EXHIBIT 10.16
*** TEXT OMITTED AND FILED SEPARATELY
PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST
UNDER 17 C.F.R. SECTION 200.80(b)(4)
AND RULE 406 UNDER THE SECURITIES
ACT OF 1933, AS AMENDED
23 JULY 2004
PATENT AND KNOW HOW LICENSE
BETWEEN
SHIRE BIOCHEM INC.
TANAUD IRELAND INC.
TANAUD INTERNATIONAL B.V.
AND
STRUCTURAL GENOMIX, INC.
----------------------------------------
PATENT AND KNOW HOW LICENSE
Relating to the development, registration and sale of TROXATYL(R)
----------------------------------------
PATENT AND KNOW HOW LICENSE
DATE: 23 JULY 2004
PARTIES:
(1) SHIRE BIOCHEM INC., a company incorporated in Canada, whose address is 275
boul. Armand-Frappier, Laval, QC, Canada H7V 4A7 ("SHIRE BIOCHEM");
(2) TANAUD IRELAND INC., a company incorporated in Ireland, whose address is
Shannon Airport House, Shannon, County Clare, Ireland ("TANAUD IRELAND");
(3) TANAUD INTERNATIONAL B.V., a company incorporated in the Netherlands, whose
address is Fred Roeskestraat 123, First Floor, 1076 EE Amsterdam, The
Netherlands ("TANAUD BV"); and
(4) STRUCTURAL GENOMIX, INC., a company incorporated in Delaware, whose address
is 10505 Roselle Street, San Diego, CA 92121, U.S.A. ("LICENSEE").
BACKGROUND
(A) Shire BioChem (formerly BioChem Pharma Inc.) is a pharmaceutical company
engaged in, among other things, the research and development of certain
pharmaceutical products including the Licensed Product (as defined below).
(B) During the course of its research and development of the Licensed Product,
Shire BioChem generated the Compound Patents, the Background Patents and
the Shire Know-How (each defined below) in connection with the Licensed
Product.
(C) On 3 January 1996, Shire BioChem entered into the License Agreement (as
defined below) which, among other things, granted Shire BioChem the
exclusive right to use the University Patents (as defined below).
(D) The Licensee is engaged in, among other things, the research and
development of certain pharmaceutical products.
(E) The Licensee has requested, and Shire agrees to grant, an exclusive license
to make, have made, use, supply and sell the Licensed Product in the
Territory (as defined below) on the terms and conditions set out in this
Agreement.
OPERATIVE PROVISIONS
1. INTERPRETATION
1.1 In this Agreement:
2
"ACCELERATED APPROVAL" means approval for Marketing Authorisation of
the Licensed Product in the United States of America on the basis of an
application made to the FDA pursuant to the Code of Federal
Regulations, Title 21, Part 314 (subpart H - accelerated approval of
new drugs for serious or life threatening illnesses) or its equivalent
in any jurisdiction;
"AFFILIATE" means any firm, person or company which controls, is
controlled by or is under common control with a Party to this Agreement
and for the purpose of this definition the term "control" means the
possession, directly or indirectly, of the power to direct or cause the
direction of the management and policies of such firm, person or
company, whether through the ownership of voting securities, by
contract or otherwise or the ownership either directly or indirectly of
more than 50% of the voting securities of such firm, person or company;
"BACKGROUND PATENTS" means the patents and patent applications owned by
or licensed to Shire Biochem, Tanaud Ireland or Tanaud BV as set out in
Part I of Schedule 2;
"BUSINESS DAY" means any day other than Saturday or Sunday on which the
banks in New York are open for business;
"CANADIAN TERRITORY" means Canada;
"CHANGE OF CONTROL" means a transaction or series of related
transactions (other than an equity financing the principal purpose of
which is to raise new capital for the Licensee or an IPO or follow-on
public offering), that result directly or indirectly in the change of:
(a) control of more than half of the voting power of the issued
share capital of the Licensee; or
(b) control of more than half of the issued share capital
(excluding any part thereof which carries no right to
participate beyond a specified amount in the distribution of
either profit or capital) of the Licensee; or
(c) control of the power to direct or cause the direction of the
management and policies of the Licensee, by virtue of any
power conferred under the articles of association or other
documents relating to the Licensee;
"CLAIMS" shall have the meaning given in clause 14.1;
"CLINICAL PROOF OF CONCEPT" means either (a) completion of the
[...***...] patient phase II study of the Compound [...***...] Acute
Myelogenous Leukemia (AML) patients with a complete response rate (CR
and CRp in aggregate) [...***...] AML patients of at least [...***...]%
with a CR rate of at least [...***...]%; or (b) continuation of such
phase II study with additional patients or Initiation of a phase III
study. For the purposes of this Agreement, "CR" shall have the meaning
given to it in Journal of Clinical Oncology, Vol. 21, 2003: 4642-4649:
"Morphologic complete remission: A CR designation requires that the
patient achieve the morphologic leukemia-free state and have an
absolute neutrophil count of more than 1,000/uL and platelets of
100,000/uL. Hemoglobin concentration or hematocrit has no bearing on
remission status, although the patient must be red cell and platelet
transfusion
3 ***CONFIDENTIAL TREATMENT REQUESTED
independent (no red cell transfusion for 2 weeks and no platelet
transfusion for 1 week). The bone marrow would have less than 5% blasts
and no Auer rods. There is no requirement for bone marrow cellularity.
There should be no residual evidence of extramedullary leukemia," and
"CRp" means CR but with platelets of >25,000/uL and
<100,000uL;
"COMMERCIAL SALE" means any sale of the Licensed Product to a third
party in any country in the Territory after the receipt of the
Marketing Authorization for that country;
"COMMITTEE MEMBERS" shall have the meaning given in clause 4.1;
"COMPETING PRODUCT" means any pharmaceutical product (other than the
Licensed Product) indicated for the treatment of acute myeloid leukemia
that is marketed or near to market (phase II clinical development or
later) which in Shire's reasonable opinion is likely to compete with
the Licensed Product to the detriment of the Licensed Product, but
excluding:
(a) any pharmaceutical product which is a kinase inhibitor owned
or licensed by the Licensee; and
(b) pharmaceutical products with scientifically documented
evidence, demonstrating the potential for use in combination
with the Licensed Product.
"COMPOUND" means the compound troxacitabine;
"COMPOUND PATENTS" means the patents and patent applications set out in
Part II of Schedule 2;
"CONFIDENTIAL INFORMATION" means any scientific, technical,
formulation, process, manufacturing, clinical, non-clinical,
regulatory, marketing, financial or commercial information or data
relating to the business, projects or products of either Party and
provided by one Party to the other by written, oral, electronic or
other means in connection with this Agreement;
"CONSULTANCY AGREEMENT" means the consultancy agreement dated 20
February 1996 between BioChem Therapeutic Inc. and [...***...];
"DEVELOPMENT COMMITTEE" means the committee set up by the Parties in
accordance with clause 4.1;
"DEVELOPMENT DATA" means any data, charts, studies, summaries,
analyses, reports, know-how and other information created, generated or
discovered in connection with the Development Plan or any other
pre-clinical or clinical trials or studies of the Licensed Product
conducted by or on behalf of the Licensee;
"DEVELOPMENT PLAN" means the plan for the development of the Licensed
Product by the Licensee as set out in Schedule 1 including the
anticipated Timelines and development budget for the phase II study of
the Licensed Product;
4 ***CONFIDENTIAL TREATMENT REQUESTED
"EFFECTIVE DATE" means the date of this Agreement;
"EXCLUDED PATENTS" means the patents and patent applications identified
in Schedule 9 which are excluded from the license granted to the
Licensee under this Agreement;
"FDA" means the United States Food and Drug Administration and any
successor thereto;
"FIELD" means all pharmaceutical uses of the Licensed Product except
that in relation to the University Patents and University Technology,
"Field" means the treatment of cancer only;
"FORCE MAJEURE" means in relation to either Party any circumstances
beyond the reasonable control of that Party;
"GENERIC PRODUCT" means any pharmaceutical product that is recognized
by a Regulatory Authority in a particular country in the Territory as
"AA or AB" rated (or the equivalent rating in any jurisdiction) against
the Licensed Product or is substitutable at the pharmacy by a
pharmacist for a prescription written for the Licensed Product;
"IMPROVEMENT" means any and all discoveries, developments, inventions,
enhancements or modifications, patentable or otherwise, specifically
relating to the Licensed Product and for use in the Field created,
generated or discovered by or on behalf of either Party or its
Affiliates during the term of this Agreement, but excluding the
Development Data and any regulatory material generated in connection
with an application for Marketing Authorization;
"INTELLECTUAL PROPERTY RIGHTS" means patents, trade marks, service
marks, logos, trade names, rights in designs, copyright, utility
models, rights in know-how and other intellectual property rights, in
each case whether registered or unregistered and including applications
for registration, and all rights or forms of protection having
equivalent or similar effect anywhere in the world;
"INITIATION" means the date of first dosing of the first patient in the
relevant clinical study;
"IPO" means an initial public offering of the Licensee's equity
securities for admission to listing or trading on a recognized
securities exchange or listing or trading on a recognized securities
market;
"LAUNCH" means the commencement of Commercial Sale of the Licensed
Product in any country of the Territory;
"LICENSE AGREEMENT" means the license agreement dated 3 January 1996
between the University of Georgia Research Foundation Inc., Yale
University, Shire BioChem Inc. (formerly BioChem Pharma Inc.), Tanaud
Holdings (Barbados) Limited and Tanaud LLC, as amended from time to
time;
5
"LICENSED PRODUCT" means any pharmaceutical formulations that contain
the Compound alone as a therapeutically active ingredient, or in
combination with any other pharmaceutically active ingredient;
"MARKETING AUTHORIZATION" means the grant of all necessary permits,
authorizations, licenses, approvals (including pricing and
reimbursement approvals, if applicable) or waivers from any relevant
Regulatory Authority required for the research, development,
manufacture, marketing, storage, import, export, transport, use or sale
of the Licensed Product in any country of the Territory;
"MARKETING PLAN" means the marketing plan for the Launch, marketing and
commercialization of the Licensed Product in each country of the
Territory prepared in accordance with clause 6.2;
"MEMORANDUM OF UNDERSTANDING" means a memorandum of understanding
between the University and the Licensee substantially in the form of
Schedule 7;
"MINIMUM SALES FORECASTS" means [...***...]% of the [...***...];
[...***...]% of the [...***...]; [...***...]% of the [...***...]; and
[...***...]% of the [...***...];
"MILESTONE EVENT" means the event identified in Schedule 3 which
triggers a payment under clause 7.2;
"MILESTONE PAYMENT" means the payment by the Licensee to Shire of the
sums identified in Schedule 3 on the occurrence of a Milestone Event;
"MILESTONE PAYMENT TERMS" means the payment of any Milestone Payment or
other applicable payment under clause 7, to Shire as follows:
[...***...]% of such payment to Tanaud Ireland; [...***...]% of such
payment to Tanaud BV; and [...***...]% of such payment to Shire
BioChem;
"NDA" means a new drug application and all supplements filed with the
FDA, including all documents, data and other information concerning the
Licensed Product which are necessary for, or included in, a Marketing
Authorization to use, sell, supply or market the Licensed Product in
the United States of America;
"NET SALES" means the gross amount invoiced by the Licensee, its
Affiliates or Sub-Licensees to third parties in respect of sales of the
Licensed Product, less:
(a) trade, quantity and cash discounts or rebates actually allowed
and taken, provided that such discounts or rebates are not
applied disproportionately to the Licensed Product as compared
with similar products of the selling entity, including those
granted for rejected, damaged and recalled goods;
(b) freight, shipping and related insurance charges, provided that
such charges are no more than 1% of Net Sales;
6 ***CONFIDENTIAL TREATMENT REQUESTED
(c) tax, tariff or customs duties or other government duties
(other than income tax) levied on the sale, transportation or
delivery of the Licensed Product; and
(d) credits, rebates, charge backs or similar payments granted or
given to wholesalers or other third party distributors, health
care insurance carriers, pharmacy benefit management companies
or health care organizations.
For the avoidance of doubt, sales or other transfers between
the Licensee and its Affiliates or its Sub-Licensees are not sales to
third parties, but Net Sales shall include any subsequent sales of the
Licensed Product by such Affiliates or Sub-Licensees to any third
parties. Where the Licensed Product is sold otherwise than on an arms
length basis, the amount that would have been charged in an arms length
sale shall be deemed to be the invoice price for such Licensed Product
and where the Licensed Product is disposed of for consideration other
than cash, such consideration shall be valued at the fair market value.
"OTHER TERRITORIES" means throughout the world, except for the Canadian
Territory and the US Territory;
"PARTY" AND "PARTIES" means respectively Shire or the Licensee, or as
the case may be, both such parties;
"PREMIUM ON EQUITY" means in relation to the acquisition by any third
party of any equity (or any form of security convertible into equity)
in the Licensee or its Affiliates in connection with any Sub-License
Agreement, the excess of actual purchase price paid for such equity
over the fair market value of such equity. For clarity, if the fair
market value of the equity is $8.00 and the amount paid by the third
party is $10.00, the Premium on Equity is $2.00. Any dispute over the
fair market value of the Licensee's stock shall be resolved through the
dispute resolution procedure set out in clause 24.2;
"PRINCIPAL MARKETS" means the United States of America, Canada, Japan,
the United Kingdom, Germany, France, Italy and Spain;
"QUARTER" means a three month period ending on the last day of March,
June, September or December in any calendar year;
"REASONABLE COMMERCIAL EFFORTS" means commercial efforts consistent
with normal business practices and effort used by the Licensee in
connection with other products of similar market size or importance
which the Licensee intends to launch or has launched and sold in the
Territory, or in the absence of any such similar products then such
effort shall be assessed by reference to good business practice in the
light of all the circumstances;
"REGULATORY AUTHORITY" means any competent government agency,
regulatory authority or other administrative body responsible for
granting Marketing Authorization in a particular country or
multinational group of countries in the Territory, including the FDA;
"REMEDIES" shall have the meaning given in clause 12.2;
7
"SALES FORECASTS" means the sales of the Licensed Product anticipated
by the Licensee for a 4 year period from Launch of the Licensed Product
in the US Territory as set out in Schedule 4;
"SEC" means the Securities Exchange Commission in the United States of
America and any successor thereto;
"SHIRE" means Shire BioChem, Tanaud Ireland or Tanaud BV or
collectively Shire BioChem, Tanaud Ireland and Tanaud BV as the case
may be;
"SHIRE INTELLECTUAL PROPERTY" means the Shire Patents, the University
Patents, University Technology and the Shire Know-How;
"SHIRE KNOW-HOW" means all information, procedures, instructions,
techniques, data, technical information (including toxicological,
pharmaceutical, non-clinical, clinical and medical data, health
registration data and marketing data), processing specifications,
pricing studies and market evaluation materials owned by Shire or its
Affiliates (other than Shire Laboratories Inc.) and reasonably
necessary for the development, or in the case of pricing and market
evaluation materials, for commercialization, of the Licensed Product in
the Territory;
"SHIRE MATERIALS" means the Compound and other materials identified in
Schedule 5;
"SHIRE PATENTS" means the Compound Patents and Background Patents and
including, in each case, any divisionals, extensions, reissues,
substitutions, renewals, continuations, continuations-in-part,
provisionals, re-examinations and foreign counterparts thereof
(including European supplementary protection certificates) and patents
issuing thereon;
"SUB-LICENSEE" means any non-Affiliate third party sub-licensee of the
rights (or any part of the rights) granted to the Licensee under this
Agreement;
"SUB-LICENSE AGREEMENT" means any agreement between the Licensee and
the Sub-Licensee granting the right or license under the Shire
Intellectual Property (or any part of it) to develop, manufacture, have
manufactured, use, sell, offer for sale, import or supply the Licensed
Product;
"SUB-LICENSE INCOME" means any consideration in any form received by
the Licensee or its Affiliates in connection with a Sub-License
Agreement, but excluding royalties on Net Sales and amounts received
under arms length non-convertible debt instruments negotiated on
standard commercial terms, including (a) upfront fees, milestone
payments, license maintenance fees, distribution or joint marketing
fees, development funding (in excess of the Licensee's cost of
performing such development), and any investment in the Licensee, and
(b) exchange products, cross-licensed products, options, marketing
rights and such other forms of non-cash consideration that may be
deemed to have value;
"SUB-LICENSEE MOU" means a memorandum of understanding between Shire
and a Sub-Licensee substantially in the form of Schedule 7;
8
"TERRITORY" means the Canadian Territory, the US Territory and the Other
Territories;
"THIRD PARTY ACTION" shall have the meaning given in clause 13.1;
"TIMELINES" means the timelines for the research, development,
registration and Launch of the Licensed Product as set out in the
Development Plan;
"TRADE MARKS" means the trade marks and applications for trade marks set
out in Schedule 6;
"UNIVERSITY" means each of the University of Georgia Research Foundation
Inc. and Yale University;
"UNIVERSITY PATENTS" means the patents and patent applications set out in
Part III of Schedule 2 and including, any divisionals, extensions,
reissues, re-examinations, continuations, and foreign counterparts
thereof and patents issuing thereon;
"UNIVERSITY TECHNOLOGY" means the "Licensed Technology" as defined in the
License Agreement; and
"US TERRITORY" means the United States of America and its territories and
possessions.
