Exhibit 4.13
* Portions
of this exhibit have been omitted pursuant to a request for
confidential treatment and have been filed
separately
with the Commission.
This
Exclusive License Agreement (this “
Agreement”) is made as of 15th day of December,
2004 (“
Effective Date”) by and between MacroMed, Inc., a Utah corporation, having its
principal offices at 0000 X. Xxxxx, Xxxxxx, Xxxxx, Xxxx 00000 (“
MacroMed”) and Diatos SA, a
French corporation, having its principal offices at 000 xxxxxxxxx xx Xxxxxxxxxxxx, 00000 Xxxxx,
Xxxxxx (“
Diatos”). MacroMed and Diatos shall be referred to herein, collectively, as the
“
Parties,” and may be referenced individually as a “
Party.”
BACKGROUND
WHEREAS, MacroMed owns and/or controls certain patent rights, data, know-how and regulatory
authorizations pertaining to the OncoGel®
product (as further described below, the
“Product”).
WHEREAS, Diatos desires to obtain, and MacroMed desires to grant Diatos, an exclusive license,
with a right to grant and authorize sublicenses, under the Licensed Technology (as defined below)
to develop and commercialize Products in the Diatos Territory (as defined below), in accordance
with the terms and conditions herein.
WHEREAS, MacroMed desires to supply Diatos with, and Diatos desires to purchase from MacroMed, all
or a portion of Diatos’s requirements of the Existing Products for its development and
commercialization in the Diatos Territory, in accordance with the terms and conditions herein.
WHEREAS, MacroMed desires to continue the development and/or commercialization of the Product in
the MacroMed Territory (as defined below), by itself, with its other licensees or through Diatos
(as described herein).
NOW, THEREFORE, in consideration of the mutual covenants and premises herein contained, the Parties
agree as follows:
ARTICLE 1
DEFINITIONS
As used in this Agreement, the following terms shall have the meaning indicated:
1.1 “Affiliate” shall mean an entity which controls, is controlled by or is under common
control with a party. For purposes of this definition only, “control” shall mean having the power
to direct or cause the direction of the management and policies of the subject entity, whether
through the ownership of voting securities, by contract or otherwise, and shall include beneficial
ownership (direct or indirect) of at least fifty percent (50%) of the shares of the subject entity
entitled to vote in the election of directors (or, in the case of an entity that is not a
corporation, in the election of the corresponding managing authority).
1
1.2
“Asia” shall mean the countries of Afghanistan, Armenia, Azerbaijan, Bangladesh, Bhutan,
Birmania, Brunei Darussalam, Cambodia, China (including Hong Kong and Macau), India, Indonesia,
Japan, Kazakhstan, Kyrgyzstan, Laos, Malaysia, Maldives,Mongolia, Myanmar, Nepal, Pakistan,
Philippines, Republic of Georgia, Singapore, Sri Lanka,Taiwan, Tajikistan, Thailand, Turkmenistan,
Uzbekistan, Vietnam. Notwithstanding the foregoing, Asia shall not include any countries within
Europe (as defined below).
1.3
“Clinical Trial” shall mean any clinical trial involving the administration of a Product
to a human subject for the purpose of evaluating the safety, efficacy, performance or other
characteristic of such Product.
1.4 “Commercially Reasonable Efforts” means the commercially reasonable efforts that a
business person or company would expend in the normal course of its business to accomplish an
important high-priority objective.
1.5
“Confidential Information” of a Party shall men any information furnished by such Party under this Agreement or the Mutual Confidential Disclosure Agreement between the
parties dated April 29, 2004 (the “CDA”) which is (a) marked “Confidential” or with another similar legend if disclosed in writing, or (b) summarized and confirmed in writing as
“Confidential” within a reasonable period of time, if disclosed orally or by other intangible
means. In addition, all Data disclosed by a Party shall be deemed Confidential Information of such
Party, whether or not so marked or confirmed. Notwithstanding the foregoing, Confidential
Information shall not include, to the extent it can be established by the receiving Party by
competent proof, any information which: (i) was already known to the receiving Party, other than
under an obligation of confidentiality, at the time of disclosure, (ii) was or becomes generally
available to the public or otherwise part of the public domain, other than through any act or
omission of the receiving party in breach of this Agreement, (iii) was subsequently lawfully
disclosed to the receiving Party by a Third Party who did not receive such information, directly or
indirectly, from the disclosing Party, or (iv) is independently
developed by the receiving Party without use of any information or
materials disclosed by the disclosing Party.
1.6 “Control” or “Controlled” by a Party shall mean, with respect to an item of
information or intellectual property rights, possession by such Party of the power and authority,
whether arising by ownership, license, or other authorization, to disclose such item as required by
this Agreement, and/or to grant and authorize licenses or sublicenses under such items that are
within the scope granted to the other Party under this Agreement, without violating the terms of
any written agreement with any Third Party under which such Party first acquired such rights to
such item of information or intellectual property.
1.7 “Data” of a Party shall mean: (a) research data, pharmacology data, chemistry,
manufacturing and control (CMC) data, pre-clinical or non-clinical data, clinical data, safety
data; regulatory filings and supporting documentation and data (including information in any drug
master files); and any other similar data or documentation; in each case generated, created or used
by or under authority of such Party in connection with researching, developing or commercializing
Products, including conducting Clinical Trials thereof and seeking or maintaining Marketing
Approval therefore; and (b) to the extent available and Controlled by
2
such Party, at any time during the term of this Agreement, any other information submitted, or
required to be submitted by either Party in any filings with to Regulatory Authorities in
connection with Products.
