Document:

Ex-4.14

 

Exhibit 4.14

*
Portions of this exhibit have been omitted pursuant to a request for
confidential treatment and have been filed separately
   with the
Commission.

ONCOGEL/GENEXOL

RESTATED LICENSE AND SUPPLY AGREEMENT

     Dated:
 JUNE 20th , 2006

 

 

TABLE OF CONTENTS

	 	 	 	 	 
	RECITALS
	 	 	1	 
	 
	 	 	 	 
	Section 1 Definitions 
	 	 	2	 
	Section 2 Product and Trademark License
	 	 	4	 
	Section 3 Royalties
	 	 	4	 
	Section 4 Accounting Records
	 	 	6	 
	Section 5 Product Development and Marketing
	 	 	6	 
	Section 6 Genexol Supply
	 	 	8	 
	Section 7 Technology Ownership and Maintenance
	 	 	12	 
	Section 8 Representations and Warranties of MacroMed
	 	 	12	 
	Section 9 Representations and Warranties of Genex
	 	 	12	 
	Section 10 Indemnification and Insurance
	 	 	13	 
	Section 11 Infringement
	 	 	14	 
	Section 12 Confidentiality
	 	 	15	 
	Section 13 Effective Date, Term and Termination
	 	 	16	 
	Section 14 Miscellaneous Provisions
	 	 	17	 
	14.1 Force Majeure
	 	 	17	 
	14.2 Entire Agreement
	 	 	17	 
	14.3 R&D Agreement
	 	 	17	 
	14.4 Parties Independent
	 	 	17	 
	14.5 Severability
	 	 	17	 
	14.6 Governing Law
	 	 	17	 
	14.7 Assignment and Business Combination
	 	 	18	 
	14.8 Waivers and Amendments
	 	 	18	 
	14.9 Arbitration
	 	 	18	 
	14.10 Notices
	 	 	18	 
	14.11 Implementation
	 	 	19	 
	14.12 Parties’ Rights and Duties in Bankruptcy
	 	 	19	 
	14.13 Counterparts/Facsimile or Email Signatures
	 	 	19	 

 

 

ONCOGEL/GENEXOL

RESTATED LICENSE AND SUPPLY AGREEMENT

     This RESTATED LICENSE AND SUPPLY AGREEMENT (hereinafter the “Restated
Agreement”) is made and entered into                     , 2006 (the “Restated
Agreement Date”), intended to be effective retroactively to November 23, 2001, by and between
SAMYANG GENEX CORPORATION (“Genex”), a Korean corporation, having its principal place of business
at 263 Yeonji-dong, Chongno-gu, Seoul, Korea, and MACROMED, INC. (“MacroMed”), a Utah corporation,
having its principal place of business at 9520 South State Street, Sandy, Utah 84070, U.S.A. This
Restated Agreement amends, restates, and supersedes, in its entirety, that certain OncoGel/Genexol
License and Supply Agreement dated November 23, 2001 (the “Original Agreement”).

     Each of the parties is referred to herein sometimes individually as a “Party” and
collectively as the “Parties.”

RECITALS:

     A. MacroMed and Genex entered into a Research and Development Agreement dated February 1,
1998 (the “R&D Agreement”) which, among other things,
established the terms of certain license rights to develop, manufacture, and market OncoGel® (the “Product”);

     B. Also on February 1, 1998, the Parties entered into an Equity Investment Agreement (the
“Equity Investment Agreement”), pursuant to which Genex has invested sums in MacroMed in exchange
for shares of MacroMed Common Stock;

     C. MacroMed and Genex have previously performed their respective obligations under the R&D
Agreement, as amended, and under the Equity Investment Agreement, as amended;

     D. Effective November 23, 2001, the Parties entered into the Original Agreement, which
provided, among other things, for a license from MacroMed to Genex of certain development,
manufacturing and marketing rights, an agreement by Genex to supply Genex’s paclitaxel product,
Genexol, to MacroMed, and an agreement by each Party to make certain royalty payments to the other
Party;

     E. The Parties desire to amend and restate the Original Agreement in its entirety, as provided
herein; and

     F. The consideration for the Parties’ willingness to enter into and perform this Restated
Agreement includes, without limitation: (1) the covenants, terms, and conditions contained herein,
(2) the covenants, terms, and conditions contained in the Original Agreement, (3) the covenants,
terms, payments, and conditions set forth in and previously paid and performed pursuant to the R&D
Agreement, as amended; and (4) the covenants, terms, payments, and conditions set forth in and
previously paid and performed pursuant to the Equity Investment

1

 

Agreement, as amended; and (5) all other consideration and benefits provided by either
Party to the other Party prior to the Restated Agreement Date.

NOW, THEREFORE, for the consideration described in Recital F above, the Parties agree as follows:

Section 1 Definitions

     For all purposes of this Restated Agreement, the following terms have the respective
meanings described:

     “Affiliate” means, for any Party, any other person or entity that directly or
indirectly controls, is controlled by (such as, for example, a subsidiary) or is under common
control with, that Party.

     “Business Combination” means a business combination in any form involving a Party,
including without limitation:

     (a) a lease, exchange, or sale of all or substantially all of the Party’s assets;

     (b) a merger or consolidation;

     (c) a sale or exchange of a controlling interest in the Party’s capital stock; or

     (d) a lease, exchange, or sale of all or substantially all of the assets of an
entity controlled by the Party.

     “Confidential Information” of each Party means information relating to the
technologies, products, services, business, personnel, research, development, manufacturing, or
commercial activities of each Party including, but not limited to, the Product and Genexol and any
associated data directly related thereto received by MacroMed from Genex for use in furtherance of
the Project and any associated data directly related thereto received by Genex from MacroMed for
use in furtherance of the Project; formulae; compilations; programs; devices; concepts; tests;
results; designs; methods; techniques; marketing; advertising; and commercial strategy, processes,
data, concepts, and know-how; and unique combinations of separate items which individually may or
may not be confidential, which information is not generally known to the public.

     “GMP-grade Genexol” means Genexol that has been approved for sale in one or more
territories regulated by either FDA or EMEA

     “GMP list price” means offer price of Genexol for territories regulated by either FDA
or EMEA

     “Designated Territory One” means North and South Korea.

2

 

     “Designated Territory Two” means the entire world excluding North and South
Korea.

     “Effective Date” means November 23, 2001.

     “EMEA” means the European Agency for the Evaluation of Medicinal Products.

     “FDA” means the U.S. Food and Drug Administration.

     “Five-Year Special Supply Period” has the meaning set forth in Section 6.3 below.

     “Genexol” means paclitaxel produced by Genex under the trademark Genexol®.

     “Licensed Patents” means all patents owned or licensed by MacroMed having any claim that
covers or reads on or is related to the Product, and any continuations and continuations-in-part,
divisions, reissues and/or reexamination certificates thereof.

     “License Waiver” has the meaning set forth in-Section 2.3 below.

     “Net Sales” means the gross amount invoiced by each Party and its subsidiaries and
Affiliates for the Product, less each and all of the following: normal and customary trade
discounts; quantity and cash discounts; rebates; and credits and allowances granted on account of
price adjustments, billing errors, and the rejection and return of goods. No tax will be deducted
in arriving at Net Sales.

     “Product” means the OncoGel® product, MacroMed’s proprietary formulation of
paclitaxel utilizing the ReGel® technology, and any variation or derivation thereof.

     “Project” means the activities related to research, development, manufacture,
and marketing of the Product subject to the terms and conditions of this Restated Agreement.

     “Restated Agreement Date” means the date first shown above.

     “Technology” means all Confidential Information relating to the development,
manufacture, use, and sale of the Products which MacroMed possessed as of the Effective Date and
any improvements or modifications thereof to be developed by MacroMed during the term of this
Restated Agreement.

     “ Third Party” means any third party that is not an Affiliate.

     “Third Party Revenues” means the gross revenues received by a Party from a license or
sublicense of the Product or any Licensed Patent to a Third Party including, but not limited,
royalty revenues, milestone payments, license fees, and sublicense fees.

     “Trademark” means the trademark OncoGel® and all derivations thereof.

3

 

Section 2 Product and Trademark License

     2.1 During the term stated in Section 13.1(a) below, MacroMed grants to Genex an
exclusive, irrevocable right and license under the Licensed Patents and the Technology to use,
market, sell, offer for sale, import, and otherwise distribute the Product in Designated Territory
One, including the right to sublicense these rights in Designated Territory One. The
consideration for this license is the covenant by Genex to pay royalties under Section 3.1 below.
During the term of the license under this Section 2.1, MacroMed shall have no right to market,
sell, or offer for sale Product directly, or indirectly through any distributor or other party, in
Designated Territory One.

     2.2 MacroMed retains all rights in the Product in Designated Territory Two.

     2.3 Subject to the prior mutual, written agreement of the Parties, Genex shall waive its
exclusive license granted under Section 2.1 in the event that a worldwide license agreement
relating to the Product and the Licensed Patents is entered into between MacroMed and a Third Party
(the “License Waiver”).

     2.4 MacroMed shall supply Genex with all necessary information in its possession that is
required for Genex to achieve regulatory approval of the Product in Territory One. MacroMed shall
supply to Genex any improvements and modifications of the Product within fifteen (15) days of the
date of any such improvement or modification.

     2.5 For the duration of the license granted under Section 2.1, Genex shall also have the
exclusive right and license to advertise, market and sell Product by, package Product under, and
otherwise use, the Trademark, within Designated Territory One, including the right to sublicense
these rights in Designated Territory One. The consideration for this license is the covenant by
Genex to pay royalties under Section 3.1 below. Genex may (but will not be obligated to) file for
trademark protection for the Trademark within Designated Territory One. However, ownership of and
title to the Trademark will remain in MacroMed. Genex may also choose, in its discretion, to market
and sell the Product under a different trademark than the Trademark. MacroMed shall have the right
to review and approve all advertising, marketing materials, promotional materials, packaging,
labeling and all other materials related to the Product that will be presented to Third Parties and
to the public due to product regulatory compliance, FDA compliance and legal liability issues.
MacroMed will not withhold its consent or approval unreasonably.

Section 3 Royalties

     3.1 Genex shall pay to MacroMed: (a) a royalty of 5% of Net Sales of the Product in
Designated Territory One by Genex and its Affiliates; and (b) 12% of all Third Party Revenues
received with respect to Designated Territory One by Genex and its Affiliates.

4

 

     3.2 MacroMed shall pay to Genex: (a) a royalty of 5% of Net Sales of the Product in
Designated Territory Two by MacroMed and its Affiliates; and (b) 12% of all Third Party
Revenues with respect to all or any portion of Designated Territory Two by MacroMed and its
Affiliates, including without limitation all license fees received before or after the
Restated Agreement Date by MacroMed from any licensee or its Affiliate (including without
limitation Diatos, S.A., a French corporation and its Affiliates), which license fees the
parties hereby agree constitute “Third Party Revenues”).

     3.3 In the case of a License Waiver by Genex under Section 2.3 above, MacroMed shall pay
to Genex a royalty equal to *% of all Third Party Revenues received by MacroMed or its
Affiliate solely with respect to Designated Territory One.

     3.4
Royalties owed by Genex under Section 3.1(a) shall be payable to MacroMed from *. Royalties owed by
MacroMed under Section 3.2(a) shall be payable to Genex from the
*. Royalties owed under Sections 3.1(a) and 3.2(a) shall
be payable * from the first calendar quarter in which commercial sales begin, within
* of the end of each quarter in which the royalties are earned.

     3.5 Payment of Third Party Revenues owed by Genex under Section 3.1(b) shall be payable
within 45 days after the date of receipt of payment by Genex or its Affiliate. Payment of
Third Party Revenues owed by MacroMed under Section 3.2(b) shall be payable within 45 days
after the date of receipt of payment by MacroMed or its Affiliate. Regarding the payment of
Third Party Revenues owed by MacroMed under Section 3.2(b), it is understood that MacroMed
shall have the right to negotiate with Genex the timing and the form of payments that are due
before first commercial sale of the Product (e.g. payment in MacroMed common stock in lieu of
cash). Genex should not deny or refuse such a request unreasonably.

     3.6 Payment of Third Party Revenues owed by MacroMed under Section 3.3 shall be payable
to Genex within 45 days after the date of receipt of payment by MacroMed or its Affiliate.

     3.7
Royalty payments under Sections 3.1(a) and 3.2(a) shall be *% of the royalty rates
listed in Sections 3.1 (a) and 3.2(a) if the Product is sold in a country where there is not
valid patent protection for the Product, or upon expiration of a valid patent for the Product
in any country. For all purposes of this Agreement, an issued patent in any country shall be
presumed valid except to the extent a final, nonappealable decision and order by a court of
competent jurisdiction finds that it is not valid.

     3.8 All royalty payments between the Parties will be in U.S. dollars, except as provided
in Section 3.5 for payment of Third Party Revenues accrued by MacroMed prior to first
commercial sale.

* confidential treatment
requested

5

 

Section 4 Accounting Records

     4.1 At the time a Party (the “Royalty Paying Party”) pays royalties to the other Party
(the “Royalty Receiving Party”) pursuant to Section 3, the Royalty Paying Party shall render to the
Royalty Receiving Party a written statement of account regarding the Royalty Paying Party’s Net
Sales of the Product, and regarding Third Party Revenues on which royalties are payable under
Section 3, during the preceding calendar quarter. In addition, the Royalty Paying Party shall keep
accurate records and books of account showing the amount of royalties due to the Royalty Receiving
Party.

     4.2 The Royalty Paying Party agrees to permit an independent, certified public accountant
selected by the Royalty Receiving Party an adequate opportunity to inspect and audit the records
and books described in Section 4.1 and to make extracts of copies for the purpose of auditing the
same materials. The audit shall be limited to the records for the immediately preceding year of
such inspection. All expenses of any such inspection shall be borne by the Royalty Receiving Party;
provided, however, that the Royalty Paying Party shall pay for such inspection if such inspection
reveals that the royalty for the period audited was underpaid by *
percent (*%) or more.

     4.3 If as a result of such audit, it is established that there is any underpayment or
overpayment in the amount of royalties paid with respect to the period audited, adjustments thereto
will be made and the relevant Party shall make such compensating payment as may be necessary to
bring the royalties paid into compliance with Section 3 within thirty (30) days of receipt of the
report of such inspection. Interest at a rate equal to the prime rate (as published by the Wall
Street Journal online, www.bankrate.com/brm/ratewatch/leading-rates.asp, in effect as of the date
the payment was owed under Section 3) plus 200 points, shall also be paid on the underpayment or
overpayment sum from the date the payment was owed under Section 3 to the date the compensating
payment under this Section 4.3 is paid in full.

     4.4 The rights and obligations of the Parties under this Section 4 will survive
termination or cancellation of this Restated Agreement.

Section 5 Product Development and Marketing

     5.1 MacroMed shall be solely responsible, at MacroMed’s sole cost, to proceed in a
diligent and commercially reasonable manner to: (a) obtain all government and regulatory approvals
required for the sale of the Product in Designated Territory Two; and (b) commence marketing and
selling the Product in Designated Territory Two. MacroMed represents to Genex that currently
MacroMed is engaged in “Phase II clinical trials” for the Product in the U.S.A. MacroMed shall
also supply the Product to Genex in sufficient quantities to support any development for a price
negotiated by the Parties in good faith and commercialization (pricing and terms to be agreed upon)
efforts by Genex in Designated Territory One.

     5.2 Subject to the provisions of Sections 5.3 and 5.4 below, Genex shall be solely
responsible, at Genex’s sole cost, to proceed in a diligent and commercially reasonable manner

* confidential treatment requested

6

 

to: (a) obtain all government and regulatory approvals required for the sale of the Product in
Designated Territory One; and (b) commence marketing and selling the Product in Designated
Territory One.

     5.3 Genex has the exclusive right and obligation to develop the Product in Designated
Territory One at its own cost independently of the commercialization rights for the Product
granted to Genex in Section 2.1. However it is understood that Genex has the right to delay
the development until MacroMed provides Genex with its official, completed Phase II Clinical
Study Report for the FDA or the EMEA, which can be used by Genex for regulatory approval for
development in Territory One. Genex shall provide MacroMed within * of receipt of the
official, completed Phase II Clinical Study report for the FDA or the EMEA, a written
development plan for one indication for the Product. If Genex fails or is unwilling to provide
MacroMed with a development plan, without reason, all development rights of the Product return
to MacroMed with no further obligation for either parties to develop the product in Territory
One. In such a case Genex agrees to provide MacroMed with additional 5 kg of Genexol under the
conditions of Section 6.4.

