Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
Exhibit 10.24
EXECUTION COPY
SUPPLY AGREEMENT
This Supply Agreement (this "AGREEMENT") is entered into on this 16th day
of February, 2005 (the "EFFECTIVE DATE"), by and between Xxxxxxx Pharma
Manufacturing, Inc., an Indiana corporation, doing business at 0000 "X" Xxxxxx
Xxxx, Xxxxxxx, Xxxxxxx 00000 ("XXXXXXX"), and NitroMed, Inc., a Delaware
corporation, with a principal place of business at 000 Xxxxxx Xxxxxx, Xxxxxxxxx,
Xxxxxxxxxxxxx 00000 ("NITROMED"). Xxxxxxx and NitroMed are sometimes referred to
herein together as "PARTIES" or individually as a "PARTY".
RECITALS
WHEREAS, NitroMed wishes to engage Xxxxxxx to manufacture and supply the
Product (as defined below) to NitroMed subject to and in accordance with the
terms and conditions set forth in this Agreement, and Xxxxxxx wishes to be so
engaged.
NOW, THEREFORE, in consideration of the foregoing recital and the mutual
covenants contained herein, and other good and valuable consideration, the
receipt and sufficiency of which is hereby acknowledged, the Parties agree as
follows:
ARTICLE I
DEFINITIONS
SECTION 1.1. As used herein, the following terms shall have the following
meanings:
"ACT" shall mean the United States Food, Drug and Cosmetic Act (21
U.S.C.sections 301, et seq.) and the regulations promulgated thereunder, as each
may be amended from time to time.
"AFFILIATES" shall mean, with respect to either Party, any person or entity
controlling, controlled by or under common control with such Party, with the
term "control" (and its derivatives) meaning the direct or indirect ownership of
fifty percent (50%) or more of the voting common stock or similar equity
ownership interest.
"API" shall mean the active pharmaceutical ingredients isosorbide dinitrate
and hydralazine or either of such ingredients, as the context requires.
"API SPECIFICATIONS" shall mean the specifications for the API as set forth
in Schedule II attached hereto, with such modifications as Xxxxxxx and NitroMed
may agree upon from time to time in accordance with SECTION 3.5.
"cGMP" shall mean current good manufacturing practices required by the Act.
"CURRENT FORMULATIONS" means the dosage strength combinations of the
Product containing (a) 20 mg of isosorbide dinitrate and 37.5 mg of hydralazine
and (b) 40 mg of isosorbide dinitrate and 75 mg of hydralazine, in each case,
solely in the dosage forms and formulations manufactured by Xxxxxxx hereunder.
"DEVELOPMENT AGREEMENT" shall mean that certain Development Agreement,
dated as of February 28, 2001, between the Parties, as amended or otherwise
modified by the Parties from time to time.
"FAILURE TO SUPPLY" shall mean that, during any twelve (12) month period
during the Term (which period shall be measured as set forth below), (i)
multiple instances of Inability to Supply have occurred and (ii) as a result of
such instances of Inability to Supply, the aggregate quantity of conforming
Product that Xxxxxxx has supplied during such twelve (12) month period, either
on time or within the sixty (60) day cure period applicable to any Inability to
Supply, represents less than [**] percent ([**]%) of the aggregate quantity of
Product specified in Valid Purchase Orders submitted to Xxxxxxx in accordance
with this Agreement for shipment during such twelve (12) month period. The
twelve (12) month period applicable to any determination of whether a Failure to
Supply has occurred shall commence upon the required delivery date specified in
the Valid Purchase Order to which the first applicable instance of Inability to
Supply relates.
"FDA" shall mean the United States Food and Drug Administration.
"FULL BATCH QUANTITY" shall mean, subject to the last sentence of
SECTION 2.5, a Product quantity of (i) in the case of the dosage strength
combination thereof containing 20 mg of isosorbide dinitrate and 37.5 mg of
hydralazine, [**] tablets, (ii) in the case of the dosage strength
combination thereof containing 40 mg of isosorbide dinitrate and 75 mg of
hydralazine,[**] tablets, and (iii) in the case of any other dosage strength
combination of the Product, the number of tablets mutually agreed upon by the
Parties.
"INABILITY TO SUPPLY" shall mean, with respect to any Valid Purchase Order
submitted to Xxxxxxx in accordance with the terms of this Agreement, that (i)
subject to the last sentence of SECTION 2.5, Xxxxxxx has failed to supply at
least the aggregate quantity of conforming Product specified in such Valid
Purchase Order on or prior to the delivery date specified in such Valid Purchase
Order and (ii) Xxxxxxx has failed to cure such failure within sixty (60) days
following Xxxxxxx'x receipt of written notice from NitroMed of such failure by
supplying, prior to the expiration of such sixty (60) day period, the quantity
of conforming Product which, together with the quantity theretofore supplied in
respect of such Valid Purchase Order, equals at least the aggregate quantity of
Product specified in such Valid Purchase Order.
"LAUNCH DATE" shall mean the first date on which the Product is
commercially sold in the United States or any of its territories or possessions.
"LICENSED RIGHTS" shall mean all (i) patents, know-how, trade secrets,
technology, specifications, methods of manufacturing, technical data and other
intellectual property rights owned by NitroMed or which NitroMed has the right
to use, and all of NitroMed's permits, licenses or other approvals, in each
case, which are necessary or useful in the manufacture of the Product, as
contemplated herein and (ii) any and all trademarks, service marks and trade
dress reflected in the Product or included in any labels or packaging for the
Product contemplated hereby or by the Product Specifications, the API
Specifications or the Quality Agreement.
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"NDA" shall mean the New Drug Application filed with the FDA in respect of
the Product, including any amendment and any sNDA and all subsequent submissions
in respect of such New Drug Application, amendment, or sNDA.
"PRODUCT" shall mean all dosage strengths and dosage forms of any
immediate-release pharmaceutical drug product for human use containing the
active ingredients isosorbide dinitrate and hydralazine and no other active
ingredient, including the product currently known as BiDil(R) in the dosage
strength combinations thereof containing (a) 20 mg of isosorbide dinitrate and
37.5 mg of hydralazine and (b) 40 mg of isosorbide dinitrate and 75 mg of
hydralazine; PROVIDED, HOWEVER, that the term "Product" shall not refer to any
extended-release version of any such pharmaceutical product.
"PRODUCT SPECIFICATIONS" shall mean the specifications for the Product as
set forth in Schedule I attached hereto, with such modifications as Xxxxxxx and
NitroMed may agree upon from time to time in accordance with SECTION 3.5.
"REGULATORY AUTHORITY" means any national, supra-national, regional, state
or local regulatory agency, department, bureau, commission, council or other
governmental entity in the Territory having regulatory jurisdiction over the
Product, including, without limitation, the FDA.
"TABLET EQUIVALENT" shall mean a Product quantity equivalent to one tablet
containing 20 mg of isosorbide dinitrate and 37.5 mg of hydralazine. For
example, a Product tablet containing 40 mg of isosorbide dinitrate and 75 mg of
hydralazine would constitute a quantity of Product equal to two Tablet
Equivalents.
"TERRITORY" shall mean the entire world.
"VALID PURCHASE ORDER" shall mean a purchase order which meets the
requirements of ARTICLE II.
SECTION 1.2. OTHER DEFINED TERMS. The following terms are defined in the
Articles or other sections of the Agreement indicated below.
Action................................................................10.1
Aggrieved Party.......................................................10.1
Agreement.........................................................preamble
Detailed Product Forecast............................................2.3.2
Due Date...............................................................4.3
Effective Date....................................................preamble
Initial Order........................................................2.4.4
Forecast Commencement Date...........................................2.3.2
Liabilities...........................................................10.1
Long-Term Product Forecast...........................................2.3.1
NitroMed..........................................................preamble
NitroMed Indemnified Party............................................10.2
NitroMed Proprietary Information ......................................9.1
Party.............................................................preamble
Proprietary Information................................................9.1
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Quality Agreement......................................................3.1
Requirements.........................................................2.2.1
Xxxxxxx...........................................................preamble
Xxxxxxx Indemnified Party.............................................10.3
Xxxxxxx Intellectual Property........................................6.5.2
Xxxxxxx Proprietary Information........................................9.1
Term...................................................................7.1
Using Party............................................................9.1
Section 1.3. INTERPRETATION. Unless otherwise indicated to the contrary
herein by the context or use thereof (i) the words, "herein," "hereto," "hereof"
and words of similar import refer to this Agreement as a whole and not to any
particular Section or paragraph hereof, (ii) the word "including" means
"including, but not limited to", (iii) words importing the singular will also
include the plural, and vice versa, and (iv) any reference to any federal,
state, local, or foreign statute or law will be deemed also to refer to all
rules and regulations promulgated thereunder. References to $ will be references
to United States Dollars, and with respect to any contract, obligation,
liability, claim or document that is contemplated by this Agreement but
denominated in currency other than United States Dollars, the amounts described
in such contract, obligation, liability, claim or document will be deemed to be
converted into United States Dollars for purposes of this Agreement as of the
applicable date of determination.
ARTICLE II
PURCHASE AND SALE
SECTION 2.1. AGREEMENT TO SUPPLY; EXCLUSIVITY. Xxxxxxx shall manufacture,
package and sell to NitroMed, all such quantities of the Product as NitroMed
shall order from Xxxxxxx in accordance with the terms and conditions, and
subject to the limitations, set forth in this Agreement, including SECTION 2.3
hereof. Subject to NitroMed meeting its obligations under SECTION 2.2, Xxxxxxx
shall not manufacture the Product for any third party during the Term.
SECTION 2.2. AGREEMENT TO PURCHASE; EXCLUSIVITY.
SECTION 2.2.1. Subject to the terms and conditions of this Agreement
(including SECTION 2.7 hereof), (i) NitroMed agrees to purchase exclusively from
Xxxxxxx NitroMed's entire commercial and clinical requirements of the Product
for use, distribution, sale or resale in the Territory (hereinafter referred to
as NitroMed's "REQUIREMENTS") and (ii) NitroMed shall not manufacture itself or
purchase or procure from any other manufacturer or source, including any of its
Affiliates, partners or any other parties with which any of them has entered
into any collaboration arrangement regarding the Product, any of its
Requirements of the Product.
