EXHIBIT NO. 10.7
CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
COLLABORATION AND LICENSE AGREEMENT
THIS COLLABORATION AND LICENSE AGREEMENT is made and entered into as of
January 22, 1999 by and between NITROMED, INC. ("NitroMed"), a Delaware
corporation with offices at 00 Xxx Xxxx Xxxxx, Xxxxxxx, Xxxxxxxxxxxxx, 00000,
and Xxxxxxxxx Xxx X. Xxxx ("LICENSOR"), whose principal address is 0000 Xxxxxxx
Xxxxxx Xxxxx, Xxxxxxxxxxx, Xxxxxxxxx 00000.
INTRODUCTION
1. NitroMed is engaged in the business of developing and commercializing
medical products, including therapeutics for cardiovascular disease.
2. LICENSOR has developed certain proprietary technology related to the
combination of hydralazine and isosorbide dinitrate for the treatment of
cardiovascular disease.
3. NitroMed and LICENSOR have agreed to collaborate together in order to
develop, improve, and commercialize therapeutics for the treatment of
cardiovascular disease based upon LICENSOR's proprietary technology.
4. LICENSOR is willing to grant, and NitroMed is desirous of acquiring,
exclusive rights to use such proprietary technology in accordance with the terms
and conditions set forth in this Agreement.
NOW, THEREFORE, in consideration of the terms and conditions set forth in
this Agreement, and other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, NitroMed and LICENSOR hereby agree
as follows:
1. DEFINITIONS
As used in this Agreement, the following terms shall have the following
definitions.
1.1 AFFILIATE. "Affiliate" of a Party shall mean any company controlling,
controlled by or under common control with such Party. For purposes of this
Section 1.1, "control" shall mean (a) in the case of corporate entities, direct
or indirect ownership of at least fifty percent (50%) of the stock or shares
having the right to vote for the election of directors, and (b) in the case of
non-corporate entities, direct or indirect ownership of at least fifty percent
(50%) of the equity interest with power to direct the management and policies of
such non-corporate entities. A company shall be considered an "Affiliate" for
only so long as such ownership or control exists.
1
1.2 ANNUAL SALES VOLUME. "Annual Sales Volume" means total worldwide Net
Sales of all Collaboration Products during the twelve (12) month period
commencing with the first full month following First Commercial Sale of a
Collaboration Product. The first such Annual Sales Volume period for a
Collaboration Product shall also include any partial month preceding such first
full month.
1.3 BUSINESS DAY. "Business Day" shall mean a day on which banks are open
for business in Boston, Massachusetts.
1.4 COLLABORATION. "Collaboration" shall mean the development collaboration
to be conducted by NitroMed and LICENSOR pursuant to this Agreement.
1.5 COLLABORATION PRODUCT. "Collaboration Product" shall mean a product
in the Field that is developed in the course of the Collaboration.
1.6 CONFIDENTIAL INFORMATION. "Confidential Information" means all
materials, know-how or other information relating to the Field, including,
without limitation, proprietary information and materials (whether or not
patentable) regarding a Party's technology, products, business information or
objectives, which is designated as confidential in writing by the disclosing
Party, whether by letter or by the use of an appropriate stamp or legend, prior
to or at the time any such material, trade secret or other information is
disclosed by the disclosing Party to the other Party. Notwithstanding the
foregoing to the contrary, materials, know-how or other information which is
orally, electronically or usually disclosed by a Party, or is disclosed in
writing without an appropriate letter, stamp or legend, shall constitute
Confidential Information of a Party if the disclosing Party at the time of
disclosure identifies such information as confidential or proprietary and,
within ten (10) days after such disclosure, delivers to the other Party a
written document or documents describing the materials, know-how or other
information and referencing the place and date of such oral, visual, electronic
or written disclosure and the names of the persons to whom such disclosure was
made.
1.7 EFFECTIVE DATE. "Effective Date" shall mean the date first indicated
above.
1.8 FIELD. "Field" shall mean the combination of hydralazine and isosorbide
dinitrate (with or without one or more additional active ingredients) for the
treatment of cardiovascular diseases.
1.9 FIRST COMMERCIAL SALE. "First Commercial Sale" means, for each
Collaboration Product, the first commercial sale thereof in a country as part of
a nationwide introduction by NitroMed, its Affiliates or its sublicensees. Sales
for test marketing, clinical trial purposes or compassionate or similar use
shall not be considered to constitute a First Commercial Sale.
1.10 LICENSED TECHNOLOGY. "Licensed Technology" shall mean the Patent
Rights and the Technical Information.
1.11 NDA. "NDA" means a New Drug Application filed with the U.S. Food and
Drug Administration.
2
1.12 NET SALES. "Net Sales" shall mean the gross amount received from an
unrelated third party by NitroMed, its Affiliates and/or sublicensees on sales
or other dispositions of Collaboration Products, less the following items: (a)
trade, cash and quantity discounts, allowances and rebates actually allowed and
taken directly with respect to such sales or dispositions; (b) tariffs, duties,
excises, value-added and sales taxes or other taxes imposed upon and paid by
NitroMed or through NitroMed by customers with respect to such sales or
dispositions (excluding national, state and local taxes based on income); (c)
actual amounts repaid or credited by reason of rejections, defects, recalls and
returns or because of rebates or retroactive price reductions; and (d) freight,
postage, insurance and other transportation charges separately invoiced in
shipping such Collaboration Product.
1.13 PARTY. "Party" shall mean either NitroMed or LICENSOR "Parties" shall
mean NitroMed and LICENSOR, collectively.
1.14 PATENT RIGHTS. "Patent Rights" shall mean:
(a) the patents and patent applications owned by or licensed to
LICENSOR listed on EXHIBIT A attached to this Agreement, including foreign
counterparts thereof, and any and all continuations, divisions, reissues,
extensions and foreign counterparts that LICENSOR may file;
(b) Any and all patents, patent applications and other intellectual
property rights with respect to any invention or discovery in the Field relating
to such patents and patent applications, which patents, patent applications and
such other rights (i) LICENSOR owns (either directly or through his Affiliates)
at any time during the term of this Agreement; or (ii) which LICENSOR (either
directly or through his Affiliates) acquires the right to use at any time during
the term of this Agreement, with the right to grant licenses, sublicenses and
rights of the type described in Article 2 below.
(c) Any and all patents, patent applications and other intellectual
property rights with respect to any invention or discovery in the Field, which
patents, patent applications or other rights LICENSOR and NitroMed own jointly
as a result of the Collaboration under this Agreement.
1.15 TECHNICAL INFORMATION. "Technical Information" shall mean all trade
secrets, know-how, computer programs (including copyrights in said software),
knowledge, technology, preclinical or clinical data, means, methods, processes,
practices, formulas, techniques, procedures, technical assistance, designs,
drawings, apparatus, written and oral rectifications of data, specifications,
assembly procedures, schematics and other valuable information of whatever
nature, whether confidential or not, and whether proprietary or not, which is
now in (or hereafter, during the term of this Agreement, comes into) the
possession of LICENSOR and which is relevant to the development, manufacture,
use and/or commercialization of any Collaboration Product, PROVIDED THAT
Technical Information shall not include such information as shall come into
LICENSOR's possession after the Effective Date to the extent that LICENSOR does
not have the right to use or disclose such information as a result of an
agreement with a third party or otherwise.
3
1.16 VALID CLAIM. "Valid Claim" means any claim(s) in an unexpired patent
which has not been held unenforceable, unpatentable or invalid by a decision of
a court or other governmental agency of competent jurisdiction, unappealable or
unappealed within the time allowed for appeal, and which has not been admitted
to be invalid or unenforceable through reissue, reexamination, disclaimer or
otherwise.
2. GRANT OF RIGHTS AND LICENSES; TRANSFER OF ASSETS
Subject to all of the terms and conditions set forth in this Agreement:
2.1 LICENSE GRANT. LICENSOR hereby grants to NitroMed an exclusive,
worldwide right and license during the term of this Agreement under all of
LICENSOR's rights in the Patent Rights and Technical Information to make, have
made, use, have used, sell, have sold, and import, Collaboration Products.
