Exhibit 10.1
DEVELOPMENT AGREEMENT
This Development Agreement
(this “Agreement” ) is entered into as of
December 19, 2005 (the “Effective
Date” ) by and between MEMORY Pharmaceuticals Corp.
, a Delaware corporation ( “MEMORY” ),
with offices at 100 Philips Parkway, Montvale, New Jersey 07645,
and The Stanley Medical
Research Institute , a nonprofit organization (
“SMRI” ), having offices at 5430
Grosvenor Lane, Suite 200, Bethesda, Maryland 20814.
Recitals
Whereas , MEMORY is focused on developing
innovative drugs for the treatment of debilitating central nervous
system (CNS) disorders such as schizophrenia and bipolar
disorder;
Whereas, SMRI is the
world’s leading nonprofit organization that supports research
on the causes and treatment of schizophrenia and bipolar disorder,
both through its own laboratories and support of researchers
worldwide; and
Whereas, SMRI desires to
support the further development and commercialization of the
Compound (as defined below) in order to accelerate the introduction
of a novel therapy for the benefit of bipolar patients worldwide by
providing a maximum of $3.2 million for development of the
Compound.
Now, Therefore, in
consideration of the foregoing and the covenants and premises
contained in this Agreement, the parties agree as follows:
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1.
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Definitions . As used herein,
the following terms shall have the following meanings:
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1.1.
“Affiliate” shall mean any company or
entity controlled by, controlling, or under common control with a
party hereto and shall include any company or entity of which
greater than fifty percent (50%) of the voting stock or
participating profit interest of which is owned or controlled,
directly or indirectly, by a party, and any company or entity which
owns or controls, directly or indirectly, greater than fifty
percent (50%) of the voting stock of a party.
1.2. “Applicable
Rate” shall mean the greater of prime plus [*]
percent ( [*] %) or [*] percent ( [*] %) per
annum, compounded quarterly.
1.3. “Common
Stock” shall have the meaning set forth in
Section 4.1(a).
1.4.
“Compound” shall mean MEM1003 as used in
schizophrenia or bipolar disorder, a CNS-optimized dihydropyridine
that is a neuronal L-type calcium channel modulator .
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1.5. “Confidential Information” shall
mean all information disclosed by a party to the other pursuant to
this Agreement including, without limitation, manufacturing,
marketing, financial, personnel, scientific and other business
information and plans, and the material terms of this Agreement,
whether in oral, written, graphic or electronic form.
1.6. “Development
Advisory Committee” or
“DAC” shall mean the committee formed
pursuant to Section 3.1.
1.7. “Development
Plan” shall mean the plan for conducting the
Development Program, including a budget, prepared by MEMORY on an
annual basis during the Development Term, as may be amended from
time to time by MEMORY pursuant to Section 2.2.
1.8. “Development
Program” shall mean the research and development
program with respect to the Compound conducted during the
Development Term.
1.9. “Development
Program Inventions” shall mean, collectively,
(i) all inventions, improvements and discoveries, whether or
not patentable, made, conceived or first reduced to practice in the
course of work conducted in the Development Program that is
actually funded by SMRI hereunder, if any, whether solely by
employees or contractors of SMRI, solely by employees or
contractors of MEMORY, or jointly by employees or contractors of
SMRI and MEMORY, and (ii) all patents, patent applications and
copyrights that claim or cover such inventions, improvements or
discoveries.
1.10. “ Development
Program Results” shall mean all data and results
generated in the course of work conducted in the Development
Program that is actually funded by SMRI hereunder.
1.11. “Development
Term” shall mean the period ending upon the earlier
of (i) completion of the Development Program, or
(ii) three (3) years following the Effective Date, as may
be extended for additional, consecutive one (1) year periods
by written agreement of the parties.
1.12. “Disclosing
Party” shall have the meaning provided in
Section 8.1.
1.13. [*]
1.14. “First Commercial
Sale” of a MEMORY Product shall mean the first sale
for use or consumption of such MEMORY Product in a country after
Regulatory Approval has been granted by the governing health
regulatory authority of such country. Sale to an Affiliate or
Licensee shall not constitute a First Commercial Sale unless the
Affiliate or Licensee is the end user of the MEMORY Product.
1.15. “First
Maximum” shall have the meaning provided in
Section 4.2(c)(1).
