EXHIBIT 10.55
*Certain information omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2(b).
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INTEGRATED ACCESS CENTER
SERVICES AGREEMENT
This Integrated Access Center Services Agreement ("Agreement")
made this 27th day of May, 1997 by and between ALTERNATE SITE
DISTRIBUTORS, INC. ("ASD") and INTERFERON SCIENCES, INC. ("ISI").
RECITALS
I. ISI is a biopharmaceutical Company currently engaged in the study,
manufacture and sale of pharmaceutical products based on its natural source,
multispecies alpha interferon Interferon Alfa-n3.
ISI has developed Alferon N Injection(r) ("Alferon") which product
has U.S.F.D.A. approval for human use.
II. ASD is in the business of providing distribution and product
service support services through a single-point-of-contact
Integrated Access Center.
III. ISI desires to engage ASD to provide an integrated access
center with four core service components which are Distribution
Services, Clinical Services, Reimbursement Services and Patient
Assistance Services.
NOW THEREFORE, for good and valuable consideration the receipt and
sufficiency of which is hereby acknowledged, the parties hereto
agree as follows:
1.0 Development of Integrated Access Center
1.1 Exclusivity
1. ISI hereby appoints ASD as its sole distributor of
Alferon in the U.S.A. and the U.S. territories. ISI agrees not to
appoint or contract with any other entity as a distributor of
Alferon in the U.S.A. and the U.S. territories.
2. ASD hereby agrees that it shall not design,
implement or manage a single point of contact distribution program
similar to the Interferon Integrated Access Center for any other
alpha interferon product which is used in any of the following
therapeutic indications: Human Immunio Deficiency Virus - positive
patients, Hepatitis C - patients and genital warts patients. ISI
acknowledges that the exclusivity granted in this section
specifically excludes ASD's core distribution business.
1.2 ISI hereby engages ASD to develop the Interferon Sciences
Integrated Access Center ("Center") for the provision of services
to ISI as described below. ASD agrees to develop the Center for
the fee listed in Schedule "A" attached hereto and by this
reference made a part hereof.
1.3 The Center shall comprise the following:
1. A fully-integrated telecommunications and
information management system that will capture and manage key
information from each customer audience requesting information or
specific services relating to Alferon.
2. A single-point-of-contact product distribution and patient
support system.
3. Insurance eligibility and coverage verification and the
payment policy for Alferon.
4. Referral of patients to appropriate providers.
5. A toll-free Alferon-dedicated telephone and fax number.
1.4 ISI and ASD will together develop:
1. Brochures for targeted physicians describing how to access
Alferon.
2. An enrollment form to be completed by patients and physicians.
2.0 Distribution Services
For the fees listed in Schedule "A", ASD will provide the following
services:
2.1 Order Process Management.
ASD will provide customer service representatives to perform the
following order process management activities.
1. staffing during normal customer service hours;
2. management of inbound telephone calls, faxes and EDI
transmissions;
3. new account processing, including credit verification;
4. return goods processing; and
5. triaging calls to Interferon Sciences, if requested.
2.2 Distribution/Warehousing.
ASD will warehouse and inventory Alferon at ASD's distribution
facility at Louisville, Kentucky, (the "ASD Facility"). Alferon that has met
all regulatory product release requirements will be received, and placed into
inventory for distribution. ASD and ISI will comply with all FDA regulations
including product lot record retention. Distribution and warehousing services
include the following:
1. continuous inventory maintenance
2. Invoicing on ASD invoice stock;
3. Shipment tracking;
4. Shipping costs;
5. Security costs;
6. Receipt of returned/damaged goods; and
7. Shipment of outdated/damaged goods to site of disposal.
ISI will pay all costs, expenses, insurance, and import duties, if
any, for delivery of all Alferon to the ASD facility. ASD will visually
inspect each shipment of Alferon for external container or package damage or
loss in transit (based upon records provided to ASD from ISI). Contingent upon
ASD receiving the appropriate records to enable batch verification, ASD shall
notify ISI when damage or loss has occurred within three business days of
receipt of Alferon by ASD. ASD will store and ship all Alferon in compliance
with good manufacturing practice guidelines and other FDA requirements.
