EX-10.11



 





Exhibit 10.11




Portions of this exhibit marked [*] are omitted and are requested to be treated confidentially.




LICENSE AGREEMENT




     THIS LICENSE AGREEMENT (this “Agreement”) dated as of December 6, 2006 (the “Effective Date”)
is entered into between TMRC CO., LTD., a privately-held corporation organized under the laws of
Japan (“TMRC”), having a place of business at 4-3 Akasaka, 3-chome, Minato-ku, Tokyo 107-0052,
Japan and INNOVIVE PHARMACEUTICALS, INC., a corporation organized under the laws of the State of
Delaware, U.S.A. (“Innovive”), having a place of business at 555 Madison Avenue, New York, NY
10022, U.S.A.



     WHEREAS, TMRC owns or has rights in the Technology (as defined below).



     WHEREAS, Innovive desires to obtain an exclusive license under TMRC’s rights in the Technology
on the terms and conditions set forth below.



     NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein
contained, the parties hereby agree as follows:



     1. DEFINITIONS



     For purposes of this Agreement, the terms defined in this Section 1 shall have the respective
meanings set forth below:



          1.1 “Affiliate” shall mean, with respect to any Person, any other Person which
directly or indirectly controls, is controlled by, or is under common control with, such Person. A
Person shall be regarded as in control of another Person if it owns, or directly or indirectly
controls, at least fifty percent (50%) of the voting stock or other ownership interest of the other
Person, or if it directly or indirectly possesses the power to direct or cause the direction of the
management and policies of the other Person by any means whatsoever.




          1.2 “Competent Authority(ies)” shall mean, collectively, the governmental entities in
each country in the Territory responsible for (a) the regulation of any Product intended for use in
the Field, including the FDA, (b) the establishment, maintenance and/or protection of rights
related to the Licensed Patent Rights, or (c) any other applicable regulatory or administrative
agency in any country in the Territory that is comparable to, or a counterpart of, the foregoing.




          1.3 “FDA” shall mean the Food and Drug Administration of the United States, or the
successor thereto.




          1.4 “Field 1” shall mean the pharmaceutical prevention or treatment in humans of the
following indications: acute promyelocytic leukemia (APL), “ Field  2” shall mean
the pharmaceutical prevention or treatment in humans of the following indications : multiple




 









 







myeloma (MM), myelodysplatic syndrome (MDS), and all solid tumor indications and
“Field” shall collectively mean Field 1 and Field 2.




          1.5 “First Commercial Sale” shall mean, with respect to any Product, the first sale of
such Product after all applicable marketing and pricing approvals (if any) have been granted by the
applicable governing health authority of such country.




          1.6 “ Joint Work” shall mean work in which TMRC participates by means of payment in
part relating to animal studies and human clinical trial of Product in Field 1 to be conducted by
Innovive, as listed on Exhibit C .




          1.7 “Licensed IP Rights” shall mean, collectively, the Licensed Patent Rights,
Licensed Trademark Rights and the Licensed Know-How Rights.




          1.8 “Licensed Know-How Rights” shall mean all trade secret and other know-how rights
in and to all data, information, compositions and other technology (including, but not limited to,
formulae, procedures, protocols, techniques and results of experimentation and testing) that are
not Licensed Patent Rights and which are available to TMRC and are necessary or useful for Innovive
to make, use, develop, sell or seek regulatory approval to market a composition, or to practice any
method or process, at any time claimed or disclosed in any issued patent or pending patent
application within the Licensed Patent Rights or which otherwise relates to the Technology.




          1.9 “Licensed Patent Rights” shall mean (a) the patents and patent applications listed
on Exhibit A hereto, (b) all U.S. Canadian and Mexican patents and patent applications that claim
or cover the Technology in which TMRC heretofore or hereafter has an
ownership or

(sub)licensable
interest, (c) all divisions, continuations, continuations-in-part, that claim priority to, or
common priority with, the patent applications listed in clauses (a) — (b) above or the patent
applications that resulted in the patents described in clauses (a) — (b) above, and (d) all patents
that have issued or in the future issue from any of the foregoing patent applications, including
utility, model and design patents and certificates of invention, together with any reissues,
reexaminations, renewals, extensions or additions thereto.




          1.10 “Licensed Trademark Rights” shall mean all common law rights and registered
rights in and to the Trademark.




          1.11 “NDA” shall mean a New Drug Application, or similar application for marketing
approval of a Product for use in the Field submitted to the FDA, or its foreign equivalent.




          1.12 “Net Sales” shall mean, with respect to any Product, the gross sales price of
such Product invoiced by Innovive and its sublicensees or its Affiliate to customers who are not
Affiliates (or are Affiliates but are the end users of such Product) less, to the extent actually
paid or accrued by Innovive and its sublicensees or its Affiliate (as applicable), (a) credits,
allowances, discounts and rebates to, and chargebacks from the account of, such customers for
nonconforming, damaged, out-dated and returned Product; (b) freight and insurance costs incurred by
Innovive and its sublicensees or its Affiliate (as applicable) in transporting such Product to such
customers; (c) cash, quantity and trade discounts, rebates and other price reductions for such
Product given to




 









 







such customers under price reduction programs; (d) sales, use, value-added and other direct
taxes incurred on the sale of such Product to such customers; (e) customs duties, tariffs,
surcharges and other governmental charges incurred in exporting or importing such Product to such
customers; (f) sales commissions incurred on the sale of such Product to such customers; and (g) an
allowance for uncollectible or bad debts determined in accordance with generally accepted
accounting principles.




          1.13 “Person” shall mean an individual, corporation, partnership, limited liability
company, trust, business trust, association, joint stock company, joint venture, pool, syndicate,
sole proprietorship, unincorporated organization, governmental authority or any other form of
entity not specifically listed herein.




          1.14 “Phase II Clinical Trial” shall mean a human clinical trial in any country in the
Territory that is sponsored by Innovive or its Affiliate and that is intended to initially evaluate
the effectiveness of a Product for a particular indication or indications in patients with the
disease or indication under study or would otherwise satisfy requirements of 21 CFR 312.21(b), or
its foreign equivalent.




          1.15 “Product(s)” shall mean any therapeutic or preventative pharmaceutical product
made from or comprising Technology for human use in the Field.




          1.16 “Registration(s)” shall mean any and all permits, licenses, authorizations,
registrations or regulatory approvals (including NDAs) required and/or granted by any Competent
Authority as a prerequisite to the development, manufacturing, packaging, marketing and selling of
any product.