1.8 “Diatos Territory” shall mean world-wide except for the United States of
America, Canada, Mexico, North Korea and South Korea.
1.9 “Europe” shall mean (a) the countries of the European Union (as then currently
constituted, including any successors thereto), and (b) to the extent not in the European Union as
described in clause (a), the countries of: Albania, Andorra, Austria, Belarus, Belgium,
Bosnia-Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Xxxxxxxxxxxx, Lithuania,
Luxembourg, Macedonia, Malta, Moldova, Monaco, Netherlands, Norway, Poland, Portugal, Romania,
Russia, San Marino, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, United
Kingdom, Yugoslavia.
1.10 “Field” shall mean any and all fields of use and indications.
1.11 “First Commercial Sale” in a country, Region or the Diatos Territory shall mean
the first commercial sale of a Product by Diatos, its Affiliates and/or their Sublicensees in such
country, Region or Diatos Territory, after Marketing Approval in such country, Region or the Diatos
Territory, respectively, has been obtained.
1.12 “Force Majeure” with respect to a Party, shall mean that performance of such
Party (except for payment obligations) is rendered impossible by strike, fire, earthquake, flood,
acts of god, acts of public enemy (including terrorism), insurrections, riots, boycotts,
governmental acts or orders or restrictions, failure of suppliers (despite use of Commercially
Reasonable Efforts to manage the same), failure of the other Party, or any other reason where
failure to perform, is beyond the reasonable control and not caused by the negligence, intentional
conduct or misconduct of such Party.
1.13 “Licensed Patents” shall mean (a) those patents and patent applications set forth
in Exhibit B, and (b) all issued, unexpired patents and all reissues, renewals, re-examinations
and extensions thereof (including any Supplementary Certificate of Protection of a member state of
the European Union or any similar protective rights in other countries), and patent applications
therefor, and any division or continuations, in whole or in part, substitutions or patents of
additions thereof, owned or Controlled by MacroMed as of the Effective Date, or at any time
thereafter during the term of this Agreement, which claim or otherwise would be required or useful
for the manufacture, sale or use of a Product within the Field in the Diatos Territory. To be
clear, though Licensed Patents are generally referred to herein, this term “Licensed Patents,” or
any other specific or non-specific reference to a particular patent, such as a patent number in
Exhibit B, does not infer that any patent is licensed as a whole to Diatos under this Agreement.
Only Product(s) within the Field in the Diatos Territory is/are licensed herein, and Licensed
Patents merely provide patent protection for the Product(s) within the Field in the Diatos
Territory.
3
1.14 “Licensed Know-how” shall mean (a) all Data of MacroMed, and (b) all other
information, data, documentation, trade secrets, know-how and tangible materials related to the
development, sale, manufacture or use of a Product; provided that clauses (a) and (b) shall be
deemed to include only such Data, information or materials to the extent Controlled by MacroMed as
of the Effective Date, or at any time thereafter during the term of this Agreement,
1.15 “Licensed Technology” shall mean the Licensed Patents and the Licensed Know- how.
1.16 “Licensed Marks” shall mean the trade and service marks, logos, trade dress, trade
names or other symbols identified with the Product owned or Controlled by MacroMed, including
the trade name OncoGel® or any other name under which the Product may be marketed by
MacroMed.
1.17 “MacroMed Territory” shall mean United States of America, Canada, Mexico, North
Korea and South Korea.
1.18 “Major European Country” shall mean France, Germany or the United Kingdom.
1.19 “MAA” shall mean a fully completed marketing authorization application (a New
Drug Application filed with the U.S.FDA, if in the United States, and a comparable application if
outside the United States), including all supporting documentation and data required for such
application to be accepted for substantive review, filed with a Regulatory Authority to seek
Marketing Approval for a particular indication in a particular country. It is understood that
MAA does not include applications for pricing or reimbursement approval.
1.20
“Manufacturing Patents” Manufacturing Know-how” and “Manufacturing
Technology” shall mean the Licensed Patents, Licensed Know-how and Licensed Technology,
respectively, that are useful solely for the manufacturing of the Products, and not for the
research, development, conduct of clinical trials, filing XXXx and obtaining Marketing Approval
for, marketing or sale of Products.
1.21 “Marketing Approval” shall mean all approvals, registrations or authorizations of
any governmental entity that are neccessary for the manufacturing, use, storage, import, transport
and sale of a Product in a regulatory Jurisdiction. For countries where governmental approval is required for
pricing or reimbursement for the Product to be reimbursed by national health insurance, Marketing
Approval shall not be deemed to occur until such pricing or reimbursement approval is obtained;
provided, that Marketing Approval shall be deemed to have occurred in such country where government
approval of pricing has not been obtained if, at any time, the Party undertakes a full commercial
launch of such Product in the country without obtaining such pricing approval.
1.22
“Net Sales” of a Party shall mean the amounts actually received by such Party,
its Affiliates or Sublicensees in consideration of their sales of Product to Third Party
customers, less: (a) normal and customary trade, cash and other discounts, allowances and credits actually
given; (b) credits or allowances for damaged goods, returns, rejections or recalls of Product
4
actually given; (c) sales taxes, value added taxes, withholding, import/export taxes or other
similar taxes (excluding taxes on the income of the selling entity) actually paid; (d) charge back
payments or rebates; and (e) packaging, handling fees, prepaid freight, insurance and the like.