1.2 In this Agreement, unless the context requires otherwise:
(a) the headings are included for convenience only and shall not
affect its construction;
(b) references to "persons" includes individuals, bodies corporate
(wherever incorporated), unincorporated associations and
partnerships;
(c) words denoting the singular shall include the plural and vice
versa;
(d) references to the word "including" are to be construed without
limitation;
(e) words denoting one gender shall include each gender and all
genders; and
(f) any reference to an enactment or statutory provision is a
reference to it as it may have been, or may from time to time be
amended, modified, consolidated or re-enacted.
1.3 The Schedules comprise part of and shall be construed in accordance with
the terms of this Agreement. In the event of any inconsistency between
the Schedules and the terms of this Agreement, the terms of this
Agreement shall prevail.
2. GRANT OF LICENSE
2.1 Subject to the terms of this Agreement, Shire hereby grants the Licensee:
9
(a) an exclusive license under the Shire Patents and Shire Know-How to
develop, manufacture, have manufactured, use, sell, offer for
sale, import and supply the Licensed Product in the Territory and
in the Field; and
(b) an exclusive sub-license under the University Patents and
University Technology to develop, manufacture, have manufactured,
use, sell, offer for sale, import and supply the Licensed Product
in the Territory and in the Field.
2.2 Except to the extent necessary to enable Shire to perform its obligations
under this Agreement and subject to the terms of the License Agreement
(and in particular the University's rights under Articles 2.2 and 2.4 of
the License Agreement) the term "exclusive" for the purposes of clause
2.1, means to the exclusion of all others, including Shire and its
Affiliates.
2.3 This Agreement and the grant of any license pursuant to clauses 2.1 and
10.1 shall in all respects be conditional upon the Licensee receiving
US$12 million in cash from its investors and providing documentary
evidence, to Shire's reasonable satisfaction, of receipt of such sum by
no later than September 30, 2004. If such condition subsequent is not
fulfilled (or waived) on or before September 30, 2004, this Agreement
shall automatically terminate, Shire shall be entitled to retain any
upfront payment received and neither party shall have a claim of any
nature whatsoever against the other party under this Agreement (except in
respect of any rights or liabilities of the parties which have accrued
prior to termination).
2.4 The Licensee undertakes to:
(a) use all reasonable efforts to ensure that the condition subsequent
in clause 2.3 is fulfilled as soon as reasonably practicable and
in any event by September 30, 2004; and
(b) keep Shire informed of the progress towards satisfaction of such
condition precedent and in particular promptly disclose in writing
to Shire anything which will or may prevent the condition
subsequent from being satisfied.
3. SUB-LICENSING
3.1 The Licensee shall have the right to sub-license the rights granted under
this Agreement to its Affiliates or any third party, provided that:
(a) the Licensee provides Shire the opportunity to review the
Sub-License Agreement (which, subject to the disclosure to the
University to the extent required under the License Agreement and
subject to the Universities' confidentiality obligations
thereunder, Shire shall treat as Confidential Information of the
Licensee) prior to its execution and considers in good faith any
reasonable amendments to the Sub-License Agreement requested by
Shire and subject to clause 3.1A, shall obtain the University's
prior consent (such consent not be unreasonably withheld or
delayed);
10
(b) any Sub-License Agreement shall be in writing and, with the
exception of the financial terms, be consistent with the terms of
this Agreement (except that the Sub-Licensee shall not have the
right to sub-license, unless Shire and the University have
consented to such right, which consent, if requested by the
Licensee, shall not be unreasonably withheld or delayed); and
(c) the Licensee shall remain responsible to Shire with respect to all
the operations of its Sub-Licensee relevant to the use Licensed
Product under this Agreement as if such operations were carried
out by the Licensee, including the provision of Reasonable
Commercial Efforts in the development, manufacture, registration
and Launch of the Licensed Product, the making of any payments
under this Agreement, the provision of indemnities, the provision
of insurance and compliance with applicable law.
3.1A The Licensee may enter into a Sublicense Agreement without the prior
consent of the University if:
(a) the relevant territory of the Sub-License Agreement is outside the
Principal Markets; or
(b) the relevant territory of the Sub-License Agreement is within the
Principal Markets, provided that, the Sub-Licensee, at the time of
grant:
(i) is listed on a recognized securities exchange and has
market capitalization of not less than U.S.$ [...***...]
million, or is a private company with cash of not less than
U.S.$ [...***...] million; and
(ii) has a current marketing authorization for at least one
other regulatory-approved pharmaceutical oncology product
in any country in the Principal Markets prior to the date
of the Sub-License Agreement.
3.2 Shire shall use reasonable endeavours to procure that the University
signs a Memorandum of Understanding, and shall provide the same to the
Licensee on the Effective Date for countersignature by the Licensee. Upon
request by the Licensee, Shire shall consent (which consent shall not be
unreasonably withheld or delayed) to signing a Sub-Licensee MOU, provided
that, the reason for the termination of this Agreement does not relate in
any way to any act or omission of the Sub-Licensee, its Affiliates,
representatives or sub-licensees.
3.3 In the event that the Licensee enters a Sub-License Agreement pursuant to
clause 3.1, the Licensee shall promptly after execution of such
Sub-License Agreement, provide Shire with a copy of the final form of the
Sub-License Agreement, which Shire shall treat as Confidential
Information of Licensee.
3.4 The Licensee shall not, and shall procure that its Affiliates and
Sub-Licensees shall not:
(a) utilize any part of the Shire Intellectual Property in the making
of any patent application, except as otherwise agreed in writing
by the Parties pursuant to the terms of this Agreement; or
11 ***CONFIDENTIAL TREATMENT REQUESTED
(b) manufacture, supply, market or sell, or knowingly assist any
third party to manufacture, supply, market or sell any
Competing Product anywhere in the Territory; unless in the
event of a Change of Control of Licensee, the new controlling
party has a Competing Product and Shire does not terminate the
Agreement pursuant to clause 19.2(c), in which event, this
sub-clause 3.3(b) shall not apply.
3.5 Shire agrees not to terminate the License Agreement without the prior
written consent of the Licensee (which consent shall not be unreasonably
withheld or delayed). Shire further agrees that within 5 Business Days
after a request from Licensee, Shire shall provide the University with
the written notice under clause 2.2(a) of the Memorandum of
Understanding, provided that the reason for the termination of the
License Agreement by the University does not relate in any way to any act
or omission of the Licensee, its Affiliates, representatives or
Sub-Licensees.
4. THE DEVELOPMENT COMMITTEE
4.1 The Parties shall establish a Development Committee consisting of 4
individuals ("COMMITTEE MEMBERS"); 2 of whom shall be nominated by Shire;
and 2 of whom shall be nominated by the Licensee. Either Party may
replace its Committee Members by notice to the other Party. The Committee
Members shall be appropriately qualified and experienced in order to make
a meaningful contribution to Development Committee meetings.
4.2 The purpose of the Development Committee is to provide a forum for the
Parties to share information and knowledge on the on-going research,
development and commercialisation of the Licensed Product including
monitoring the progress of non-clinical and clinical studies, reviewing
clinical trial programmes, considering proposed regulatory filings,
Launch plans, marketing and promotional plans, reviewing competitor
activity and discussing any regulatory, technical, quality assurance or
safety issues in relation to the Licensed Product. The Development
Committee shall conduct its discussions in good faith with a view to
operating to the mutual benefit of the Parties and in furtherance of the
successful development and commercialisation of the Licensed Product.
4.3 The Development Committee shall meet as often as the Committee Members
may determine, but in any event not less than once per calendar year. The
Committee Members may invite individuals with special skills to attend
such meetings where it is considered to be relevant and appropriate. The
quorum for Development Committee meetings shall be 2 Committee Members,
comprising 1 Committee Member from each Party.
5. DEVELOPMENT AND MARKETING AUTHORIZATIONS
5.1 Shire shall use reasonable efforts within 90 days from the Effective
Date:
(a) to deliver to the Licensee (or its nominee) the Shire Know-How to
the extent that it is reasonably necessary for the research and
development of the Licensed Product by the Licensee in accordance
with the Development Plan, the University Technology under Shire's
possession or control;
(b) to deliver to the Licensee (or its nominee) the Shire Materials;
12
(c) transfer the investigational new drug application (filed with the
FDA) relating to the development and use of Licensed Product to
the Licensee; and
(d) transfer its rights and obligations to the Licensee under the
clinical research services agreements relating to the phase I
clinical studies ([...***...] and [...***...]) of the Licensed
Product between Shire Pharmaceutical Development Inc. and
Quintiles Inc. From the Effective Date, the Licensee shall bear
the cost of and risk in such phase I studies.
5.2 For a period of 3 months following the Effective Date, Shire shall
provide the Licensee with a reasonable amount of access during normal
business hours to [...***...], and [...***...], as is reasonably
necessary to teach the Shire Know-How to the Licensee, provided that, the
personnel remain employed or engaged by Shire and such access is limited
to no more than an aggregate of 25 person working days and no more than 2
working days in any working week. Shire shall not terminate the
employment or engagement of any of the above personnel for 3 months
following the Effective Date. Shire shall promptly inform the Licensee
if, during such period, any of the relevant personnel cease to work for
Shire. In the event that the Licensee requires additional access to Shire
personnel, the Parties shall in good faith negotiate the cost to the
Licensee of such access.
5.3 The Licensee shall:
(a) at [...***...], use its Reasonable Commercial Efforts to perform,
or procure the performance of, the activities and services in the
Development Plan;
(b) perform, or procure the performance of, any such activities and
services with reasonable care and skill and ensure that personnel
employed or engaged by it in the provision of any such activities
and services are competent and have appropriate professional
qualifications, training and experience;
(c) complete the Development Plan as expeditiously as reasonably
possible using its Reasonable Commercial Efforts to meet and
comply with the Timelines; and
(d) update Shire at regular intervals, to be agreed between the
Parties, on the progress of the Development Plan and submit a
written report to Shire and the University every [...***...] as
soon as reasonably practicable after [...***...] of each year and
in any event by [...***...] respectively, detailing its progress
of the research, development, registration and commercialisation
of the Licensed Product and the amount of direct expenditures
associated with the development of the Licensed Product for the
previous [...***...] months.
5.4 Upon completion of the Development Plan, the Licensee shall, at
[...***...], use, or cause its Affiliates and Sub-Licensees to use,
Reasonable Commercial Efforts to prepare, file, prosecute and maintain
all applications for Marketing Authorization and any other necessary
licenses, permits, authorizations and approvals (or waivers) required by
any Regulatory Authority for the Launch, use, promotion, import, sale,
distribution or commercialisation of the Licensed Product in the
Principal Markets. The Licensee shall file its application for
13 ***CONFIDENTIAL TREATMENT REQUESTED
NDA in the United States of America no later than [...***...] following
completion of the Development Plan with respect to that country.
6. LAUNCH AND MARKETING EFFORTS
6.1 The Licensee shall, at [...***...] use its Reasonable Commercial Efforts,
or procure that its Affiliates or Sub-Licensees use their Reasonable
Commercial Efforts, to:
(a) Launch the Licensed Product in the Principal Markets as soon as
reasonably practicable following receipt of Marketing
Authorization in the relevant country and in any event Launch the
Licensed Product no later than [...***...] following receipt of
Marketing Authorization in such country; and
(b) research, develop, manufacture, distribute and sell, or cause its
Affiliates or Sub-Licensees (except for third party contract
research organisations or pharmaceutical manufacturers) to
research, develop, manufacture, distribute and sell the Licensed
Product in the Principal Markets.
6.2 The Licensee shall, within [...***...] from filing the NDA for the
Licensed Product, provide the Development Committee with its Marketing
Plan setting out its strategy for the Launch of the Licensed Product
including revised Sales Forecasts (if applicable), anticipated pricing
levels and reimbursement levels, if appropriate, and marketing and
promotion plans and spend, in relation to the Licensed Product for the
calendar year following approval of the NDA. Thereafter, and on or before
31 October of each calendar year, the Licensee shall provide the
Development Committee with its Marketing Plan for the next calendar year.
Each Marketing Plan shall include net sales targets, projections with
respect to sales force staffing levels, marketing research strategies,
marketing and promotion plans, physician education plans and general
advertising and related budgets for sales of the Licensed Product in the
relevant calendar year.
6.3 Licensee shall:
(a) perform, or procure the performance of, the activities set out in
the Marketing Plan;
(b) use Reasonable Commercial Efforts to meet the Sales Forecasts; and
(c) on reasonable request from Shire, provide it with copies of the
packaging, packaging inserts and any advertising or promotional
materials (including translations, if necessary) used in
connection with the sale of the Licensed Product in the Territory.
6.4 The Licensee acknowledges that the Sales Forecasts are its good faith
estimates of sales of the Licensed Product in the Territory based on
information available to the Licensee at the Effective Date.
6.5 The Licensee may, on submitting the first Marketing Plan and subject to
the terms of this Agreement, revise the Sales Forecasts. Any reduction in
the Sales Forecasts must be based on the following:
14 ***CONFIDENTIAL TREATMENT REQUESTED
(a) an unexpected and materially adverse change in the market for the
Licensed Product in the Territory;
(b) unexpected clinical data generated from the Development Plan or an
unexpected pricing decision from a Regulatory Authority which, in
each case, has an adverse effect on the anticipated sales of the
Licensed Product; or
(c) advice from a Regulatory Authority which specifies restrictions to
the use of the Licensed Product that reduces the anticipated
market for the Licensed Product in the Territory.