2.2 RIGHT TO SUBLICENSE. NitroMed shall have the right to sublicense any of
the rights and licenses granted hereunder, so long as each sublicensee confirms
in writing to NitroMed that it agrees to be bound by all of the terms and
conditions contained in this Agreement. However, any such sublicense shall not
release NitroMed from its obligations under this Agreement.
2.3 NO RIGHTS BY IMPLICATION. No rights or licenses with respect to
Licensed Technology are granted or deemed granted hereunder or in connection
herewith, other than those rights or licenses expressly granted in this
Agreement.
2.4 TRANSFER OF ASSETS. Effective as of the Effective Date, LICENSOR shall
transfer and assign to NitroMed all of LICENSOR's rights in the assets,
documentation, materials and data set forth on EXHIBIT C to this Agreement (the
"Assets"). LICENSOR agrees to execute such further assignments and instruments
as may be reasonably requested by NitroMed to effectively transfer all of
LICENSOR's right, title and interest in and to the Assets to NitroMed. Without
limiting the generality of the foregoing, it is the intention of the Parties
that NitroMed be the holder of the NDA for all Collaboration Products (including
the NDA currently submitted to the FDA), and, accordingly, LICENSOR shall as of
the Effective Date execute all assignments and instruments necessary to
constitute NitroMed as such NDA holder.
3. COLLABORATION; DEVELOPMENT PROGRAM; REGULATORY MATTERS; AND
COMMERCIALIZATION.
NitroMed and LICENSOR agree to collaborate to develop and to commercialize
Collaboration Products as follows:
3.1 DEVELOPMENT PROGRAM. NitroMed shall be responsible for conducting,
directly or through third parties, the clinical and other development work and
tests with respect to Collaboration Products, in accordance with the development
and commercialization plan attached as part of EXHIBIT B to this Agreement (the
"Development Plan").
3.2 REGULATORY MATTERS. NitroMed, in consultation with LICENSOR, will be
responsible, at its sole expense, directly or through third parties, for the
preparation and filing of all regulatory documents with respect to all
Collaboration Products. LICENSOR shall provide exclusively to NitroMed all
available files used in the previous NDA filed for BiDil (a combination of
hydralazine and isosorbide dinitrate) as well as all other available enabling
data and materials. Such available files, data and materials shall be delivered
to NitroMed within thirty (30) days after the Effective Date.
4
3.3 MANUFACTURING AND MARKETING. Pursuant to the license set forth in
Section 2.1, NitroMed has the exclusive right to manufacture, market and
commercialize Collaboration Products during the term of this Agreement, and
shall have full autonomy over all decisions relating thereto.
3.4 DILIGENCE. NitroMed will use reasonable best efforts, either directly
or through Affiliates, sublicensees or third parties, to develop in accordance
with the Development Plan and, upon receipt of required regulatory approvals, to
manufacture, market and commercialize Collaboration Products in such countries
as NitroMed may determine to be appropriate. NitroMed will have the full
autonomy over the commercialization of the Collaboration Products, but will keep
LICENSOR regularly informed on a quarterly basis regarding annual marketing,
budget, and sales plans, as provided in Section 3.5.
3.5 REPORTS. NitroMed shall prepare and deliver quarterly reports to
LICENSOR within thirty (30) days after the end of each calendar quarter
summarizing the status of development and regulatory activities relating to
Collaboration Products and the activities set forth in Sections 3.3 and 3.4.
3.6 LACK OF DILIGENCE. If LICENSOR concludes that NitroMed is not meeting
its obligations under Section 3.4 for any reason other than (a) the withholding
by a regulatory agency of marketing approval despite NitroMed's reasonable
effort to obtain such approval; (b) unanticipated technical or scientific
problems which have been promptly reported to LICENSOR in writing; or (c) other
causes beyond the reasonable control of NitroMed which have been promptly
reported to LICENSOR in writing; then LICENSOR may give written notice to
NitroMed stating the basis for its conclusion and what additional efforts
LICENSOR believes should be made by NitroMed. Upon receipt of such written
notice, LICENSOR and NitroMed shall enter into good faith negotiations in order
to reach mutual agreement as to what efforts by NitroMed shall satisfy the
requirements of Section 3.4, and if such mutual agreement is not reached for any
reason within ninety (90) days after receipt of such written notice, then
LICENSOR may exercise any available rights under Section 10.2.
3.7 SAB MEMBERSHIP. LICENSOR shall be appointed by NitroMed to its
Scientific Advisory Board ("SAB") and will sign an SAB Consulting Agreement in
the form attached as EXHIBIT D to this Agreement, pursuant to which LICENSOR
will receive a consulting fee of $[**] per half day for services and be granted
a nonstatutory stock option to purchase 10,000 shares of NitroMed Common Stock.
Notwithstanding anything contained in this Agreement to the contrary, except as
set forth in the SAB Consulting Agreement, LICENSOR shall not be required to
render any services under this Agreement or in connection with the
Collaboration.
5
4. COMPENSATION PAYABLE TO LICENSOR.
4.1 MILESTONE PAYMENTS. Within thirty (30) days after the first achievement
of each of the following milestones, NitroMed shall pay to LICENSOR the amounts
set forth below, all of which shall be non creditable against royalties:
MILESTONE AMOUNT OF PAYMENT
--------- -----------------
1. [**] $[**]
2. [**]
$[**]
4.2 ROYALTIES.
(a) NitroMed shall pay to LICENSOR royalties on Net Sales of
Collaboration Products at the following rates:
ANNUAL SALES VOLUME ROYALTY RATE
------------------- ------------
0 to $[**] million [**]%
>$[**] million to $[**] million [**]%
Over $[**] million [**]%
For purposes of clarification, if in a given annual royalty period there are Net
Sales of $[**]million, the [**]% rate shall apply to the first $[**] million of
Net Sales, the [**]% rate shall apply to the next $[**] million of Net Sales and
the [**]% rate shall apply to the remaining $[**] million of Net Sales.
(b) Although the rights granted to NitroMed in Section 2.1 above and
elsewhere in this Agreement shall last for the entire term of this Agreement,
NitroMed's obligation to pay royalties in accordance with this Section 4.2 shall
only apply with respect to a Collaboration Product sold in a particular country
until the later of (i) the expiration of the last-to-expire Valid Claim under
any of the Patent Rights in such country which cover the Collaboration Product,
or (ii) ten (10) years after the First Commercial Sale of such Collaboration
Product in such country; PROVIDED, HOWEVER, that if in any country, there is no
Valid Claim under any of the Patent Rights which covers the Collaboration
Product, then the royalties which are otherwise payable under this Section 4.2
for such Collaboration Product in such country shall be reduced by [**]% of the
royalty rates otherwise applicable.
(c) In the event NitroMed, its Affiliates or sublicensees become
obligated to pay amounts to a third party under a license or similar agreement
with respect to a Collaboration Product, then, subject to compliance with
Section 8.3, NitroMed may deduct [**] percent ([**]%) of such amounts owing to
such third party (prior to reductions) from the royalty owing to LICENSOR for
such Collaboration Product However, the amount to be paid to LICENSOR will not
be so reduced to less than [**] percent ([**]%) of the amount that would
otherwise be due to LICENSOR.
6
(d) Once a Collaboration Product is sold or otherwise disposed of and
a royalty becomes payable hereunder, no other royalty shall become payable
hereunder on that particular Collaboration Product, regardless of how such
Collaboration Product may subsequently be sold or used.