1.16. “Fourth
Maximum” shall have the meaning provided in
Section 4.2(c)(4).
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1.17.
“Indemnitee” shall have the meaning
provided in Section 9.1.
1.18.
“Licensee” shall mean any Third Party who
has obtained a license to sell MEMORY Products from MEMORY.
1.19. “License
Grant” shall have the meaning provided in
Section 6.2(a).
1.20. “MEMORY
Product” shall mean any product containing the
Compound that receives Regulatory Approval and is commercialized by
MEMORY or its Affiliates or Licensees, including all formulations
and modes of administration thereof for schizophrenia or bipolar
disorder.
1.21. “MEMORY
Proprietary Information” means all Development
Program Inventions and all patents, patent applications,
copyrights, trademarks, trade secrets, know-how and other
intellectual property rights related thereto, owned or licensable
by MEMORY.
1.22. “Net
Sales” shall mean, with respect to any MEMORY
Product, the amount invoiced for the sale of such MEMORY Product by
MEMORY and its Affiliates or its Licensees, as applicable, to Third
Parties which are not Affiliates or sublicensees of the selling
party, unless such Affiliates or sublicensees are the end users of
such MEMORY Product in which case the amount billed therefor shall
be deemed to be the amount that would be invoiced to a Third Party
in an arm’s length transaction, less:
(a) cash discounts and/or
quantity discounts allowed;
(b) credits and allowances for
returns, rejections and recalls;
(c) charges for freight,
insurance and transportation specifically included in the amount
invoiced;
(d) sales and use taxes, duties
or other governmental tariffs and other similar taxes incurred and
government mandated rebates; and
(e) accruals for estimated
wholesaler chargebacks, contract rebates and bid rebates and
Medicaid and other similar government mandated rebates as MEMORY
may be required to pay from time to time, all of which shall be
determined in accordance with MEMORY’s standard accounting
methods.
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1.23. “Receiving Party” shall have the
meaning provided in Section 8.1.
1.24. “Regulatory
Approval” shall mean any and all approvals (including
price and reimbursement approvals), licenses, registrations, or
authorizations of the United States or European Union or any
country, federal, state or local regulatory agency, department,
bureau or other government entity that is necessary for the
manufacture, use, storage, import, transport and/or sale of a
product in a given jurisdiction.
1.25. “Royalty
Term” shall mean the period of time commencing on the
First Commercial Sale of any MEMORY Product and ending upon the
termination of MEMORY’s payment obligations under Section 4.2
or [*] , whichever is earlier.
1.26. “Second
Maximum” shall have the meaning set forth in
Section 4.2(c)(2).
1.27. “Securities
Purchase Agreement” means the Securities Purchase
Agreement in the form attached hereto as Exhibit A to
be entered into between SMRI and MEMORY.
1.28. “Strategic
Alliance” shall mean an agreement entered into by
MEMORY with a Third Party with respect to the development of the
Compound, but excluding an agreement with a Third Party with
respect to only the manufacturing, sale and/or promotion of the
Compound and/or MEMORY Products or for the transfer or sale of all
or substantially all of the business of MEMORY to which this
Agreement relates to an Affiliate or Third Party, whether by
merger, sale of stock, sale of assets or otherwise.
1.29.
“Term” shall have the meaning set forth
in Section 10.1.
1.30. “Third
Maximum” shall have the meaning set forth in
Section 4.2(c)(3).
1.31. “Third
Party” shall mean any entity other than SMRI or
MEMORY or an Affiliate of SMRI or MEMORY.
2.1. Development Program.
During the Development Term, MEMORY shall use commercially
reasonable efforts to conduct the Development Program in accordance
with the Development Plan and the terms of this Agreement. The
initial Development Plan will be completed by MEMORY and presented
to the DAC within thirty (30) days of the Effective Date.
