1
EXHIBIT 10.1
AGREEMENT
THIS AGREEMENT is made the 5th day of February 1996 between CAMBRIDGE ANTIBODY
TECHNOLOGY LIMITED ("CAT") whose registered office is at Xxx Xxxxxxx Xxxx,
Xxxxxxxxx, Xxxxxxx, Xxxxxxxxxxxxx, XX0 0XX, XX, and TECHNICLONE INTERNATIONAL
CORPORATION ("TCLN") of 00000 Xxxxxxxx Xxxxxx, Xxxxxx, Xxxxxxxxxx.
BACKGROUND
CAT and TCLN wish to enter into a collaborative venture to produce human
antibodies to replace murine antibodies currently being used in the treatment
of cancer using the Tumor Necrosis Therapy ("TNT") technology on the terms and
conditions set out below.
CAT has obtained rights from Genetech Inc. relating to the Cabilly patent. If
a license to the Cabilly patent is required for the performance of this
Agreement, CAT will use one of its options for a Cabilly license for
anti-histone antibodies, if this is the most cost-effective route for obtaining
such a license.
The venture is to be concerned initially with in vivo radioimmunoconjugate
applications of the technology. The parties will, however, keep the venture
under constant review through the Business Committee to be established pursuant
to the Agreement with a view to expanding and extending the venture into
broader applications of the technology which are of mutual interest.
IT IS AGREED
DEFINITIONS
In this Agreement, unless the context otherwise requires, the following
expressions shall have the following meanings:
Antibody a molecule comprising or containing one or more
immunoglobulin variable domains or parts of such
domains and that binds or is intended to bind to the
Antigen.
Antigen any antigen the use of antibodies against which would
infringe the Techniclone Patents
CAT Patents PCT/GB91/01134, EPO 368 684, the patents when granted
and any patents issuing pursuant to those patents or
applications, including any division, continuation,
continuation-in-part, renewal, extension,
re-examination, reissue or foreign counterpart
Designated Cell-line a cell-line intended for the production of human
Antibodies and designated pursuant to sub-clause
2.2(b) below
Direct Cost direct cost shall mean labor, material and production
overhead costs which are directly attributable to
manufacturing the Product for Phase III clinical
6
2
trials. "Direct Cost" does not include general and
administrative costs or general overhead
Effective Date the date of signature of this Agreement
Field in vivo use of necrotic tissue using Antibodies as
radioimmuno-conjugate(s), as such use is covered by
the Techniclone Patents with targeting moietics
applicable to the Techniclone Patents and developed
pursuant to this Agreement, including without
limitation antibodies TNT1, TNT2 and TNT3 chimeric
and human antibodies to those antigens, including
vasopermeation technology when linked to or used in
conjunction with Products
Improvements any improvements to the Field (whether or not
patentable) created by either or both parties
pursuant to the performance of this Agreement.
Intellectual Property the CAT Patents, the Techniclone Patents, related
unpatented intellectual property rights and
Improvements
Net Royalties those royalties remaining after deduction of any
payments that are required to be made to third parties
Net Selling Price the selling price of Products invoiced to independent
third parties in an arm's length transaction less:
(a) cash, trade or quantity discounts;
(b) credits for returns or replacements;
(c) carriage, packing and insurance charges;
(d) sales and other similar taxes where such items
are individually itemized on the appropriate
invoice
Overall Field applications relating to necrotic tissue targeting
covered by the Techniclone Patents other than
applications in the Field
Product a finished product made using or incorporating one or
more Antibodies
Techniclone Patents U.S. 5,019,368, U.S. 4,861,581, and EPO 270340 (for
vasopermeation. The European notice of grant has
been issued -- in the U.S., the application is
pending.) The patents when granted and any patents
issuing pursuant to those patents or application,
including any division, continuation,
continuation-in-part, renewal extension,
re-examination, reissue or foreign counterpart
1. LICENSES
1.1 Each party shall grant to the other such co-exclusive licenses
to the Intellectual Property in the Field as may be necessary
to allow each party to perform this Agreement and to make,
have made, use and sell Products.
7
3
1.2 CAT acknowledges that TCLN has licensed some aspects of the
Field relating to chimeric antibodies in China and that such
aspects will therefore not be available for license to CAT in
the territory of China in relation to this Agreement.
1.3 Each party shall give the other the first right to negotiate
with regard to commercial applications of the Overall Field
and the parties shall conduct good faith negotiations relating
to such commercial applications.
1.4 CAT has obtained rights from Genetech Inc. relating to the
Cabilly patent. If a license to the Cabilly patent is
required for the performance of this Agreement, CAT will use
one of its options for a Cabilly license for anti-histone
antibodies, if this is the most cost-effective route for
obtaining such a license.