(e) In the event the Collaboration Product is sold as part of a
Combination Product (as defined below), the Net Sales from the Combination
Product, for the purposes of determining royalty payments, shall be determined
by multiplying the Net Sales of the Combination Product during the applicable
royalty reporting period, by the fraction, A/A+B, where A is the average sale
price of the Collaboration Product when sold separately in finished form and B
is the average sale price of the other product(s) included in the Combination
Product when sold separately in finished form, in each case during the
applicable royalty reporting period or, if sales of both the Collaboration
Product and the other product(s) did not occur in such period, then in the most
recent royalty reporting period in which sales of both occurred. In the event
that such average sale price cannot be determined for both the Collaboration
Product and all other product(s) included in the Combination Product, Net Sales
for the purposes of determining royalty payments shall be calculated by
multiplying the Net Sales of the Combination Product by the fraction of C/C+D
where C is the fair market value of the Collaboration Product and D is the fair
market value of all other pharmaceutical product(s) included in the Combination
Product In such event, NitroMed shall in good faith make a determination of the
respective fair market values of the Collaboration Product and all other
pharmaceutical products included in the Combination Product, and shall notify
LICENSOR of such determination and provide LICENSOR with data to support such
determination. LICENSOR shall have the right to review such determination and
supporting data, and to notify NitroMed if it disagrees with such determination.
If the Parties are unable to agree in good faith as to such respective fair
market values, then such matter shall be subject to arbitration pursuant to
Section 11.3. As used above, the term "Combination Product" means any
pharmaceutical product which comprises the Collaboration Product and other
active compounds and/or active ingredients. During any such arbitration,
NitroMed shall pay to LICENSOR the royalties determined by NitroMed, which
payment shall be adjusted based upon the arbitrator's decision.
5. REPORTS AND PAYMENTS
5.1 CONTENTS OF NITROMED'S REPORTS. NitroMed shall deliver to LICENSOR
within thirty (30) days after the end of each calendar quarter, beginning with
the calendar quarter in which the First Commercial Sale occurs, a written report
describing, for the applicable quarter: (a) the gross sales for each
Collaboration Product by NitroMed, its Affiliates and sublicensees, together
with the deductions therefrom and resulting Net Sales; and (b) the total royalty
due on such Net Sales under Section 4.2 above. Each report shall be accompanied
by full payment to LICENSOR of the royalties payable under Section 4.2 above.
7
5.2 ROYALTIES MISTAKENLY PAID ON RETURNED COLLABORATION PRODUCTS. If
NitroMed pays a royalty on a Collaboration Product which has been or is
subsequently returned to NitroMed or its Affiliate or sublicensee, the amount of
the royalty so paid shall be deemed a nonrefundable credit against royalties
payable by NitroMed for subsequent calendar quarters.
5.3 Payment of Royalties.
(a) All payments under Section 5.1, above shall be made by check or
wire transfer to such bank and account as LICENSOR may from time to time
designate in writing. All such payments shall be made in U.S. Dollars.
(b) Whenever any payment hereunder shall be stated to be due on a day
which is not a Business Day, such payment shall be made on the immediately
succeeding Business Day.
(c) If the Net Sales of any Collaboration Product is stated in a
currency other than U.S. Dollars, then, for the purpose of determining the
amount of royalties payable hereunder, such Net Sales shall be converted into
U.S. Dollars at the exchange rate between those two currencies most recently
quoted in the WALL STREET JOURNAL in New York on or prior to the date which is
five (5) Business Days before the date on which such royalties become due.
(d) All payments due under Section 5.1 above but not paid by NitroMed
on the due date thereof shall bear interest (in U.S. Dollars) at the U.S. prime
rate of Citibank N.A. plus 2%. Such interest shall accrue on the balance of
unpaid amounts from time to time outstanding from the date on which portions of
such amounts become due and owing until payment thereof in full.
5.4 NITROMED'S BOOKS AND RECORDS. NitroMed agrees to make and keep, and
agrees to cause its Affiliates and sublicensees to make and keep, full and
accurate books and records in sufficient detail to enable royalties payable
hereunder to be determined. On thirty (30) days' prior written notice to
NitroMed, LICENSOR and its certified public accountants, on one occasion during
each calendar year, shall each have reasonable access to such books and records
of NitroMed and its Affiliates and sublicensees pertaining to activities under
this Agreement and shall each have the right to make copies therefrom at
LICENSOR's expense. LICENSOR and its certified public accountants shall each
have such access at all reasonable times and from time to time during normal
business hours. Prompt adjustment shall be made by the proper Party to
compensate for any errors or omissions disclosed by such audit. LICENSOR shall
bear the costs of such audit, unless such audit reveals that royalties paid by
NitroMed for the audited period were less than ninety-five percent (95%) of the
royalties actually due hereunder for such period, in which case NitroMed shall
reimburse LICENSOR in full for its reasonable costs incurred in connection with
such audit. LICENSOR agrees to hold confidential all information learned in the
course of any examination of books and records hereunder, except when it is
necessary for LICENSOR to reveal such information in order to enforce its rights
under this Agreement in court or similar dispute resolution or enforcement
proceeding or action, or except when compelled by law or when such information
is publicly available without breach by LICENSOR.
8
5.5 NITROMED'S REPORTS CONCLUSIVELY CORRECT. In the absence of fraud, all
reports and payments not disputed as to correctness by LICENSOR within three (3)
years after receipt thereof shall thereafter conclusively be deemed correct for
all purposes.
6. INVENTIONS
6.1 INVENTIONS IN THE FIELD; MODIFICATIONS AND/OR IMPROVEMENTS OF
COLLABORATION PRODUCTS. Each Party shall own any inventions in the Field
(including improvements and modifications to Collaboration Products) which are
developed solely by such Party (the "developing Party"), subject to the licenses
set forth in this Agreement. The Parties shall own jointly inventions in the
Field (including improvements and modifications to Collaboration Products),
developed jointly by NitroMed and LICENSOR during the term of this Agreement,
subject to the licenses set forth in this Agreement. NitroMed shall be
responsible, at its sole cost, for filing and prosecuting patent applications
for jointly-owned inventions and for prosecuting patent applications for the
Patent Rights licensed hereunder. NitroMed shall keep LICENSOR fully informed
with respect to the prosecution of patent applications with claims relating to
Collaboration Products. The developing Party agrees to notify the other Party of
each invention in the Field (including improvements and modifications to
Collaboration Products) which the developing Party has developed. Each Party
hereto shall, at the request of the other Party, both during and after the term
of this Agreement, execute such documents and render such assistance as may be
reasonable and appropriate to enable NitroMed to file and prosecute patent
applications in any jurisdiction in accordance with this Section 6.1.
7. CONFIDENTIAL INFORMATION
7.1 CONFIDENTIAL INFORMATION. All Confidential Information disclosed under
this Agreement by a Party (the "disclosing Party") to the other Party (the
"receiving Party") during the term of this Agreement shall not be used by the
receiving Party except in connection with the activities contemplated by this
Agreement, shall be maintained in confidence by the receiving Party (except to
the extent reasonably necessary for regulatory approval of products developed by
NitroMed or its Affiliates and sublicensees or for the filing, prosecution and
maintenance of Patent Rights), and shall not otherwise be disclosed by the
receiving Party to any other person, firm, or agency, governmental or private,
without the prior written consent of the disclosing Party, except to the extent
that the Confidential Information (as determined by competent documentation):
(a) was known or used by the receiving Party prior to its date of
disclosure to the receiving Party; or
(b) either before or after the date of the disclosure to the receiving
Party is lawfully disclosed to the receiving Party by sources other than the
disclosing Party rightfully in possession of the Confidential Information; or
(c) either before or after the date of the disclosure to the receiving
Party becomes published or generally known to the public (including information
known to the public through the sale of products in the ordinary course of
business) through no fault or omission on the part of the receiving Party or its
sublicensees; or
9
(d) is independently developed by or for the receiving Party without
reference to or reliance upon the Confidential Information; or
(e) is required to be disclosed by the receiving Party to comply with
applicable laws, to defend or prosecute litigation or to comply with
governmental regulations, PROVIDED THAT the receiving Party provides prior
written notice of such disclosure to the disclosing Party and takes reasonable
and lawful actions, at the disclosing party's expense, to avoid and/or minimize
the degree of such disclosure.