     5.4
Genex shall provide to MacroMed a written plan, within * of Product regulatory
approval for sale by the FDA or the EMEA, for regulatory approval and commercialization in
Designated Territory One. Failure of Genex to provide such plan without reason shall
constitute a withdrawal of all Genex’s license rights of the Product in Section 2.1 and all
rights to Third Party Revenues under this Restated Agreement. However, it is agreed that Genex
shall have the right of Third Party Revenues up to the amount related to all Genex expenses
including but not limited to the original investment of USD 750,000; the Genexol price
subsidies; and any development costs. MacroMed agrees to pay on this amount an additional
interest at a rate, equal to the prime rate (as published by the Wall Street Journal online,
www.bankrate.com/brm/ratewatch/leading-rates.asp, in effect as of the date the payment is due)
plus *. Genex will provide such expenses to MacroMed and MacroMed shall not disagree
with these expenses unreasonably.

     5.5 Each Party shall keep the other Party fully informed of its efforts to obtain
government and regulatory approvals.

     5.6 In the case of a License Waiver under Section 2.3 above, Genex shall be excused of
its obligations and covenants under Sections 5.3 and 5.4 above.

     5.7 Unless and until Genex executes a License Waiver, Genex shall have the sole right and
discretion to determine pricing, marketing strategies, and other business strategies for the
Product in Designated Territory One. However, MacroMed shall have the right to review and
approve all advertising materials, marketing materials, promotional materials, packaging,
labeling and all other materials related to the Product that will be presented to Third
Parties and to the public due to product regulatory compliance, FDA compliance and legal
liability issues. MacroMed shall not withhold its approval unreasonably.

* confidential treatment requested

7

 

Section 6 Genexol Supply

     6.1 Genex will continue to provide to MacroMed pertinent and necessary data, procedures, and
information regarding Genexol in order to facilitate the development, manufacturing, and marketing
of the Product, including FDA and EMEA filings and quality, regulatory, and clinical data on
Genexol.

     6.2 The following terms and conditions apply to all commitments by Genex to supply Genexol to
MacroMed and shall supersede any inconsistent terms contained in any purchase order:

          (a) During the period specified in Section 6.5 below, MacroMed shall not incorporate, nor
permit to be incorporated, any Genexol supplied by Genex into any product other than the OncoGel®
Product. In addition, MacroMed shall not at any time incorporate, nor permit to be incorporated,
any Genexol supplied by Genex under Section 6.3 below, into any Product that is sold or marketed
for sale.

          (b) Genexol shall meet the specifications required by MacroMed as defined in Exhibit A
attached to and made a part of this Agreement by reference (the “Specifications”), which can be
modified upon mutual agreement by the Parties and each batch or shipment shall be accompanied by a
Certificate of Analysis.

          (c) During
the period specified in Section 6.5 below, MacroMed shall procure at least *% of
its requirements of paclitaxel for the Product from Genex unless Genex fails or is unable to
deliver MacroMed’s Specifications in volume or quality. Although MacroMed will attempt to procure
more than *% of its paclitaxel requirements from Genex, Genex acknowledges that MacroMed is
required by FDA to have a second source supplier of paclitaxel and that MacroMed will procure less
than *% of its paclitaxel requirements from such second source supplier, unless Genex is unable to
supply at least *% of MacroMed’s paclitaxel requirement or governmental regulations require
MacroMed to purchase more than *% of its paclitaxel requirement from its second source supplier.
Genex shall notify MacroMed as soon as it comes to Genex’s actual knowledge that Genex will fail or
be unable to supply the Genexol ordered by MacroMed. Genex shall reimburse MacroMed for losses or
expenses directly caused by any unreasonable delay in notifying MacroMed of Genex’s inability to
supply the requested Genexol to MacroMed.

          (d) Except as expressly permitted in this Agreement, MacroMed shall not supply or sell Genexol
supplied by Genex to any Third Party.

          (e) Within 60 days after the Restated Agreement Date, MacroMed will provide Genex with a
schedule of its Genexol requirements (under Sections 6.3, 6.4, and 6.5 below) for remainder of the
current calendar year. For each of the following calendar years MacroMed shall deliver to Genex a
forecast of MacroMed’s Genexol quantity requirements for each calendar year at least one full
calendar quarter prior to that calendar year. Each forecast required herein will be broken down
between Genexol needs under each of Sections 6.3 (free supply), 6.4 (discounted price), and 6.5
(list price) below. Genex shall notify MacroMed, within

* confidential treatment requested

8

 

45 days after receipt of the forecast, if such forecast exceeds Genex’s Genexol production
capacity for that calendar year.

          (f) MacroMed shall give Genex a periodic written purchase order for Genexol. Each purchase
order shall specify the quantity of Genexol being ordered under Sections 6.3 (free supply), 6.4
(discounted price), and 6.5 (list price), respectively. All orders for Genexol received by Genex
are subject to its acceptance in its sole and absolute discretion, and Genex shall have no
liability if it is unable to supply the Products for any reason, except as provided in Section
6.2(c). No purchase order shall be effective for any purpose until received and accepted in writing
by Genex. Notwithstanding the foregoing, if at any time MacroMed is in default with respect to any
of its covenants or obligations under this Restated Agreement, Genex reserves the right to refuse
orders for Genexol and to refuse to ship previously accepted orders.

          (g) All risk of loss shall pass from Genex to MacroMed at the time the Genexol batch is
delivered to the applicable airport as provided in Section 6.2(j) below. Five weeks shall be
allowed for delivery, subject to delays caused by customs, governmental regulations, and obtaining
regulatory approvals and certificates (including without limitation the “CITES” certification
required by the Convention on International Trade in Endangered Species of Wild Fauna and Flora).
All Genexol received by MacroMed will be deemed to be acceptable to and accepted by MacroMed unless
Genex receives from MacroMed a written notice of rejection of the shipment within ten (10) business
days after the applicable shipment is received by MacroMed. A shipment may be partially or wholly
rejected at any time if the Genexol received by MacroMed does not conform to the Specifications
defined in Section 6.2(b). In the event a shipment is partially or wholly rejected, upon MacroMed
written request, Genex shall provide to MacroMed the amount of Genexol that was rejected, or
reimbursement or credit of any funds that were previously paid by MacroMed for the rejected
shipment. In the event that Genex fails or is unable to provide Genexol within the time frame
requested, at the Specifications, or at the agreed upon cost, MacroMed shall have the right to
obtain paclitaxel on a batch by batch basis from a Third Party supplier

          (h) Genex shall have the right to review MacroMed’s records related to disposition of Genexol
at any time upon reasonable notice to MacroMed.

          (i) Genex shall provide MacroMed with first priority in the allocation of its Genexol
manufacturing capacity.

          (j) Genex shall deliver Genexol on a C.I.F. basis to the nearest international airport to
MacroMed’s site of Product formulation.

          (k) MacroMed shall be responsible, at its sole cost, for all import and customs clearance and
all import taxes and duties payable in the U.S.A. for the import of Genexol in the U.S.A.

          (l) Genex will package the Genexol in accordance with generally accepted specifications and
accompanied by all applicable quality and testing records, which shall be substantially in a form
acceptable for FDA and EMEA requirements.

9

 

          (m) MacroMed shall make payment on each Genex invoice within thirty (30) days following the
later of the date of the invoice or deemed approval of a Genexol shipment. MacroMed shall pay
interest, at a rate equal to the prime rate (as published by the Wall Street Journal online,
www.bankrate.com/brm/ratewatch/leadingrates.asp, in effect as of the date the invoice date) plus
* points, on any balance remaining unpaid at the end of the 30-day period until it is paid in
full. All payments will be in U.S. Dollars and will be paid by wire transfer in accordance with
written wiring instructions to be provided by Genex.

          (n) Upon termination of this Restated Agreement, regardless of the reason, Genex will have no
obligation to repurchase MacroMed’s inventory of Genexol.

          (o) MacroMed agrees to forward to Genex, upon Genex’s request, copies of records and official
documents required for credit approval by the Korean Government. Genex will treat all such
documents as Confidential Information.

     6.3
During the period commencing as of the Restated Agreement Date and ending * later
(the “* Special Supply Period”), Genex shall supply to MacroMed such reasonable quantities
of GMP-grade Genexol that meet Specifications, * as MacroMed may order, subject to the
limitations set forth below and subject to the terms and conditions of Section 6.2 above:

          (a) Genexol will be supplied under this Section 6.3 only for the limited purpose of being used
by MacroMed in conducting research and development, clinical development, and testing of the
Product until the first commercial sale of the Product in Designated Territory Two.

          (b) Quantities of Genexol to be supplied by Genex under this Section 6.3 will not exceed:

               (i) Genex’s production capacity; or

               (ii)
* kg in the aggregate.

     6.4
During the * Special Supply Period, Genex shall also supply to MacroMed such
reasonable quantities of GMP-grade Genexol that meet Specifications as MacroMed may order,
licensees, * (as described below), as set forth below and subject also to the
terms and conditions of Section 6.2 above:

          (a) Quantities of Genexol to be supplied by Genex under this Section 6.4 are only for use for
OncoGel under this license agreement and will not exceed:

               (i) Genex’s production capacity;

               (ii)
* kg in any one calendar year; or

* confidential treatment requested

10

 

               
(iii) * kg in the aggregate.

          (b) The calculation of the purchase price for the Genexol supplied under this Section 6.4
shall be based upon Genex’s then GMP list price or the average price of three quotes (the “Official
Market Price”) from independent Third Party suppliers, of paclitaxel (the “Suppliers”) obtained by
MacroMed and agreed by both parties in respect to production capacities of the Suppliers and the
technical specifications and quality of the Suppliers and their respective products, subject to
the terms and conditions of Section 6.2 above. The actual purchase price under Section 6.4 will be
the lower of the Genex’s then GMP list price or the Official
Market Price multiplied by *% (i.e.,
yielding a *% discount). However, in no event will the discounted purchase price under this
Section 6.4 be lower than U.S. $* per gram. In the event the Official Market Price decreases
below U.S. $* per gram, MacroMed shall have the right to renegotiate the purchase price. In the
event that Genex is unable or unwilling renegotiate the purchase price, MacroMed shall have the
right to obtain its requirements of paclitaxel on a batch by batch basis from alternative
suppliers.

     6.5 During the period commencing on the Restated Agreement Date and continuing through the end
of the last calendar quarter in which royalties accrue and are payable to Genex by MacroMed under
any provision of Section 3, Genex shall supply to MacroMed (in
addition to the * supply of
Genexol under Section 6.3 above and over and above quantities to be supplied under Section 6.4
above) such reasonable quantities of GMP-grade Genexol as MacroMed may order from time to time, at
the lower of * or the * (as defined in
Section 6.4) quotes obtained by MacroMed and agreed by both parties in respect to production
capacities of the Suppliers and quality of their Suppliers and their respective products, subject
to the terms and conditions of Section 6.2 above. Quantities of Genexol to be supplied by Genex
under this Section 6.5 will not exceed Genex’s production capacity.

     6.6 Product complaints will be handled as follows:

          (a) MacroMed shall promptly notify Genex in writing of any and all
complaints received relating to the Products. At any time MacroMed becomes aware of a claim or
allegation that a Product has caused or contributed to an injury, death or other loss, MacroMed
will give Genex prompt written notice thereof.

          (b) MacroMed shall maintain (and make available to Genex and its agents, for inspection upon
reasonable notice) records regarding all such Product complaints and other matters referenced in
Section 6.6(a) above, including without limitation (i) date of notice of complaint or other claim;
(ii) name, address, and telephone number of reporting or complaining person; (iii) lot number of
Product; (iv) customer name, address, and telephone number; (v) date and description of incident;
and (vi) other information as may be required by applicable law and regulations.

     6.7 Each Party shall at all times conduct its efforts and actions under this Restated
Agreement in strict compliance with all applicable laws and regulations and with the highest
commercial standards.

* confidential treatment requested

11

 

Section 7 Technology Ownership and Maintenance

     7.1 If a patentable invention is conceived or reduced to practice in the course of the
Project by one or more employees of MacroMed, Genex, or jointly by the Parties, as determined by
United States laws of inventorship, which invention is specifically related to the Product, such
invention shall be the sole property of MacroMed. However, MacroMed hereby grants to Genex, per
Section 2, a license and right to use such invention during the term of the license granted in this
Restated Agreement to Genex in Territory One under Section 2.1 above. Genex shall notify MacroMed
of any such invention of which a Genex employee is involved and shall see that appropriate
documents perfecting MacroMed’s ownership rights are executed by Genex and its employees. MacroMed
shall, at its option, file or cause to have filed a United States patent application covering such
invention as well as any corresponding foreign patent applications. MacroMed shall have title to
any such patent application(s) and to any patent(s) maturing therefrom, subject to the license
rights of Genex under this Restated Agreement.

     7.2 All expenses, including but not limited to attorney and other legal fees, associated with
the preparation, filing, prosecution, and maintenance of such patent applications or patents shall
be the sole responsibility of MacroMed, and MacroMed shall ensure that any and all issued patents
are maintained in force and in good standing through the payment of maintenance fees.

     7.3 If MacroMed declines to file either a United States or foreign patent application, the
claims of which would be inclusive of the Product as defined herein, MacroMed shall notify Genex
thereof and, at Genex’s option, Genex may file or cause to have filed such applications on
MacroMed’s behalf and assigned to MacroMed. Any expenses incurred by Genex in the filing,
prosecution, and maintenance of any patent applications or patents under this Section 7 shall be
credited against any royalties which may become payable to MacroMed by Genex relative to the
making, using, or selling of such Product or be payable by MacroMed in cash on demand, at Genex’s
option.

     7.4 Except as provided in this Agreement, neither Party has any right or license to use any
intellectual property whatsoever of the other Party.

Section 8 Representations and Warranties of MacroMed

MacroMed hereby represents and warrants to Genex as follows:

     8.1 MacroMed has the right (legal or equitable) to furnish and/or supply, and lawfully owns,
the Technology so that Genex shall receive all of the benefits as contemplated by this Restated
Agreement.

     8.2 MacroMed has no outstanding commitments or obligations, contractual or otherwise,
which would in anyway impede its ability and right to enter into this Restated Agreement
and/or fulfill any and all of its obligations hereunder.

12

 

     8.3 EXCEPT AS EXPRESSLY PROVIDED IN THIS RESTATED AGREEMENT,
MACROMED MAKES NO WARRANTIES, EXPRESS OR IMPLIED, AND HEREBY DISCLAIMS ALL WARRANTIES,
INCLUDING WITHOUT LIMITATION THE IMPLIED WARRANTIES OF MERCHANTABILITY, NONINFRINGEMENT,
AND FITNESS FOR A PARTICULAR PURPOSE. MACROMED MAKES NO REPRESENTATIONS OR WARRANTIES
WHATSOEVER IN THIS RESTATED AGREEMENT TO ANY PERSON OR ENTITY OTHER THAN GENEX.

Section 9 Representations and Warranties of Genex

Genex hereby represents, warrants, and covenants to MacroMed as follows:

     9.1 Genex will make commercially reasonable efforts to meet its supply obligations
under this Restated Agreement. However, MacroMed understands and acknowledges that Genex’s
production facility is still being developed, is still experimental, and has not been fully
validated by the FDA. In addition, Genex’s ability and capacity to supply could be
interrupted by a number of varied causes such as regulations, approvals or. technical
problems. Therefore Genex does not and will not guarantee its ability to continue to supply
Genexol under the provisions of this Restated Agreement.

     9.2 Genex has no outstanding commitments or obligations, contractual or otherwise,
which would in anyway impede its ability and right to enter into this Restated Agreement
and/or fulfill any and all of its obligations hereunder.

     9.3 This Restated Agreement, when executed, will constitute a valid and binding
contract of Genex.

     9.4 EXCEPT AS EXPRESSLY PROVIDED IN THIS RESTATED AGREEMENT, GENEX MAKES NO
WARRANTIES, EXPRESS OR IMPLIED, AND HEREBY DISCLAIMS ALL WARRANTIES, INCLUDING WITHOUT
LIMITATION THE IMPLIED WARRANTIES OF MERCHANTABILITY, NONINFRINGEMENT, AND FITNESS
FOR A PARTICULAR PURPOSE. GENEX MAKES NO REPRESENTATIONS OR WARRANTIES WHATSOEVER IN THIS
RESTATED AGREEMENT TO ANY PERSON OR ENTITY OTHER THAN MACROMED.

