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EXHIBIT 10.8
Confidential Materials omitted and filed separately with
the Securities and Exchange Commission. Asterisks denote omissions.
DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
This Development and Commercialization Agreement (the "Agreement"),
effective the 16th day of August, 1999 (the "Effective Date"), is between
GyneLogix, Inc. ("Licensor"), with principal offices at 000 Xxxxx Xxxxxx Xxx.,
Xxxxx 000, Xxxxxxxxxx, Xxxxxxxx, and The Medicines Company (the "Licensee"),
with principal offices at Xxx Xxxxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000.
BACKGROUND
1. Licensor owns certain Proprietary Property, including certain Patent
Rights and Know-How, relating to a novel Lactobacillus crispatus strain known as
CTV-05 and all technology related to its fermentation, stabilization and
manufacture, details of which are more fully described in APPENDIX A to this
Agreement.
2. Licensee desires to license the Proprietary Property in order to
develop, obtain regulatory approval, manufacture, use and sell products falling
within the scope of the Proprietary Property.
3. Licensor is willing to grant Licensee a license to the Proprietary
Property subject to the terms and conditions set forth in this Agreement.
NOW, THEREFORE, Licensor and Licensee, intending to be legally bound,
hereby agree as follows:
1. DEFINITIONS. As used in this Agreement, the following terms shall have the
meanings set forth below:
1.1 "AFFILIATE" means any person, corporation, firm, partnership or entity,
which directly or indirectly owns, is owned by, or is under the common ownership
of a party to this Agreement to the extent of greater than fifty percent (50%)
of the equity of the owned entity, having the power to vote on or direct the
affairs of the owned entity, or any person, corporation, firm, partnership, or
other entity actually controlled by, controlling or under common control with a
party to this Agreement.
1.2 "COMBINATION PRODUCT" means any pharmaceutical product that is
comprised of a Royalty-Bearing Product and at least one other active ingredient.
1.3 "CONFIDENTIAL INFORMATION" means all Know-How or other information,
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 visually disclosed by a party, or is disclosed in
writing without an appropriate letter, stamp or legend, shall constitute
Confidential Information of a party (a) if the disclosing party, within thirty
(30) days after such disclosure, delivers to the other party a written document
or documents
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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, or (b) such information
is of the type that is customarily considered to be confidential information by
persons engaged in activities that are substantially similar to the activities
being engaged in by the parties pursuant to this Agreement. Confidential
Information shall not include information encompassed by the exceptions as set
forth in Section 7.1.
1.4 "CTV-05" means (a) a novel Lactobacillus crispatus strain having ATCC
Deposit No. 202225, and (b) the underlying stabilization and preservation
technologies applying specifically to such novel Lactobacillus crispatus strain
and generally to Lactobacilli, all as more fully described in Appendix A to this
Agreement.
1.5 "CTV-05 PRODUCTS" means products or processes that are based upon or
derived from CTV-05 or any Improvements thereto.
1.6 "FIELD" shall mean the ex vivo and in vivo diagnosis, monitoring,
prevention and treatment of all diseases, conditions and disorders which affect
human females.
1.7 "IMPROVEMENTS" shall mean any product or process enhancement owned or
controlled, in whole or in part, by Licensor, or to which Licensor has any right
of use or right of exploitation, relating to CTV-05, including enhancements
relating to the manufacture, formulation, ingredients, preparation, means of
delivery, dosage or packaging thereof.
1.8 "KNOW-HOW" means any technical information related to the preparation
or development of CTV-05 Products owned or controlled in whole or in part, by
Licensor, or to which Licensor has any right of use or right of exploitation.
1.9 "ROYALTY-BEARING PRODUCT" shall mean any CTV-05 Product whose
manufacture, use or sale is covered by a Valid Claim of any of the Patent
Rights.
1.10 "NET SALES" means, with respect to a Royalty-Bearing Product, the
gross amount received by Licensee and/or its Affiliates on sales of
Royalty-Bearing Products to unrelated third parties, less the following
deductions:
(a) Trade, cash and quantity discounts actually allowed and taken directly
with respect to such sales;
(b) Tariffs, duties, excises, sales taxes or other taxes imposed upon and
paid directly with respect to the production, sale, delivery or use of the
Royalty-Bearing Product (excluding national, state or local taxes based on
income);
(c) Amounts repaid or credited by reason of rejections, defects, recalls or
returns or because of chargebacks, refunds, rebates or retroactive price
reductions; and
(d) Freight, insurance and other transportation charges incurred in
shipping a Royalty-Bearing Product to third parties (to the extent such charges
are invoiced to such third parties).
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In the event the Royalty-Bearing 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 (as defined in the standard Net Sales
definition), during the applicable royalty reporting period, by the fraction,
A/A+B, where A is the average sale price of the Royalty-Bearing Product when
sold separately in finished form and B is the average sale price of the other
active ingredient 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 Royalty-Bearing Product and the other active ingredient 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 Royalty-Bearing Product and all other active
ingredient included in the Combination Product, Net Sales for the purpose 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 Royalty-Bearing Product and D is the fair market value of all other
pharmaceutical active ingredient included in the Combination Product. In such
event, the Joint Steering Committee (as defined below), in accordance with
Section 3.4.2, shall in good faith make a determination of the respective fair
market values of the Royalty-Bearing Product and all other pharmaceutical active
ingredient included in the Combination Product, and provide Licensor with data
to support such determination. Licensor shall have the right to review such
determination and supporting data, and to notify Licensee if it disagrees with
such determination. If Licensor does not agree with such determination and if
the parties are unable to agree in good faith as to such respective fair market
values, then such matter shall be referred to the chief executive officers of
the parties.
1.11 "PATENT RIGHTS" means those patents or patent applications listed on
Appendix B to this Agreement; and any patents or patent applications which cover
CTV-05 Products which are owned or controlled, in whole or in part, by Licensor
or to which Licensor has any right of use or right of exploitation. Included
within the definition of Patent Rights are any continuations,
continuations-in-part, divisions, patents of addition, foreign counterparts,
reissues, renewals or extensions thereof.
1.12 "PROPRIETARY PROPERTY" shall mean all Patent Rights, Know-How and
other intellectual property rights, including trademarks, owned by Licensor
covering and relating to CTV-05 Products.
1.13 "SUBLICENSEE PROCEEDS" means payments received by Licensee or its
Affiliates with respect to sales of Royalty Bearing Products by sublicensees.
Sublicensee Proceeds shall not include license fees, milestone payments,
research and development funding and equity investments received from
sublicensees.
1.14 "VALID CLAIM" means a claim of any unexpired United States or foreign
patent which shall not have been donated to the public, disclaimed, nor held
invalid or unenforceable by a court of competent jurisdiction in an unappealed
or unappealable decision.