7.2 PUBLICATIONS. The Parties acknowledge that scientific lead time is a
key element of the value of LICENSOR's proprietary technology in the Field and
further agree that scientific publications must be strictly monitored to prevent
any material adverse effect of the premature publication of Technical
Information or other information relating to Collaboration Products. The Parties
shall establish a procedure for publication review and approval and each Party
(a "publishing Party") shall first submit to the other Party (the "reviewing
Party") an early draft of all such publications, whether they are to be
presented orally or in written form, at least thirty (30) days prior to
submission for publication. Each Party shall review each such proposed
publication in order to avoid the unauthorized disclosure of the reviewing
Party's Confidential Information and to preserve the patentability of inventions
in the Field. If, as soon as reasonably possible but no longer than thirty (30)
days following receipt of an advance copy of a publishing Party's proposed
publication, the reviewing Party informs the publishing Party that its proposed
publication contains Confidential Information of the reviewing Party, then the
publishing Party shall delete such Confidential Information from its proposed
publication. If, as soon as reasonably possible but no longer than thirty (30)
days following receipt of an advance copy of the publishing Party's proposed
publication, the reviewing Party informs the publishing Party that its proposed
publication could be expected to have a material adverse effect on any Patent
Rights, then the publishing Party shall delay such proposed publication
sufficiently long to permit the timely preparation and first filing of patent
application(s) on the information involved.
8. PROTECTION OF LICENSED TECHNOLOGY
8.1 INFRINGEMENT OF LICENSED TECHNOLOGY.
(a) NitroMed shall have the initial right to take any and all actions,
legal or otherwise, which are necessary to: (i) terminate infringements of
patent rights or other intellectual property rights relating to any part of the
Collaboration Products; or (ii) terminate any misappropriation of the Technical
Information, including without limitation obtaining damages, injunctions and all
other appropriate relief. NitroMed shall keep LICENSOR informed regarding the
status and progress of all actions instituted by NitroMed pursuant to this
subsection (a). NitroMed shall bear all the expenses of all actions which it
initiates pursuant to this subsection (a) (including without limitation
attorneys' fees).
(b) If NitroMed does not institute an action within one hundred twenty
(120) days after receiving notice from LICENSOR of an infringement of patent
rights or other intellectual property rights relating to any part of the
Collaboration Products or of a misappropriation of Technical Information, then
LICENSOR may institute an action with respect thereto. LICENSOR shall keep
NitroMed informed regarding the status and progress of all such actions
instituted by LICENSOR pursuant to this subsection (b). LICENSOR shall bear all
the expenses of all actions which LICENSOR initiates pursuant to this subsection
(b) (including without limitation attorneys' fees).
10
(c) Any recoveries or settlement fees received from suits or
settlements involving an action initiated pursuant to subsections (a) and (b)
above or agreed to shall be paid: (i) first, to the Party instituting such
action under subsection (a) or (b) above as reimbursement for the expenses of
such action (including without limitation attorneys' fees) which it incurred;
and (ii) the balance (if any) shall be divided [**]% to the Party which
initiated such action in accordance with subsections (a) or (b) hereof, and
[**]% to the other Party.
(d) Notwithstanding subsections (a), (b) and (c) above, NitroMed and
LICENSOR may agree to jointly institute an action in order to: (i) terminate
infringements of patent rights or other intellectual property rights relating to
any part of the Collaboration Products; or (ii) terminate any misappropriation
of Technical Information. NitroMed and LICENSOR shall share equally: (x) the
expenses of all actions which they initiate pursuant to this subsection (d)
(including without limitation attorneys' fees); and (y) the proceeds of any
judgment rendered therein.
8.2 USE OF NAME IN SUIT. Where, in the judgment of the Party initiating an
action under Section 8.1, it is necessary to use the other Party's name to
prosecute such action, such other Party agrees to allow the initiating Party to
so use the name of such other Party; provided, however, that the initiating
Party agrees to defend and hold such other Party harmless against the award of
court costs and damages resulting solely from the use of such other Party's name
by the initiating Party in such action.
8.3 CLAIMED INFRINGEMENT. In the event that a Party becomes aware of any
claim that the practice by NitroMed of Patent Rights and Technical Information
that has been licensed to NitroMed pursuant to Section 2.1 infringes the
intellectual property rights of any third party, such Party shall promptly
notify the other Party. In any such instance, the Parties shall reasonably
cooperate and shall mutually agree upon an appropriate course of action.
9. REPRESENTATIONS, WARRANTIES AND COVENANTS
9.1 NITROMED REPRESENTATIONS.
(a) RIGHT, POWER AND AUTHORITY. NitroMed has full right, power and
authority to enter into this Agreement and there is nothing which would prevent
it from performing its obligations under the terms and conditions imposed on it
by this Agreement.
(b) BINDING OBLIGATION. This Agreement has been duly authorized by all
necessary corporate and stockholder action of NitroMed and constitutes a valid
and binding obligation of NitroMed, enforceable in accordance with the terms
hereof.
(c) CORPORATE GOOD STANDING. NitroMed represents and warrants that it
is a corporation duly organized and validly existing in good standing under the
laws of Delaware, United States, and is duly qualified and authorized to do
business wherever the nature of its activities or properties requires such
qualification or authorization.
11
(d) NO GOVERNMENT APPROVALS NEEDED. Except as expressly contemplated
hereunder, no registration with or approval of any government agency or
commission of any jurisdiction is necessary for the execution, delivery or
performance by it of any of the terms of this Agreement, or for the validity and
enforceability hereof or with respect to its obligations hereunder.
(e) NO PROVISION CONTRAVENED. There is no provision in NitroMed's
corporate charter, By-Laws and no provision in any existing mortgage, indenture,
contract or agreement binding on it which would be contravened by the execution,
delivery or performance by NitroMed of this Agreement. Without limiting the
generality of the foregoing, NitroMed has not entered into any agreement or
commitment that is inconsistent with the provisions of this Agreement.
(f) NO PROCEEDINGS PENDING. There is no action or proceeding pending
to NitroMed's knowledge, threatened against NitroMed before any court,
administrative agency or other tribunal which might have a material adverse
effect on its business or condition, financial or otherwise, or its operation of
any business.
(g) NOT CONTRAVENE ANY LAW. Neither the execution nor delivery of this
Agreement by NitroMed, nor its fulfillment of or compliance with the terms and
provisions hereof shall contravene any provision of the laws of any
jurisdiction, including, without limitation, any statute, rule, regulation,
judgment, decree, order, franchise or permit applicable to it.
(h) NO OTHER REPRESENTATIONS. Except as expressly set forth in this
Section 9.1, NitroMed is not making any representations or warranties to
LICENSOR.
9.2 LICENSOR REPRESENTATIONS.
(a) RIGHT, POWER AND AUTHORITY. LICENSOR has full right, power and
authority to enter into this Agreement and there is nothing which would prevent
him from performing his obligations under the terms and conditions imposed on
LICENSOR by this Agreement.
(b) BINDING OBLIGATION. This Agreement constitutes a valid and binding
obligation of LICENSOR enforceable in accordance with the terms hereof.
(c) NO GOVERNMENT APPROVALS NEEDED. No registration with or approval
of any government agency or commission of any jurisdiction is necessary for the
execution, delivery or performance by LICENSOR of any of the terms of this
Agreement, or for the validity and enforceability hereof or with respect to its
obligations hereunder.
(d) NO PROVISIONS CONTRAVENED. There is no provision in any existing
mortgage, indenture, contract or agreement binding on LICENSOR which would be
contravened by the execution, delivery or performance by LICENSOR of this
Agreement. Without limiting the generality of the foregoing, LICENSOR has not
entered into any agreement or commitment that is inconsistent with the
provisions of this Agreement.
12
(e) NO PROCEEDINGS PENDING. There is no action or proceeding pending
or, to LICENSOR's knowledge, threatened against LICENSOR before any court,
administrative agency or other tribunal which might have a material adverse
effect on his ability to enter into and perform this Agreement.