6.6 Notwithstanding anything contained in clause 6.5, any such reduction in
the Sales Forecast in the first Marketing Plan must:
(a) be supported by a written report explaining, to Shire's reasonable
satisfaction, the reasons for such reduction;
(b) not be due to reasons which could have reasonably been foreseen by
the Licensee at the Effective Date and shall not, in any event, be
less than the [...***...] identified at the Effective Date; and
(c) be more than [...***...]% of the initial Sales Forecast before the
Licensee shall be entitled to seek such a reduction.
6.7 In the event that the Licensee fails to meet a Minimum Sales Forecasts in
any calendar year, the Licensee shall pay Shire, within 30 days from the
end of the relevant calendar year, an additional payment representing
[...***...] that [...***...] on the [...***...] the [...***...] for the
[...***...] and the [...***...].
7. ROYALTY AND MILESTONE PAYMENTS
7.1 In consideration of the rights granted under this Agreement, the Licensee
shall pay Shire (or its nominee) the non-creditable and non-refundable
sum of US$3 million within 3 Business Days from the Effective Date and
the non-creditable and non-refundable sum of US$1 million within 5
Business Days of the first anniversary of the Effective Date, in
accordance with the Milestone Payment Terms.
7.2 Upon the occurrence of each Milestone Event, the corresponding
non-refundable Milestone Payment shall be made by the Licensee to Shire
in accordance with the Milestone Payment Terms. For the avoidance of
doubt, each Milestone Payment shall be made no more than once with
respect to the achievement of a Milestone Event, but shall be payable the
first time the Milestone Event is achieved. [...***...]% of any
development Milestone Payments (but not sales Milestone Payments) shall
be creditable against royalties due to Shire under sub-clauses 7.3(a),
7.3(b), 7.3(c), 7.3(d) (but not royalties under sub-clause 7.3(e)), and
if applicable, sub-clauses 7.4(a), 7.4(b), 7.4(c), 7.4(d) (but not
royalties under sub-clause 7.4(e)), provided that, in no event will the
credit for such development Milestone Payments reduce the royalties
payable to Shire in any Quarter by more than [...***...]%. Any amount
that has not been so credited
15 ***CONFIDENTIAL TREATMENT REQUESTED
may be credited against royalties due in subsequent Quarters, subject to
the limitation described in the previous sentence. For the avoidance of
doubt, upon expiry or termination of this Agreement, Shire shall not be
liable to the Licensee for any credit amount accrued and not credited.
7.3 Subject to clauses 7.4, 7.7(b) and 8.2, during the term of this
Agreement, the Licensee shall pay Shire:
(a) a royalty of [...***...]% of the first US$[...***...] of Net Sales
of the Licensed Product in the Territory in any calendar year;
(b) a royalty of [...***...]% of any Net Sales in excess of
US$[...***...] and up to US$[...***...] in the Territory in any
calendar year;
(c) a royalty of [...***...]% of any Net Sales in excess of
US$[...***...] and up to US$[...***...] in the Territory in any
calendar year;
(d) a royalty of [...***...]% of any Net Sales in excess of
US$[...***...] in the Territory in any calendar year; and
(e) any royalties or other payments to be made by Shire or its
Affiliates under the License Agreement or the Consultancy
Agreement, incurred after the Effective Date, other than payments
under Articles 4.5 and 4.6 of the License Agreement. [...***...]%
of any payments made by the Licensee for milestone payments
properly paid by the Licensee under Article 4.2(c) of the License
Agreement shall be creditable against royalties in accordance with
clause 7.2 above.
7.4 At any time during calendar year [...***...], Licensee shall have the
right to pay to Shire the non-creditable and non-refundable sum of
US$[...***...] in accordance with the Milestone Payment Terms and in such
event, Licensee shall have no obligation to make any payments to Shire
under clause 7.3, but instead shall pay Shire the following:
(a) a royalty of [...***...]% of the first US$[...***...] of Net Sales
of the Licensed Product in the Territory in any calendar year;
(b) a royalty of [...***...]% of any Net Sales in excess of
US$[...***...] and up to US$[...***...] in the Territory in any
calendar year;
(c) a royalty of [...***...]% of any Net Sales in excess of
US$[...***...] and up to US$[...***...] in the Territory in any
calendar year;
(d) a royalty of [...***...]% of any Net Sales in excess of
US$[...***...] in the Territory in any calendar year; and
(e) any royalties or other payments to be made by Shire or its
Affiliates under the License Agreement or the Consultancy
Agreement, incurred after the Effective Date, other than payments
under Articles 4.5 and 4.6 of the License Agreement.
16 ***CONFIDENTIAL TREATMENT REQUESTED
7.5 In the event that the Licensee supplies a Licensed Product to any
customer as part of a package or combination of products, then the Net
Sales of the Licensed Product shall be whichever is the higher of:
(a) the fair market value of such Licensed Product when sold by
itself; or
(b) the proportion of the selling price of such package of products
which is reasonably attributable to the Licensed Product.
7.6 For the purposes of clause 7.5, fair market value means the value of
Licensed Product sold to similar customers in the Territory with similar
pricing and reimbursement structures and for similar quantities. Any
dispute as to the determination of fair market value or proportion of the
selling price of a package of products attributable to the Licensed
Product shall be resolved through the dispute resolution procedure set
out in clause 24.2.
7.7 Subject to clauses 7.9 and 8.2, in the event that Licensee or its
Affiliates enters into a Sub-License Agreement in any Territory, then
Licensee shall pay to Shire in addition to the Milestone Payments:
(a) subject to clause 7.10, [...***...]% of any Sub-License Income;
and
(b) in lieu of royalties under clauses 7.3 or 7.4 applicable to Net
Sales by such Sub-Licensee in its particular territory, the
greater of:
(i) [...***...]% of any royalty payments received by Licensee
or its Affiliates from the Sub-Licensee or its Affiliates
for sales of Licensed Products by or on behalf of the
Sub-Licensee; or
(ii) [...***...]% of Net Sales by the Sub-Licensee and its
Affiliates.
7.8 In the event that Sub-License Income corresponds to a Milestone Payment
under this Agreement which has not already been paid by the Licensee and
such Sub-License Income is greater than the respective Milestone Payment,
the Licensee shall pay Shire on the occurrence of the Milestone Event the
full Milestone Payment plus [...***...]% of the difference between the
Sub-License Income and the relevant Milestone Payment.
7.9 In addition to any payments made by the Licensee under clause 7.7, the
Licensee shall pay any royalties or other payments to be made by Shire or
its Affiliates under the License Agreement and the Consultancy Agreement,
incurred after the Effective Date, other than payments under Articles 4.5
and 4.6 of the License Agreement.
7.10 In the event that the Licensee or its Affiliates receives any Sub-License
Income by way of cash consideration in relation to the acquisition of
equity (or any form of security convertible into equity) in the Licensee
or its Affiliates or non-cash consideration upon which payment would be
due to Shire under clause 7.7, the Licensee shall pay Shire:
(a) in relation to the acquisition of equity (or any form of security
convertible into equity) in the Licensee or its Affiliates the
greater of:
17 ***CONFIDENTIAL TREATMENT REQUESTED
(i) [...***...]% of the Premium on Equity; or
(ii) [...***...]% of the total amount received or to be received
by the Licensee or its Affiliates; or
(b) in relation to the payment of non-cash consideration, [...***...]%
of the fair market cash value of such non-cash consideration at
the date of receipt of the non-cash consideration by the Licensee
or its Affiliate.
8. PAYMENT TERMS
8.1 Unless otherwise expressly stated, payments due under this Agreement
shall be made by the Licensee to Shire (or its nominee) as follows:
(a) in respect of any development Milestone Payments, within
[...***...] days from identification of the occurrence of the
development Milestone Event by the Licensee;
(b) in respect of any sales Milestone Payments, within [...***...]
days from the end of the Quarter in which the relevant Milestone
Event occurred;
(c) in respect of Net Sales royalty payments during any Quarter,
within [...***...] days from the end of that Quarter;
(d) in respect of any payments under clause 7.7, within [...***...]
days from receipt of the Sub-Licensing Income by the Licensee or
its Affiliates from the Sub-Licensee, or in relation to royalties
on Net Sales within [...***...] days from the end of the relevant
Quarter; and
(e) in respect of any payments to be made under the License Agreement
during any Quarter, within [...***...] days from the end of the
Quarter.
8.2 The payment of all Net Sales royalty revenue from the Licensee, its
Affiliates or its Sub-Licensees, to Shire shall:
(a) in respect of sales of the Licensed Product in the US Territory,
be paid to Tanaud Ireland;
(b) in respect of sales of the Licensed Product in the Canadian
Territory, be paid to Shire BioChem; and
(c) in respect of sales of the Licensed Product in the Other
Territories, be paid to Tanaud BV.
8.3 All payment sums due under this Agreement to Shire shall be paid in US
dollars. Net Sales shall be determined in the currency in which the
Licensed Product was sold and shall be converted into US dollars using
the spot rate on the last day of the relevant Quarter as
18 ***CONFIDENTIAL TREATMENT REQUESTED
published by the Wall Street Journal for the relevant Quarter for which
such payment is being determined.
8.4 At the same time as payment of any Net Sales royalty falls due, the
Licensee shall submit to Shire a statement in writing recording the
calculation of the amounts payable and including:
(a) the number of Licensed Products which have been supplied in each
country of the Territory during the previous Quarter;
(b) the Net Sales generated in each country of the Territory during
the previous Quarter; and
(c) the amount of royalties due and payable to Shire in relation to
sales of the Licensed Product in the US Territory, the Canadian
Territory, the Other Territories, and the Territory as a whole
(including where appropriate the exchange rate used).
8.5 Interest shall be payable by the Licensee on any amounts payable to Shire
under this Agreement which are not paid by the due date for payment. All
interest shall accrue and be calculated on a daily basis (both before and
after any judgment) at the rate of [...***...]% per annum above the base
rate of Barclays Bank plc from time to time, for the period from the due
date for payment until the date of actual payment.
8.6 Notwithstanding any other provision of this Agreement, if at any time
legal restrictions prevent the prompt remittance of part or all of the
payments required hereunder in any country, payment shall be made through
such lawful means as Shire may determine.
8.7 Any tax that the Licensee, its Affiliates or Sub-Licensees are required
to withhold to comply with relevant laws with respect to the royalties
and other payments due under this Agreement, shall be deducted from said
payments prior to remittance; provided, however, that in regard to any
tax so deducted, the Licensee shall give or cause to be given to Shire
such assistance, including documentary evidence, as may reasonably be
necessary to enable Shire to claim exemption therefrom or credit
therefor, and in each case, the Licensee shall furnish to Shire proper
evidence of the taxes paid on its behalf. Unless otherwise expressly
stated, all sums due under this Agreement shall be paid without
deduction, set-off or counterclaim.
8.8 The obligation of the Licensee to pay royalties and any other payments
due under this Agreement, shall continue on a country-by-country basis
for the term of this Agreement. Subject to clause 8.9, in the event that
there are no issued Shire Patents or University Patents covering the use
of the Licensed Product in a country in the Territory, the royalty
payments due to Shire (but not those due to the University under the
License Agreement) for Net Sales in such country shall be reduced by
[...***...]%, provided that:
(a) one or more Generic Products have been granted marketing
authorization and are being sold in such country; and
18 ***CONFIDENTIAL TREATMENT REQUESTED
(b) IMS data demonstrates that the market share for the Licensed
Product in such country has been reduced by [...***...]% or more
in any two consecutive Quarters following the launch of the
Generic Product in such country.
8.9 In the event that after the grant of marketing authorization of the
Generic Product any Shire Patent or University Patent application is
issued, and such patent is able to prevent the sale of the Generic
Product in the relevant country the royalty payments due to Shire for Net
Sales in such country shall return to the royalty rates set out in clause
7.3 or 7.4 as applicable.
9. RECORDS AND REPORTS
9.1 During the term of this Agreement, and for a period of [...***...] years
after its expiry or termination, the Licensee shall, and shall procure
that its Affiliates and Sub-Licensees shall, keep at its or their normal
place of business detailed, accurate and up to date records and books of
account showing the sales of the Licensed Product in each country in the
Territory sufficient to ascertain:
(c) any Net Sales generated in connection with the sale of the
Licensed Product and royalties payable to Shire under this
Agreement; and
(d) the achievement or progress towards achievement of any Milestone
Event, provided that, in the event that the Milestone Event
relates to the development of the Licensed Product, the Licensee
has failed to meet the Timelines and, in Shire's reasonable
opinion, the Licensee has failed to adequately explain the reasons
for the delay.
9.2 On no less than [...***...] Business Days notice from Shire, the Licensee
shall make, or procure that its Affiliates or Sub-Licensees make, such
records and books of account available for inspection by Shire (or its
nominee) for the purpose of audit to confirm payments due under this
Agreement, but not more than [...***...] in any calendar year in relation
to royalties payable to Shire under this Agreement and not more than
[...***...] in any calendar year in relation to the achievement of any
Milestone Event. Shire (or its nominee) shall be entitled to take copies
or extracts from such records or books of account during any such review
or audit.
9.3 Shire shall be solely responsible for its costs and expenses in making
any such review or audit, unless Shire identifies a discrepancy in the
sums paid in any calendar year from those payable under this Agreement
for that calendar year of greater than [...***...]%, in which event the
Licensee shall pay Shire's costs and expenses incurred in connection with
the review or audit, and make good the deficit in the payments (including
any interest amount calculated in accordance with clause 8.5).
9.4 All information disclosed by the Licensee, its Affiliates or its
Sub-Licensees pursuant to this clause 9 shall be deemed Confidential
Information of Licensee, its Affiliates or its Sub-Licensees, as
applicable.
20 ***CONFIDENTIAL TREATMENT REQUESTED
10. TRADE MARKS
10.1 Shire hereby grants the Licensee an exclusive license, with the right
to sublicense, to use the Trade Marks in relation to the sale,
promotion and marketing of the Licensed Product in the Territory for
the term of this Agreement. The Licensee shall:
(a) use the Trade Marks only in a manner which conforms to the
reasonable directions and standards notified to it by Shire
from time to time;
(b) market the Licensed Product throughout the Territory under the
Trade Marks and ensure that all marketing materials for the
Product shall display the Trade Marks;
(c) not use, register or attempt to register any trade marks,
company, business or trading names or domain names which are
identical or similar to (or which incorporate) any of the
Trade Marks, any aspect of them, or any other trade marks or
trade names used by Shire, without Shire's prior written
consent; and
(d) not do anything which could, in Shire's reasonable opinion,
bring the Trade Marks or Shire into disrepute or which could
otherwise damage the goodwill attaching to the Trade Marks or
any other trade marks or trade names of Shire.
10.2 Shire shall, [...***...], maintain the registrations for the Trade
Marks, and shall use reasonable efforts to prosecute any applications
for registration of the Trade Marks through to grant in the Territory.
10.3 The Licensee acknowledges that:
(a) it shall not acquire, nor claim, any right, title or interest
in or to any of the Trade Marks or the goodwill attaching to
them by virtue of this Agreement or its use of the Trade
Marks, other than the rights specifically granted to it under
clause 10.1; and
(b) all goodwill arising from use of the Trade Marks by the
Licensee before, during or after the term of this Agreement
shall accrue and belong to Shire, and the Licensee shall, at
Shire's request and cost, promptly execute all documents
required by Shire to confirm this.