          1.17 “Royalty Term” shall mean, with respect to each Product in each country, the term
for which a Valid Claim remains in effect and would be infringed but for the license granted by
this Agreement, by the use, offer for sale, sale or import of such Product in such country.




          1.18 “Technology” shall mean the compound known as TM-411 (Tamibarotene) listed on
Exhibit B and any parts, analogs or derivatives thereof.




          1.19 “Territory” shall mean North America (the United States of America, Canada, and
Mexico).




          1.20 “Third Party” shall mean any Person other than TMRC, Innovive and their
respective Affiliates.




          1.21 “Trademark” shall mean a trademark defined in the letter agreement titled “Re:
Trademark relating to TM411 dated December 5th, 2006.




          1.22 “Valid Claim” shall mean a claim of an issued and unexpired patent or
Trademark included within the Licensed Patent Rights and Licensed Trademark Rights, which
has not been held permanently revoked, unenforceable or invalid by a decision of a court or other
governmental agency of competent jurisdiction, unappealable or unappealed within the time




 









 







allowed for appeal, and which has not been admitted to be invalid or unenforceable through
reissue or disclaimer or otherwise.




     2. REPRESENTATIONS AND WARRANTIES



     Each party hereby represents and warrants to the other party as follows:



          2.1 Corporate Existence. Such party is a corporation duly organized, validly existing
and in good standing under the laws of the state in which it is incorporated.




          2.2 Authorization and Enforcement of Obligations. Such party (a) has the corporate
power and authority and the legal right to enter into this Agreement and to perform its obligations
hereunder, and (b) has taken all necessary corporate action on its part to authorize the execution
and delivery of this Agreement and the performance of its obligations hereunder. This Agreement
has been duly executed and delivered on behalf of such party, and constitutes a legal, valid,
binding obligation, enforceable against such party in accordance with its terms.




          2.3 No Consents. All necessary consents, approvals and authorizations of all
governmental authorities and other Persons required to be obtained by such party in connection with
license of this Agreement have been obtained.




          2.4 No Conflict. The execution and delivery of this Agreement and the performance of
such party’s obligations hereunder (a) do not conflict with or violate any requirement of
applicable laws or regulations, and (b) do not conflict with, or constitute a default under, any
contractual obligation of it.




          2.5 Licensed IP Rights. As to TMRC only, TMRC (a) is the sole owner or exclusive
licensee of the Licensed IP Rights, and except as TMRC has expressly informed Innovive in writing
prior to the date of this Agreement, has not granted to any Third Party any license or other
interest in the Licensed IP Rights in Territory, (b) is not aware of any Third Party patent, patent
application or other intellectual property rights that would be infringed (i) by practicing any
process or method or by making, using or selling any composition which is claimed or disclosed in
the Licensed Patent Rights or which constitutes Licensed Know-How Rights, or (ii) by making, using
or selling Products, and (c) is not aware of any infringement or misappropriation by a Third Party
of the Licensed IP Rights.




          2.6 TMRC’s REPRESENTATION AND WARRANTIES. EXCEPT AS EXPRESSLY STATED IN THIS
AGREEMENT NOTHING IN THIS AGREEMENT IS OR SHALL BE CONSTRUED AS (i) A WARRANTY OR REPRESENTATION
BY TMRC AS TO THE VALIDITY OR SCOPE OF ANY LICENSED PATENT RIGHTS (ii) A WARRANTY OR
REPRESENTATION THAT ANYTHING MADE, USED, SOLD, OR OTHERWISE DISPOSED OF UNDER ANY LICENSE GRANTED
IN THIS AGREEMENT IS OR WILL BE FREE FROM INFRINGEMENT OF PATENTS OR OTHER INTELLECTUAL PROPERTY OF
THIRD PARTIES; OR (iii) A REPRESENTATION OR WARRANTY BY TMRC OF THE ACCURACY, SAFETY, OR
USEFULNESS FOR ANY PURPOSE OF ANY TMRC KNOW-HOW AT ANY TIME MADE AVAILABLE BY TMRC. TMRC SHALL
HAVE NO LIABILITY WHATSOEVER TO INNOVIVE OR ANY OTHER PERSON FOR OR ON ACCOUNT OF ANY INJURY,
LOSS, OR DAMAGE, OF ANY KIND OR NATURE,


 









 






SUSTAINED BY, OR ANY DAMAGE ASSERTED OR ASSERTED AGAINST, OR ANY OTHER LIABILITY INCURRED BY
OR IMPOSED ON INNOVIVE OR ANY OTHER PERSON, ARISING OUT OF IN CONNECTION WITH OR RESULTING FROM (A)
THE PRODUCTION, USE , OR SALE OF ANY PRODUCT BY INNOVIVE, OR THE PRACTICE OF THE LICENSED PATENT
RIGHTS BY INNOVIVE; OR (B) THE USE BY INNOVIVE OF ANY TMRC KNOW-HOW, AND INNOVIVE SHALL HOLD
TMRC, OR ITS OFFICERS, EMPLOYEES , OR AGENTS, HARMLESS IN THE EVENT TMRC, OR ITS OFFICERS,
EMPLOYEES, OR AGENTS, IS HELD LIABLE THEREFOR, EXCEPT TO THE EXTENT RESULTING FROM THE NEGLIGENCE
OR WILLFUL MISCONDUCT OF TMRC OR ITS OFFICERS, EMPOYEES, OR AGENTS.




     3. LICENSE GRANT



          3.1 Licensed IP Rights. TMRC hereby grants to Innovive an exclusive license (with the
right to grant sublicenses ) under the Licensed IP Rights to conduct research and to develop, make,
have made, use, offer for sale, sell and import Products in the Territory for use in the Field 1,
and Field 2 under Section 3.6.