(f) NOT CONTRAVENE ANY LAW. Neither the execution nor delivery of this
Agreement by LICENSOR, nor his fulfillment of or compliance with the terms and
provisions hereof shall, to LICENSOR's knowledge, contravene any provision of
the laws of any jurisdiction, including, without limitation, any statute, rule
regulation, judgment, decree, order, franchise or permit applicable to him.
(g) INTELLECTUAL PROPERTY. To the knowledge of LICENSOR, and without
any requirement of investigation by LICENSOR relating thereto, as of the
Effective Date, (i) neither the conduct by NitroMed of the Collaboration nor the
commercialization of Collaboration Products infringes the rights of any third
party in respect of Third Party Know How (as defined below) or issued patents or
published patent applications owned by such third party; and (ii) none of the
Patent Rights or Technical Information licensed NitroMed pursuant to Section 2.1
is being infringed by any third party. As of the Effective Date, LICENSOR has
not received written notice of any claim or demand by any person pertaining to,
and no proceeding against LICENSOR is pending or, to the knowledge of LICENSOR,
threatened, that challenges the rights of LICENSOR in respect of the Patent
Rights and/or Technical Information. As used above, "Third Party Know How" means
trade secrets, know how, technology, preclinical or clinical data, methods,
processes and other proprietary information owned by a third party.
(h) NO OTHER REPRESENTATIONS. Except as expressly set forth in this
Section 9.2, LICENSOR is not making any representations or warranties to
NitroMed.
10. TERM AND TERMINATION
10.1 TERM OF AGREEMENT. Unless it is terminated earlier pursuant to this
Article 10, this Agreement shall Continue in full force and effect in
perpetuity.
10.2 TERMINATION FOR CAUSE. Upon any material breach of this Agreement by
either Party (in such capacity, the "Breaching Party"), the other Party (in such
capacity, the "Non-Breaching Party") may terminate this Agreement by providing
thirty (30) days' written notice to the Breaching Party, specifying the material
breach. The termination shall become effective at the end of the thirty (30) day
period unless (a) the Breaching Party cures such breach during such thirty (30)
day period, or (b) if such breach is not susceptible to cure within thirty (30)
days of the receipt of written notice of the breach, the Breaching Party is
diligently pursuing a cure (unless such breach, by its nature, is incurable, in
which case the Agreement may be terminated immediately). Nonpayment of any
amount in excess of $[**] shall be deemed a material breach.
10.3 TERMINATION BY NITROMED. NitroMed shall have the right to terminate
this Agreement at any time, effective thirty (30) days after provision of
written notice to LICENSOR to such effect.
10.4 TERMINATION BY LICENSOR. LICENSOR shall have the right to terminate
this Agreement within thirty (30) days after the occurrence of a Nonperformance
Event (as defined below), by providing written notice to NitroMed of such
Nonperformance Event Such termination shall be effective thirty (30) days after
provision of such notice. As used above, a "Nonperformance Event" shall be
deemed to have occurred if, within twelve (12) months following approval by the
U.S. Food and Drug Administration of the clinical development plan for the first
Collaboration Product, NitroMed has not enrolled the first patient in such
clinical trial.
13
10.5 CONSEQUENCES OF TERMINATION.
(a) The Parties agree that, upon termination of this Agreement
pursuant to Sections 10.2, 10.3 or 10.4, (i) the licenses set forth under this
Agreement shall terminate, except as is provided in subsection (b) below, (ii)
NitroMed, its Affiliates and sublicensees shall cease any use or practice of the
Licensed Technology, except as is provided in subsection (b) below, (iii)
NitroMed shall transfer and reassign to LICENSOR all of the Assets in its
possession as of the effective date of such termination, and (iv) except in the
case of a termination by NitroMed under Section 10.2 where LICENSOR is the
Breaching Party, NitroMed will transfer and assign to LICENSOR all of its rights
in any and all patents, patent applications and other technical information and
know-how of every kind with respect to any invention or discovery in the Field
as of the effective date of termination. Upon termination of this Agreement, all
sublicenses granted by NitroMed during the term of this Agreement shall
terminate. Each Party shall, at its own expense, return to the other Party all
Confidential Information as soon as practicable after the date of such
termination, including, but not limited to, original documents, drawings,
computer diskettes, models, samples, notes, reports, notebooks, letters,
manuals, prints, memoranda and any copies thereof, which have been received or
derived by such Party. All such Confidential Information shall remain the
exclusive property of the disclosing Party during the term of this Agreement and
thereafter. Notwithstanding the foregoing, LICENSOR shall, on any such
termination, own all Confidential Information relating to or derived from
Collaboration Products.
(b) The Parties hereto agree that, once this Agreement is terminated
(other than pursuant to Section 10.2 if NitroMed is the Breaching Party),
NitroMed, its Affiliates and sublicensees shall have the right:
(i) subject to the same terms and conditions which existed
immediately prior to such date of termination (including the payment
of royalties), to make, use, sell and import Collaboration Products,
whose manufacture commenced on or prior to such date of termination,
for a period of one hundred twenty (120) days after such date of
termination; and
(ii) to continue to use the Licensed Technology in
connection with their activities in accordance with subsection (b) (i)
above.
10.6 PAYMENT OBLIGATIONS CONTINUE. Upon termination of this Agreement,
nothing shall be construed to release NitroMed from its obligations to pay
LICENSOR any and all royalties or other amounts accrued but unpaid hereunder
prior to the date of such termination.
14
11. MISCELLANEOUS
11.1 ASSIGNMENTS. This Agreement and any and all of the rights and
obligations of either Party hereunder shall not be assigned, delegated, sold,
transferred or otherwise disposed of, by operation of law or otherwise, without
the prior written consent of the other Party; PROVIDED, HOWEVER, that either
Party may assign, delegate, sell, transfer or otherwise dispose of rights and
obligations hereunder without such prior written consent to: (A) any of its
respective Affiliates; and (b) in the case of NitroMed, to any purchaser of all
or substantially all of the assets or stock of such Party, through merger,
consolidation or otherwise, PROVIDED THAT in any such case such assignee or
successor expressly assumes the obligations of the assignor hereunder and, if
assigned to an Affiliate, NitroMed remains liable hereunder unless otherwise
agreed to by LICENSOR. This Agreement shall be binding upon, and inure to the
benefit of, NitroMed and LICENSOR and their respective successors and assigns,
to the extent such assignments are in accordance with this Section 11.1.
11.2 GOVERNING LAW. This Agreement shall be governed, interpreted and
construed in accordance with, and any arbitration hereunder shall apply, the
laws of the Commonwealth of
Massachusetts applicable to agreements made and to
be fully performed therein.
11.3 DISPUTE RESOLUTION.
(a) Any dispute, controversy or claim arising out of or relating to this
Agreement, or to a breach thereof, including its interpretation, performance or
termination, shall be submitted to and finally resolved by arbitration. The
arbitration shall be conducted in accordance with the commercial arbitration
rules of the American Arbitration Association ("AAA"). The arbitration,
including the rendering of the award, shall take place in New York, New York.
The decision of the arbitrators shall be executory, final and binding upon the
parties hereto, shall be in writing setting forth the basis therefor, shall not
exceed or expand the terms of this Agreement and the fees of the arbitration
shall be paid as the arbitrators determine. Each Party shall bear its own
attorneys' fees in such proceedings.
(b) The arbitration shall be conducted by a single arbitrator nominated by the
Parties or, if they cannot agree on the arbitrator, by the President of the
American Arbitration Association.
(c) Notwithstanding anything contained in Sections 11.3 (a) and (b) above to the
contrary, each Party shall have the right to institute judicial proceedings
against the other Party or anyone acting by, through or under such other Party
in order to enforce the instituting Party's rights hereunder through reformation
of contract, specific performance, injunction or similar equitable relief.
11.4 WAIVER. A waiver of any breach of any provision of this Agreement
shall not be construed as a continuing waiver of other breaches of the same or
other provisions of this Agreement.