SECTION 2.2.2. Anything to the contrary notwithstanding, for purposes of
this Agreement, NitroMed's Requirements shall be deemed to include all of the
following parties' requirements of the Product for use, distribution, sale and
resale in the Territory: NitroMed and its Affiliates and partners and any other
party with whom any of them has entered into any collaboration arrangement
involving the Product. NitroMed shall not avoid its purchase
4
obligations under this Agreement by purchasing or selling Product indirectly
through distributors, co-promotion partners, licensees or similar purchasing or
selling arrangements.
Section 2.3. FORECASTS.
SECTION 2.3.1. No later than January 15th of each calendar year during the
Term, NitroMed shall provide Xxxxxxx with a forecast (a "LONG-TERM PRODUCT
FORECAST") setting forth NitroMed's estimate of its Requirements of Product for
each of the three (3) years following the date of such forecast, which shall in
all cases represent a good faith estimate of its actual demand for the Product
based on market conditions and NitroMed's need for a reasonable safety stock.
The initial Long-Term Product Forecast is attached hereto as EXHIBIT A.
SECTION 2.3.2. On the Effective Date and thereafter at least ninety (90)
days prior to the commencement of each calendar quarter (with respect to the
forecast for the period then commencing, the "FORECAST COMMENCEMENT QUARTER")
during the Term, NitroMed shall provide Xxxxxxx with a written estimate of
NitroMed's requirements for each dosage strength and package size of the Product
during the four (4) calendar quarters commencing with the Forecast Commencement
Quarter, delineated by month (a "DETAILED PRODUCT FORECAST"). NitroMed's
forecasted requirements for the first three (3) months of each Detailed Product
Forecast provided hereunder shall be firm and binding upon NitroMed and each
Detailed Product Forecast shall be accompanied by a Valid Purchase Order for the
quantities of Product specified for such three-month period in such Detailed
Product Forecast. The remaining portion of each Detailed Product Forecast shall
be firm, subject to the permissible variances set forth in SECTION 2.3.3. If
NitroMed fails to timely provide any updated Detailed Product Forecast, the
Detailed Product Forecast last provided by NitroMed shall be deemed to be
NitroMed's Detailed Product Forecast for the next succeeding four (4) quarter
period. NitroMed's initial Detailed Product Forecast, covering the period from
April 1, 2005 through March 31, 2006 together with a valid purchase order for
the period April 1, 2005 through June 30, 2005, is attached hereto as EXHIBIT B.
SECTION 2.3.3. Each subsequent Detailed Product Forecast may be updated to
modify the amounts estimated in the previous Detailed Product Forecast for the
periods of time in question subject to the following limitations:
(a) The volume specified for the first calendar quarter covered by
such subsequent Detailed Product Forecast shall not be increased or
decreased by more than [**] percent ([**]%) from the volume specified for
such quarter in the prior Detailed Product Forecast without Xxxxxxx'x
consent;
(b) The volume specified for the second calendar quarter covered by
such subsequent Detailed Product Forecast shall not be increased or
decreased by more than [**] percent ([**]%) from the volume specified for
such quarter in the prior Detailed Product Forecast without Xxxxxxx'x
consent; and
(c) The volume specified for the third calendar quarter covered by
such subsequent Detailed Product Forecast shall not be increased or
decreased by more than [**] percent ([**]%) from the volume specified for
such quarter in the prior Detailed Product Forecast without Xxxxxxx'x
consent.
5
If so requested by NitroMed in a Valid Purchase Order relating to any period
covered by a Detailed Product Forecast, Xxxxxxx may, but shall in no way be
obligated to, supply quantities of Product in excess of the quantity forecast
for such period.
SECTION 2.3.4. All Detailed Product Forecasts submitted hereunder shall be
prepared by NitroMed in good faith and shall in all cases represent a good faith
estimate of actual demand for the Product based on market conditions and
Nitromed's need for a reasonable safety stock.
Section 2.4. PURCHASE ORDERS.
SECTION 2.4.1. In accordance with the terms of this Agreement, NitroMed
will initiate orders for the Product by submitting written purchase orders to
Xxxxxxx at the following address, using the form of purchase order attached
hereto as EXHIBIT C:
Xxxxxxx Pharma Manufacturing, Inc.
Attention: Distributor Sales Coordinator,
Materials Management Department
0000 "X" Xxxxxx Xxxx
Xxxxxxx, XX 00000
Fax: (000) 000-0000
SECTION 2.4.2. Each purchase order submitted by NitroMed shall specify a
required delivery date not less than ninety (90) days after the date of such
purchase order. Xxxxxxx will provide written confirmation of each purchase order
within ten (10) days after receipt thereof; PROVIDED, HOWEVER, that Xxxxxxx
shall have no obligation to accept or confirm any purchase order that is
inconsistent with the terms of this Agreement.
SECTION 2.4.3. All purchase orders shall be governed exclusively by the
terms of this Agreement. Any term or condition in any purchase order,
confirmation, invoice or other document furnished by Xxxxxxx or NitroMed that is
in any way inconsistent with the terms and conditions of this Agreement shall be
null and void, unless specifically and mutually agreed upon in a writing signed
by each Party.
SECTION 2.4.4. NitroMed's binding initial purchase order (the "INITIAL
ORDER") covering the period from the Effective Date to March 31, 2005 is
attached hereto as EXHIBIT D. Anything to the contrary herein notwithstanding
the delivery dates for the Product covered by the Initial Order shall be as set
forth in the Initial Order; provided that NitroMed complies with its obligations
hereunder as necessary to enable Xxxxxxx to comply with such delivery dates and,
provided further, that there is no regulatory impediment to complying with such
delivery dates.
Section 2.5. FULL BATCH QUANTITIES. Unless otherwise mutually agreed upon
by the Parties, all Detailed Product Forecasts and purchase orders for Product
hereunder shall be for Full Batch Quantities. To the extent actual batch sizes
manufactured by Xxxxxxx consist of more or less than the applicable number of
tablets specified in the definition of "Full Batch Quantity" due to variations
in yield within a reasonable variance to be identified in the Quality Agreement,
the quantities of actual Product units contemplated by the applicable purchase
orders will be automatically adjusted to reflect the actual batch sizes
manufactured by Xxxxxxx.
6
SECTION 2.6. SHIPMENT. Product ordered by NitroMed hereunder will be
shipped to NitroMed FOB (Incoterms 2000) Xxxxxxx'x facility in Seymour, Indiana
via the carrier designated by NitroMed.
SECTION 2.7. RIGHT TO COVER. In the event that an Inability to Supply has
occurred, NitroMed shall have the right, upon written notice to Xxxxxxx, to
manufacture itself or procure from any Affiliate of NitroMed or any third party
up to, but not more than, the portion of the quantity of Product specified in
the Valid Purchase Order to which such Inability to Supply relates which Xxxxxxx
has failed to supply.
ARTICLE III
MANUFACTURE
SECTION 3.1. SPECIFICATIONS; QUALITY AGREEMENT. Not later than sixty (60)
days following the Effective Date, the Parties shall enter into a Pharmaceutical
Quality Agreement in form and substance reasonably acceptable to both Parties
(the "QUALITY AGREEMENT"). All Product supplied to NitroMed hereunder shall
conform to the Product Specifications and shall be manufactured in accordance
with the Quality Agreement and cGMP. Each shipment of Product hereunder shall be
accompanied by a certificate of analysis reflecting that such Product conforms
to the Product Specifications.
SECTION 3.2. SUPPLY OF API. NitroMed shall supply to Xxxxxxx without charge
(unless otherwise required herein) all API, conforming to the API
Specifications, which is required to manufacture Product hereunder. NitroMed
shall supply API which meets the API Specifications on dates and in amounts
necessary to allow Xxxxxxx to supply Product to NitroMed consistent with the
Detailed Product Forecasts furnished by NitroMed in accordance with SECTION 2.3
and shall ensure that Xxxxxxx is at all times in possession of sufficient API
which meets API Specifications to satisfy NitroMed's Requirements, as set forth
in the Detailed Product Forecasts in effect from time to time. Each shipment of
API to Xxxxxxx hereunder shall be accompanied by a certificate of analysis
confirming that such API conforms to the API Specifications. Notwithstanding any
other provision of this Agreement, Xxxxxxx shall not be liable for any failure
or delay to meet its obligations hereunder to the extent such failure or delay
is attributable to NitroMed's failure or delay to supply API which meets the API
Specifications on a timely basis. NitroMed shall be solely responsible for all
aspects of securing and maintaining API supply, including, without limitation,
obtaining FDA approval for any and all API suppliers and complying with all
relevant legal and regulatory requirements regarding API supply. Xxxxxxx shall
provide quarterly inventory reports of the API held by Xxxxxxx within five (5)
business days following the end of each calendar quarter. Xxxxxxx and NitroMed
agree and acknowledge that a true and correct report of the inventory of the API
held by Xxxxxxx as of the Effective Date is set forth in SCHEDULE 3.2. Title to
the API shall at all times remain with NitroMed and Xxxxxxx shall not use the
API for any purpose other than performance of its obligations under this
Agreement. NitroMed shall at all times bear the risk of loss of API, except to
the extent that any loss is directly attributable to Xxxxxxx not storing, or
otherwise handling, the API in accordance with this Agreement, the Quality
Agreement and cGMP.
7
SECTION 3.3. LABELS AND PACKAGING. All Product supplied to NitroMed
hereunder shall be packaged in accordance with the Product Specifications, the
Quality Agreement and cGMP. NitroMed will provide camera-ready artwork for the
Product labels and the content of all package inserts required in connection
with the Product to Xxxxxxx or one or more third party vendors specified by
Xxxxxxx at least forty-five (45) days prior to the first delivery date for the
Product requiring such labels and/or such inserts, as specified in NitroMed's
purchase orders. Subject to the foregoing, all labels and package inserts
required for the Product supplied by Xxxxxxx hereunder shall be furnished by
Xxxxxxx or a third party selected by Schwarz. All artwork and content provided
by NitroMed hereunder shall comply with all applicable regulatory requirements.
SECTION 3.4. LICENSES. NitroMed hereby grants to Xxxxxxx a fully paid-up,
royalty-free license or sub-license, as applicable, to use the Licensed Rights
solely in connection with Xxxxxxx'x performance of its obligations under this
Agreement.