Sales between or among a Party, its Affiliates or Sublicensees shall be excluded from the
computation of Net Sales if such Party, Affiliate or Sublicensee is not an end-user, but Net Sales
shall include the subsequent re-sale of such Products to Third Parties. Net Sales shall not include
amounts in respect of Product sold or used for development applications (including for clinical
trials) or a reasonable number of commercial samples.
1.23 “Product” shall mean the injectible ReGel®-based formulation of paclitaxel, known
as OncoGel, which is the subject of the Investigational New Drug (IND) application no. 60938,
including as such may be modified in order to obtain Marketing Approval in either Party’s Territory
(the “Existing Product”) and Second Generation Products, if any.
1.24
“Phase IIa Trial” shall mean a Clinical Trial of the Product in patients with a
specific tumor type to evaluate safety and preliminary evidence of efficacy, but is not designed to
determine an optimal dose of the product.
1.25 “Phase IIb Trial” means a clinical trial of the Product in human patients
conducted at multiple study sites, the primary endpoints of which to define the optimal dose and
clinical end points that will be used during a Phase III Pivotal Trial.
1.26
“Phase III Pivotal Trial” means a clinical trial of the Product conducted in
an expanded patient population at multiple sites which is sufficiently powered and designed to
establish safety and efficacy of one or more particular doses in the patients being studied and
to provide the statistical and clinical basis for Regulatory Approval of the Product.
1.27 “Region” shall mean each of (a) Europe, (b) Asia and (c) ROW.
1.28 “Regulatory Authority” shall mean any national (e.g., the FDA), supra-national
(e.g., the European Commission, the Council of the European Union, or the EMEA), or other
governmental entity in any jurisdiction of the world involved in the granting of Marketing Approval
for pharmaceutical products.
1.29 “ROW” shall mean the countries in the Diatos Territory outside Europe and Asia.
1.30 “Royalty Term” shall mean, with respect to the Existing Product, the period
commencing on the Effective Date and continuing until the later of
(a) * or (b) *. With respect to each Second Generation
Product, the Royalty Term shall mean, the period commencing on the *,
and continuing until the * or (b) *
* confidential treatment requested
5
*
1.31 “Second Generation Product” shall mean any injectible formulation or other
formulation for local administration, or any formulation for controlled or sustained release, of a
Taxoid(s) (an “Formulated Taxoid”), other than the Existing Product, which is being developed or
commercialized by or under the authority of MacroMed, or in which MacroMed otherwise has an
interest, at any time during the term of this Agreement. It is
understood that each Second Generation Product shall include any modifications made thereto in order to obtain Marketing
Approval in either Party’s Territory. Notwithstanding the foregoing, Second Generation Product
shall not include the HySolv® or ReSolv® formulation of a Taxoid, which are IV and oral
formulations respectively.
1.31.1 Mechanism for Notification and Inclusion. No Formulated Taxoid being developed
by or under the authority of MacroMed shall be eligible to become a Second Generation Product
until after MacroMed successfully manufactures such Formulated Taxoid in compliance with GMP.
MacroMed shall give Diatos prompt written notice of such successful GMP manufacture, with such
notice requesting under this Section 1.31 whether Diatos desires to include the Formulated Taxoid as
a Second Generation hereunder. Diatos shall have ninety (90) days following delivery of such
written notice during which to request that such Formulated Taxoid be designated as a Second
Generation Product under this Section 1.31. If Diatos does not request that such Formulated Taxoid
be designated as a Second Generation Product, such Formulated Taxoid shall not be deemed, for any
purpose to be a Product hereunder, and such Formulated Taxoid shall not be subject to or governed
by the terms of this Agreement. For clarity, except for purposes of Section 3.1(d) below, a
Formulated Taxoid shall not become a “Second Generation Product” under this Agreement unless and
until Diatos has requested MacroMed to include such Second Generation Product within this Agreement
and the Parties confirm in writing that it meets the definition of
this Section 1.31; provided,
however, that MacroMed shall not grant any Affiliate, or Third Party, any rights in or for the Diatos Territory with
respect to any Formulated Taxoid(s) until it has provided Diatos an opportunity to include such
Formulated Taxoid(s) as a Second Generation Product hereunder, and Diatos has elected not to do so,
in each case in accordance with this Section 1.31.1.
1.32 “Sublicensee” of a Party shall mean a Third Party to whom such Party has granted:
(a) the right to make and sell Products to other Third Parties, with respect to Products made and
sold by such Third Party, and (b) the right to distribute a Product in a territory, provided that
such Third Party is primarily responsible for the marketing and promotion of such Product within
such territory. For the avoidance of doubt, Diatos and MacroMed shall not be deemed Sublicensees of
the other, nor shall either Party be deemed to be acting “under authority” of the other Party.
