in writing and signed by both Parties. All schedules,
Exhibits, Appendixes referred to in this Agreement are incorporated herein and
made a part hereof as fully as if set forth herein.
25. Successors
Except as set forth in this Section, 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, which
consent shall not be unreasonably withheld. After providing written notice to
IMMU, ICS may assign this Agreement to a party that succeeds to all or
substantially all of ICS's business or assets relating to this Agreement whether
by sale, merger, operation of law or otherwise.
26. Approvals
When this Agreement requires the approval of one or both of
the parties to this Agreement, each and every such approval sought will not be
unreasonably withheld by the party required to provide its approval.
27. Relationship of the Parties
The relationship of the Parties is and shall be that of
independent contractors. This Agreement does not establish or create a
partnership or joint venture among the Parties.
28. Interpretation
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The parties have jointly negotiated this Agreement and, thus,
neither this Agreement nor any provision hereof shall be interpreted for or
against any party on the basis the party or the party's attorney drafted the
Agreement or the provision at issue.
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.
IMMUNOMEDICS, INC. INTEGRATED COMMERCIALIZATION
SOLUTIONS, INC.
By:/s/ Xxxxx F.X. Xxxxxx By:/s/ Xxxxxxx X. Xxxxx
Name: Xxxxx F.X. Xxxxxx Name: Xxxxxxx X. Xxxxx
Title: Vice President-Finance and Title: Vice President, Operations
Administration and
Chief Financial Officer
Address and facsimile number: Address and facsimile number:
000 Xxxxxxxx Xxxx 0000 Xxxxxxxx Xxxx
Xxxxxx Xxxxxx, Xxx Xxxxxx 00000 Suite 200
Attn: Xxxxx F.X. Xxxxxx Xxxxxxx, Xxxxx 00000
Vice President-Finance and Attn: Xxxxxxx X. Xxxxx
Administration and Vice President, Operations
Chief Financial Officer Facsimile: (000) 000-0000
Facsimile: (000) 000-0000
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APPENDIX A
As used in this Agreement,
"Act" means the Federal Food, Drug and Cosmetic Act, Title 21, United States
Code, as amended, and the regulations thereunder.
"BLA" means Biological License Application as defined in and contemplated by the
Act.
"Confidential Information" shall mean information, and data considered
confidential by the party owning such information, whether visual, oral or in
written form, but does not include (1 ) information which is or becomes public
without the fault or participation of the other party to this Agreement or which
is responsive to legal process or obligation, (2) any information lawfully in
the receiving party's possession prior to the date the receiving party receives
the disclosing party's information, or (3) any information which either party
receives from a third party who rightfully possesses and discloses such
information.
"Governmental Authority" shall mean any nation or government, any state or other
political subdivision thereof, or any entity exercising executive, legislative,
judicial, regulatory or administrative functions of or pertaining to government.
"Person" or "Persons" means any corporation, natural person, firm, joint
venture, partnership, trust, unincorporated organization, government or any
department or agency of any government.
"Related Parties" mean the successors, subsidiaries, parent corporations,
affiliates, Directors, employees, agents, representatives, related entities and
assigns of any Person.
"Requirement(s) of Law" means any law (including, without limitation, consumer
law), treaty, rule or regulation or a final and binding determination of an
arbitrator or a determination of a court or other Governmental Authority, in
each case applicable to or binding upon such Person or any of its property or to
which such Person or any of its property is subject.
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SCHEDULE A
Fee Schedule
Fixed Monthly Fee for Services Rendered Under Sections 1, 2 and 3 of this
Agreement:
Average Number of Orders
Processed and Shipped Per Day
During a Calendar Month Fee For Such Month
[*] [*]
[*] [*]
[*] [*]
[*] [*]
Additional Costs Fee
ICS will store up to [*] pallets of refrigerated product per month without
charge. ICS will assess a monthly storage charge of [*] each for additional
pallets held for IMMU sale to customers.
Customer reporting/software design [*]
Customer management report setup (specific software design [*]
requirements for customer beyond specific reports)
Travel on IMMU's request [*]
Freight and Courier charges [*]
[*]
Telecommunication, facsimile, Fed Ex/UPS and postage [*]
expenses
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SCHEDULE B
CONTINUING GUARANTY AND INDEMNIFICATION AGREEMENT
The undersigned does hereby guarantee to Integrated Commercialization Solutions,
Inc., its parent Bergen Xxxxxxxx Corporation ("BBC") and each of BBC's
subsidiary corporations (together the "Group") that each shipment or other
delivery of any food, drugs, devices, cosmetics, or other merchandise now or
hereafter made by the undersigned, its subsidiaries, divisions or affiliated
companies to or on the order of any member of the Group will not be, at the time
of such shipment or delivery, adulterated, misbranded, or otherwise prohibited
within the meaning of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.A. #301
et seq., as amended, and in effect at the time of said shipment or delivery (the
Act) or within the meaning of any applicable state or municipal law in which the
definition of adulteration or misbranding are substantially the same as those
contained in the Act; and such merchandise is not, at the time of such shipment
or delivery, merchandise which may not be introduced or delivered for
introduction into interstate commerce under the provisions of section 404 or 405
of the Act (21 U.S.C.A. #344 and #355); and such merchandise is merchandise
which may be legally transported or sold under the provisions of any other
applicable federal, state or municipal law; and the undersigned guarantees
further that only those chemicals or sprays approved by federal, state or
municipal authorities have been used, and any residue in excess of the amount
allowed by any such authorities has been removed therefrom.
The undersigned hereby agrees to defend, indemnify and hold the Group harmless
against any and all claims, losses, damages, and liabilities whatsoever (and
expenses connected therewith, including reasonable counsel fees), arising as a
result of (a) any actual or asserted violation of the Act or any other federal,
state or local law or regulation by virtue of which products sold, supplied, or
delivered by the undersigned shall be alleged or determined to be adulterated,
misbranded, mislabeled or otherwise not in full compliance with any federal,
state or local law or regulation, and (b) the possession, distribution, sale
and/or use of, or by reason of the seizure of, any of the undersigned's
products, including any prosecution or action whatsoever by any government body
or agency or (subject to Section 14 of the Distribution and Product Services
Agreement between us) by any private party, including claims of bodily injury,
death or property damage. The undersigned further agrees to maintain primary and
noncontributing Products Liability Insurance of not less than $5,000,000.00
Combined Single Limit (Bodily Injury and Property Damage) including each member
of the Group as Additional Insured as respects Broad Form Vendors Coverage, with
provision for at least 30 days prior written notice to the Additional Insured in
the event of cancellation or material reduction of coverage, and upon request
promptly submit satisfactory evidence of such
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insurance. The provisions set forth herein are in addition to, and not in lieu
of, any terms set forth in any purchase orders accepted by the undersigned.
IMMUNOMEDICS, INC. /s/ Xxxxx F.X. Xxxxxx August 7, 1998
Guarantor(Name) Signature of Authorized Officer Date
Xxxxx F.X. Xxxxxx, Vice President-Finance and
Administration and
Chief Financial Officer
Name and Title
000 Xxxxxxxx Xxxx, Xxxxxx Xxxxxx, XX 00000
Address of Company
(000) 000-0000
Phone
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