SECTION 3.5. CHANGES TO SPECIFICATIONS. Subject to the remaining provisions
of this SECTION 3.5, the API Specifications and the Product Specifications may
be changed from time to time (i) if required by applicable U.S. laws or the FDA
or (ii) upon the request of either Party and with the consent of the other
Party. The following provisions shall apply to changes in the API Specifications
or the Product Specifications:
(a) The Party seeking the change(s) shall promptly advise the other
Party in writing of any such change(s) to the Product Specifications or the
API Specifications, and Xxxxxxx shall promptly advise NitroMed as to any
scheduling, price or other adjustments that may result from such change(s),
if any.
(b) In the event of a change of the nature described in CLAUSE (i)
above, the Party seeking the change shall notify the other Party in writing
promptly upon being informed of or identifying the potential need for such
change and shall consult with the other Party on an ongoing basis regarding
such change, including the need for such potential change and the
appropriate way to address the issue giving rise to such potential change.
(c) Each Party shall use its commercially reasonable efforts to
implement any required or agreed-upon changes to the Product Specifications
or the API Specifications, as applicable, as soon as practicable after the
nature of the change is determined and, if applicable, the applicable Party
has consented to the change; PROVIDED, HOWEVER, that in no event shall any
change be implemented until such time as such change has been approved by
the FDA.
(d) NitroMed shall be responsible for, and shall promptly reimburse
Xxxxxxx for, all reasonable costs and expenses incurred by or on behalf of
Xxxxxxx or its supply contractors in connection with the implementation of
changes to the Product Specifications or the API Specifications that are
mandatory or are requested by NitroMed. Additionally, if any changes to the
Product Specifications or the API Specifications result in an increase in
Xxxxxxx'x manufacturing costs with respect to the
8
Product, the supply prices set forth on SCHEDULE 4.1 shall be adjusted to
fully account for the amount of such increase.
SECTION 3.6. CERTAIN EQUIPMENT. Each Party acknowledges that Xxxxxxx is
currently using a certain roller-compactor (the "MACHINE") leased by NitroMed
from a third party. Xxxxxxx shall have the right to continue to use the Machine
throughout the Term. Until such time as Xxxxxxx assumes the lease applicable to
the Machine or purchases the Machine, as contemplated below, (i) NitroMed shall
be solely responsible for the cost of all required maintenance and repair of the
Machine and (ii) anything to the contrary notwithstanding, any failure by
Xxxxxxx to meet its obligations hereunder shall be excused to the extent that
such failure is attributable to the malfunction or disrepair of the Machine,
provided that such malfunction or disrepair is not attributable to any negligent
or wrongful act or omission by Xxxxxxx. Xxxxxxx shall not use the Machine for
the production of any product other than the Product unless and until NitroMed
either sells the Machine to Xxxxxxx or causes the lease covering the Machine to
be assigned to Xxxxxxx or an alternative arrangement has been made, as
contemplated below. If so requested by Xxxxxxx during the Term or upon the
expiration or termination of the Term, NitroMed shall either sell the Machine to
Xxxxxxx for the then-current fair market value thereof or, if applicable, use
its reasonable best efforts to cause the lease covering the Machine to be
assigned to Xxxxxxx, provided, however, that if such lease cannot be assigned to
Xxxxxxx, the Parties shall agree upon alternative arrangements to permit Xxxxxxx
to continue to use the Machine for products other than the Product.
ARTICLE IV
PRICE AND PAYMENT
SECTION 4.1. PRICE. Xxxxxxx shall supply the Product at the prices set
forth on SCHEDULE 4.1 hereto, subject to SECTION 3.5(c) and SECTION 4.2;
PROVIDED, HOWEVER, that NitroMed shall have the option to purchase up to a total
of [**] tablets of the Product during the period beginning on the Effective Date
and ending on the date that is two (2) years following the Launch Date for a
price equal to $[**] per Tablet Equivalent, which option may be exercised by so
notifying Xxxxxxx thereof in the purchase order(s) applicable to such Product.
SECTION 4.2. PRICE ADJUSTMENTS FOR INCREASED DOSAGE STRENGTHS. In the event
that Xxxxxxx supplies a dosage strength of the Product containing more than one
Tablet Equivalent of API to NitroMed, the price per tablet payable by NitroMed
to Xxxxxxx shall be determined in accordance with the following formula:
[**] where:
P = [**];
X = [**];
Y = [**]; and
Z = [**].
9
For example, if (i) NitroMed's [**] for a tablet containing one Tablet
Equivalent of API is $[**] and its [**] for a tablet containing two Tablet
Equivalents of API is $[**] and (ii) the [**] price payable to Xxxxxxx hereunder
for a tablet containing one Tablet Equivalent of API is $[**], then the price
payable to Xxxxxxx for a tablet containing two Tablet Equivalents of API would
be $[**]. The foregoing notwithstanding, in no event shall the per-tablet price
payable by NitroMed hereunder for any new dosage strength of the Product be less
than the applicable price set forth on SCHEDULE 4.1.
Section 4.3. INVOICES AND PAYMENT. All invoices from Xxxxxxx for services
rendered under the terms of this Agreement shall be payable within thirty (30)
days after receipt by NitroMed (the "DUE DATE").
Section 4.4. LATE PAYMENTS. Any amounts not paid by NitroMed by the Due
Date shall be subject to interest beginning on the Due Date, up to and including
the date on which payment is received by Schwarz, at a rate equal to the lesser
of (a) one percent (1%) per month or (b) the highest rate permitted by
applicable law. In each case, applicable interest shall be calculated daily on
the basis of a 360-day year comprised of 30-day months.
Section 4.5. TAXES. NitroMed shall pay all national, state, municipal or
other sales, use, excise, property or other similar taxes, tariffs or
assessments, assessed upon or levied against the sale of the Product (other than
taxes or charges imposed on Xxxxxxx'x income).
Section 4.6. OUTSTANDING INVOICE. The Parties agree and acknowledge that
NitroMed is currently indebted to Xxxxxxx for development activities performed
by Xxxxxxx in connection with the Product, including as set forth on the
invoices attached hereto as EXHIBIT E, and that NitroMed shall pay such amounts
and any additional amounts owing to Xxxxxxx from time to time pursuant to the
Development Agreement in accordance with the Development Agreement.
ARTICLE V
QUALITY
SECTION 5.1. NON-CONFORMING GOODS.
SECTION 5.1.1. No later than fifteen (15) business days from the date of
arrival of a Product shipment at NitroMed's facility, NitroMed shall examine
such shipment for patent damage, defects or shortage and may, at NitroMed's
option, analyze the Product using the methods of analysis set forth in the
Quality Agreement. If NitroMed determines within such 15-business-day period
that any portion of a Product shipment is not in conformity with the Product
Specifications, it shall promptly (and in no event more than ten (10) business
days following such determination) notify Xxxxxxx of such determination, furnish
a sample of each allegedly non-conforming Product lot and provide reasonable
supporting evidence that the alleged damage, defect or shortage resulted from
processing and/or packaging of the Product by Xxxxxxx and not from any
mishandling during shipment or as a result of non-conforming API supplied by
NitroMed. If, within ten (10) business days of Xxxxxxx'x receipt of any such
notice, Product sample(s) and reasonable supporting evidence, Xxxxxxx does not
agree with NitroMed that such Product is non-conforming, the Parties will
arrange for the lot or lots in question to be tested by a
10
mutually acceptable independent laboratory for conformity with the Product
Specifications, and the determination of such laboratory will be final and
binding upon the Parties. The cost of any such testing by an independent
laboratory shall be borne by the Party whose judgment as to the conformity of
any lot of the Product with the Product Specifications proves to be incorrect.
Any lots of the Product that are not in conformity with the Specifications
shall, at the request of Schwarz, be destroyed by NitroMed or returned to
Xxxxxxx for destruction or reprocessing. The cost of destroying non-conforming
Product or returning non-conforming Product to Xxxxxxx shall be borne by Schwarz
if such non-conformity is determined to be the result of processing and/or
packaging of such Product by Xxxxxxx. For the avoidance of doubt, NitroMed shall
be obligated to pay in full for any rejected shipment of Product that is
subsequently found to be in conformity with the Product Specifications.
SECTION 5.1.2. With respect to any Product determined to be not in
conformity with the Product Specifications at the time of shipment as a result
of processing and/or packaging by Xxxxxxx, Xxxxxxx shall, at Xxxxxxx'x option,
either (a) give NitroMed full credit or, at NitroMed's request, a full refund,
for such non-conforming Product or (b) furnish conforming replacement Product in
substitution of any Product which did not conform to the Product Specifications,
as soon as reasonably practicable and at no additional cost to NitroMed. Except
to the extent Xxxxxxx may otherwise have an indemnification obligation pursuant
to SECTION 10.3 in respect of any Liability attributable to damages incurred by
third parties as a result of the use or ingestion of Product not in conformity
with the Product Specifications, Xxxxxxx'x sole obligation regarding Product
determined to be not in conformity with the Product Specifications as a result
of processing and/or packaging by Xxxxxxx shall be the credit, refund or
replacement contemplated by the foregoing sentence and such credit, refund or
replacement shall be NitroMed's sole remedy in respect of such non-conforming
Product and any lost profits attributable thereto.
SECTION 5.1.3. All claims against Xxxxxxx with respect to any shipment of
the Product resulting from patent defects shall be deemed waived unless NitroMed
timely notifies Xxxxxxx thereof in writing in accordance with SECTION 5.1.1. The
waiver contained in the immediately preceding sentence shall not apply to any
shipment of Product found not to meet the Product Specifications at the time of
delivery by virtue of a latent defect; PROVIDED, HOWEVER, that Xxxxxxx shall
have no liability for any non-conforming Product that is reported to Xxxxxxx (i)
later than ten (10) business days after the day on which NitroMed discovers or
should have discovered such latent defect or (ii) after the expiration date of
such Product.
SECTION 5.1.4. Notwithstanding the foregoing, to the extent non-conformity
of any Product arises from NitroMed's storage and handling of the Product or the
failure of NitroMed to provide API meeting the API Specifications, Xxxxxxx shall
have no liability to NitroMed on the basis of this Agreement or otherwise.
Without limiting the generality of the foregoing, in the situation described in
this SECTION 5.1.4, Xxxxxxx shall have no obligation to replace such Product,
refund or credit any amount paid by NitroMed for such Product, or reimburse
NitroMed for the cost of the API used in such Product. In the situation
described in this SECTION 5.1.4, NitroMed shall replace non-conforming API with
API meeting the API Specifications free of charge upon Xxxxxxx'x request. If API
becomes unusable based on Xxxxxxx'x negligence, willful misconduct or failure to
comply with the terms of this Agreement, Xxxxxxx shall purchase replacement API
at NitroMed's acquisition price.
