SUPPORT SERVICES AGREEMENT Confidential Treatment
requested for all bracketed
BETWEEN ([ ]) information. The
confidential portion has
BIO-TECHNOLOGY GENERAL CORP. been so omitted
and filed separately with
AND the Commission.
QUANTUM HEALTH RESOURCES
SUPPORT SERVICES AGREEMENT
BETWEEN
BIO-TECHNOLOGY GENERAL CORP.
AND
QUANTUM HEALTH RESOURCES
EXECUTION SHEET
In consideration of the mutual promises and covenants contained herein and
other good and valuable consideration, the undersigned have agreed to be bound
by the Support Services Agreement between Bio-Technology General Corp. and
Quantum Health Resources.
QUANTUM HEALTH RESOURCES BIO-TECHNOLOGY GENERAL CORP.
By:_______________________________ By:_______________________________
Name:_____________________________ Name:_____________________________
Title:____________________________ Title:____________________________
Date:_____________________________ Date:_____________________________
TABLE OF CONTENTS
Page
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SUPPORT SERVICES AGREEMENT................................................. 1
1.0 SUPPORT SERVICES............................................... 1
2.0 COMPENSATION................................................... 2
3.0 PROJECT LEADERS................................................ 2
4.0 RECORDS AND ACCOUNTING......................................... 3
5.0 ASSIGNMENT..................................................... 3
6.0 INSURANCE...................................................... 3
7.0 INDEMNIFICATION................................................ 4
8.0 ADDITIONAL SERVICES............................................ 6
9.0 FORCE MAJEURE.................................................. 6
10.0 CONFIDENTIALITY AND REPORTS.................................... 6
11.0 JOINT PUBLICITY ............................................... 7
12.0 TERM AND TERMINATION OF AGREEMENT.............................. 8
13.0 NON-SOLICITATION............................................... 9
14.0 MISCELLANEOUS.................................................. 10
15.0 SCHEDULE OF EXHIBITS .......................................... 13
EXHIBIT A - WAREHOUSING SERVICES ....................................... A-1
EXHIBIT B - PATIENT AND PROVIDER COMMUNICATIONS SERVICES................ B-1
EXHIBIT C - CONSULTING SERVICES RELATING TO THIRD PARTY
COVERAGE AND PAYMENT FOR BTG DESIGNATED PRODUCTS .............. C-1
EXHIBIT D - CO-MARKETING SERVICES AND SUPPORT SERVICES
RELATING TO TREATMENT IND PROTOCOLS............................ D-1
EXHIBIT E - IND DESIGNATED PRODUCT PROTOCOLS............................ E-1
EXHIBIT E-1 - IND DESIGNATED PRODUCT PROTOCOL...........................E-1-1
SUPPORT SERVICES AGREEMENT
This Support Services Agreement is entered into by and between
Bio-Technology General Corp. ('BTG'), a Delaware corporation, and Quantum Health
Resources ('QHR'), a California corporation, with respect to the following:
R E C I T A L S
WHEREAS, BTG, a Delaware company, is a manufacturer and distributor of
pharmaceutical products with no current capabilities of providing warehousing,
patient and provider communications, reimbursement, marketing, administration of
treatment investigational new drugs ('IND'), and distribution and pharmacy
services in the Territory; and
WHEREAS, QHR, a California company, provides a wide range of services
relating to pharmaceutical products in the Territory; and
WHEREAS, BTG desires to make available for sale in the Territory some of
its pharmaceutical products; and
WHEREAS, BTG desires to obtain from QHR certain support services described
herein in connection with its pharmaceutical products to be sold in the
Territory; and
WHEREAS, QHR desires to provide such support services upon the terms set
forth in this Agreement.
NOW, THEREFORE, in consideration of the above recitals, the terms and
conditions hereinafter set forth, and other good and valuable consideration, the
receipt and sufficiency of which are acknowledged, and for their mutual
reliance, the parties agree as follows:
1.0 SUPPORT SERVICES
1.1 QHR agrees to provide BTG with designated warehousing space and
related warehousing services for Designated Products according to the
terms set forth in Exhibit A. BTG agrees to deal exclusively with QHR
for these warehousing services for Designated Products in the
Territory with the sole exception of samples and research materials
that may emanate directly from BTG or its subsidiaries.
1.1.1 Title to and ownership of Designated Products in the designated
warehouse space will pass directly to BTG's Distributor of
Designated Products in the Territory as of the date that QHR
receives instruction to ship the Designated Products to the BTG
Distributor.
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1.2 QHR shall provide BTG with patient and provider communications
services as set forth in Exhibit B.
1.3 QHR shall provide BTG with consulting services related to third party
coverage and payment for Designated Products as set forth in Exhibit
C.
1.4 QHR shall distribute BTG's marketing material and provide marketing
support from time to time as set forth in Exhibit D. QHR does not
ratify or approve such BTG marketing material. In addition, QHR shall
provide BTG with support services for the administration of treatment
investigational new drugs ('IND DESIGNATED PRODUCTS') under Food and
Drug Administration ('FDA') protocols and for transition of the IND
Designated Products to commercial distribution. Each IND Designated
Product shall be included under Exhibit E to this Agreement, beginning
with Exhibit E-1.
2.0 COMPENSATION
2.1 BTG shall compensate QHR for the provision of the support services set
forth in this Agreement in accordance with the Compensation Schedule
enumerated in each Exhibit.
2.2 Both parties acknowledge and agree that the compensation specified in
each Exhibit of this Agreement has been set in advance, is consistent
with the fair market value of the applicable service in an
arm's-length transaction, and has not been determined in a manner that
takes into account the volume or value of any referrals or business
otherwise generated between the parties.