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2.2. Amendments to the
Development Plan. MEMORY may amend the Development Plan from
time to time in its sole discretion. Prior to finalizing any such
amendment to the Development Plan which materially reduces funding
for development of the Compound or materially extends the timeline
for development of the Compound, MEMORY shall provide the proposed
amendment to the members of the DAC and SMRI, and the DAC and SMRI
shall have fifteen (15) days from the date the DAC and SMRI
receive such proposed amendment to review and provide MEMORY
comments on such proposed amendment. MEMORY shall consider any such
input in good faith when finalizing such amendment and shall
distribute the finalized amendment to the DAC and SMRI. In the
event that SMRI reasonably believes that the finalized amendment
will have a material adverse effect on the development of the
Compound, SMRI may notify the DAC and MEMORY in writing of such
belief, which notice shall include in reasonable detail the basis
for such belief, provided that such notice is given within fifteen
(15) days of receipt of the final amendment. If SMRI provides
such notice within such fifteen (15) day period, SMRI may
delay or withhold payment of any funding due under this Agreement
pending resolution of the issue in accordance with this
Section 2.2. Within fifteen (15) days after receipt of
such notice from SMRI (or such longer period as agreed by MEMORY
and SMRI), each member of the DAC shall provide notice in writing
to MEMORY of whether it approves the final amendment as proposed,
or not. If a majority of the members of the DAC approve the
amendment as proposed, MEMORY may proceed with the amendment and
this Agreement shall continue in effect. If a majority of the
members of the DAC do not approve the amendment as proposed, MEMORY
may, in its sole discretion, proceed with the amendment;
provided, however, that if MEMORY proceeds with the
amendment, SMRI shall have the right to terminate this Agreement
pursuant to Section 10.4.
2.3. Clinical Trial
Registration . MEMORY shall register each clinical trial to be
conducted pursuant to the Development Program with
(i) SMRI’s quarterly trial reporting system and
(ii) if and to the extent required by law, the US FDA’s
www.ClinicalTrial.gov website.
2.4. Clinical Trials Addendum
. The “Addendum For Clinical Trials Involving Human
Subjects,” a copy of which is annexed hereto as
Exhibit B , is hereby incorporated with and into this
Agreement.
3.1. Development Advisory
Committee. Promptly after the Effective Date, the parties will
form a Development Advisory Committee comprised of [*] of
MEMORY, who shall initially be [*] , [*] of SMRI, who
shall initially be [*] , and two (2) third party
advisors mutually agreed upon by MEMORY and SMRI. One
(1) member of the DAC shall be selected to act as the
chairperson of the DAC, with each chairperson acting for a term of
twelve (12) months. The chairperson shall be selected by
MEMORY. The DAC shall review the data and activities of the
Development Program and monitor the progress of development in
relation to the Development Plan. The DAC shall meet on a
semi-annual basis or at such other frequency as the DAC agrees. The
parties shall agree upon the time and place of meetings. A
reasonable number of additional representatives of a party may
attend meetings of the DAC. [*] .
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3.2. Information and Reports.
Except as otherwise provided in this Agreement, MEMORY will make
available and disclose to SMRI and each member of the DAC all
results of the work conducted pursuant to the Development Plan
prior to and in preparation for DAC meetings and/or SMRI payments
hereunder.
4.1. Funding.
(a) On the Effective Date, SMRI
shall purchase from MEMORY, and MEMORY shall issue and sell to
SMRI, 440,367 shares of MEMORY’s common stock, par value of
$.001 per share (the “Common Stock” ),
and warrants to purchase an additional 154,128 shares of Common
Stock, for an aggregate purchase price of $960,000, on and subject
to the terms and conditions set forth in the Securities Purchase
Agreement.
(b) Subject to the terms and
conditions set forth herein, in consideration for the rights
granted to SMRI hereunder, SMRI shall pay by check to MEMORY the
following amounts in cash within thirty (30) days of receipt
of reports, including the final study report, on the following
events in support of the Development Program:
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Event
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Amount
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[*]
[*]
[*]no later than December 31, 2007
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[*]
[*]
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(c) MEMORY shall spend all
amounts paid to MEMORY by SMRI under this Section 4.1 on the
Development Program. MEMORY shall refund to SMRI any amounts that
are advanced by SMRI under Section 4.1(b) that are not
expended in support of the Development Program prior to
December 31, 2007, together with interest thereon at the
Applicable Rate from the date such funds were advanced by SMRI.
(d) If MEMORY fails to
[*] on or prior to December 31, 2007, then not later
than January 31, 2008 MEMORY shall refund to SMRI all amounts
that are advanced by SMRI under Section 4.1(b), together with
interest thereon at the Applicable Rate from the date such funds
were advanced by SMRI.
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4.2. Royalty Payments.