Section 10 Indemnification and Insurance

     10.1 Subject to the conditions and provisions of this section, each Party (the
“Indemnifying Party”) hereby agrees to indemnify, defend, and hold harmless the other
Party and its officers, directors, shareholders, employees, and agents (the “Indemnified
Parties”) from and against any and all losses, damages, claims, liabilities, and expenses
(including without limitation attorneys’ fees and costs), asserted against, resulting to,
imposed upon or incurred by any of the Indemnified Parties, directly or indirectly, by
reason of or resulting from: (a) any misrepresentation or breach of any representation or
warranty, or noncompliance with any conditions or other agreements, given or made by the
Indemnifying Party in this Restated

13

 

Agreement or in any document furnished by or on behalf of the Indemnifying Party under this
Restated Agreement; or (b) any negligent or intentional act or omission by the Indemnifying Party
or its officer, employee, or agent. MacroMed shall also indemnify the Genex Indemnified Parties
with respect to any product liability claim relating to the Product.

     10.2 One or more of the Indemnified Parties shall give written notice to the Indemnifying
Party promptly upon receipt by any of the Indemnified Parties of any such claim, loss, damage,
liability, and expense with respect to which indemnity is sought.

     10.3 IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY LOSS OF PROFITS, LOSS
OF BUSINESS, LOSS OF USE OR OF DATA, INTERRUPTION OF BUSINESS, OR FOR INDIRECT, SPECIAL,
INCIDENTAL, OR CONSEQUENTIAL DAMAGES OF ANY KIND, WHETHER UNDER THIS RESTATED AGREEMENT OR
OTHERWISE, EVEN IF EITHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

     10.4 For period specified in Section 6.5 above, MacroMed covenants and agrees to maintain with
a reputable insurance company standard products liability insurance, in a reasonable amount, with
Genex as an additional-named insured. MacroMed shall supply proof of such insurance to Genex from
time to time, as requested in writing by Genex.

     10.5 The rights, covenants, and obligations of the Parties under this Section 10 will survive
the termination or cancellation of this Agreement.

Section 11 Infringement

     11.1 If any claim, suit, action, or other proceeding shall be brought against Genex and/or
MacroMed involving any claim of patent infringement based on Genex’s permitted use of the
Technology or the Licensed Patents, the Party who comes to know the facts first shall give the
other Party prompt written notice of such claim, suit, action, or other proceeding and shall send
the other Party copies of all papers served in connection therewith. However, failure to give such
prompt notice will not relieve MacroMed of its duty herein to defend and indemnify. MacroMed shall,
at its own expense, assume the defense of any such claim, suit, action, or other proceeding and
shall indemnify Genex with respect to any loss or damage incurred by Genex in connection with such
claim, suit, action, or other proceeding. Genex shall cooperate with MacroMed in all reasonable
ways in the defense of such claim, suit, action, or proceeding; provided, however, that if MacroMed
fails to assume such defense, then, Genex shall be authorized to defend such claim, suit, action,
or other proceeding at MacroMed’s expense. In addition, even if MacroMed does properly assume such
defense, Genex may, at its discretion, retain its own counsel at its own expense.

     11.2 If any other person, during the term of this Restated Agreement, infringes any of the
Technology in Designated Territory One during the time Genex continues to hold the license granted
under Section 2.1, the Party learning of such infringement shall promptly notify the other thereof.
MacroMed shall have the option, at its own expense, of instituting and prosecuting a

14

 

claim, suit, action or other proceeding against such person for infringement, at its expense
and through counsel of its choice, in which case Genex shall cooperate with MacroMed in all reasonable
ways in the prosecution of such claim, suit, action, or other proceeding against such infringement
in Designated Territory One. If MacroMed gives up its right to prosecute such claim, suit, action,
or other proceeding, then Genex shall be authorized to prosecute such proceeding at MacroMed’s
expense.

     11.3 The rights, covenants, and obligations of the Parties under this Section 11 will
survive the termination or cancellation of this Restated Agreement.

Section 12 Confidentiality

     12.1 Except as otherwise expressly provided in this Restated Agreement, neither Party shall
disclose to any Third Party nor use for any purpose unrelated to the Project any Confidential
Information received from the other Party. Except as otherwise expressly provided in this Restated
Agreement, the Parties shall retain in confidence all Confidential Information generated pursuant
to the Project; provided, however, that such Confidential Information may be disclosed only insofar
as such disclosure is necessary to allow a Party to defend itself against litigation related to the
Project, to file and prosecute patent applications or to comply with governmental obligations. Such
obligations of confidentiality and non-use shall be waived as to information which (a) is in the
public domain; (b) comes into the public domain through no fault of the Party claiming waiver; (c)
was known to the Party claiming waiver prior to its disclosure by the other Party; or (d) is
disclosed by Genex to Third Party consultants who may be asked to assist Genex with the
evaluation of the Product within the scope of this Restated Agreement; provided that such Third
Party consultants will have agreed to obligations of confidentiality no less stringent than those
set forth above and that such Third Party’s use shall only be for the benefit of Genex. Said Third
Party consultants must not be competitors of MacroMed. Both Parties shall use their best efforts to
ensure that only those persons whose duties require them to possess any Confidential Information
provided by the other Party shall have access thereto and shall be obligated to treat the same as
confidential. Any such employee shall be subject to confidentiality arrangements no less stringent
than those contained in this Restated Agreement. The obligations of confidentiality in this Section
12.1 will survive the termination or cancellation of this Restated Agreement and shall expire the
earlier of ten (10) years after the termination of (x) Genex’s right to royalties and other payments
under Section 3 above or (y) the expiration of Genex’s license under Section 2.1 above.

     12.2 (a) Genex agrees to provide MacroMed the opportunity to review and will provide copies
of any proposed abstracts or manuscripts that include Product data generated during the Project and
under this Restated Agreement at least thirty (30) days prior to its intended submission for
publication and, at MacroMed’s request, shall delay submission for a period sufficient to permit
adequate steps to be taken to secure patent protection for any patentable subject matter referred
to therein. Unless mutually agreed in writing, Genex shall not be required to delay publication for
a period longer than sixty (60) days beyond the initial thirty (30)-day review period. MacroMed
shall take reasonable steps to secure such protection on inventions in accordance with the
provisions of Section 7. If such proposed publication contains

15

 

Confidential Information, such Confidential Information shall be removed if requested
in writing by MacroMed. Genex agrees that it has no right to publish any information related to the
Product gained under the Project without prior written approval from MacroMed.

          (b) MacroMed likewise agrees to provide Genex the opportunity to review and will provide
copies of any proposed abstracts or manuscripts that include Product data generated during the
Project and under this Restated Agreement at least thirty (30) days prior to its intended
submission for publication and, at Genex’s request, shall delay submission for a period sufficient
to permit adequate steps to be taken to secure patent protection for any patentable subject matter
referred to therein. Unless mutually agreed in writing, MacroMed shall not be required to delay
publication for a period longer than sixty (60) days beyond the initial thirty (30) day review
period. MacroMed shall take reasonable steps to secure such protection on inventions in accordance
with the provisions of Section 7. If such proposed publication contains Confidential Information,
such Confidential Information shall be removed if requested in writing by Genex. MacroMed agrees
that it has no right to publish any information related to the Product gained under the Project
without prior written approval from Genex.

Section 13 Effective Date, Term and Termination

     13.1 This Restated Agreement is intended to be effective retroactively to the Effective Date
and will continue in force as follows:

          (a) The license granted by MacroMed to Genex under Section 2 above shall continue until
expiration of the last of the Licensed Patents to expire; and

          (b) Genex’s rights to royalties and other payments under Section 3 above shall continue for so
long as MacroMed derives any revenue from the Product, paid according to Section 3.

          (c) MacroMed’s rights to royalties and other payments under Section 3 above shall continue for
so long as Genex derives any revenue from the Product, paid according to Section 3.

     13.2 This Restated Agreement may be terminated by written mutual agreement of the Parties, or
unilaterally due to material breach of this Restated Agreement; provided, that in the case of a
material breach, the Party which claims a breach must submit written notification to the other
Party which shall have sixty (60) days to remedy the breach. However, if the breach is a failure to
pay a monetary sum owed under this Restated Agreement, then the 60 days will be shortened to ten
(10) days. In addition, if the breach is a non-monetary breach and is of such a nature that the
breaching Party reasonably needs more than sixty (60) days to cure the breach, the breaching Party
will be given a reasonable, extended period in which to cure the breach provided the breaching
Party is working diligently to cure the breach.

16

 

     13.3 Termination shall not relieve either Party of any of its obligations, monetary
or otherwise, pursuant to this Restated Agreement which have accrued prior to the termination
of this Restated Agreement.

     13.4 Upon termination of this Restated Agreement, all obligations and rights of
the Parties other than obligations that have accrued prior to the termination of this
Restated Agreement, shall terminate forthwith, except as otherwise provided in various
provisions of this Restated Agreement. Sections 1, 10, 11, 12, 13.3, 13.4 and 14 shall
survive termination of this Restated Agreement.

Section 14 Miscellaneous Provisions

     14.1 Force Majeure. Neither Party shall be liable for any delay or
failure to perform any of its obligations under this Restated Agreement if and to the
extent such delay or failure is due to circumstances beyond the control of such Party
(whether or not foreseen or foreseeable), including but not limited to, fires, floods,
explosions, accidents, acts of God, declared and undeclared wars, terrorist acts, riots,
strikes, lockouts or other concerted acts of workmen, or any government act, omission,
regulation, license, order, or rule. The Parties shall exercise their best efforts during
or after such an event of force majeure to fulfill their respective obligations pursuant
to the Restated Agreement.

     14.2 Entire Agreement. This Restated Agreement amends, restates, and
supersedes in its entirety the Original Agreement. This Restated Agreement may be amended
or modified only by an instrument in writing duly executed and signed by authorized
officers of both Parties.

     14.3 R&D Agreement. The R&D Agreement was terminated by the Original
Agreement as of the Effective Date.

     14.4 Parties Independent. Except as agreed in this Restated Agreement, the
Parties are acting and shall act at all times independently and nothing contained in this
Restated Agreement shall be construed or implied to create an agency, partnership, or
fiduciary relationship between MacroMed and Genex. At no time shall any Party make
commitments or incur any charges or expenses for or in the name of the other Party.
Neither Party will have any power to act in behalf of or to bind the other Party in any
respect or for any purpose whatsoever.

     14.5 Severability. This Restated Agreement is divisible and separable. If
any provision of this Restated Agreement is held to be or becomes invalid, illegal or
unenforceable, such provision shall be reformed to approximate as nearly as possible the
intent of the Parties and shall remain valid and enforceable to the greatest extent
permitted by law.

     14.6 Governing Law. Subject to the arbitration provisions of Section 14.9
below, Genex hereby consents to the jurisdiction of the State of Utah in all matters
pertaining to this Restated Agreement. This Restated Agreement shall be deemed to have
been entered into and shall be construed and enforced in accordance with the laws of the
United States of America and the State of Utah.

17

 

     14.7 Assignment and Business Combination.

          (a) All covenants, rights, and obligations of the Parties under this Restated Agreement shall
survive any Business Combination involving either Party and shall under all circumstances be
binding upon and inure to the benefit of the Parties, their respective successors, and permitted
assigns.

          (b) In any Business Combination involving either Party, that Party will cause this Restated
Agreement and all liabilities, covenants, and obligations of that Party under this Restated
Agreement to be assumed fully by the acquiring entity in the Business Combination.

          (c) Notwithstanding the foregoing provisions of this Section 14.7, neither Party shall have
the right to assign any right, license, benefits, option, duty, obligation, or privilege under this
Restated Agreement without the prior written consent of the other Party, unless specifically
provided in this Restated Agreement. Such written consent will not be unreasonably withheld.

          (d) Any contract, assignment, or Business Combination entered into or consummated in
contravention of this Section 14.7 shall be void and of no force or effect and shall constitute a
material breach of this Agreement by the applicable Party.

          (e) For the purposes of this Restated Agreement, any Business Combination by either Party will
constitute an assignment by that Party.

     14.8 Waivers and Amendments. The failure of either Party to insist upon the
performance of any of the terms of this Restated Agreement or to exercise any right hereunder,
shall not be construed as a waiver or relinquishment of the future performance of any such term, or
the future exercise of such right. This Restated Agreement may be amended or modified and any of
the provisions hereof may be waived by the Parties only in writing.

     14.9 Arbitration. All disputes arising in connection with this Restated Agreement
shall be finally settled by arbitration at the Singapore International Arbitration Center under the
Rules of Conciliation and Arbitration of the International Chamber of Commerce by three (3)
arbitrators one selected by Genex, one selected by MacroMed, and the third selected jointly by the
two arbitrators. Any award of such arbitrators shall be, as between the Parties, final and entitled
to all of the protections and benefits of a final judgment. Any award of such arbitrators shall not
be reviewable or appealable to any court.

     14.10 Notices. Any notice or other communication required or permitted to be made or
given to either Party pursuant to this Restated Agreement shall be sufficiently made or given on
the date of receipt, if sent to such Party by certified or registered mail, or by facsimile with
the original sent by certified or registered mail, or by express courier, postage prepaid,
addressed as follows:

18

 

	 	 	 	 	 
	 

	 	If to MacroMed:
	 	MacroMed, Inc.
	 

	 	 	 	9520 South State Street
	 

	 	 	 	Sandy, Utah 84070
	 

	 	 	 	USA
	 

	 	 	 	Fax No.: (801) 565-8562
	 

	 	 	 	Attn: Business Development
	 
	 	 	 	 
	 

	 	If to Genex:
	 	Samyang Genex Corporation
	 

	 	 	 	263 Yeonji-Dong, Chongno-Gu
	 

	 	 	 	Seoul, Korea 110-725
	 

	 	 	 	Fax No.: (822) 740-7988
	 

	 	 	 	Attn: Bio Business Team

or to such other address as either Party shall designate by written notice, similarly given, to
the other Party.

     14.11 Implementation. Each of the Parties shall execute and deliver to, or cause
to be executed and delivered to, the other Party, such further instruments, or take such other
action, in good faith, as may reasonably be requested of it hereunder, to consummate more
effectively the transactions contemplated hereby.

     14.12 Parties’ Rights and Duties in Bankruptcy. The Parties acknowledge that their
respective rights and duties may be affected if either Party files for bankruptcy relief under
11 U.S.C. § 101, et seq. Therefore, the parties agree that the non-bankrupt Party may bring a
motion before a court of competent jurisdiction to shorten the time within which the debtor
Party may assume or reject this Restated Agreement under 11 U.S.C. § 365, and the parties agree
that 60 days is a reasonable period of time of election of an assumption or rejection of this
Restated Agreement by the debtor Party.

     14.13 Counterparts/Facsimile or Email Signatures. This Restated Agreement may be
executed in one or more counterparts, each of which when executed shall be deemed to be an
original but all of which taken together shall constitute one and the same agreement.
Signatures transmitted via facsimile or email (as a pdf file) will constitute original
signatures.

19

 

     IN WITNESS WHEREOF, the Parties have executed this Amended and Restated Agreement on the
dates shown below, intended to be effective retroactively to November 23, 2001.

	 	 	 	 	 	 	 
	 

For MacroMed, Inc.

	 	 	 	 

For Samyang Genex Corporation
	 	 
	 
	 	 	 	 	 	 
	/s/ Thomas Bergmann

	 	 	 	/s/ Ryang Kim	 	 
	 

	 	 	 	 	 	 
	Date

	 	 	 	Date	 	 
	 
	 	 	 	 	 	 
	06/20/06

	 	 	 	07/03/06	 	 
	 

	 	 	 	 	 	 
	Thomas Bergmann

	 	 	 	President and CEO	 	 
	President and CEO

	 	 	 	Samyang Genex Corporation	 	 
	MacroMed, Inc.
	 	 	 	 	 	 

20Ex-4.15

 

Exhibit 4.15

* Portions
of this exhibit have been omitted pursuant to a request for
confidential treatment and have been filed separately
   with the Commission.

Collaboration Agreement

Protherics Medicines Development Limited

and

Advanced In Vitro Cell Technologies S.L.

6 December 2006

 

 

CONTENTS

CONTENTS

	 	 	 	 	 	 	 
	CLAUSE	 	 	 	PAGE
	1.

	 	DEFINITIONS AND INTERPRETATION
	 	 	1	 
	2.

	 	COLLABORATION
	 	 	7	 
	3.

	 	ESCROW ACCOUNT
	 	 	8	 
	4.

	 	JOINT PROJECT TEAM
	 	 	10	 
	5.