2. LICENSE GRANT, ASSIGNMENT AND TECHNOLOGY TRANSFER.
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2.1 GRANT OF LICENSE. Licensor grants Licensee an exclusive worldwide
license under the Proprietary Property, including Improvements, to develop,
make, market, use, import and sell CTV-05 Products in the Field, subject to the
terms and conditions of this Agreement, including the right to grant
sublicenses. Licensee shall notify Licensor in writing of any sublicense it
grants within thirty (30) days of the execution of a sublicense agreement and
shall obtain the written commitment of such sublicensee to abide by all
applicable terms and conditions of this Agreement. Additionally, Licensee will
make reasonable efforts to notify Licensor in advance of the execution of
sublicensee agreement provided that the failure to provide such advanced notice
will not be deemed a breach of this Development and Commercialization agreement.
2.2 KNOW-HOW TRANSFER. Upon execution of this Agreement, but in no event
later than thirty (30) days following the Effective Date of this Agreement,
Licensor shall disclose and transfer as requested by Licensee all Know-How that
is necessary or useful to the development, regulatory approval and
commercialization of CTV-05 Products for use in the Field. Without limiting the
generality of the foregoing, Licensor shall provide to Licensee full copies of
all data and documentation related to the CTV-05 Products and their manufacture,
and shall deliver and/or make available to Licensee all finished product,
together with quality control data, in the possession of Licensor or its
Affiliates as of the Effective Date. Thereafter, Licensor will promptly disclose
and transfer to Licensee Know-How as requested by Licensee from time to time
during the term of this Agreement.
2.3 ACCESS TO PERSONNEL. Licensor shall provide Licensee with cooperation
and reasonable access to its technical and scientific staff in order to permit
the timely, orderly and complete transfer of the Know-How and to permit the
Licensee to exploit the rights granted hereunder. Such staff shall include, but
not be limited to, Xx. Xxxxxx Xxxxxxxx. Licensor and Licensee agree that Xx.
Xxxxxxxx is an invaluable resource with considerable expertise in the
Proprietary Property. Licensor agrees to continue to employ Xx. Xxxxxxxx
(together with his scientific and administrative support infrastructure
(including laboratory personnel) in place as of the Effective Date) for 24
months and agrees to ensure that Xx. Xxxxxxxx and such personnel will be
available to work on the projects contemplated by the Development Plan on a full
time basis for 24 months. Notwithstanding the foregoing, Xx. Xxxxxxxx, with the
agreement of the Joint Steering Committee, may adjust personnel in a manner
deemed appropriate and to accommodate contemplated scale up and manufacturing
activities.
2.4 REGULATORY SUBMISSIONS. Licensor shall transfer or cause the transfer
of all regulatory submissions and approvals relating to the CTV-05 Products and
its manufacture to Licensee. Licensor agrees to take all steps reasonably
necessary to effect such transfer as of the Effective Date, including taking
such actions as may be necessary to cause the National Institutes of Health
("NIH") to transfer the IND relating to CTV-05 Products to Licensee or to permit
Licensee to have exclusive reference rights to such IND and full and continuing
access to all related data within 30 days of the Effective Date.
3. DUTIES OF LICENSEE.
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3.1 GENERAL. Licensee shall use its commercially reasonable efforts,
which for the purposes of this Agreement shall mean efforts consistent with the
usual practice followed by a medium-sized biopharmaceutical company in pursuing
the development, commercialization and
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marketing of pharmaceutical products of similar market potential, at its own
expense, to develop and commercialize CTV-05 Products in accordance with a
development plan to be provided by the Licensee and approved by the Joint
Steering Committee and thereafter updated on an annual basis (the "Development
Plan").
3.2 SPECIFIC LICENSEE RESPONSIBILITIES. Without limiting the generality
of Section 3.1, Licensee shall assume the following responsibilities relating to
the development and commercialization of the CTV-05 Products:
3.2.1 PRE-CLINICAL AND CLINICAL DEVELOPMENT. Licensee shall be
solely responsible for the pre-clinical and clinical development of CTV-05
Products. Following review by the Joint Steering Committee, the continuation of
any preclinical or clinical trial shall be at the sole discretion of the
Licensee, including any trials currently under discussion with NIH. Licensee
shall bear the financial responsibilities for the funding of all pre-clinical
and clinical trials, either directly or through strategic partnerships.
3.2.2 MANUFACTURING. The Licensee shall be solely responsible for
the manufacture of CTV-05 Products, including, without limitation, the selection
of the manufacturer and the development of manufacturing processes and
commercial scale-up. Licensee shall bear the financial responsibility (including
all capital investments required) associated with the manufacturing of CTV-05
Products. Funding of these activities will be either directly or through
strategic partnerships.
It is the current expectation and desire of the parties that the CTV-05 Products
be manufactured at the Boulder, CO facility of the Licensor. A manufacturing
agreement shall be duly negotiated by both parties not later than completion of
proof of concept trial. Both parties also recognize that technical, regulatory,
legal, environmental and/or commercial issues may necessitate, or that Licensee
may find it more advantageous, that all or a portion of the manufacturing of
these products be carried out at an alternate site(s) and could potentially
involve the services of third parties. Final decisions regarding the choice of
manufacturer(s) and manufacturing site(s) will be the sole responsibility of the
Licensee. In the event that Licensee determines not to manufacture CTV-05
Products at the Licensor's Boulder facility, Licensor and Licensee recognize
that further process development work on CTV-05 Products, or other products of
mutual interest agreed by Licensor and Licensee, if needed, may continue at the
Boulder facility. The decision to continue funding the Boulder facility under
such circumstances, in part or in whole, shall be decided by the Joint Steering
Committee in accordance with Section 3.4.2.
3.2.3 REGULATORY MATTERS. Following review by the Joint Steering
Committee, the Licensee shall be solely responsible for all determinations
relating to regulatory issues and all filings and interactions with regulatory
authorities. Licensee shall bear the financial responsibilities for all
regulatory matters, either directly or through strategic partnerships.
3.2.4 SALES AND MARKETING. Licensee shall be solely responsible for
all sales and marketing activities relating to CTV-05 Products, including
advertising, sales training, exhibitions, seminars and other promotional
activities. Licensee shall bear the financial responsibilities for all sales and
marketing activities, either directly or through strategic partnerships.
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Confidential Materials omitted and filed separately with
the Securities and Exchange Commission. Asterisks denote omissions.
3.3 REPORTS. Licensee shall report to Licensor on the status and progress
of Licensee's efforts to develop and commercialize CTV-05 Products at such times
as Licensor may reasonably request (not to exceed three per calendar year).
3.3.1 COMPOSITION; RESPONSIBILITIES. The parties shall establish a
joint steering committee (the "Joint Steering Committee"), comprised of two (2)
representatives of Licensor and two (2) representatives of Licensee. Each party
shall make its designation of its representatives prior to the Effective Date.