(a) Royalty Payments by
MEMORY. Subject to MEMORY having received the initial $960,000
payment when due under Section 4.1(b), MEMORY shall pay to
SMRI during the Royalty Term, a royalty of (A) [*] percent (
[*] ) of annual Net Sales of MEMORY Products by MEMORY and
its Affiliates, and (B) [*] percent ( [*] ) of
royalty payments received by MEMORY from Licensees on sales of
MEMORY Products by such Licensees. Royalties on Net Sales shall be
calculated based on the year-to-date sales and shall be paid
quarterly.
(b) Sublicensee Payments.
If, prior to the end of the Term, MEMORY licenses to a Third party
rights to any Development Program Invention, MEMORY shall pay to
SMRI [*] percent ( [*] ) of any cash fees or other
payments actually received by MEMORY from such Third party for such
license, excluding (i) royalties on the sale of the MEMORY
Product, (ii) amounts specifically allocated to research and
development for, or to the manufacture or supply of the Compound or
the MEMORY Product, (iii) amounts that MEMORY is required to
repay ( e.g., a loan), and (iv) amounts received in
exchange for securities of MEMORY.
(c) Maximum Payment
Amount.
(1) In the event that MEMORY
makes total payments to SMRI under this Section 4.2 of at
least [*] percent ( [*] ) of the total amount SMRI
has paid to MEMORY under Section 4.1(b) (the
“First Maximum” ) prior to the [*]
anniversary of the Effective Date, MEMORY’s obligation to
make payments to SMRI pursuant to this Section 4.2 shall
terminate. At any time prior to the [*] anniversary of the
Effective Date, MEMORY may make a lump sum cash payment to SMRI
equaling the amount by which the First Maximum exceeds the total
amount already paid to SMRI under this Section 4.2, and upon
receipt of such payment by SMRI, MEMORY’s obligation to make
payments to SMRI pursuant to this Section 4.2 shall
terminate.
(2) In the event that MEMORY
makes total payments to SMRI under this Section 4.2 of at
least [*] percent ( [*] ) of the total amount SMRI
has paid to MEMORY under Section 4.1(b) (the
“Second Maximum” ) prior to the
[*] anniversary of the Effective Date, MEMORY’s
obligation to make payments to SMRI pursuant to this
Section 4.2 shall terminate. At any time after the [*]
anniversary of the Effective Date and prior to the [*]
anniversary of the Effective Date, MEMORY may make a lump sum cash
payment to SMRI equaling the amount by which the Second Maximum
exceeds the total amount already paid to SMRI under this
Section 4.2, and upon receipt of such payment by SMRI,
MEMORY’s obligation to make payments to SMRI pursuant to this
Section 4.2 shall terminate.
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(3) In the event that MEMORY
makes total payments to SMRI under this Section 4.2 of at
least [*] percent ( [*] ) of the total amount SMRI
has paid to MEMORY under Section 4.1(b) (the
“Third Maximum” ) prior to the [*]
anniversary of the Effective Date, MEMORY’s obligation to
make payments to SMRI pursuant to this Section 4.2 shall
terminate. At any time after the [*] anniversary of the
Effective Date and prior to the [*] anniversary of the
Effective Date, MEMORY may make a lump sum cash payment to SMRI
equaling the amount by which the Third Maximum exceeds the total
amount already paid to SMRI under this Section 4.2, and upon
receipt of such payment by SMRI, MEMORY’s obligation to make
payments to SMRI pursuant to this Section 4.2 shall
terminate.
(4) In the event that MEMORY
makes total payments to SMRI under this Section 4.2 of at
least [*] percent ( [*] ) of the total amount SMRI
has paid to MEMORY under Section 4.1(b) (the
“Fourth Maximum” ) prior to the
[*] anniversary of the Effective Date, MEMORY’s
obligation to make payments to SMRI pursuant to this
Section 4.2 shall terminate. At any time after the [*]
anniversary of the Effective Date and prior to the [*]
anniversary of the Effective Date, MEMORY may make a lump sum cash
payment to SMRI equaling the amount by which the Fourth Maximum
exceeds the total amount already paid to SMRI under this
Section 4.2, and upon receipt of such payment by SMRI,
MEMORY’s obligation to make payments to SMRI pursuant to this
Section 4.2 shall terminate.
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5.
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Payments; Records; Audits .
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5.1. Payment; Reports.
