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EXHIBIT 10.19
THERAPEUTIC ANTIBODIES INC.
X.X. XXXXXXXX & CO. LIMITED
CLINICAL TRIALS AND REGISTRATION AGREEMENT
OCTOBER 4, 1996
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TABLE OF CONTENTS
Page
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1. Recitals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2. Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
3. Clinical Trials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
4. Registration and Marketing Approvals In the New Territories . . . . . . . . . . . . . . . . . . . . . . . . 4
5. Exclusive Distribution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
6. Compliance and Subcontractors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
7. Initial Payment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
8. Confidentiality, Trademarks, and Proprietary Rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
9. Duration and Termination of Agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
10. Indemnification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
11. Representations and Warranties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
12. Disclaimer of Warranties Limited Liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
13. Enforcement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
14. General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
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CLINICAL TRIALS AND REGISTRATION AGREEMENT
This Clinical Trials and Registration Agreement ("Agreement") is
entered into and effective as of ______________ 1996, by and between X.X.
Xxxxxxxx & Co. Limited (ACN 007 870 984), a company incorporated and carrying
on business in South Australia ("FHF"), and Therapeutic Antibodies Inc., a
Delaware corporation, located in Nashville, Tennessee, USA ("TAb").
1. Recitals.
1.1 TAb has developed and is the sole owner of all
worldwide right, title, and interest in and to an anti-tumor necrosis factor
product which may be used for, among other applications, treatment of cerebral
malaria, more particularly described in Schedule 1.1 (the "Product").
1.2 TAb is attempting to obtain registration and
marketing approval for the Product for various uses in the territories referred
to in Schedule 1.2 (the "Registration Territories").
1.3 TAb has requested that (a) FHF or its nominee
provide financial support for clinical trials to be conducted by TAb in
connection with registrations and marketing approvals in the territories
referred to in Schedule 1.3 (the "New Territories"), and that (b) FHF or its
nominee obtain registrations and marketing approvals for the Product for
treatment of cerebral malaria from the relevant health authorities in the New
Territories.
2. Definitions.
2.1 "Clinical Trials" shall mean any and all
investigations, evaluations, or experiments relating to the potential use of
the Product, that are conducted on human beings.
2.2 "Confidential Information of TAb" means all
information obtained or developed by FHF or any third party which relates to
TAb's business or the Product, regardless of the form in which such information
is transmitted, including, without limitation, all such information previously
obtained by FHF pursuant to a Confidentiality Agreement dated July l, 1992,
between TAb and FHF (the "Confidentiality Agreement"), all information provided
to FHF pursuant to a Registration and Distribution Agreement dated August 31,
1995, between TAb and FHF, all information furnished to FHF or any
Subcontractor pursuant to Section 4 below, all Results, and all Trade Secrets.
The following shall not be considered Confidential Information of TAb for
purposes hereof:
(a) Information that is already in the possession of
FHF or the Subcontractor at the time it is received from TAb or developed on
TAb's behalf, and the receiving party promptly notifies TAb of its belief that
the information is excepted under the terms of this subsection;
(b) Information received by FHF or a Subcontractor
from a Person which has the right to disclose the same, and the receiving party
promptly notifies TAb of its belief that the information is excepted under the
terms of this subsection; or
(c) Information that is or becomes published, or is or
becomes otherwise publicly available without the fault of FHF or a
Subcontractor.
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In the event of a dispute regarding the applicability of the above exceptions
to the definition of Confidential Information of TAb, FHF shall have the burden
of producing clear and convincing proof that the information should be excepted
from the definition of Confidential Information of TAb.
2.3 "Confidential Information of FHF" means all
information obtained by TAb which relates to FHF's business; provided, however,
that this definition does not include or apply to either the Confidential
Information of TAb or:
(a) Information that is already in the possession of
TAb at the time it is received from FHF, and the receiving party promptly
notifies FHF of its belief that the information is excepted under the terms of
this subsection;
(b) Information received by TAb from a Person which
has the right to disclose the same, and the receiving party promptly notifies
FHF of its belief that the information is excepted under the terms of this
subsection; or
(c) Information that is or becomes published, or is or
becomes otherwise publicly available without the fault of TAb.
In the event of a dispute regarding the applicability of the above exceptions
to the definition of Confidential Information of FHF, TAb shall have the burden
of producing clear and convincing proof that the information should be excepted
from the definition of Confidential Information of FHF.
2.4 "Confidential Information" means collectively
Confidential Information of TAb and Confidential Information of FHF.
2.5 "Documentation" means any and all labels,
instructions, manuals, specifications, warnings and similar documentation
regarding the Product prepared by or for TAb.
2.6 "Person" means an individual, corporation,
company, partnership, trust, association, entity, governmental authority or
other entity.
2.7 "Product" means the Product listed on Schedule 1.1.