The Joint Steering Committee shall meet within forty-five (45) days after the
Effective Date and, thereafter, on a quarterly basis during the period in which
CTV-05 Products are in clinical development (or on a more frequent basis if
reasonably requested by Licensee) for purposes including, but not limited to (i)
reviewing the Development Plan for CTV-05 Products, (ii) reviewing and approving
amendments to the Development Plan, and (iii) reviewing and approving annual
budgets for operating expenses of the Boulder Facility for the development of
CTV-05 Products. The location of such meetings of the Joint Steering Committee
shall alternate between Licensor's principal place of business and Licensee's
principal place of business, or as otherwise agreed by the parties. All travel
and related expenses of Licensor's representatives in connection with such
meetings shall be paid by Licensee. The Joint Steering Committee may also meet
by means of a telephone conference call. Each party may change any one or more
of its representatives to the Joint Steering Committee at any time upon notice
to the other party. Each party shall use reasonable efforts to cause its
representatives to attend the meetings of the Joint Steering Committee. If a
representative of a party is unable to attend a meeting, such party may
designate an alternate to attend such meeting in place of the absent
representative. In addition, each party may, with the consent of the other
party, invite non-voting employees, consultants or scientific advisors, to
attend the meetings of the Joint Steering Committee to, among other things,
review and discuss the Development Plan and its results.
3.3.2 DECISION MAKING. The goal of all decision making shall be to
achieve consensus. Decisions of the Joint Steering Committee shall be made by
the majority vote of all of the members of the Joint Steering Committee. If the
Joint Steering Committee is unable to reach agreement on any matter within
fifteen (15) days after the matter is first referred to it, such matter shall be
referred for resolution to the chief executive officers of the parties. If such
officers are unable to resolve a matter referred to them under this Section
within three (3) days thereafter, the final determination shall be made by
Licensee acting in its sole discretion.
4. FINANCIAL PROVISIONS.
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4.1 MILESTONE PAYMENTS. In partial consideration of the exclusive license
granted by Licensor pursuant to this Agreement, Licensee shall pay to Licensor,
the following milestone payments:
(a) [**] within thirty (30) days of the execution of this Agreement,
(without any credit for any prior payments made to Licensor) or if later, upon
the receipt of the written contractual agreement of the NIH to co-manage and
co-fund (in equal parts) the proof of concept trial by TMC.
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Confidential Materials omitted and filed separately with
the Securities and Exchange Commission. Asterisks denote omissions.
(b) [**] upon successful completion of a Phase II/Proof of Concept Trial of any
CTV-05 Product and the decision by Licensee or its sublicensee to proceed with
Phase III clinical trials of such CTV-05 Product; and
(c) [**] upon the issuance by the U.S. Patent and Trademark office of the
first patent covering substantially all of the claims included in the patent
application described in Appendix B to this Agreement, the test of which shall
be all claims included in Appendix B relating to strain and use of strain in the
Field and the decision by TMC to go forward with the development of product.
Each of the foregoing milestones shall be payable only once upon the first
achievement of the applicable event, and shall be non-refundable and
non-creditable. Milestone payments for 4.3(a), (b) and (c) shall be paid within
thirty (30) days of the achievement thereof.
For purposes of this Section 4.3(b), "Phase II/Proof of Concept Trial"
shall mean a test or study using an extensive patient base which is required to
provide definitive evidence of efficacy and safety to proceed with a Phase II
dose ranging trial and/or Phase III trial for a CTV-05 Product including, but
not limited to tests and studies which are required by the regulatory
authorities pursuant to regulations, guidelines or otherwise necessary for the
filing of a New Drug Application with the U.S. Food and Drug Administration.
4.2 PAYMENT OF CERTAIN EXPENSES. Commencing on the Effective Date,
Licensee shall assume financial responsibility for the continued operation of
the Boulder Facility for the development of CTV-05 Products in accordance with
the Development Plan. Licensee's financial responsibility hereunder shall
terminate at such time as no further development under the Development Plan is
ongoing at the Boulder facility. Licensor represents that the current average
monthly operating expenses for the Boulder Facility is not more than [**], as
set forth more fully on APPENDIX C to this Agreement. Any actions or decisions
that would materially alter the current operating expenses for activities as
described in Section 3.2.2, including expenses, such as additions to personnel,
acquisition of equipment and changes in operations, shall be subject to the
Joint Steering Committee's prior written approval. If Licensee does not approve
of any such action or decision, Licensor may implement such action or decision
at its own expense, and Licensee shall not be responsible for reimbursing
Licensor for such incremental expenses unless such actions or decisions are
later determined by the Joint Steering Committee to be warranted. Licensee
acknowledges that additional costs will be required during prototyping and later
scale-up and manufacturing. Prior to the beginning of each calendar year,
Licensor shall provide a budget for such calendar year relating to the operation
of the Boulder Facility to the Joint Steering Committee at least ten (10) days
prior to next meeting of the Joint Steering Committee. Licensor shall invoice
Licensee monthly for the operating expenses of the Boulder Facility for the
development of CTV-05 Products, setting forth in reasonable detail the amounts
expended in various operating expense categories, PROVIDE THAT no monthly
invoice may exceed $[**] unless the Joint Steering Committee has previously
agreed in writing upon such excess expense. Licensee shall pay such invoices
within thirty (30) days after receipt, PROVIDED THAT Licensee may dispute
particular expenses by providing written notice to Licensor within such 30-day
period. In such event, Licensee may withhold the disputed portion of the invoice
and remit the balance to Licensor. Any such dispute shall be submitted to the
Joint Steering Committee for discussion and resolution. Licensor shall keep
complete and accurate records of
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Confidential Materials omitted and filed separately with
the Securities and Exchange Commission. Asterisks denote omissions.
the latest three (3) years of operating expenses of the Boulder Facility.
Licensee shall have the right at its expense, through its own personnel, a
certified public accountant or like person reasonably acceptable to Licensor, to
examine such records during the term of this Agreement and for six (6) months
after its termination. If the review reflects an overpayment of expenses to
Licensor, such overpayment shall be promptly remitted to Licensee. If the
overpayment is equal to or greater than [**] of the amount that was otherwise
due, Licensor shall pay Licensee for the expense of such audit. Licensee shall
have no further obligation to assume financial responsibility for the Boulder
Facility upon termination of this Agreement or as otherwise provided for in this
Section 4.2.
4.3 ROYALTIES; SUBLICENSE PAYMENTS. As additional consideration for the
exclusive license granted by Licensor pursuant to this Agreement, Licensee
shall:
(a) pay to Licensor royalties on Net Sales of Royalty-Bearing Products by
Licensee and its Affiliates in an amount equal to:
[**] of Net Sales of Royalty-Bearing Products on calendar-year annual Net
Sales of up to US$[**] million;
[**] of Net Sales of Royalty-Bearing Products on calendar-year annual Net
Sales in excess of US$[**] million and up to US$[**] million; and
[**] of Net Sales of Royalty-Bearing Products on calendar-year annual Net
Sales in excess of US $[**] million; and
(b) pay to Licensor [**] of Sublicensee Proceeds received by Licensee from
its sublicensees, with respect to sales of Royalty-Bearing Products.