11.5 NO OTHER RELATIONSHIP. Nothing herein contained shall be deemed to
create a joint venture, agency or partnership relationship between the Parties
hereto. Neither Party shall have any power to enter into any contracts or
commitments in the name of, or on behalf of, the other Party, or to bind the
other Party in any respect whatsoever.
15
11.6 NOTICES.
(a) Each notice required or permitted to be sent under this Agreement shall be
given by facsimile transmission or by registered or recorded delivery letter to
NitroMed and to LICENSOR at the addresses and facsimile numbers indicated below.
For NitroMed
00 Xxx Xxxx Xxxxx
Xxxxxxx, Xxxxxxxxxxxxx 00000
Attention: Xx. Xxxxxx Xxxxxx
Facsimile: 0-000-000-0000
with a copy to:
Xxxxxx X. Xxxxxx, Esq.
Xxxx and Xxxx LLP
00 Xxxxx Xxxxxx
Xxxxxx, Xxxxxxxxxxxxx 00000
Facsimile: 1-617-526-5000
For LICENSOR
Xx. Xxx Xxxx
0000 Xxxxxxx Xxxxxx
Xxxxx Xxxxxxxxxxx, Xxxxxxxxx 00000
Facsimile: 000-000-0000
with a copy to:
Xxxxxx X. Xxxxxx, Esq.
Xxxxxxx Celler Spett & Xxxxxx, P.C.
000 Xxxx Xxxxxx
Xxx Xxxx, XX 00000
Facsimile: 0-000-000-0000
Either Party may change its address, contact person and/or facsimile number for
purposes of this Agreement by giving the other Party written notice of its new
address, contact person and/or facsimile number.
(b) Any properly addressed notice if given or made by registered or
recorded delivery letter shall be deemed to have been received on the earlier of
the date actually received and the date five (5) Business Days after the same
was posted (and in proving such it shall be sufficient to prove that the
envelope containing the same was properly addressed and posted as aforesaid) and
if given or made by facsimile transmission shall be deemed to have been received
at the time of dispatch, unless such date of deemed receipt is not a Business
Day, in which case the date of deemed receipt shall be the next succeeding
Business Day.
16
11.7 ENTIRE UNDERSTANDING. This Agreement between the Parties entered into
as of the date hereof embody the entire understanding between the Parties
relating to the subject matter hereof, whether written or oral, and there are no
prior representations, warranties or agreements between the Parties not
contained in this Agreement
11.8 INVALIDITY. If any provision of this Agreement is declared invalid or
unenforceable by a court having competent jurisdiction, it is mutually agreed
that this Agreement shall endure except for the part declared invalid or
unenforceable by order of such court. The Parties shall consult and use their
best efforts to agree upon a valid and enforceable provision which shall be a
reasonable substitute for such invalid or unenforceable provision in light of
the intent of this Agreement.
11.9 AMENDMENTS. Any amendment or modification of any provision of this
Agreement must be in writing, dated and signed by both parties hereto.
11.10 SURVIVAL OF AGREEMENT. Notwithstanding anything else in this
Agreement to the contrary, the Parties agree that Sections 5.3, 5.4, 5.5, 6.1,
7.1, 72, 9.1, 92, 10.5, 10.6, and 11.3 shall survive the termination of this
Agreement.
11.11 FORCE MAJEURE.
(a) Neither NitroMed nor LICENSOR shall be liable in damages, or shall be
subject to termination of this Agreement by the other party, for any delay or
default in performing any obligation hereunder (other than payment obligations)
if that delay or default is due to any cause beyond the reasonable control and
without fault or negligence of such Party; PROVIDED, HOWEVER, that: (i) in order
to excuse its delay or default hereunder, a Party shall notify the other Party
of the occurrence or the cause, specifying the nature and particulars thereof
and the expected duration thereof; (ii) within ten (10) Business Days after the
termination of such occurrence or cause, such Party shall give notice to the
other Party specifying the date of termination thereof. All obligations of both
Parties shall return to being in full force and effect upon the termination of
such occurrence or cause.
(b) For the purposes of this Section 11.11, a "cause beyond the reasonable
control" of a Party shall include, without limitation, any act of God, act of
any government and exports (but excluding herefrom any delay by the FDA in
approving the NDA) or other authority or statutory undertaking, industrial
dispute, fire, explosion, accident, power failure, flood, riot or war (declared
or undeclared).
11.12 COMPLIANCE WITH LAWS. NitroMed covenants and agrees that all of its
activities under or pursuant to this Agreement shall comply with all applicable
laws, rules and regulations. Specifically, but without limitation, NitroMed
shall be responsible for obtaining all licenses, permits and approvals which are
necessary or advisable for sales of the Collaboration Products and for the
performance of its duties hereunder.
17
11.13 PUBLIC ANNOUNCEMENTS. Any announcements or similar publicity with
respect to the execution of this Agreement shall be agreed upon by the Parties
in advance of such announcement. Each Party understands that this Agreement is
likely to be of interest to investors, analysts and others. The Parties agree
that any public announcement will not contain confidential business or technical
information and, if disclosure of confidential business or technical information
is required by law or regulation, will make reasonable efforts to minimize such
disclosure and obtain confidential treatment for any such information which is
disclosed to a governmental agency or group. Each Party agrees to provide to the
other Party with a copy of any public announcement as soon as reasonably
practicable under the circumstances prior to its scheduled release. Except under
extraordinary circumstances, each Party shall provide the other with an advance
copy of any press release at least five (5) business days prior to the scheduled
disclosure. Each Party shall have the right to expeditiously review and
recommend changes to any announcement regarding this Agreement or the subject
matter of this Agreement, provided that such right of review and recommendation
shall only apply for the first time that specific information is to be
disclosed, and shall not apply to the subsequent disclosure of substantially
similar information that has previously been disclosed. Except as otherwise
required by law, the Party whose press release has been reviewed shall remove
any information the reviewing Party reasonably deems to be inappropriate for
disclosure. The term "public announcements" does not include discussions at
seminars, classes, clinics, symposia or like proceedings which do not violate
Sections 7.1 and 7.2.
11.14 HEADINGS. Any headings contained herein are for directory purposes
only, do not constitute a part of this Agreement, and shall not be employed in
interpreting this Agreement.
11.15 COUNTERPARTS. This Agreement may be executed in any number of
counterparts and each such counterpart shall be deemed to be an original.
11.16 EXHIBITS. All exhibits referred to in this Agreement are attached
hereto and incorporated herein by this reference.
IN WITNESS WHEREOF, the parties hereto have signed this Agreement.
By /s/ Xxx Xxxx
---------------------------------------
Xxxxxxxxx Xxx Xxxx
NITROMED, INC.
By /s/ Xxxxxxx X. Xxxxxx
---------------------------------------
Name: Xxxxxxx X. Xxxxxx
Title: CEO
18
EXHIBIT A
PATENT RIGHTS
U.S. Patent No. 4,868,179 (issued September 19, 1989) entitled "Method of
Reducing Mortality Associated with Congestive Heart Failure Using 1-Hydralazine
and Isosorbide Dinitrate" (Xxx X. Xxxx).
19
EXHIBIT B
DEVELOPMENT PLAN
1. NITROMED shall, in consultation with the U.S. Food and Drug
Administration, develop a plan for refiling the NDA (201-727, BiDil) for
Collaboration Products with the FDA. It is the goal of the Parties that the NDA
be refiled without the need to conduct additional clinical studies. NITROMED
will seek to meet with the FDA within six (6) months after the Effective Date
with respect to the NDA.
2. NITROMED shall make its First Commercial Sale of a Collaboration Product
in the United States and shall commence distribution of Collaboration Products
within six (6) months after FDA approval of the NDA.
3. If NITROMED is required by the FDA to conduct additional clinical
studies, it will promptly submit a clinical development plan to the FDA and
enroll the first patient in such clinical trial within twelve (12) months
following approval by the FDA of such plan and will complete such clinical trial
pursuant to such plan.