	 	STEERING COMMITTEE
	 	 	12	 
	6.

	 	GENERAL MATTERS CONCERNING THE JOINT PROJECT TEAM AND THE STEERING COMMITTEE
	 	 	14	 
	7.

	 	LICENCE
	 	 	15	 
	8.

	 	DELIVERY OF KNOW-HOW
	 	 	15	 
	9.

	 	ROYALTIES AND MILESTONES
	 	 	16	 
	10.

	 	CONFIDENTIALITY
	 	 	18	 
	11.

	 	OWNERSHIP OF THE PATENTS AND KNOW-HOW
	 	 	19	 
	12.

	 	INFRINGEMENT
	 	 	20	 
	13.

	 	LIABILITY/INDEMNITY
	 	 	22	 
	14.

	 	WARRANTIES
	 	 	23	 
	15.

	 	TERM
	 	 	24	 
	16.

	 	TERMINATION
	 	 	24	 
	17.

	 	RIGHTS ON TERMINATION
	 	 	27	 
	18.

	 	FORCE MAJEURE
	 	 	27	 
	19.

	 	FURTHER ASSURANCE
	 	 	28	 
	20.

	 	ASSIGNMENT AND SUB-LICENSING
	 	 	28	 
	21.

	 	MISCELLANEOUS
	 	 	28	 
	22.

	 	NOTICES
	 	 	30	 
	23.

	 	DISPUTE RESOLUTION
	 	 	30	 
	24.

	 	GOVERNING LAW AND JURISDICTION
	 	 	31	 
	25.

	 	SUPPLY AGREEMENT
	 	 	31	 
	 
	 	 	 	 	 	 
	SCHEDULE	 	 	33	 
	Patent	 	 	33	 

 

 

THIS
AGREEMENT is made on 6 December 2006

BETWEEN:

	(1)	 	PROTHERICS MEDICINES DEVELOPMENT LIMITED (No. 19396431) whose registered office is at The
Heath Business and Technical Park, Runcorn, Cheshire WA7 4QF (“Protherics"); and

	(2)	 	ADVANCED IN VITRO CELL TECHNOLOGIES S.L. (No. ESB62520877) whose registered office is at the
Barcelona Scientific Park, Baldiri Reixac 10-12, Barcelona 08028 Barcelona, Spain
(“Advancell").

RECITAL

	(A)	 	Protherics is an integrated biopharmaceutical company focused on developing, manufacturing
and marketing critical care and medicinal products, seeking to use industry collaboration to
achieve its business goals and long-term growth.

	(B)	 	Protherics considers that it has the scientific, technical , personal, material and logistic
means necessary to assume and comply with its commitments in this agreement.

	(C)	 	Advancell is a biotechnology company, whose main activities are advanced research and the
commercialisation of products from cellular-growing systems and through tissue-engineering;
and the development of new therapies based on technologies acquired from the Spanish Academia.

	(D)	 	Advancell owns the Patents (as defined below) and other Intellectual Property Rights
pertaining to the use of the Product for the Indication (all as also defined below).

	(E)	 	The parties wish to undertake, or have undertaken, the Development Programme (as defined
below) to obtain relevant Health Registration Approvals (as defined below) for the
commercialisation by of for Protherics of the Product, throughout the world, for the
Indication.

	(F)	 	The parties wish for Protherics to have all rights it may require for the purpose of
developing, commercialising and otherwise exploiting the Product, world-wide, as so described,
to which end Advancell will grant to Protherics all necessary licences.

THE PARTIES AGREE AS FOLLOWS:

	1.	 	DEFINITIONS AND INTERPRETATION

	1.1	 	Definitions
	 
	 	 	In this agreement, unless the context otherwise requires:
	 
	 	 	“Acadesine” means
5-aminoimidazole-4-carboxamide-1-b-D-ribofuranoside, CAS number:
2627-69-2;
	 
	 	 	“Affiliate” means any business entity which, from time to time, controls, is controlled by,
or is under common control of either party; and, for the purposes of this definition, a
business entity will be deemed to “control” another business entity if it owns, directly or
indirectly, in excess of fifty (50) per cent. of the outstanding voting securities or
capital stock of such business entity and has the right, directly or indirectly, to appoint
more than half of the members of the board of directors of such business entity, or owns,
directly or indirectly, any other comparable equity or ownership interest with respect to a
business entity other than a corporation;
	 
	 	 	“Claim” means any claim, counterclaim, suit, action or proceedings;

1

 

“Claiming Party” has the meaning given in clause 18.1;

“Clinical Studies” means those studies of the Product described as such in the Development
Programme, and “Clinical Study” means any of them;

“Confidential Information” means any confidential information disclosed to a party by, or
at the direction of, the other in connection with this agreement, regardless of form or
medium;

“Cost” means cost and expense of any nature whatsoever (including legal costs and
disbursements);

“Deductions” means applicable trade and cash discounts and (where such items are
specifically shown in the relevant invoice) purchase, applicable sales and import taxes,
Value Added Taxes, and the costs of delivery and insurance;

“Development Programme” means the manufacturing, non-clinical and clinical development and
studying of the Product undertaken further to this agreement, as determined pursuant to
clause 5.7(e) or 5.13;

“Disclosing Party” has the meaning given in clause 10.1;

“Dispute” means any dispute or controversy of whatever nature arising out of, or in any way
relating to, this agreement or its formation or Termination, including any Claim;

“Drug Product” means Product processed so as to be ready for human use;

“Effective Date” means the date of signature this agreement by the second party to sign;

“Encumbrance” means any licence, mortgage, charge (fixed or floating), pledge, lien,
hypothecation, trust, right of set off or other third party right or interest (legal or
equitable) including any right of pre-emption, assignment by way of security, reservation
of title or any other security interest of any kind however created or arising or any other
agreement or arrangement (including a sale and repurchase arrangement) having similar
effect, and “Encumber” will be construed accordingly;

“Entire Agreement” means this agreement, together with any other documents referred to in
it;

“Escrow Account” means an interest-bearing deposit account with the Escrow Account Bank;

“Escrow Account Bank” means Barclays Bank plc or such other bank or financial institution
as the parties may agree from time to time in writing;

“Event of Force Majeure” has the meaning given in clause 18.1;

“Export Control Laws” has the meaning given in clause 21.13;

“Field of Use” means any and all areas of human use of the Product;

“First Clinical Study” means the clinical study in which the Product is given, for the
first time, to human subjects, but not including any extensions of such study after the
first set of data derived from it have been analysed;

“First Commercial Sale” means, with respect to any country or territory, the first disposal
for value of any quantity of the Product for use in the Indication after the grant of

2

 

all Health Registration Approvals and Pricing Approvals in such country or territory, not
including any Named Patient Sale;

“Good Clinical Practice” means those principles, and the guidelines in line with those
principles, provided for in Commission Directive 2005/28/EC, and their equivalents anywhere
in the world;

“Good Manufacturing Practice” means those principles and guidelines provided for in
Commission Directive 2003/94/EC, and their equivalents anywhere in the world;

“Good Industry Practice” means the exercise of that degree of skill, diligence, prudence
and foresight which would reasonably and ordinarily be expected from a skilled and
experienced business seeking in good faith to comply with its contractual obligations and
engaged in the same type of undertaking, and under the same or similar circumstances and
conditions, as those envisaged by this agreement, including, as applicable, compliance with
Good Clinical Practice, Good Manufacturing Practice and Good Laboratory Practice;

“Good Laboratory Practice” means those rules and criteria applicable to Quality Assurance,
as are relevant in the circumstances, concerned with the organisational process and the
conditions under which non-clinical health and environmental safety studies are planned,
performed, monitored, recorded, reported and archived;

“Health Authority” means any applicable supra-national, national, federal, regional, state,
provincial or local agency, department, bureau, commission, council or other entity
regulating, or otherwise exercising authority with respect to, the development, testing,
manufacture, marketing or sale of pharmaceutical products;

“Health Registration Approval” means, with respect to a country or territory, any and all
approvals, licences, registrations or authorisations of any Health Authority necessary
lawfully to:

	 	(a)	 	distribute, sell and market the Product for the Indication in such country
or territory, including, where applicable, post-approval marketing authorisations,
labelling approvals and technical, medical and scientific licences and pricing or
reimbursement approvals; or
	 
	 	(b)	 	undertake clinical studies;

“Indemnify” means defend, indemnify and hold harmless;

“Indication” means the treatment of chronic lymphocytic leukaemia;

“Independent Valuer” means Christian Wagner of Bioscience Valuation BSV GmbH, registered in
Germany with its place of business at Am Zigeunerbergl 3, 82491 Grainau, Germany, or such
other person of comparable skill and experience as such company may designate;

“Indirect Loss” means any loss which would be recoverable only under the second limb of the
relevant test set out in Hadley -v- Baxendale (1854) 9 Ex.341, that is, such losses beyond
those arising naturally, but of a type as may reasonably be supposed to have been in the
contemplation of both parties, at the time they made the agreement, as the probable result
of the breach of it;

“Intellectual Property Rights” means any and all trade marks, domain names, rights in
designs, get-up, business names, database rights, copyrights, future copyrights, and
patents (whether registered or not and any applications to register or rights to apply for
registration of any of the foregoing), rights in inventions, know-how, trade secrets and

3

 

other confidential information, and all other intellectual property rights of a similar or
corresponding nature, which may now or in the future subsist in any part of the world;

“Joint Project Team” means the committee referred to by that name in clause 4, constituted
and having the functions and responsibilities specified therein;

“Know-how” means the technical information and data pertaining to the Product, including
such as arises from the Development Programme, in the possession, or under the control, of
Advancell, now or hereafter (including all biological, chemical, pharmacological,
toxicological, clinical, assay, control and manufacturing data and any other information
relating to the Product useful for the Development Programme, in each case to the extent
that the same is secret, substantial and identified);

“Law” means all (or the highest) statutory, common law, equitable governmental and
regulatory obligations in the relevant part of the world, including any order of a court of
competent jurisdiction or government department or agency or the rules and standards of any
recognised securities exchange (including the Listing Rules of the UK Listing Authority) or
the rules and requirements of any other regulatory body, including any Health Authority;
and any rules or requirements relating to export or import;

“Liable Party” has the meaning given in clause 13.6;

“Licence” means the rights and licences granted, or to be granted, to Protherics by clause
7;

“Licensor Information” has the meaning given in clause 10.2;

“Loss” means any losses or damages of any nature whatsoever, comprising:

	 	(a)	 	Indirect Loss; and
	 
	 	(b)	 	any loss which under English law would properly be considered as direct loss
or which does not constitute Indirect Loss;

“Marketing Authorisation” means any Health Registration Approval which is a marketing
authorisation for the purposes of Directive 2001/83/EC of the European Parliament and of
the Council (as amended), and any equivalent Health Registration Approval, including a
product licence having effect as such an authorisation and a parallel import licence;

“Named Patient Sale” means the lawful placing on the market, or distribution by way of
wholesale dealing, of the Product for which no Marketing Authorisation is in force in the
part of the world in which it is placed on the market or distributed by way of wholesale
dealing at the time of such placing on the market or distribution;

“Net Selling Price” means the gross receipts of Protherics, or its relevant Sub-Licensee,
as applicable, in cash or otherwise, in respect of any Royalty Event, less any Deductions;

“Non-claiming Party” has the meaning given in clause 18.2;

“Non-clinical Studies” means those studies of the Product described as such in the
Development Programme, and “Non-clinical Study” means any of them;

“Notifying Party” and “Notified Party” have the respective meanings given to them in clause
16.7;

“Orphan Drug” means a pharmaceutical product designated as such by the relevant Health
Authority;

4

 

“Orphan Drug Designation” means the designation of the Product as an Orphan Drug for the
Indication and the benefits of such designation conferred on its applicant;

“Patents” means:

	 	(a)	 	the patents and patent applications specified in schedule 1 and any patent
which may be granted pursuant to any such application;
	 
	 	(b)	 	any patent or application corresponding to any such patent or application
which may be granted or made; and
	 
	 	(c)	 	any re-issue, extension or restoration of any such patent, and any division
or continuation of any such application;

“Personnel” means the relevant party’s employees, agents and sub-contractors;

“Phase IIb Study means a study in patients designed to compare the safety and efficacy of a
range of dosing regimens of the Product, and which is not a Phase III Study;

“Phase III Study” means a large scale, pivotal, multi-centre, human clinical study to be
conducted in a number of patients estimated to be sufficient to establish efficacy of the
Product at a standard suitable to obtain a Health Registration Approval, or otherwise
intended to provide the substantial evidence of efficacy necessary to support an approvable
filing for a Health Registration Approval;

“Pricing Approvals” means pricing or reimbursement approvals in the relevant country or
territory;

“Product” means any injectable formulation of Acadesine developed prior to the Effective
Date;

“Project Manager” means, with respect to Protherics, Sally Waterman; and with respect to
Advancell, Clara Campàs, or such other persons as the relevant party may appoint by notice
in their place;

“Quality Assurance” means the sum total of the arrangements made with the object of
ensuring that products are of the quality required for their intended purpose;

“Quarter” means the period ending on 31 March, 30 June, 30 September and 31 December in
each year, and “Quarterly” will be construed accordingly;

“Receiving Party” has the meaning given in clause 10.1;

“Regulatory Documentation” means all applications, registrations, licences, authorisations
and approvals relating to the use of the Product for the Indication;

“Relevant Technology or Products” has the meaning given in clause 21.13;

“Retention” means the sum for the time being standing to the credit of the Escrow Account,
together with interest which accrues thereon, or so much thereof as remains subject to the
provisions of clause 3 from time to time;

“Royalty Event” means any sale of the Product (including a Named Patient Sale, and
regardless of the location of the sale and the identity of the Purchaser) for the
Indication by or on behalf of Protherics, or any of its Sub-licensees, to any third party,
provided that:

	 	(a)	 	if the third party is an Affiliate of Protherics, Royalty Event means the
first such sale of the Product to a third party which is not an Affiliate of
Protherics; and

5

 

	 	(b)	 	if, at the time of the sale by or on behalf of Protherics, its Sub-Licensee
or its Affiliate (as the case may be), the Product is not in the form of a Drug
Product, Royalty Event means the first such sale of the Product which is a Drug
Product;

“Senior Executives” means Barry Riley of Protherics and Luis Ruiz-Avila of Advancell, or
such other persons as the relevant party may appoint by notice in their place;

“Shared Costs” has the meaning given in clause 13.6;

“Steering Committee” means the committee referred to by that name in clause 5, constituted
and having the functions and responsibilities specified therein;

“Study” means any Clinical Study or Non-clinical Study;

“Sub-licence” means a sub-licence under the Licence, and “Sub-license” will be construed
accordingly;

“Sub-licensee” means the sub-licensee under any Sub-licence;

“Term” means the term of this agreement;

“Termination” means termination of this agreement, by either party, at any time on any
lawful ground, as well as expiry of this agreement;

“Valid Claim” means any claim of any Patent which:

	 	(a)	 	has not been held permanently revoked, unenforceable or invalid by a decision
of a court or governmental agency of competent jurisdiction, which decision is
unappealable or unappealed within the time allowed for appeal;
	 
	 	(b)	 	has not been abandoned, disclaimed, denied or admitted to be invalid or
unenforceable through re-issue, disclaimer or otherwise; and
	 
	 	(c)	 	with respect to a Patent which is a pending patent application, has not been
abandoned or finally disallowed without the possibility of appeal or re-filing of the
application; and

“Value Added Tax” means value added tax or any other tax of a similar nature that may be
substituted for or levied in addition to it in each case at the rate current from time to
time.

1.2 Interpretation

In this agreement, unless otherwise expressly specified, a reference to:

	 	(a)	 	“agreed” means agreed by the parties in writing;
	 
	 	(b)	 	“include” means include without limitation; and
	 
	 	(c)	 	a “third party” means any person other than the parties.