For the sake of clarity, assuming Licensee has Net Sales of Royalty-Bearing
Products of $[**] million in a calendar year and receives $[**] million from a
sublicensee based on sales of Royalty-Bearing Products by such sublicensee in a
calendar year, Licensee shall pay to Licensor royalties totaling $[**] million
([**] of the first $[**] million in Net Sales, [**] of the next $[**] million
in Net Sales and [**] of the remaining $[**] million in Net Sales) and
sublicense fees totaling $[**] million ([**] of the $[**] million received by
Licensee from its sublicensee).
4.4 EXPIRATION AND NON GRANT OF PATENT. Royalty and sublicense payment
obligations due under this Agreement shall expire on a country-by-country basis
in each country effective at such time as there no longer exists in such country
a Valid Claim of any Patent Right covering the Royalty-Bearing Products in such
country. Upon expiration of such royalty and sublicense payment obligations in
any country, Licensee shall have a perpetual, fully paid up, exclusive right and
license under the Know-How in such country. However, in acknowledgement of
GyneLogix's proprietary know-how it is envisioned that TMC shall upon expiration
of said patents, on a country-by-country basis pay to GyneLogix [**] markup over
direct costs on CTV-05 products manufactured by GyneLogix, the details of which
will be specified in a manufacturing agreement to be signed by both parties. In
the event that Patent Rights, as outlined in Appendix B, are not granted to
GyneLogix and TMC outsources manufacture of a Royalty-Bearing Product to a third
party, TMC will in consideration of GyneLogix proprietary expertise transferred
by GyneLogix to third party, pay to GyneLogix not more than [**]
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of net profit margin enjoyed by said third party contract manufacturer to be
negotiated on a country by country basis as necessary. Said net profit margin in
the absence of third party cost basis will be established by mutual agreement
between TMC and GyneLogix. In the event of a disagreement with regard to said
net profit margin, TMC and GyneLogix will abide by the opinion of an expert
industry consultant to be chosen by the CEO's of both companies.
4.5 THIRD PARTY PATENT PAYMENTS. In the event that Licensee is obligated
to make payments to non-affiliated third parties ("Third Party Patent Payments")
to obtain licenses to patented technology which, in the reasonable judgment of
the Steering Committee, are required in connection with the development and
commercialization of Royalty-Bearing Products, then Licensee may deduct said
third party payments from payments otherwise due under Sections 4.3(a) and
4.3(b), it being understood that if such third party patent payments exceed
payments under 4.3(a) and 4.3(b) Licensee may not seek payment from Licensor for
such excess.
4.6 ROYALTIES PAYABLE ONLY ONCE. The obligation to pay royalties is
imposed only once with respect to the same unit of a Royalty-Bearing Product.
Except as specifically provided in this Agreement, it is understood and agreed
that there shall be no deductions from the royalties payable under this
Agreement.
4.7 SALES TO AFFILIATES AND SUBLICENSEES. Sales of Royalty-Bearing
Products between Licensee and its Affiliates or permitted sublicensees, or among
such Affiliates and permitted sublicensees, shall not be subject to royalties
under Section 4.3, but in such cases the royalties shall be calculated on the
Net Sales by such Affiliates to a third party or Sublicensee Proceeds received
by Licensee, as the case may be.
4.8 ROYALTY REPORTS AND PAYMENTS. Within fifty (50) days after the close
of each calendar quarter, Licensee shall deliver to Licensor a true accounting
of all Royalty-Bearing Products sold by Licensee and its Affiliates and
sublicensees during such quarter and shall at the same time pay all royalties
and sublicensee payments due. Such accounting shall show sales on a
country-by-country and Royalty-Bearing Product-by-Royalty-Bearing Product basis.
4.9 RECORDS; AUDITS. Licensee shall keep and require its Affiliates and
sublicensees to keep complete and accurate records of all sales of
Royalty-Bearing Products under the licenses granted herein. Licensor shall have
the right at its expense, through a certified public accountant or like person
reasonably acceptable to Licensee, to examine such records during regular
business hours during the term of this Agreement and for six (6) months after
its termination; provided, however, that such examination shall not take place
more often than once a year, and shall not cover such records for more than the
preceding three (3) years and provided further that such accountant shall report
to Licensee only as to the accuracy of the royalty statements and payments. In
the event that any such audit reveals that Licensee has paid less than the
royalty payments then due, Licensee shall promptly remit the shortfall to
Licensor and shall pay the Licensor for the expense of such audit in the event
that such shortfall is greater than ten percent (10%) of the royalty payments
then due. In the event that any such audit reveals that Licensee has paid more
than the royalty payments then due, Licensor shall promptly remit the
overpayment amount to Licensee.
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4.10 TAX WITHHOLDINGS. Any tax paid or required to be withheld by
Licensee by the Internal Revenue service or other taxing authorities on account
of royalties or other amounts payable to Licensor under this Agreement shall be
deducted from the payments otherwise due. Licensee shall secure and send to
Licensor written proof of any such taxes withheld and paid by Licensee or its
sublicensees for the benefit of Licensor.
4.11 PAYMENT CURRENCY; BLOCKED PAYMENTS. All royalties due under this
Agreement shall be payable in U.S. Dollars. In the event that, by reason of
applicable laws or regulations in any country, it becomes impossible or illegal
for Licensee or its Affiliates or sublicensees, to transfer, or have transferred
on its behalf, royalties or other payments to Licensor, such royalties or other
payments shall be deposited in local currency in the relevant country to the
credit of Licensor in a recognized banking institution designated by Licensor
or, if none is designated by Licensor within a period of thirty (30) days, in a
recognized banking institution selected by Licensee or its Affiliates or
sublicensees, as the case may be, and identified in a notice in writing given to
Licensor.
4.12 CURRENCY CONVERSIONS. Monetary conversions from the currency of a
country in which Royalty-Bearing Products are sold, into U.S. Dollars shall be
made at the exchange rate at which the applicable currency can be sold for U.S.
Dollars, as reported in THE WALL STREET JOURNAL at closing on the last business
day of the calendar quarter for which the royalties are being paid. Under all
circumstances Licensor shall bear the currency exchange risk for the conversion
of royalties being paid hereunder.
5. REPRESENTATIONS AND WARRANTS
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5.1 REPRESENTATIONS OF AUTHORITY. Licensor and Licensee each represents
and warrants to the other that it has full right, power and authority to enter
into this Agreement and to perform its respective obligations under this
Agreement. Licensor represents and warrants to Licensee that it has the right to
grant to Licensee the license granted pursuant to this Agreement.
5.2 CONSENTS. Licensor and Licensee each represents and warrants that all
necessary consents, approvals and authorizations of all government authorities
and other persons required to be obtained by such party in connection with
execution, delivery and performance of this Agreement have been and shall be
obtained.