3.0 PROJECT LEADERS
3.1 QHR and BTG shall each designate a person (the 'PROJECT LEADER') who
shall be responsible for supervising and coordinating the obligations
of each of QHR and BTG, respectively, under this Agreement. Until
otherwise designated in writing to the other party under the notice
procedures set out in Section 14.4 of this Agreement, the Project
Leaders shall be:
For QHR:
Thomas Halstead, Senior Vice President
New Business Development
Quantum Health Resources
9100 Keystone Crossing
Suite 500
Indianapolis, IN 46240
2
For BTG:
William H. Pursley
Senior Vice President
Marketing, Sales and Commercial
Development
Bio-Technology General Corp.
70 Wood Avenue South
Iselin, NJ 08830
4.0 RECORDS AND ACCOUNTING
4.1 During the term hereof and for three (3) years thereafter, or such
longer period as may be required by law, QHR shall maintain accurate
records as required to meet applicable local, state and federal laws
and regulations. Except as otherwise required by any such laws or
regulations, QHR shall provide BTG access to any requested
documentation related to the administration of the support services
under this Agreement during reasonable business hours. BTG shall give
QHR seven (7) days' prior written notice of such examination. Such
examinations will not occur more than twice annually, and such
examination will be undertaken only to such extent necessary to verify
that QHR has complied with the terms of this Agreement.
5.0 ASSIGNMENT
5.1 Neither party may assign any of its rights or delegate any of its
duties under this Agreement without the prior written consent of the
other party except in connection with the sale of a party's entire
business operations, which shall not require consent. Notwithstanding
the previous sentence, either party may assign its rights or delegate
its duties to any of its parents, subsidiaries, or affiliates without
written consent of the other party. Any unauthorized attempted
assignment or delegation shall be null and void and of no force or
effect.
6.0 INSURANCE
6.1 BTG will maintain in effect during the term of this Agreement a
comprehensive general liability policy and products liability policy
on the Designated Products and BTG shall promptly after the execution
of this Agreement designate QHR as an additional named insured on such
policies. This comprehensive insurance policy shall be in an amount
not less than One Million Dollars ($1,000,000) per incident and Three
Million Dollars ($3,000,000) in the aggregate and shall include
coverage for claims of patent, trademark, copyright, trade secret, or
other forms of unfair competition including but not limited to all
claims under Section 43(a) of the Lanham Act. The deductible for such
policy shall be no more than
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Five Hundred Thousand Dollars ($500,000). The policy shall provide for
ten (10) days' notice to QHR by the Insurer by Registered or Certified
Mail, Return Receipt Requested, in the event of any modifications,
cancellation, or termination thereof. BTG agrees to provide QHR with a
certificate of insurance evidencing compliance with this section
within ten (10) days of execution of this Agreement.
6.2 QHR will maintain in effect during the term of this Agreement a
comprehensive general liability policy and QHR shall promptly after
the execution of this Agreement designate BTG as an additional named
insured on such policy. This comprehensive insurance policy shall be
in an amount not less than One Million Dollars ($1,000,000) per
incident and Three Million Dollars ($3,000,000) in the aggregate. The
deductible for such policy shall be no more than One Hundred Thousand
Dollars ($100,000). The policy shall provide for ten (10) days' notice
to BTG by the Insurer by Registered or Certified Mail, Return Receipt
Requested, in the event of any modifications, cancellation, or
termination thereof. QHR agrees to provide BTG with a certificate of
insurance evidencing compliance with this section within ten (10) days
of execution of this Agreement.
7.0 INDEMNIFICATION
7.1 BTG will indemnify, defend, and hold harmless QHR, its affiliates,
parents, subsidiaries, directors, officers, agents and employees
(collectively, 'QHR INDEMNITEES') from and against and reimburse QHR
Indemnitees for any and all claims, demands, actions, causes of
action, losses, judgements, damages, costs and expenses (including,
but not limited to, attorneys' fees, court costs and costs of
settlement) arising out of claims against a QHR Indemnitee based on:
(a) BTG's manufacture of a Designated Product; (b) the death of, or
bodily injury to, any person on account of the use of a Designated
Product, to the extent such death or bodily injury results from a
defect in the design, workmanship or manufacture of a Designated
Product; (c) any recall or withdrawal of a Designated Product; (d)
BTG's violation of any applicable law or government regulation; (e)
any claims that QHR's activities with respect to a Designated Product
infringes the patent or other proprietary rights of any third party;
or (f) any breach by BTG of any of its representations, warranties,
covenants or agreements in this Agreement.
7.2 QHR will indemnify, defend, and hold harmless BTG, its affiliates,
parents, subsidiaries, directors, officers, agents and employees
(collectively 'BTG Indemnitees') from and against, and reimburse BTG
Indemnitees for, any and all claims, demands, actions, causes of
action, losses, judgements, damages, costs and expenses (including,
but not limited to, attorneys' fees, court costs and costs of
settlement) arising out of claims against a BTG Indemnitee based on:
(a) the death of, or bodily injury to, any person on account of the
use of a Designated Product, to the extent such death or bodily injury
results from QHR's negligence
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or willful misconduct; (b) QHR's violation of any applicable law or
governmental regulation; or (c) any breach by QHR of any of its
representations, warranties, covenants or agreements in this
Agreement.
7.3 QHR agrees that upon receipt of any claim or liability asserted in
writing against it which would give rise to a claim against BTG under
this Section, it shall promptly notify BTG in writing of the same
within fifteen (15) days. BTG agrees that QHR is entitled to retain
counsel of its own choosing at QHR's expense to the extent necessary,
in QHR's sole discretion, to protect QHR's interests and to act as
co-counsel in the litigation or settlement of any claim or threatened
claim. QHR agrees that so long as BTG does not enter any settlement
agreement or consent judgment that admits liability on the part of QHR
or which fails to include an unconditional release of QHR from all
liability from all asserted or threatened claims, BTG shall have the
right to control the defense, settlement, and prosecution of any
litigation. Anything in this section notwithstanding:
7.3.1 If there is a reasonable probability in the opinion of QHR's
counsel that a claim may materially and adversely affect QHR
other than as a result of monetary damages or other monetary
payments for which BTG will be able to indemnify QHR, QHR shall
have the right to defend, and with BTG's prior consent,
compromise and settle such claim. QHR's right to
indemnification in such cases shall be limited to its
reasonable attorney's fees and costs plus any monetary
settlement amount.