2.8 "Proprietary Rights" means the rights and
properties described in Section 8.6.
2.9 "Regulatory Filing" shall mean any filing outside
of the United States that is equivalent to Notice of Claimed Investigational
Exemption for a New Drug ("IND"), Product License Application ("PLA"),
Establishment License Application ("ELA"), or New Drug Application ("NDA") in
the United States pursuant to the regulations and procedures required by any
regulatory authority for any country for the testing, manufacture,
distribution, sale, or specific use of a Product.
2.10 "Results" means all technology, ideas (whether or
not copyrightable), know-how, data, improvements, modifications, innovations,
inventions, methodology, processes, techniques, and results, tangible and
intangible, developed or discovered by TAb, FHF or any Subcontractor in
connection with the clinical trials, registrations, and approvals contemplated
by Sections 3 and 4, or otherwise in connection with the Product or this
Agreement.
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2.11 "Subcontractor" means a Person approved by TAb
pursuant to Section 6 below, to whom FHF has delegated responsibilities
regarding registration and approval.
2.12 "Trademarks" means all trademarks, trade names,
and other designations of origin used on or in connection with the Product,
including, without limitation, CytoTAb(TM).
2.13 "Trade Secrets" means all techniques, technology,
processes, and know-how related to production and purification of polyclonal
antibodies developed by or on behalf of TAb, including (a) the design and
syntheses of immunogens which can produce high affinity antibodies in large
quantities, (b) the selection, immunization, and handling of animals to produce
therapeutic polyclonal antibodies (including breed comparison studies), (c) the
aseptic collection and handling of antisera, and (d) closed systems for fully
processing and purifying antibodies; types and configuration of processing
equipment; lists of suppliers; development plans; methods of operation and
management; cost control methods; methods of setting prices; reporting methods;
quality assurance programs; information systems; training manuals; databases;
production solutions; financial information; customer and prospective customer
lists; and all other trade secrets of TAb.
2.14 "TAb" includes any related corporation of TAb
where that corporation controls, is controlled by, or is under common ownership
with TAb.
3. Clinical Trials.
3.1 TAb shall submit a budget and clinical protocol to
FHF for written approval by FHF before TAb begins to conduct clinical trials or
to incur any clinical trial expenses in any country in the New Territories.
Variations in the budget or clinical protocol must be approved by FHF in
writing before they are undertaken or incurred for FHF to be liable to
reimburse TAb for them, but such consent shall not be unreasonably withheld.
3.2 TAb shall be solely responsible for the conduct of
the clinical trials in any country in the New Territories; provided, however,
TAb agrees to comply with the protocol (the "Protocol") attached hereto as
Schedule 3.2, consult in good faith with FHF and to provide reports to FHF upon
FHF's reasonable request regarding the conduct of each clinical trial. TAb
shall not subcontract the performance of any clinical trials without FHF's
prior written consent (not to be unreasonably withheld). TAb shall conduct all
clinical trials accounted for in the budget approved by FHF as necessary to
enable registration to be obtained in the New Territories. In such clinical
trials, TAb shall use its best efforts to develop all clinical information and
data which it is reasonably able to obtain as may be necessary in connection
with any registration and marketing approvals in the New Territories. TAb shall
provide for the clinical trials all necessary quantities of Product, which
shall be manufactured in accordance with current Good Manufacturing Practices
as set forth in the United States Food and Drug Administration regulations and
any applicable laws in appropriate facilities. Products used in clinical trials
shall be supplied by TAb at no cost to FHF. TAb shall maintain books of account
and other records relating to the clinical trials during the term of this
Agreement that TAb reasonably believes will be sufficient for FHF to ascertain
upon inspection thereof an accurate and detailed knowledge of the allocation of
its funds and the status of the trials. Upon reasonable notice and during TAb's
normal business hours, FHF may inspect all of TAb's books of account and other
records relating to the subject matter of this Agreement for the purpose of
ascertaining or confirming their accuracy. TAb shall request that any third
parties performing any clinical trials permit FHF to inspect the locations of
the clinical trials upon reasonable notice.
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3.3 FHF agrees to reimburse TAb for the costs of
clinical trials for the Product in any country in the New Territories. TAb
shall prepare and send to FHF an invoice of actual costs incurred by TAb each
month. FHF shall make full payment of the stated amount within thirty (30) days
of receipt of TAb's invoice. FHF shall not be liable for any expenses in excess
of the budgeted amount in any clinical trial budget approved by FHF or any
expenditures not included in such an approved budget.
3.4 TAb shall promptly disclose to FHF any information
that it has regarding an adverse drug experience and shall also make any
reports regarding such adverse experiences as are required by law. FHF shall
not be liable for any claims, actions, or demands arising out of any adverse
drug experiences or injuries occurring to any person as a result of his or her
involvement in clinical trials for the Product in any country in the New
Territories.