1.33 “Sublicense Fees” received by a Party shall mean all cash payments, securities
(i.e. the cash value thereof) and other amounts received by such Party in consideration of a
sublicense in and to the Licensed Technology granted by such Party to a Sublicensee, including
license issue fees and milestone payments. Notwithstanding the foregoing, Sublicense Fees shall
exclude: (a) royalties on any sales of products or services, including royalties on Sublicensee’s
* confidential treatment requested
6
Net Sales; (b) reimbursement for actual internal or out-of-pocket costs incurred or to be
incurred by or for such Party for research, development, patent prosecution, materials,
equipment or clinical testing, but only to the extent that such costs have not already been
reimbursed by a Third Party; (c) payment for ongoing or future research or development
activities by or for such Party on a full-time equivalent (FTE) basis at reasonable and
customary FTE rates; (d) amounts received for services, products, equipment or securities
(equity or debt) actually provided to the Third Party by such Party, including transfer pricing
for Products or components thereof; (e) amounts received in consideration of intellectual
property rights other than Licensed Technology, allocated as set forth in the sublicense
agreement, or if not so set forth, as reasonably allocated by such Party, (f) amounts in
consideration for the sale of all or substantially all of the business or assets of such Party
or its Affiliates whether by merger, acquisition of stock or assets or otherwise; and (g) any
governmental charges, including withholding or other taxes (but not income taxes), paid or
payable by company on amounts received in consideration for a sublicense under Licensed
Technology.
1.34 “Sublicense Royalties” received by a Party shall mean any royalties on the
sale of Products received by such Party in consideration of a sublicense under the Licensed
Technology granted by such Party to a Sublicensee, but excluding amounts described in clauses (b)
through (g) of Section 1.33 above; provided that Sublicense Royalties shall include transfer price
for the ongoing supply of Products by such Party, less the fully burdened costs of such Party in
supplying such Products.
1.35 “Taxoid” shall mean any biologically-active agent isolated from yew (Taxus)
trees, or any biologically-active agent produced through fermentation processes or otherwise
synthesized into the same or a similar structure and function, including paclitaxel, docetaxel,
baccatin III and Cephalomannine, and any derivatives or analogues thereof.
1.36 “Territory” shall mean in the case of Diatos, the Diatos Territory, and in
the case of MacroMed, the MacroMed Territory.
1.37 “Third Party” shall mean any person or entity other than Diatos, MacroMed and
their Affiliates.
1.38 “Valid Claim” shall mean (a) a claim of an issued and unexpired patent within
the Licensed Patents, which has not been held unenforceable, unpatentable or invalid by a final
decision of a court or other governmental agency of competent jurisdiction, and which has not
been admitted to be invalid or unenforceable through reissue, disclaimer or otherwise, or (b) a
claim in a pending patent application within the Licensed Patents being prosecuted in good faith
that has not been abandoned or finally rejected and which has been pending for less than five (5)
years after the earliest priority date to which it is entitled. In the event subsequent to such
five (5) year period, such pending claim is issued as a claim of an issued and un-expired patent
included within clause (a) above, such claim shall be reinstated thereafter as a “Valid Claim” in
accordance with clause (a) above.
ARTICLE 2
LICENSE
7
2.1 Grant. Subject to the terms and conditions of this Agreement, MacroMed hereby
grants to Diatos a right and license under the Licensed Technology (a) to use, research, conduct
Clinical Trials, develop, register, market, distribute, sell, offer for sale and import Products in
the Field in the Diatos Territory and (b) subject to Article 6 below and Exhibit A, to make and have
made of the Products worldwide for purposes of clause (a) above. For the avoidance of doubt, Diatos
shall not be entitled to exercise rights under this Section 2.1 with respect to, Manufacturing
Technology, except pursuant to its Alternate Source rights under Exhibit A.
2.1.1 Exclusivity. The license set forth in Section 2.1 (a) shall be exclusive even as
to MacroMed in the Diatos Territory; provided that MacroMed may manufacture or have manufactured
the Products, anywhere in the world (including within the Diatos Territory), for purposes of using,
researching, developing, registering, marketing, distributing, selling, offering for sale and
importing the Products in the Field in the MacroMed Territory and for supplying Products to Diatos
in accordance with Exhibit A hereto.
2.1.2 Clinical Trials. Upon the request of MacroMed for each proposed Clinical Trial
of Products outside the MacroMed Territory, and upon the consent of Diatos therefor (which consent
shall not be unreasonably withheld or delayed), MacroMed may conduct such Clinical Trial
outside the MacroMed Territory, for purposes of using, researching, developing, registering,
marketing, distributing, selling, offering for sale and importing the Products in the Field in the
MacroMed Territory. Likewise, MacroMed hereby grants Diatos a license under the Licensed Technology
to conduct Clinical Trials of Products outside the Diatos Territory, upon its request for each such
proposed Clinical Trial and MecroMed’s consent therefor (which consent shall not be unreasonably
withheld or delayed), for purposes of using, researching, developing, registering, marketing,
distributing, selling, offering for sale and importing the Products in the Field in the Diatos Territory. Each Party agrees to
ensure that any Third Party to whom it grants exclusive rights to conduct Clinical Trials of
Products in a country shall be required to not unreasonably withhold or delay a request by the
other Party under this Section 2.1.2 to conduct a proposed Clinical Trial of Products in the
country to which such Third Party has exclusive rights.
2.1.3 No Sales outside its Respective Territory. Except as otherwise mutually agreed
in writing, Diatos and its Affiliates and Sublicensees shall not market, distribute, sell or offer
to sell any Products outside the Diatos Territory, nor authorize or assist any Third Party to do
so, and MacroMed and its Affiliates and Sublicensees shall not market, distribute, sell or offer to
sell any Products outside the MacroMed Territory (except the Products to Diatos hereunder), nor
authorize or assist any Third Party to do so.