7.3.2 In the event that QHR determines in its sole discretion, based
upon the written advice of counsel, that there is a conflict in
the position or defenses to be asserted by BTG and QHR
regarding liability, QHR shall be entitled to its own defense,
including the right, with BTG's prior consent, to settle or
compromise all or any of the claims against it, at BTG's
expense.
7.4 BTG agrees that upon receipt of any claim or liability asserted in
writing against it which would give rise to a claim against QHR under
this Section, it shall promptly notify QHR in writing of the same
within fifteen (15) days. QHR agrees that BTG is entitled to retain
counsel of its own choosing at BTG's expense to the extent necessary,
in BTG's sole discretion, to protect BTG's interests and to act as
co-counsel in the litigation or settlement of any claim or threatened
claim. BTG agrees that so long as QHR does not enter any settlement
agreement or consent judgment that admits liability on the part of BTG
or which fails to include an unconditional release of BTG from all
liability from all asserted or threatened claims, QHR shall have the
right to control the defense, settlement, and prosecution of any
litigation. Anything in this section notwithstanding:
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7.4.1 If there is a reasonable probability in the opinion of BTG's
counsel that a claim may materially and adversely affect BTG
other than as a result of monetary damages or other monetary
payments for which QHR will be able to indemnify BTG, BTG shall
have the right to defend, and with QHR's prior consent,
compromise and settle such claim. BTG's right to
indemnification in such cases shall be limited to its
reasonable attorney's fees and costs plus any monetary
settlement amount.
7.4.2 In the event that BTG determines in its sole discretion, based
upon the written advice of counsel, that there is a conflict in
the position or defenses to be asserted by BTG and QHR
regarding liability, BTG shall be entitled to its own defense,
including the right, with QHR's prior consent, to settle or
compromise all or any of the claims against it, at QHR's
expense.
7.5 The obligations of an indemnifying party under this Section 7.0 shall
not be diminished by the indemnifying party's failure to provide the
notice required above except to the extent such failure actually and
materially adversely affects the indemnifying party's ability to
defend such matter.
8.0 ADDITIONAL SERVICES
8.1 QHR has the ability to provide additional services to BTG. If BTG
requests QHR to provide any additional services, both parties shall
negotiate in good faith an appropriate fee for such additional
services.
9.0 FORCE MAJEURE
9.1 Notwithstanding any provision contained herein to the contrary,
neither party shall be deemed to be in default hereunder for failing
to perform or provide any of the services or other obligations to be
performed or provided pursuant to this Agreement if such failure is
the result of any labor dispute, act of God, inability to obtain labor
or materials, governmental restrictions or any other event which is
beyond the reasonable control of the party.
10.0 CONFIDENTIALITY AND REPORTS
10.1 'CONFIDENTIAL INFORMATION' of a party shall mean any and all
information including, but not limited to, the terms and conditions of
this Agreement that is or has been disclosed in writing or orally by
such party to the other party which is either confidential or
proprietary in nature; provided however, that 'Confidential
Information' shall not include information which:
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10.1.1 is or becomes generally available to the public through no
fault of the receiving party;
10.1.2 was known to the receiving party before such party received it
under this Agreement and was not acquired, directly or
indirectly, from the disclosing party; or
10.1.3 is disclosed in good faith to the receiving party by a third
party lawfully in possession of such information and who was
not under an obligation of nondisclosure with respect of such
information.
10.2 Each party acknowledges that it may have heretofore received and may
from time to time hereafter receive Confidential Information of the
other party, and such party receiving such Confidential Information
shall do the following:
10.2.1 maintain such Confidential Information in confidence and shall
not disclose such Information to any third party;
10.2.2 not use such Confidential Information other than in performance
of this Agreement; and
10.2.3 disclose such Confidential Information to its employees or to
employees of its affiliates only to the extent that such
employees need to know such Confidential Information to carry
out the receiving party's obligations under this Agreement.
10.3 Each party agrees to maintain as confidential both during the term of
this Agreement and thereafter all Confidential Information provided to
it pursuant to this Agreement and shall not, without the specific
written consent of the other party, disclose it to any third party
(except as required by law) or use it for its own purpose (except as
contemplated herein).
11.0 JOINT PUBLICITY
11.1 If either party wishes to make a public disclosure concerning this
Agreement and such disclosure mentions the other party by name or
description, such other party shall be provided with an advance copy
of the disclosure and shall have five (5) business days within which
to approve or disapprove such use of its name or description
(including mention of the name of the Designated Product). Approval
shall not be unreasonably withheld by either party. Failure to respond
within such five (5) business days shall be deemed to be approval.
Absent approval, no public disclosure shall use the name of or
otherwise describe such party except to the extent required by law, or
to the extent that the description of the other party is limited to
public information about the availability of the Designated
7
Product. Notwithstanding the foregoing, QHR acknowledges that BTG is a
publicly traded company, and hereby consents to BTG's disclosure of
this Agreement and its relationship with QHR in its filings with the
Securities and Exchange Commission and its disclosures to its
stockholders; provided however, that BTG shall use its commercially
reasonable efforts not to disclose the specific financial terms and
conditions of this Agreement except when such disclosure is required
by law.
12.0 TERM AND TERMINATION OF AGREEMENT
12.1 Term. This Agreement shall commence upon the Effective Date and shall
continue for a term of five (5) years. This Agreement shall
automatically renew for successive additional one (1) year terms
unless, not less than one hundred eighty (180) days prior to the
anniversary date, either party notifies the other of its intent to
terminate this Agreement as of the anniversary date.