Alferon will be shipped in regulatory compliant refrigerated shippers
upon receipt of the order transmission from customer service. Orders received
by 6:00 pm EST will be shipped the same day. Orders will be distributed via UPS
Next Day Air, 2 Day or 5 Day Ground for bulk shipments. Products will be
distributed on an FEFO (first expired, first out) basis.
2.3 Wholesaler and Direct Distribution
ASD will receive direct orders for Alferon by any of electronic
transmission, fax or phone. Orders may be processed in two ways:
1. Direct accounts will be established and invoiced directly; or
2. Orders received by ASD will be processed as a dropship through
the accounts' designated wholesaler if so requested by the customer.
3.0 CLINICAL SERVICES
ASD will hire, train, and manage Customer Service
Representatives and Clinical Specialists to answer drug information
questions that come through the Integrated Access Center. Customer
Service Representatives shall respond to calls of minimal service
complexity (Level 1) and Clinical Specialists will handle calls of
moderate service complexity (Level 2). Questions that are deemed
to be complex or comprehensive (Level 3) will be transmitted via a
"hot-key" to Interferon Services Medical Affairs.
3.1 Promotional Materials
ASD shall warehouse and manage the inventory and
distribution (fulfillment) of Alferon promotional materials that
are sent to ISI sales representatives. These materials will be
developed and provided by ISI for use in the Integrated Access
Center. ISI will provide ASD with bulk clinical and promotional
materials which will be regarded as units. For the purposes of
this Agreement, 50 brochures in a shrink-wrapped package will be
regarded as one unit. Bulk clinical and promotional materials will
further be categorized as "line items" at the ASD warehouse. ISI
will be charged for the shipping costs per "line item" processed
(see Schedule "A"). ASD will ship orders for weekly promotional
materials via UPS Second Day Air unless otherwise specified by ISI.
ASD will charge ISI actual costs for out-of-scope shipments to
sales representatives as listed in Schedule "A".
Requests for promotional materials will be directed to ASD by ISI
sales representatives or other authorized ISI marketing personnel
via telephone, fax, or electronic media. In addition to shipments
to ISI sales representatives, ASD will also ship promotional
materials to medical conventions. ASD will also ship bulk clinical
and promotional materials to caregivers and providers, for the fees
listed in Schedule "A", for the first year of this contract. At
the end of the first year of this Agreement, ASD and ISI senior
management will determine if this service is still beneficial for
both parties.
3.2 The parties agree that no promotional materials to be
utilized pursuant to this Agreement that refer to any specific
pharmaceutical products shall be disseminated until such materials
have been reviewed by ISI with regard to all applicable laws and
regulations, including, but not limited to, laws and regulations
administered by the U.S. Food and Drug Administration regarding the
advertising and promotion of pharmaceutical products, and approved
by ISI as compliant with such laws and regulations. The parties
further agree that ASD shall bear no liability whatsoever for the
content of any materials so reviewed and approved by ISI, and ISI
shall indemnify ASD against all liability, damages, and costs
arising from the use of any such materials.
3.3 ASD will receive adverse event information from treating
physicians, medical treatment centers and/or other healthcare
professionals and will report such information to ISI in an FDA
compliant form.
3.4 Skilled Nursing Support (if required)
If skilled nursing support services are required ASD will
determine during the health insurance eligibility and coverage
assessment process which skilled nursing service is an appropriate
provider. ASD will also determine that the skilled nursing
services provided will be reimbursed by the responsible payer. If
such services are not reimbursable, ASD shall inform the patient
that he/she shall be responsible for payment. ASD will refer the
patient to an appropriate local skilled nursing service if
preferred by the patient or physician. If no preference is stated,
ASD will utilize a national home health agency to provide skilled
nursing services to patients or physicians who request a referral.