2.2 Sublicenses. Subject to Section 3.2 below, Diatos shall have the right to grant
and authorize sublicenses to its Affiliates and Third Parties under the license set forth in
Section 2.1 above; provided that the terms and conditions of each such sublicense do not conflict
with the terms and conditions of this Agreement. Promptly upon entering into any sublicense
agreement with respect to the Licensed Technology, Diatos shall provide to MacroMed a redacted copy
of such sublicense agreement, disclosing the identity of the sublicensee and all other items that
affect MacroMed’s revenues and rights under this Agreement therefrom.
8
2.3 Diligence. Diatos shall use Commercially Reasonable Efforts to develop,
obtain Marketing Approval for and commercialize, by itself or through Sublicensee(s), at least one
Product in one or more of the Major European Countries, in Japan (as described in Section 2.3.2
below), and in any other countries in the Diatos Territory deemed appropriate by Diatos. MacroMed
shall use Commercially Reasonable Efforts to develop and commercialize, by itself or through
Sublicensee(s), at least one Product in the United States and in any other countries in the
MacroMed Territory deemed appropriate by MacroMed. The obligations of the Parties to develop and
commercialize Products, as set forth in this Section 2.3, shall extend to and include Second
Generation Products, if any; provided that it is understood that this sentence shall not require
either Party to be developing more than one Product at any particular time.
2.3.1 Europe. Diatos, by itself or through Sublicensee(s) shall use Commercially
Reasonable Efforts to initiate a first Clinical Trial of the first Product in or for Europe, on or
prior to * after (a) MacroMed certifies to
Diatos, in writing, that it has completed its transfer
of all Data and other Licensed Know-how to Diatos pursuant to Section 3.4 below, including its
current plans for a Clinical Trial, the protocols therefor and other supporting information
collected or developed for such trial, provided Diatos has not
identified to MacroMed within * after receiving such certificate any specific Data or Licensed Know-how that have been
not transferred, and (b) adequate Clinical Supplies for such trial, to be supplied by MacroMed in
accordance with Exhibit A, have been released in accordance Regulatory Requirements in Europe
(“Release Date”); and provided that (c) such Clinical Supplies are actually delivered to Diatos in
a timely manner for such trial, and (d) there are no factors beyond Diatos’s reasonable control
that would prevent Diatos (despite its use of Commercially Reasonable Efforts) from iniuating such
Clinical Trial within such time period, including e.g. regulatory difficulties, the inability of
clinical investigator(s) to recruit the appropriate number and type patients, death, retirement,
relocation or other withdrawal of clinical investigator(s) from
conducting such trial, etc.
2.3.2 Japan. Diatos, by itself or through Sublicensee(s), shall use Commercially
Reasonable Efforts to commence development and/or commercialization of at least one Product in
Japan * after the Effective Date, unless otherwise mutually agreed by the
Parties. As used herein, for purposes of this Section 2.3.2, Diatos shall be deemed to have
“commenced” development and/or commercialization in Japan if, without limitation, Diatos has
initiated Clinical Trials of a Product in or for Japan or if Diatos has obtained a Sublicensee
for a Product in Japan.
2.3.3 Sublicenses. With respect to a Sublicensee to whom Diatos grants rights to
control the development of, and/or rights to control the marketing and commercialization of,
Product(s) in a particular territory, Diatos shall require that such Sublicensee agree to exercise
Commercially Reasonable Efforts in such development and/or commercialization, respectively, of such
Product(s) in such territory.
2.4 Responsibility for Development and Commercialization. Each Party shall be
responsible for all its costs of development activities required to obtain Marketing Approval of
the Products in its Territory. As between the Parties, each Party shall control the development
* confidential treatment requested
9
and commercialization of the Products in its Territory, subject to the terms and conditions of this
Agreement. Each Party shall own all regulatory filings made by such Party in its Territory.
2.5 Abandonment of countries in each Party’s Territory. On an Abandoned
Market-by-Abandoned Market (as defined below) basis, in the event a Party makes an affirmative
company decision that it does not desire to develop or commercialize the Products, by itself or
through Sublicensees, in such Abandoned Market in its Territory, then such Party (the “Abandoning
Party”) shall promptly notify the other Party of such company decision, in writing. Such other
Party shall then have a right of discussion as follows: upon the request of the non-Abandoning
Party within ninety (90) days after such notice, the Parties agree to meet and to negotiate in good
faith to enter into an agreement with respect to development and/or commercialization rights for
the Products in the Abandoned Market(s), on mutually agreeable terms; provided that neither Party
shall be obligated to negotiate for more than a ninety (90) day period after such request by the
non-Abandoning Party (“Negotiation Period”). In the event the Parties do not agree on the terms of
such an agreement within the Negotiation Period, then the non-Abandoning Party may, upon written
request within thirty (30) days after the end of the Negotiation Period, submit the question of
commercially reasonable terms for the development and/or commercialization of Products in the
Abandoned Market to binding arbitration in accordance with
Section 12.3. Such terms shall be
determined based on the developmental, clinical or commercial stage of the Products in such
Abandoned Market, the relative contribution of the Parties thereto, anticipated margins and
commercial potential, the terms and conditions of this Agreement and the royalty rates and
financial terms then-prevailing and/or customary in the marketplace for like products for such
Abandoned Market. In the event the non-Abandoning Party does not request such arbitration within
such thirty (30) day period, then this Section 2.5 shall have no further force or effect with
respect to the Abandoned Market. As used herein, an “Abandoned Market” means a country in
either Party’s Territory, except that all of the countries that constitute the European Union shall
be deemed, collectively, a single Abandoned Market.