5.3 NO CONFLICT. Licensor and Licensee each represents and warrants that
notwithstanding anything to the contrary in this Agreement, the execution and
delivery of this Agreement and the performance of such party's obligations
hereunder (a) do not conflict with or violate any requirement of applicable laws
or regulations and (b) do not and will not conflict with, violate or breach or
constitute a default or require any consent under, any contractual obligations
of such party, except such consents as shall have been obtained prior to the
Effective Date.
5.4 EMPLOYEE OBLIGATIONS. Licensor and Licensee each represents and
warrants that all of its employees, officers, and consultants have executed (and
any future employees, officers and consultants will execute) agreements or have
existing obligations under law requiring, in the case of employees and officers,
assignment to such party of all inventions made during the
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course of and as the result of their association with such party and obligating
the individual to maintain as confidential such party's Confidential Information
as well as confidential information of a third party which such party may
receive, to the extent required to support such party's obligations under this
Agreement.
5.5 INTELLECTUAL PROPERTY. Licensor represents and warrants that, to its
knowledge, except as disclosed in writing by Licensor to Licensee, (a) the
development and commercialization of CTV-05 Products does not and will not
infringe or conflict with the rights of any third party in respect of Know-How
or issued patents or published patent applications owned by such third party,
and (b) Proprietary Property that is expected to be utilized by Licensee in the
development and commercialization of CTV-05 Products is not being infringed by
any third party. Licensor represents and warrants that there is no claim or
demand of any person pertaining to, or any proceeding which is pending or, to
the knowledge of Licensor, threatened, that challenges the rights of Licensor in
respect of Proprietary Property Licensor represents and warrants that it is the
record owner of the Proprietary Property, which is free and clear of all liens,
claims and encumbrances.
5.6 NO WARRANTIES. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH HEREIN, THE
PARTIES MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTIES OF ANY KIND EITHER
EXPRESS OR IMPLIED, INCLUDING WHETHER ROYALTY-BEARING PRODUCTS WILL BE
SUCCESSFULLY DEVELOPED HEREUNDER, AND IF DEVELOPED, WILL HAVE COMMERCIAL UTILITY
OR MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
6. PATENTS, KNOW-HOW, INVESTIONS AND INFRINGEMENT
----------------------------------------------
6.1 OWNERSHIP. Licensor shall retain sole title to the Know-How and the
Patent Rights as presently existing and as developed or invented by Licensor or
on its behalf during the term of this Agreement. Licensee shall have sole title
to any Improvements developed or invented solely by Licensee or on its behalf
during the term of this Agreement. Licensor and Licensee shall jointly own any
Improvements developed or invented by both parties or on their behalf during the
term of this Agreement. The determination of inventorship shall be made in
accordance with relevant patent laws; in the event of a dispute regarding
inventorship or ownership that the parties are unable to resolve, mutually
acceptable outside patent counsel not regularly employed by either party shall
be retained to resolve such dispute.
6.2 PATENT RESPONSIBILITIES. Licensee shall, at its own cost and expense,
assume the responsibilities for preparing, filing, prosecuting and maintaining
patent applications and patents included within the Patent Rights or
Improvements licensed hereunder with patent counsel of its choosing. Within 30
days after the Effective Date, Licensor shall forward to Licensee or its
designee, at Licensee's expense, all documentation, including copies of file
histories and cited prior art, required for Licensee to assume such
responsibility. Licensor agrees to execute such documents and take such actions
as may be reasonably necessary to enable Licensee to undertake such
responsibilities. If Licensee shall decide not to file, prosecute or maintain
any of the Patent Rights in any country, Licensee shall so inform Licensor in a
prompt fashion (i.e., at least thirty (30) days prior to any filing deadline)
and Licensor shall have the right to assume the filing, prosecution and/or
maintenance thereof in such country at its own expense.
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6.3 THIRD PARTY INFRINGEMENT.
------------------------
6.3.1 NOTIFICATION. Each party shall promptly inform the other party
of any suspected infringement or misappropriation by any third party of any
Proprietary Property. Licensee shall, within 120 days of the first notice under
this Section 6.3.1, inform Licensor whether or not Licensee intends to institute
suit against such third party. Licensor need not take any steps toward
instituting suit against any such third party until Licensee has informed
Licensor of its intention pursuant to the previous sentence.
6.3.2 JOINT SUIT. If Licensee notifies Licensor that it desires to
institute suit against such third party with respect to infringement, and
Licensor notifies Licensee within 30 days after receipt of such notice that
Licensor desires to institute suit jointly, the suit shall be brought jointly in
the names of both parties. In consultation with the Joint Steering Committee,
the Licensee shall control the prosecution of such suit, and all costs thereof
shall be shared between the parties as the interests of the parties were
affected by the infringement, including reference to the relative monetary
injury suffered by each party. Recoveries, if any, whether by judgment, award,
decree or settlement, shall, after the reimbursement of each of the parties for
their shares of the joint costs in such action, be shared between the parties as
the interests of the parties were affected by the infringement, including
reference to the relative monetary injury suffered by each party.
6.3.3 LICENSEE SUIT. If Licensee notifies Licensor that it intends
to institute suit against such third party with respect to infringement, and
Licensor decides not to join in such suit, as provided in Section 6.3.2,
Licensee may bring such suit on its own and shall in such event bear all costs
of, and shall exercise all control over, such suit. Licensee may, at its
expense, bring such action in the name of Licensor and/or cause Licensor to be
joined in the suit as a plaintiff. Recoveries, if any, whether by judgment,
award, decree or settlement, shall belong solely to Licensee. Any expenses
incurred by Licensor as a result of being added to such suit by Licensee shall
be paid for and/or reimbursed promptly by Licensee.
6.3.4 LICENSOR SUIT. If Licensee notifies Licensor that it does not
intend to institute suit against such third party, Licensor may institute suit
on its own. Licensor shall bear all costs of, and shall exercise all control
over, such suit. Licensor may, at its expense, bring such action in the name of
Licensee and/or cause Licensee to be joined in the suit as a plaintiff.
Recoveries, if any, whether by judgment, award, decree or settlement, shall
belong solely to Licensor. Any expenses incurred by Licensee as a result of
being added to such suit by Licensor shall be paid for and/or reimbursed
promptly by Licensor.
6.3.5 ABANDONMENT OF SUIT. Should any party commence a suit under
the provisions of this Section 6.3 and thereafter elect to abandon the same, it
shall give timely notice to the other party, which may, if it so desires, be
joined as a plaintiff in the suit (or continue as such if it is already one) and
continue prosecution of such suit, provided, however, that the sharing of
expenses and any recovery of such suit shall be as agreed upon between the
parties.