4. Registration and Marketing Approvals In the New Territories.
4.1 FHF shall exercise all commercially reasonable
efforts, on a continuous basis, to obtain all necessary registration and
marketing approvals for the Product and with the least possible delay from all
relevant governmental authorities in each country within the New Territories,
at FHF's sole cost and expense. FHF shall prepare and submit all necessary
Regulatory Filings for the Product in the New Territories. TAb shall promptly
supply FHF with all information and data in its possession or which it is
reasonably able to obtain as may be necessary or useful in connection with any
registrations and approvals, including relevant information prepared for
treatment of cerebral malaria in other countries. TAb shall permit the release
by FHF to government officials with TAb's prior written consent of such of its
Confidential Information as is necessary to obtain registration of the Product.
FHF shall provide TAb with written certification that the Product has obtained
all registrations and approvals necessary in order for distribution and sale of
the Product in a given country to commence, promptly upon receipt of the
requisite registrations and/or approvals. FHF agrees that neither it nor any
Subcontractor shall modify or alter the Product in any respect, whether in
relation to design, content, manufacture, use or otherwise, without the prior
written consent of TAb. If FHF reasonably forms a view that registration cannot
be obtained in a particular country within the Territory, FHF may cease its
efforts to seek registration as set forth in this Section 4 provided that FHF
consults with TAb prior to ceasing such registration efforts in the particular
country at issue. In the event of such a cessation, the rights and obligations
set forth in Section 9.2 hereof shall apply to the parties' activities in that
particular country.
4.2 All registrations and approvals obtained by FHF
hereunder shall be the sole and exclusive property of TAb. All registrations
and approvals shall be held in the name of TAb or, if required by applicable
law or regulatory authorities, in the name of FHF or a third party on TAb's
behalf. All Results shall be the sole and exclusive property of TAb, and FHF
hereby assigns to TAb any and all right, title, and interest it may now or in
the future have in the Results.
4.3 As FHF receives any information relating to the
status of applications for registration and marketing approval and requests for
the Product, it shall promptly provide such information to TAb.
4.4 FHF may delegate its responsibilities under this
Section 4 to any Subcontractor, with TAb's prior written approval pursuant to
Section 6.
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4.5 Set forth as Schedule 4.5 hereto is the time and
events schedule for the registration and approval activities contemplated by
this Section 4. The schedule will be reviewed and revised, if necessary, as the
parties shall mutually agree. The time and events schedule is intended to be a
guideline only and is not a binding legal obligation.
5. Exclusive Distribution.
5.1 As soon as FHF certifies to TAb that the Product
has obtained all necessary registration and approval rights for distribution
and sale in a particular country in the New Territories, FHF shall have an
exclusive option, which FHF may exercise or refuse to exercise at its sole
discretion during the period set forth in Section 5.2 hereof, to enter into an
exclusive ten-year agreement (the "Distribution and Profit Sharing Agreement")
based upon the key commercial terms set forth in Schedule 5.1 and pursuant to
which FHF or its nominee would distribute a form of the Product intended solely
for treatment of cerebral malaria in such country, and TAb and FHF would share
in the profits arising from the exploitation of the Product. The reimbursements
by FHF of approved clinical trial expenses as set forth in Section 3 are not
refundable to FHF for any reason; however, if the parties enter into a
Distribution and Profit Sharing Agreement, the reimbursements by FHF to TAb of
clinical trial expenses, and the US[$ * ] fee referred to in Section 7, are
jointly creditable against a maximum, when combined, of [ * ]% of earned
royalties per year under the Distribution and Profit Sharing Agreement during
the first [ * ] years following the date on which total sales of the Product
in the New Territories exceed US$[ * ]. The parties acknowledge that the
Product has other applications, and the Distribution and Profit Sharing
Agreement shall grant no rights to FHF and impose no restrictions on TAb with
regard to such additional applications.
5.2 In the event that the parties have not executed a
Distribution and Profit Sharing Agreement within ninety (90) days after the
date on which FHF certifies receipt of all necessary registration and marketing
approvals for the applicable country in the New Territories, TAb or one of its
affiliates may market the Product in the respective country within the New
Territories or TAb may enter into similar arrangements with one or more third
parties, provided such arrangements are on no more favorable terms than those
offered to FHF.
6. Compliance and Subcontractors.
6.1 FHF shall insure that its conduct in performing
its obligations under this Agreement complies with all applicable laws and
regulations of the countries within the New Territories, and of the United
States to the extent that FHF, as a foreign corporation located outside the
United States, seeking registration solely outside the United States, for a
Product that is manufactured by a U.S. registered corporation, would be subject
to U.S. jurisdiction and statutes, including, without limitation, laws and
regulations governing bribery of foreign officials, labels for pharmaceutical
products, applicable export controls, and antitrust and unfair competition. If
any approval shall be required at any time during the term of this Agreement
with respect to compliance with exchange regulations or other requirements so
as to assure the right of remittance abroad of U.S. dollars, FHF shall
immediately take whatever steps may be necessary in this respect, and any
charges incurred in connection therewith shall be borne by FHF.