ARTICLE 3
COLLABORATlON
3.1 Collaboration Committee. The Parties shall establish a committee (the
“Collaboration Committee or “CC”) to coordinate and facilitate communications regarding the
development and commercialization of the Products worldwide. The CC will consist of two (2)
representatives from each Party, one of whom shall be a senior executive of each Party. The CC will
(a) discuss regulatory strategy and activities and the clinical studies of the Products that are to
be conducted, including projected requirements of clinical supplies of Products by Diatos, (b)
review and provide comments on the protocols for such clinical studies and the regulatory filings
for the Products, including clinical trials under Section 2.1.2
above, (c) discuss commercialization strategy and activities, including sublicensing plans, and manufacturing issues
such as validation, regulatory qualification, and scale-up to commercial production, (d) discuss
any actual or potential Second Generation Products, plans therefor and the progress of their
development and/or commercialization, (e) facilitate the exchange of Data and other information
and/or materials between the Parties, and (f) otherwise coordinate the development of the Products
in the Diatos Territory and the MacroMed Territory.
10
3.1.1 Meetings The CC shall meet once each calendar quarter until First Commercial Sale
of the Products in the Diatos Territory, and thereafter twice annually during the term of this
Agreement, unless otherwise agreed by the Parties. Such meetings shall be in person at least every
other meeting, alternating between the facilities of each Party unless otherwise mutually agreed,
and the other meetings may be through telephone or video conference or other mutually agreeable
means. With the consent of the CC members, other representatives of MacroMed or Diatos may attend CC
meetings as observers. Each Party shall bear its own personnel and travel costs and expenses
relating to CC meetings.
3.1.2 Reports. In addition to any other information required to be provided by each
Party hereunder, prior to each CC meeting under Section 3 .1.1
above, each Party shall provide the
CC at least five (5) business days prior to each meeting, with a written report summarizing the
progress of the development and commercialization activities of such Party, its Affiliates and
Sublicensees during the preceding period, including informing the CC of any significant events
relating to the development and commercialization of the Products that may impact the other Party
or any Product.
3.1.3 Advisory Nature. The CC shall be advisory in nature only. Each
Party shall retain the rights, powers and discretion granted to it
hereunder, and the CC shall not be delegated or vested with such rights, powers or discretion unless such delegation or vesting is expressly provided herein
or the Parties expressly so agree in writing. The CC shall not have the power to amend or modify
this Agreement, and its decisions shall not be in contravention of any terms and conditions of this Agreement.
3.1.4. Escalation. Notwithstanding Section 3.1.3 above, in the event that either Party
(“Concerned Party”) reasonably believes that an action proposed by the other Party (“Acting Party”) would adversely impact the
development, approval or marketing of any Product
in the Concerned Party’s Territory, or the other Party has materially changed the form or
composition of the Product(s) for which such other Party is seeking Marketing Approval in such
other Party’s Territory, the Concerned Party may refer the matter to be discussed by the CEO’s of
MacroMed and who Diatos, who shall meet promptly and negotiate in good faith to resolve the dispute. If
dispite such good faith efforts, the parties are unable to resolve such dispute, it is understood
that the Acting Party shall have the right to proceed with its desired course of action, provided
that such course is consistent with the terms and conditions of this Agreement, and Article 12
shall not apply thereto.
3.2 Sublicense Activities. The Parties shall, from time to time as mutually agreed, discuss
and coordinate their respective sublicensing activities and opportunities with respect to the
Licensed Technology, in order for the Parties to maximize the financial and strategic value of
Products and of the Licensed Technology worldwide. It is understood and agreed that neither Party
shall be obligated under this Section 3.2 to pursue any specific sublicensing opportunities or
grant any sublicenses to any third party, except as agreed by such
Party. However, each Party shall
use Reasonable Commercial Efforts to ensure that the other Party shall have access to relevant
information in such Party’s possession regarding the proposed deal terms and the identity, plans
and capabilities of the proposed Sublicensee, to the extent pertaining to the Products or the
Licensed Technology, as requested by the other Party.
11
3.3 Sharing of Data. Each Party shall promptly provide the other Party access to,
copies of and rights to reference all Data to the extent Controlled by such Party, including at any
time upon request of such other Party. For purposes of the foregoing, each Party shall ensure that
it has obtained access to, copies of, and rights to reference all Data generated or in the
possession of its Affiliates, Sublicensees and contractors so that it may provide the same to the
other Party for use and disclosure as permitted under this Section 3.3, Each Party may use and
disclose the Data provided by the other Party as may be necessary or desirable in developing,
manufacturing and/or commercializing the Product in its respective Territory subject to the
obligations of confidentiality contained in Article 8 below.
3.4 Technology Transfer. MacroMed shall at its own cost provide to Diatos (a) within
forty five (45) days after the Effective Date a copy of each tangible item of Licensed Know-how in
its possession other than Manufacturing Know-how, and (b) within sixty (60) days after the
Effective Date a copy of each tangible item of Manufacturing Know-how.