6.4 CLAIMED INFRINGEMENT. In the event that a third party at any time
provides written notice of a claim to, or brings any action, suit or proceeding
against a party or such party's Affiliates or sublicensees claiming infringement
of its patent rights or unauthorized use or
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misappropriation of its technology based upon an assertion or claim arising out
of the practice of the Proprietary Property in the development, manufacture, use
or sale of Royalty-Bearing Product(s), such party shall promptly notify the
other party of the claim or commencement of such action, suit or proceeding,
enclosing a copy of the claim and/or all papers served relating thereto. In such
instance, Licensee (or a sublicensee, if so provided in the applicable
sublicense agreement) shall have the right to defend such claim, action, suit or
proceeding, at Licensee's (or such sublicensees) sole cost and expense, and
shall keep Licensor informed of the status and progress of the resolution of
such matter. Licensee may, after notification to Licensor, withhold up to 50% of
the payments otherwise due Licensor hereunder and may apply such withheld
amounts to reimbursement of the expenses incurred in defending any such action,
claim or proceeding, provided that any damages recovered by Licensee in any such
action, claim or proceeding shall first be applied to the reimbursement of any
such withheld amounts. The parties hereto shall negotiate in good faith any
adjustment to the provisions of this Agreement in the event that the final
result of such claim, action, suit or proceeding has any negative effect on the
development, manufacture, use or sale of Royalty-Bearing Product(s) hereunder.
6.5 PATENT INVALIDITY CLAIM. If a third party at any time asserts a claim
that any Patent Right is invalid or otherwise unenforceable (an "Invalidity
Claim"), whether as a defense in an infringement action brought by Licensee or
Licensor pursuant to Section 6.3 or in an action brought against Licensee or
Licensor under Section 6.4, the parties shall cooperate with each other in
preparing and formulating a response to such Invalidity Claim. Neither party
shall settle or compromise any Invalidity Claim without the consent of the other
party, which consent shall not be unreasonably withheld.
6.6 PATENT TERM EXTENSIONS. The parties shall cooperate, if necessary and
appropriate, with each other in gaining patent term extension wherever
applicable to Patent Rights covering Royalty-Bearing Products. The Parties
shall, if necessary and appropriate, use reasonable efforts to agree upon a
joint strategy relating to patent extensions. All filings for such extension
shall be made by the party which is the assignee of the patent, PROVIDED,
HOWEVER, that in the event that such party elects not to file for an extension,
such party shall (i) inform the other party of its intention not to file and
(ii) grant the other party the right to file for such extension.
7. CONFIDENTIALITY
---------------
7.1 CONFIDENTIAL INFORMATION. All Confidential Information disclosed by a
party to the other 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 the conduct of clinical trials of CTV-05
Products, regulatory approval of CTV-05 Products 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, provided that such
information shall not be deemed Confidential Information 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
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(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
(d) is independently developed by or for the receiving party without
reference to or reliance upon the particular 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 to avoid and/or minimize the degree of such disclosure.
7.2 EMPLOYEE AND ADVISOR OBLIGATIONS. Licensor and Licensee each agree
that they shall provide Confidential Information received from the other party
only to their respective employees, consultants and advisors, and to the
employees, consultants and advisors of such party's affiliates, who have a need
to know and have an obligation to treat such information and materials as
confidential.
7.3 TERM. All obligations of confidentiality imposed under this Article 7
shall expire five (5) years following termination or expiration of this
Agreement.
7.4 PUBLICATIONS. The parties acknowledge that scientific lead time is a
key element of the value of the development program for the CTV-05 Products and
further agree that scientific publications must be strictly monitored to prevent
any adverse effect of the premature publication of results of the development
program for the CTV-05 Products. The parties shall establish a procedure for
publication review and approval and each party shall first submit to the other
party an early draft of all such publications, whether they are to be presented
orally or in written form, at least sixty (60) days prior to submission for
publication. Each party shall review each such proposed publication in order to
avoid the unauthorized disclosure of a party's Confidential Information and to
preserve the patentability of inventions. If, as soon as reasonably possible but
no longer than sixty (60) days following receipt of an advance copy of a party's
proposed publication, the other party informs such party that its proposed
publication contains Confidential Information of the other party, then such
party shall delete such Confidential Information from its proposed publication.
If as soon as reasonably possible but no longer than sixty (60) days following
receipt of an advance copy of a party's proposed publication, the other party
informs such party that its proposed publication could be expected to have a
material adverse effect on any Patent Rights or Know-How of such other party,
then such party shall delay such proposed publication sufficiently long to
permit the timely preparation and first filing of patent application(s) on the
information involved.
7.5 PUBLIC ANNOUNCEMENTS.
--------------------
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7.5.1 GENERAL. Any announcements or similar publicity with respect to
the execution of this Agreement (including the timing and the contents of such
announcements or similar publicity) shall be determined by the Licensee, acting
in its sole discretion. The parties agree that any such 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.
7.5.2 LICENSEE DISCLOSURE RIGHTS. Notwithstanding the provisions of
Section 7.5.1, (a) Licensee shall have the right to disclose the existence and
financial and other terms of this Agreement to potential investors, lenders and
corporate partners and (b) Licensee shall have the right to issue a press
release and related public relations materials relating to the execution of this
Agreement and the CTV-05 Product, PROVIDED THAT Licensee shall provide a copy of
such release and materials to Licensor in advance of such issuance, for
Licensor's review.
8. INDEMNIFICATION
---------------
8.1 LICENSEE INDEMNIFICATION. Licensee shall indemnify, defend and hold
harmless Licensor and its officers, directors, Affiliates, employees and agents
from and against all third party costs, claims, suits, expenses (including
reasonable attorneys' fees) and damages arising out of or resulting from any
willful misconduct or negligent act or omission by Licensee related to the
subject matter of this Agreement or the distribution, sale, use by or
administration to any person of any CTV-05 Products, or that arises out of any
defect in the manufacture or the labeling, advertising, or sales of CTV-05
Products by Licensee or its sublicensees (except where such cost, claim, suit,
expense or damage arose or resulted from (a) the infringement of the CTV-05
Product(s) on the rights and/or patents of third parties, or (b) any willful
misconduct or negligent act or omission by Licensor), provided that Licensor
gives reasonable notice (no later than thirty (30) days after its receipt of
such claim) to Licensee of any such claim or action, tenders the defense of such
claim or action to Licensee and reasonably assists Licensee at Licensee's
expense in defending such claim or action and does not compromise or settle such
claim or action without Licensee's prior written approval (which approval shall
not be unreasonably withheld).
8.2 LICENSOR INDEMNIFICATION. Licensor shall indemnify, defend and hold
harmless Licensee and its officers, directors, Affiliates, employees, agents and
sublicensees from and against all third party costs, claims, suits, expenses
(including reasonable attorney's fees) and
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damages arising out of or resulting from any willful misconduct or negligent act
or omission by Licensor relating to the subject matter of this Agreement (except
where such cost, claim, suit, expense or damage arose or resulted from (a) the
infringement of the CTV-05 Products on the rights and/or patents of third
parties, or (b) any willful misconduct or negligent act or omission by Licensee
or its sublicensees), provided that Licensee gives reasonable notice (no later
than thirty (30) days after its receipt of such claim) to Licensor of any such
claims or action, tenders the defense of such claim or action to Licensor and
assists Licensor at Licensor's expense in defending such claim or action and
does not compromise or settle such claim or action without Licensor's prior
written approval (which approval shall not be unreasonably withheld).