6.2 TAb shall insure that its conduct in performing
its obligations under this Agreement complies with all applicable laws and
regulations of the countries within the New Territories and of the United
States.
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* Confidential treatment requested. Omitted material filed separately.
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6.3 FHF agrees that during the term of this Agreement,
it may make such arrangements with third parties which it, in its reasonable
judgment, believes necessary to maximize its ability to obtain registration and
approval of all Product in all countries within the New Territories, and TAb
agrees that it will provide FHF with such assistance as FHF may reasonably
require. Any such arrangements made with third parties shall be made only with
third parties which, after due inquiry, FHF knows to be reputable and
competent. Any such third parties selected by FHF for registration and approval
work shall be referred to as "Subcontractors." FHF shall be responsible for
ensuring that each Subcontractor complies with all applicable provisions of
this Agreement and all applicable laws and regulations of the U.S., and of
foreign governments (and political subdivisions thereof). In addition, FHF
agrees that it will not enter into any agreements, understandings, or other
arrangements, with any Subcontractor, without the prior written approval of
TAb, which approval shall not be unreasonably withheld if:
(a) TAb shall have received from FHF reasonable and satisfactory
information concerning the business activities and qualifications of the
Subcontractor, the reputation of the Subcontractor, and the number of years FHF
has done business with the Subcontractor; and
(b) FHF shall have furnished TAb with (i) an undertaking of the
Subcontractor, in form reasonably satisfactory to TAb, to respect the rights of
TAb in and to the Product and the Proprietary Rights (defined herein), and to
treat confidentially the Confidential Information of TAb; and (ii) an
acknowledgement by the Subcontractor that TAb shall have the rights of an
express third party beneficiary of any agreement, understanding, or other
arrangement between FHF and such Subcontractor.
7. Initial Payment.
In consideration for the rights granted to FHF hereunder, FHF shall
pay TAb a US$[ * ] licensing fee on signing the Agreement. The foregoing
payment is fully earned on the date hereof and is not refundable; however, if
the parties subsequently enter into a Distribution and Profit Sharing
Agreement, this payment and the creditable reimbursements by FHF to TAb of the
clinical trials expenses referred to in Section 5.1 are jointly creditable
against a maximum, when combined, of [ * ]% of earned royalties
per year under the Distribution and Profit Sharing Agreement during the first
[ * ] years following the date on which total sales of the Product in the
New Territories exceed US$[ * ].
8. Confidentiality, Trademarks, and Proprietary Rights.
8.1 Neither party shall use or permit the use of the
other party's Confidential Information by any Person other than for the limited
purposes expressly permitted by this Agreement.
8.2 Neither party shall disclose or disseminate the
other party's Confidential Information to any Person or entity other than to
employees, officers, and directors of that party or an affiliate (as defined in
the regulations promulgated under the Securities Exchange Act of 1934) of that
party and to Subcontractors who require access thereto in order to perform that
party's obligations hereunder ("Recipients"). Recipients shall be granted
access to the Confidential Information strictly on a "need to know" basis. Each
party shall take all reasonable steps to ensure that Recipients comply with the
terms of this Agreement, including all restrictions on use, disclosure, and
dissemination of Confidential Information. Such steps shall include, without
limitation, measures to insure that each Recipient has read, understands, and
agrees to the provisions hereof. Each party shall notify the other immediately
upon becoming aware of any breach hereof and shall take reasonable steps to
prevent any further disclosure or unauthorized use.
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* Confidential treatment requested. Omitted material filed separately.
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8.3 Upon termination or expiration of this Agreement,
each party shall deliver to the other party (a) all of the other party's
Confidential Information, all copies thereof, and all documents or data storage
media containing such Confidential Information, (b) the names and addresses of
all Recipients, and (c) a written certification that the party has complied
with its obligations under this Section 8.
8.4 During the term of this Agreement and for a period
of ten (10) years after the termination date of this Agreement, each Recipient
shall keep confidential and not use, except as provided herein, all
Confidential Information.
8.5 FHF agrees that it shall not adopt or use for any
purpose the Trademarks or any variation of the Trademarks until and unless the
parties execute a Distribution and Profit Sharing Agreement and then only on
the terms set forth in such Agreement.