Royalty payments due under Section 4.2 and reports for the
sale of MEMORY Products by MEMORY and its Affiliates and royalty
payments received by MEMORY from Licensees on sales of MEMORY
Products shall be calculated and reported for each calendar
quarter. All royalty payments due to SMRI under Section 4.2
shall be paid within sixty (60) days of the end of each
calendar quarter. Each payment of royalties shall be accompanied by
a report of Net Sales of MEMORY Products in sufficient detail to
permit confirmation of the accuracy of the royalty payment made,
including, without limitation, the number of each MEMORY Product
sold by MEMORY and its Affiliates, the gross sales and Net Sales of
such MEMORY Products sold by MEMORY and its Affiliates in U.S.
dollars, the
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exchange rates used, the royalty payments received by MEMORY
from Licensees on the sale of MEMORY Products, and any other
information necessary to determine the appropriate amount of
royalties due under Section 4.2. MEMORY will keep complete and
accurate records pertaining to such calculation to permit SMRI to
confirm the accuracy of royalty payments due hereunder. MEMORY
shall pay SMRI interest at the Applicable Rate on any payments
pursuant to Section 4.2(a) that are not timely paid by MEMORY
to SMRI.
5.2. Exchange Rate; Manner and
Place of Payment. All payments hereunder shall be payable in
U.S. dollars. With respect to each quarter, for countries other
than the United States, whenever conversion of payments from any
foreign currency shall be required, such conversion shall be made
at an exchange rate equal to the weighted average of the rates of
exchange for the currency of the country from which payments are
payable as published by The Wall Street Journal, Western
U.S. Edition, during the calendar quarter for which a payment is
due. All payments owed under this Agreement shall be made by check
payable to the order of the payee, unless otherwise specified by
such payee.
5.3. Records and Audits. On
thirty (30) days’ prior written notice, SMRI shall have
the right to have an independent certified public accountant
inspect the books and records of MEMORY and/or its Affiliates
and/or its Licensees, no more than once per fiscal year during
usual business hours for the sole purpose of and only to the extent
necessary to verify the completeness and accuracy of the records
and payments made under this Agreement. Such examination with
respect to any fiscal year shall not take place later than two
(2) years following the end of such fiscal year. The
accountant shall inform SMRI only if there has been an underpayment
or an overpayment or misappropriation of payments, and if so, the
amount thereof. The expense of any such inspection shall be borne
by SMRI; provided, however, that, if the inspection
discloses an underpayment in excess of ten percent (10%), then
MEMORY shall pay the out of pocket costs of such audit.
5.4. Withholding of Taxes.
Any withholding of taxes levied by tax authorities outside the
United States on the payments hereunder shall be borne by the party
receiving such payment and deducted by the party making such
payment from the sums otherwise payable by it hereunder for payment
to the proper tax authorities. The parties agree to cooperate with
each other in the event a party claims exemption from such
withholding or seeks deductions under any double taxation or other
similar treaty or agreement from time to time in force, such
cooperation to consist of providing receipts of payment of such
withheld tax or other documents reasonably available.
5.5. Exchange and Royalty Rate
Controls. If at any time legal restrictions prevent the prompt
remittance of part or all royalties with respect to any country
where any MEMORY Product is sold, payment shall be made through
such lawful means or methods as MEMORY may determine. When in any
country the law or regulations prohibit both the transmittal and
deposit of royalties on sales in such a country, royalty payments
shall be suspended for as long as such prohibition is in effect,
and as soon as such prohibition ceases to be in effect, all
royalties
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that would have been obligated to be
transmitted or deposited, but for the prohibition, shall forthwith
be deposited or transmitted promptly to the extent allowable, as
the case may be. If any 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.
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6.
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Intellectual Property Rights
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6.1. Intellectual
Property.
(a) SMRI hereby acknowledges
that, as between the parties, other than as provided for herein,
MEMORY owns all right, title and interest in and to all MEMORY
Proprietary Information and that, except to the extent expressly
provided herein, no right or license in any of the MEMORY
Proprietary Information is granted to SMRI hereunder.
(b) MEMORY agrees to use
commercially reasonable efforts to cause any principal investigator
or institution with which it contracts to conduct work in the
Development Program to assign to MEMORY all ownership rights in
Development Program Inventions and Development Program Results.
MEMORY shall notify SMRI promptly in writing of each Development
Program Invention that it owns, if any, and any other information
reasonably request