	1.3	 	Further Interpretation
	 
	 	 	In this agreement, unless otherwise expressly specified:

	 	(a)	 	the index to, and the headings in, this agreement are for information only
and are to be ignored in construing it;

6

 

	 	(b)	 	a reference to a statute or statutory instrument, or any of their
provisions, is to be construed as a reference to that statute or statutory
instrument, or such provision, as the same may have been or may after the Effective
Date be amended or re-enacted;
	 
	 	(c)	 	grammatical variants of terms defined in this clause 1 will bear their
corresponding meanings;
	 
	 	(d)	 	references to recitals, clauses, paragraphs or the schedule are to
recitals, clauses and paragraphs of, and the schedule to, this agreement. The
schedule forms part of the operative provisions of this agreement and references to
this agreement will, unless the context otherwise requires, include references to the
recitals and the schedule;
	 
	 	(e)	 	where a clause refers to a matter coming to a party’s “awareness” or
“attention” or to a similar effect, this will be taken as a reference to the state of
mind of the executive directors and officers holding such positions at the relevant
time;
	 
	 	(f)	 	where, in any provision or provisions, a general concept is followed by a
specific one, there will be no implication that the scope of the general concept is
to be narrowed as a result; and
	 
	 	(g)	 	words denoting the singular will include the plural and vice versa and
words denoting any gender will include all genders.

	2.	 	COLLABORATION
	 
	2.1	 	The parties will undertake, or have undertaken, the Development Programme, on the terms and
subject to the conditions of this agreement and as provided in the Development Programme.
	 
	2.2	 	In performance of their obligations pursuant to clause 2.1:

	 	(a)	 	Advancell will undertake, or have undertaken, the Non-clinical Studies
required to enable the proper conduct of the First Clinical Study of the Product for
the Indication, in accordance with the Development Programme;
	 
	 	(b)	 	Advancell will manufacture, or have manufactured, those quantities of the
Product required to enable the proper conduct, in accordance with the Development
Programme, of the First Clinical Study of the Product for the Indication; and
	 
	 	(c)	 	Protherics and Advancell will jointly undertake, or have undertaken, the
remainder of the Development Programme.

	2.3	 	The party responsible for the undertaking of any part of the Development Programme will
undertake it, or procure that it is undertaken:

	 	(a)	 	in accordance with

	 	(i)	 	all applicable Laws;
	 
	 	(i)	 	Good Industry Practice; and
	 
	 	(ii)	 	the requirements of all applicable Health Authorities; and

	 	(b)	 	otherwise with reasonable skill, care and attention,

7

 

	 	 	having regard to the objective of the Development Programme to obtain relevant Health
Registration Approvals for the commercialisation by or for Protherics of the Product,
throughout the world, for the Indication.
	 
	2.4	 	Subject to clause 2.6, Advancell will pay all Costs attributable to the undertaking of those
matters described in clause 2.2(a) and 2.2(b).
	 
	2.5	 	Subject to clause 2.6, the parties will share equally all third party Costs attributable to
the undertaking of those matters described in clause 2.2(c), including the costs of the
Acadesine required to manufacture the Product used in the Clinical Studies.
	 
	2.6	 	Where any Product manufactured to enable the First Clinical Study is not used in such
Clinical Study, the same shall be made available, where appropriate, for use otherwise in the
Development Programme, and Protherics shall not be liable for any of the Costs of, or
attributable to, manufacturing it or having it manufactured, which Costs shall be for
Advancell in accordance with clause 2.4.
	 
	2.7	 	Each party will, subject to any limits approved by the Steering Committee, provide such
assistance as the other reasonably requests in that other’s performance of its obligations
pursuant to this clause 2, and the reasonable Costs of such assistance will be borne as
provided in clauses 2.4 and 2.5.
	 
	2.8	 	Only Protherics will apply for, or hold, any Health Registration Approvals relating to the
use of the Product for the Indication, or any Regulatory Documentation, save:

	 	(a)	 	where Advancell is required by Law in the course of the Development
Programme to apply for and/or hold any of them; or
	 
	 	(b)	 	where the Development Programme provides that Advancell is to do so,

	 	 	in which case Advancell will assign the same to Protherics (or procure their assignment to
Protherics), including in accordance with clause 8.6, where applicable.
	 
	3.	 	ESCROW ACCOUNT
	 
	3.1	 	The parties will, as soon as reasonably practicable following the Effective Date, open the
Escrow Account as a joint account in their joint names for the sole purpose of receiving and
holding the Retention.
	 
	3.2	 	The debt owed to the parties by the Escrow Account Bank by virtue of its receipt and holding
of the Retention will be held by them on trust in equal shares on the terms set out in this
clause 3, and the parties will use all reasonable endeavours to procure that the Escrow
Account Bank designates the Escrow Account as a trustee account.
	 
	3.3	 	The monies making up the Retention will be kept separate from, and not co-mingled with, any
other monies (save for interest on the Retention).
	 
	3.4	 	All interest accruing on the Retention credited to the Escrow Account will belong to the
parties jointly and any sum of such interest to be paid to either party will be subject to
deduction of tax thereon or other amounts (if any) required by Law to be deducted in respect
of such sum.
	 
	3.5	 	Subject to clause 3.6, the division of Costs provided by clause 2.5 will be achieved by use
of the Escrow Account as follows:

	 	(a)	 	each party will notify the other, from time to time, of the anticipated,
applicable up-coming Costs attributable to the undertaking of any part of the
Development Programme for which it proposes to contract with any third party to pay
(including the Costs of purchasing relevant quantities of the Product and of
manufacturing

8

 

	 	 	 	the drug substance from which it is made), in advance of incurring them, and, in
each case, at the same time, will provide that other with its calculations or other
reasonable evidence thereof;
	 
	 	(b)	 	following any such notice, the parties will use their reasonable endeavours
to agree, as quickly as reasonably practicable, the appropriateness and acceptability
of such Costs;
	 
	 	(c)	 	within fifteen (15) days of reaching any such agreement, each party will
pay into the Escrow Account a sum equal to one-half of that specified in the relevant
notice given pursuant to clause 3.5(a) or as otherwise agreed pursuant to clause
3.5(b);
	 
	 	(d)	 	subject to clause 3.11, the notifying party will pay from the Retention
such of those Costs as arise;
	 
	 	(e)	 	the notified party will, from time to time, sign and deliver to the Escrow
Account Bank or the notifying party, as the notifying party directs, such bank
mandates as the notifying party may require for such purpose; and
	 
	 	(f)	 	the notified party will not unreasonably withhold or delay any signature
and/or action required to facilitate the making of any such payment.

	3.6	 	If Protherics grants any Sub-licence between the completion of the First Clinical Study
undertaken in the course of the Development Programme and the filing of the first application
for a Marketing Authorisation for the Product for the Indication, and Protherics receives from
its Sub-licensee thereunder any payment of any of its Costs of undertaking any of the matters
described in clause 2.2(c):

	 	(a)	 	Protherics shall pay the same into the Escrow Account;
	 
	 	(b)	 	such payment will belong to the parties in equal shares;
	 
	 	(c)	 	the parties shall, subject to clause 3.12, use such payment only to pay
Costs actually incurred in undertaking any of the matters described in clause 2.2(c);
and
	 
	 	(d)	 	the parties shall not so use, or commit so to use, the same in advance of
agreeing such Costs pursuant to clause 3.5(b).

	3.7	 	Each party will act reasonably in trying to minimise (having regard to its obligations
hereunder) and in calculating any Costs notified by it to the other pursuant to clause 3.5(a)
and will, where appropriate and practicable, base such calculations on estimates provided to
it by such third parties (including clinical research organisations) as it may be considering
contracting to conduct the relevant part(s) of the Development Programme or purchase Product.
	 
	3.8	 	Without limitation, any Dispute between the parties concerning the calculation,
appropriateness or acceptability of any anticipated up-coming Cost notified by either party to
the other pursuant to clause 3.5(a) shall be referred for resolution as provided in clause 23.
	 
	3.9	 	Should either party, acting reasonably, consider that the Retention may fall to zero, or be
overdrawn, or should the Retention fall to zero or be overdrawn, it may notify the other of
the amount it reasonably considers each party will have to pay into the Escrow Account to
avoid, or rectify, such situation, as applicable (which amount may be greater than the
difference between the then balance of the Retention and the agreed budgeted Costs of the then
remaining portion of the Development Programme), and at the same time provide that other with
its calculations of such amount.

9

 

	3.10	 	Within five (5) days of any notice given pursuant to clause 3.9, each party will pay into the
Escrow Account a sum equal to one-half of the amount notified pursuant to that clause.
	 
	3.11	 	Should either party, at any time, be unable to fund from the Escrow Account any of the Costs
referred to in clauses 2.5 or 2.6 for which it has properly contracted, or will properly
contract, with any third party to pay, it may:

	 	(a)	 	fund them itself, in which case it will be entitled to reclaim from the
other party one-half thereof by invoicing that other the relevant sum; and that other
party will pay any such invoice within five (5) days; or
	 
	 	(b)	 	postpone entering into, or making any payment under, any such third party
contract until sufficient sums are available in the Escrow Account, without liability
to the other under this agreement for any resulting delays to the Development
Programme; provided that it alone will be liable to any third party affected by the
postponement.

	3.12	 	As soon as reasonably practicable following the earlier of Termination and the payment of the
last Cost to which clause 2.5 relates, the parties will pay half the Retention to each of them
and then close the Escrow Account.
	 
	3.13	 	No payment out of the Escrow Account will be made, authorised or requested, except as set out
herein.
	 
	4.	 	JOINT PROJECT TEAM
	 
	4.1	 	Within thirty (30) days following the Effective Date the parties will establish the Joint
Project Team.
	 
	4.2	 	The membership of the Joint Project Team will be comprised of an equal number of
representatives of each party, and initially no more than four (4) representatives of each
party.
	 
	4.3	 	Without prejudice to clause 6.3, the parties may, by agreement from time to time, increase or
decrease the number of members of the Joint Project Team, and each may replace those members
appointed by it at will by notice to the other.
	 
	4.4	 	Each party will:

	 	(a)	 	promptly notify the other of its appointments to, replacements for or
removals from, the Joint Project Team of its representatives thereon;
	 
	 	(b)	 	ensure that the members thereof appointed by it and present on the Joint
Project Team are at all times suitably skilled, willing, available and qualified to
undertake their roles as members thereof, as such roles may change over time; and
	 
	 	(c)	 	remove from the Joint Project Team, and promptly replace, any of them who
is not, or otherwise provide them with such training or other assistance as may be
required such that they are so skilled, willing, available and qualified, as soon as
reasonably practicable.

	4.5	 	Notwithstanding clause 4.4, if the members of the Joint Project Team reasonably object to the
inclusion in the membership of the Joint Project Team of any person, they may remove him with
immediate effect if a majority of the members decide that he should be removed and they first
give their reasons for that decision to the parties.

10

 

	4.6	 	The Joint Project Team will be responsible for overseeing the proper undertaking of the
Development Programme and, where relevant, for making decisions with respect thereto,
including with respect to:

	 	(a)	 	the quality and quantity of Product required for the Non-clinical Studies
and Clinical Studies undertaken in the course of the Development Programme;
	 
	 	(b)	 	the design of the Non-clinical Studies and Clinical Studies undertaken in
the course of the Development Programme; and
	 
	 	(c)	 	the selection of third party contractors to be involved in the Development
Programme,

	 	 	but will not be responsible for any matter specified in this agreement as the
responsibility of the Steering Committee, and, for the avoidance of doubt, shall not be
entitled to amend this agreement.
	 
	4.7	 	The Joint Project Team will meet where and when it determines, provided that:

	 	(a)	 	each of its meetings will be at a location reasonably accessible to all its
members, which will alternate with each meeting between the United Kingdom and Spain;
	 
	 	(b)	 	its members will be entitled to attend its meetings by telephone and that
suitable telephone facilities are present at its meetings to enable this; and
	 
	 	(c)	 	it will meet on no less than one week’s notice to all its members sent to
each member in such manner as he may have reasonably specified or otherwise by fax or
first class post (and for the purposes of this clause 4 the provisions of clause 22
will apply mutadis mutandis).

	4.8	 	The parties’ Project Managers will take turns, alternating at each meeting of the Joint
Project Team, as the chairman of such meeting, and Protherics’ Project Manager will chair its
first meeting.
	 
	4.9	 	The Joint Project Team will discharge its functions in such manner as it reasonably sees fit.
	 
	4.10	 	The Joint Project Team will determine its own quorum, provided that this will always include
equal numbers of representatives of each of Protherics and Advancell.
	 
	4.11	 	The Joint Project Team will only decide any matter if quorate and, if any member of the Joint
Project Team wishes any decision to be voted upon, each of its members will have one vote,
with the chairman not having a casting vote.
	 
	4.12	 	All decisions, and actions, of the Joint Project Team made at any of its meetings will be
minuted, and the minutes provided to the members of the Steering Committee for the time being
within seven (7) days of the relevant meeting (and for these purposes the provisions of clause
22 will apply mutadis mutandis; provided that minutes may also be provided by email to such
relevant addresses as are provided in advance, in which case they will be deemed to be
received upon sending).
	 
	4.13	 	The parties will use their reasonable endeavours to bring about agreement of the members of
the Joint Project Team with respect to all matters addressed by it as quickly as reasonably
practicable but if the Joint Project Team is unable to reach a decision on any matter within a
reasonable time, the Joint Project Team will, and any of its members may, refer the matter in
writing to the Steering Committee with:

	 	(a)	 	such information as the Steering Committee may reasonably require to decide
the matter; and

11

 

	 	(b)	 	details of the date by which the matter must be decided,

	 	 	and from the time of such reference, the matter will be for the Steering Committee, and not
the Joint Project Team, to decide.
	 
	4.14	 	The chairman of the relevant meeting of the Joint Project Team will oversee its compliance
with clauses 4.6 to 4.7 and 4.9 to 4.13, and such compliance will be the responsibility of the
party of which such person is the Project Manager.
	 
	5.	 	STEERING COMMITTEE
	 
	5.1	 	Within thirty (30) days following the Effective Date the parties will establish the Steering
Committee.
	 
	5.2	 	Without prejudice to clause 6.3, the membership of the Steering Committee will be comprised
of three (3) representatives of each party, including the Project Managers of each party.
	 
	5.3	 	Each party may, from time to time, replace those members appointed by it to the Steering
Committee at will and upon notice to the other party.
	 
	5.4	 	The parties, beginning with Protherics, will take turns to appoint, on each occasion for a
one-year term, a member of the Steering Committee as chairman of the Steering Committee, the
first appointment to take effect from the first meeting of the Steering Committee; and the
party which does not appoint the then appointed chairman of the Steering Committee shall, at
the same time, appoint the secretary of the Steering Committee, for such one-year term, from
amongst its other members. Should any chairman or secretary of the Steering Committee cease
to be a member of the Steering Committee, the party which appointed him/her as chairman or
secretary, as applicable, shall appoint another member thereof to such position from his/her
ceasing to be a member until the end of what would have been his/her term.
	 
	5.5	 	Each party will ensure that the members of the Steering Committee appointed by it, and
present on the Steering Committee, are at all times suitably skilled, willing, available and
qualified to undertake their roles as members thereof, as such roles may change over time, and
will remove from the Steering Committee, and promptly replace, any of them who is not, or
otherwise provide them with such training or other assistance as may be required such that
they are so skilled, willing, available and qualified as soon as reasonably practicable.
	 
	5.6	 	Notwithstanding clause 5.5, if the members of the Steering Committee reasonably object to the
inclusion in the membership of the Steering Committee of any person, they may remove him with
immediate effect if a majority of the members decide that he/she should be removed and they
first give their reasons for that decision to the parties.
	 
	5.7	 	The Steering Committee will be responsible for overseeing the general working relationships
under this agreement and the Joint Project Team. In particular, the responsibilities of the
Steering Committee will include:

	 	(a)	 	resolving disputes arising from the Joint Project Team;
	 
	 	(b)	 	appointing additional committees and/or working groups from time to time as
may be agreed by the Steering Committee as necessary to facilitate the Development
Programme;
	 
	 	(c)	 	maintaining a good working relationship between the parties;
	 
	 	(d)	 	overseeing the operation of the Escrow Account in accordance with clause 3;

12

 

	 	(e)	 	agreeing the terms of the Development Programme, and any amendments to the
Development Programme;
	 
	 	(f)	 	agreeing the budget for the Development Programme and any amendments to it
which will, or may, increase the total cost of the Development Programme by more than
£100,000; and
	 
	 	(g)	 	any other matters which this agreement requires to be resolved or managed
by the Steering Committee,

	 	 	but, for the avoidance of doubt, the Steering Committee shall not be entitled to amend this agreement.
	 
	5.8	 	The Steering Committee will meet where and when it determines, provided that:

	 	(a)	 	each of its meetings will be at a location reasonably accessible to all its
members, which will alternate with each meeting between the United Kingdom and Spain;
	 
	 	(b)	 	its members will be entitled to attend its meetings by telephone and that
suitable telephone facilities are present at its meetings to enable this;
	 
	 	(c)	 	it will meet no less than once every six (6) months, the first meeting to
be within three (3) months of the Effective Date, and otherwise within a reasonable
time to determine any matter referred to it; and
	 
	 	(d)	 	it will meet on no less than one week’s notice to all its members sent to
each member in such manner as he/she may have reasonably specified or otherwise by
fax or first class post (and for the purposes of this clause 5 the provisions of
clause 22 will apply mutadis mutandis).