          3.2 Availability of the Licensed IP Rights. TMRC shall provide Innovive with a copy
of all information available to TMRC (including information regarding the Japanese filing for the
product) relating to the Licensed IP Rights, Products or Technology, including without limitation:
(a) regulatory submissions including all protocols, protocol amendments and investigator brochures,
(b) communications with the Competent Authorities (including the minutes of any meetings as well as
all pharmacovigilance documents heretofore or hereafter prepared), (c) trial master files,
including case report forms, (d) listings and tables of results from the clinical trials, (e)
treatment-related serious adverse event reports from the clinical trials, (f) storage of and access
permission to any retained samples of materials used in clinical trials, and (g) access to CROs
involved in the clinical trials. Innovive shall provide TMRC, at TMRC’s cost and to the extent
Innovive is not legally or contractually prohibited therefrom, with all data and reports developed
by Innovive under this Agreement and are specific to the Licensed IP Rights. Innovive shall grant
to TMRC a nonexclusive license to use such data and reports outside the Territory, subject to TMRC
paying to Innovive such costs, and Innovive grants to TMRC’s other licensees of the Technology, to
the extent Innovive is not legally or contractually prohibited therefrom, a nonexclusive license to
use such data and reports in the Field outside the Territory subject to a royalty to be mutually
agreed upon by the parties in good faith prior to the granting of such license.



Notwithstanding foregoing TMRC has joint ownership for the data and reports accrued from Joint Work
and TMRC is free to use such data and reports in and outside the Territory without any restriction.




          3.3 Technical Assistance. For a period of [*] following the date of this Agreement,
Innovive may request that TMRC provides directly , or indirectly if reasonably possible to TMRC,
such technical assistance to Innovive in Field 1as Innovive reasonably requests regarding the
Licensed IP Rights, Products or Technology, including without limitation making all data relevant
to regulatory filings available to Innovive and providing to Innovive all or part of TMRC’s
inventory of GMP and non-GMP Technology as the parties mutually agree. In the




 




[*] Confidential treatment requested; certain information omitted and filed separately
with the SEC.




 









 







event TMRC has adequate personnel available, TMRC shall undertake such technical assistance on
Innovive’s behalf. Innovive shall pay to TMRC its pre-approved, documented reasonable costs
including but not limited to all salary, round trip fee and accommodation fee of providing such
technical assistance. In addition, upon signing of this agreement, TMRC will make available to
Innovive an English translation of the Japanese summary of approval.




          3.4 Registrations. TMRC acknowledges and agrees that Innovive shall own all
Registrations for Products for use in the Field in each country in the Territory. TMRC hereby
grants to Innovive a free-of-charge right to reference and use and have full access to all other
Registrations and all other regulatory documents that relate to the Licensed IP Rights, Products or
Technology, including INDs, BLAs, NDAs and DMFs (whether as an independent document or as part of
any NDA, and all chemistry, manufacturing and controls information), and any supplements,
amendments or updates to the foregoing (for the purposes of this Section, the “Right of Reference”)
which TMRC has right to do so. Innovive shall have the right to (sub)license the Right of
Reference to its sublicensees and Affiliates. TMRC shall promptly notify Innovive of any written
or oral notices received from, or inspections by any Competent Authority relating to any such
Registrations, and shall promptly inform Innovive of any responses to such written notices or
inspections and the resolution of any issue raised by such Competent Authority. During the time
that TMRC is the holder of a Registration, Innovive shall be entitled to attend any major meetings
and participate in telephone calls with the Competent Authorities, including without limitation any
major meeting preparation, meeting co-ordination and preparation of minutes.




          3.5 Product Supply. Subject to the terms and conditions contained herein, Innovive
shall purchase all the requirements of the pharmaceutical Products in the Territory from TMRC at a
price of [*] Japanese Yen (¥[*]) per 2mg Tamibarotene tablet. Innovive shall provide TMRC with an
annual non-binding forecast by calendar quarter Innovive’s estimated requirements. If purchase of
the pharmaceutical Products is not feasible due to a problem in compliance with regulations in the
Territory, or due to TMRC’s inability or unwillingness to provide the total amounts required by
Innovive, then the parties shall discuss in good faith how to solve such problem and explore the
alternatives including allowing Innovive to manufacture product on its own. If after such good
faith discussions it becomes clear that TMRC is unable to provide such required amounts of Product
due toTMRC’s inability or unwillingness, then Innovive shall have the right to manufacture the
Product itself, or to purchase the pharmaceutical Products from Third Parties; provided, however,
that TMRC, Innovive and such Third Parties shall in good faith discuss terms and conditions
concerning such Third Parties’ manufacture. Within [*] months of the Effective Date, TMRC and
Innovive shall enter into a definitive agreement of Supply Agreement separately, on the terms and
conditions outlined in this section 3.5 to cover manufacture and supply of Products to Innovive.




          3.6 First Refusal Right. With respect to the use of the Technology for either
multiple myeloma or a solid tumor indication (including hepatic cancer), within [*] months
following the date that (a) TMRC has provided to Innovive completed Phase II data from an
applicable clinical trial sponsored by or for TMRC, or (b) if TMRC did not sponsor such a clinical
trial, upon written notice to Innovive regarding any such use, Innovive shall have the exclusive
right and option to include all patent and other intellectual property regarding such use within
the scope of the Licensed IP Rights in Field 2 and included within the license grant to Innovive
set forth in Section 3.1. Such right and option may be exercised at any time within such [*]
months by





 




[*] Confidential treatment requested; certain information omitted and filed separately
with the SEC.





 









 







Innovive sending to TMRC written notice of such exercise. Upon exercise of such right and
option, all patent and other intellectual property regarding such use shall be included within the
scope of the Licensed IP Rights and included within the license grant to Innovive set forth in
Section 3.1, and Innovive shall owe any applicable milestone payments for such indication as set
forth in Section 4.3. If the [*] months expires with respect to a use and Innovive has not
provided such written notice, Innovive shall retain the right to negotiate in good faith for any
other such uses.




     4. FINANCIAL CONSIDERATIONS



          4.1 Royalties.




               4.1.1 Royalty Rate. In consideration for the licenses granted to Innovive herein,
during the Royalty Term for a Product, Innovive shall pay to TMRC royalties, with respect to each
Product, equal to (a) [*] percent ([*]%) of Net Sales of such Product by Innovive, its Affiliates
and its sublicensees up to [*] US Dollars ($[*] USD) in any calendar year, (b) [*] percent ([*]%)
of Net Sales of such Product by Innovive , its Affiliates and its sublicensees in excess of [*] US
Dollars ($[*] USD) but less than [*] US Dollars ($[*] USD) in any calendar year, and (c) [*]
percent ([*]%) of Net Sales of such Product by Innovive, its Affiliates and its sublicensees in
excess of [*] US Dollars ($[*] USD) in any calendar year. Innovive shall use the Trademark on any
Product; provided, however, that Innovive may cease to use the Trademark if the registration of
Trademark is not obtained. During the Royalty Term for a Product, Innovive shall pay to TMRC an
additional royalty of [*] percent ([*] %) of Net Sales of such Product by Innovive and its
Affiliates.