20
EXHIBIT C
ASSETS
4. All regulatory documents, correspondence and submissions relating to
clinical trials in the Field, including CMCC information and the Investigational
New Drug (IND) and the New Drug Application (NDA) entitled "201-727,BiDil".
5. Clinical supplies and inventories relating to the Field.
6. All preclinical and clinical data relating to the Field.
7. Marketing and product launch plans for the Collaboration Products.
8. Supply contracts for the Collaboration Products.
9. All relevant trademarks used by LICENSOR in the Field, including
"BiDil", and all registrations for such trademark.
The terms "Assets" does not include Patent Rights, it being expressly
agreed that rights under Patent Rights are licensed under Section 2.1.
21
EXHIBIT D
SAB CONSULTING AGREEMENT
THIS SCIENTIFIC ADVISORY BOARD AGREEMENT (the "Agreement"), effective as of
April 1, 1999, is entered into by NitroMed, Inc., a Delaware corporation with
its principal place of business at 00 Xxx Xxxx Xxxxx, Xxxxxxx, Xxxxxxxxxxxxx
00000 (the "Company"), and Xx. Xxx Xxxx, 0000 Xxxxxxx Xxxxxx Xxxxx, Xxxxxxxxxxx,
Xxxxxxxxx 00000 (the "Advisor").
INTRODUCTION
The Company desires to retain the services of the Advisor as a member of
its Scientific Advisory Board ("SAB"), and the Advisor desires to serve as a
member of the SAB. Accordingly, in consideration of the mutual covenants and
promises contained herein and other good and valuable consideration, the receipt
and sufficiency of which is hereby acknowledged by the parties hereto, the
parties agree as follows:
1. SERVICES. The Advisor agrees to serve on the SAB and, in connection
therewith, to use his reasonable best efforts to perform such advisory and
related services for the Company as may be reasonably requested from time to
time by the Company. The Company anticipates that the SAB shall meet no more
than three (3) times each year not to exceed one day's duration each, at times
and locations to be determined by the Company in consultation with SAB members,
PROVIDED THAT Advisor's attendance at any meetings in excess of four (4) in any
calendar year shall require Advisor's consent. If the Advisor has a conflict of
interest, or potential conflict of interest, with respect to any matter
presented at a meeting of the SAB, he shall excuse himself from the discussion
of such matter.
2. TERM. This Agreement shall commence on the date hereof and shall
continue until March 31, 2000 (such period, as it may be extended in a writing
signed by both parties, being referred to as the "Advisory Period"). Either
party to this Agreement may terminate the Advisory Period upon 30 days' prior
written notice to the other party. In the event of such termination, the Advisor
shall be entitled to payment for fees and expenses incurred prior to the
effective date of termination.
3. COMPENSATION.
3.1 ADVISORY FEES. The Company shall pay to the Advisor an advisory fee of
$[**] per half day (4 hours).
3.2 STOCK OPTIONS. Subject to approval by the Board of Directors, the
Company shall issue to the Advisor a non-statutory stock option to purchase
10,000 shares of the Common Stock, $.01 par value per share, of the Company,
such stock option to have such terms and conditions, including terms with
respect to exercise price, vesting and expiration, as shall be set forth in a
stock option agreement by and between the Company and the Advisor.
3.3 REIMBURSEMENT OF EXPENSES. The Company shall reimburse the Advisor for
all reasonable and necessary expenses incurred or paid by the Advisor in
connection with, or related to, his attendance at SAB meetings within 30 days
after receipt of an itemization and documentation of such expenses.
22
4. INVENTIONS AND PROPRIETARY INFORMATION.
4.1 INVENTIONS. All inventions, discoveries, computer programs, data,
technology, designs, innovations and improvements (whether or not patentable and
whether or not copyrightable) ("Inventions") related to the business of the
Company which are made, conceived, reduced to practice, created, written,
designed or developed by the Advisor, solely or jointly with others and whether
during normal business hours or otherwise, either (a) in the course of the
performance of services hereunder during the Advisory Period, or (b) during the
Advisory Period or within one (1) year after the expiration of the Advisory
Period if resulting or directly derived from Proprietary Information (as defined
in Section 4.2(b) below), shall be the sole property of the Company. The Advisor
shall promptly disclose and hereby assigns to the Company all Inventions and any
and all related patents, copyrights, trademarks, trade names, and other
industrial and intellectual property rights and applications therefor, in the
United States and elsewhere. Upon the request of the company and at the
Company's expense, the Advisor shall execute such further assignments, documents
and other instruments as may be necessary or desirable to fully and completely
assign all such Inventions to the Company and to assist the Company in applying
for, obtaining and enforcing patents or copyrights or other rights in the United
States and in any foreign country with respect to any Invention.
4.2 PROPRIETARY INFORMATION.
(a) The Advisor acknowledges that his relationship with the Company is
one of high trust and confidence and that in the course of his service to the
Company he will have access to and contact with Proprietary Information. The
Advisor agrees that he will not, during the Advisory Period or at any time
thereafter, disclose to others, or use for his benefit or the benefit of others,
any Proprietary Information.
(b) For purposes of this Agreement, Proprietary Information shall mean
all information (whether or not patentable and whether or not copyrightable)
owned, possessed or used by the Company, including, without limitation, any
Invention, formula, vendor information, customer information, apparatus,
equipment, trade secret, process, research, report, technical data, knowhow,
computer program, software, software documentation, hardware design, technology,
marketing or business plan, forecast, unpublished financial statement, budget,
license, price, cost and employee list that is communicated to, learned of,
developed or otherwise acquired by the Advisor in the course of his performance
of services as an Advisor to the Company.
(c) The Advisor's obligations under this Section 4.2 shall not apply
to any information that (i) is or becomes known to the general public under
circumstances involving no breach by the Advisor of the terms of this Section
4.2, (ii) is generally disclosed to third parties by the Company without
restriction on such third parties, or (iii) is approved for release by written
authorization of the Board of Directors of the Company, or (iv) is known by the
Advisor prior to such disclosure or (v) is required to be disclosed by law,
provided Advisor gives Company prompt notice and an opportunity to contest such
disclosure, or (v) is independently developed by Advisor or is lawfully
disclosed to the Advisor by sources other than the Company having the right to
disclose such information
23
(d) Upon termination of this Agreement or at any other time upon
request by the Company, the Advisor shall promptly deliver to the Company all
Company records, files, memoranda, notes, designs, data, reports, price lists,
customer lists, drawings, plans, computer programs, software, software
documentation, sketches, laboratory and research notebooks and other documents
(and all copies or reproductions of such materials) relating to the business of
the Company, PROVIDED THAT the Advisor may retain one copy of all such materials
for recordkeeping purposes.
(e) The Advisor represents that his retention as an advisor with the
Company and his performance under this Agreement does not, and shall not, breach
any agreement that obligates him to keep in confidence any trade secrets or
confidential or proprietary information of his or of any other party or to
refrain from competing, directly or indirectly, with the business of any other
party. The Advisor shall not disclose to the Company any trade secrets or
confidential or proprietary information of any other party.
4.3 REMEDIES. The Advisor acknowledges that any breach of the provisions of
this Section 4 may result in serious and irreparable injury to the Company for
which the Company cannot be adequately compensated by monetary damages alone.
The Advisor agrees, therefore, that, in addition to any other remedy it may
have, the Company shall be entitled to enforce the specific performance of this
Agreement by the Advisor and to seek both temporary and permanent injunctive
relief (to the extent permitted by law) without the necessity of proving actual
damages.
5. INDEPENDENT CONTRACTOR STATUS. The Advisor shall perform all services
under this Agreement as an "independent contractor" and not as an employee or
agent of the Company. The Advisor is not authorized to assume or create any
obligation or responsibility, express or implied, on behalf of, or in the name
of, the Company or to bind the Company in any manner and likewise the Company
may not bind the Advisor in any manner.