8.6 FHF acknowledges that all Trademarks and all
rights and goodwill pertaining thereto are the exclusive property of TAb. FHF
further acknowledges that TAb is the sole and exclusive owner of all present
and future right, title, and interest in and to (a) all worldwide patent
rights, registrations and registration rights, copyrights, and related rights,
in or related to the Product and any present and future renewals thereof, (b)
all rights (including copyrights) in the appearance, packaging, design, trade
dress, and other identifying features of the Product and the promotional and
packaging materials, (c) the Trade Secrets and the Results, (d) any
adaptations, additions, derivatives, translations, and/or improvements to any
of the foregoing, and (e) all other intangible rights in the Product. The
Trademarks and other rights and properties described in this Section 8.6 are
referred to collectively as the "Proprietary Rights."
8.7 FHF agrees it will not challenge, oppose or
cancel, or permit any act or thing that would endanger any right of TAb in the
Product or the Proprietary Rights, nor will FHF claim any proprietary interest
in the Product or the Proprietary Rights.
8.8 FHF acknowledges that no Trademarks are presently
registered in the New Territories.
8.9 TAb shall exercise its best efforts to both pursue
and, if obtained, maintain necessary and appropriate intellectual property
protection for the Product to be distributed in the New Territories without
infringement of any third party's intellectual property rights.
9. Duration and Termination of Agreement
9.1 The effective date of this Agreement is as set
forth above and, unless earlier terminated in accordance with the provisions
hereof, this Agreement shall terminate five (5) years from the effective date
of this Agreement.
9.2 FHF may terminate this Agreement, with TAb's prior
consent which may not be unreasonably withheld, with respect to a country
within the New Territories by sixty (60) days' prior written notice to TAb in
the event that (i) FHF reasonably forms an opinion that all relevant
governmental authorities in such country within the New Territories will refuse
to issue all necessary registration and marketing approvals for the Product, or
(ii) FHF determines that to continue the clinical trials and registration
process for the Product in the New Territories is no longer commercially
viable. Upon any such
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termination, FHF shall only be responsible for the costs of ongoing clinical
trials incurred by TAb during the sixty (60) day period following the date of
notice of termination as well as reasonable termination costs incurred by TAb
(including reasonable severance payments and reasonable buy-outs of
pre-existing contracts reasonably entered into); provided, however, TAb shall
use its best efforts to mitigate and control such termination costs, and FHF
must approve in writing any expenditures for obligations that are entered into
after TAb receives notice of termination. If the termination notice applies to
all countries within the New Territories, then FHF will immediately return to
TAb all Confidential Information upon providing notice of termination, and TAb
or one of its affiliates may seek registration and marketing approvals for the
Product or may enter into agreements with one or more third parties to seek
such approvals, immediately upon receipt of notice of termination. As of the
termination date, FHF will have no rights, and TAb will have no obligations
with respect to the Distribution and Profit Sharing Agreement.
9.3 If either party breaches any of its obligations
under this Agreement, the other party may give notice of such breach in
accordance with the provisions of Section 14.2 hereof. If the breaching party
does not cure the breach to the satisfaction of the notifying party within
thirty (30) days from the date of receipt of the notice, then the notifying
party may terminate this Agreement.
9.4 Either party hereto shall have the right to
terminate this Agreement immediately and without prior notice in the event that
the other party files a petition for voluntary bankruptcy, has a petition for
involuntary bankruptcy filed against it (which petition is not withdrawn within
sixty (60) days of such filing), is adjudicated to be or becomes bankrupt,
places any of its property in liquidation for the purpose of meeting claims of
its creditors, is otherwise unable to pay its debts as such debts become due
(including, but not limited to, payments due hereunder), or ceases to function
as a going concern.
9.5 If the parties fail to enter into a Distribution
and Profit Sharing Agreement, TAb shall be free to enter into similar
arrangements with one or more third parties.
9.6 The obligations of FHF under Sections 6, 8, 9.2,
10, and 13 hereof shall survive the expiration or termination of this
Agreement. The obligations of TAb under Sections 6 and 13 hereof shall survive
the expiration or termination of this Agreement.
9.7 Upon termination or expiration of this Agreement
for any reason, TAb shall have no liability for actual or alleged loss of
goodwill, prospective profits or anticipated orders, or on account of any
expenditures, investments, leases, or commitments made by FHF. Upon termination
or expiration of this Agreement for any reason, FHF shall have no liability for
actual or alleged loss of goodwill, prospective profits or anticipated orders,
or on account of any expenditures, investments, leases, or commitments made by
TAb.
9.8 Upon FHF's issuing notice of termination or upon
termination by TAb or expiration of this Agreement for any reason, FHF shall
immediately return all Documentation and Confidential Information to TAb.
9.9 Except in the event of intellectual property
infringement, neither party shall be liable to the other for any incidental,
consequential, or special damages of any nature whatsoever, including, without
limitation, lost profits. As of the date of termination of this Agreement for
any reason, neither party will have any rights or obligations with respect to
the Distribution and Profit Sharing Agreement.