               4.1.2 Third Party Royalties. If Innovive, its Affiliates or sublicensees is required
to pay royalties to any Third Party in order to exercise its rights hereunder to make, have made,
use, sell, offer to sale or import any Product, then Innovive shall have the right to credit one
hundred percent (100%) of such Third Party royalty payments against the royalties owing to TMRC
under Section 4.1.1 above with respect to sales of such Product in such country; provided,
however, that Innovive shall not reduce the amount of the royalties paid to TMRC under
Section 4.1.1 above by reason of this Section 4.1.2, with respect to sales of such Product in such
country, to less than [*] percent ([*]%) of Net Sales of such Product in such country.



          4.2 Combination Products. If a Product consists of components that are covered by a
Valid Claim and components that are not covered by a Valid Claim, then for purposes of the royalty
payments under Section 4.1 for Net Sales of such Products, such Net Sales, prior to the royalty
calculation set forth in Section 4.1, first shall be multiplied by the fraction A/(A+B), where A is
the value of the component covered by the Valid Claim as reasonably determined by Innovive, and B
is the value of the component that is not covered by the Valid Claim as reasonably determined by
Innovive, and such resulting amount shall be the “Net Sales” for purposes of the royalty
calculation in Section 4.1 for such Product.




          4.3 Milestones. Innovive shall pay to TMRC the following milestone payments within
thirty (30) days following the first achievement of the applicable milestone:




          (i)Upon signing of this Agreement, Innovive shall pay TMRC ¥10,000,000 in cash




 




[*] Confidential treatment requested; certain information omitted and filed separately with
the SEC.




 









 









(ii)Upon 1st Patient Enrollment in the 1st US Bridging Study
for pharmacokinetic analysis to demonstrate bioequivalency of a Product in non-Asian
individuals, Innovive shall pay TMRC ¥ [*] in cash; provided, however, that TMRC
shall pay to Innovive the sum of up to ¥[*] at maximum at 1st Patient
Enrollment for Joint Work listed on Exhibit C.




(iii)Upon 1st NDA submission in the Territory, Innovive shall pay TMRC
¥[*] in cash




(iv)Upon 1st NDA Approval in the Territory, Innovive shall pay TMRC ¥[*]
in cash




(v)Upon the First Commercial Sale for the first Product in the Territory, Innovive
shall pay TMRC ¥[*] in cash




(vi)Upon achieving Net Sales of US $[*] ($[*] USD) in one calendar year in the
Territory, Innovive shall pay TMRC ¥[*] in cash




(vii)Upon the exercise of Innovive’s right of first refusal as set forth in Section
3.6 for a MM use, Innovive shall pay TMRC ¥[*] in cash




(viii)At FDA approval of an NDA for a Product with specific application for MM,
Innovive shall pay TMRC ¥[*] in cash




(ix)At exercise of each right of first refusal as set forth in Section 3.6 for solid
tumor indications, Innovive shall pay TMRC ¥[*] in cash




(x)At each FDA approval of an NDA for a Product with specific application for solid
tumor indications, Innovive shall pay TMRC ¥[*] in cash



     5. ROYALTY REPORTS AND ACCOUNTING



          5.1 Royalty Reports. Within sixty (60) days after the end of each calendar quarter
during the term of this Agreement following first to occur of the First Commercial Sale of a
Product and the receipt by Innovive or its Affiliates of Net Sublicensing Revenues, Innovive shall
furnish to TMRC a quarterly written report showing in reasonably specific detail (a) the
calculation of Net Sales during such calendar quarter; (b) the calculation of Net Sublicensing
Revenues for such quarter; (c) the calculation of the royalties, if any, that shall have accrued
based upon such Net Sales and Net Sublicensing Revenues; (d) the withholding taxes, if any,
required by law to be deducted with respect to such sales; and (e) the exchange rates, if any, used
in determining the amount of United States dollars. With respect to sales of Products invoiced in
United States dollars, the gross sales, Net Sales and royalties payable shall be expressed in
United States dollars. With respect to (i) Net Sales invoiced in a currency other than United
States dollars and (ii) cash consideration paid in a currency other than United States dollars by
Innovive’s sublicensees hereunder, all such amounts shall be expressed both in the currency in
which the distribution is invoiced and in the United States dollar equivalent. The United States
dollar equivalent shall be calculated using the average of the exchange rate (local currency per
US$1) published in The Wall Street Journal, Western Edition, under the heading “Currency
Trading” on the last business day of each month during the applicable calendar quarter.




 




[*] Confidential treatment requested; certain information omitted and filed separately
with the SEC.




 









 

\






          5.2 Audits.




               5.2.1 Upon the written request of TMRC and not more than once in each calendar year, Innovive
shall permit an independent certified public accounting firm of nationally recognized standing
selected by TMRC and reasonably acceptable to Innovive, at TMRC’s expense, to have access during
normal business hours to such of the financial records of Innovive as may be reasonably necessary
to verify the accuracy of the payment reports hereunder for the eight (8) calendar quarters
immediately prior to the date of such request (other than records for which TMRC has already
conducted an audit under this Section.



               5.2.2 If such accounting firm concludes that additional amounts were owed during the audited
period, Innovive shall pay such additional amounts within thirty (30) days after the date TMRC
delivers to Innovive such accounting firm’s written report so concluding. The fees charged by such
accounting firm shall be paid by TMRC; provided, however, if the audit discloses that the royalties
payable by Innovive for such period are more than [*] percent ([*]%) of the royalties actually paid
for such period, then Innovive shall pay the reasonable fees and expenses charged by such
accounting firm.



               5.2.3 TMRC shall cause its accounting firm to retain all financial information subject to
review under this Section 5.2 in strict confidence; provided, however, that Innovive shall have the
right to require that such accounting firm, prior to conducting such audit, enter into an
appropriate non-disclosure agreement with Innovive regarding such financial information. The
accounting firm shall disclose to TMRC only whether the reports are correct or not and the amount
of any discrepancy. No other information shall be shared. TMRC shall treat all such financial
information as Innovive’s Confidential Information



     6. PAYMENTS



          6.1 Payment Terms. Royalties shown to have accrued by each royalty report provided
for under Section 5 above shall be due on the date such royalty report is due. Payment of
royalties in whole or in part may be made in advance of such due date.