4.0 REIMBURSEMENT SERVICES
ASD will provide the following services for the fees as listed
in Schedule "A" attached hereto:
4.1 Reimbursement Guide.
ASD will develop a reimbursement guide to offer
information to physicians and health care providers to illustrate
how to properly code and submit "clean claims" to payers for prompt
payment and to reduce payment denials. The guide may also be
utilized by ISI or ASD to train internal ISI personnel and the ISI
sales force. The guide will include a brief description of
Alferon, the rationale for treatment, package insert, and:
1. brief overviews of key payer coverage and payment
policy
2. medical necessity criteria
3. diagnosis (ICD-9-CM), CPT-4, HCPCS and revenue
source codes (if applicable)
4. examples of completed claim forms specific to the
treatment setting, e.g., HCFA 1500
5. access to the toll-free Interferon Sciences'
Integrated Access Center
4.2 *
4.3 *
4.4 Alferon Treatment Assurance Program (ATAP)
1. Uninsured Patient Exposure Analysis
ASD will estimate ISI's overall product exposure
based on financial and health insurance models that include income,
family size, age, the shift to Medicare and Medicaid as primary
payers as the disease progresses, the percentage of Medicare
beneficiaries who have secondary prescription drug coverage, and
various levels of financial eligibility guidelines. ASD will
evaluate the benefits of structuring the ATAP under a foundation
with 501(c)3 status versus a straight-forward company-sponsored
program. ASD will also research the eligibility guidelines and
structure of competitive manufacturer patient support programs and
other manufacturer sponsored patient assistance programs to
recommend a specific program structure and proposed eligibility
criteria. For purposes of this research, ISI has indicated that
its overall objectives are:
(1) to provide access to Alferon for patients who
are uninsured, are not eligible for city county, state or federal
assistance, and cannot afford the cost of therapy
(2) to establish appropriate program guidelines to
fairly disperse a limited supply of product
(3) to identify patients who may qualify for
alternate health insurance/funding to maintain the Alferon
Treatment Assurance Program as the "payer of last resort"
(4) identify various State Medicaid program
initiatives intended to shift patients from a state administered
program to a managed healthcare program
(5) to develop a user-friendly, streamlined program
application process that is not in itself a hardship for patients
and physicians to complete while maintaining necessary program
controls
(6) to provide appeals assistance and profile
payers that do not provide coverage for Alferon
2. Initial Enrollment Kits
If requested ASD together with ISI and its
designated advertising agency will develop ATAP enrollment kits.
The enrollment kit will consist of a program brochure providing a
description of the program, enrollment procedures, and a program
application form. If requested, an initial supply of ATAP
enrollment kits will be distributed to sales representatives with
additional supplies maintained in the fulfillment materials
warehouse for re-orders. For the fees listed in Schedule "A",
ISI/ASD sales representatives will distribute program enrollment
kits to key physicians. ASD will direct-mail a supply of the
enrollment kits to remote physicians and other Alferon prescribers
including those who cannot be reached by the sales force during
product launch. ATAP enrollment kits will be made available on a
per request basis for reorders by contacting the Interferon
Sciences Integrated Access Center.
3. Initial Enrollment Process
It is anticipated by ASD and ISI that:
(1) Patients and physicians will complete the ATAP
enrollment application and attach all required supporting
documentation (e.g., W-2, pay check stubs, physician statement of
medical necessity, insurance policies or EOBS) required to confirm
that the patient is uninsured and cannot afford the cost of
therapy.
(2) Enrollment applications may be faxed or mailed
to the ATAP.
(3) Enrollment application data will be input into
the Alferon Patient Support Management System which creates a
system-generated response regarding the patient's eligibility for
ATAP participation based on:
(a) income/assets
(b) health insurance coverage status
(c) current out-of-pocket medical expenses
(d) eligibility for alternate health
insurance/funding from Medicaid and other state and federal
pharmaceutical assistance programs including state ▇▇▇▇ ▇▇▇▇▇ and
other AIDS drug assistance programs (ADAPS)
(4) Should referrals to the ATAP exceed two percent
(2%) of all active patients treated with Alferon (excluding ATAP
patients currently enrolled), ASD shall notify ISI and together ASD
and ISI will re-evaluate the program eligibility criteria.
(5) All completed ATAP applications shall be
forwarded to the ISI Director of Product Reimbursement.
(6) If a patient is approved for ATAP
participation, and Alferon is requested, ASD will schedule a
delivery date for a 30- or 90-day supply of Alferon. ASD will
create an order entry record and EDI the order to the ASD Finished
Goods Warehouse for picking, packing in appropriate containers for
refrigerated product, and direct shipment to the physician.