6. NOTICES. All notices required or permitted under this Agreement shall be
in writing and shall be deemed effective upon personal delivery or upon deposit
in the United States Post Office, by registered or certified mail, postage
prepaid, addressed to the other party at the address shown above, or at such
other address or addresses as either party shall designate to the other in
accordance with this Section.
7. MISCELLANEOUS. This Agreement constitutes the entire agreement between
the parties and supersedes all prior agreements and understandings, whether
written or oral, relating to the subject matter of this Agreement except it does
not supersede or modify the
Collaboration and License Agreement dated as of
January 22, 1999 between the Company and the Advisor. This Agreement may be
amended or modified only by a written instrument executed by both the Company
and the Advisor. This Agreement shall be construed, interpreted and enforced in
accordance with the laws of the Commonwealth of
Massachusetts. This Agreement
shall be binding upon, and inure to the benefit of, both parties and their
respective successors and assigns, including any corporation with which, or into
which, the Company may be merged or which may succeed to its assets or business,
PROVIDED THAT such successor or assignee expressly assumes the obligations of
the Company, and provided further, that the obligations of the Advisor are
personal and shall not be assigned by him.
24
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of
the day and year set forth above.
NITROMED, INC.
By
----------------------------------------------
Title
-------------------------------------------
ADVISOR
------------------------------------------------
Social Security No.
25
AMENDMENT TO
COLLABORATION
AND LICENSE AGREEMENT
THIS AMENDMENT (the "Amendment") TO
COLLABORATION and LICENSE AGREEMENT
(the "Agreement") is made and entered as of January 29, 2001 by and between
NitroMed, Inc. ("NITROMED"), a Delaware corporation with offices at 00 Xxx Xxxx
Xxxxx, Xxxxxxx, Xxxxxxxxxxxxx 00000, and Xxxxxxxxx Xxx X. Xxxx ("LICENSOR"),
whose principal address is 0000 Xxxxxxx Xxxxxx Xxxxx, Xxxxxxxxxxx, Xxxxxxxxx
00000.
1. LICENSOR has granted and NITROMED has acquired exclusive rights to use
certain proprietary technology in accordance with the terms and conditions
set forth in the Agreement.
2. NITROMED represents and warrants that it will incur the following estimated
increased out-of-pocket costs in excess of its planned costs because of
prior licensee's limited work on the Collaboration Products as follows:
A-HeFT CLINICAL STUDY
Contract Research Organization $[**]
Patient Costs [**]
Clinical Travel [**]
Consulting [**]
Manufacturing [**]
-------
Total $[**]
3. NITROMED requests that LICENSOR temporarily reduce royalties under Section
4.2(a) of the Agreement so that NITROMED can recover such costs actually
expended and documented to Licensor.
NOW THEREFORE the parties agree as follows:
1
1. NITROMED shall certify to LICENSOR the actual increase out-of-pocket costs
("Excess Costs") incurred by NITROMED associated with the A-HeFT Clinical
Study and provide documentary evidence thereof. To the extent such
documentation is reasonably satisfactory to LICENSOR, LICENSOR will reduce
("Reduction") the Royalty Rates set forth in Section 4.2(a) to a flat [**]%
at all levels, until the aggregate savings ("Excess Cost Savings") to
NITROMED, by reason of such reduced Royalty Rates, equal a maximum of [**]
the aggregate amount of such Excess Costs or $[**], whichever is less. Upon
such Excess Cost Savings being so recovered, the Royalty Rates will be
reinstated to [**]%, [**]% and [**]% respectively, on a going forward
basis. In consideration of the deferral NITROMED shall grant LICENSOR the
option to purchase 50,000 shares of common stock at $1.30 per share.
2. In the event NITROMED grants a sublicense to an independent third party
with respect to the sale of Collaboration Products, the royalties payable
by NITROMED with respect to the Net Sales of Collaboration Products by such
Sublicensee (the "Sublicensee Sales") shall be the lower of the rate in
effect set forth in Paragraph 1 of this Amendment or [**]% of the royalties
payments received by NITROMED. For example, if NITROMED receives a royalty
of [**]% while the [**]% rate is in effect LICENSOR shall receive [**]% of
the Sublicensee Sales and if the Royalty Rate subsequently increases after
Excess Cost Savings have been recovered, LICENSOR shall receive [**]% of
the Sublicense Sales.
3. All other terms and conditions of the Agreement remain in full force and
effect without amendment.
IN WITNESS WHEREOF, the parties have signed this Amendment to the Agreement.
/s/ Xxx Xxxx
___________________________
Xxxxxxxxx Xxx Xxxx
NITROMED, INC.
By: /s/ Xxxxxxx X. Xxxxxx
___________________________
2
AMENDMENT TO
COLLABORATION
AND LICENSE AGREEMENT
THIS AMENDMENT (the "Amendment") TO
COLLABORATION and LICENSE AGREEMENT
(the "Agreement") is made and entered as of March 15, 2002 by and between
NitroMed, Inc. ("NITROMED"), a Delaware corporation with offices at 00 Xxx Xxxx
Xxxxx, Xxxxxxx, Xxxxxxxxxxxxx 00000, and Xxxxxxxxx Xxx X. Xxxx ("LICENSOR"),
whose principal address is 0000 Xxxxxxx Xxxxxx Xxxxx, Xxxxxxxxxxx, Xxxxxxxxx
00000.
4. LICENSOR has granted and NITROMED has acquired exclusive rights to use
certain proprietary technology in accordance with the terms and conditions
set forth in the Agreement.
5. NITROMED represents and warrants that it will incur the following estimated
increased out-of-pocket costs in excess of its planned costs because of
prior licensee's limited work on the Collaboration Products as follows:
A-HeFT CLINICAL STUDY
CRO and Patient Costs $[**]
Testing, Distribution, Recruiting, etc. [**]
Committees [**]
Consulting [**]
Clinical Drug Supply [**]
----
Total $[**]
6. NITROMED requests that LICENSOR temporarily reduce royalties under Section
4.2(a) of the Agreement so that NITROMED can recover such costs actually
expended and documented to Licensor.
1
NOW THEREFORE the parties agree as follows:
4. NITROMED shall certify to LICENSOR the actual increase out-of-pocket costs
("Excess Costs") incurred by NITROMED associated with the A-HeFT Clinical
Study and provide documentary evidence thereof. To the extent such
documentation is reasonably satisfactory to LICENSOR, LICENSOR will reduce
("Reduction") the Royalty Rates set forth in Section 4.2(a) to a flat [**]%
at all levels, until the aggregate savings ("Excess Cost Savings") to
NITROMED, by reason of such reduced Royalty Rates, equal one times the
amount Excess Costs exceeding $7,500,000. The arrangement for first
$7,500,000 of such Excess Costs is specified in the amendment to the
Agreement dated January 29, 2001 and remains unchanged. Upon such Excess
Cost Savings being so recovered, the Royalty Rates will be reinstated to
6.0%, 7.0% and 8.0% respectively, on a going forward basis.
5. In the event NITROMED grants a sublicense to an independent third party
with respect to the sale of Collaboration Products, the royalties payable
by NITROMED with respect to the Net Sales of Collaboration Products by such
Sublicensee (the "Sublicensee Sales") shall be the lower of the rate in
effect set forth in Paragraph 1 of this Amendment or [**]% of the royalties
payments received by NITROMED. For example, if NITROMED receives a royalty
of [**]% while the [**]% rate is in effect LICENSOR shall receive [**]% of
the Sublicensee Sales and if the Royalty Rate subsequently increases after
Excess Cost Savings have been recovered, LICENSOR shall receive [**]% of
the Sublicense Sales.
6. All other terms and conditions of the Agreement remain in full force and
effect without amendment.
IN WITNESS WHEREOF, the parties have signed this Amendment to the
Agreement.
/s/ Xxx Xxxx
----------------------------------
Xxxxxxxxx Xxx Xxxx
NITROMED, INC.
By: /s/ Xxxxxxx X. Xxxxxx
-----------------------------------
2