	5.9	 	The Steering Committee will determine its own quorum, provided that this will always include
at least one representative of each of Protherics and Advancell.
	 
	5.10	 	The Steering Committee will discharge its functions in such manner as it reasonably sees fit.
	 
	5.11	 	The Steering Committee will only decide any matter if quorate and, if any member of the
Steering Committee wishes any decision to be voted upon, each of its members will have one
vote.
	 
	5.12	 	If any vote of the Steering Committee is tied, whichever of its then chairman and secretary
has been appointed by Protherics shall have the casting vote, provided that such casting vote:

	 	(a)	 	is exercised to further the objectives of the Development Programme;
	 
	 	(b)	 	does not change the budget of the Development Programme; and
	 
	 	(c)	 	does not require either party to incur expenditure additional to any as has
previously been agreed (by the parties, the Joint Project Team or the Steering
Committee),

	 	 	and if, because of such proviso, any vote remains tied notwithstanding this clause 5.12,
the vote shall be deemed not to have passed, and any purported casting vote cast contrary
to such proviso shall be void.
	 
	5.13	 	If any vote of the Steering Committee concerning agreeing the terms of the Development
Programme, or any amendment to the Development Programme, is tied, the matter shall be
resolved as follows:

13

 

	 	(a)	 	the matter shall, from the time of such vote, be referred to the Chief
Executive Officer for the time being of Protherics and the President for the time
being of Advancell, who may decide the matter on behalf of the parties;
	 
	 	(b)	 	if the matter is not so decided within a period of ten (10) Business Days,
either such person may require it to be referred to a third party expert in matters
of that nature agreed between them and:

	 	(i)	 	the parties which they represent shall use their reasonable
endeavours to procure that such persons agree the identity of such expert as
quickly as reasonably practicable;
	 
	 	(ii)	 	the parties shall afford such expert all reasonable assistance
in deciding the matter, and shall use their reasonable endeavours to procure
that he decides it as quickly as practicable and with the intention of
furthering the objective of the parties set out in the recitals;
	 
	 	(iii)	 	such expert’s decision shall be binding on the parties and the
parties shall procure that he records it, together with his reasons for
reaching it, and delivers such record to the parties as quickly as reasonably
practicable; and
	 
	 	(iv)	 	the parties shall share equally the costs of such expert.

	5.14	 	The secretary of the Steering Committee will oversee its compliance with clauses 5.8 to 5.13,
and such compliance will be the responsibility of the party which appointed to the Steering
Committee the member who is its secretary.
	 
	5.15	 	The secretary will minute all actions and decisions of the Steering Committee, and provide
copies of the minutes to its members within seven (7) days of the relevant meeting (and for
these purposes the provisions of clause 22 will apply mutadis mutandis; provided that minutes
may also be provided by email to such relevant address as are provided in advance, in which
case they will be deemed to be received upon sending).
	 
	5.16	 	Minutes of the actions and decisions of the Steering Committee will not be considered
definitive until signed by the Chairman of the Steering Committee with the approval of the
Steering Committee.
	 
	6.	 	GENERAL MATTERS CONCERNING THE JOINT PROJECT TEAM AND THE STEERING COMMITTEE
	 
	6.1	 	The parties will ensure that neither the Joint Project Team nor the Steering Committee acts
contrary to this agreement, and clauses 4 and 5 will be interpreted accordingly.
	 
	6.2	 	The parties will use their reasonable endeavours to ensure that the Joint Project Team and
the Steering Committee discharge their functions with all due diligence and expeditiously.
	 
	6.3	 	The Joint Project Team and the Steering Committee may each co-opt such persons as they decide
to attend their meetings in order to assist them in discharging their functions and/or as
additional members, provided that all such persons are bound by obligations of confidentiality
at least as protective of each of the parties, and their interests, as those of this
agreement.
	 
	6.4	 	The agenda of each meeting of each of the Joint Project Team and the Steering Committee will
include a resolution for the approval of the minutes of the previous meeting.
	 
	6.5	 	The meetings of the Joint Project Team and the Steering Committee, and the minutes of their
decisions and actions, will be in the English language.

14

 

	6.6	 	The chairman of each of the Joint Project Team and the Steering Committee, from time to time,
will oversee its compliance with this clause 6, and such oversight will be the responsibility
of the party which appointed the chairman.
	 
	7.	 	LICENCE
	 
	7.1	 	Subject to clause 7.2, Advancell grants to Protherics, as of the Effective Date, an
exclusive, sub-licensable licence in the Field of Use under:

	 	(a)	 	the Patents; and
	 
	 	(b)	 	such Intellectual Property Rights as subsist, or come into subsistence, in
the Know-how,

	 	 	to develop, make, dispose of, offer to dispose of, use, import and keep the Product, and
any product derived from or incorporating the Product, including by way of the Development
Programme.
	 
	7.2	 	The exclusivity of the licence granted by clause 7.1 will be subject only to Advancell being
entitled to undertake, or have undertaken, the Development Programme as provided by this
agreement.
	 
	7.3	 	Subject to clause 7.2, any development, making, disposal of, offer to dispose of, use,
importation or keeping of the Product, or any product derived from or incorporating the
Product, in the Field of Use, will require the prior written agreement of, and the grant of a
sub-license from, Protherics.
	 
	7.4	 	Advancell will, from time to time, assist Protherics, as Protherics may request (including by
signing any necessary documents), to record the interest of Protherics and any Sub-licensees
under the Patents (including such as are filed and/or granted during the Term) on any relevant
patent register.
	 
	7.5	 	Without prejudice to the exclusivity of the Licence (subject to clause 7.2), Advancell will
not, at any time, do anything to lessen its entitlement to, or Encumber or grant any third
party any right in or to, any of the Intellectual Property Rights licensed hereby, save as
permitted by clause 11.5.
	 
	7.6	 	Protherics shall use its reasonable endeavours to commercialise the Product for the
Indication, bearing in mind the potential market therefor.
	 
	8.	 	DELIVERY OF KNOW-HOW
	 
	8.1	 	Advancell will deliver to Protherics all of the Know-how which Protherics reasonably requires
to perform, or enjoy the benefit of, this agreement, but Advancell will retain copies thereof
for the purposes of its own performance of this agreement.
	 
	8.2	 	Advancell will deliver to Protherics all of the Know-how referred to in clause 8.1 as soon as
reasonably practicable following the Effective Date or its creation or its coming into
Advancell’s possession or under its control, as applicable.
	 
	8.3	 	Advancell will provide such assistance as Protherics may request to transfer the Know-how to
Protherics or to assist in the use thereof in Protherics’ undertaking of, or having
undertaken, the Development Programme and/or the commercialisation of the Product for the
Indication.
	 
	8.4	 	The assistance referred to in clause 8.3 may include:

	 	(a)	 	preparing for, or attending, meetings with any Health Authority;

15

 

	 	(b)	 	dealing with requests or enquiries from any Health Authority;
	 
	 	(c)	 	and preparing and filing applications for Health Registration Approvals.

	8.5	 	If at any time Advancell becomes aware of any defect or insufficiency in any Know-how it will
immediately notify Protherics with full details.
	 
	8.6	 	To the extent permitted by Law, Advancell hereby assigns to Protherics, or will procure the
assignment to Protherics, in each case with effect from the Effective Date or the same coming
into existence, whichever is the sooner, all right, title and interest in and to the Orphan
Drug designation of the Product for the Indication in the European Union, and the pending
Orphan Drug designation of the Product for the Indication in the United States of America, in
the name of Advancell.
	 
	9.	 	ROYALTIES AND MILESTONES
	 
	9.1	 	In consideration of the rights granted by this agreement, Protherics will make the payments
specified in this clause 9.
	 
	9.2	 	Protherics will pay Advancell five hundred thousand pounds (£500,000) within five (5) days
following the Effective Date.
	 
	9.3	 	Protherics will pay to Advancell a royalty at the rate of twelve point eight per cent.
(12.8%) of:

	 	(a)	 	the Net Selling Price in respect of each Royalty Event concluded in the
European Union or the United States of America; and
	 
	 	(b)	 	the Net Selling Price of Protherics in respect of each other Royalty Event,

	 	 	as provided in clause 9.4.
	 
	9.4	 	Protherics shall pay royalties in accordance with clause 9.3 from the first disposal for
value of the Product for the Indication until, on a country-by-country, or
territory-by-territory basis, the later to occur of:

	 	(a)	 	the * anniversary of the First Commercial Sale of the Product in such
country or territory; and
	 
	 	(b)	 	the expiry of the last Valid Claim of any Patent in such country or
territory claiming the use of the Product for the Indication,

	 	 	and, following such cessation of the obligation to pay royalties in a country or territory,
the Licence will continue in effect in such country or territory on a fully paid-up basis
for the remainder of the Term. .
	 
	9.5	 	If Protherics grants any Sub-licence before filing its first application for the grant of a
Marketing Authorisation for the Product for the Indication anywhere in the European Union or
in the United States of America, Protherics will pay Advancell * per
cent. (*%) of
Protherics’ receipts in the form of development or commercialisation milestones, whether cash
or otherwise (other than any Net Selling Price and any sum the subject of clause 3.6),
pursuant to such Sub-licence, received by Protherics prior to the grant of the first such
Marketing Authorisation, including any development-related milestones.
	 
	9.6	 	Payments pursuant to clauses 9.3 or 9.5 will be made Quarterly thirty (30) days after the end
of the Quarter in which Protherics (or in the case of clause 9.3(a), its relevant
Sub-licensee) receives the Net Selling Price or other receipt on which they are calculated.

* confidential treatment
requested

16

 

	9.7	 	Subject to clause 9.9, Protherics will pay Advancell milestone payments as follows (and no
such milestone will be payable more than once):

	 	(a)	 	£3,500,000 at the start of the first Phase IIb Study;
	 
	 	(b)	 	£* at the start of the *;
	 
	 	(c)	 	£* upon *;
	 
	 	(d)	 	£* upon *;
	 
	 	(e)	 	£* upon the *;
and
	 
	 	(f)	 	£* upon the *.

	9.8	 	For the purposes of this agreement, a Phase IIb Study or Phase III Study will be considered
to start when the first patient involved therein is dosed in the course thereof.
	 
	9.9	 	If Protherics files any application for a Marketing Authorisation for the Product for the
Indication without having first completed a Phase IIb Study and/or Phase III Study, the sums
specified in clauses 9.7(a) and (b) shall become payable at the time of such filing.
	 
	9.10	 	Protherics will, within thirty (30) days of the occurrence of each such event, notify
Advancell of the occurrence of each of the events referred to in any of clauses 9.7(a) to (d)
and, within thirty (30) days following receipt of any such notification, Advancell will
deliver to Protherics an invoice for the amount payable in respect of such event pursuant to
the relevant such clause.
	 
	9.11	 	Protherics will pay the sums properly specified in the invoices issues pursuant to clause
9.10 within thirty (30) days following the end of the month in which the relevant invoice is
received by Protherics.
	 
	9.12	 	All payments pursuant to this clause 9 will be made in Euros to Advancell’s account no.
*, or as otherwise specified
by Advancell in advance from time to time.
	 
	9.13	 	For the purpose of calculating payments due hereunder, conversions from the currency in which
the relevant sale of the Product is made into Euros will, where applicable, be calculated at
the actual average rate of exchange for the year to date as used by Protherics in producing
its accounts.
	 
	9.14	 	Protherics will keep at its usual place of business true and accurate books of account
containing all information necessary for the determination of all royalties due under this
agreement, and will procure that its relevant Sub-licensees do likewise.
	 
	9.15	 	Protherics will permit Advancell’s external representatives a right of access, once per year,
during normal business hours upon reasonable notice, to the books of account kept pursuant to
clause 9.14, and to take copies of them.
	 
	9.16	 	Advancell will keep confidential any information which it may acquire in the exercise of its
rights under this clause 9.15, in accordance with clause 10.
	 
	9.17	 	All sums paid hereunder will be exclusive of any applicable Value Added Tax due.
	 
	9.18	 	Any overdue sum payable under this agreement will bear interest, accruing from the due date
until the date of actual payment, whether before or after judgment, calculated at a

* confidential treatment
requested

17

 

	 	 	daily rate equivalent to one (1) per cent. above the United Kingdom base rate for the time
being of Barclays Bank plc and compounded annually at the end of year, and, if this
agreement is terminated other than at the end of a year, on the date of Termination.

	9.19	 	Payments hereunder will be made without set-off or deduction, other than such amount as the
paying party is required to deduct or withhold by law. If requested, evidence as to the
payment of such tax or sum withheld will be given by the paying party to the other and the
parties will co-operate reasonably to claim recovery or exemption under any double taxation or
similar agreement with respect to any such deduction.
	 
	10.	 	CONFIDENTIALITY
	 
	10.1	 	At all times during the Term, and for a period of five (5) years following Termination, each
party (the “Receiving Party”) will, and will cause its officers, directors, employees, agents
and Affiliates to, keep confidential, and not publish or otherwise disclose, and not use,
directly or indirectly, for any purpose, any Confidential Information provided to it by or on
behalf of the other party (the “Disclosing Party”), except to the extent such disclosure or
use is expressly permitted by the terms of this agreement or is reasonably necessary for the
performance of the Development Programme or otherwise for the purposes envisaged by this
agreement.
	 
	10.2	 	Advancell recognises that, by reason of Protherics’ status as an exclusive licensee pursuant
to clause 7, Protherics has an interest in Advancell’s retention in confidence of certain
confidential information of Advancell. Accordingly, Advancell will, and will cause its
Affiliates and their respective officers, directors, employees and agents to, keep
confidential, and not publish or otherwise disclose, any confidential information in its
possession, or under its control, relating to the Product, including the Know-How (the
“Licensor Information”). The disclosure by Advancell to Protherics of Licensor Information
will not, in itself, cause such information to cease to be confidential.
	 
	10.3	 	Notwithstanding clause 10.1, each party may disclose, and permit the disclosure of,
Confidential Information to the extent that such disclosure is:

	 	(a)	 	made in response to a valid order of a court of competent jurisdiction or
other competent authority (including any Health Authority), provided, however, that
the Receiving Party will, subject to Law, first have given notice to the Disclosing
Party and given the Disclosing Party a reasonable opportunity to seek to overturn any
such order or obtain a protective order requiring that the Confidential Information
subject of such order be held in confidence by such court or authority or, if
disclosed, be used only for the purpose for which the order was issued; and provided
further that if such order is not overturned or a protective order is not obtained,
the relevant Confidential Information disclosed in response to such court or
governmental order will be limited to that which is legally required to be disclosed
in response to such court or governmental order;
	 
	 	(b)	 	made by the Receiving Party to a Health Authority as may be necessary or
reasonably useful in connection with any filing, application or request for a Health
Registration Approval; provided, however, that reasonable measures will first be
taken to assure confidential treatment of such Confidential Information, to the
extent such protection is available;
	 
	 	(c)	 	made by the Receiving Party to a relevant authority, as required and/or
permitted hereby, where necessary or reasonably useful for the purposes of obtaining
or enforcing a Patent or any Intellectual Property Right in the Know-How, as required
and/or permitted hereby, provided, however, that the Receiving Party will take
reasonable measures to assure confidential treatment of such information, to the
extent such protection is available; or

18

 

	 	(d)	 	otherwise required by Law, provided, however, that the Receiving Party
will, subject to Law:

	 	(i)	 	provide the Disclosing Party with reasonable advance notice of,
and an opportunity to comment on, any such required disclosure;
	 
	 	(ii)	 	if requested by the Disclosing Party, seek confidential
treatment with respect to any such disclosure to the extent available; and
	 
	 	(iii)	 	use its reasonable endeavours to act upon the comments of the
Disclosing Party in making any such disclosure.

	10.4	 	Protherics may disclose, and otherwise use, Confidential Information as necessary in
developing, studying and commercialising the Product, provided that Protherics takes such
steps as are reasonable in the circumstances to protect the confidentiality of such
Confidential Information, to the extent not incompatible with its legitimate interests.
	 