4. Re-Qualification / Re-Enrollment
(1) The ATAP participating patient or patient
representative will be contacted by ASD once each calendar quarter
to determine the level of customer satisfaction, if any further
assistance is required, and to confirm that there has been no
change in insurance and financial status.
(2) ASD will mail the ATAP participating patient or
patient representative a re-enrollment application with a
notification to the treating physician 60 days prior to the end of
the semi-annual ATAP participation award period (i.e., every six
months). A letter will be enclosed requesting that all financial,
insurance and medical enrollment information be updated to continue
participation in the program. The patient will also be re-screened
for alternate health insurance/funding eligibility.
4.5 Under-insured Patient Assistance Program
Under -insured patients, for purposes of this Agreement
are those patients who are financially unable to pay for the full
cost of Alferon and associated care for the following reasons:
a) their insurance policy has high deductibles
and/or co-payment obligations; or
b) their insurance policies have annual drug
benefit limitations and the cost of Alferon exceeds such limits; or
c) their insurance policies have spend-down
requirements that must be met prior to the Alferon costs becoming
reimbursable.
ASD and ISI will work together to develop a program to assist these
patients.
5.0 DATA MANAGEMENT AND REPORTING (Key Program Activity and
Management Reports)
All integrated access center activities will be linked to a
central repository (data warehouse) of information from which the
following types of reports will be available to Interferon Sciences
for the fees listed in Schedule "A" attached hereto:
1. transmission of daily sales by unit and dollars
2. sales reports by territory/region
3. inventory reports
4. inventory management program designed to support
ISI's treatment continuity guarantee
5. credits
6. new accounts
7. chargeback, rebate data
8. program utilization data including call volume, type
of caller and reason for inquiry down to the state level and/or
sales territory level
9. payer profiling and formulary status
10. patient, health care professional and provider
profiling
11. reimbursement outcomes
12. program performance measures jointly developed and
mutually agreed by ASD and ISI
ISI and ASD 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. Although standard reports are covered under this
Agreement, there will be additional charges for special reports
based upon programming charges.
6.0 RECALLS
6.1 In the event that it becomes necessary to conduct a
recall, market withdrawal or field correction (a "Recall") of any
Product, ISI shall conduct the Recall and shall have primary
responsibility therefor, and ASD shall cooperate with ISI in
recalling any affected Alferon. If the Recall was due to the acts
or omissions of ISI, then ISI shall pay or reimburse, as the case
may be, all of ASD's direct out-of-pocket expenses, including but
not limited to any reasonable attorney's fees and expenses,
incurred by ASD in connection with performing any such Recall. If
the Recall was due to the acts or omissions of ASD then ASD shall
pay or reimburse, as the case may be, all of ISI's direct
out-of-pocket expenses, including but not limited to any reasonable
attorneys fees or expenses, incurred by ISI 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. ISI shall inform ASD of the proposed Recall within
forty-eight (48) hours of the initiation of the Recall. ISI and
ASD will jointly develop Recall standard operating procedures.
6.2 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 the Alferon 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. ASD shall notify ISI of any FDA
inspections of ASD's facilities specifically relating to any of the
Alferon and, if reasonably possible, shall afford ISI the
opportunity to be present at such inspection.
7.0 PURCHASE OF PRODUCT/RISK
Upon execution of this Agreement:
7.1 ASD shall buy such quantities of Alferon from ISI as
required to satisfy its obligations hereunder. ISI shall sell
Alferon to ASD on purchase terms as follows:
1. *
2. *
7.2 ASD will obtain title to all Alferon on receipt and
acceptance of the Alferon at the ASD Facility. ASD shall insure
Alferon in its control against loss in shipment from the ASD
Facility, damage or natural catastrophes, acts of God or other
reasons of force majeure.
7.3 *
8.0 TERM AND TERMINATION
8.1 Initial Term
This Agreement shall be effective immediately upon
execution provided that the parties hereto acknowledge that full
service will be operational within one hundred twenty (120) days
after the date of execution by both parties and shall continue in
full force and effect thereafter for a period of three (3) years
from the date of execution unless sooner terminated as provided
herein.