8.3 SEPARATE LEGAL COUNSEL. In any action subject to the indemnification
provisions hereof, if the defendants in any such action include both Licensor
and Licensee and any party concludes that there may be legal defenses available
to it which are different from, additional to, or inconsistent with, those
available to the other(s), that party shall have the right to select separate
counsel to participate in the defense of such action on its behalf and such
party shall thereafter bear the cost and expense of such separate defense.
8.4 INSURANCE.
---------
8.4.1 LICENSEE INSURANCE. Licensee shall maintain and will continue to
maintain product liability insurance coverage appropriate to the risks involved
in the development and marketing of CTV-05 Products, as reviewed by the Joint
Steering Committee, but not less than US$2 million, and will no more than
annually present evidence to Licensor that such coverage is being maintained if
so requested in writing by Licensor. Licensee shall have the option of
self-insuring for such coverage, on the condition that it provide Licensor upon
request with an audited financial statement that evidences its ability to
self-insure for an amount reasonably satisfactory to Licensee.
8.4.2 LICENSOR INSURANCE. Licensor shall maintain and will continue
to maintain workers' compensation, general liability and other insurance with
respect to the Boulder Facility, including insurance against loss, damage, fire,
theft, public liability, environmental liability and other risks, in an amount
of at least US$2 million, and will no more than annually present evidence to
Licensee that such coverage is being maintained if so requested in writing by
Licensee.
9. EARLY TERMINATION
-----------------
9.1 TERMINATION FOR BREACH. 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
sixty (60) days' written notice to the Breaching Party, specifying the material
breach. The termination shall become effective at the end of the sixty (60) day
period unless (a) the Breaching Party cures such breach during such sixty (60)
day period or (b) if such breach is not susceptible to cure within sixty (60)
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) and effects such cure
within an additional sixty (60) days after the end of the initial sixty (60) day
cure period.
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9.2 LICENSEE TERMINATION RIGHT. Licensee shall have the right to
terminate this Agreement for convenience at any time upon sixty (60) days prior
written notice to Licensor. Following such termination, neither Licensee nor its
sublicensees shall have any rights to distribute, manufacture, sell or otherwise
distribute any CTV-05 Products in the Field.
9.3 EFFECT OF TERMINATION.
---------------------
9.3.1 PAYMENT. Upon the early termination of this Agreement by
Licensor pursuant to Section 9.1, or termination of this Agreement by Licensee
pursuant to Section 9.2, Licensor shall have the right to retain any sums
already paid by Licensee, and Licensee shall pay all sums accrued hereunder
which are then due.
9.3.2 TERMINATION BY LICENSEE FOR BREACH. Upon the early termination
of this Agreement by Licensee pursuant to Section 9.1, the rights and licenses
granted to Licensee under this Agreement shall not be affected, provided
Licensee continues to comply with its obligations hereunder for the term
thereof.
9.3.3 TRANSFER OF DATA AND FILINGS. Upon termination of this
Agreement by Licensor pursuant to Section 9.1, or termination of this Agreement
by Licensee pursuant to Section 9.2, Licensee will transfer to Licensor all
clinical data, patent and regulatory filings and government market approvals and
all other data developed by Licensee relating to the CTV-05 Products.
9.4 SURVIVAL OF PROVISIONS. In addition to the other provisions
concerning the survivability of terms and conditions hereof, under all
circumstances, the provisions of Sections 6, 7, 8, 9, and 12 hereof shall
survive the expiration or early termination of this Agreement.
10. EFFECT OF BANKRUPTCY ON LICENSES
All rights and licenses granted under or pursuant to any section of this
Agreement are and shall otherwise be, deemed to be, for purposes of Section
365(n) of the Bankruptcy Code, licenses of rights to "intellectual property" as
defined under Section 101(35A) of the Bankruptcy Code. The parties shall retain
and may fully exercise all of their respective rights and elections under the
Bankruptcy Code. Upon the bankruptcy of any party, the non-bankrupt parties
shall further be entitled to a complete duplicate of (or complete access to, as
appropriate) any such intellectual property, and such, if not already in its or
their possession, shall be promptly delivered to the nonbankrupt parties, unless
the bankrupt parties elect to continue, and continues, to perform all of its or
their obligations under this Agreement. All technology and know-how that may be
developed by Licensee during the term of this Agreement that relates in any way
to CTV-05 Products shall be and remain the property of Licensor.
11. OTHER AGREEMENTS
----------------
11.1 FINANCIAL STATEMENTS. Licensor warrants that it will provide annual
financial statements to Licensee in accordance with US GAAP within 90 days of
the end of each fiscal year.
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11.2 NON-COMPETE. During the term of this Agreement, neither Licensor nor
Xx. Xxxxxxxx shall, without the prior written consent of Licensee, engage in any
research, development or commercialization activities in the Field involving
lactobacilli or any products or processes that are based upon or derived from
lactobacilli, except in accordance with the Development Plan.
12. MISCELLANEOUS PROVISIONS
------------------------
12.1 DISPUTE RESOLUTION. With the specific exception of those matters
permitted or required to be decided by the joint Steering Committee, by the CEO
of the Licensee, or by the Licensee as outlined in section 3 and elsewhere in
this Agreement ("Excluded Matters"), if one of the parties hereto declares that
a dispute between the parties has arisen related to or arising from this
Agreement, such dispute shall, in the first instance, be the subject of good
faith negotiations between the parties to resolve such dispute. Should the
negotiations not lead to a settlement of the dispute within thirty (30) days
after a party declares that the dispute has arisen, either party may submit the
issue to binding arbitration. Such arbitration shall take place in Boston,
Massachusetts if submitted by Licensor and in Denver, Colorado if submitted by
Licensee and shall be conducted by a single arbitrator appointed by the Boston
or Denver office, as the case may be, of the American Arbitration Association
and in accordance with the commercial arbitration rules of the American
Arbitration Association. The arbitrator shall be a person who has had experience
in pharmaceutical licensing and shall be given full power to hear and finally
determine and dispose of all disputes (other than Excluded Matters) between the
parties that may arise from or that are related to this Agreement. The
arbitrator will use his best efforts to deliver a ruling in writing no later
than thirty (30) days after the hearing (which will be held within 30 days of
the appointment of the arbitrator hearing) and the decision will be binding on
the parties. Judgment upon the decision rendered may be entered in any court
having jurisdiction or application may be made to such court of a judicial
acceptance of the award and an order of enforcement, as the case may be. Each
party shall pay its own attorney's fees. All other fees and expenses payable
with respect to the arbitration proceedings shall be paid in the manner
determined by the arbitrator. Notwithstanding the foregoing, nothing in this
Section 12.1 shall be construed as limiting in any way the right of a party to
seek injunctive relief with respect to any actual or threatened breach of this
Agreement, which breach would cause irreparable harm to the party seeking such
relief, from a court of competent jurisdiction.