3.4.1 Assistance. During the six (6) month period after the Effective Date, MacroMed
shall at its own cost make its personnel reasonably available as requested by Diatos for
consultation regarding any Licensed Know-how or the Products or the use, development, manufacture
and/or sale of the Products. In addition, during such six (6) month period, MacroMed shall at its
own cost provide such reasonable further assistance as requested by Diatos, to ensure the effective
transfer of the Licensed Know-how to Diatos and to assist in Diatos’s efforts to understand and
implement the same. After such six (6) month period, MacroMed agrees that it shall not unreasonably
refuse any request for other consultation or technical assistance by Diatos to ensure effective
transfer of the Licensed Know-how. Without limiting the foregoing, if Diatos identifies a
particular item of Licensed Know-how that MacroMed possesses but that
was not transferred to Diatos,
and Diatos would be impeded by not having such item, MacroMed shall at its own cost use
Commercially Reasonable Efforts to provide the same to Diatos as soon as practicable. The “costs”
for which MacroMed shall be responsible in connection with providing the assistance required by
this Section 3.4.1 shall not include the actual and reasonable travel costs and expenses of its
employees incurred when providing assistance to Diatos outside the Salt Lake City, Utah
metropolitan area All such costs and expenses shall be the sole responsibility of Diatos.
3.4.2 Updates. During the Royalty Term, MacroMed shall at its’ own cost, regularly on its own
initiative and at any time upon the request of Diatos, update its transfer of Licensed Know-how
hereunder, including by providing Diatos copies of Licensed Know-how developed or acquired after
the Effective Date.
3.5 Adverse Event Reporting. The Parties will prepare a standard operating procedure governing
the collection, investigation, reporting, and exchange of information concerning adverse drug
reactions, quality and other complaints, sufficient to permit each party to comply with its legal
and regulatory obligations. Such standard operating procedure will be promptly updated if required
by changes in legal or regulatory requirements. Subject to the foregoing, each Party shall promptly
inform the other party about any adverse drug reactions, as well as any non-adverse serious (e.g.
from Product overdose) and any toxicity, sensitivity, failure of expected pharmacological action,
or laboratory abnormality which is, or is thought by the
12
reporter, to be serious
or associated with relevant clinical signs or symptoms, in each case of
which such party becomes aware or is informed about regarding the use of a Product in either Party’
Territory. Each Party shall ensure that its Affiliates and Sublicensees shall comply with the
foregoing obligations as if a Party.
ARTICLE 4
LICENSE FEES AND MILESTONES
4.1 License Fee. In partial consideration of the rights and license granted by
MacroMed to Diatos under this Agreement, Diatos shall pay MacroMed a
license fee of * Dollars (US $*) within thirty (30) days after the Effective Date. It
is understood and agreed that the Fifty Thousand Dollars (US $50,000) paid by Diatos to MacroMed in
connection with the Exclusivity Letter shall be fully creditable against such license fee.
4.2 European Milestones. In further consideration of the rights and license granted by
MacroMed to Diatos under this Agreement,
4.2.1
*. Diatos agrees to pay MacroMed *
Dollars (US $*) within thirty (30) days * by Diatos or its
Affiliates.
(a) Notwithstanding
the foregoing, in the event the milestone set forth in
Section 4.2.1
above is not triggered within * after Release
Date (as defined in Section 2.3.1),
and provided that the Clinical subject to such release are actually delivered to Diatos in a timely
manner in accordance with Exhibit A, Diatos shall pay MacroMed * (US
$*) within thirty (30) days after the end of such * period, and
* Dollars (US $*) within thirty
(30) days after * by Diatos or its
Affiliates. The Parties agree
that the such payments shall be in lieu of, and not in addition to,
the *
Dollars (US $*) set forth in Section 4.2.1 above.
(b) For clarity, the total amounts paid under this Section 4.2.1 shall not
exceed * Dollars (US $*), unless Section 4.2.1(a) applies, in which case
it shall not exceed * Dollars (US $*).
4.2.2
*. Diatos agrees to pay MacroMed * Dollars (US
$*) within thirty (30) days after the * by Diatos or its Affiliates.
4.2.3
*. Diatos agrees to pay MacroMed * Dollars (US $*) within
thirty (30) days after the * by Diatos or its
Affiliates.
* confidential treatment requested
13
4.2.4
*. In the event the * by
Diatos or its Affiliates is *, Diatos agrees to pay MacroMed *
Dollars (US $*) within thirty (30) days after such *. In
the event such *, Diatos agrees to pay MacroMed * Dollars (US $*)
within thirty (30) days after such *, and an additional
* Dollars (US $*) within thirty (30) days after * by Diatos or its Affiliates. It is understood
and agreed that the total amounts paid under this Section 4.2.4
shall not exceed * Dollars (US $*).
4.2.5
*. In the event the * by Diatos or
its Affiliates’ * is *,
Diatos agrees to pay MacroMed * Dollars (US $*) within thirty (30) days
after such *. In the event such *, Diatos agrees to pay MacroMed *
Dollars (US $*) within thirty (30) days after such *, and
an additional * Dollars (US $*) within thirty (30) days after the
* by Diatos or its Affiliates is *. It is understood and agreed that the total amounts paid under this Section
4.2.5 shall not exceed * Dollars (US $*).