8.2 Termination
This Agreement may be terminated by either party without
cause on one hundred twenty (120) days written notice to the other.
8.3 A party may terminate this Agreement immediately upon
written notice for the following causes:
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;
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;
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
4. the other party's failure to perform the
distribution services as described in Section 2.0 for a period of
more than thirty (30) days as a result of a force majeure event
specified in Section 22.
8.4 For the purposes of Section 8.3(c) above, the failure of
performance by ASD hereunder shall be measured against mutually
agreed ▇.▇.▇▇ and program performance measures.
8.5 If ASD shall terminate this Agreement without cause, or
if ISI shall terminate this Agreement with cause, within the first
ninety (90) days after execution hereof, then and only then shall
ASD refund to ISI *
8.6 All accrued payment obligations of the parties under this
Agreement, Sections 1 through 6, inclusive 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. The development fees shall
be non-refundable except in the limited circumstances set out in
Section 8.5 above. Within thirty (30) days of termination, for
whatever cause or no cause, ISI shall repurchase all inventory sold
to ASD at ASD's acquisition cost . If ASD shall have terminated
this Agreement without cause, or if ISI shall have terminated for
cause, ASD shall pay the freight costs to deliver such inventory to
ISI. If this Agreement shall have terminated for any other reason,
ISI shall pay the reasonable freight costs to deliver such
inventory to ISI.
8.7 ASD agrees that for a period of six months following the
termination of this Agreement, for any reason or no reason, it
shall not design, implement or manage a single point of contact
program for any alpha interferon product used in any of the three
therapeutic indications specified in Section 1.1(b) below.
9.0 DISASTER RECOVERY
ASD and ISI shall cooperate to develop a disaster recovery
service specific to ISI's needs during the implementation process.
This shall be drafted as a standard operating procedure ("SOP").
10.0 COMPENSATION - FEES FOR SERVICES
10.1 *
10.2 *
10.3 *
10.4 *
10.5 Auditing Rights
ASD shall keep records relating to the transactions
covered by this Agreement, which records shall be available for
inspection by ISI to confirm that the correct amounts have been
paid under this Agreement. Such inspections shall take place not
more than once per year at ASD's offices and on no less than thirty
(30) days notice and during normal business hours.
11.0 COMPLIANCE WITH LAWS
11.1 During the term of this Agreement, each party shall
conduct its activities in connection with this Agreement in
compliance with all applicable laws. Specifically, ASD shall
comply with all applicable Requirements of Law related to the
storage, handling and distribution of Alferon, and ISI shall comply
with all applicable Requirements of Law related to the importation,
manufacture, distribution, labeling, storage, sale and handling of
Alferon. ISI 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 ASD's facilities to confirm compliance with all
applicable Requirements of Law related to the storage, handling and
distribution of Alferon, provided that ISI acknowledges that such
inspection shall be limited to such extent required to comply with
laws and to maintain the confidentiality of ASD's other customers
and clients.
11.2 ISI agrees and does hereby represent and warrant to ASD
during the term of this Agreement that (1) all Alferon, and each
shipment of each, or other delivery now and hereafter made by ISI
to or on the order of ASD 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 Alferon is not, at the time of
shipment or delivery to ASD, 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 Alferon will be the subject of a duly approved NDA or ANDA and
may be legally transported or sold under applicable Requirements of
Law and ISI 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 Alferon, and (4) all
Alferon have been duly approved by all Governmental Authority for
commercial sale and shipment within the United States.
12.0 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 Alferon 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 Alferon,
any actions taken or to be taken pursuant to this Agreement, and
(f) the Alferon, 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
Alferon.
13.0 TRADEMARKS/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 in
the production of marketing documents and brochures as contemplated
herein, without the prior written approval of that Party. Data and
information which shall be deemed to belong to ISI will be the
identity of Alferon customers, prescribing physician data and the
identity of payor coverage and reimbursement policy data related to
Alferon. Data and information which shall be deemed to belong to
ASD shall be the data and information related to all goods, Alferon
and services offered and sold by ASD and all data and information
relating to any of ASD's customers and their respective profiles.