2. MANAGEMENT OF THE PROJECT
2.1 The parties shall establish a Business Committee and a
Scientific Committee, each of which shall comprise an equal
number of representatives (not exceeding three (3) in each
case) from each party.
2.2 The Business Committee:
(a) shall be responsible for the management of the
project, contemplated by this Agreement;
(b) shall decide, in consultation with the Scientific
Committee, which cell-lines shall be Designated
Cell-lines as soon as reasonably practicable after
TCLN has completed its evaluation of any such
cell-lines pursuant to sub-clause 3.2(a) below;
(c) in consultation with the Scientific Committee, shall
decide which Products (if any) shall be developed,
manufactured and/or licensed with a view to
commercial sale;
(d) shall be responsible for the timing and conduct of
third-party negotiations relating to licensing of or
other transactions connected with Products; and
(e) shall decide what if any intellectual property
protection should be sought for Improvements;
2.3 Any decision of the Business Committee shall be, if not
unanimous, by a majority.
2.4 If in the opinion of the Business Committee any Product would
benefit from intellectual property protection, the Business
Committee shall meet to review the most appropriate approach
to be taken to obtaining that protection.
2.5 The Scientific Committee shall act in an advisory capacity to
the Business Committee.
2.6 Either party may make substitutions to the membership of
either Committee on notice to the other.
8
4
2.7 Each Committee shall meet at least twice a year at locations
to be mutually agreed not less than thirty (30) days before
each meeting. Meetings shall be more frequent in
circumstances referred to elsewhere in this Agreement. Each
party shall bear the expenses associated with its own members'
attendance at any such meetings.
3. OBLIGATIONS OF THE PARTIES
3.1 CAT shall at its expense:
(a) use all reasonable endeavors to isolate human
Antibodies at least equivalent in terms of affinity
and specificity to the murine antibodies known as
TNT1, TNT2 and TNT3;
(b) within two (2) years of the Effective Date use all
reasonable endeavors to construct mammalian
cell-line(s) suitable for the production of human
antibodies (if any) isolated pursuant to sub-clause
3.1(a) above;
(c) supply to TCLN cell-lines constructed pursuant to
sub-clause 3.1(b) above; and
(d) provide the Business Committee with any information
it may reasonably request to assist in evaluation of
any cell-line for designation as a Designated
Cell-line.
3.2 TCLN shall at its expense as soon as reasonably practicable
after the provision of any cell-line to it by CAT:
(a) evaluate that cell-line as a candidate for a
Designated Cell-line and provide the Business
Committee with any information it may reasonably
request to assist in evaluation of any cell-line for
designation as a Designated Cell-line;
(b) within one (1) year of the designation of any
cell-line as a Designated Cell-line develop
manufacturing process(es) in eukaryotic cells from
such Designated Cell-lines; and
(c) manufacture sufficient quantities of human Antibodies
from Designated Cell-lines to allow toxicological
testing and the performance of Phase I and Phase II
clinical trials.
3.3 If CAT and TCLN agree to develop any Product through Phase III
clinical trials, then TCLN agrees to manufacture and supply
sufficient quantities of Product for the Phase III clinical
trials at its Direct Cost. CAT and TCLN agree to fund TCLN's
Direct Cost in the same percentage as their percentage of
ownership.
3.4 Any Designated Cell-line will have a specific production rate
of at least ten (10) picograms per cell per day determined in
a standard assay.
3.5 Both parties shall fund fifty percent (50%) each of the cost
of external work necessary for the performance of this
Agreement, such work to include (without limitation) the cost
of any necessary work to be done in Xx Xxxx Xxxxxxx'x
9
5
laboratory in connection with the Field and clinical trials as
decided by the Business Committee.
3.6 Both parties shall prosecute and maintain protection for the
Intellectual Property for which it is responsible and each
party shall bear fifty percent (50%) of the cost of applying
for and maintaining any intellectual property protection in
relation to Improvements.
4. MANUFACTURING OF PRODUCTS
4.1 TCLN shall have and retain the manufacturing rights for
Products in mammalian cells. TCLN shall at its expense make
all necessary arrangements to allow it so to manufacture
Products, including without limitation obtaining any necessary
licenses required from third parties.
4.2 In the absence of prior express written agreement,
manufacturing costs for each Product shall be the greater of
(i) a minimum of twenty-three percent (23%) of the Net Selling
Price of the relevant Product, including any royalties payable
to third parties to allow manufacture of Products by TCLN, or
(ii) the average of the industry standard for similar
products.
4.3 Notwithstanding anything else contained in this Agreement,
TCLN shall lose manufacturing rights if a third party is able
to commit, prior to Phase III clinical trials, to
manufacturing for less than or equal to half the cost of
TCLN's cost of manufacture of the relevant Product and TCLN is
unwilling to meet such commitment.