11. INTELLECTUAL PROPERTY, IMPROVEMENTS AND PATENTS
11.1 Except as set out in this Agreement and the License Agreement, all
right, title and interest in the Shire Intellectual Property and the
Trade Marks shall belong to Shire, and the Licensee shall not have any
right, title or interest in the Shire Intellectual Property or the
Trade Marks.
11.2 All Intellectual Property Rights in the Development Data shall belong
to the Licensee. The Licensee shall disclose reasonably detailed
summaries of the Development Data to Shire through the Development
Committee.
11.3 Shire shall, at its sole option, file, prosecute, maintain or extend
the Shire Patents. Subject to the terms of the License Agreement, Shire
shall:
21 ***CONFIDENTIAL TREATMENT REQUESTED
(a) keep the Licensee reasonably informed of any material
developments or notices in connection with the prosecution of
any Shire Patents or University Patent applications, but only
to the extent that the material developments or notices relate
to the Licensed Product;
(b) give the Licensee a reasonable opportunity to comment on any
Shire response to such developments or notices that are
intended to be filed in any patent office in relation to the
Compound Patents and consider in good faith any such comments;
and
(c) give the Licensee a reasonable opportunity to liaise and
cooperate with the University in the prosecution and
maintenance of the University Patents.
11.4 Any expenses incurred after the Effective Date in the filing,
prosecution or maintenance of:
(a) the University Patents, shall borne by the Licensee;
(b) the Compound Patents shall be borne by the Licensee and shall
be creditable (but non-refundable) against royalty payments
due from Licensee to Shire under clause 7 (including for the
avoidance of doubt, payments under clause 7.7(b)), provided
that, in no event will any credit amount under this Agreement
reduce the royalties payable to Shire in any Quarter by more
than [...***...]% (and any amount that has not been so
credited may be credited against royalties due in subsequent
Quarters, subject to the limitation described in the previous
sentence); and
(c) the Background Patents, shall be borne by Shire.
11.5 In the event that Shire elects not to continue to file, prosecute or
maintain patent protection for any of the Compound Patents, the
Licensee shall have the right, at its option, to maintain such Compound
Patents on behalf of Shire. Without limiting the generality of the
foregoing, in no event shall Shire provide the Licensee with notice of
abandonment of any Compound Patents less than 30 days prior to its date
of lapse.
11.6 Shire shall maintain patent protection for all Background Patents
identified as [...***...] and [...***...] in the Principal Markets.
11.7 Shire reserves all of its rights not expressly granted to the Licensee
under this Agreement. The Licensee shall not, and shall not attempt or
purport to file or prosecute in any country any patent application
which claims, or purports to claim, any Shire Intellectual Property,
except as permitted under clause 11.5. Additionally, the Licensee shall
not, directly or indirectly prevent or attempt to prevent Shire from
filing or prosecuting in any country any patent application which
claims, discloses or uses or purports to claim, disclose or use any
Shire Intellectual Property.
12. INFRINGEMENT OF SHIRE INTELLECTUAL PROPERTY RIGHTS
12.1 Each Party shall promptly notify the other, with such details as it has
in its possession, on becoming aware of any third party infringement,
or suspected infringement, of any part of the Shire Intellectual
Property or the Trade Marks in the Territory.
22 ***CONFIDENTIAL TREATMENT REQUESTED
12.2 Subject to the terms of the License Agreement, Shire shall have the
first right, but not the obligation, to take action in respect of any
infringements of the Shire Intellectual Property or the Trade Marks,
including any injunctive, compensatory or other remedies or relief
(collectively "REMEDIES") as may be necessary or desirable to prevent
such infringement and preserve the Shire Intellectual Property. The
Licensee shall permit any such Remedies to be brought in its name if
permitted or required by law. Shire may compromise or settle any of the
Remedies at its sole discretion, provided that, Shire shall not make
any settlement or compromise that adversely affects the interests of
the Licensee in respect of the Licensed Products in the Territory
without the prior written consent of the Licensee, such consent not to
be unreasonably withheld or delayed.
12.3 In the event that Shire does not pursue any Remedies with respect to
the Shire Intellectual Property or the Trade Marks within 60 days
following notice of alleged infringement or 10 days before the time
limit, if any, for the filing of any infringement action, whichever is
sooner, then the Licensee shall, subject to the terms of the License
Agreement, have the right but, not the obligation, to pursue the
Remedies against such third party infringer at its sole cost, provided
that, the Licensee does not make any settlement or compromise that
adversely affects the interests of Shire without the prior written
consent of Shire, such consent not to be unreasonably withheld or
delayed. For the avoidance of doubt, the Licensee's right to pursue any
Remedies with respect to the infringement, or suspected infringement,
of any part of the Shire Intellectual Property is limited to the extent
that such infringement, or suspected infringement relates to the
Compound.
12.4 In the event that either Party pursues the Remedies under clauses 12.2
or 12.3:
(a) the other Party shall provide reasonable assistance to and
cooperate with the Party pursuing such Remedies, including
providing access to relevant documents and personnel and
furnishing a power of attorney if required by law;
(b) the Party that pursues the Remedy shall keep the other Party
fully informed of the progress of, and developments in, any
proceedings including any settlement discussions with the
defendants or potential defendants of such proceedings;
(c) each Party shall bear its own costs and expenses relating to
its pursuit of the Remedies or in providing assistance and
cooperation; and
(d) any damages or other amounts awarded or obtained by either
Party shall, subject to the terms of the License Agreement, be
distributed as follows:
(i) firstly to cover any legal costs and expenses
incurred by the Party that pursued the Remedies; and
then
(ii) to cover those legal costs and expenses, if any,
incurred by the other Party relating to the pursuit
of such Remedies; and then
(iii) any remaining amount identified as damages for lost
sales of the Licensed Product, after the deductions
set out above, shall be paid to Licensee except that
23
Shire shall receive a portion equivalent to the
royalties it would have received under this Agreement
if such amount were deemed Net Sales; and then
(iv) any remaining amount of damages awarded, other than
for damages for lost sales, shall be divided
[...***...], with Licensee receiving [...***...]% and
Shire receiving [...***...]%.
12.5 Notwithstanding anything contained in this Agreement, Shire reserves
the right to control, at its sole expense, any opposition, protest,
claim, proceedings, challenge or litigation relating to the validity of
the Background Patents. The Licensee shall, and shall procure that its
Affiliates and Sub-Licensees shall, provide such reasonable assistance
and co-operation to Shire, at Shire's reasonable expense, as is
necessary for the conduct of any such opposition, protest, claim,
proceedings, challenge or litigation. The Licensee may participate in
the defence or settlement of any opposition, protest, claim,
proceedings, challenge or litigation relating to the validity of the
Background Patents at its own cost with counsel of its choice, provided
that:
(a) Shire has control of the conduct of such opposition, protest,
claim, proceedings, challenge or litigation relating to the
validity of the Background Patents; and
(b) the Licensee shall not, and shall procure that its Affiliates
and Sub-Licensees shall not, during the course of such
proceedings make any statement or admission that compromises
the validity of the Background Patents.
13. INFRINGEMENT OF THIRD PARTY RIGHTS
13.1 In the event that any third party commences or threatens to commence
patent, trade secret or other patent infringement action against the
Licensee during the term of this Agreement, alleging that its use of
the Licensed Product in the Territory infringes the third party's
Intellectual Property Rights ("THIRD PARTY ACTION"), the Licensee shall
by written notice promptly inform Shire of the Third Party Action,
providing all such details of the Third Party Action as are in its
possession. Upon receipt of the notice, the Parties shall promptly
discuss the best way to respond to the Third Party Action.
13.2 The Licensee shall, at its sole cost and in its sole discretion, defend
and control the defence of any such Third Party Action using counsel of
its own choice, provided that:
(a) Shire may participate in the defence or settlement of the
Third Party Action at its own cost with counsel of its
choice; and
(b) the Licensee shall not settle the Third Party Action in a
manner adverse to Shire, except as agreed in writing by Shire,
such agreement not to be unreasonably withheld or delayed.
13.3 In any Third Party Action under this clause 13, the Parties shall
cooperate with each other in connection with any such claim, suit or
proceeding and shall keep each other reasonably informed of any
material development in connection with the Third Party Action,
including providing access to relevant documents, personnel or other
evidence.
24 ***CONFIDENTIAL TREATMENT REQUESTED
14. INDEMNIFICATION AND INSURANCE
14.1 The Licensee shall defend, indemnify and hold harmless Shire, its
Affiliates and its and their directors, officers, employees and
contractors ("SHIRE PARTIES") from and against any and all claims,
actions, demands, losses, damages, costs and reasonable expenses
(including reasonable legal, counsel and expert fees) made or brought
by any third parties ("CLAIMS") arising from or in connection with the
research, development, testing, manufacture, marketing, distribution,
sale or use of the Licensed Product by Licensee or its Affiliates or
its or their Sub-Licensees, except to the extent that such Claims
result from the negligence or willful default of the Shire Parties.
14.2 Shire shall promptly:
(a) inform the Licensee by written notice of any Claims or the
discovery of a fact upon which Shire intends to base a request
for indemnification;
(b) provide the Licensee with copies of all papers and official
documents received in respect of any Claims; and
(c) cooperate as reasonably requested by the Licensee in the
defence against any Claims.
14.3 The Licensee shall have the sole control over the defence of any
Claims, provided that, the Licensee shall obtain the written consent of
Shire, prior to settling or otherwise disposing of such Claims if as a
result of the settlement or Claim disposal Shire's interests are in any
way adversely affected. Any costs and expenses, incurred by Shire in
connection with any Claims shall be reimbursed by the Licensee on a
Quarterly basis, subject to an obligation of reimbursement if it is
determined by a court of competent jurisdiction that such Claims are
not subject to indemnification under clause 14.1.
14.4 Shire shall defend, indemnify and hold harmless Licensee, its
Affiliates and its and their directors, officers, employees and
contractors ("LICENSEE PARTIES") from and against any and all Claims
resulting from a breach of clause 16.2.
14.5 Notwithstanding anything contained in this Agreement, in no event shall
either Party or their respective Affiliates be liable for special,
indirect, incidental or consequential loss or damage based on contract,
tort or any other legal theory arising out of this Agreement. Nothing
in this Agreement shall limit either Party's liability to any person
for death or personal injury caused by negligence.
14.6 The Licensee shall, at its own cost, during the term of this Agreement
and for a period of 10 years thereafter, maintain insurance which is
reasonable and customary in the United States of America pharmaceutical
industry for companies of comparable size and activities, and in any
event:
(a) listing Shire and the Indemnitees (as defined in the License
Agreement) as additional insureds on the policy by no later
than October 1, 2004;
25
(b) covering product liability in relation to the studies
undertaken in connection with the development of the Licensed
Product in amounts no less than US$1 million per incident and
US$3 million annual aggregate; and
(c) covering comprehensive product liability insurance and general
commercial liability insurance with respect to the
manufacture, use or sale Licensed Product from receipt of
Marketing Authorization in amounts not less than
US$5 million per incident and US$10 million annual
aggregate.
14.7 Upon reasonable request from Shire, the Licensee shall provide, or
procure that its Sub-Licensees provide documents from its insurer
confirming the existence and renewal of the relevant insurance policies
conforming with the requirements of clause 14.6.
15. CONFIDENTIALITY AND PUBLICATIONS
15.1 The Parties, their Affiliates and their respective directors, officers,
employees, officers and consultants shall keep and maintain any
Confidential Information supplied by the other Party during the term of
this Agreement strictly confidential. The confidentiality obligations
contained in this Agreement shall not apply to the extent that such
Confidential Information is:
(a) at the time of disclosure by one Party to the other in the
public domain or otherwise publicly known;
(b) after disclosure by one Party to the other becomes part of the
public domain, other than by breach of any obligation of
confidentiality;
(c) information which the receiving Party can establish by
documentary evidence was already in its possession at the time
of receipt or was independently developed by the receiving
Party without use of the Confidential Information of the
disclosing Party; or
(d) received from a third party who was lawfully entitled to
disclose such information without an obligation of
confidentiality.
15.2 Notwithstanding clause 15.1, the Party receiving Confidential
Information may disclose such Confidential Information:
(a) to Regulatory Authorities or other government agencies to gain
approval to conduct clinical trials in relation to the
Licensed Product or to file, prosecute and maintain the
Marketing Authorizations and any other required filings for
the Licensed Product, provided that, the disclosure is limited
to the extent reasonably necessary to obtain such
authorizations or approvals;
(b) to the extent that such disclosure is required by any
applicable law, regulation, court of competent jurisdiction or
governmental authority (including the FDA and the SEC),
provided that, the Confidential Information may be disclosed
only to the extent
26
required and wherever practicable, the disclosing Party has
been given sufficient written notice in advance to enable it
to seek protection or confidential treatment of such
Confidential Information;
(c) to Affiliates, actual or potential Sub-Licensees,
sub-contractors, employees, consultants and agents who have a
need to know the information for the purposes of this
Agreement, and are bound by obligations of confidentiality no
less protective than those contained in this Agreement; or
(d) to Third Parties in connection with due diligence
investigations in relation to the Licensee (for example,
potential investors), provided that, such Third Parties are
bound by confidentiality obligations no less protective than
those contained in this Agreement; or
(e) representatives of the University, provided that, such
representatives are bound by confidentiality obligations no
less protective than those contained in this Agreement.
15.3 The Parties shall consult with each other, in advance, with regard to
the terms of all proposed press releases, public announcements and
other public statements relating to any Confidential Information or the
transactions contemplated under this Agreement. Shire acknowledges that
in connection with any public offering of the stock of Licensee,
Licensee may be required to file this Agreement with the SEC, subject
to confidential treatment requests.
16. WARRANTIES
16.1 Shire and the Licensee each warrant that:
(a) it has obtained all corporate authorisations required to enter
into and perform its obligations under this Agreement; and
(b) this Agreement is valid and binding obligation enforceable
against it in accordance with its terms and conditions.
16.2 At the Effective Date, Shire warrants that:
(a) the Shire Patents are owned by Shire and the University
Patents are exclusively licensed to Shire under the terms of
the License Agreement;
(b) all renewal and maintenance fees in relation to the Shire
Patents and University Patents have been paid on or before the
due date for payment;
(c) so far as it is aware, there are no current oppositions or
interferences relating to the Shire Patents or University
Patents;
(d) it has not received any notice from any third party in the
last 6 years alleging that the Compound infringes any third
party Intellectual Property Rights;
27
(e) it has not sent any notice to any third party in the last
6 years alleging that the third party is infringing the Shire
Intellectual Property with respect to the Compound;
(f) so far as it is aware, Shire has no royalty or other license
payment obligations to third parties with respect to the
research, use, manufacture or sale of the Compound other than
under the License Agreement and Consultancy Agreement; and
(g) except for the Excluded Patents, the list of Licensed Patents
in Schedule 2 of this Agreement is a complete list of the
patents and patent applications owned by or licensed to Shire
containing claims relating to the Compound.
16.3 Notwithstanding anything contained in this Agreement, Shire gives no
warranty and makes no representation that any patent application
identified in Schedule 2 shall proceed to grant or will be valid and
enforceable.