12.2 Termination. The initial term of this Agreement or any renewal term
may be terminated only as follows:
12.2.1 Mutual Consent. This Agreement may be terminated, with or
without cause, at any time upon the mutual written consent of
both parties.
12.2.2 Without Cause. This Agreement may be terminated in its entirety
by either party without cause, upon one hundred eighty (180)
days' prior written notice to the other party.
12.2.3 Event of Material Breach: Good Cause. This Agreement may be
terminated by either party if the other party shall default in
the performance of any material obligation of this Agreement,
upon forty-five (45) days' prior written notice to the other,
specifying the nature of the default, unless such other party
shall cure that default within the forty-five (45) day notice
period.
12.2.4 Insolvency. This Agreement may be terminated by either party
immediately upon notice to the other, if the other party shall
make an assignment for the benefit of creditors, shall file a
petition in bankruptcy, is adjudicated insolvent or bankrupt,
or if a receiver or trustee is appointed with respect to a
substantial part of such other party's property or a proceeding
is commenced against it which will substantially impair its
ability to perform hereunder.
12.2.4.1 Notwithstanding anything to the contrary, all rights
granted under or pursuant to this Agreement by BTG to
QHR are,
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and shall otherwise be deemed to be, for purposes of
Section 365(n) of the United States Bankruptcy Code,
or replacement provision therefor (the 'Code'),
licenses to rights to 'intellectual property' as
defined in the Code. The parties agree that QHR as the
licensee of such rights under this Agreement, shall
retain and may fully exercise all of its rights and
elections under the Code. The parties further agree
that, in the event of the commencement of bankruptcy
proceedings by or against BTG under the Code, QHR
shall be entitled, at its option, to retain all of its
rights under the Agreement in accordance with the
provisions of the Code.
12.2.4.2 Notwithstanding anything to the contrary, all rights
granted under or pursuant to this Agreement by QHR to
BTG are, and shall otherwise be deemed to be, for
purposes of Section 365(n) of the Code, or replacement
provision therefor, licenses to rights to
'intellectual property' as defined in the Code. The
parties agree that BTG as the licensee of such rights
under this Agreement, shall retain and may fully
exercise all of its rights and elections under the
Code. The parties further agree that, in the event of
the commencement of bankruptcy proceedings by or
against QHR under the Code, BTG shall be entitled, at
its option, to retain all of its rights under the
Agreement in accordance with the provisions of the
Code.
12.3 Remedies. Each of the parties to this Agreement shall be entitled to
enforce its rights under this Agreement to recover damages and costs
(including reasonable attorney's fees) caused by any breach of any
provision of this Agreement and to exercise all other rights existing
in its favor, regardless of any termination of this Agreement by such
breaching party pursuant to Section 12.2.3. The parties hereto agree
and acknowledge that money damages would not be an adequate remedy for
any breach of Sections 1.0, 10.0, and 13.0 of this Agreement and that
any party may, in its sole discretion, apply to any court of law or
equity of competent jurisdiction (without posting any bond or deposit)
for specific performance and/or other injunctive relief in order to
enforce, or prevent any violations of, these Sections of this
Agreement.
13.0 NON-SOLICITATION
13.1 BTG agrees that during the term of this Agreement, and for one (1)
year thereafter, it shall not: (i) employ or retain on an independent
contractor basis; or (ii) solicit for employment or for independent
consulting any person who was
9
in the immediately preceding twelve (12) month period employed by QHR
or any of its affiliates, subsidiaries, or parents.
13.2 QHR agrees that during the term of this Agreement, and for one (1)
year thereafter, it shall not: (i) employ or retain on an independent
contractor basis; or (ii) solicit for employment or for independent
consulting any person who was, at any time during the immediately
preceding twelve (12) month period, employed by BTG, or any of its
affiliates, subsidiaries, or parents.
14.0 MISCELLANEOUS
14.1 Definitions. For purposes of this Agreement, the following terms
apply:
14.1.1 'BTG's Distributor' refers to the company which has entered
into an agreement with BTG to be the distributor of Designated
Products in the Territory.
14.1.2 'Designated Product' or 'Designated Products' refers to any BTG
product that BTG transfers to the warehouse as described in
Exhibit A.
14.1.3 'Effective Date' refers to December 1, 1995.
14.1.4 'Territory' refers to all of the fifty (50) states and the
territories and the possessions of the United States.
14.2 Choice of Law
14.2.1 This Agreement shall be governed by and construed under the
laws of the State of Indiana, inclusive of its
conflicts-of-laws rules.
14.3 Waiver
14.3.1 No waiver of any default hereunder by either party or any
failure to enforce any rights hereunder shall be deemed to
constitute a waiver of any subsequent default with respect to
the same or any other provision hereof. No waiver shall be
effective unless made in writing with specific reference to the
relevant provision(s) of this Agreement and signed by a duly
authorized representative of the party granting the waiver.
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14.4 Notice
14.4.1 All notices and other communications made or given under or in
connection with this Agreement shall be validly given or made
if in writing and shall be effective either (a) when delivered
in person to the other party, or (b) on the same business day
that it is transmitted by facsimile to the facsimile number(s)
set forth below, if transmitted prior to 5:00 p.m. Eastern Time
on such business day, or on the first business day following
such transmission if transmitted after 5:00 p.m. Eastern Time
or if transmitted on a day other than a business day; provided
a hard copy is deposited within one (1) day after such
transmissions in the U.S. mail, postage prepaid, and addressed
as set forth below for notices by U.S. mail; or (c) on the
second business day following its deposit in the U.S. mail,
postage prepaid, and addressed as follows:
if to BTG:
Bio-Technology General Corp.
70 Wood Avenue South
Iselin, NJ 08830
Attention: William H. Pursley
Facsimile: 908-767-1349
if to QHR:
Quantum Health Resources
9100 Keystone at the Crossing, Suite 500
Indianapolis, IN 46240
Attention: Thomas Halstead
Facsimile No.: 317-580-6843
with a copy to:
John McIlwraith, Esq.