          6.2 Exchange Control. If at any time legal restrictions prevent the prompt remittance
of part or all royalties with respect to any country in the Territory where the Product is sold,
Innovive shall have the right, in its sole discretion, to make such payments by depositing the
amount thereof in local currency to TMRC’s account in a bank or other depository institution in
such country. If the royalty rate specified in this Agreement should exceed the permissible rate
established in any country, the royalty rate for sales in such country shall be adjusted to the
highest legally permissible or government-approved rate.




          6.3 Withholding Taxes. Innovive shall be entitled to deduct the amount of any
withholding taxes, value-added taxes or other taxes, levies or charges with respect to such
amounts, other than United States taxes, payable by Innovive, its Affiliates or sublicensees, or
any taxes required to be withheld by Innovive, its Affiliates or sublicensees, to the extent
Innovive, its Affiliates or sublicensees pay to the appropriate governmental authority on behalf of
TMRC such taxes, levies or charges. Innovive shall use reasonable efforts to minimize any such
taxes, levies or charges required to be withheld on behalf of TMRC by Innovive, its Affiliates or
sublicensees.




 




[*] Confidential treatment requested; certain information omitted and filed separately
with the SEC.




 









 







Innovive promptly shall deliver to TMRC proof of payment of all such taxes, levies and other
charges, together with copies of all communications from or with such governmental authority with
respect thereto.




     7. RESEARCH AND DEVELOPMENT OBLIGATIONS



          7.1 Research and Development Efforts. Innovive shall use its commercially reasonably
efforts to conduct such human clinical trials as Innovive determines are necessary or desirable to
obtain regulatory approval to manufacture and market such Products as Innovive determines are
commercially feasible in the Territory in accordance with Exhibit D hereto, and shall use its
commercially reasonably efforts to obtain regulatory approval to market, and following approval to
commence marketing and market each such Product in such countries in the Territory as Innovive
determines are commercially feasible in accordance with Exhibit D hereto. TMRC shall supply
Innovive with pharmaceutical products for such human clinical trials. The quantity and price of
such products shall be determined between TMRC and Innovive, separately but shall not exceed [*].
Innovive will not publish any preclinical studies of Tamibarotene without a prior written approval
from the TMRC, such approval not to be unreasonably withheld. Innovive shall grant to TMRC to the
extent Innovive is not legally or contractually prohibited therefrom, a nonexclusive license to use
data based on such human clinical trials and regulatory approval in the Field outside the
Territory, subject to TMRC paying Innovive’s costs to provide such data to TMRC, and Innovive
grants to TMRC’s other licensees of the Technology, to the extent Innovive is not legally or
contractually prohibited therefrom, a nonexclusive license to use such data in the Field outside
the Territory subject to a royalty to be mutually agreed upon by the parties in good faith prior to
the granting of such license. Notwithstanding foregoing TMRC has joint ownership for the data
based on such human clinical trials and regulatory approval accrued from Joint Work and TMRC and
TMRC’s licensees are free to use such data and reports outside the Territory and within the
Territory outside the Field without any restriction.




          7.2 Records. Innovive shall maintain records, in sufficient detail and in good
scientific manner, which shall reflect all work done and results achieved in the performance of its
research and development regarding the Products.




          7.3 Reports. Within ninety (90) days following the end of each half calendar year
during the term of this Agreement, Innovive shall prepare and deliver to TMRC a written summary
report which shall describe (a) the research performed to date employing the Licensed IP Rights,
(b) the progress of the development, and testing of Products in clinical trials, and (c) the status
of obtaining regulatory approvals to market Products and Innovive shall inform TMRC of the new
development of clinical trial and regulatory approval from time to time.




     8. CONFIDENTIALITY



          8.1 Confidential Information. During the term of this Agreement, and for a period of
[*] years following the expiration or earlier termination hereof, each party shall maintain in
confidence all information of the other party that is disclosed by the other party and identified
as, or acknowledged to be, confidential at the time of disclosure (the “Confidential Information”),
and shall not use, disclose or grant the use of the Confidential Information except on a
need-to-know basis to those directors, officers, affiliates, employees, permitted licensees,




 




[*] Confidential treatment requested; certain information omitted and filed separately
with the SEC.




 









 







permitted assignees and agents, consultants, clinical investigators or contractors, to the
extent such disclosure is reasonably necessary in connection with performing its obligations or
exercising its rights under this Agreement. To the extent that disclosure is authorized by this
Agreement, prior to disclosure, each party hereto shall obtain agreement of any such Person to hold
in confidence and not make use of the Confidential Information for any purpose other than those
permitted by this Agreement. Each party shall notify the other promptly upon discovery of any
unauthorized use or disclosure of the other party’s Confidential Information.




          8.2 Permitted Disclosures. The confidentiality obligations contained in Section 8.1
above and 8.3 below shall not apply to the extent that (a) any receiving party (the “Recipient”) is
required (i) to disclose information by law, regulation or order of a governmental agency or a
court of competent jurisdiction, or (ii) to disclose information to any governmental agency for
purposes of obtaining approval to test or market a product, provided in either case that the
Recipient shall provide written notice thereof to the other party and sufficient opportunity to
object to any such disclosure or to request confidential treatment thereof; or (b) the Recipient
can demonstrate that (i) the disclosed information was public knowledge at the time of such
disclosure to the Recipient, or thereafter became public knowledge, other than as a result of
actions of the Recipient in violation hereof; (ii) the disclosed information was rightfully known
by the Recipient (as shown by its written records) prior to the date of disclosure to the Recipient
by the other party hereunder; (iii) the disclosed information was disclosed to the Recipient on an
unrestricted basis from a source unrelated to any party to this Agreement and not under a duty of
confidentiality to the other party; or (iv) the disclosed information was independently developed
by the Recipient without use of the Confidential Information disclosed by the other party.
Notwithstanding any other provision of this Agreement, Innovive may disclose Confidential
Information of the TMRC relating to information developed pursuant to this Agreement to any Person
with whom Innovive has, or is proposing to enter into, a business relationship, as long as such
Person has entered into a confidentiality agreement with Innovive.