4.4 TCLN shall be solely liable for any and all claims which arise
from manufacturing of the Product. Except for its liability
as a manufacturer, TCLN shall be jointly liable with CAT for
any claims arising from the Products. Such liability shall be
in proportion to TCLN's interest in this venture. TCLN shall
maintain appropriate product liability insurance in relation
to the Products and shall make such policy of insurance
available to CAT for inspection on request.
4.5 If any Product requires manufacture in non-mammalian cells,
the parties shall each fund fifty percent (50%) of the cost of
development of processes and manufacture. Neither party shall
have manufacturing rights in these circumstances.
5. OWNERSHIP OF PRODUCTS AND REVENUE SHARING
5.1 Except for TCLN's right to manufacture the Products, each
party shall own a fifty-percent (50%) share of each Product,
it being agreed that the contributions of the parties under
clause 3 above are of equivalent value.
5.2 If in the opinion of either party any Product is patentable,
that party shall notify the other of its opinion. The parties
shall then meet to agree the appropriate course of action in
relation to that Product.
10
6
5.3 If either party decides to sell, grant an exclusive license or
otherwise transfer their ownership of the Product, then, prior
to any such transfer, the party proposing to transfer
ownership (the "Transferring Party") must offer the other
party to this Agreement (the "Non-Transferring Party") the
right to acquire the ownership of the Product at the same
price and on the same terms and conditions as the Transferring
Party as have been offered by the Transferring Party to a
third party transferee (the "Third Party Transferee"). If the
Non-Transferring Party and the Third Party Transferee decline
to accept such offer and the Transferring Party changes the
price or the terms of such offer, then the Transferring Party
shall again offer the Non- Transferring Party the right to
purchase the ownership of the Product at the price and on the
same terms and conditions as the Transferring Party is now
offering.
5.4 After the obligations referred to in clause 3 above have been
satisfied, if either party during Phase I and Phase II
clinical trials declines or is unable to continue to
contribute to the development of a Product ("the Declining
Party"), then except for TCLN's manufacturing rights, the
other party shall own the development and/or sale of the
relevant Product ("Ownership Party") and the Declining Party
shall be deemed to have granted any necessary licenses or
other intellectual property rights as may be required by the
other party.
5.5 The Ownership Party must use its most reasonable business
efforts to develop the Product. If the Ownership Party fails
to use its most reasonable business efforts to develop the
Product or discontinues developing the Product, the Declining
Party will have its ownership of the Product reinstated in the
proportion that the Declining Party's financial contribution
to the development of the specific Product bears from time to
time to the total financial contribution made by both parties
to the development of the specific Product.
5.6 The revenue sharing percentage of the Declining Party in
relation to specific Products shall, for the balance of the
duration of this Agreement, be reduced pro-rata to the
proportion that the Declining Party's financial contribution
to the development of the specific Product bears from time to
time to the total financial contribution made by both parties
to the development of the specific Product; provided, however,
that the revenue sharing percentage shall not be reduced to
less than twenty-five percent (25%) of what it would have
otherwise been.
5.7 Except as provided for in sub-clause 5.8 below, both parties
shall share equally in any revenues (including without
limitation sales revenues and licensing fees) generated by any
Products.
5.8 In the event that TCLN is manufacturing the Product(s), CAT
shall be entitled to receive and/or retain Net Royalties to
the extent of five percent (5%) of the Net Selling Price of
any Product(s). TCLN shall be entitled to receive and/or
retain Net Royalties in excess of five percent (5%) of the Net
Selling Price of any Product(s) and up to ten percent (10%) of
the Net Selling Price of any Product(s). The parties shall
share equally Net Royalties in excess of ten percent (10%) of
the Net Selling Price of Product(s).
11
7
5.9 The parties shall account to each other within thirty (30)
days of 31 December and 30 June in each calendar year
beginning with the calendar year of the first receipts
pursuant to sub-clause 5.7 or 5.8 above (as the case may be)
by either party and, if either party owes any revenue share to
the other, such amount shall be paid within thirty (30) days
of the accounts referred to in this sub-clause having been
rendered by both parties.
5.10 Either party may, not more than once in each calendar year in
which accounts are rendered pursuant to sub-clause 5.9 above,
have audited at a mutually convenient time by an independent
accountant bound by acceptable provisions as to
confidentiality, the books of account and records kept by the
other party in relation to revenues receivable contemplated by
this Agreement. Should any adjustment be found to be
necessary, the sum due shall be remitted by the appropriate
party within thirty (30) days of the conclusion of the
relevant audit.
5.11 In the event that either party to this Agreement desires to
acquire the marketing rights, such party shall make an offer
to this venture to obtain such marketing rights. The offer
shall contain the terms, conditions and consideration offered
by the offering party to obtain the marketing rights. Upon
the joint venture receiving this offer, the parties hereto
agree that the non-offering party is afforded the right to
obtain the marketing rights pursuant to the terms, conditions
and for the consideration offered by the other party. If the
non-offering party declines to obtain the marketing rights,
then the offering party may obtain the marketing rights from
this venture on the terms, conditions and for the
consideration proposed.