Senior Vice President of Strategic
Planning and Legal Counsel
Quantum Health Resources
9100 Keystone at the Crossing, Suite 500
Indianapolis, IN 46240
Facsimile No.: 317-580-6843
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14.5 Amendment
14.5.1 Neither this Agreement nor any of the terms hereof may be
terminated, amended, supplemented, waived or modified orally,
except by an instrument in writing signed by each party.
14.6 Survival of Provisions
14.6.1 All indemnification and confidentiality provisions contained
herein shall survive the expiration or other termination of
this Agreement.
14.7 Relationship of Parties
14.7.1 QHR's relationship with BTG hereunder shall be that of
independent contractor, and neither party shall be considered
the agent, partner or employee of or a joint venture with the
other party, in its performance of all duties under this
Agreement.
14.8 Cumulative Remedies
14.8.1 Except as expressly provided in this Agreement, and to the
extent permitted by law, any remedies described in this
Agreement are cumulative and not alternative to any other
remedies available at law or in equity.
14.9 Severability
14.9.1 In the event that any one or more of the provisions contained
in this Agreement shall for any reason be held to be invalid,
illegal or unenforceable in any respect, such invalidity,
illegality or unenforceability shall not affect any other
provision of this Agreement, and this Agreement shall be
construed as if such invalid, illegal or unenforceable
provision or provisions had never been included. The parties
shall, in good faith, amend this Agreement to provide, to the
extent possible, each party with the benefits provided by such
invalid or unenforceable provision.
14.10 Headings
14.10.1 The headings contained in this Agreement are for reference
purposes only and shall not affect in any way the meaning or
interpretation of this Agreement.
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14.11 Counterparts
14.11.1 This Agreement may be executed in multiple counterparts, each
of which shall be deemed an original, but all of which, when
taken together, shall constitute one and the same instrument.
14.12 Signature Authority
14.12.1 Each signatory to this Agreement has signature authority and
is empowered on behalf of his or her respective party to
execute this Agreement.
14.13 Integration
14.13.1 This Agreement, together with all agreements attached hereto,
constitutes the entire agreement between the parties with
respect to the subject matter hereof, and supersedes all
prior oral or written agreements, commitments or
understandings with respect thereto.
15.0 SCHEDULE OF EXHIBITS
EXHIBIT A: Warehousing Services
EXHIBIT B: Patient and Provider Communications Services
EXHIBIT C: Consulting Services Relating to Third Party Coverage and
Payment for BTG Designated Products
EXHIBIT D: Co-Marketing Services and Support Services Relating to
Treatment IND Protocols
EXHIBIT E: IND Designated Product Protocol
EXHIBIT E-1: IND Designated Product Protocol
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EXHIBIT A
WAREHOUSING SERVICES
1.0 OBLIGATIONS OF QHR
1.1 QHR will make available to BTG sufficient warehousing space as
determined by QHR for receipt and storage of Designated Products in
the Territory.
1.2 QHR will maintain written documentation attesting to the proper
storage of Designated Products in QHR's warehousing space, in
accordance with BTG's reasonable written specifications.
1.3 QHR will provide adequate security and handling of Designated Products
to avoid loss or damage to Designated Products while stored in the
warehousing space.
1.4 In response to orders received from or on behalf of BTG, QHR will
pick, pack, and ship as specified below:
1.4.1 For each order received by QHR at or before 2:00 p.m. Eastern
Time, QHR will pick, pack, and ship the order the same day the
order is received.
1.4.2 For each order received by QHR after 2:00 p.m. Eastern Time, QHR
will pick, pack, and ship the order the day following receipt of
the order.
1.4.3 QHR will pick the quantity and type of Designated Products
ordered utilizing stock rotation based on expiration dating
(shortest dated Designated Products shipped first).
1.5 QHR will maintain accurate current inventory records, provide BTG
monthly reports, and perform for the benefit of BTG all other duties
commonly performed by a pharmaceutical industry warehouse.
1.6 QHR will provide clerical, warehouse, and management personnel
required to service BTG distribution fulfillment needs.
1.7 Upon ten (10) days' prior written notice, QHR will allow BTG personnel
to perform physical inventory audits of Designated Products maintained
by QHR in the warehouse space at any time during normal working hours.
QHR will provide to BTG monthly reports on the status of the
inventory.
A-1
1.8 QHR will communicate with BTG promptly upon knowledge that any
Designated Product is in a form unacceptable for shipping out to BTG's
Distributor.
1.9 Designated Products returned by customers will be shipped to QHR for
subsequent return to BTG for replacement of Designated Product.
1.10 Each party agrees to inform the other party promptly (but in no event
no later than forty-eight (48) hours after becoming aware of same) of
any information concerning any package or complaint involving a
Designated Product or any adverse drug experience (as defined in 21
CFR 314.80), injury, toxicity, or sensitivity reaction associated with
the clinical use of the Designated Product, whether or not considered
related to the Designated Product.
If the adverse drug experience is serious, as defined in 21 CFR 314.80
(including an adverse drug reaction that is fatal or life-threatening,
is permanently disabling, requires inpatient hospitalization, or is a
congenital anomaly, cancer or overdose), then each party shall notify
the other party within twenty-four (24) hours. All notifications to
BTG shall be by facsimile and on BTG's designated adverse event forms.
1.11 QHR shall visually inspect each inbound shipment of the Designated
Products and make an external quality control evaluation of each
shipment. In the event that any shipment, in whole or part, is
defective or shall have been packaged or shipped under conditions
which do not comply with then applicable Food and Drug Administration
('FDA') requirements which are evident solely from visual inspection,
QHR shall give prompt notice (and in any event no later than thirty
(30) days after receipt) thereof to BTG, specifying the manner in
which such shipment is defective. QHR shall not dispose of any
nonconforming shipment of the Designated Product without prior written
authorization and instructions from BTG.