          8.3 Terms of this Agreement. Except as otherwise provided in Section 8.2 above, TMRC
and Innovive shall not disclose any terms or conditions of this Agreement to any Third Party
without the prior consent of the other party. Notwithstanding the foregoing, prior to execution of
this Agreement, Innovive and TMRC have agreed upon the substance of information that can be used to
describe the terms of this transaction for IPO, equity financing and actual investors, and Innovive
and TMRC may disclose such information, as modified by mutual agreement from time to time, without
the other party’s consent.




     9. PATENTS



          9.1 Patent Prosecution and Maintenance. Innovive shall have the right to control, at
[*] cost, the preparation, filing, prosecution and maintenance of all patents and patent
applications within the Licensed Patent Rights. Innovive shall give TMRC an opportunity to review
and comment on the text of each patent application subject to this Section 9.1 before filing, and
shall supply TMRC with a copy of such patent application as filed, together with notice of its
filing date and serial number. TMRC shall cooperate with Innovive, execute all lawful papers and
instruments and make all rightful oaths and declarations as may be necessary in the preparation,
prosecution and maintenance of all patents and other filings referred to in this Section 9.1. TMRC
has joint ownership for the patent accrued in the course of Joint Work and TMRC is free to practice




 




[*] Confidential treatment requested; certain information omitted and filed separately
with the SEC.




 









 







the inventions claimed in such patent outside Territory and within the Territory outside the
Field without any restriction. If Innovive, in its sole discretion, decides to abandon the
preparation, filing, prosecution or maintenance of any patent or patent application in the Licensed
Patent Rights, then Innovive shall notify TMRC in writing thereof and following the date of such
notice (a) TMRC may control, at [*] cost, the preparation, filing, prosecution and maintenance of
such patents and patent applications, and (b) Innovive shall thereafter have no license under this
Agreement to such patents and patent applications. TMRC represents and warrants that as of the
Effective Date and throughout the term of this Agreement (i) TMRC has and shall maintain the
exclusive rights in Territory to control the preparation, filing, prosecution and maintenance of
all patents and patent applications within the Licensed Patent Rights, and (ii) TMRC has and shall
maintain the necessary rights to grant to Innovive the right to control, with a prior consent of
TMRC’s licensors of the Licensed Patents Rights, the preparation, filing, prosecution and
maintenance of all patents and patent applications within the Licensed Patent Rights as set forth
in this Agreement.




          9.2 Notification of Infringement. Each party shall notify the other party of any
substantial infringement in the Territory known to such party of any Licensed Patent Rights and
shall provide the other party with the available evidence, if any, of such infringement.




          9.3 Enforcement of Patent Rights. Innovive, at [*] expense, shall have the right to
determine the appropriate course of action to enforce Licensed Patent Rights or otherwise abate the
infringement thereof, to take (or refrain from taking) appropriate action to enforce Licensed
Patent Rights, to defend any declaratory judgments seeking to invalidate or hold the Licensed
Patent Rights unenforceable, to control any litigation or other enforcement action and to enter
into, or permit, the settlement of any such litigation, declaratory judgments or other enforcement
action with respect to Licensed Patent Rights, in each case in Innovive’s own name and, if required
by law, in the name of TMRC and shall consider, in good faith, the interests of TMRC in so doing.
If Innovive does not, within one hundred twenty (120) days of receipt of notice from TMRC, abate
the infringement or file suit to enforce the Licensed Patent Rights against at least one infringing
party in the Territory, TMRC shall have the right to take whatever action it deems appropriate to
enforce the Licensed Patent Rights; provided, however, that, within thirty (30) days after receipt
of notice of TMRC’s intent to file such suit, Innovive shall have the right to jointly prosecute
such suit and to fund up to [*] the costs of such suit. The party controlling any such enforcement
action shall not settle the action or otherwise consent to an adverse judgment in such action that
diminishes the rights or interests of the non-controlling party without the prior written consent
of the other party. All monies recovered upon the final judgment or settlement of any such suit to
enforce the Licensed Patent Rights shall be shared, after reimbursement of expenses, in relation to
the damages suffered by each party.




          9.4 Cooperation. In any suit to enforce and/or defend the License Patent Rights
pursuant to this Section 9, the party not in control of such suit shall, at the request and expense
of the controlling party, cooperate in all respects and, to the extent possible, have its employees
testify when requested and make available relevant records, papers, information, samples,
specimens, and the like.



 




[*] Confidential treatment requested; certain information omitted and filed separately
with the SEC.




 









 








     10. TERMINATION



          10.1 Expiration. Subject to Sections 10.2 and 10.4 below, this Agreement shall expire
on the expiration of the last to expire Valid Claim or, if later, fifteen (15) years from the date
of First Commercial Sale of the Product in the Territory. Upon expiration of this Agreement (a)
Innovive shall have a fully paid-up, non-exclusive license under the Licensed Know-How Rights and
Licensed Trademark Rights to make, have made, use, sell, offer for sale and import Products in the
Territory for use in the Field, and (b) Section 3.4 shall survive.




          10.2 Termination by Innovive. In the event of material change in the safety profile of
the Product which makes it impossible to continue the development of the Product to obtain
regulatory approval, Innovive shall have the right to terminate this Agreement upon ninety (90)
days advance written notice to TMRC. In this case, TMRC shall be entitled to a complete duplicate
of (or complete access to, as appropriate) any intellectual property obtained in the course of
development of the Product and all embodiments of such intellectual property shall be promptly
delivered to it upon any such termination of this Agreement. Furthermore Innovive shall pay
equivalent money of milestone payments for Field 1 described in Section 4.3 (ii), (iii) and (iv)
to TMRC, which have not been paid at the time of termination of this Agreement under Section 10.2,
within thirty (30) days of such termination. Section 10.2 shall survive termination of this
Agreement.




          10.3 Except as otherwise provided in Section 12, Innovive may terminate this Agreement upon or
after the breach of any material provision of this Agreement by TMRC if TMRC has not cured such
breach within ninety (90) days after notice thereof by Innovive; provided, however, if any default
is not capable of being cured within such ninety (90) day period and TMRC is diligently undertaking
to cure such default as soon as commercially feasible thereafter under the circumstances, Innovive
shall have no right to terminate this Agreement.