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SECTION 5.2. RECALL AND SEIZURE.
SECTION 5.2.1. During the Term, the Parties shall keep each other promptly
and fully informed of any notification or other information, whether received
directly or indirectly, which might affect the marketability, safety or
effectiveness of the Product and/or which might necessitate a recall, or result
in the seizure, of any Product.
SECTION 5.2.2. If NitroMed determines that a recall of Product may be
necessary, NitroMed shall promptly inform Xxxxxxx of such determination. To the
extent that such potential recall relates to Product manufactured by Xxxxxxx,
Xxxxxxx shall use commercially reasonably efforts to assist NitroMed in
NitroMed's investigation to determine the cause and extent of the problem giving
rise to such potential recall. NitroMed shall perform any required recall of
Product.
SECTION 5.2.3. In the event of any recall or seizure resulting primarily
from Xxxxxxx'x willful misconduct, grossly negligent act or omission, or breach
of any provision of this Agreement, Xxxxxxx shall, at Xxxxxxx'x election,
either:
(a) supply Product, without charge, to NitroMed, in an amount
sufficient to replace the amount of the Product recalled or seized;
(b) give credit to NitroMed against the purchase price of Product to
be delivered to NitroMed in the future, in amounts equal to the purchase
price paid by NitroMed for the Product so recalled or seized and all
transportation costs and export or import duties incurred by NitroMed with
respect to such recalled or seized Product; or
(c) refund to NitroMed all amounts paid to Xxxxxxx for the recalled or
seized Product and reimburse NitroMed for all transportation costs and
export or import duties incurred by NitroMed with respect to such recalled
or seized Product.
SECTION 5.2.4. Subject to SECTION 5.2.6, except to the extent that any
recall or seizure results primarily from Xxxxxxx'x willful misconduct, grossly
negligent act or omission, or breach of any provision of this Agreement,
NitroMed shall be solely responsible for the costs incurred by NitroMed relating
to any recall or seizure of the Product.
SECTION 5.2.5. For purposes of this SECTION 5.2 "recall" means any recall
or withdrawal or other action by NitroMed or any Affiliate of NitroMed to
recover title to or possession of Product sold or shipped to third parties. For
purposes of this SECTION 5.2, "seizure" means any action by any government
agency to seize or destroy Product or permanently prevent release of Product.
SECTION 5.2.6. Except to the extent Xxxxxxx may otherwise have an
indemnification obligation pursuant to SECTION 10.3 in respect of any Liability
attributable to damages incurred by third parties as a result of the use or
ingestion of Product not in conformity with the Product Specifications,
Xxxxxxx'x sole obligation in connection with any recall or seizure shall be as
set forth in this SECTION 5.2 and the credit, refund or replacement contemplated
by SECTION 5.2.3 shall be NitroMed's sole remedy in respect of seized or
recalled Product and any lost profits attributable thereto.
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SECTION 5.3. REPORTING; RESPONSE TO INQUIRIES.
SECTION 5.3.1. During the Term, each Party shall notify the other Party
within two (2) business days of receipt of any inquiry, complaint, claim or
adverse reaction report regarding the Product (any of the foregoing, a
"Report"), including, without limitation, any inquiry or notice from the FDA or
any other Regulatory Authority regarding any alleged regulatory non-compliance
of the Product, which notice shall describe in reasonable detail all information
contained in the Report or otherwise known to the applicable Party regarding the
subject matter thereof and shall include copies of any documentation comprising
such Report.
SECTION 5.3.2. With respect to any inquiry of the FDA or another applicable
Regulatory Authority in respect of Product manufactured by Xxxxxxx, Xxxxxxx
shall use its commercially reasonable efforts to (a) notify NitroMed of any such
inquiry directed to Xxxxxxx, (b) respond fully and accurately to all such
inquiries directed to Xxxxxxx, (c) assist NitroMed in responding to inquiries
directed to NitroMed, (d) provide the FDA or such other Regulatory Authority
with such information or data in Xxxxxxx'x possession as the FDA or such other
Regulatory Authority requests in connection with such inquiry or the Product,
and (e) consult with NitroMed regarding Xxxxxxx'x response to any such inquiry.
ARTICLE VI
ADDITIONAL AGREEMENTS
SECTION 6.1. COMPLIANCE WITH LAW. Xxxxxxx and NitroMed shall each comply
with the laws, rules and regulations applicable to the manufacture, supply,
marketing and sale of the Product. Notwithstanding the foregoing, NitroMed shall
be solely responsible for, and shall bear all liability and expense relating to,
all legal and regulatory compliance required in connection with the use, sale,
distribution and marketing of the Product in all countries in the Territory.
SECTION 6.2. RECORD RETENTION. Xxxxxxx shall keep and maintain all
production, control, laboratory and other records in accordance with all
applicable laws, rules and regulations, including but not limited to, those
required to be maintained by cGMP. Subject to ARTICLE IX, Xxxxxxx shall make
such records available to NitroMed and NitroMed's representatives upon
NitroMed's reasonable request, and to the representatives of any Regulatory
Authority. Xxxxxxx shall furnish, or permit NitroMed or its representative to
make, copies of such records from time to time upon NitroMed's reasonable
request. NitroMed shall not disclose such copies to any third party without
Xxxxxxx'x prior written consent, which consent shall not unreasonably be
withheld.
SECTION 6.3. INSPECTIONS. Subject to the terms of this SECTION 6.3,
NitroMed shall have the right to inspect such portions of Xxxxxxx'x
manufacturing facility as are relevant to the manufacture of the Product upon
fifteen (15) days' advance notice or on less notice if reasonably required in
order to timely respond to or comply with inquiries from or requirements imposed
by the FDA. Such inspections shall be performed during regular business hours,
conducted in such a manner as to minimize disruption to Xxxxxxx'x business
operations and limited to two (2) business days per inspection. All information
disclosed to or obtained by NitroMed in connection with any such inspection
shall be subject to the confidentiality provisions set forth in
13
ARTICLE IX. Such information shall not be used for any purpose other than
evaluating Xxxxxxx'x compliance with its obligations under this Agreement and
responding to and complying with inquiries from or requirements imposed by the
FDA. Such inspections shall not occur more often than calendar year of the Term,
PROVIDED, HOWEVER, that, during the Term, NitroMed shall be permitted to inspect
more than once per calendar year in the event that (i) its first inspection
reveals material deficiencies in Xxxxxxx'x performance of its obligations
hereunder or (ii) additional inspections are required in order for NitroMed to
timely respond to or comply with inquiries from or requirements imposed by the
FDA; provided that any such additional inspections shall be no more numerous
than is reasonably necessary.
SECTION 6.4. FDA FEES. NitroMed shall timely pay all establishment and
product fees assessed to NitroMed by the FDA in connection with the Product.
SECTION 6.5. PROPRIETARY RIGHTS.
SECTION 6.5.1. NITROMED PROPRIETARY RIGHTS. Xxxxxxx acknowledges and agrees
that, subject to the license granted under this Agreement, all Licensed Rights
are and shall remain the exclusive property of NitroMed.
SECTION 6.5.2. XXXXXXX PROPRIETARY RIGHTS. NitroMed acknowledges and agrees
that any and all patents, trade secrets, technology, know-how or other
intellectual property rights developed, owned or used by Xxxxxxx prior to the
Effective Date of this Agreement or developed by Xxxxxxx after the Effective
Date ("XXXXXXX INTELLECTUAL PROPERTY") are and shall remain the exclusive
property of Xxxxxxx.
SECTION 6.5.3. LICENSE GRANT. Without limiting NitroMed's obligations under
SECTION 2.2.1, Xxxxxxx hereby grants to NitroMed a non-exclusive, fully paid-up,
perpetual license, with the right to grant sublicenses, to any intellectual
property that is owned by or licensed to (provided Xxxxxxx has the right to
sublicense) Xxxxxxx and that forms a part of the manufacturing technology and
manufacturing processes used to manufacture the Current Formulations and any
improvements to such intellectual property, provided such improvements form a
part of the manufacturing technology and manufacturing processes used to
manufacture the Current Formulations, solely for use in connection with (a) the
Product, (b) combination products containing active ingredient(s) contained in
the Product as well as other active ingredient(s) and (c) extended-release
products containing active ingredient(s) contained in the Product.
SECTION 6.6. INSURANCE. Throughout the Term, each Party shall maintain
comprehensive general business liability insurance coverage, with minimum limits
of $10,000,000 per occurrence and $10,000,000 annual aggregate of all claims. In
addition, from and after NitroMed's commercial launch of the Product, during the
Term, each Party shall maintain product liability insurance coverage, with
minimum limits of $10,000,000 per occurrence and $10,000,000 annual aggregate of
all claims.
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ARTICLE VII
TERM AND TERMINATION
SECTION 7.1. TERM. This Agreement shall commence and be effective as of the
Effective Date and shall expire on the five (5) year anniversary of the
Effective Date, provided, HOWEVER, that this Agreement shall renew automatically
upon the expiration of the then-current Term for successive one (1) year terms
unless either Party provides written notice of termination at least six (6)
months prior to the expiration of the then-current Term. The initial term,
together with any extensions thereof is referred to herein as the "TERM".
SECTION 7.2. TERMINATION BY EITHER PARTY.
SECTION 7.2.1. MATERIAL BREACH. Except with respect to (i) payment defaults
by NitroMed, which shall be governed by SECTION 7.3.1 (ii) an impairment of the
licenses granted to Xxxxxxx hereunder, which shall be governed by SECTION 7.3.2
and (iii) any failure or delay by Xxxxxxx in supplying Product or Xxxxxxx'x
supply of non-conforming Product, which shall be governed by SECTIONS 2.7,
5.1.2, 5.2.3 and 7.4, if either Party shall at any time fail to discharge any of
its material obligations hereunder and fail to correct such default within sixty
(60) days after the other Party has given written notice to it thereof, or, if
such default is incapable of cure within such sixty (60) day period, fail to
commence good faith action to correct such default during such sixty (60) day
period, then the non-breaching Party shall have the right to terminate this
Agreement immediately upon notice to the breaching Party. This SECTION 7.2.1
shall not be exclusive and shall not be in lieu of any other remedies available
to a Party hereto for any breach hereunder on the part of the other Party.