16.4 Except for the warranties set out in clause 16, no warranty, condition,
term, undertaking or representation (express or implied, statutory or
otherwise) is given by Shire to the Licensee in respect of the Shire
Intellectual Property, the Licensed Product or any other products
developed, manufactured, sold or supplied by the Licensee using the
Shire Intellectual Property and all such warranties, conditions, terms,
undertakings and representations are to the extent permitted by law
expressly excluded.
17 COMPLIANCE WITH LAW
17.1 In exercising its rights and obligations under this Agreement, the
Licensee shall comply with, or shall procure compliance by its
Affiliates and Sub-Licensees with, all applicable national and local
laws, rules and regulations including but not limited to the
requirements of any Marketing Authorization s or any relevant laws,
rules or regulations concerning the research, development, manufacture,
delivery, transport, import, advertising, packaging, labelling,
storage, sale or use of the Licensed Product in the Territory or any
part of it.
17.2 The Licensee shall use reasonable efforts to promptly inform Shire of
any new laws, rules or regulations in the Territory (or any part of it)
or any amendments, or proposed amendments to the current laws, rules or
regulations that may have material impact on the use, distribution or
sale of the Licensed Product.
17.3 In performing any of their respective rights and obligations under this
Agreement, each Party shall comply with all applicable data protection
laws and regulations.
18 TERM
18.1 This Agreement commences on the Effective Date and, subject to earlier
termination in accordance with clause 19, shall with respect to each of
the countries in the Territory expire on the last to occur of:
(a) expiry of the last to expire of the issued Shire Patents or
the University Patents in the applicable country, including
patents issued on patent applications within Shire Patents or
University Patents as the case may be; or
28
(b) 10 years from the date of first commercial sale in that
country.
19 TERMINATION
19.1 Either Party shall be entitled to terminate this Agreement by written
notice to the other if:
(a) the other Party commits a material breach of this Agreement,
and in the case of a breach which is capable of remedy fails
to remedy it within 60 days of receipt of notice from the
first Party of such breach and of its intention to exercise
its rights under this clause; or
(b) an order is made or a resolution is passed for the winding up
of the other Party (other than voluntarily for the purposes of
solvent amalgamation or reconstruction) or an order is made
for the appointment of an administrator to manage the other
Party's affairs, business and property or if a receiver (which
expression shall include an administrative receiver) is
appointed over any of the other Party's assets or undertaking
or if circumstances arise which entitle the court or a
creditor to appoint a receiver or manager or which entitle the
court to make a winding-up order or if a voluntary arrangement
is proposed in respect of the other Party or if the other
Party takes or suffers any similar or analogous action in
consequence of debt, and such order, appointment or similar
action is not removed within 90 days.
19.2 This Agreement may be terminated by Shire by notice in writing to the
Licensee at any time (except as provided in clause 19.2(a)) if:
(a) the Licensee fails to make the upfront payment of
US$3 million to Shire within 3 Business Days from the
Effective Date pursuant to clause 7.1, with immediate effect
from receipt of the notice from Shire; which right of
termination will terminate on the earlier of (i) payment by
Licensee of the upfront payment of US$3 million to Shire or
(ii) 28 days from the expiration of the 3 Business Days from
the Effective Date;
(b) the Licensee, its Affiliates or its Sub-Licensees fail to make
any Milestone Payments or other payments of any sums due under
this Agreement (other than the upfront payment pursuant to
clause 7.1) within 30 days of receiving notice from Shire
requiring such payment;
(c) the Licensee, its Affiliates or its Sub-Licensees, directly or
indirectly, challenge the validity of the Shire Intellectual
Property or the Trade Marks or the right of Shire to use or
license the use of any of such Shire Intellectual Property or
the Trade Marks, or the Licensee assists any third party to
challenge the validity of such Shire Intellectual Property or
the Trade Marks;
(d) subject to clause 19.3, in the event of a Change of Control
where the new controlling party of the Licensee owns or
licenses a Competing Product;
(e) the Licensee ceases or threatens by written notice to cease to
carry on its business relating to oncology products;
29
(f) in the event that the Licensee or its Affiliates or
Sub-Licensees has not commenced a phase II study of the
Licensed Product in the United States of America within
12 months from the Effective Date;
(g) subject to clause 19.4, in the event that the Licensee or its
Affiliates or Sub-Licensees has not filed for Accelerated
Approval or commenced a phase III study of the Licensed
Product in the United States of America by 31 December 2007;
(h) in the event that the Licensee or its Affiliates or
Sub-Licensees has not filed an NDA by 31 December 2009,
provided that, Shire may not terminate this Agreement under
this sub-clause if the Licensee can reasonably demonstrate
that such delay or failure to file an NDA by 31 December 2009
is due to circumstances directly relating to Development Plan
and beyond its reasonable control, in which event the Licensee
shall have a further period of 12 months to achieve such
event;
(i) in the event that for a reason attributable to the Licensee,
its Affiliates or its Sub-Licensees any NDA or Marketing
Authorization in the Principal Markets lapses or is revoked by
any competent Regulatory Authority in the Territory; or
(j) in the event that the Licensee fails to provide Shire with any
semi-annual reports under clause 5.3(d).
19.3 In the event of Change of Control, where the new controlling party of
the Licensee owns or licenses a Competing Product, the Licensee shall
by written notice inform Shire of the Change of Control and Shire shall
have 90 days from receipt of such notice to exercise its right of
termination under clause 19.2(c). Notwithstanding anything contained in
this clause, the Parties agree that Shire may not terminate this
Agreement pursuant to clause 19.2(c) if the new controlling party
agrees to divest such Competing Product and in fact so divests such
Competing Product within 6 months from the date of completion of the
Change of Control (subject to extension for an additional 3 months if
the new controlling party has entered into a binding agreement with
respect to such divestiture within such 6 month period). If the new
controlling party is unable or unwilling to divest the Competing
Product within such period, Shire shall be entitled to terminate this
Agreement by 30 days written notice to the Licensee.
19.4 In the event that the Licensee's application for Accelerated Approval
is unsuccessful, the Licensee shall have 6 months from date of receipt
of the Accelerated Approval rejection notice to commence a phase III
study of the Licensed Product in the United States of America, failing
which, Shire may terminate this Agreement by written notice with
immediate effect.
19.5 This Agreement may be terminated by Licensee by 90 days written notice
to Shire, at any time after the second anniversary of the Effective
Date, if:
(a) after making a reasonable evaluation of the safety, efficacy
or other data generated during the Development Plan, the
Licensee determines that the Licensed Product is not a
scientifically or commercially viable for further development
or commercialisation; or
30
(b) the Licensee reasonably believes it will be unable to obtain
Marketing Authorization in the United States of America
after diligent pursuit of such Marketing Authorization.
19.6 If the Licensee, its Affiliates or any Sub-Licensee, after having
Launched the Licensed Product in any country in the Territory,
discontinues the sale of the Licensed Product in such country for a
period of 6 months or more for reasons unrelated to Force Majeure or
regulatory or safety issues in relation to the use of the Licensed
Product, and subsequently fails to resume sales of any Licensed Product
in such country within 90 days of having been notified in writing
of the failure to supply by Shire, then Shire may terminate the rights
granted to the Licensee under this Agreement and the Trade Mark license
solely with respect to such country by written notice to the Licensee.
For the purpose of this clause, sales of minimal or commercially
insignificant quantities of Licensed Product in a country shall be
deemed to constitute a discontinuation of sales in such country.
20 CONSEQUENCES OF TERMINATION
20.1 On termination of this Agreement by either Party the license and
sub-license (subject to the terms of the Memorandum of Understanding
and Sub-Licensee MOU) granted under this Agreement shall immediately
cease and the Licensee shall, and shall procure that its Affiliates and
Sub-Licensees shall:
(a) subject to clause 20.4, immediately cease to carry out any of
the activities permitted by this Agreement (or any relevant
Sub-License Agreement) and cease to use or exploit in any way
the Licensed Product, the Trade Marks or the Shire
Intellectual Property;
(b) within 60 days of the date of the termination notice make all
outstanding payments including any royalty payments due to
Shire at the date of termination; and
(c) promptly return, or at Shire's option, destroy any Shire
Know-How and any materials containing the Shire Know-How in
its possession, custody or power except for such records as
may be required to be retained by the Licensee by any national
or local laws, rules or regulations.
20.2 On termination of this Agreement by either Party for any reason, other
than by the Licensee under clause 19.1, the Licensee shall, and shall
procure that its Affiliates and, Sub-Licensees subject to the terms of
the Sub-Licensee MOU, shall:
(a) promptly deliver up to Shire any Development Data,
Improvements or other materials generated by the Licensee, its
Affiliates or Sub-Licensees in the development, registration
or commercialization of the Licensed Product;
(b) within 90 days from the date of termination, assign to Shire
(or its nominated Affiliate) all right, title and interest in
any Marketing Authorization in the Territory; and
31
(c) grant Shire an exclusive, royalty free, worldwide, irrevocable
and perpetual license to use (with the right to sub-license)
the Development Data and any registration materials developed
or acquired by or on behalf of the Licensee its Affiliates or
Sub-Licensees during the term of this Agreement.
20.3 On expiry of this Agreement, Shire shall grant, the Licensee an
exclusive, royalty-free, worldwide, irrevocable and perpetual license
to use and exploit (with the right to sub-license) the Shire Know-How,
including the right use the Shire Know-How to make, have made, use,
offer for sale, sell and import the Licensed Products.
20.4 The Licensee, its Affiliates and Sub-Licensees shall be entitled to
continue to sell existing stocks of the Licensed Products in the
Territory for a period of not longer than 6 months following the date
of termination, provided that, the Licensee pays Shire any royalties
due in respect of such sales in accordance with the provisions of this
Agreement.
20.5 Subject to clause 20.6, on termination of this Agreement by Shire under
Sections 19.1 or 19.2, the Licensee hereby grants Shire an option to
exclusively license any Intellectual Property Rights owned or licensed
(with the right to sublicense) by the Licensee that claim or cover any
Improvements generated by the Licensee during the term of this
Agreement ("OPTION"). The Option shall be exercisable by Shire at any
time within [...***...] from the date of notice of termination. Within
15 days from receipt by the Licensee, of notice from Shire confirming
the exercise of the Option, Shire and the Licensee shall negotiate in
good faith for a period not to exceed [...***...] the grant to Shire of
a exclusive, royalty bearing, worldwide, license to use (with the right
to sub-license) the Improvement developed or acquired by or on behalf
of the Licensee during the term of this Agreement, on commercially
reasonable terms.
20.6 In the event that this Agreement is terminated as a result of the
termination of the License Agreement by the University, and no license
for the University Patents is granted to the Licensee pursuant to the
Memorandum of Understanding, the Licensee shall grant the University
the Option rights set out in clause 20.5 instead of to Shire under
clause 20.6.
20.7 Subject to any separate agreement with the Sub-Licensee pursuant to
clause 3.2, upon the termination or expiry of this Agreement, the
Licensee shall, and shall procure that its Affiliates and Sub-Licensees
shall execute such documents as Shire may reasonably require to record
at all appropriate patent offices throughout the Territory that the
Licensee or the relevant Sub-Licensee has ceased to be entitled to use
and exploit the Licensed Patents.
20.8 In the event that the Licensee wishes to continue the use of the Trade
Mark for the sale of the Licensed Product after the expiration of this
Agreement, Shire shall grant to the Licensee an exclusive
non-transferable license for the Trade Mark in the Territory on terms
to be agreed between the Parties, provided that the Licensee notifies
Shire within [...***...] of the date of such expiry that it wishes to
take such a license and the Licensee shall pay Shire a perpetual Trade
Mark royalty of [...***...]% of the Net Sales of the Licensed Product
in accordance with clause 8.2.
32 ***CONFIDENTIAL TREATMENT REQUESTED
20.9 The termination or expiry of this Agreement shall not release either of
the Parties from any liability which at the time of termination or
expiry has already accrued to the other Party, nor affect in any way
the survival of any other right, duty or obligation of the Parties
which is expressly stated elsewhere in this Agreement to survive such
termination or expiry.
20.10 Clauses 1, 9, 14, 15.1, 15.2, 16.3, 16.4, 20, 22, 23, and 24 shall
survive the termination or expiry of this Agreement.
21 FORCE MAJEURE
21.1 Neither Party shall be entitled to terminate this Agreement or shall be
liable to the other under this Agreement for loss or damages
attributable to any Force Majeure, provided that, the Party affected
shall give prompt notice thereof to the other Party. Subject to clause
21.2, the Party giving such notice shall be excused from such of its
obligations hereunder for so long as it continues to be affected by
Force Majeure.
21.2 If such Force Majeure continues unabated for a period of at least 90
days, the Parties will meet to discuss in good faith what actions to
take or what modifications should be made to this Agreement as a
consequence of such Force Majeure in order to alleviate its
consequences on the affected Party.
22 NOTICES
22.1 Any notice or other document given under this Agreement shall be in
writing in the English language and shall be given by hand or sent by
prepaid airmail or by fax transmission to the address of the receiving
Party as set out in clauses 22.3 below unless a different address or
fax number has been notified to the other in writing for this purpose.
22.2 Each such notice or document shall:
(a) if sent by hand, be deemed to have been given when delivered
at the relevant address;
(b) if sent by prepaid airmail, be deemed to have been given 7
days after posting; or
(c) if sent by fax transmission be deemed to have been given when
transmitted provided that a confirmatory copy of such
facsimile transmission shall have been sent by prepaid airmail
within 24 hours of such transmission.
22.3 The address for services of notices and other documents on the Parties
shall be:
TO SHIRE BIOCHEM TO THE LICENSEE
275 boul. Armand-Frappier, ADDRESS: 10505 Roselle Street
Laval, QC, San Diego, CA 92121
Canada H7V 4A7 U.S.A.
FAX: +1 450 978 7767 FAX: +1 858 558 3402
33
ATTENTION: Claude Perron ATTENTION: Michael Grey
COPY TO: Shire Legal Department COPY TO: Legal Department
+44 (0)1256 894 710 +1 858 558 3402
TO TANAUD IRELAND TO TANAUD BV
Shannon Airport House, Fred Roeskestraat 123,
Shannon, Co Clare, First Floor, 1076 EE Amsterdam,
Ireland The Netherlands
FAX: +353 61 472 060 FAX: +31 20 577 1188
ATTENTION: Alan Kane ATTENTION: Dirk Stolp
23 ASSIGNMENT
23.1 Subject to clause 23.2, the Licensee shall not assign or transfer any
of its rights or obligations under this Agreement without the prior
written consent of Shire, such consent not to be unreasonably withheld
or delayed; provided that the Licensee may assign or transfer this
Agreement and its rights and obligations hereunder without Shire's
consent in connection with the sale or transfer of all or substantially
all of the Licensee's business to which this Agreement relates to a
third party, whether by merger, sale of stock, sale of assets or
otherwise. In the event of any such transaction however, Intellectual
Property Rights of the acquiring party under such transaction shall not
be included in the Intellectual Property Rights subject to this
Agreement.
23.2 The Licensee may sub-license all or any of its rights under this
Agreement provided that the Licensee complies with its obligations set
out in clause 3.
23.3 Shire shall be entitled to assign all or any of its rights or
obligations under this Agreement to an Affiliate.
24 GENERAL PROVISIONS
24.1 Nothing in this Agreement is deemed to constitute a partnership between
the Parties nor constitute either Party the agent of the other Party
for any purpose.