14.0 CONFIDENTIALITY
14.1 Each Party acknowledges that as a result of this
Agreement, that each Party shall learn Confidential Information of
the other Party. 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 (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.
14.2 The obligation of confidentiality hereunder shall survive
the termination of this Agreement for a period of three (3) years.
14.3 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.
15.0 INDEMNIFICATION
15.1 Each Party shall indemnify and hold harmless the other
and their respective Related Parties 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, ISI does hereby protect, indemnify and
hold harmless ASD 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 ASD and/or its
Related Parties related to or arising from (1) any claim of patent
or copyright infringement and (2) any loss of or damage to
property, accident, injury to or death of a person or persons
occurring or arising from the storage and handling of the Alferon,
use, non-use, demonstration, consumption, ingestion, digestion,
manufacture, production and assembly, of the Alferon and its
transportation to ASD, excepting only for claims arising out of the
act, negligence or omission of ASD or its employees. Further, ASD
does hereby agree to protect, indemnify and hold harmless ISI 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 ISI and/or its Related Parties 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 ASD (or its employees), excepting herefrom, any act,
negligence or omission of ISI 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 LOST PROFITS, 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 8 ANY EXPENSES, CHARGES, COSTS OR LIABILITIES, WHETHER
FORESEEN OR UNFORESEEN, ARISING FROM OR RELATED TO THE ACT OF
TERMINATING THIS AGREEMENT.
15.2 The obligations and liabilities of ISI or ASD with
respect to ASD Indemnified Claims or ISI Indemnified Claims,
respectively, (collectively, the "Indemnified Claims"), resulting
from the assertion of liability by third parties (each, a "Third
Party Claim") shall be subject to the following terms and
conditions:
(1) The party claiming indemnification (the
"Indemnified Person") shall give prompt written notice to the other
party of any Third Party Claim which may give rise to a Third Party
Claim against the other party (the "Indemnifying Person"), stating
the nature and basis of said Third Party Claim and the amount
thereof to the extent known. Each Notice of Claim shall be
accompanied by copies of all relevant documentation with respect to
such Third Party Claim, including, without limitation, any summons,
complaint or other pleading which may have been served or written
demand or other document or instrument.
(2) If the Indemnifying Person shall acknowledge in
a writing delivered to the Indemnified Persons that the
Indemnifying Person shall be obligated under the terms of its
indemnity hereunder in connection with such Third Party Claim, then
the Indemnifying Person shall have the right to assume the defense
of any Third Party Claim at its own expense and by its own counsel
(reasonably satisfactory to the Indemnified Persons); provided,
however, that the Indemnifying Person shall not have the right to
assume the defense of any Third Party Claim, notwithstanding the
giving of such written acknowledgment, if (aa) such Third Party
Claim seeks an injunction, restraining order, declaratory relief or
other nonmonetary relief and, if decided adversely, such Third
Party Claim could have a material adverse effect on the financial
condition, properties, assets, liabilities, business, operations or
prospects of any of the Indemnified Persons or (bb) the named
parties to any such action or proceeding (including any impleaded
parties) include both the Indemnified Persons and the Indemnifying
Person and the former shall have been advised by counsel that there
are one or more legal or equitable defenses available to them which
are different from or additional to those available to the
Indemnifying Person, and, in the reasonable opinion of the
Indemnified Persons, counsel for the Indemnifying Person could not
adequately represent the interests of the Indemnified Persons
because such interests could be in conflict with those of the
Indemnifying Person (any Third Party Claim of the type referred to
in (aa) or (bb) being a "Nonassumable Claim").
(3) If, in accordance with the provisions of the
preceding subparagraph (ii), the Indemnifying Person shall assume
the defense of a Third Party Claim (other than a Nonassumable
Claim), the Indemnifying Person shall not be responsible for any
legal or other defense costs subsequently incurred by the
Indemnified Persons in connection with the defense thereof. If the
Indemnifying Person does not exercise its right to assume the
defense of such a Third Party Claim by giving the written
acknowledgment referred to in subparagraph (ii) above or may not
assume such defense pursuant to such subparagraph (ii) above, then
the Indemnified Persons may assume such defense and the costs,
expenses and reasonable attorneys' fees incurred shall continue to
constitute Losses hereunder, provided, however, that the
Indemnifying Person shall not be responsible for the fees and
expenses of more than one law firm in the aggregate for all
Indemnified Persons.