1.12 QHR shall notify BTG promptly of any inspection by any federal, state,
or local regulatory representative concerning any Designated Product
and shall provide BTG a summary of the results of such inspections and
of the actions, if any, taken to remedy conditions cited in such
inspections.
2.0 OBLIGATIONS OF BTG
2.1 BTG will:
2.1.1 assume all responsibility for compliance with importing laws and
regulations and FDA laws and regulations related to Designated
Products;
A-2
2.1.2 deliver quantities of Designated Products to QHR at the QHR's
warehouse during normal working hours;
2.1.3 endeavor to maintain a satisfactory supply of its Designated
Products with QHR at all times to meet the demands of
distributions of BTG Designated Products;
2.1.4 deliver Designated Products for storage properly marked and
packaged including a manifest showing sizes or specific stock
keeping units;
2.1.5 be fully and solely responsible for ensuring that the Designated
Products comply with all federal, state, local and other laws
and regulations including, without limitation, those with
respect to safety, labeling and advertising;
2.1.6 be responsible to customers (including patients) for all
warranties, express or implied, with respect to the Designated
Products;
2.1.7 bear the risk of loss, theft, destruction or damage of each
Designated Product shipment until delivery of such Designated
Product to a customer. Until the delivery of the Designated
Product to a customer, QHR shall, at its expense, insure all
Designated Products in its warehousing space for their
replacement (i.e., market) value against fire, theft, loss or
destruction, and such other risks as are customarily insured
against by prudent persons in a similar line of business, with a
deductible not to exceed One Hundred Thousand Dollars ($100,000)
with an insurance carrier qualified to do business (in the State
of Indiana or such other place as BTG may authorize), and QHR
shall permit BTG to negotiate and settle any claims with the
insurance company and BTG shall be entitled to all recoveries
under such insurance;
2.1.8 will, if the parties exercise their rights of termination under
Section 12.0, bear the risk of cost of the return of all
Designated Products remaining in QHR's warehouse; and
2.1.9 deal exclusively with QHR for warehouse services with respect to
the Designated Products in the Territory except for samples and
research materials that may emanate directly from BTG or its
subsidiaries.
2.2 Title to and ownership of any Designated Product subject to these
warehousing services shall be vested in BTG until received by the
purchaser.
A-3
3.0 COMPENSATION
3.1 BTG shall pay QHR a warehousing fee of [ ] percent ([ ]%) per annum
of the purchase price to BTG Distributors of Designated Products
shipped by QHR to BTG's Distributors during the applicable calendar
year. QHR shall, on a monthly basis, submit to BTG an invoice for such
fee including an accounting of the value of the Designated Products
shipped to BTG's Distributors during such month and BTG shall pay QHR
accordingly within thirty (30) days of receipt of such invoice. The
parties acknowledge that such warehousing services increase as
Designated Products are sold.
3.2 In the event that BTG fails to pay any warehousing fee in full within
thirty (30) days after its receipt of the invoice, BTG shall pay QHR
late charges of eight percent (8%) per annum on all unpaid amounts due
pursuant to this compensation schedule calculated from the end of that
thirty day period.
3.3 Should any provision of this Agreement violate any law, rule or
regulation pertaining to usury or the contracting or charging of
interest, then the excess of interest contracted for or charged or
collected over the maximum lawful rate of interest shall be applied as
a prepayment of future obligations due by BTG to QHR.
3.4 Renegotiation of Warehousing Fee
3.4.1 The warehousing fee that BTG pays to QHR for warehousing
services provided for herein shall be renegotiated by the
parties prior to the end of each year, with changes in the
warehousing fee, if any, to become effective with respect to the
Designated Products received by QHR after the end of the year.
3.4.2 In the event that the parties are unable to agree in advance on
the warehousing fee to be paid during any year (or portion
thereof), the previously existing fee shall continue until the
earlier of the parties' agreement on such new fee, or the
termination of the Agreement.
A-4
AGREED
QUANTUM HEALTH RESOURCES BIO-TECHNOLOGY GENERAL CORP.
By:_______________________________ By:_______________________________
Name:_____________________________ Name:_____________________________
Title:____________________________ Title:____________________________
Date:_____________________________ Date:_____________________________
A-5
EXHIBIT B
PATIENT AND PROVIDER COMMUNICATIONS SERVICES
1.0 TELEPHONE ASSISTANCE
1.1 QHR agrees to operate, staff and maintain a telephone assistance
service using the telephone number 1-800-xxxx. This wide area
telephone service ('WATS') shall be used solely to answer questions
regarding the Designated Products and use of the Designated Products.
Such telephone service shall be staffed twenty-four (24) hours a day
with competent medical personnel qualified to take calls from patients
and patient representatives regarding the Designated Products and use
of the Designated Products.
1.2 QHR shall operate the telephone number on behalf of BTG, but QHR shall
have responsibility for the cost of maintaining, staffing and
operating this WATS number.
2.0 COMPENSATION
2.1 In consideration of the patient and provider communications services
set forth herein, BTG shall pay QHR a fee of [ ] percent ([ ]%) per
annum of the purchase price to BTG's Distributors of Designated
Products shipped by QHR to BTG's Distributors during the applicable
calendar year. QHR shall, on a monthly basis, submit to BTG an invoice
for such fee including an accounting of the value of the Designated
Products shipped to BTG's Distributors during such month and BTG shall
pay QHR accordingly within thirty (30) days of receipt of such
invoice. The parties acknowledge that such patient and provider
communications services increase as Designated Products are sold.
2.2 In the event that BTG fails to pay any fee in full within thirty (30)
days after its receipt of the invoice, BTG shall pay QHR late charges
of eight percent (8%) per annum on all unpaid amounts due pursuant to
this compensation schedule calculated from the end of that thirty day
period.