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10. Indemnification.
10.1 FHF shall indemnify and hold harmless TAb and its
subsidiaries, affiliates, officers, and directors, notwithstanding termination
of this Agreement, against any liability, damage, loss, cost, or expense
(including reasonable attorneys' fees) relating to any third party claims
arising from:
(a) default under any provision of the Agreement by
FHF or any Subcontractor; or
(b) any negligence, gross negligence, or intentional
misconduct of FHF,
provided that upon receipt of notice by TAb of any such
claims, TAb shall immediately notify FHF. TAb shall permit FHF to handle such
claims at FHF's sole cost, and TAb shall give FHF all reasonable assistance
(except financial assistance) in the conduct of any such claims. In no event is
FHF authorized to settle or compromise any claim, or to consent to the entry of
any order or judgment, without the prior written consent of TAb.
10.2 TAb shall indemnify and hold harmless FHF, its
subsidiaries and affiliates, officers, and directors, notwithstanding
termination of this Agreement, against any liability, damage, loss, cost, or
expense (including reasonable attorneys' fees) relating to any third party
claims arising from:
(a) any supply or use of Product in the New
Territories by FHF consequent upon any act or omission in the manufacture,
storage, or shipment of Product by TAb;
(b) default under any provision of the Agreement by
TAb;
(c) any suit against FHF arguing that the Product as
provided to FHF by TAb infringes the intellectual property rights of any third
party as enforceable in the New Territories; and
(d) any negligence, gross negligence, or intentional
misconduct of TAb;
provided that upon receipt of notice by FHF of any such claims, FHF shall
immediately notify TAb. FHF shall permit TAb to handle such claims at TAb's
sole cost and discretion and shall give TAb all assistance (except financial
assistance) it can in the conduct of any such claims. In no event is TAb
authorized to settle or compromise any claim, or to consent to the entry of any
order or judgment, without the prior written consent of FHF.
11. Representations and Warranties.
11.1 FHF represents and warrants that (a) it is a
company duly organized and validly existing under the laws of Australia; (b)
the execution and delivery by FHF of this Agreement, the performance by FHF of
all the terms and conditions thereof to be performed by it and the consummation
of the transactions contemplated hereby have been duly authorized by all
necessary action, and no other act or approval of any person or entity is
required to authorize such execution, delivery, and performance, other than the
registrations and approvals referred to in Section 4 of this Agreement; (c) the
Agreement constitutes a valid and binding obligation of FHF, enforceable in
accordance with its terms; (d) this Agreement and the execution and delivery
thereof by FHF, does not, and the fulfillment and compliance with the terms and
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conditions hereof and the consummation of the transactions contemplated hereby
will not, (i) conflict with any of, or require the consent of any person or
entity under, the terms, conditions, or provisions of the memorandum and
articles of association of FHF or its company charter, (ii) violate any
provision of, or require any consent, authorization, or approval under, any law
or administrative regulation or any judicial, administrative, or arbitration
order, award, judgment, writ, injunction, or decree applicable to FHF other
than the registrations and approvals referred to in Section 4 of this
Agreement, or (iii) conflict with, result in a breach of, or constitute a
default under, any material agreement or obligation to which FHF is a party.
11.2 TAb represents and warrants that (a) it is a
corporation duly organized and validly existing under the laws of the State of
Delaware; (b) the execution and delivery by TAb of this Agreement, the
performance by TAb of all the terms and conditions thereof to be performed by
it and the consummation of the transactions contemplated hereby have been duly
authorized by all necessary action, and no other act or approval of any person
or entity is required to authorize such execution, delivery, and performance;
(c) the Agreement constitutes a valid and binding obligation by TAb,
enforceable in accordance with its terms; (d) this Agreement and the execution
and delivery thereof by TAb, does not, and the fulfillment and compliance with
the terms and conditions hereof and the consummation of the transactions
contemplated hereby will not (i) conflict with any of, or require the consent
of any person or entity under, the terms, conditions, or provisions of the
organizational documents of TAb, (ii) violate any provision of, or require any
consent, authorization, or approval under, any law or administrative regulation
or any judicial, administrative, or arbitration order, award, judgment, writ,
injunction, or decree applicable to TAb, or (iii) conflict with, result in a
breach of, or constitute a default under, any material agreement or obligation
to which TAb is a party; and (e) as of the date of this Agreement, TAb has no
knowledge of any third party proprietary rights that would prevent the sale of
the Product in the New Territories.
12. Disclaimer of Warranties Limited Liability.
Under no circumstances shall either party be liable to the other party
on account of any claim (whether based upon principles of contract, warranty,
negligence or other tort, breach of any statutory duty, principles of
indemnity, the failure of any limited remedy to achieve its essential purpose,
or otherwise) for any special, consequential, incidental or exemplary damages,
including but not limited to lost profits, or for any damages or sums paid by a
party to third parties, even if the other party has been advised of the
possibility of such damages.