SECTION 7.2.2. REGULATORY ACTION. Either Party may terminate this Agreement
upon written notice to the other Party in the event the FDA takes any action the
result of which is to permanently prohibit the manufacture, sale, offer for sale
or use of the Product which may not be contested in good faith or remedied in
the ordinary course of business. Upon a termination pursuant to this SECTION
7.2.2, the Parties will attempt to affix responsibility for all costs associated
with outstanding or unfinished purchase orders between themselves; PROVIDED that
NitroMed shall reimburse Xxxxxxx for Xxxxxxx'x costs associated with work in
progress and materials on hand.
SECTION 7.2.3. BANKRUPTCY, INSOLVENCY, Etc. Either Party may terminate this
Agreement immediately upon written notice to the other Party if such other Party
(i) becomes or is adjudged insolvent, (ii) makes a general assignment for the
benefit of its creditors, (iii) commences under the laws of any jurisdiction any
proceeding involving its insolvency, bankruptcy, reorganization, adjustment of
debt, dissolution, liquidation or any other similar proceeding for the release
of financially distressed debtors, (iv) has a petition filed in bankruptcy for
or against it (which, in the case of any involuntary petition, is not stayed
within sixty (60) days of being filed against it), (v) goes into liquidation
(except for the purposes of a bona fide amalgamation or other reorganization) or
(vi) has a receiver appointed over all or a significant portion of the property
or assets of that other Party.
SECTION 7.3. TERMINATION BY XXXXXXX.
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SECTION 7.3.1. NONPAYMENT. In addition to any other remedies available to
it, Xxxxxxx may terminate this Agreement immediately upon written notice to
NitroMed if, thirty (30) days after written notice from Xxxxxxx, NitroMed fails
to pay in full any invoice that is past due.
SECTION 7.3.2. IMPAIRMENT OF LICENSE. Xxxxxxx may terminate this Agreement
upon termination of or material diminution of Xxxxxxx'x rights under any of the
licenses or sub-licenses granted by NitroMed hereunder which has the effect of
precluding or materially impairing Xxxxxxx'x ability to perform its obligations
hereunder or results in a material increase in the cost of such performance.
SECTION 7.4. TERMINATION BY NITROMED. NitroMed may terminate this Agreement
immediately upon written notice to Xxxxxxx upon the occurrence of a Failure to
Supply, provided that NitroMed's right to terminate this Agreement upon the
occurrence of a Failure to Supply must be exercised within ninety (90) days
after the end of the twelve (12) month period in which such Failure to Supply
has occurred.
SECTION 7.5. SURVIVAL. The following provisions shall survive the
expiration or termination of this Agreement in accordance with their respective
terms: SECTIONS 5.1 through 5.3, 6.2, 6.5, 7.5, 7.6 and ARTICLES IV, IX, X and
XI.
SECTION 7.6. EFFECT OF TERMINATION. Termination or expiration of this
Agreement, in whole or in part, shall be without prejudice to the right of
either Party to receive all payments accrued and unpaid at the effective date of
such termination or expiration, without prejudice to any remedy available to
either Party in respect of any previous breach of any of the representations,
warranties or covenants herein contained and without prejudice to any other
provisions hereof which expressly or necessarily call for performance after such
termination or expiration. Upon expiration or termination of this Agreement,
NitroMed shall have the option to purchase from Xxxxxxx all residual inventories
of raw material (other than API supplied to Xxxxxxx by NitroMed) contemplated by
Xxxxxxx to be used for the Product that is usable by NitroMed at cost and all
finished packaged Product at the applicable then-current prices. Xxxxxxx shall,
as soon as practicable following any such termination or expiration, return to
NitroMed any unused API previously supplied by NitroMed at NitroMed's sole cost
and in accordance with NitroMed's instructions.
ARTICLE VIII
REPRESENTATIONS AND WARRANTIES
Section 8.1. REPRESENTATIONS AND WARRANTIES OF XXXXXXX. Xxxxxxx represents
and warrants to NitroMed as follows:
SECTION 8.1.1. AUTHORITY; BINDING EFFECT; NO VIOLATION.
(a) Xxxxxxx is a corporation duly organized, validly existing
and in good standing under the laws of the state of Indiana.
16
(b) Xxxxxxx has the corporate power and authority necessary to
enter into and be bound by the terms and conditions of this Agreement and
to perform its obligations hereunder. All corporate action on the part of
Xxxxxxx necessary for Xxxxxxx'x authorization, execution and delivery of
this Agreement and Xxxxxxx'x performance of all of its obligations
hereunder has been taken.
(c) This Agreement, when executed and delivered, will be the
legal, valid and binding obligation of Xxxxxxx, enforceable against Xxxxxxx
in accordance with its terms, except as such enforceability may be limited
by applicable bankruptcy, insolvency, moratorium, reorganization, or
similar laws as from time to time in effect, and neither the execution and
delivery of this Agreement by Xxxxxxx nor the performance of the
obligations contemplated hereby will: (x) conflict with or result in any
violation of or constitute a breach of any of the terms or provisions of,
or result in the acceleration of any obligation under, or constitute a
default under any provision of the Articles of Incorporation or By-laws or
similar organizational document of Xxxxxxx or any contract or any other
obligation to which Xxxxxxx is a party or under which it is subject or
bound, or (y) violate any judgment, order, injunction, decree or award of
any court, administrative agency, arbitrator or government body against, or
affecting or binding upon, Xxxxxxx or upon the securities, property or
business of Xxxxxxx, or (z) constitute a violation by Xxxxxxx of any
applicable law or regulation of any jurisdiction as such law or regulation
relates to Xxxxxxx or to the property or business of Xxxxxxx.
SECTION 8.1.2. PRODUCT QUALITY. All Product supplied hereunder shall
have been manufactured, processed, packaged and shipped in conformance with the
Quality Agreement and cGMP, and, at the time of shipment, shall conform to the
Product Specifications and shall not be adulterated or misbranded within the
meaning of the Act. All Product delivered pursuant to this Agreement shall be
delivered to NitroMed free and clear of any liens or encumbrances of any kind
imposed, or caused to be imposed, by Schwarz.
SECTION 8.1.3. ABSENCE OF PROCEEDINGS. There are no pending or, to
Xxxxxxx'x knowledge, threatened, judicial, administrative or arbitral actions,
claims, suits or proceedings against Xxxxxxx relating to the activities
contemplated by this Agreement or the Product, or that otherwise could
reasonably be expected to have a material adverse effect on Xxxxxxx in
performing its obligations under this Agreement.
SECTION 8.1.4. NONINFRINGEMENT OF THIRD PARTY RIGHTS. There is no pending
or, to Xxxxxxx'x knowledge, threatened proceeding, demand or claim against
Xxxxxxx or its Affiliates asserting that any of the manufacturing technology and
manufacturing processes used by Xxxxxxx to perform its obligations under this
Agreement, other than any of the foregoing which constitute Licensed Rights,
infringe or violate the rights of any third party and nothing has come to the
attention of Xxxxxxx which has, or reasonably should have, led Xxxxxxx to
believe that any of the manufacturing technology and manufacturing processes to
be used by Xxxxxxx to perform its obligations under this Agreement will infringe
or violate any proprietary right of any third party.
SECTION 8.2. LIMITED WARRANTIES. THE LIMITED REPRESENTATIONS AND WARRANTIES
SET FORTH IN SECTION 8.1 ARE XXXXXXX'X SOLE
17
REPRESENTATIONS AND WARRANTIES WITH RESPECT TO THE PRODUCT OR ANY OTHER SUBJECT
MATTER HEREOF AND ARE GIVEN IN LIEU OF ANY AND ALL OTHER REPRESENTATIONS OR
WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY
IMPLIED WARRANTIES OF MERCHANTABILITY OR SUITABILITY FOR A PARTICULAR PURPOSE.
THE REMEDIES AFFORDED TO NITROMED FOR ANY BREACH OF REPRESENTATION OR WARRANTY
WILL BE LIMITED TO THOSE EXPRESSLY SET FORTH IN THIS AGREEMENT, TO THE EXCLUSION
OF ANY AND ALL OTHER REMEDIES.
SECTION 8.3. REPRESENTATIONS AND WARRANTIES OF NITROMED. NitroMed
represents and warrants to Xxxxxxx as follows:
SECTION 8.3.1. AUTHORITY; BINDING EFFECT; NO VIOLATION.
(a) NitroMed is a corporation duly organized, validly existing
and in good standing under the laws of the state of Delaware.
(b) NitroMed has the corporate power and authority necessary to
enter into and be bound by the terms and conditions of this Agreement and
to perform its obligations hereunder. All corporate action on the part of
NitroMed necessary for NitroMed's authorization, execution and delivery of
this Agreement and NitroMed's performance of all of its obligations
hereunder has been taken.
(c) This Agreement, when executed and delivered, will be the
legal, valid and binding obligation of NitroMed, enforceable against
NitroMed in accordance with its terms, except as such enforceability may be
limited by applicable bankruptcy, insolvency, moratorium, reorganization,
or similar laws as from time to time in effect, and neither the execution
and delivery of this Agreement by NitroMed nor the performance of the
obligations contemplated hereby will: (x) conflict with or result in any
violation of or constitute a breach of any of the terms or provisions of,
or result in the acceleration of any obligation under, or constitute a
default under any provision of the Articles of Incorporation or By-laws or
similar organizational document of NitroMed or any contract or any other
obligation to which NitroMed is a party or under which it is subject or
bound, or (y) violate any judgment, order, injunction, decree or award of
any court, administrative agency, arbitrator or government body against, or
affecting or binding upon, NitroMed or upon the securities, property or
business of NitroMed, or (z) constitute a violation by NitroMed of any
applicable law or regulation of any jurisdiction as such law or regulation
relates to NitroMed or to the property or business of NitroMed.
SECTION 8.3.2. ABSENCE OF PROCEEDINGS. There are no pending or, to
NitroMed's knowledge, threatened judicial, administrative or arbitral actions,
claims, suits or proceedings against NitroMed relating to the activities
contemplated by this Agreement or the Product, or that otherwise could
reasonably be expected to have a material adverse effect on NitroMed in
performing its obligations under this Agreement.