12.2 GOVERNING LAW. This Agreement shall be construed and the respective
rights of the parties hereto determined according to the substantive laws of the
Commonwealth of Massachusetts notwithstanding the provisions governing conflict
of laws to the contrary, except matters of intellectual property law which shall
be determined in accordance with the national intellectual property laws
relevant to the intellectual property in question.
12.3 ASSIGNMENT. Neither party may assign this Agreement in whole or in
part without the consent of the other, except if such assignment occurs in
connection with the sale or transfer of all or substantially all of the business
and assets of such party to which the subject matter of this Agreement pertains.
Notwithstanding the foregoing, any party may assign its rights (but not its
obligations) pursuant to this Agreement in whole or in part to an Affiliate of
such party.
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12.4 AMENDMENTS. This Agreement constitutes the entire agreement between
the parties with respect to the subject matter hereof, and supersedes all
previous arrangements with respect to the subject matter hereof, whether written
or oral. Any amendment or modification to this Agreement shall be made in
writing signed by both parties.
12.5 NOTICES.
-------
Notices to Licensor shall be addressed to:
GyneLogix, Inc.
000 Xxxxx Xxxxxx Xxxxxx
Xxxxx 000
Xxxxxxxxxx, XX ________
Attention: ___________________________
Facsimile No: (____) _________________
With a copy to:
Xxxxxx X. Xxxxxxx, Esq.
Xxxxxxxx Xxxx P.C.
0000 Xxxxxxx Xxxxxx, Xxxxx 0000
Xxxxxx, XX 00000
Telephone No. (000) 000-0000
Facsimile No. (000) 000-0000
Notices to Licensee shall be addressed to:
The Medicines Company
Xxx Xxxxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Attention: President
Facsimile No.: (___) __________________
with a copy to:
Xxxx and Xxxx LLP
00 Xxxxx Xxxxxx
Xxxxxx, XX 00000
Attention: Xxxxxx X. Xxxxxx, Esq.
Facsimile No.: (000) 000-0000
Any party may change its address by giving notice to the other party in the
manner herein provided. Any notice required or provided for by the terms of this
Agreement shall be in writing and shall be (a) sent by registered or certified
mail, return receipt requested, postage prepaid, (b)
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sent via a reputable overnight courier service, or (c) sent by facsimile
transmission, in each case properly addressed in accordance with the paragraph
above. The effective date of notice shall be the actual date of receipt by the
party receiving the same.
12.6 FORCE MAJEURE. No failure or omission by the parties hereto in the
performance of any obligation of this Agreement shall be deemed a breach of this
Agreement or create any liability if the same shall arise from any cause or
causes beyond the control of the parties, including, but not limited to, the
following: acts of God; acts or omissions of any government; any rules,
regulations or orders issued by any governmental authority or by any officer,
department, agency or instrumentality thereof; fire; storm; flood; earthquake;
accident; war; rebellion; insurrection; riot; and invasion and provided that
such failure or omission resulting from one of the above causes is cured as soon
as is practicable after the occurrence of one or more of the above-mentioned
causes.
12.7 INDEPENDENT CONTRACTORS. It is understood and agreed that the
relationship between the parties hereunder is that of independent contractors
and that nothing in this Agreement shall be construed as authorization for
either Licensor or Licensee to act as agent for the other.
12.8 NO STRICT CONSTRUCTION. This Agreement has been prepared jointly and
shall not be strictly construed against any party.
12.9 HEADINGS. The captions or headings of the sections or other
subdivisions hereof are inserted only as a matter of convenience or for
reference and shall have no effect on the meanings of the provisions hereof.
12.10 NO IMPLIED WAIVERS; RIGHTS CUMULATIVE. No failure on the part of
Licensor or Licensee to exercise, and no delay in exercising, any right, power,
remedy or privilege under this Agreement, or provided by statute or at law or in
equity or otherwise, shall impair, prejudice or constitute a waiver of any such
right, power, remedy or privilege or be construed as a waiver of any breach of
this Agreement or as an acquiescence therein, nor shall any single or partial
exercise of any such right, power, remedy or privilege preclude any other or
further exercise thereof or the exercise of any other right, power, remedy or
privilege.
12.11 SEVERABILITY. If any provision hereof should be held invalid,
illegal or unenforceable in any respect in any jurisdiction, then, to the
fullest extent permitted by law, (a) all other provisions hereof shall remain in
full force and effect in such jurisdiction and shall be liberally construed in
order to carry out the intentions of the parties as nearly as may be possible
and (b) such invalidity, illegality or unenforceability shall not affect the
validity, legality or enforceability of such provision in any other
jurisdiction. To the extent permitted by applicable law, Licensor and Licensee
hereby waive any provision of law that would render any provision hereof
prohibited or unenforceable in any respect.
12.12 EXECUTION IN COUNTERPARTS. This Agreement may be executed in
counterparts, each of which counterparts, when so executed and delivered, shall
be deemed to be an original, and all of which counterparts, taken together,
shall constitute one and the same instrument.
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IN WITNESS WHEREOF, the parties have executed this Agreement, individually
or by their duly authorized officers, as appropriate, on the date first written
above.
GYNELOGIX, INC. THE MEDICINES COMPANY
By: /s/ Xxxxxx X. Xxxxxxxx By: /s/ Xxxxx X. Xxxxxxxx
----------------------------------- ----------------------------------
Name: Xxxxxx X. Xxxxxxxx Name: Xxxxx X. Xxxxxxxx
--------------------------------- --------------------------------
Title: President and CEO Title: President and CEO
-------------------------------- -------------------------------
For purposes of Section 11.2 hereof,
/s/ Xxxxxx X. Xxxxxxxx
--------------------------------------
Xxxxxx Xxxxxxxx
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Confidential Materials omitted and filed separately with
the Securities and Exchange Commission. Asterisks denote omissions.
APPENDIX A
CTV-05
------
a. LACTOBACILLUS CRISPATUS strain CTV-05, as deposited in American Type Culture
Collection, Accession No. 202225;
b. any additional LACTOBACILLUS species and/or strains possessed, owned or
controlled by Licensor as of the Effective Date which has similar beneficial
attributes or utility within the Field and that is described in U.S. patent
application Serial No. [**], and any Know-How and any Improvements thereof as
of the Effective Date, including without limitation all information contained
in any SOP or FDA document owned, submitted or controlled by Licensor which
relates to the Field.
23
Confidential Materials omitted and filed separately with
the Securities and Exchange Commission. Asterisks denote omissions.
APPENDIX B
PATENT RIGHTS
1. PATENT RIGHTS
-------------
U.S. Patent Application No. [**]
PCT Patent Application No. [**]
24
APPENDIX C
BOULDER FACILITY BUDGET
(To Be Supplied)