          10.4 Termination by TMRC . Except as otherwise provided in Section 12, TMRC may
terminate this Agreement upon or after the breach of any material provision of this Agreement by
Innovive if Innovive has not cured such breach within ninety (90) days after notice thereof by
TMRC; provided, however, if any default is not capable of being cured within such ninety (90) day
period and Innovive is diligently undertaking to cure such default as soon as commercially feasible
thereafter under the circumstances, TMRC shall have no right to terminate this Agreement.
Notwithstanding termination by TMRC under this Section 10.4, any royalties or milestone payments
that have accrued prior to such termination shall survive such termination.




          10.5 Insolvency or Bankruptcy. To the extent permitted by applicable laws, either
party may, in addition to any other remedies available to it by law or in equity, terminate this
Agreement, in whole or in part, by written notice to the other party in the event the other party
shall have become insolvent or bankrupt, or shall have made assignment for the benefit of its
creditors, or there shall have been appointed a trustee or receiver of the other party. The
parties agree that , (i) in the event of the commencement of a bankruptcy proceeding by or against
Innovive under applicable laws that has not been dismissed or resolved within ninety (90) days,
TMRC shall be entitled to a complete duplicate of (or complete access to, as appropriate) any
intellectual property obtained in the course of development of the Product and all embodiments of
such intellectual property shall be promptly delivered to it upon any such termination of this




 









 







Agreement, upon expiration of such ninety (90) day period upon its written request therefore,
unless Innovive elects to continue to perform all of its obligations under this Agreement or (ii)
in case of a commencement of bankruptcy proceeding by or against TMRC under applicable laws, TMRC
shall, free of charge, furnish Innovive with TMRC’s data under Licensed Know-How Rights which
TMRC has at the time of such commencement and TMRC has right to do so.




          10.6 Effect of Expiration or Termination. Expiration or termination of this Agreement
shall not relieve the parties of any obligation accruing prior to such expiration or termination,
and the provisions of Sections 8, 9, 10, 11 and 13 shall survive the expiration or termination of
this Agreement. Upon any termination of this Agreement, TMRC shall grant a direct license to any
sublicense of Innovive hereunder having the same scope as such sublicense and on terms and
conditions no less favorable to such sublicensee than the terms and conditions of this Agreement,
provided that such sublicensee is not in default of any applicable obligations under this Agreement
and agrees in writing to be bound by the terms and conditions of such direct license.




     11. INDEMNIFICATION



          11.1 Indemnification. Innovive shall defend, indemnify and hold TMRC harmless from
all losses, liabilities, damages and expenses (including attorneys’ fees and costs) incurred as a
result of any claim, demand, action or proceeding arising out of any breach of this Agreement by
Innovive, or the gross negligence or willful misconduct of Innovive in the performance of its
obligations under this Agreement, except in each case to the extent arising from the gross
negligence or willful misconduct of TMRC or the breach of this Agreement by TMRC.




          11.2 Procedure. TMRC promptly shall notify Innovive of any liability or action in
respect of which TMRC intends to claim such indemnification and Innovive shall have the right to
assume the defense thereof with counsel selected by Innovive. The indemnity agreement in this
Section 11 shall not apply to amounts paid in settlement of any loss, claim, damage, liability or
action if such settlement is effected without the consent of Innovive, which consent shall not be
withheld unreasonably. The failure to deliver notice to Innovive within a reasonable time after
the commencement of any such action, if prejudicial to its ability to defend such action, shall
relieve Innovive of any liability to TMRC under this Section 11, but the omission so to deliver
notice to Innovive will not relieve it of any liability that it may have to TMRC otherwise than
under this Section 11. TMRC under this Section 11, its employees and agents, shall cooperate fully
with Innovive and its legal representatives in the investigation and defense of any action, claim
or liability covered by this indemnification.




          11.3 Insurance. Innovive shall maintain product liability insurance with respect to
the research, development, manufacture and sales of Products by Innovive in such amount as Innovive
customarily maintains with respect to the research, development, manufacture and sales of its
similar products. Innovive shall maintain such insurance for so long as it continues to research,
develop, manufacture or sell any Products, and thereafter for so long as Innovive customarily
maintains insurance covering the research, development, manufacture or sale of its similar
products.




 









 








     12. FORCE MAJEURE



     Neither party shall be held liable or responsible to the other party nor be deemed to have
defaulted under or breached this Agreement for failure or delay in fulfilling or performing any
term of this Agreement to the extent, and for so long as, such failure or delay is caused by or
results from causes beyond the reasonable control of the affected party including but not limited
to fire, floods, embargoes, war, acts of war (whether war be declared or not), acts of terrorism,
insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, acts of God
or acts, omissions or delays in acting by any governmental authority or the other party.



     13. MISCELLANEOUS



          13.1 Notices. Any consent, notice or report required or permitted to be given or made
under this Agreement by one of the parties hereto to the other party shall be in writing, delivered
by any lawful means to such other party at its address indicated below, or to such other address as
the addressee shall have last furnished in writing to the addressor and (except as otherwise
provided in this Agreement) shall be effective upon receipt by the addressee.




	 	 	 	 	 
	 

	 	If to TMRC:
	 	TMRC Co., Ltd.
	 

	 	 	 	4-3, Akasaka 3-chome, Minato-ku-
	 

	 	 	 	Tokyo 107-0052
	 

	 	 	 	Attention: Takeki Baba, Director Legal Dept.
	 
	 	 	 	 
	 

	 	If to Innovive:
	 	Innovive Pharmaceuticals, Inc.
	 

	 	 	 	555 Madison Avenue, 25th Floor
	 

	 	 	 	New York, NY 10022, U.S.A.
	 

	 	 	 	Attention: Eric Poma, VP Business Development






          13.2 Governing Law. This Agreement shall be governed by and construed in accordance
with the laws of England, without regard to the conflicts of law principles thereof.




          13.3 Arbitration. Any dispute, controversy or claim initiated by either party arising
out of or relating to this Agreement, its negotiations, execution or interpretation, or the
performance by either party of its obligations under this Agreement (other than (a) any dispute,
controversy or claim regarding the validity, enforceability, claim construction or infringement of
any patent rights, or defenses to any of the foregoing, or (b) any bona fide third party action or
proceeding filed or instituted in an action or proceeding by a Third Party against a party to this
agreement), whether before or after termination of this Agreement, shall be finally resolved by
binding arbitration. Whenever a party shall decide to institute arbitration proceedings, it shall
give prompt written notice to that effect to the other party. Any such arbitration shall be
conducted in the English language under the International Dispute Resolution Procedures and
Arbitration Rules of the American Arbitration Association (the “Rules”) by a panel of three (3)
arbitrators appointed in accordance with such Rules. Any such arbitration shall be held in New
York, NY if Innovive is a defendant or in Tokyo, Japan if TMRC is a defendant. The method and
manner of discovery in any such arbitration proceedings shall be governed by the Rules. The
arbitrators shall have the authority to grant specific performance and to allocate between the
parties the costs of arbitration (including attorneys’ fees and expenses of the parties) in such
equitable manner as they determine.