2.3 Should any provision of this Agreement violate any law, rule or
regulation pertaining to usury or the contracting or charging of
interest, then the excess of interest contracted for or charged or
collected over the maximum lawful rate of interest shall be applied as
a prepayment of future obligations due by BTG to QHR.
B-1
2.4 Renegotiation of Fee
2.4.1 The fee that BTG pays to QHR for patient and provider
communications services provided for herein shall be
renegotiated by the parties prior to the end of each year, with
changes in the patient and provider communications fee, if any,
to become effective with respect to the Designated Products
received by QHR after the end of the year.
2.4.2 In the event that the parties are unable to agree in advance on
the patient and provider communications fee to be paid during
any year (or portion thereof), the previously existing fee shall
continue until the earlier of the parties' agreement on such new
fee, or the termination of the Agreement.
AGREED
QUANTUM HEALTH RESOURCES BIO-TECHNOLOGY GENERAL CORP.
By:_______________________________ By:_______________________________
Name:_____________________________ Name:_____________________________
Title:____________________________ Title:____________________________
Date:_____________________________ Date:_____________________________
B-2
EXHIBIT C
CONSULTING SERVICES RELATING TO THIRD PARTY COVERAGE AND
PAYMENT FOR BTG DESIGNATED PRODUCTS
1.0 CONSULTING SERVICES
1.1 QHR shall provide payer education information and presentations from
time to time as necessary to assist BTG in obtaining favorable
formulary status with payers for Designated Products.
1.2 QHR shall respond to inquiries from prescribers and patients using BTG
Designated Products generally with third party coverage and payment
issues.
1.3 QHR shall set up, operate and maintain a telephone assistance service
using the telephone number 1-800-xxxx. Such wide area telephone
service ('WATS') telephone number shall be staffed eight (8) hours a
day with competent coverage and payment counselors to take calls from
patients, patient representatives and providers concerning third party
coverage for Designated Products. The WATS telephone number required
under this Exhibit C shall be operated independently from the WATS
number referred to in Exhibit B.
1.4 The consulting services provided by QHR shall include:
1.4.1 consultation regarding the availability of financial assistance
on copayments and deductibles;
1.4.2 assistance with federal and state payment programs;
1.4.3 consultation regarding whether to receive product at home or at
a local drug store;
1.4.4 assistance with insurance forms and claims including job loss or
change and assignment of benefits; and
1.4.5 advocacy if a claim is delayed, denied, or sent to a case
manager.
1.5 QHR shall provide regulatory consulting to BTG related to BTG's
products in connection with the Health Care Financing Administration
and any State Government Health Programs.
C-1
2.0 COMPENSATION
2.1 In consideration of the consulting services relating to third party
payer coverage and payment set forth herein, BTG shall pay QHR a fee
of [ ] percent ([ ]%) per annum of the purchase price to BTG's
Distributors of Designated Products shipped by QHR to BTG's
Distributors during the applicable calendar year. QHR shall, on a
monthly basis, submit to BTG an invoice for such fee including an
accounting of the value of the Designated Products shipped to BTG's
Distributors during such month and BTG shall pay QHR accordingly
within thirty (30) days of receipt of such invoice. The parties
acknowledge that such consulting services increase as Designated
Products are sold.
2.2 In the event that BTG fails to pay any fee in full within thirty (30)
days after its receipt of the invoice, BTG shall pay QHR late charges
of eight percent (8%) per annum on all unpaid amounts due pursuant to
this compensation schedule calculated from the end of that thirty day
period.
2.3 Should any provision of this Agreement violate any law, rule or
regulation pertaining to usury or the contracting or charging of
interest, then the excess of interest contracted for or charged or
collected over the maximum lawful rate of interest shall be applied as
a prepayment of future obligations due by BTG to QHR.
2.4 Renegotiation of Fee
2.4.1 The fee that BTG pays to QHR for consulting services relating to
third party payer coverage and payment provided for herein shall
be renegotiated by the parties prior to the end of each year,
with changes in the consulting fee, if any, to become effective
with respect to the Designated Products received by QHR after
the end of the year.
2.4.2 In the event that the parties are unable to agree in advance on
the consulting fee relating to third party payer coverage and
payment to be paid during any year (or portion thereof), the
previously existing fee shall continue until the earlier of the
parties' agreement on such new fee, or the termination of the
Agreement.
C-2
AGREED
QUANTUM HEALTH RESOURCES BIO-TECHNOLOGY GENERAL CORP.
By:_______________________________ By:_______________________________
Name:_____________________________ Name:_____________________________
Title:____________________________ Title:____________________________
Date:_____________________________ Date:_____________________________
C-3
EXHIBIT D
CO-MARKETING SERVICES AND SUPPORT SERVICES RELATING TO
TREATMENT IND PROTOCOLS
CO-MARKETING SERVICES
1.0 DISTRIBUTION OF MARKETING MATERIAL
1.1 BTG will supply to QHR all marketing material regarding Designated
Products for distribution and use by QHR's sales force when the sales
force visits provider organizations including, but not limited to,
physician offices, trade association meetings and medical society
meetings.
1.2 BTG shall supply to QHR all marketing material regarding Designated
Products for distribution and use by QHR's sales force and when the
sales force visits consumer organizations, including but not limited
to, local, regional and national chapters for specific diseases and
other relevant non-profit organizations.
1.3 QHR shall utilize its national sales force to assist in these
marketing activities in conjunction with the other marketing
activities that QHR normally provides.
1.4 QHR shall not, and shall not permit its sales force to make any
representations or claims with respect to the Designated Products
which is not contained in the Marketing Materials provided by BTG. QHR
shall indemnify and hold harmless BTG in accordance with Section 7.0
of the Master Agreement for any claim, liability and cost incurred by
BTG as a result of QHR's representation or claim in violation of the
first sentence of this Section 1.4.