6. PROVISIONS RELATING TO INTELLECTUAL PROPERTY
6.1 During the term of this Agreement, neither party shall work
with any third party on the subject-manner of this Agreement,
nor shall it make available to any third party any license
relating to the Field without the express prior written
consent of the other.
6.2 If either party becomes aware that any intellectual property
rights relating to the Intellectual Property are being
infringed by a third party, that party shall inform the
Business Committee accordingly. The Business Committee shall
meet as soon as possible to review what action should be taken
in respect of such infringement.
7. CONFIDENTIALITY AND PUBLICITY
7.1 Each party undertakes to treat any and all confidential
information communicated to it by the other party as strictly
confidential and not to divulge it to any third party for any
purpose whatsoever and not to make use of such information or
any part of it for any purpose other than for the performance
of this Agreement.
7.2 The undertakings in sub-clause 7.1 above shall not apply to:
12
8
(a) information that at the time of disclosure is
published or otherwise generally available to the
public;
(b) information which after disclosure by the discloser
is published or otherwise becomes generally available
to the public, otherwise than through any act or
omission on the part of the recipient;
(c) information that the recipient can show was in its
possession at the time of disclosure and which was
not acquired directly or indirectly from the
discloser; or
(d) information rightly acquired from others who did not
obtain it under a pledge of secrecy to the discloser.
7.3 Except as required by law, neither party may disclose the
terms of this Agreement without the prior written consent of
the other, such consent not to be unreasonably withheld.
Either party shall have the right to issue a press release or
other public statement concerning this Agreement provided that
the content of such release or statement has first been agreed
by the other party, such agreement not to be unreasonably
withheld or delayed.
8. DURATION AND TERMINATION
8.1 Unless terminated earlier in accordance with any of the other
provisions of this clause 8, this Agreement shall expire with
the last to expire of the Techniclone Patents or any patents
relating to Improvements or fifteen years from the Effective
Date, which ever is the latest.
8.2 Either party may terminate this Agreement immediately on
notice to the other if the other party is in irremediable
breach of any of the provisions of this Agreement or, if the
breach can be remedied, it is not remedied within thirty (30)
days after the giving of notice to remedy.
8.3 Either party may terminate this Agreement on notice to the
other if the other goes into administration, receivership or
liquidation (or any analogous proceedings in the appropriate
jurisdiction) other than liquidation for the purposes of
reconstruction or amalgamation.
8.4 Termination of this Agreement shall be without prejudice to
any rights or either party that have accrued prior to such
termination.
9. GENERAL PROVISIONS
9.1 Any notices to be given under this Agreement shall be in
writing and shall be delivered in person, by first class
registered mail or by facsimile. Notices delivered in person
shall be effective on receipt, by mail seven days after
posting and by facsimile, at the beginning of the working day
immediately following transmission.
9.2 The waiver of any right by either party shall not constitute a
continuing waiver of the right waived.
13
9
9.3 This Agreement shall not be capable of assignment by either
party without the prior written consent of the other, except
that either party may assign this Agreement in whole or in
part to any purchaser of all or substantially all of its
assets or to any successor corporation resulting from any
merger or consolidation of such party with or into such
corporations.
9.4 Neither party shall be liable for failure to perform any of
its obligations under this Agreement if such failure is due to
circumstances beyond that party's control. Performance of any
such obligation shall be suspended for the duration of the
circumstances beyond that party's control, after which the
party affected shall be obliged to fulfil its obligations so
suspended.
9.5 If any provision of this Agreement is found to be invalid by a
court of competent jurisdiction, the remaining provisions
shall continue to be fully effective.
9.6 The parties shall attempt to resolve any dispute or difference
between them arising out of this Agreement by negotiation.
Should such attempted resolution be unsuccessful, the parties
agree to refer the dispute or difference to an alternative
dispute resolution procedure (including, without limitation,
mediation or arbitration) before having recourse to
litigation.
9.7 Clause headings are for ease of reference only and shall not
affect the interpretation of this Agreement.
9.8 This Agreement embodies the entire agreement between the
parties relating to the subject-matter covered by it.
9.9 This Agreement shall be governed by English Law.
IN WITNESS WHEREOF, the undersigned have executed this Agreement as of
February 5, 1996.
"TCLN" TECHNICLONE INTERNATIONAL CORPORATION
By: /s/ XXX XXXXX
---------------------------
Xxx Xxxxx
Its: President
"CAT" CAMBRIDGE ANTIBODY TECHNOLOGY LIMITED
By: /s/ XXXXX XXXXXXXX
---------------------------
Xxxxx Xxxxxxxx
Its: Chief Operating Officer
14