 









 







Judgment upon the award so rendered may be entered in any court having jurisdiction or
application may be made to such court for judicial acceptance of any award and an order of
enforcement, as the case may be. In no event shall a demand for arbitration be made after the date
when institution of a legal or equitable proceeding based upon such claim, dispute or other matter
in question would be barred by the applicable statute of limitations. Notwithstanding the
foregoing, either party shall have the right, without waiving any right or remedy available to such
party under this Agreement or otherwise, to seek and obtain from any court of competent
jurisdiction any interim or provisional relief that is necessary or desirable to protect the rights
or property of such party, pending the selection of the arbitrators hereunder or pending the
arbitrators’ determination of any dispute, controversy or claim hereunder.




          13.4 Assignment. Innovive shall not assign its rights or obligations under this
Agreement without the prior written consent of TMRC; provided, however, that
Innovive may, without such consent, assign this Agreement and its rights and obligations hereunder
(a) to any Affiliate, or (b) in connection with the transfer or sale of all or substantially all of
its business, or in the event of its merger, consolidation, change in control or similar
transaction. Any permitted assignee shall assume all obligations of its assignor under this
Agreement.




          13.5 Waivers and Amendments. No change, modification, extension, termination or
waiver of this Agreement, or any of the provisions herein contained, shall be valid unless made in
writing and signed by duly authorized representatives of the parties hereto.




          13.6 Entire Agreement. This Agreement embodies the entire agreement between the
parties and supersedes any prior representations, understandings and agreements between the parties
regarding the subject matter hereof except secrecy agreement as of June 26, 2006 between TMRC and
Innovive. There are no representations, understandings or agreements, oral or written, between the
parties regarding the subject matter hereof that are not fully expressed herein except the secrecy
agreement as of June 26, 2006 between TMRC and Innovive. Nothing in this Agreement removes or
overrides any right of action by any party in respect of any fraudulent misrepresentation,
fraudulent concealment or other fraudulent action.




          13.7 No Benefit to Third Parties. The provisions of this Agreement are for the sole
benefit of the parties and their successors and permitted assigns, and shall not be construed as
conferring any rights in any other Persons. The Contracts (Rights of Third Parties) Act 1999 shall
not apply to this Agreement. No Person who is not a party to this Agreement (including any
employee, officer, agent, representative, licensee or subcontractor of either party) shall have the
right (whether under the Contracts (Rights of Third Parties) Act 1999 or otherwise) to enforce any
term of this Agreement which expressly or by implication confers a benefit on that Person without
the express prior agreement in writing of the parties, which agreement must refer to this Section
13.7.




          13.8 Severability. Any of the provisions of this Agreement which are determined to be
invalid or unenforceable in any jurisdiction shall be ineffective to the extent of such invalidity
or unenforceability in such jurisdiction, without rendering invalid or unenforceable the remaining
provisions hereof and without affecting the validity or enforceability of any of the terms of this
Agreement in any other jurisdiction.




 









 








          13.9 Waiver. The waiver by either party hereto of any right hereunder or the failure
to perform or of a breach by the other party shall not be deemed a waiver of any other right
hereunder or of any other breach or failure by said other party whether of a similar nature or
otherwise.




          13.10 Counterparts. This Agreement may be executed in two or more counterparts, each
of which shall be deemed an original, but all of which together shall constitute one and the same
instrument.




          IN WITNESS WHEREOF, the parties have executed this Agreement effective as of the Effective
Date.




	 	 	 	 	 
	 	 	TMRC CO., LTD.
	 
	 	 	 	 
	 

	 	By:	 	 
	 

	 	 	 	 
	 	 	Name: Hisao Ekimoto
	 	 	Title:   Representative Director
	 

	 	 	 	Executive Vice President
	 
	 	 	 	 
	 	 	INNOVIVE PHARMACEUTICALS, INC.
	 
	 	 	 	 
	 

	 	By:	 	 
	 

	 	 	 	 
	 

	 	Name:	 	 
	 

	 	 	 	 
	 

	 	Title :	 	 
	 

	 	 	 	 





 









 






EXHIBIT A




Licensed Patent Rights



US Patent [*] (PCT/[*] regarding manufacturing method)



US Patent Publication [*] (PCT/[*] regarding Polymorphism)



CANADA Publication [*] (PCT/[*] regarding Polymorphism)



New Application for usage (regarding combination use) (PCT application of which is planned.)



 




[*] Confidential treatment requested; certain information omitted and filed separately with
the SEC.




 









 








EXHIBIT B




 TM-411 (Tamibarotene)









 









 





EXHIBIT C




Joint Work





	 	1)	 	1st US Bridging Study for pharmacokinetic analysis to demonstrate
bioequivalency in non-Asian individuals,
	 
	 	2)	 	[*]
	 
	 	3)	 	[*]
	 
	 	4)	 	Others defined






 




[*] Confidential treatment requested; certain information omitted and filed separately with
the SEC.




 









 








EXHIBIT D




Innovive’s Clinical Trial and Schedule



Pivotal Study



A Phase II Study of Tamibarotene in Patients With Relapsed or Refractory Acute Promyelocytic
Leukemia




     Design: Open-label, non-randomized study



       Subject: Adult patients with relapsed or refractory acute promyeloctic leukemia (APL) Objectives




	 	1)	 	Determine PK profile of Tamibarotene (monotherapy) in APL
	 
	 	2)	 	Determine safety and tolerability of Tamibarotene in APL





       Treatment




	 	1)	 	Induction therapy






20 patients will receive oral tamibarotene of 6mg/m2/day for 56 days
at maximum




	 	2)	 	Consolidation therapy






Morphologic leukemia-free or CR patients in induction therapy will receive oral
tamibarotene of 6mg/m2/day for 28 days, 2-3 cycles.



	 	 	 
	Preparation period:

	 	February 2007 – March 2007
	Study period:

	 	March 2007 – February 2008
	Interim meeting:

	 	August 2007
	Study report:

	 	April 2008