24.2 Any disagreement between Shire and the Licensee on the interpretation
of this Agreement or any aspect of the performance by either Party of
its obligations under this Agreement shall be resolved in accordance
with the dispute resolution procedure set out in Schedule 8 provided
that either Party shall have the right to seek urgent injunctive or
other equitable relief in any court of competent jurisdiction.
24.3 Each of the Parties shall do execute and perform and shall procure to
be done executed and performed all such further acts deeds documents
and things as the other Party may reasonably require from time to time
to give full effect to the terms of this Agreement.
34
24.4 Each Party shall pay its own costs, charges and expenses incurred in
connection with the negotiation, preparation and completion of this
Agreement.
24.5 This Agreement sets out the entire agreement and understanding between
the Parties in respect of the subject matter of this Agreement and
supersedes any heads of agreement which shall cease to have any further
force or effect. It is agreed that:
(a) no Party has entered into this Agreement in reliance upon any
representation, warranty or undertaking of the other Party
which is not expressly set out in this Agreement;
(b) no Party shall have any remedy in respect of misrepresentation
or untrue statement made by the other Party or for any breach
of warranty which is not contained in this Agreement; and
(c) this clause shall not exclude any liability for, or remedy in
respect of, fraudulent misrepresentation.
24.6 Nothing in this Agreement shall operate to:
(a) exclude any provision implied into this Agreement by law and
which may not be excluded by law; or
(b) limit or exclude any liability, right or remedy to a greater
extent than is permissible under law.
24.7 No variation of this Agreement shall be valid unless it is in writing
and signed by or on behalf of both Parties.
24.8 Unless expressly agreed, no variation shall constitute a general waiver
of any provisions of this Agreement, nor shall it affect any rights,
obligations or liabilities under or pursuant to this Agreement which
have already accrued up to the date of variation, and the rights and
obligations of the Parties under or pursuant to this Agreement shall
remain in full force and effect, except and only to the extent that
they are so varied.
24.9 If and to the extent that any provision of this Agreement is held to be
illegal, void or unenforceable, such provision shall be given no effect
and shall be deemed not to be included in this Agreement but without
invalidating any of the remaining provisions of this Agreement.
24.10 No failure or delay by either Party in exercising any right or remedy
provided by law under or pursuant to this Agreement shall impair such
right or remedy or operate or be construed as a waiver or variation of
it or preclude its exercise at any subsequent time and no single or
partial exercise of any such right or remedy shall preclude any other
or further exercise of it or the exercise of any other right or remedy.
35
24.11 The rights and remedies of each of the Parties under or pursuant to
this Agreement are cumulative, may be exercised as often as such Party
considers appropriate and are in addition to its rights and remedies
under general law.
24.12 If in any jurisdiction the effect of any provision of this Agreement or
the absence from this Agreement of any provision would be to prejudice
the Licensed Patents or any remedy under the Licensed Patents, the
Parties will make such amendments to this Agreement and execute such
further agreements and documents limited to that part of the Territory
which falls under such jurisdiction as may be necessary to remove such
prejudicial effects.
24.13 This Agreement may be executed in any number of counterparts and by the
Parties on separate counterparts, each of which is an original but all
of which together constitute one and the same instrument.
24.14 The Licensee, or any Sub-Licensee or assignee, shall not create, assume
or permit to exist any lien, pledge, security interest or other
encumbrance on this Agreement or any Sub-License Agreement, provided
that, Licensee or any Sub-Licensee shall be permitted to create, assume
or permit to exist any lien, pledge, security interest or other
encumbrance on this Agreement or any Sub-License Agreement:
(a) pursuant to obligations to its creditors outstanding as of the
Effective Date; and
(b) pursuant to the Loan and Security Agreement dated as of July
23, 2004 between the Licensee and its creditors thereto.
24.15 This Agreement and the obligations of the Parties shall be governed by
and construed in accordance with the laws of the state of New York and
subject to the jurisdiction of the New York courts.
The rest of this page has been left intentionally blank.
36
AS WITNESS this Agreement has been signed by the duly authorised representatives
of the Parties on the day and year first before written.
SIGNED for and on behalf of ) /s/ Angus Russell
SHIRE BIOCHEM INC. ) -----------------------------------
)
Angus Russell, Director
-----------------------------------
PRINT NAME AND TITLE
SIGNED for and on behalf of ) /s/ Joseph Rus
TANAUD IRELAND INC. ) -----------------------------------
)
Joseph Rus, Director
-----------------------------------
PRINT NAME AND TITLE
SIGNED for and on behalf of ) /s/ Joseph Rus
TANAUD INTERNATIONAL B.V. ) -----------------------------------
)
Joseph Rus, Director
-----------------------------------
PRINT NAME AND TITLE
SIGNED for and on behalf of ) /s/ M.G. Grey
STRUCTURAL GENOMIX, INC. ) -----------------------------------
)
M.G. Grey, President
-----------------------------------
PRINT NAME AND TITLE
37
SCHEDULE 1
DEVELOPMENT PLAN AND TIMELINE
ACTIVITY ANTICIPATED TIMING
Initiate Transition Plan July 2004
AML
Complete Open Phase 1 Trial [...***...]
Last cohort of patients dosed at [...***...] days
[...***...] was [...***...] with [...***...]
[...***...] had [...***...] the [...***...] of [...***...]
An increase in [...***...]
[...***...] to be [...***...] days)
[...***...]
[...***...]
Commence [...***...] Trial [...***...]
Patient Population
[...***...]
[...***...]
Trial Size
[...***...]
[...***...]
Study Endpoints
[...***...]
[...***...]
Treatment Centers
[...***...]
Complete [...***...] Trial [...***...]
[...***...] [...***...]
[...***...] for [...***...]
[...***...] if [...***...] in the [...***...] is [...***...]
[...***...] to [...***...]
[...***...]
38 ***CONFIDENTIAL TREATMENT REQUESTED
Complete [...***...] Trial [...***...]
Commence [...***...] Trial ([...***...]) [...***...]
Patient Population
[...***...] over [...***...] of age
[...***...]
Treatment and Trial Size
[...***...] at [...***...]
[...***...] at [...***...]
Treatment Centers
[...***...]
Study Endpoints
[...***...] is [...***...] of [...***...]
[...***...] is [...***...] of [...***...]
Complete [...***...] Trial [...***...]
BLAST PHASE CML
Based on review of clinical opportunities with CML experts:
Commence [...***...] Trial [...***...]
Patient population
[...***...] CML-BP [...***...] or [...***...]
Treatment and trial size
[...***...] at [...***...]
~[...***...]
Study Endpoints
[...***...] to [...***...] CML [...***...]
[...***...] of [...***...]
Complete [...***...] Trial [...***...]
Evaluate next steps [...***...]
MDS
Based on review of clinical opportunities with MDS experts:
39 ***CONFIDENTIAL TREATMENT REQUESTED
Commence [...***...] MDS Trial [...***...]
SOLID TUMOR
Evaluate Open Phase 1 solid tumor
Continuous infusion study [...***...]
Complete Phase 1 if existing data are supportive [...***...]
Initiate Phase 2 [...***...]
40 ***CONFIDENTIAL TREATMENT REQUESTED
SCHEDULE 2
LICENSED PATENTS
PART I - BACKGROUND PATENTS
[...***...], SYNTHESIS AND USE THEREOF
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
41 ***CONFIDENTIAL TREATMENT REQUESTED
[...***...] AND USE THEREOF
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
PROCESS FOR [...***...] SYNTHESIS OF NUCLEOSIDES
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
42 ***CONFIDENTIAL TREATMENT REQUESTED
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
43 ***CONFIDENTIAL TREATMENT REQUESTED
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
PROCESS FOR DIASTEREOSELECTIVE SYNTHESIS OF NUCLEOSIDES
<Table>
<Caption>
DOCKET NUMBER APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
44 ***CONFIDENTIAL TREATMENT REQUESTED
<Table>
<Caption>
DOCKET NUMBER APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
STEREOSELECTIVE SYNTHESIS OF [...***...] USING [...***...] INTERMEDIATE
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
45 ***CONFIDENTIAL TREATMENT REQUESTED
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
METHOD AND COMPOSITIONS FOR THE SYNTHESIS OF [...***...] WITH [...***...]
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
46 ***CONFIDENTIAL TREATMENT REQUESTED
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
47 ***CONFIDENTIAL TREATMENT REQUESTED
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
STEREOSELECTIVE SYNTHESIS OF [...***...]
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
PROCESS FOR PRODUCING [...***...]
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
48 ***CONFIDENTIAL TREATMENT REQUESTED
[...***...]
STEREOSELECTIVE PROCESS FOR THE PRODUCTION OF [...***...]
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
PART II - COMPOUND PATENTS
METHOD OF TREATING [...***...]
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
49 ***CONFIDENTIAL TREATMENT REQUESTED
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
METHODS OF TREATING CANCER USING A [...***...]
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
PHARMACEUTICAL [...***...] FOR THE TREATMENT OF CANCER
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
50 ***CONFIDENTIAL TREATMENT REQUESTED
[...***...]
[...***...] FOR IMPROVED [...***...] DELIVERY
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
METHODS OF TREATING [...***...]
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
51 ***CONFIDENTIAL TREATMENT REQUESTED
PHARMACEUTICAL [...***...] AND METHODS FOR THE TREATMENT OF [...***...]
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
METHODS OF [...***...] OF TROXACITABINE
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
METHOD FOR THE TREATMENT OF [...***...]
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
PART III - UNIVERSITY PATENTS
COMPOUNDS AND METHODS FOR THE TREATMENT OF CANCER
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
52 ***CONFIDENTIAL TREATMENT REQUESTED
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
53 ***CONFIDENTIAL TREATMENT REQUESTED
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
COMPOUNDS AND METHODS FOR THE TREATMENT OF CANCER
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
54 ***CONFIDENTIAL TREATMENT REQUESTED
SCHEDULE 3
MILESTONE EVENTS AND MILESTONE PAYMENTS
<Table>
<Caption>
NO. MILESTONE EVENT MILESTONE PAYMENT (US$)
- ---------- ------------------------------------------------------------------- ------------------------
DEVELOPMENT MILESTONES
1. On the Licensee obtaining [...***...] $[...***...]
2. $[...***...]
The earlier of:
o the [...***...] of the [...***...] of the [...***...]; or
o the [...***...] of the [...***...] after [...***...] for
the [...***...]; or
o [...***...] of [...***...] that the [...***...].
3. The earlier of:
o the [...***...] the [...***...] of the [...***...] for
[...***...]; or
o the [...***...] the [...***...] of the [...***...] for the $[...***...]
[...***...]; or
o [...***...] of [...***...] that the [...***...].
4. File for Marketing Authorization for first indication
([...***...]) of the Licensed Product in any of the [...***...]. $[...***...]
5. File for Marketing Authorization for [...***...] of the Licensed
Product in any of the [...***...]. $[...***...]
6. Receipt of Marketing Authorization from any Regulatory Authority
for the first indication ([...***...]) of the Licensed Product in
any of the $[...***...]
</Table>
55 ***CONFIDENTIAL TREATMENT REQUESTED
<Table>
[...***...].
7. Receipt of Marketing Authorization from any Regulatory Authority $[...***...]
for the [...***...] of the Licensed Product in any of the
[...***...]
8. Receipt of Marketing Authorization from any Regulatory Authority
for the second indication ([...***...]) of the Licensed Product in $[...***...]
any of the [...***...]
8. Receipt of Marketing Authorization from any Regulatory Authority
for the [...***...] of the Licensed Product in any of the $[...***...]
[...***...]
SALES MILESTONES
9. The first time that Net Sales of the Licensed Product in the $[...***...]
Territory surpass US$[...***...] in any calendar year
10 The first time that Net Sales of the Licensed Product in the $[...***...]
Territory surpass US$[...***...] in any calendar year
11. The first time that Net Sales of the Licensed Product in the $[...***...]
Territory surpass US$[...***...] in any calendar year
12. The first time that Net Sales of the Licensed Product in the $[...***...]
Territory surpass US$[...***...] in any calendar year
</Table>
56 ***CONFIDENTIAL TREATMENT REQUESTED
SCHEDULE 4
SALES FORECASTS AND MINIMUM SALES
<Table>
<Caption>
No. YEAR SALES FORECAST MINIMUM SALES FORECAST
- ------- ------------------------------------ ------------------- ----------------------
1. First year following Launch US$[...***...] US$[...***...]
2. Second year following Launch US$[...***...] US$[...***...]
3. Third year following Launch US$[...***...] US$[...***...]
4. Fourth year following Launch US$[...***...] US$[...***...]
</Table>
57 ***CONFIDENTIAL TREATMENT REQUESTED
SCHEDULE 5
SHIRE MATERIALS
<Table>
<Caption>
EXPIRY
DATE/RETEST
MATERIAL DESCRIPTION LOT NUMBER QUANTITY DATE WAREHOUSE SITE
- ----------------------------- ----------- ----------- ----------- ----------------
Troxatyl 2 mg IMP [...***...] [...***...] [...***...] [...***...]
Troxatyl 10 mg IMP [...***...] [...***...] [...***...] [...***...]
Troxatyl 2 mg IMP [...***...] [...***...] [...***...] [...***...]
Troxatyl 10 mg IMP [...***...] [...***...] [...***...] [...***...]
Troxatyl API [...***...] [...***...] [...***...] [...***...]
Troxatyl API [...***...] [...***...] [...***...] [...***...]
Troxatyl API [...***...] [...***...] [...***...] [...***...]
API Reference Standard [...***...] [...***...] [...***...] [...***...]
Ongoing Compound stability samples
including available impurities
standards (samples to remain at
stability testing site)
</Table>
58 ***CONFIDENTIAL TREATMENT REQUESTED
SCHEDULE 6
TRADE MARKS
<Table>
<Caption>
NO. TRADE MARK OWNER COUNTRY CLASS NUMBER APP/REG DATE STATUS
- ---------- ------------ ----------------- ----------- ---------- ----------- ------------ ------------
1. TROXATYL Shire BioChem [...***...] [...***...] [...***...] [...***...]
2. TROXATYL Shire BioChem [...***...] [...***...] [...***...] [...***...] [...***...]
3. TROXATYL Shire BioChem [...***...] [...***...] [...***...] [...***...]
4. TROXATYL Shire BioChem [...***...] [...***...] [...***...] [...***...]
5. TROXATYL Shire BioChem [...***...] [...***...] [...***...] [...***...] [...***...]
6. TROXATYL Shire BioChem [...***...] [...***...] [...***...] [...***...] [...***...]
7. TROXATYL Shire BioChem [...***...] [...***...] [...***...] [...***...] [...***...]
8. TROXATYL Shire BioChem [...***...] [...***...] [...***...] [...***...] [...***...]
9. TROXATYL Shire BioChem [...***...] [...***...] [...***...] [...***...]
10. TROXATYL Shire BioChem [...***...] [...***...] [...***...] [...***...] [...***...]
11. TROXATYL Shire BioChem [...***...] [...***...] [...***...] [...***...] [...***...]
12. TROXATYL Shire BioChem [...***...] [...***...] [...***...] [...***...] [...***...]
13. TROXATYL Shire BioChem [...***...] [...***...] [...***...]
14. TROXATYL Shire BioChem [...***...] [...***...] [...***...] [...***...] [...***...]
15. TROXATYL Shire BioChem [...***...] [...***...] [...***...] [...***...] [...***...]
16. TROXATYL Shire BioChem [...***...] [...***...] [...***...] [...***...] [...***...]
17. TROXATYL Shire BioChem [...***...] [...***...] [...***...] [...***...] [...***...]
18. TROXATYL Shire BioChem [...***...] [...***...] [...***...] [...***...]
</Table>
59 ***CONFIDENTIAL TREATMENT REQUESTED
SCHEDULE 7
MEMORANDUM OF UNDERSTANDING
MEMORANDUM OF UNDERSTANDING
DATED: 23 JULY 2004
BETWEEN:
(1) UNIVERSITY OF GEORGIA RESEARCH FOUNDATION, INC., a nonprofit Georgia
corporation with offices located in Boyd Graduate Studies Research
Center, The University of Georgia, Athens, Georgia 30602 ("UGARF");
(2) YALE UNIVERSITY located in New Haven, Connecticut ("YALE"); and
(3) STRUCTURAL GENOMIX, INC., a company incorporated in Delaware, whose
address is 10505 Roselle Street, San Diego, CA 92121, U.S.A.