2.0 DRAFTING MARKETING MATERIAL
2.1 BTG shall be solely responsible for drafting the marketing material
for BTG's Designated Products and shall indemnify QHR in accordance
with Section 7.0 of the Agreement for any claim, liability and cost
incurred by QHR as a result of its use of such material.
D-1
SUPPORT SERVICES RELATING TO TREATMENT IND PROTOCOLS
3.0 INVESTIGATIONAL NEW DRUG SERVICES
3.1 From time to time, BTG may request from QHR the support services
relating to treatment IND protocols as set forth herein. If the
parties reach mutual agreement, then the terms of such IND Designated
Product protocol shall be set forth in Exhibit E. In such case, all
other terms and conditions of this Agreement shall apply to that
Exhibit.
3.2 QHR shall manage the IND Designated Products reporting duties required
under FDA laws and regulations and shall distribute clinical trial
materials and related supplies to patients on behalf of investigators
with respect to IND Designated Product protocols.
3.3 QHR shall segregate all IND Designated Product inventory from other
inventory that QHR is warehousing on behalf of BTG.
3.4 In performing these support services, QHR shall comply in all
applicable respects with the IND Designated Product protocol which is
attached hereto as Exhibit E and incorporated herein by reference.
3.5 QHR shall comply with all federal, state and local laws and
regulations applicable to carrying out the services under this
Agreement, including without limitation, the Food, Drug and Cosmetic
Act, as amended, rules and regulations thereunder and any other
requirements that may be imposed by the FDA.
4.0 DUTIES OF BTG
4.1 BTG shall provide, at its sole cost and expense, all IND Designated
Products and enrollment kits required by QHR in connection with the
services enumerated in this Agreement.
4.2 BTG agrees to comply with all applicable U.S. federal and state laws
governing the regulation, design, testing, inspection, labeling,
warning and instructions for use of IND Designated Products.
5.0 PROPERTY OWNERSHIP
5.1 All materials, documents, information, Confidential Information,
databases, complete and incomplete case report forms and all data that
BTG supplies to QHR or that QHR prepares or develops specifically for
the IND services designated by this Agreement or generated by
investigational sites during the conduct of the IND study shall be the
sole and exclusive property of BTG ('BTG PROPERTY').
D-2
5.2 Unless otherwise required by law or the terms of this agreement, QHR
shall maintain all BTG Property which QHR shall have in its possession
for a period of not less than three years. QHR shall organize the BTG
Property in such a manner that it can be accessed promptly within 24
hours' notice, and when accessed, will be organized for immediate
reference for auditing purposes by BTG and the FDA.
5.3 Upon termination of this Agreement, QHR shall return to BTG all unused
clinical trial material and supply inventory that BTG furnishes to QHR
within thirty (30) days.
6.0 DEBARMENT CERTIFICATION REQUIREMENTS
6.1 QHR certifies that it has not been debarred under the provisions of
the Generic Drug Enforcement Act of 1992, 21 U.S.C. ss. 335(a) and
(b). In the event that during the term of this Agreement, Quantum (i)
becomes debarred or (ii) receives notice of an action or threat of an
action with respect to its debarment, QHR shall notify BTG
immediately.
6.2 QHR hereby certifies that it has not and will not use in any capacity
the services of any individual, corporation, partnership or
association which has been debarred under 21 U.S.C. ss. 335(a) or (b).
In the event that QHR becomes aware of the debarment or threatened
debarment of any individual, corporation, partnership or association
providing services to QHR which directly or indirectly relate to
activities under this Agreement, QHR shall notify BTG immediately.
7.0 COMPENSATION
7.1 In consideration for the co-marketing services and support services
relating to treatment IND protocols set forth herein, BTG shall pay
QHR a fee of [ ] percent ([ ]%) of the purchase price to BTG's
Distributors of Designated Products shipped by QHR to BTG's
Distributors during the applicable calendar year. QHR shall, on a
monthly basis, submit to BTG an invoice for such fee including an
accounting of the value of the Designated Products shipped to BTG's
Distributors during such month and BTG shall pay QHR accordingly
within thirty (30) days of receipt of such invoice. The parties
acknowledge that such services increase as Designated Products are
sold.
7.2 In the event that BTG fails to pay any fee in full within thirty (30)
days after its receipt of the invoice, BTG shall pay QHR late charges
of eight percent (8%) per annum on all unpaid amounts due pursuant to
this compensation schedule calculated from the end of that thirty day
period.
D-3
7.3 Should any provision of this Agreement violate any law, rule or
regulation pertaining to usury or the contracting or charging of
interest, then the excess of interest contracted for or charged or
collected over the maximum lawful rate of interest shall be applied as
a prepayment of future obligations due by BTG to QHR.
7.4 Renegotiation of Fee
7.4.1 The fee that BTG pays to QHR for co-marketing services and
support services related to IND protocols services provided for
herein shall be renegotiated by the parties prior to the end of
each year, with changes in the co-marketing services and support
services related to IND protocols fee, if any, to become
effective with respect to the Designated Products received by
QHR after the end of the year.
7.4.2 In the event that the parties are unable to agree in advance on
the co-marketing services and support services related to IND
protocols fee to be paid during any year (or portion thereof),
the previously existing fee shall continue until the earlier of
the parties' agreement on such new fee, or the termination of
the Agreement.
AGREED
QUANTUM HEALTH RESOURCES, INC. BIO-TECHNOLOGY GENERAL CORP.
By:_______________________________ By:_______________________________
Name:_____________________________ Name:_____________________________
Title:____________________________ Title:____________________________
Date:_____________________________ Date:_____________________________
D-4
EXHIBIT E
IND DESIGNATED PRODUCT PROTOCOLS
E-1
EXHIBIT E-1
IND DESIGNATED PRODUCT PROTOCOL
1.0 NAME OF DESIGNATED PRODUCT
2.0 IND PROTOCOLS
E-1-1
E-1-2
Support Services Agreement - Bio-Technology General Corp. and Quantum Health Resources
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