SECTION 8.3.3. API QUALITY. All API provided by or on behalf of NitroMed to
Xxxxxxx and all methods of delivery of such API shall, at the time of shipment,
conform to all
18
applicable laws and regulations and API Specifications. All API delivered
pursuant to this Agreement shall be delivered to Xxxxxxx free and clear of any
liens or encumbrances of any kind imposed, or caused to be imposed, by NitroMed.
SECTION 8.3.4. SPECIFICATIONS. The API Specifications and the Product
Specifications provided by NitroMed to Xxxxxxx are and will be those included in
the NDA.
SECTION 8.3.5. LICENSED RIGHTS. Except for proprietary rights relating to
the manufacturing technology and manufacturing processes used by Xxxxxxx to
perform its obligations under this Agreement, the intellectual property rights
which NitroMed has licensed or sublicensed, as applicable, to Xxxxxxx pursuant
to SECTION 3.4 hereof constitute all of the proprietary rights necessary to
enable Xxxxxxx to manufacture each dosage strength of the Product and to engage
in all other activities as contemplated by this Agreement. NitroMed is the
lawful owner of, or has a valid license to use, the Licensed Rights. NitroMed
has the right to license or sublicense, as applicable, the Licensed Rights as
contemplated by this Agreement. There is no pending or, to NitroMed's knowledge,
threatened proceeding, demand or claim against NitroMed or its Affiliates
asserting that any of the Licensed Rights infringes or violates the rights of
any third party or that Xxxxxxx, by practicing under the Licensed Rights in
performing its obligations hereunder, would violate any of the proprietary
rights of any third party, and nothing has come to the attention of NitroMed
which has, or reasonably should have, led NitroMed to believe that any of the
Licensed Rights infringes or violates any proprietary right of any third party.
NitroMed is not aware of and has not received any communication challenging the
ownership or use, or the validity or effectiveness of any of the Licensed
Rights.
SECTION 8.4. LIMITED WARRANTIES. THE LIMITED REPRESENTATIONS AND WARRANTIES
SET FORTH IN SECTION 8.3 ARE NITROMED'S SOLE REPRESENTATIONS AND WARRANTIES WITH
RESPECT TO THE PRODUCT OR ANY OTHER SUBJECT MATTER HEREOF AND ARE GIVEN IN LIEU
OF ANY AND ALL OTHER REPRESENTATIONS OR WARRANTIES, WHETHER EXPRESS OR IMPLIED,
INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR
SUITABILITY FOR A PARTICULAR PURPOSE. THE REMEDIES AFFORDED TO XXXXXXX FOR ANY
BREACH OF REPRESENTATION OR WARRANTY WILL BE LIMITED TO THOSE EXPRESSLY SET
FORTH IN THIS AGREEMENT TO THE EXCLUSION OF ANY AND ALL OTHER REMEDIES.
ARTICLE IX
CONFIDENTIALITY
SECTION 9.1. CONFIDENTIALITY. Xxxxxxx shall treat as confidential all
information of NitroMed of which Xxxxxxx becomes aware in connection with
performing its obligations under this Agreement (collectively, "NITROMED
PROPRIETARY INFORMATION"). Xxxxxxx shall neither disclose NitroMed Proprietary
Information to any third party nor use NitroMed Proprietary Information for any
purpose other than as contemplated in this Agreement. NitroMed shall treat as
confidential all information of Xxxxxxx of which NitroMed becomes aware in
connection with this Agreement (collectively, "XXXXXXX PROPRIETARY INFORMATION"
and, together with the NitroMed Proprietary Information, "PROPRIETARY
INFORMATION"). NitroMed shall neither disclose
19
Xxxxxxx Proprietary Information to any third party nor use Xxxxxxx Proprietary
Information for any purpose other than as contemplated in this Agreement.
Nothing contained herein will in any way restrict or impair either Party's
(the "USING PARTY") right to use, disclose or otherwise deal with any
Proprietary Information of the other Party which:
(a) at the time of disclosure is known to the public or thereafter
becomes known to the public by publication or otherwise through no fault of
the Using Party;
(b) the Using Party can establish was in its possession prior to the
time of the disclosure and was not obtained directly or indirectly from the
other Party;
(c) is independently made available as a matter of right to the Using
Party by a third party who is not thereby in violation of a confidential
relationship with the other Party;
(d) is developed by the Using Party independently of the Proprietary
Information received from the other Party, and the Using Party can
establish such development;
(e) is information required to be disclosed by legal or regulatory
process; provided, in each case, the Using Party timely informs the other
Party and uses reasonable efforts to limit the disclosure and maintain
confidentiality to the extent possible and permits the other Party to
intervene and contest or attempt to limit the disclosure; or
(f) is information that the Using Party reasonably determines should
be disclosed to a Regulatory Authority.
SECTION 9.2. PUBLICITY. Subject to SECTION 9.1, all publicity, press
releases and other announcements relating to this Agreement or the transactions
contemplated hereby shall be reviewed in advance by, and shall be subject to the
written approval of, both Parties. Notwithstanding the foregoing, each Party
shall be entitled to make such announcements relating to this Agreement as such
Party reasonably determines is required to comply with any law or regulation
requiring such announcements, including without limitation any rule or
regulation under the United States securities laws or any rule of a stock
exchange or the Nasdaq National Market requiring disclosure.
ARTICLE X
INDEMNIFICATION; CONTROL OF LITIGATION
SECTION 10.1. NOTICE AND ASSISTANCE. Each Party shall promptly notify the
other, in writing, if it learns of any litigation, claim, administrative or
criminal proceeding (collectively "ACTIONS"), asserted or threatened against
such Party (the "AGGRIEVED PARTY") for which such Party may be entitled to
indemnification hereunder from the other Party. With respect to any such Action,
the other Party shall, at no out-of-pocket expense to it except as otherwise
provided
20
in this ARTICLE X, reasonably cooperate with and provide such reasonable
assistance to such Aggrieved Party as such Aggrieved Party may reasonably
request. Such reasonable assistance may include, without limitation, providing
copies of all relevant correspondence and other materials that the Aggrieved
Party may reasonably request; PROVIDED, HOWEVER, that any Proprietary
Information so provided shall be treated in accordance with the provisions of
ARTICLE IX hereof.
SECTION 10.2. INDEMNIFICATION BY NITROMED. NitroMed shall indemnify, defend
and hold harmless Xxxxxxx and its Affiliates and each of its and their
respective employees, officers, directors and agents (each, a "XXXXXXX
INDEMNIFIED PARTY") from and against any and all liability, loss, damage, cost,
and expense (including reasonable attorneys' fees) (collectively, "LIABILITIES")
which the Xxxxxxx Indemnified Party may incur, suffer or be required to pay
resulting from or arising in connection with (a) the storage, distribution,
promotion, sale or use of any Product by NitroMed or any of NitroMed's
sublicensees, distributors, agents or other parties with which NitroMed has
entered into any collaboration regarding the Product, (b) the use of the Product
by any patient or other third party, (c) any withdrawal, recall or seizure of
the Product, that is not attributable primarily to a breach by Xxxxxxx of this
Agreement, (d) except to the extent attributable to the Xxxxxxx Intellectual
Property or Xxxxxxx'x practice thereof, infringement or contributory
infringement of any patent, trademark, copyright or other proprietary right of
any third party by virtue of the manufacture, distribution, promotion, sale or
use of the Product, (e) NitroMed's breach of its representations, warranties,
covenants or other obligations under this Agreement, or (f) gross negligence or
willful misconduct of NitroMed Indemnified Party, except to the extent any such
Liability arises out of the material breach, gross negligence or willful
misconduct of a Xxxxxxx Indemnified Party.
SECTION 10.3. INDEMNIFICATION BY XXXXXXX. Xxxxxxx shall indemnify, defend
and hold harmless NitroMed and its Affiliates, and each of its and their
respective employees, officers, directors and agents (each, a "NITROMED
INDEMNIFIED PARTY") from and against any Liability which the NitroMed
Indemnified Party may incur, suffer or be required to pay resulting from or
arising in connection with (a) Xxxxxxx'x breach of its representations,
warranties, covenants or other obligations under this Agreement or (b) gross
negligence or willful misconduct of a Xxxxxxx Indemnified Party, except to the
extent any such Liability arises out of the material breach, gross negligence or
willful misconduct of a NitroMed Indemnified Party.
SECTION 10.4. FOR THE AVOIDANCE OF DOUBT, THE FOREGOING INDEMNIFICATION
PROVISIONS SHALL APPLY TO CLAIMS OF THE PARTIES HERETO, AS WELL AS THIRD PARTY
CLAIMS.
SECTION 10.5. LIABILITY TO THIRD PARTIES. With respect to third party
Liabilities, the indemnifying Party shall have sole control over, and shall
assume all expense with respect to, the defense, settlement, adjustment or
compromise of any Action as to which this ARTICLE X requires it to indemnify the
other Party, provided that (a) the indemnifying Party shall use counsel
reasonably satisfactory to the Aggrieved Party, (b) the Aggrieved Party may, if
it so desires and at its own expense, participate in and employ counsel to
assist in the handling of such claim, (c) the Parties shall reasonably cooperate
in the sharing of pertinent information related to the Action, and (d) the
indemnifying Party shall obtain prior written approval of the Aggrieved Party,
which shall not be unreasonably withheld, before entering into any settlement,
adjustment
21
or compromise of such Action, or ceasing to defend against such Action, if
pursuant thereto, or as a result thereof, injunctive or other non-monetary
relief would be imposed upon the Aggrieved Party or monetary relief would be
imposed upon the Aggrieved Party for which the Aggrieved Party is not
indemnified hereunder.
SECTION 10.6. CONDITIONS TO INDEMNIFICATION. The obligations of an
indemnifying Party under SECTION 10.2 or SECTION 10.3 are conditioned upon the
delivery of written notice to the indemnifying Party of any potential Liability
promptly after the indemnified Party becomes aware of such potential Liability;
PROVIDED, that the failure of the indemnified Party to give such notice or any
delay thereof shall only affect the indemnified Party's right to indemnification
hereunder to the extent that such failure or delay impairs the indemnifying
Party's ability to defend or contest any Action relating to such Liability.