("SUB-LICENSEE").
BACKGROUND:
(A) On 3 January 1996, UGARF and Yale entered into a license agreement with
Shire BioChem Inc. (formerly BioChem Pharma Inc.), Tanaud Holdings
(Barbados) Limited and Tanaud LLC (collectively "SHIRE") under which
the University Patents and Licensed Technology (as defined below) were
exclusively licensed to Shire ("HEAD LICENCE").
(B) On 23 July 2004, Shire entered into a licence agreement with the
Sub-Licensee under which certain patents and know how were exclusively
licensed to the Sub-Licensee and the University Patents and Licensed
Technology were sub-licensed to the Sub-Licensee ("SHIRE LICENCE").
(C) Yale and UGARF have agreed to grant a licence under the University
Patents and Licensed Technology to the Sub-Licensee on the same
financial terms to the Head Licence in the event that the Head Licence
is terminated as more specifically set out in this Memorandum of
Understanding ("MEMORANDUM").
OPERATIVE PROVISIONS
1 DEFINITIONS
1.1 In this Memorandum:
"AFFILIATE" means any firm, person or company which controls, is
controlled by or is under common control with a Party to this Agreement
and for the purpose of this definition the term "control" means the
ownership either directly or indirectly of more than 50% of the voting
securities of such firm, person or company;
60
"COMPOUND" means the compound troxacitabine;
"FIELD" means use of the Licensed Product in the treatment of cancer;
"LICENSED PRODUCT" means any pharmaceutical formulations that contain
the Compound alone as a therapeutically active ingredient, or in
combination with any other pharmaceutically active ingredient;
"LICENSED TECHNOLOGY" shall mean all designs, technical information,
know-how, knowledge, data, specifications, test results and other
information, whether or not patented, which are licensed by UGARF and
Yale under the Head Licence and are useful for the development,
commercialization, manufacture, use or sale of any Licensed Product;
"UNIVERSITY" means UGARF or Yale or collectively UGARF and Yale as the
case may be; and
"UNIVERSITY PATENTS" means the patents and patent applications set out
in Part III of Schedule 2 and including, any divisionals, extensions,
reissues, re-examinations, continuations, and foreign counterparts
thereof and patents issuing thereon;
1.2 In this Memorandum, unless the context requires otherwise:
(a) the headings are included for convenience only and shall not
affect its construction;
(b) references to "persons" includes individuals, bodies corporate
(wherever incorporated), unincorporated associations and
partnerships;
(c) words denoting the singular shall include the plural and vice
versa;
(d) words denoting one gender shall include each gender and all
genders; and
(e) any reference to an enactment or statutory provision is a
reference to it as it may have been, or may from time to time
be amended, modified, consolidated or re-enacted.
2 AGREEMENT TO GRANT LICENCE
2.1 Subject to clause 2.2, the parties agree that, in the event the
University terminates the Head Licence, and provided that the reason
for such termination does not relate in any way to any act or omission
of the Sub-Licensee, its Affiliates, representatives or sub-licensees,
the University shall grant the Sub-Licensee (or its nominated
Affiliate), from the date of such termination, an exclusive worldwide
licence under the University Patents and Licensed Technology to
develop, manufacture, have manufactured, use, sell, offer for sale,
import and supply the Licensed Product in the Field on the same
financial terms as the Head Licence and substantially similar due
diligence and other terms as those contained in the Shire Licence ("NEW
LICENCE").
61
2.2 This Agreement and the grant of any licence under the University Patent
and Licensed Technology pursuant to clauses 2.1, shall in all respects
be conditional upon the University receiving the following:
(a) written notice from Shire, confirming that the Sub-Licensee is
in compliance with its obligations under the Shire Licence;
(b) copies of any arrangements, agreements or related transactions
(and any amendments thereto) between the Sub-Licensee and
Shire relating to the Licensed Product or any rights licensed
to the Sub-Licensee under the Shire Licence;
(c) written representation from Sub-Licensee, confirming that the
Sub-Licensee is in compliance with its obligations under the
Shire Licence;
(d) a detailed written update on the development and
commercialization of the Licensed Product that shall include,
without limitation, a summarized budget for development plan
expenses;
(e) documentary evidence confirming, to the University's
reasonable satisfaction, that the Sub-Licensee has sufficient
funds to carry on the development or commercialization of the
Licensed Product for not less than [...***...] months; and
(f) copies of agreements between the Sub-Licensee and any third
party relating to the sublicense of the rights granted to the
Sub-Licensee (or any part of such rights) under the Shire
Licence.
2.3 If each of the conditions precedent identified in clause 2.2 are not
fulfilled (unless waived by the University) within 60 days of the
termination of the Head Licence, the University shall have no
obligation to the Sub-Licensee to grant the licence under clause 2.1,
and neither party shall have a claim of any nature whatsoever against
the other party under this Agreement.
2.4 The Sub-Licensee undertakes to use all reasonable efforts to ensure
that the conditions precedent in clause 2.2 are fulfilled as soon as
reasonably practicable following termination of the Head Licence, and
in any event within 60 days from the date of termination of the Head
Licence.
2.5 Yale and UGARF shall notify Sub-Licensee if a notice of termination of
the Head Licence has been provided to Shire and the parties shall
promptly meet to discuss in good faith to arrange for the finalisation
and execution of the New Licence.
2.6 Yale and UGARF each agree that activities of the Sub-Licensee, its
Affiliates and sublicensees shall constitute activities of Shire for
the purposes of Article 3 of the Head License.
62 ***CONFIDENTIAL TREATMENT REQUESTED
3 FURTHER ASSURANCES
3.1 Each party shall do all acts and execute all documents as may be
reasonably necessary to give effect to the grant of the New Licence and
the exercise of the rights granted therein.
4 LAW AND JURISDICTION
4.1 This Memorandum and the obligations of the Parties shall be governed by
and construed in accordance with the laws of the state of New York and
subject to the jurisdiction of the New York courts.
AGREED by the parties through their duly authorised representations on the date
written above:
SIGNED for and on behalf of ) /s/ Gordhan L. Patel
UNIVERSITY OF GEORGIA ) ---------------------------------------
RESEARCH FOUNDATION, INC. )
Gordhan L. Patel, Executive Vice
President
---------------------------------------
PRINT NAME AND TITLE
SIGNED for and on behalf of ) /s/ Jon Soderstrom
YALE UNIVERSITY ) ---------------------------------------
)
Jon Soderstrom, Managing Director, OCR
---------------------------------------
PRINT NAME AND TITLE
SIGNED for and on behalf of ) /s/ Tim Harris
STRUCTURAL GENOMIX, INC. ) ---------------------------------------
)
CEO
---------------------------------------
PRINT NAME AND TITLE
63
SCHEDULE 1
THE UNIVERSITY PATENTS
COMPOUNDS AND METHODS FOR THE TREATMENT OF CANCER
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
64 ***CONFIDENTIAL TREATMENT REQUESTED
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
COMPOUNDS AND METHODS FOR THE TREATMENT OF CANCER
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
</Table>
65 ***CONFIDENTIAL TREATMENT REQUESTED
SCHEDULE 8
DISPUTE RESOLUTION PROCEDURE
1. NEGOTIATION
1.1 Representatives of the Parties shall, within 10 Business Days of
receipt of a written request from either Party, convene a meeting of
the Development Committee (with additional members from each Party as
appropriate for the particular dispute) to discuss and in good faith
try to resolve any claim, dispute, controversy, or disagreement between
the Parties arising out of or in connection with the terms (or
interpretation of the terms) of this Agreement (DISPUTE) without
recourse to legal proceedings.
1.2 If resolution of the Dispute does not occur within 20 Business Days
from the Development Committee meeting, the matter shall be escalated
for determination by the respective Group Legal Counsel or heads of
applicable business units of the Parties (OFFICERS) who may resolve the
matter themselves or jointly appoint a mediator. The Officers shall
negotiate in good faith to achieve a resolution of the Dispute referred
to them within 20 Business Days after such notice is received.
1.3 If the Officers are unable to settle the Dispute between themselves
within 20 Business Days from referral, the Officers shall report to the
Parties on the progress of the negotiations in writing and the Dispute
shall then be referred to mediation in accordance with sections 2.1 -
2.4.
2. MEDIATION
2.1 If the Parties have failed to resolve the Dispute by negotiation
pursuant to sections 1.1 - 1.3, the Dispute shall be referred to
mediation to be resolved in accordance with the rules of the American
Arbitration Association ("AAA"). The place of the mediation shall be
New York, United States and the language of the mediation shall be
English.
2.2 To initiate a mediation, either Party shall give notice in writing
(NOTICE) to the other Party in accordance with the provisions of clause
22, requesting.
2.3 If the Dispute is not resolved within 60 days (or such longer period as
the parties may agree) from the giving of the Notice, or if one of the
Parties refuses to participate in mediation, the dispute shall be
referred to arbitration in accordance with the provisions of section 3.
2.4 If Notice is not given prior to the commencement of arbitration, the
Party commencing the arbitration must serve Notice on the other party
to the arbitration within 21 days.
3. ARBITRATION
66
3.1 If after the procedures set forth in sections 1 and 2, the Dispute has
not been resolved, either Party may decide to institute arbitration
proceedings by written notice to that effect to the other Party. Any
unresolved Dispute shall be referred to and finally resolved by
arbitration under the Rules of Arbitration of the International Chamber
of Commerce (ICC) , which rules are deemed to be incorporated by
reference into this clause.
3.2 The Tribunal shall consist of three arbitrators to be appointed having
experience in the pharmaceutical industry: Shire and the Licensee shall
each appoint one arbitrator and the third arbitrator, who shall be the
Chairman of the tribunal, shall be appointed by the two-Party appointed
arbitrators.
3.3 The place of arbitration shall be New York and the language of the
arbitration shall be English.
3.4 Each Party shall bear its own costs and expenses incurred in connection
with any arbitration proceeding and the Parties shall equally share the
cost of the mediation and arbitration levied by the AAA or the ICC.
67
SCHEDULE 9
EXCLUDED PATENTS
STEREOSELECTIVE SYNTHESIS OF [...***...]
<Table>
<Caption>
SHIRE REFERENCE APPL'N DATE COUNTRY APPL'N NO. GRANT DATE PATENT NUMBER STATUS EXP. DATE
- ------------------- ----------------- -------------- ----------------------- ------------ --------------- ----------- -----------
[...***...]
Any patents or patent applications owned or licensed by [...***...]
</Table>
68 ***CONFIDENTIAL TREATMENT REQUESTED
SHIRE BIOCHEM INC.
2250 Alfred-Nobel Blvd., Suite 500
Ville Saint-Laurent, Quebec H4S 2C9 Canada
Tel. 514 787-2300 Fax 514 787-2427
www.shire.com
(SHIRE LOGO)
Claude Perron
Vice President and General Manager
Tel.: 514-787-2345 Fax: 514-787-2428
e-mail: cperron@ca.shire.com
March 8, 2005 By Courier
----------
Structural GenomiX, Inc
Attention: Mr. Michael Grey, President
10505 Roselle Street
San Diego, CA 92121
USA
Re: Amendment to the License Agreement
- --------------------------------------------------------------------------------
Dear Sir:
We refer to the patent and know how license between Shire BioChem Inc., Shire
Pharmaceutical Development Limited, Tanaud International BV (together SHIRE) and
Structural GenomiX, Inc. (SGX) dated 23 July 2004 as amended (LICENSE
AGREEMENT).
Shire and SGX desire to amend the License Agreement and this letter sets out the
agreed amendment to the License Agreement. All capitalised terms in this letter
shall, unless the context requires otherwise, have the meaning given to them in
the License Agreement.
Shire and SGX agree and acknowledge that from the date of this letter the
License Agreement shall be amended by deleting the definition of "Compound"
under clause 1.1 and replacing it with the following new definition:
"COMPOUND" means the compound troxacitabine and its prodrugs;
Except as expressly amended by the terms of this letter, the terms and
conditions of the License Agreement shall remain in full force and effect,
unamended.
Please confirm your acceptance of the above amendment to the License Agreement
by signing, dating and returning to Shire a copy of this letter.
Yours faithfully,
/s/ Claude Perron
Claude Perron
Vice President and General Manager
Amendment to the License Agreement Page 2
- --------------------------------------------------------------------------------
Agreed to: Agreed to:
/s/ Claude Perron /s/ Matthew Emmens
- --------------------------------- ----------------------------------------
Claude Perron, Vice President and Matthew Emmens
General Manager Director
For and on behalf of For and on behalf of
SHIRE BIOCHEM INC. SHIRE PHARMACEUTICAL DEVELOPMENT LIMITED
Agreed to: Agreed to:
/s/ Joseph Rus /s/ Stephen K. Burley
- --------------------------------- ----------------------------------------
Joseph Rus Stephen K. Burley
Director CSO
For and on behalf of For and on behalf of
TANAUD INTERNATIONAL BV STRUCTURAL GENOMIX, INC.
THIS NOVATION AGREEMENT is made the 19th day of January, 2005
BETWEEN:
1. Shire BioChem Inc. (formerly known as BioChem Pharma Inc.) of 2250
Alfred-Nobel Blvd., Suite 500, Ville Saint-Laurent, Quebec, H4S 2C9,
Canada ("SBI");
2. Tanaud International B.V. of Fred Roekestraat 123, First Floor, 1076 EE
Amsterdam, The Netherlands ("TANAUD BV");
3. Structural Genomix, Inc. of 10505 Roselle Street, San Diego, CA 92121,
U.S.A. ("GENOMIX"); and
4. Tanaud Ireland Inc. of 2250 Alfred-Nobel Blvd., Suite 500, Ville
Saint-Laurent, Quebec, H4S 2C9, Canada ("TII").
WHEREAS:
(A) Pursuant to the Licence (as defined below) SBI, Tanaud BV and TII
licensed certain patents, technology and know-how to Genomix.
(B) TII wishes to be released and discharged from the Licence and the
parties have agreed to release and discharge TII from the Licence upon
the terms of SBI's undertaking to perform the Licence and be bound by
its terms and conditions in place of TII.
NOW IT IS AGREED as follows.
1. DEFINITIONS
In this agreement:
"COUNTERPARTIES" means, together, Genomix and Tanaud BV;
"EFFECTIVE DATE" means 1 January 2005; and
"LICENCE" means a patent and know-how licence between
SBI, TII, Tanaud BV and Genomix, dated 23
July 2004 a copy of which is annexed hereto
and initialled by the parties for the
purposes of identification only.