	10.5	 	Notwithstanding the foregoing, Confidential Information will not include any information
that:

	 	(a)	 	is or hereafter becomes part of the public domain by or through no wrongful
act, fault or negligence on the part of the Receiving Party;
	 
	 	(b)	 	can be demonstrated by documentation, or other competent proof, to have
been in the Receiving Party’s possession prior to disclosure by the Disclosing Party,
free of any obligation of confidence owed to any third party;
	 
	 	(c)	 	is subsequently received by the Receiving Party from a third party who is
not bound by any obligation of confidentiality with respect to said information;
	 
	 	(d)	 	is generally made available to third parties by the Disclosing Party
without restriction on use or disclosure; or
	 
	 	(e)	 	can be demonstrated by documentation, or other competent proof, to have
been independently developed by or for the Receiving Party without reference to the
Disclosing Party’s Confidential Information.

	10.6	 	Specific aspects or details of Confidential Information will not be deemed to be within the
public domain, or in the possession of the Receiving Party, merely because the Confidential
Information is embraced by more general information in the public domain or in the possession
of the Receiving Party, and any combination of Confidential Information will not be considered
in the public domain or in the possession of the Receiving Party merely because individual
elements of such Confidential Information are in the public domain or in the possession of the
Receiving Party unless the combination and its principles are in the public domain or in the
possession of the Receiving Party.
	 
	10.7	 	This clause 10 will not be construed to prohibit either party from identifying the other
party in its internal business communications, provided that any Confidential Information in
such communications remains subject to this clause 10.
	 
	10.8	 	Clauses 10.3 and 10.5 to 10.7(with the exception of clauses 10.5 (b)) will apply, mutatis
mutandis, to Licensor Information as they do to Confidential Information and, for these
purposes, Advancell will be deemed to be the Receiving Party, and Protherics the Disclosing
Party, thereof.
	 
	10.9	 	The text of any press release or other communication to be published by or in the media
concerning the subject matter of this agreement will require the approval of both parties.
	 
	11.	 	OWNERSHIP OF THE PATENTS AND KNOW-HOW

19

 

	11.1	 	Advancell will, with all reasonable skill, care and attention:

	 	(a)	 	file applications for Patents;
	 
	 	(b)	 	prosecute all those Patents that are patent applications (including those
filed hereafter), and
	 
	 	(c)	 	maintain all those Patents that are granted patents,

	 	 	so as to acquire and maintain the broadest patent protection practicable for the inventions
claimed by the Patents listed in schedule 1, throughout the world, for the longest term
practicable (including by defending any claim, counter-claim, objection or opposition
concerning validity or entitlement).
	 
	11.2	 	Advancell will:

	 	(a)	 	give serious consideration to any proposals of Protherics concerning
Advancell’s performance of its obligations further to clause 11.1;
	 
	 	(b)	 	keep Protherics informed of progress, and of objections raised, in respect
of such matters; and
	 
	 	(c)	 	otherwise provide Protherics with evidence of its compliance with those
obligations.

	11.3	 	Without prejudice to clause 11.1, if Advancell wishes to abandon any application comprised in
the Patents, or not to renew or maintain any particular Patent, Advancell will give Protherics
sixty (60) days’ notice and will, if requested by Protherics, assign such Patent to
Protherics, for nominal consideration, free of Encumbrances.

	11.4	 	Other than pursuant to clause 11.3, Advancell will not assign any Patent, or any Intellectual
Property Right in any Know-How, in the Field of Use, nor will Advancell Encumber any of them.

	11.5	 	Advancell shall only assign or Encumber any Patent or any Intellectual Property in any
Know-How if it does so on terms that:

	 	(a)	 	protect Protherics’ benefit hereunder; and
	 
	 	(b)	 	ensure that each person to whom any such assignment or Encumbrance is
granted imposes:

	 	(i)	 	such obligation; and
	 
	 	(ii)	 	the obligation imposed by this clause 11.5(b),

on each of their successors to, and all persons deriving any benefit under, any
interest in or to any Patent and/or any such Intellectual Property,

	 	 	in each case which are directly enforceable by Protherics.
	 
	12.	 	INFRINGEMENT
	 
	12.1	 	Each party will, as soon as it becomes aware, give the other full written particulars of any
conduct or proposed conduct by any third party which amounts, or might amount, either to
infringement of any Patent or unauthorised use of any Know-how.
	 
	12.2	 	Each party will, as soon as it becomes aware, notify the other of any allegation by any third
party that:

20

 

	 	(a)	 	any Patent is invalid;
	 
	 	(b)	 	that the undertaking of the Development Programme, or exploitation of the
Product for the Indication, infringes, or will infringe, any rights of another
person; or
	 
	 	(c)	 	that the Patents are otherwise attacked or attackable,

	 	 	and will give the other full written particulars thereof, and make no comment or admission
with respect thereto, to any third party.
	 
	12.3	 	Subject to clause 12.7, Advancell will bring and conduct, with all reasonable skill, care and
attention, all Claims and other action for infringement of any Patent, or with respect to the
unauthorised use of any Know-how, which it or Protherics considers appropriate.
	 
	12.4	 	Advancell will give Protherics reasonable opportunity to comment on material issues regarding
any action to which clause 12.3 relates, and will comply with Protherics’ reasonable
directions with respect thereto.
	 
	12.5	 	Protherics will, at Advancell’s Cost, provide all reasonable assistance requested by
Advancell for the purposes of Advancell’s performance of its obligations further to clause
12.3.
	 
	12.6	 	Any damages, or account of profits, awarded further to any action taken pursuant to clause
12.3 will be divided equitably between the parties having regard to their respective losses
resulting from the relevant infringement or unauthorised use.
	 
	12.7	 	Without prejudice to Advancell’s obligations pursuant to clause 12.3, where:

	 	(a)	 	Protherics gives Advancell thirty (30) days’ notice requesting any action
of any type referred to in clause 12.3, and Advancell does not commence such action
within this time period; or
	 
	 	(b)	 	prompt action is reasonably necessary regarding the relevant matter,
Protherics gives Advancell notice to this effect and Advancell does not commence such
action within the time specified in the notice,

then Protherics:

	 	(i)	 	may commence, and conduct, such action;
	 
	 	(ii)	 	will be entitled to all of any damages, or account of profits,
awarded in respect thereof; and
	 
	 	(iii)	 	may, and at Advancell’s cost, require Advancell to join,
either as a co-plaintiff or as defendant (such choice, if available under the
applicable Law, to be made by Advancell, in its discretion), in, and assist
regarding, such action.

	12.8	 	Protherics may deduct its Costs in taking, conducting and settling any action further to
clause 12.7 from any sums payable pursuant to clause 9 in such manner as Protherics
determines, provided that Protherics may only so deduct any third party costs award made in
respect of any such action after it is made.
	 
	12.9	 	The Costs referred to in clause 12.8 shall be net of any award of costs made to Protherics in
the action to which they relate.
	 
	12.10	 	If any costs award is made to Protherics in any action further to clause 12.7 and Protherics
has, by the time of such award, deducted any of its Costs in taking,

21

 

	 	 	conducting and settling such action from any sums payable by it pursuant to clause 9,
Protherics shall pay Advancell a sum equal to such deduction at the same time as
Protherics makes its next payment to Advancell pursuant to clause 9.
	 
	13.	 	LIABILITY/INDEMNITY
	 
	13.1	 	The following provisions govern the entire liability of each party (including any liability
for the acts and omissions of its Personnel) to the other in respect of:

	 	(a)	 	any breach of its contractual obligations arising under this agreement; and
	 
	 	(b)	 	any representation, statement or tortious act or omission including
negligence arising under or in connection with this agreement.

	13.2	 	Except as is expressly stated in this agreement, no representation, condition or warranty
whatsoever is made or given by or on behalf of Protherics, and, to the greatest extent
permissible by Law, any such conditions and warranties, whether arising by operation of Law or
otherwise, are expressly excluded.

	13.3	 	No exclusion or limitation set out in this clause 13 will apply in the case of:

	 	(a)	 	fraud or fraudulent concealment;
	 
	 	(b)	 	death or personal injury resulting from the negligence of either party; or
	 
	 	(c)	 	any other liability which cannot lawfully be excluded or limited.

	13.4	 	Subject to clause 13.6, neither party will be liable to the other in respect of any act or
omission to the extent that the same arises as a result of a failure by that other, or any
third party, to fulfil its obligations under this agreement.

	13.5	 	Neither party will be liable to the other for any Indirect Loss or any related Claims and
Costs arising from any act or omission, provided that this clause will not exclude any
liability either party may have to the other in respect of any Costs incurred in connection
with repeating any part of the Development Programme.

	13.6	 	The following provisions shall apply to any liability of either or both of the parties to any
third party arising out of any act or omission of either or both of them in the course of, or
connected with, the Development Programme, and their reasonable Costs incurred in respect of
any Claim made, threatened or reasonably contemplated with respect to such matter (together,
“Shared Costs"):

	 	(a)	 	subject to clauses 13.6(b) and (c), the parties shall be jointly and
severally liable, in equal shares, as between each other for all Shared Costs;
	 
	 	(b)	 	each party’s liability pursuant to clause 13.6(a) shall be conditional on
the other:

	 	(i)	 	giving notice in writing to such party (the “Liable Party") of
such act or omission, setting out reasonable details thereof including, as far
as reasonably practicable, details of the maximum potential Shared Costs with
respect thereto;
	 
	 	(ii)	 	at all reasonable times, consulting with, and providing
reasonable information, assistance (including reasonable access to premises,
personnel and documentation) and co-operation to, the Liable Party, in a timely
manner, with respect thereto, and to the progress, conduct and settlement
thereof;

22

 

	 	(iii)	 	taking such action in relation to the matter as the Liable
Party may agree in writing to its taking (such agreement not to be unreasonably
withheld or delayed);
	 
	 	(iv)	 	from first giving notice pursuant to clause 13.6(b)(i), only
using advisers agreed with the Liable Party (such agreement not to be
unreasonably withheld or delayed) in respect of such matter;
	 
	 	(v)	 	at all times using its reasonable endeavours to keep to such
Shared Costs to a minimum and otherwise mitigating them;
	 
	 	(vi)	 	not encouraging or promoting any relevant Claim;
	 
	 	(vii)	 	not admitting any liability in respect of, or settling, any
such Claim, or agreeing to do either of the foregoing, without first obtaining
the Liable Party’s written consent (not to be unreasonably withheld or
delayed);
	 
	 	(viii)	 	if (and when) any such Claim is made, notifying the Liable Party within
reasonably sufficient time to enable the Liable Party properly to contest the
same before final judgment; and
	 
	 	(ix)	 	not waiving or otherwise compromising, and using its reasonable
endeavours to enforce against any relevant third party, the parties’ rights in
relation to or in connection with the matter, save where the parties agree
otherwise (such agreement not to be unreasonably withheld or delayed); and

	 	(c)	 	this clause 13.6 is:

	 	(i)	 	subject to clauses 2.4 to 2.7, inclusive; and
	 
	 	(ii)	 	without prejudice to clause 14.

	13.7	 	Advancell will not be liable for Protherics’ exploitation of the Product outside the
Development Programme, save to the extent that Advancell is at fault.
	 
	13.8	 	The parties will each obtain, and maintain for the Term and six (6) years thereafter,
insurance against their liabilities hereunder, in such amounts as shall be sufficient to cover
all such liabilities, with one or more reputable insurers, and will provide one another with
evidence of such insurance upon request from time to time.
	 
	14.	 	WARRANTIES
	 
	14.1	 	Each party warrants and represents to the other that:

	 	(a)	 	it has authority to enter into, and perform, this agreement and that its
entry into, and performance of, this agreement does not, and will not, conflict with
any of its other obligations; and
	 
	 	(b)	 	it will undertake, or have undertaken, the Development Programme:

	 	(i)	 	in accordance with:

	 	(A)	 	all applicable Laws;
	 
	 	(B)	 	Good Industry Practice; and
	 
	 	(C)	 	the requirements of all applicable Health
Authorities; and

23

 

	 	(ii)	 	otherwise with reasonable skill, care and attention.

	14.2	 	Advancell warrants and represents to Protherics that:

	 	(a)	 	it is the exclusive legal and beneficial owner of the patents and patent
applications specified in schedule 1, which is a complete and accurate list of all
subsisting Patents, and of all Intellectual Property Rights as subsist in the
Know-how;
	 
	 	(b)	 	it is not aware of any current or proposed Claim, valid or otherwise, to
the ownership or other interest in any Patent or any Intellectual Property Rights as
subsists in any of the Know-how, nor of any reasonable basis for the assertion of any
such Claim;
	 
	 	(c)	 	it is not aware of any current or proposed Claim, valid or otherwise, that
the undertaking of the Development Programme or any other exercise of any of the
Intellectual Property Rights licensed, or purported to be licensed, by the Licence
will or might infringe any third party rights;
	 
	 	(d)	 	the Know-how was generated in the course of the normal duties of
Advancell’s employees;
	 
	 	(e)	 	it is free to disclose and deliver the Know-how to Protherics;
	 
	 	(f)	 	except as expressly permitted by this agreement, it will take no action in
derogation of the Licence;
	 
	 	(g)	 	it has not supplied or permitted the supply of any Know-how to any person,
except under binding obligations of confidentiality, and that it is not aware of any
breach of any such obligations; and
	 
	 	(h)	 	it is not aware of any use by any third party of any of any of the
inventions claimed by any of the Patents which will, or might, amount to an
infringement, or of any unauthorised use of any of the Know-how.

	14.3	 	Protherics warrants and represents to Advancell that it intends to perform its obligations
hereunder.
	 
	14.4	 	Save for those warranties expressly given in this clause 14, neither party makes any
warranty, express or implied, and, to the extent permitted by Law, each party specifically
disclaims any warranties not expressly given in this clause 14.
	 
	15.	 	TERM
	 
	15.1	 	This agreement will commence on the Effective Date.
	 
	15.2	 	The Licence will continue in force until all of the Patents, and all Intellectual Property
Rights subsisting in any Know-how, have expired, or until the earlier termination of this
agreement.
	 
	16.	 	TERMINATION
	 
	16.1	 	The parties may agree to terminate this agreement if they consider the results of the
Development Programme to be unsatisfactory, in which case:

	 	(a)	 	the Licence will terminate;
	 
	 	(b)	 	Protherics will return to Advancell such Know-how as has been delivered by
Advancell to Protherics pursuant to clause 8.1; and

24

 

	 	(c)	 	Protherics will assign back to Advancell, or procure the assignment back to
Advancell of, the right, title and interest in Orphan Drug designations which were
assigned to Protherics pursuant to clause 8.6.

	16.2	 	Without prejudice to clause 16.1, either party may terminate this agreement, or request that
the parties re-negotiate its terms, by giving not less than thirty (30) days’ notice to the
other party at any time during the sixty (60) days following the date on which the report of
the results of the First Clinical Study is signed by the relevant representative of the second
party to sign it.

	16.3	 	If Advancell gives notice pursuant to clause 16.2:

	 	(a)	 	it will, at the time of giving it, irrevocably offer to assign to
Protherics:

	 	(i)	 	all right, title and interest in and to the Patents, and all
Intellectual Property Rights subsisting in the Know-how, or which has otherwise
acquired further to the Development Programme, free of Encumbrances;
	 
	 	(ii)	 	the benefit of all contracts to which it is party and which
relate to the Development Programme or otherwise to the Product, including any
sub-licences; and
	 
	 	(iii)	 	the names and contact details of its then current sales
agents, suppliers and distributors of the Product,

	 	 	 	in each case for such consideration as Advancell has been advised by the
Independent Valuer is a fair, open-market price therefor at that time, and will
provide Protherics with such advice, and the basis of its determination, at the
same time as making such offer;
	 
	 	(b)	 	clauses 7.1, 7.2, 7.4, 7.5 (excluding the reference therein to clause 7.2),
11, 12, 16.3, 16.5 and 16.6 shall, unless and until Protherics takes an assignment of
those rights and matters specified in clause 16.3(a) further to the offer made by
Advancell pursuant to that clause, survive Termination pursuant to such notice; and
	 
	 	(c)	 	clause 9 shall, unless and until Protherics takes an assignment of those
rights and matters specified in clause 16.3(a) further to the offer made by Advancell
pursuant to that clause, also survive such Termination, save that, from such
Termination:

	 	(i)	 	the royalty rate in clause 9.3 shall be * per
cent. (*%);
	 
	 	(ii)	 	the reference in clause 9.5 to * per cent. (*%) shall be
replaced with a reference to * per cent. (*%);
	 
	 	(iii)	 	the sum of £3,500,000 referred to in clause 9.7(a) shall be
reduced to £*;
	 
	 	(iv)	 	the sum of £* referred to in clause 9.7(b) shall be
reduced to £*;
	 
	 	(v)	 	the sum of £* referred to in clause 9.7(c) shall be
reduced to £*;
	 
	 	(vi)	 	the sum of £* referred to in clause 9.7(d) shall be
reduced to £*;

* confidential treatment
requested

25

 

	 	(vii)	 	the sum of £* referred to in clause 9.7(e) shall be
reduced to £*; and
	 
	 	(viii)	 	the sum of £* referred to in clause 9.7(f) shall be
reduced to £*.