13. Enforcement.
Each party agrees that (a) the restrictions contained in Section 8 of
this Agreement represent reasonable and necessary protection of the legitimate
interests of the other party, and that the first party's failure to observe and
comply with the covenants and agreements in that section will cause irreparable
harm to the other party and its affiliates; (b) it is and will continue to be
difficult to ascertain the nature, scope, and extent of the harm; and (c) a
remedy at law for such failure will be inadequate. Accordingly, it is the
intention of the parties that, in addition to any other rights and remedies
which either party may have in the event of any breach or threatened breach of
such Section, each party shall be entitled, and is expressly and irrevocably
authorized by the party in breach, to demand and obtain specific performance,
including, without limitation, temporary and permanent injunctive relief and
all other appropriate equitable relief against the party in breach in order to
enforce against the party in breach the covenants and agreements contained in
such Section. Such right to obtain injunctive relief may be exercised
concurrently with, prior to, after, or in lieu of, any other rights resulting
from any such breach or threatened breach. The party in breach shall
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account for and pay over to the other party all compensation, profits, and
other benefits, after taxes enuring to the benefit of the party in breach,
which are derived from or received by the party in breach or any person or
business entity controlled by it resulting from any action or transaction
constituting breach of such Section.
14. General.
14.1 No waiver or modification of the Agreement shall
be effective unless in writing and signed by the party against whom such waiver
or modification is asserted. Waiver by either party in any instance of any
breach of any term or condition of this Agreement shall not be construed as a
waiver of any subsequent breach of the same or of any other term or condition
hereof. None of the terms or conditions of this Agreement shall be deemed to
have been waived by course of dealing or trade usage.
14.2 All notices and demands hereunder shall be in
writing and shall be served by personal delivery, by registered mail, by
recognized international courier, or by facsimile transmission at the address
of the receiving party set forth below (or at such different address as may be
designated by such party by written notice to the other party).
TAb: FHF:
Therapeutic Antibodies Inc. X.X. Xxxxxxxx & Co. Limited
0000 00xx Xxxxxx Xxxxx X.X.X. Xxx 0000
Xxxxxxxxx, Xxxxxxxxx 00000 XXX Xxxxxxxx, XX 0000 Xxxxxxxxx
Attention: President Attention: Company Secretary
Fax: 0-000-000-0000 Fax: 00-0-000-0000
All notices or demands shall be deemed received on the earlier of actual
receipt or seven (7) days after posting if sent by mail, three days after
delivery to international courier, or upon receipt of fax-back confirmation if
sent by facsimile.
14.3 In the event any litigation is brought by either
party in connection with this Agreement, the prevailing party in such
litigation shall be entitled to recover from the other party all the costs,
attorneys fees and other expenses incurred by such prevailing party in the
litigation.
14.4 This Agreement shall be governed by and construed
in accordance with the laws of the State of Delaware, United States of America.
The parties agree that any claim asserted in any legal proceeding by one party
against the other shall be commenced and maintained in any state or federal
court in Nashville, Tennessee, having subject matter jurisdiction with respect
to the dispute between the parties. Both parties hereby submit to the
jurisdiction of such courts over each of them personally in connection with
such litigation, and waive any objection to venue in such courts and any claim
that such forum is an inconvenient forum.
14.5 In the event that any provision of this Agreement
shall be held by a court or other tribunal of competent jurisdiction to be
unenforceable, such provision will be enforced to the maximum extent
permissible and the remaining portions of this Agreement shall remain in full
force and effect.
14.6 Neither party shall be responsible for any failure
to perform due to unforeseen circumstances or to cause beyond such party's
control, including but not limited to acts of God, war, riot,
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embargoes, acts of civil or military authorities, fire, floods, accidents,
strikes, or shortages reasonably beyond the control of such party with regard
to transportation facilities, fuel, energy, labor or materials, and where no
reasonable alternative means of obtaining these are available.
14.7 This Agreement constitutes the entire agreement
between the parties pertaining to the subject matter hereof, and supersedes in
their entirety any and all written or oral agreements previously existing
between the parties with respect to such subject matter.
14.8 The terms of this Agreement are intended solely
for the benefit of the parties hereto. They are not intended to confer upon any
Subcontractor the status of a third party beneficiary. Except as otherwise
provided for by this Agreement, the terms hereto shall inure to the benefit of,
and be binding upon, the respective successors and assigns of the parties
hereto.