2. SBI'S UNDERTAKING
With effect from the Effective Date and in consideration of the
undertakings given by the Counterparties in clause 3, SBI hereby
undertakes to observe, perform, discharge, assume liabilities under and
be bound by the Licence as if SBI had taken the place of TII under the
Licence. Notwithstanding this undertaking, nothing in this agreement
shall:
(A) require SBI to perform any obligation created by or arising
under the Licence falling due for performance, or which should
have been performed by TII, before the Effective Date or to
make any payments due or as otherwise would be incurred and
payable by Tll prior to the Effective Date; or
(B) make SBI liable for any act, neglect, default, omission or
liability in respect of the Licence committed or incurred by
TII or occurring before the Effective Date.
2
3. COUNTERPARTIES' UNDERTAKINGS AND RELEASE OF TII
3.1 With effect from the Effective Date and in consideration of and subject
to the undertakings given by SBI in clause 2 and TII in clause 4, the
Counterparties hereby:
(A) release and discharge TII from all liabilities under the
Licence and all obligations to observe, perform, discharge and
be bound by the Licence;
(B) accept SBI's undertaking to observe, perform, discharge,
assume liabilities under and be bound by the Licence (such
undertaking being set out in clause 2); and
(C) agree to observe, perform, discharge, assume liabilities under
and be bound by the Licence as if SBI had taken the place of
TII under the Licence.
3.2 Notwithstanding the provisions of sub-clause 3.1(A), nothing in this
agreement shall affect or prejudice any claim or demand whatsoever
which the Counterparties may have against TII in relation to the
Licence and arising out of matters prior to the Effective Date.
4. TII'S UNDERTAKING AND RELEASE OF COUNTERPARTIES
With effect from the Effective Date and in consideration of the
undertakings given by the Counterparties in clause 3, TII hereby
releases and discharges the Counterparties from all liabilities under
the Licence and all obligations to observe, perform, discharge and be
bound by the Licence. Notwithstanding this undertaking and release,
nothing in this agreement shall affect or prejudice any claim or demand
whatsoever which TII may have against the Counterparties in relation to
the Licence and arising out of matters prior to the Effective Date.
5. COUNTERPARTS
5.1 This agreement may be executed in any number of counterparts, and by
the parties on separate counterparts, but shall not be effective until
each party has executed at least one counterpart.
5.2 Each counterpart shall constitute an original of this agreement, but
all the counterparts shall together constitute but one and the same
instrument.
3
6. GOVERNING LAW
This agreement shall be governed by and construed in accordance with
the laws of the state of New York and subject to the jurisdiction of
the New York courts.
IN WITNESS WHEREOF the parties have entered into this agreement on the date
first written above.
/s/ [Illegible]
- -------------------------------------------------
For and on behalf of SHIRE BIOCHEM INC.
/s/ [Illegible]
- -------------------------------------------------
For and on behalf of TANAUD INTERNATIONAL B.V.
/s/ M. Grey
- -------------------------------------------------
For and on behalf of STRUCTURAL GENOMIX, INC.
/s/ [Illegible]
- -------------------------------------------------
For and on behalf of TANAUD IRELAND INC.
THIS NOVATION AGREEMENT is made the 19th day of January, 2005
BETWEEN:
1. Shire BioChem Inc. (formerly known as BioChem Pharma Inc.) of 2250
Alfred-Nobel Blvd., Suite 500, Ville Saint-Laurent, Quebec, H4S 2C9,
Canada ("SBI");
2. Tanaud International B.V. of Fred Roekestraat 123, First Floor, 1076 EE
Amsterdam, The Netherlands ("TANAUD BV");
3. Structural Genomix, Inc. of 10505 Roselle Street, San Diego, CA 92121,
U.S.A. ("GENOMIX"); and
4. Shire Intellectual Property SrI of Chancery House, High Street,
Bridgetown, Barbados, West Indies ("SIP").
WHEREAS:
(A) Pursuant to the Licence (as defined below) SBI, Tanaud BV and Tanaud
Ireland Inc. ("TII") licensed certain patents, technology and know-how
to Genomix.
(B) By a prior novation effective as at 1 January 2005, the rights and
obligations of TII under the Licence (the "TII INTERESTS") were novated
to SBI, TII being released and discharged from the Licence upon the
terms of SBI's undertaking to perform the Licence and be bound by its
terms and conditions in place of TII.
(C) SBI now wishes to be released and discharged from the Licence to the
extent of its rights and obligations representing the TII Interests and
the parties have agreed to so release and discharge SBI from the
Licence upon the terms of SIP's undertaking to perform the Licence and
be bound by its terms and conditions in place of SBI in respect of the
TII Interests.
NOW IT IS AGREED as follows.
1. DEFINITIONS
In this agreement:
"COUNTERPARTIES" means, together, Genomix and Tanaud BV;
"EFFECTIVE DATE" means 4 January 2005; and
"LICENCE" means a patent and know-how between SBI,
TII, Tanaud BV and Genomix, dated 23 July
2004 a copy of which is annexed hereto and
initialled by the parties for the purposes
of identification only.
2. SIP'S UNDERTAKING
With effect from the Effective Date and in consideration of the
undertakings given by the Counterparties in clause 3, SIP hereby
undertakes to observe, perform, discharge, assume liabilities under and
be bound by the Licence as if SIP were a party to the Licence in place
of SBI in respect of the TII Interests only. Notwithstanding this
undertaking, nothing in this agreement shall:
(A) require SIP to perform any obligation created by or arising
under the Licence falling due for performance, or which should
have been performed, before the Effective Date or to
2
make any payments due or as otherwise would be incurred and
payable prior to the Effective Date; or
(B) make SIP liable for any act, neglect, default, omission or
liability in respect of the Licence committed or incurred by
SBI or occurring before the Effective Date.
3. COUNTERPARTIES' UNDERTAKINGS AND RELEASE OF SBI
3.1 With effect from the Effective Date and in consideration of and subject
to the undertakings given by SIP in clause 2 and SBI in clause 4, the
Counterparties hereby:
(A) release and discharge SBI, in respect of the TII Interests
only, from all liabilities under the Licence and all
obligations to observe, perform, discharge and be bound by the
Licence;
(B) accept SIP's undertaking to observe, perform, discharge,
assume liabilities under and be bound by the Licence (such
undertaking being set out in clause 2); and
(C) agree to observe, perform, discharge, assume liabilities under
and be bound by the Licence as if SIP were a party to the
Licence in the place of SBI in respect of the TII Interests.
3.2 Notwithstanding the provisions of sub-clause 3.1(A), nothing in this
agreement shall affect or prejudice any claim or demand whatsoever
which the Counterparties may have against SBI, in respect of the TII
Interests, in relation to the Licence and arising out of matters prior
to the Effective Date.
4. SBI'S UNDERTAKING AND RELEASE OF COUNTERPARTIES
With effect from the Effective Date and in consideration of the
undertakings given by the Counterparties in clause 3, SBI hereby
releases and discharges the Counterparties from all liabilities under
the Licence and all obligations to observe, perform, discharge and be
bound by the Licence. Notwithstanding this undertaking and release,
nothing in this agreement shall affect or prejudice any claim or demand
whatsoever which SBI may have against the Counterparties in relation to
the Licence and arising out of matters prior to the Effective Date.
5. NOTICES
For the purposes of all provisions in the Licence concerning the
service of notices, the address of SIP is its principal place of
business set out above.
6. COUNTERPARTS
6.1 This agreement may be executed in any number of counterparts, and by
the parties on separate counterparts, but shall not be effective until
each party has executed at least one counterpart.
6.2 Each counterpart shall constitute an original of this agreement, but
all the counterparts shall together constitute but one and the same
instrument.
3
7. GOVERNING LAW
This agreement shall be governed by and construed in accordance with
the laws of the state of New York and subject to the jurisdiction of
the New York courts.
IN WITNESS WHEREOF the parties have entered into this agreement on the date
first written above.
/s/ [Illegible]
- -----------------------------------------------------
For and on behalf of SHIRE BIOCHEM INC.
/s/ [Illegible]
- -----------------------------------------------------
For and on behalf of TANAUD INTERNATIONAL B.V.
/s/ M. Grey
- -----------------------------------------------------
For and on behalf of STRUCTURAL GENOMIX, INC.
/s/ [Illegible]
- -----------------------------------------------------
For and on behalf of SHIRE INTELLECTUAL PROPERTY SRI
THIS NOVATION AGREEMENT is made the 19th day of January, 2005
BETWEEN:
1. Shire BioChem Inc. (formerly known as BioChem Pharma Inc.) of 2250
Alfred-Nobel Blvd., Suite 500, Ville Saint-Laurent, Quebec, H4S 2C9,
Canada ("SBI");
2. Tanaud International B.V. of Fred Roekestraat 123, First Floor, 1076 EE
Amsterdam, The Netherlands ("TANAUD BV");
3. Structural Genomix, Inc. of 10505 Roselle Street, San Diego, CA 92121,
U.S.A. ("GENOMIX");
4. Shire Intellectual Property SrI of Chancery House, High Street,
Bridgetown, Barbados, West Indies ("SIP"); and
5. Shire Pharmaceutical Development Limited to Hampshire International
Business Park, Chineham, Basingstoke, Hampshire, RG24 8EP, U.K.
("SPD").
WHEREAS:
(A) Pursuant to the Licence (as defined below) SBI, Tanaud BV and Tanaud
Ireland Inc. ("TII") licensed certain patents, technology and know-how
to Genomix.
(B) By a prior novation effective as at 1 January 2005, the rights and
obligations of TII under the Licence (the "TII INTERESTS") were novated
to SBI, TII being released and discharged from the Licence upon the
terms of SBI's undertaking to perform the Licence and be bound by its
terms and conditions in place of TII.
(C) By a prior novation effective as at 4 January 2005, SBI was released
and discharged from the Licence to the extent of its rights and
obligations representing the TII Interests and the parties agreed to
release and discharge SBI from the Licence upon the terms of SIP's
undertaking to perform the Licence and be bound by its terms and
conditions in place of SBI in respect of the TII Interests.
(D) SIP now wishes to be released and discharged from the Licence to the
extent of its rights and obligations representing the TII Interests and
the parties have agreed to release and discharge SIP from the Licence
upon the terms of SPD's undertaking to perform the Licence and be bound
by its terms and conditions in place of SIP in respect of the TII
Interests.
NOW IT IS AGREED as follows.
1. DEFINITIONS
In this agreement:
"COUNTERPARTIES" means, together, Genomix and Tanaud BV;
"EFFECTIVE DATE" means 4 January 2005; and
"LICENCE" means a patent and know-how licence between
SBI, TII, Tanaud BV and Genomix, dated 23
July 2004 a copy of which is annexed hereto
and initialled by the parties for the
purposes of identification only.
2
2. SPD'S UNDERTAKING
With effect from the Effective Date and in consideration of the
undertakings given by the Counterparties in clause 3, SPD hereby
undertakes to observe, perform, discharge, assume liabilities under and
be bound by the Licence as if SPD were a party to the Licence in place
of SIP in respect of the TII Interests only. Notwithstanding this
undertaking, nothing in this agreement shall:
(A) require SPD to perform any obligation created by or arising
under the Licence falling due for performance, or which should
have been performed, before the Effective Date or to make any
payments due or as otherwise would be incurred and payable
prior to the Effective Date; or
(B) make SPD liable for any act, neglect, default, omission or
liability in respect of the Licence committed or incurred by
SBI or occurring before the Effective Date.
3. COUNTERPARTIES' UNDERTAKINGS AND RELEASE OF SIP
3.1 With effect from the Effective Date and in consideration of and subject
to the undertakings given by SPD in clause 2 and SIP in clause 4, the
Counterparties hereby:
(A) release and discharge SIP from all liabilities under the
Licence and all obligations to observe, perform, discharge and
be bound by the Licence;
(B) accept SPD's undertaking to observe, perform, discharge,
assume liabilities under and be bound by the Licence (such
undertaking being set out in clause 2); and
(C) agree to observe, perform, discharge and be bound by the
Licence as if SPD were a party to the Licence in the place of
SIP in respect of the TII Interests.
3.2 Notwithstanding the provisions of sub-clause 3.1(A), nothing in this
agreement shall affect or prejudice any claim or demand whatsoever
which the Counterparties may have against SIP in respect of the TII
Interests, in relation to the Licence and arising out of matters prior
to the Effective Date.
4. SIP'S UNDERTAKING AND RELEASE OF COUNTERPARTIES
With effect from the Effective Date and in consideration of the
undertakings given by the Counterparties in clause 3, SIP hereby
releases and discharges the Counterparties from all liabilities under
the Licence and all obligations to observe, perform, discharge and be
bound by the Licence. Notwithstanding this undertaking and release,
nothing in this agreement shall affect or prejudice any claim or demand
whatsoever which SIP may have against the Counterparties in relation to
the Licence and arising out of matters prior to the Effective Date.
5. FURTHER ASSURANCE
The parties (including any successors in business or assignees under
the Licence) agree, at their own cost, to enter into and execute a
novation agreement in a form substantially similar to this agreement to
effect the transfer of the TII Interests to SIP (or its nominee which
shall be a subsidiary of Shire Pharmaceuticals Group plc), thereby
discharging and releasing SPD from the effective date of such novation
from its obligations and liabilities under the Licence and substituting
SIP (or its nominee) as the primary obligor in respect of the TII
Interests, such agreement to be executed on or to take effect from 1
January 2010.
3
5.2 In the event the TII Interests are novated to a nominee of SIP ("SIP
Nominee") pursuant to clause 5.1 the parties (including any successors
in business or assignees under the Licence) further agree, when
requested to do so by SIP and at their own cost, to enter into and
execute a further novation agreement in a form substantially similar to
this agreement to effect the transfer of the TII Interests to SIP,
thereby discharging and releasing the SIP Nominee from the effective
date of such novation from its obligations and liabilities under the
Licence and substituting SIP as the primary obligor in respect of the
TII interests.
6. NOTICES
For the purposes of all provisions in the Licence concerning the
service of notices, the address of SPD is its principal place of
business set out above.
7. COUNTERPARTS
7.1 This agreement may be executed in any number of counterparts, and by
the parties on separate counterparts, but shall not be effective until
each party has executed at least one counterpart.
7.2 Each counterpart shall constitute an original of this agreement, but
all the counterparts shall together constitute but one and the same
instrument.
8. GOVERNING LAW
This agreement shall be governed by and construed in accordance with
the laws of the state of New York and subject to the jurisdiction of
the New York courts.
IN WITNESS WHEREOF the parties have entered into this agreement on the date
first written above.
/s/ [Illegible]
- ---------------------------------------------------------------
For and on behalf of SHIRE BIOCHEM INC.
/s/ [Illegible]
- ---------------------------------------------------------------
For and on behalf of TANAUD INTERNATIONAL B.V.
/s/ M. Grey
- ---------------------------------------------------------------
For and on behalf of STRUCTURAL GENOMIX, INC.
/s/ [Illegible]
- ---------------------------------------------------------------
For and on behalf of SHIRE INTELLECTUAL PROPERTY SRI
/s/ [Illegible]
- ---------------------------------------------------------------
For and on behalf of SHIRE PHARMACEUTICAL DEVELOPMENT LIMITED