SECTION 10.7. LIMITATION OF LIABILITY. XXXXXXX'X AND NITROMED'S LIABILITY
IN CONNECTION WITH THIS AGREEMENT AND THE SUBJECT MATTER HEREOF IS SUBJECT TO
THE FOLLOWING LIMITATIONS: (A) EXCEPT WITH RESPECT TO THE FRAUD, GROSS
NEGLIGENCE OR WILLFUL MISCONDUCT OF NITROMED OR XXXXXXX, THEIR RESPECTIVE
AFFILIATES, OFFICERS, DIRECTORS, EMPLOYEES OR AGENTS AND EXCEPT TO THE EXTENT
ATTRIBUTABLE TO A THIRD PARTY CLAIM IN RESPECT OF WHICH A PARTY MAY OTHERWISE
HAVE AN INDEMNIFICATION OBLIGATION PURSUANT TO SECTION 10.2 OR SECTION 10.3, IN
NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY MULTIPLE,
SPECIAL, PUNITIVE, INDIRECT OR INCIDENTAL DAMAGES OF ANY NATURE; (B) IN NO EVENT
SHALL XXXXXXX'X AGGREGATE LIABILITY FOR ALL CLAIMS ARISING OUT OF OR RELATING TO
THIS AGREEMENT OR THE SUBJECT MATTER HEREOF EXCEED THE AMOUNTS PAID BY NITROMED
TO XXXXXXX PURSUANT TO THIS AGREEMENT PRIOR TO THE APPLICABLE DATE OF
DETERMINATION; (C) EXCEPT TO THE EXTENT XXXXXXX MAY OTHERWISE HAVE AN
INDEMNIFICATION OBLIGATION PURSUANT TO SECTION 10.3 IN RESPECT OF ANY CLAIMS
BASED UPON DAMAGES INCURRED BY INDIVIDUALS AS A RESULT OF THE USE OR INGESTION
OF NON-CONFORMING PRODUCT, NITROMED'S SOLE REMEDY FOR CLAIMS ATTRIBUTABLE TO
XXXXXXX'X SUPPLY OF NON-CONFORMING PRODUCT, INCLUDING ANY LOST PROFITS
ATTRIBUTABLE THERETO, SHALL BE AS SET FORTH IN SECTION 5.1.2 OR SECTION 5.2.3,
AS APPLICABLE; AND (D) NITROMED'S SOLE REMEDY FOR CLAIMS ATTRIBUTABLE TO
XXXXXXX'X FAILURE TO TIMELY SUPPLY ANY QUANTITY OF PRODUCT IN ACCORDANCE WITH
THE TERMS OF THIS AGREEMENT, INCLUDING ANY LOST PROFITS ATTRIBUTABLE THERETO,
SHALL BE AS SET FORTH IN SECTIONS 2.7 AND 7.4.
ARTICLE XI
MISCELLANEOUS PROVISIONS
SECTION 11.1. NOTICES. All notices or other communications required or
permitted to be given hereunder shall be in writing and shall be deemed to have
been duly given if delivered by hand or facsimile and confirmed in writing, or
mailed first class, postage prepaid, by
22
registered or certified mail, return receipt requested (mailed notices and
notices sent by facsimile shall be deemed to have been given on the date
received) as follows:
If to NitroMed:
NitroMed, Inc.
000 Xxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Attn: President
Fax: (000) 000-0000
If to Xxxxxxx:
Xxxxxxx Pharma Manufacturing, Inc.
0000 "X" Xxxxxx Xxxx
Xxxxxxx, Xxxxxxx 00000
Attn: Vice President - Manufacturing
Fax: (000) 000-0000
With a copy to:
Xxxxxxx Pharma, Inc.
0000 Xxxx Xxxxxxxxx Xxxxx
Xxxxxx, Xxxxxxxxx 00000
Attn: General Counsel
Fax: (000) 000-0000
or in any case to such other address or addresses as hereafter shall be
furnished as provided in this SECTION 11.1 by any Party hereto to the other
Party.
SECTION 11.2. FORCE MAJEURE. The performance by either Party of any
covenant or obligation on its part to be performed hereunder, other than the
obligation of either Party to pay money to the other and NitroMed's exclusive
purchase obligations pursuant to SECTION 2.2 hereof, will be excused by reason
of strikes or other labor disturbances, riots, fires, accidents, wars, terrorist
activity, embargoes, delays of carriers, inability to obtain raw materials,
failure of power or natural resources of supply, acts, injunctions, or
restraints of government, or any other cause preventing such performance,
provided that such excuse will only be valid to the extent that cause is beyond
the reasonable control of the Party whose performance is affected thereby, and
provided that the affected Party will exert its reasonable best efforts to
eliminate any such cause(s), and resume performance of its obligations with all
reasonably possible speed. Notwithstanding the above, NitroMed shall retain its
rights pursuant to SECTION 2.7 hereof corresponding to an Inability to Supply
caused by a force majeure event as described in this SECTION 11.2 directly
affecting Xxxxxxx'x performance of its obligations under this Agreement.
SECTION 11.3. CHOICE OF LAW; DISPUTE RESOLUTION. This Agreement shall be
construed in accordance with and governed by the internal laws of the State of
New York. Each Party shall attempt in good faith, and with notice to the other
Party, to reach a mutually acceptable
23
resolution of any dispute arising under this Agreement. If no such resolution of
any dispute can be reached, the aggrieved Party shall notify the other Party in
writing of its desire to seek arbitration. Any dispute, controversy or claim
arising out of or in connection with this Agreement shall be determined and
settled by arbitration in New York, pursuant to the Rules of Arbitration then in
effect of the American Arbitration Association. Any award rendered shall be
final and conclusive upon the Parties, and a judgment thereon may be entered in
a court having competent jurisdiction. Any arbitration hereunder shall be (i)
submitted to an arbitration tribunal comprised of three (3) independent members
knowledgeable in the pharmaceutical industry, one of whom shall be selected by
Schwarz, one of whom shall be selected by NitroMed, and one of whom shall be
selected by the other two arbitrators; (ii) allow for the Parties to request
discovery pursuant to the rules then in effect under the Federal Rules of Civil
Procedure for a period not to exceed ninety (90) days; and (iii) require the
award to be accompanied by findings of fact and a statement of reasons for the
decision. Each Party shall bear its own costs and expenses, including attorney's
fees incurred in any dispute which is determined and/or settled by arbitration
pursuant to this Section. Except where clearly prevented by the area in dispute,
both Parties agree to continue performing their respective obligations under
this Agreement while the dispute is being resolved. Arbitration shall not
prevent any Party from seeking injunctive relief where such remedy is an
appropriate form of remedy under the circumstances.
SECTION 11.4. WAIVER; REMEDIES. Any term or provision of this Agreement may
be waived at any time by the Party entitled to the benefit thereof by a written
instrument executed by such Party. No delay on the Part of any Party in
exercising any right, power or privilege hereunder shall operate as a waiver
thereof, nor shall any waiver on the part of any Party of any right, power or
privilege hereunder operate as a waiver of any other right, power or privilege
hereunder nor shall any single or partial exercise of any right, power or
privilege hereunder preclude any other or further exercise thereof or the
exercise of any other right, power or privilege hereunder.
SECTION 11.5. SEVERABILITY. The provisions of this Agreement are separate
and independent covenants, and it is agreed that the invalidity or
unenforceability of one or more of the provisions hereof shall not invalidate
any other provision hereof, and this Agreement shall thereafter continue in full
force and effect. In the event that any provision of this Agreement is found to
be too broad, invalid or unenforceable by any court of competent jurisdiction,
then such court shall have the authority to reform any such provisions as shall
be necessary to make the provisions valid and enforceable; PROVIDED, HOWEVER,
that if the provision is not capable of being reformed, then that invalid or
unenforceable provision shall be deemed deleted as though it had never existed.
SECTION 11.6. INDEPENDENT CONTRACTORS. The Parties hereto are independent
contractors, and nothing contained in this Agreement shall be deemed to create
the relationship of partners, joint venturers, or of principal and agent,
franchisor and franchisee, or of any association or relationship between the
Parties other than as expressly provided in this Agreement. Xxxxxxx acknowledges
that it does not have, and Xxxxxxx shall not make representations to any third
party, either directly or indirectly, indicating that Xxxxxxx has any authority
to act for or on behalf of NitroMed or to obligate NitroMed in any way
whatsoever. NitroMed acknowledges that it does not have, and it shall not make
any representations to any
24
third party, either directly or indirectly, indicating that it has any authority
to act for or on behalf of Schwarz or to obligate Xxxxxxx in any way whatsoever.
SECTION 11.7. SUCCESSORS AND ASSIGNS; ASSIGNMENT. This Agreement shall be
binding upon and shall inure to the benefit of the Parties hereto and their
respective successors and permitted assigns; PROVIDED, HOWEVER, that neither
Party may assign any of its rights, duties or obligations hereunder without the
prior written consent of the other, which consent shall not be unreasonably
withheld, PROVIDED THAT, prior written consent shall not be required in
connection with an assignment to any Affiliate of the assigning Party or to a
third party that acquires substantially all of the assets or outstanding shares
of, or merges with, the assigning Party.
SECTION 11.8. COUNTERPARTS. This Agreement may be executed in any number of
counterparts, each of which shall be considered an original and all of which
taken together shall constitute one instrument.
SECTION 11.9. ENTIRE AGREEMENT. This Agreement, including all Exhibits and
Schedules attached hereto and the Quality Agreement, constitute the entire
understanding of the Parties with respect to the subject matter hereof, and
supersedes all prior contracts, agreements and understandings between the
Parties, including those certain Confidentiality Agreements between the Parties,
effective as of October 11, 1999 and September 14, 2004, respectively. The
Parties agree and acknowledge that the Development Agreement shall remain in
effect after the Effective Date in accordance with its terms; PROVIDED, HOWEVER,
that, in the event of any conflict between the terms of the Development
Agreement and the terms of this Agreement, the terms of this Agreement shall
prevail and be controlling.
SECTION 11.10. AMENDMENT. This Agreement may be modified or amended only by
written agreement signed by both Parties.
SECTION 11.11. CAPTIONS. All section titles or captions contained in this
Agreement, in any Schedule referred to herein or in any Exhibit annexed hereto,
and the table of contents, if any, to this Agreement are for convenience only,
shall not be deemed a part of this Agreement and shall not affect the meaning or
interpretation of this Agreement.
SECTION 11.12. ATTACHMENTS. All Schedules, Exhibits and other attachments
to this Agreement are by this reference incorporated herein and made a part of
this Agreement.
SECTION 11.13. EXPENSES. Except as otherwise set forth herein, all
expenses, including the fees, if any, incurred by any attorneys, accountants or
other consultants engaged by a Party in connection with this Agreement and the
transactions contemplated hereby, shall be paid by the Party incurring such
expenses.