14.9 The parties expressly acknowledge and agree that
FHF shall act only as an independent contractor of TAb and that this Agreement
shall not be deemed to create an agency, partnership, employment, or joint
venture relationship between TAb and FHF. Nothing in this Agreement shall be
construed as a grant of authority to either party to accept any order, waive
any right, incur any obligation or liability, enter into any agreement, grant
any release or otherwise purport to act in the name of the other party. Except
as expressly set forth herein, the parties agree that TAb shall neither
exercise control over FHF's method of operations nor provide assistance to FHF.
The operations, policies and procedures of FHF, including those related to
FHF's performance of this Agreement, are subject to the sole management and
control of FHF.
14.10 This Agreement may be executed in one or more
counterparts, each of which shall constitute an original.
14.11 Nothing contained herein shall be construed as
conferring by implication, estoppel, or otherwise any license or right under
any patent, whether or not the exercise of any right herein granted necessarily
employs an invention or any existing or later issued patent.
14.12 In the event that performance of any obligation
pursuant to this Agreement would cause either party to contravene applicable
laws or regulations, failure to take such action shall not constitute default
hereunder.
14.13 The terms of this Agreement can be modified only
by a writing which is signed by both parties.
14.14 No party to this Agreement may assign its
obligations hereunder without the prior written consent of the other parties.
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IN WITNESS WHEREOF, the parties hereto have executed this Agreement as
of the date first set forth above.
X.X. XXXXXXXX & CO. LIMITED
By: /s/ [ILLEGIBLE]
-----------------------------------
Title: Chief Operations Executive
-------------------------------
Date: 17th October, 1996
--------------------------------
THERAPEUTIC ANTIBODIES INC.
By: /s/ Xxxxxx X. Xxxxx
---------------------------------
Title: Chairman
--------------------------------
Date: October 22, 1996
--------------------------------
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SCHEDULE 1.1
THE PRODUCT
Purified ovine anti-tumor necrosis factor alpha, Fab, (lyophilized) which TAb
has identified as CytoTAb(TM) and which is being tested for treatment of
cerebral malaria in human beings
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SCHEDULE 1.2
REGISTRATION TERRITORIES
United States of America
Certain European Countries
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SCHEDULE 1.3
NEW TERRITORIES
Thailand
(other Southeast Asian countries where malaria is a problem)
[list of such countries to be supplied by FHF]
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SCHEDULE 3.2
PROTOCOL
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SCHEDULE 4.5
REGISTRATIONS AND APPROVALS
1. [Schedule will include (a) time for start of trials required
for registration, (b) time for completion of trials, and (c) time for receiving
registrations. The Schedule will be designed on a country-by-country basis.]
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SCHEDULE 5.1
KEY COMMERCIAL TERMS
Key Terms for Inclusion into Distribution Agreement in addition to those
contained in the Clinical Trials Registration Agreement.
1. Term of Agreement: Exclusive distribution rights for ten
years in each country in which the product is distributed, with automatic
rights of renewal for successive two-year periods.
2. TAb to supply fully finished pharmaceutical product.
3. Each party shall receive [ * ]% of FHF's gross profit.
TAb's portion shall be derived from FHF's purchase price and payment of
royalties.
4. Territory: Thailand plus the ability to add countries
approved by TAb as per the digitalis agreement.
5. Price: to be denominated in U.S. dollars.
6. Terms of delivery - FOB TAb's production facility.
7. Out of pocket registration expenses to be set off against a
maximum of [ * ]% of earned royalties per year.
8. FHF to promote the Product in the Territory diligently and
in a commercially appropriate manner aimed at maximizing the benefits for both
FHF and TAb.
9. FHF to provide annual forecasts of its requirements for the
Product. TAb to be required to supply orders that fit within the forecasts. TAb
to use best efforts to supply the Product for orders that exceed the forecasts
by more than 30%.
10. TAb to manufacture the Product in compliance with agreed
manufacturing specifications which:
(a) comply with and reflect all applicable regulatory
requirements and conditions of approval agreed or imposed by the relevant
regulatory authorities;
(b) specify that the Product will have an adequate
shelf life at the time of delivery to FHF so as to enable it to readily be sold
in the ordinary course of business; and
(c) ensure that the external presentation and
appearance of the Product, including its packaging, is such as to enable it to
be sold by FHF in the ordinary course of business.
11. TAb to provide assurances of both continuity of supply of
Product and quality of Product, subject to events genuinely and entirely
outside of its control.
------------
* Confidential treatment requested. Omitted material filed separately.
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12. Mutual indemnification for defaults and for acts or
omissions in each party's obligations under the Agreement.
13. FHF to pay one-half the purchase price in advance for its
first order in order to provide TAb with working capital.
14. Limits on reducing FHF's ability to reduce purchase orders a
certain percentage below sales forecasts.
15. FHF to meet annual minimum sales as agreed by the parties.
16. The terms set forth in this Schedule 5.1 shall be developed
more fully, and other terms must be negotiated for inclusion within such
agreement.