(4) Anything contained herein to the contrary
notwithstanding, neither the Indemnifying Person nor the
Indemnified Persons shall admit any liability with respect to, or
settle, compromise or discharge, any Third Party Claim without the
written consent of the other, which consent shall not be
unreasonably withheld. In addition, each of the Indemnifying
Person and the Indemnified Persons shall cooperate and act in a
reasonable and good faith manner to minimize Losses relating to any
Third Party Claim.
(5) The foregoing indemnities shall not extend to
any claims arising out of one or more of: (aa) the incorrectness of
any representation or warranty made by Indemnified Person pursuant
to this Agreement; (bb) the failure by such Indemnified Person to
perform or observe any agreement or covenant made by it in this
Agreement; or (cc) the willful misconduct or gross negligence of
such Indemnified Person.
16.0 INSURANCE
During the term of this Agreement, ISI will maintain product
liability and commercial general liability insurance having a limit
of not less than five million dollars ($5,000,000.00), pursuant to
one or more insurance policies with reputable insurance carriers.
ISI shall designate ASD as an "additional insured" under all
insurance policies referenced in this paragraph. As a condition
precedent to the effectiveness of this Agreement, ISI shall execute
the Guarantee in the form attached hereto as Schedule "B".
ASD shall provide ISI with a certificate of insurance showing
that ASD is a named insured covered by the commercial and general
liability policies of its parent company Bergen ▇▇▇▇▇▇▇▇
Corporation.
17.0 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 when: (a) 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;
(b) delivered to an express delivery service for delivery to that
Party at that address; or (c) sent by facsimile transmission, with
electronic confirmation, to that Party at its facsimile numbers set
forth at the end of this Agreement. Any Party may change its
address or facsimile number for notices under this Agreement by
giving the other Party notice of such change.
18.0 REMEDIES
With respect to the provisions of Section 14 of this
Agreement, each Party acknowledges that in the event of any
violation by that Party of any of the provisions of Section 14 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 14 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.
19.0 GOVERNING LAW
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 California excluding
the body of law relating to conflicts of laws.
20.0 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.
21.0 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.
22.0 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 its commercially reasonable efforts to
minimize the impact on the other of any force majeure event
specified in this Section.
23.0 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.
24.0 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.
25.0 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 ISI, ASD may assign
this Agreement to a party that succeeds to all or substantially all
of ASD's business or assets relating to this Agreement whether by
sale, merger, operation of law or otherwise.
26.0 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.
27.0 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.
28.0 INTERPRETATION
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.
INTERFERON SCIENCES, INC.
By:/s/▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
Address and facsimile number:
▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
Attn:▇▇▇▇▇▇ ▇▇▇▇▇▇
EVP Marketing and Sales
Facsimile: (▇▇▇)▇▇▇-▇▇▇▇
ALTERNATE SITE DISTRIBUTORS, INC.
By:/s/▇▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇▇ ▇▇▇▇▇▇▇▇
Address and facsimile number:
▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇ ▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇
Attn: ▇▇▇▇ ▇▇▇▇▇▇▇▇
EVP Marketing and
Business Development
Facsimile: (▇▇▇)▇▇▇-▇▇▇▇
APPENDIX A
"Act" means the Federal Food, Drug and Cosmetic Act, Title 21,
United States Code, as amended, and the regulations thereunder.
"Confidential Information" shall mean information, 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.
"Drug" shall have the meaning as set forth in Section 321(g)(1) of
the Act.
"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.
"NDA" means a New Drug Application as defined in and contemplated
by the Act.
"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.
SCHEDULE A
*
SCHEDULE B
CONTINUING GUARANTY AND INDEMNIFICATION AGREEMENT
The undersigned does hereby guarantee to Alternate Site
Distributors, its parent Bergen ▇▇▇▇▇▇▇▇ 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
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 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 $1,000,000.00 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
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.
Interferon Sciences, Inc. /s/▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ May 27, 1997
Guarantor ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ Date
Chief Executive Officer
▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
(▇▇▇)▇▇▇-▇▇▇▇