	16.4	 	If Protherics gives notice pursuant to clause 16.2, it will, at the time of giving it,
irrevocably offer to assign to Advancell:

	 	(a)	 	the benefit of its Health Registration Approvals relating to the Product
and all its Regulatory Documentation;
	 
	 	(b)	 	its reports of the results of, and the data generated in the course of, the
Studies;
	 
	 	(c)	 	all its right, title and interest in such Intellectual Property Rights
acquired by it further undertaking the Development Programme, and which relate
exclusively thereto, or in its Health Registration Approvals relating to the Product
or its Regulatory Documentation; and
	 
	 	(d)	 	the benefit of all contracts to which it is party and which relate
exclusively to the Development Programme or otherwise to the Product,

	 	 	for such consideration as Protherics has been advised by the Independent Valuer is a fair,
open-market price therefor at that time, and provide Advancell with such advice, and the
basis of its determination, at the same time as making such offer.
	 
	16.5	 	The party receiving any offer pursuant to clauses 16.3(a) or 16.4 will have sixty (60) days
in which to accept such offer in writing, after which time such offer will lapse.
	 
	16.6	 	Without prejudice to clause 7.5, the party making any offer pursuant to clauses 16.3(a) or
16.4 will, until the end of the sixty (60) days period referred to in clause 16.5, do nothing
to lessen its entitlement to, and will in no way Encumber or grant any third party any right
in or to, any of the subject matter of the offer.
	 
	16.7	 	If Protherics accepts any offer made by Advancell pursuant to clause 16.3(a), and
notwithstanding Termination, Advancell will continue to provide Protherics with all assistance
with respect to the development or exploitation of the Product in the Indication as Protherics
may reasonably request.
	 
	16.8	 	Either party (“Notifying Party") may terminate this agreement, immediately, by notice to the
other party (“Notified Party"), if:

	 	(a)	 	the Notified Party is in material breach of this agreement and such breach
is not capable of remedy;
	 
	 	(b)	 	the Notified Party has a receiver or an administrative receiver or
administrator appointed of the whole, or any part, of its undertaking or assets, or
has an officer appointed to perform a function analogous to that of any such officer,
or enters into any composition with its creditors;
	 
	 	(c)	 	an order is made, or a resolution passed for winding-up of the Notified
Party or the Notified Party enters administration (as such term is defined in
schedule B1 of the Insolvency Act 1986), unless such order or resolution or other
appointment is part of a scheme of solvent reconstruction of the Notified Party; or
	 
	 	(d)	 	the equivalent of any of the foregoing occurs in any relevant jurisdiction.

	16.9	 	If either party is in material breach of this agreement, and such breach is capable of
remedy, the other party may give the first party a notice of termination of this

* confidential treatment
requested

26

 

	 	 	agreement and that notice will come into effect sixty (60) days after the date on which it
is given, unless within that period the notified party has permanently remedied the
breach.
	 
	16.10	 	For the purposes of this clause 16, a “material breach” means a breach (including an
anticipatory breach) which is serious in the widest sense of having a serious effect on the
benefit which the innocent party would otherwise derive from this agreement in accordance with
its terms and for the avoidance of doubt includes any breach of clause 10.
	 
	16.11	 	Where this agreement terminated pursuant to clause 16.8:

	 	(a)	 	the Licence will terminate;
	 
	 	(b)	 	Protherics will return to Advancell such Know-how as has been delivered by
Advancell to Protherics pursuant to clause 8.1; and
	 
	 	(c)	 	Protherics will assign back to Advancell, or procure the assignment back to
Advancell of, the right, title and interest in Orphan Drug designations which were
assigned to Protherics pursuant to clause 8.6.

	17.	 	RIGHTS ON TERMINATION
	 
	17.1	 	Termination of this agreement will be without prejudice to any rights of either party against
the other which may have accrued up to the date of Termination.
	 
	17.2	 	Without prejudice to clause 16.3, the following provisions will survive Termination:

	 	(a)	 	the confidentiality obligations of clause 10;
	 
	 	(b)	 	the obligations of Protherics in respect of the accounting for, payment of
and verification of royalties due in respect of Royalty Events prior to Termination;
and
	 
	 	(c)	 	clauses 1, 3, 13, 14, 16.7, 17, 19, 21, 22 and 24.

	18.	 	FORCE MAJEURE
	 
	18.1	 	“Event of Force Majeure” means, in relation to either party, an event or circumstance beyond
the reasonable control of that party (“Claiming Party") including, strikes, lock outs and
other industrial disputes (in each case, whether or not relating to the Claiming Party’s
workforce).
	 
	18.2	 	The Claiming Party will not be deemed to be in breach of this agreement or otherwise liable
to the other party (“Non-claiming Party") for any delay in performance or any non-performance
of any obligations under this agreement (and the time for performance will be extended
accordingly) if and to the extent that the delay or non-performance is due to an Event of
Force Majeure provided that:

	 	(a)	 	the Claiming Party could not have avoided the effect of the Event of Force
Majeure by taking precautions which, having regard to all matters known to it before
the occurrence of the Event of Force Majeure and all relevant factors, it ought
reasonably to have taken but did not take; and
	 
	 	(b)	 	the Claiming Party has used reasonable endeavours to mitigate the effect of
the Event of Force Majeure and to carry out its obligations under this agreement in
any other way that is reasonably practicable.

	18.3	 	The Claiming Party will promptly notify the Non-claiming Party of the nature and extent of
the circumstances giving rise to the Event of Force Majeure.

27

 

	18.4	 	If the Event of Force Majeure in question prevails for a continuous period in excess of
ninety (90) days after the date on which it began, the Non-claiming Party may give notice to
the Claiming Party terminating this agreement. The notice to terminate must specify the
Termination date, which must be not less than thirty (30) days after the date on which the
notice to terminate is given. Once a notice to terminate has been validly given, this
agreement will terminate on the Termination date set out in the notice. Neither party will
have any liability to the other in respect of Termination due to an Event of Force Majeure.
	 
	19.	 	FURTHER ASSURANCE
	 
	 	 	Each party will, at the request and Cost of the other, from time to time after the
Effective Date, sign all such deeds and documents and do all such things as that other may
reasonably require for the purpose of giving effect to this agreement.
	 
	20.	 	ASSIGNMENT AND SUB-LICENSING
	 
	20.1	 	Neither party may assign its rights hereunder, in whole or in part, except to any of its
Affiliates and provided that:

	 	(a)	 	it notifies the other party in advance of any such assignment;
	 
	 	(b)	 	it shall procure the re-assignment thereof to itself upon such Affiliate
ceasing to be its Affiliate; and
	 
	 	(c)	 	it ensures that such Affiliates does not otherwise assign, or grant any
interest in or to, the same,

	 	 	and, notwithstanding such assignment, the assigning party shall remain fully liable for
the performance of this agreement.
	 
	20.2	 	If any assignment of a type referred to in clause 20.1 takes place, this agreement will be
binding upon the assignee and the name of the relevant party appearing in this agreement will
be deemed to include the names of such assignee.

	20.3	 	Protherics will not Sub-license without:

	 	(a)	 	first notifying Advancell of the identity of the relevant Sub-licensee and
the terms of the relevant Sub-license; and
	 
	 	(b)	 	including in the Sub-licence provisions granting Advancell’s external
representatives a right of access, once per year, during normal working hours upon
reasonable notice:

	 	(i)	 	to the books of account which Protherics requires it to keep
pursuant to clause 9.14; and
	 
	 	(ii)	 	to such other records as are necessary to verify the royalties
due to Advancell in respect of the Net Sales of such Sub-licensee,

and to take copies of them, provided that Advancell keeps confidential any
information which it may require in the exercise of its rights under such
provisions, in accordance with clause 10.

	21.	 	MISCELLANEOUS
	 
	21.1	 	Save where otherwise provided herein, each party will bear its own Costs connected with the
negotiations, preparation and implementation of this agreement.

28

 

	21.2	 	Each party will, at the request and Cost of the other party, sign any further formal document
which may be necessary to give effect to this agreement in any territory.

	21.3	 	Except in the case of fraud or fraudulent concealment, the parties acknowledge that:

	 	(a)	 	the Entire Agreement constitutes the entire and only agreement between the
parties relating to the subject matter of the Entire Agreement; and
	 
	 	(b)	 	neither party has been induced to enter into the Entire Agreement in
reliance on, nor has it been given, any representation or other statement of any
nature whatsoever other than those set out in the Entire Agreement and expressly
described as representations.

	21.4	 	This agreement may be varied only by a document signed by both of the parties.
	 
	21.5	 	No breach of this agreement will be waived or discharged, except with the consent of the
parties.
	 
	21.6	 	No failure or delay by a party to exercise any of its rights under this agreement will
operate as a waiver of it or them and no single or partial exercise of any such right will
prevent any other or further exercise of that or any other right.
	 
	21.7	 	If any of the terms of this agreement is or becomes (whether or not following any judgment or
otherwise) invalid, illegal or unenforceable in any respect under the law of any jurisdiction:

	 	(a)	 	the validity, legality and enforceability under the law of that
jurisdiction of any other provision; and
	 
	 	(b)	 	the validity, legality and enforceability under the law of any other
jurisdiction of that or any other provision,

	 	 	will not be affected or impaired in any way as a result.
	 
	21.8	 	In the circumstances set out in clause 21.7, the parties will meet to discuss the relevant
provision and will substitute a lawful and enforceable provision which so far as possible
results in the same economic effects.
	 
	21.9	 	Except as provided in clause 12, the rights and remedies provided in this agreement are
cumulative and not exclusive of any rights or remedies provided by law or in equity.
	 
	21.10	 	The Contracts (Rights of Third Parties) Act 1999 will not apply to this agreement and no
rights or benefits expressly or impliedly conferred by it will be enforceable under that Act
against the parties to it by any other person, except for rights and benefits conferred on
Protherics’ Affiliates.
	 
	21.11	 	Nothing in this agreement will create a partnership or joint venture between the parties
and, except as expressly provided in this agreement, neither party will enter into or have
authority to enter into any engagement or make representation or warranty on behalf of, or
pledge the credit of or otherwise bind or oblige, the other party, it being intended that each
party will remain an independent contractor.
	 
	21.12	 	Save as otherwise expressly provided herein, neither party will not be liable for any debts,
torts or contracts of the other.
	 
	21.13	 	Each party undertakes to comply fully with applicable international treaties and the Laws
and regulations of the United States, the European Community, the United Kingdom and any other
applicable jurisdiction governing exports, re-exports and transfers (together the “Export
Control Laws") of technology developed or disclosed as a result of this

29

 

	 	 	agreement or products made using any such technology (together the “Relevant Technology or
Products") and, without limitation, to obtain all necessary consents and licences from the
competent governmental authorities in all relevant jurisdictions for the purpose of
compliance with the Export Control Laws.
	 
	21.14	 	Each party undertakes contractually to oblige any third party to whom it discloses or
transfers any Relevant Technology or Products to make an undertaking to it in similar terms to
the one set out in clause 21.13.
	 
	21.15	 	The parties acknowledge that any performance under this agreement is subject to any
restrictions which may be imposed by any Export Control Laws.
	 
	21.16	 	Each party agrees, if requested, to provide the other party with any reasonable assistance,
at the reasonable Cost of the other party, to enable it to perform any activity required by
any competent governmental authority in any relevant jurisdiction for the purpose of
compliance with any Export Control Laws.
	 
	21.17	 	The official text of this agreement is in the English language and, in the event of any
dispute concerning the construction or interpretation of this agreement, reference will be
made only to this agreement as written in the English language and not to any translation into
any other language.
	 
	22.	 	NOTICES
	 
	22.1	 	Any communication, including any notice, given under or in connection with this agreement
will be in writing in the English language and will be delivered personally or sent by
pre-paid first class post (air mail if posted to or from a place outside the United Kingdom)
to the address of each party stated above, or sent by fax, in the case of Protherics to its
Senior Executive for the time being and in the case of Advancell, its Company President.
	 
	22.2	 	Any such communication will be deemed to have been duly given or made as follows:

	 	(a)	 	if personally delivered, upon delivery at the address of the relevant
party;
	 
	 	(b)	 	if sent by post, five (5) working days after the date of posting; and
	 
	 	(c)	 	if sent by fax, when despatched to +44 (0)1928 518 002 (in the case of
Protherics) or +34 (0)93 403 4544 (in the case of Advancell),

	 	 	provided that if, in accordance with the above provision, any such communication would
otherwise be deemed to be given or made outside normal working hours, such notice, demand
or other communication will be deemed to be given or made at the start of normal working
hours on the next business day.
	 
	23.	 	DISPUTE RESOLUTION
	 
	23.1	 	Any Dispute which arises will first be referred to Senior Executives of the parties for
resolution. Either party may give seven (7) days’ notice to the other requiring that a
Dispute be referred to Senior Executives of the parties. The Senior Executives will meet
within seven (7) days of the expiry of the notice (or earlier, if agreed) and will attempt in
good faith to resolve the Dispute. The notice requesting the meeting of Senior Executives
will contain brief details of the Dispute in question.
	 
	23.2	 	If the Dispute is resolved by the Senior Executives, the resolution will be recorded in
writing and signed by duly authorised representatives of each of the parties and that
resolution will be final and binding on the parties.

30

 

	23.3	 	If any Dispute is not resolved by the Senior Executives within seven (7) days of their
meeting pursuant to clause 23.1, or within such further period as the parties may agree in
writing, the parties will attempt to settle it by mediation in accordance with the CEDR Model
Mediation Procedure and, unless otherwise agreed between the parties, the mediator will be
nominated by CEDR.
	 
	23.4	 	The mediation will take place in London in the English language and “The Mediation Agreement”
referred to in the CEDR Model Mediation Procedure will be governed by, and construed and take
effect in accordance with, English law.
	 
	23.5	 	If any Dispute is not resolved by mediation within fourteen (14) days of commencement of the
mediation, or within such further period as the parties may agree in writing, the dispute may
only then be referred to arbitration in accordance with clause 24, provided that this clause
23 will not prevent either party seeking interim or emergency injunctive relief.
	 
	23.6	 	The foregoing provisions of this clause 23 are without prejudice to clause 5.13.
	 
	24.	 	GOVERNING LAW AND JURISDICTION
	 
	24.1	 	This agreement, and any Dispute, will be governed by and construed in accordance with English
law.
	 
	24.2	 	Subject to clause 23, all Disputes between the parties arising out of or in connection with
this agreement or its formation shall be finally settled under the Rules of Arbitration of the
International Chamber of Commerce, by one arbitrator appointed in accordance with the said
Rules; and any such arbitration shall be held in Paris, France, and the language of the
arbitration shall be the English language.
	 
	25.	 	SUPPLY AGREEMENT
	 
	25.1	 	The parties shall endeavour, in good faith, to reach, at
least * before the expected
date of the First Commercial Sale, an agreement for the supply from Advancell to Protherics of
the quantities of the Product required by Protherics for its commercialisation, and:

	 	(a)	 	the cost of supply of such Product will be limited to its cost of
manufacture, plus customary industrial margins; and
	 
	 	(b)	 	such supply agreement will contain provisions to grant Advancell preferred
provider status and to grant Protherics the right to contract with an alternative
supplier to be used in case Advancell cannot supply, in full, Protherics’ required
amount of Product for commercialisation or the cost of supply from Advancell is not
competitive compared with that of potential alternative suppliers.

	25.2	 	All Product which Protherics may need for the implementation of the Development Programme
shall be supplied by Advancell.

* confidential treatment
requested

31

 

The parties have witnessed this agreement by signing below via their respective duly authorised
representatives on the date at the head of this agreement.

Signed by

for and on behalf of

PROTHERICS MEDICINES DEVELOPMENT LIMITED

/s/
Andrew Heath Signature

Signed by

for and on behalf of

ADVANCED IN VITRO CELL TECHNOLOGIES S.L.

/s/
Luis Antonio Ruiz Avila Signature

32

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