[SIGNATURE PAGE FOLLOWS]
25
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of
the date first written above.
XXXXXXX PHARMA MANUFACTURING, INC.
By: /s/ Xxxxxxxx Xxxxx
-----------------------------------
Name: Xxxxxxxx Xxxxx
Title: Vice President - Treasurer
NITROMED, INC.
By: /s/ Xxxxxxx X. Xxxxxx
-----------------------------------
Name: Xxxxxxx X. Xxxxxx
Title: Chief Executive Officer
26
SCHEDULE I
XXXXXXX PHARMA
PRODUCT SPECIFICATIONS
PROCEDURE: P-2732A-06 Page 1
ITEM: BiDil(R)20(Isosorbide Dinitrate Effective Date:
20mg/ Hydralazine HCI 37.5mg) Tablets November 30, 2004
ITEM CODE: 2732
CUSTOMER: NitroMed, Inc.
USP/NF: No
SUPERSEDES: P-2732A-05; Effective Date: 11-09-04
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission.
27
Schedule II
XXXXXXX PHARMA
RAW MATERIAL SPECIFICATIONS
PROCEDURE: PRM-0342-01 Page 1
ITEM: Diluted Isosorbide Dinitrate USP
[ISDN/ Lactose Blend 200 Mesh (25/75)] Effective Date:
ITEM CODE: RM-0342 October 14, 2004
A/NDA: Yes
SUPERSEDES: PRM-0342-00; Effective Date: 01-11-01
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission.
28
Schedule 3.2
API INVENTORY
DESCRIPTION RM SPMI LOT MFG. LOT QUANTITY(kg)
----------- ---- -------- -------- ------------
HYDRALAZINE HCL UCP [**] [**] [**] [**]
[**] [**] [**]
[**] [**] [**]
------
TOTAL: [**]
DILUTED ISOSORBIDE DINITRATE [**] [**] [**] [**]
USP (ISDN) [**] [**] [**]
[**] [**] [**]
[**] [**] [**]
[**] [**] [**]
[**] [**] [**]
[**] [**] [**]
------
TOTAL: [**]
29
Schedule 4.1
PRICING
For Product tablets containing 20 mg of isosorbide dinitrate and 37.5 mg of
hydralazine:
PERIOD PER-TABLET PRICE
------ ----------------
From the Effective Date until the 2-year
anniversary of the Launch Date $[**]
From the 2-year anniversary of the Launch Date until the
3-year anniversary of the Launch Date $[**]
From the 3-year anniversary of the Launch Date until the
end of the Term $[**]
30
EXHIBIT A
Long-Term Product Forecast
BIDIL(R) 37.5/20mg MANUFACTURING FORECAST
(000'S) Year 1 Year 2 Year 3
------ ------ ------
Bottles (000's)
[**] [**]
180 count bottles [**]
[**] [**] [**]
42 count bottles
[**] [**] [**]
Subtotal
Tabs (000's)
[**] [**] [**]
180 count bottles
[**] [**] [**]
42 count bottles
[**] [**] [**]
Subtotal
February 16, 2005
31
EXHIBIT B
INITIAL DETAILED PRODUCT FORECAST
BIDIL(R) 37.5mg MANUFACTURING FORECAST
(000'S) 2Q05 3Q05 4Q05 1Q06
---------------------- --------------------- ---------------------- ----------------------
Bottles (000's) APR MAY JUN JUL AUG SEP OCT NOV DEC JAN FEB MAR
--- --- --- --- --- --- --- --- --- --- --- ---
180 count bottles [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
[**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
42 count bottles
[**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
Subtotal
Tabs (000's)
[**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
180 count bottles
[**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
42 count bottles
[**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
Subtotal
(000'S) YEAR 1
--------------------------- -----------
Bottles (000's) 3Q05 4Q05 1Q06 YEAR 1
---- ---- ---- ------
180 count bottles [**] [**] [**] [**]
42 count bottles [**] [**] [**] [**]
Subtotal [**] [**] [**] [**]
Tabs (000's)
180 count bottles [**] [**] [**] [**]
42 count bottles [**] [**] [**] [**]
Subtotal [**] [**] [**] [**]
February 16, 2005
EXHIBIT C
FORM OF PURCHASE ORDER
TEL: 000-000-0000
FAX: 000-000-0000
[LOGO]
PO # 20041001 PURCHASE ORDER
Date:
Vendor:
Xxxx To: Ship To:
NitroMed, Inc. NitroMed, Inc.
Attn: Accounts Payable Attn:
Attn: 000 Xxxxxx Xxxxxx 000 Xxxxxx Xxxxxx
Xxxxxxxxx, XX 00000 Xxxxxxxxx, XX 00000
ph:
fax:
Terms:
Freight:
--------------------------------------------------------------------------------------------------------
QTY UNITS CATALOG # DESCRIPTION PRICE EXTENDED REQUIRED
DATE
TOTAL
Buyer:
---------------------
Xxxx Xxxxxxxx
000-000-0000, x 4114
33
EXHIBIT D
INITIAL PURCHASE ORDER
TEL: 000-000-0000
FAX: 000-000-0000
[LOGO]
PO # 20041001 PURCHASE ORDER
Date: 02/16/05
Vendor:
Xxxxxxx Pharma Ship To:
0000 X Xxxxxx Xxxx Xxxx To: NitroMed, Inc.
Xxxxxxx, XX 00000 NitroMed, Inc. Attn:
Attn: Accounts Payable 000 Xxxxxx Xxxxxx
Attn: Xxxx Xxxxxxxx 000 Xxxxxx Xxxxxx Xxxxxxxxx, XX 00000
Xxxxxxxxx, XX 00000
ph: 000-000-0000
fax: 000-000-0000
Terms:
Freight:
QTY UNITS CATALOG # DESCRIPTION PRICE EXTENDED REQUIRED DATE
[**] Tablets Validation Batch 1 BiDil 37.5/20 ([**] Bottles x 180 Tablets) Production to begin [**] [**]
October 1, 2004 and end in December 15, 2004 of all 3 lots.
[**] Tablets Validation Batch 1 BiDil 37.5/20 ([**] Bottles x 42 Tablets) Production to begin [**] [**]
October 1, 2004 and end in December 15, 2004 of all 3 lots.
[**] Tablets Validation Batch 1 BiDil 37.5/20 ([**] Bottles x 180 Tablets) Production to begin [**] [**]
October 1, 2004 and end in December 15, 2004 of all 3 lots.
[**] Tablets Validation Batch 1 BiDil 37.5/20 ([**] Bottles x 42 Tablets) Production to begin [**] [**]
October 1, 2004 and end in December 15, 2004 of all 3 lots.
[**] Tablets Validation Batch 1 BiDil 37.5/20 ([**] Bottles x 180 Tablets) Production to begin [**] [**]
October 1, 2004 and end in December 15, 2004 of all 3 lots.
[**] Tablets Validation Batch 1 BiDil 37.5/20 ([**] Bottles x 42 Tablets) Production to begin [**] [**]
October 1, 2004 and end in December 15, 2004 of all 3 lots.
TOTAL [**]
Buyer: /s/ Xxxx Xxxxxxxx
--------------------
Xxxx Xxxxxxxx
000-000-0000, x 4114
34
EXHIBIT E
OUTSTANDING INVOICE
XXXXXXX XXXXXXX PHARMA MANUFACTURING, inc. INVOICE NUMBER 01016223 SD
P H A R M A 000 X. Xxxxxx Xxxx INVOICE DATE 1/27/05
Xxxxxxx, XX 00000 DUE DATE 2/26/05
PURCHASE ORDER SP01017
FDA NO. 1519171 PAGE NUMBER 1
DEA NO RC 0208149
PLEASE REMIT TO:
XXXXXXX PHARMA MANUFACTURING, INC.
0000 X. Xxxxxx Xxxx
XXXXXXX, XX 00000
SOLD TO: NITROMED, INC.
000 XXXXXX XXXXXX
XXXXXXXXX, XX 00000
XXXX TO: NITROMED, INC. SHIP TO: N/A
ATTN: ACCOUNTS PAYABLE
000 XXXXXX XXXXXX
XXXXXXXXX, XX 00000
CUSTOMER NUMBER DEA NUMBER TERMS ORDER NUMBER
150404 Net 30 1889624
QTY ORDERED QTY SHIPPED PRODUCT DESCRIPTION XXX # XXX XXXXXXXX XXXX XXX XXXXXXXXX
XXXX
0 0 SPO1017 BIDIL project 1 [**] [**]
INVOICE [**]
TOTAL
For Bidil
Tablets
Development
Project
from Sept.
- Dec. 04.
35
XXXXXXX PHARMA MFG INVOICE
DATE: 2/14/2005
0000 X Xxx Xxxx XXXXXXX # 00000
Xxxxxxx, XX 00000
Phone 000-000-0000
Fax 000-000-0000
XXXX TO: SHIP TO:
NitroMed, Inc. Same
Attn: Accounts Payable
000 Xxxxxx Xxxxxx
Xxxxxxxxx, XX 00000-0000
COMMENTS OR SPECIAL INSTRUCTIONS:
----------------------- --------------------- ---------------- ----------------- ------------------ ------------------
SALESPERSON P.O. NUMBER SHIP DATE SHIP VIA F.O.B. POINT TERMS
----------------------- --------------------- ---------------- ----------------- ------------------ ------------------
Xxx Xxxxxx per Xxxxxxx Xxxxxx Net 30
----------------------- --------------------- ---------------- ----------------- ------------------ ------------------
----------------------- -------------------------------------------------------- ------------------ ------------------
QUANTITY DESCRIPTION UNIT PRICE AMOUNT
----------------------- -------------------------------------------------------- ------------------ ------------------
----------------------- -------------------------------------------------------- ------------------ ------------------
1 Bin Frame/Chute for Roller Compactor $ [**] $ [**]
1 Platform for Roller Compactor [**] [**]
ROLLER COMPACTOR
----------------------- ----------------------------------------------- --------------------------- ------------------
SUBTOTAL $ [**]
------------------
SALES TAX
------------------
SHIPPING AND HANDLING
------------------
TOTAL $ [**]
------------------
Make all checks payable to Xxxxxxx Pharma Manufacturing.
If you have any questions concerning this invoice, contact Xxx Xxxx at
000-000-0000.
36