4.2.6
*. In the event the first * by
Diatos or its Affiliates *, Diatos agrees to pay
MacroMed * Dollars (US $*) within thirty (30) days after
such *. In the event such *, Diatos agrees to pay MacroMed * Dollars (US
$*) within thirty (30) days after such *, and an additional
* Dollars (US $*) within thirty (30) days after the * is
obtained by Diatos or its Affiliates in a *. It is understood and
agreed that the total amounts paid under this Section 4.2.6
shall not exceed * Dollars (US $*).
4.2.7
*. Diatos agrees to pay MacroMed *
Dollars (US $*) within thirty (30) days after * by
Diatos or its Affiliates first * Dollars (US $*).
4.2.8
*. Diatos agrees to pay MacroMed * Dollars (US $*) within
thirty (30) days after * by Diatos or its Affiliates first * Dollars (US
$*).
4.2.9
*. Diatos agrees to pay MacroMed * Dollars (US $*) within
thirty (30) days after the * by Diatos or its Affiliates, *
* confidential treatment requested
14
* by Diatos or its Affiliates.
4.2.10 Certain Conditions.
(a) Aggregate Total. For the avoidance of doubt, each milestone payment in this Section 4.2
above shall be made no more than once, and Diatos shall owe not more than an aggregate maximum of
* Dollars (US $*) under this Section 4.2.
(b) Sublicensees. The milestones set forth in this Section 4.2, and
Sections 4.3 and 4.4 below, shall be due only upon the achievement of the corresponding events by
Diatos and/or its Affiliates, but not by Sublicensees. In the case of achievement by Sublicensees,
Diatos shall pay MacroMed a percentage of the Sublicense Fees thereof in accordance with Section
4.5 below.
(c) Payment of Catch-up Milestones. If at the time any of the
milestone payments set forth in Sections 4.2.1 through Section 4.2.6 is achieved and any prior
milestones in Section 4.2 have not been triggered, then the payments for such prior milestones
shall then be triggered and due, subject, in regard to Clinical Milestones (as defined below) only,
to Section 4.2.10(d). If at the time any of the milestone
payments set forth in Sections 4.3.1
through Section 4.3.6 is achieved and any prior milestones in
Section 4.3 have not been triggered,
then the payments for such prior milestones shall then be triggered and due, subject, in regard to
Clinical Milestone only, to Section 4.2.10(d) below. If at the time any of the milestone payments
set forth in Sections 4.4.1 through Section 4.4.6 is achieved and any prior milestones in Section
4.4 have not been triggered, then the payments for such prior milestones shall then be
triggered and due, subject, in regard to Clinical Milestones only, to
Section 4.2.10 (d) below. In
each case, the amounts due for the prior milestones triggered pursuant to this Section 4.2.10(c)
shall be determined assuming the same country(ies) are involved as in the milestone which was
actually achieved.
(d) Timing of Clinical Milestones. “Clinical Milestone Payments”
shall mean the payments required by Sections 4.2.1 through 4.2.3, 4.3.1 through 4.3.3, and 4.4.1
through 4.4.3 hereof.
(i) Serial Achievement. If more than one Clinical Milestone Payment in any
Region is triggered within any twelve (12) month period by reason of the serial achievement
of more than one (1) Clinical Milestones within such twelve (12) month period (and not as
the result of the application of Section 4.2.10(c) hereof), then only the first of such
Clinical Milestone Payments shall be due within thirty (30) days following its achievement,
and the additional Clinical Milestone Payments shall be deferred as follows:
(1) If the subsequent Clinical Milestone Payment is a
payment specified in Sections 4.2.2, 4.3.2 or 4.4.2, then the required payment shall be
deferred for a period of six (6) months from the date of the triggering event; and
* confidential treatment requested
15
(2) If the subsequent Clinical Milestone Payment is a
payment specified in Sections 4.2.3, 4.3.3 or 4.4.3, the required payment shall be deferred
for a period of twelve (12) months from the date of the triggering event.
(ii) Timing of Catch-up Milestones. If more than one Clinical Milestone
payment in any Region is triggered by the achievement of a Clinical Milestone and the
application of Section 4.2.10(c) above, then Diatos shall only be required to pay the
highest of such Clinical Milestone Payments within thirty (30) days following the triggering
event, and the remainder of the required Clinical Milestone Payments shall be deferred for a
period of six (6) months from the date of the triggering event, at which time they shall be
paid by Diatos in full. For clarity, if more than one Clinical Milestone Payment in a Region
is triggered by the achievement, in such Region, of a non-Clinical
Milestone (i.e. the
milestones specified in Sections 4.2.4 through 4.2.6, 4.3.4
through 4.3.6, and 4.4.4 through
4.4.6 hereof), then this Section 4.2.10(d)(ii) shall not apply, and all Clinical Milestone
Payments so triggered shall be due within thirty (30) days of the triggering event.
(iii)
Interest. Any Clinical Milestone Payments which are deferred by reason
of the provisions of this Section 4.2.10(d) shall bear interest from thirty (30) days after
the triggering event in question until payment thereof is made by Diatos, in full, at an
annual rate equal to “prime” (as quoted in the Western Edition of the Wall Street Journal
under the heading “Money Rates” on the next business day following the date of the
triggering event).
(e) Single
Event. In the event a single * triggers more than one milestone
payment under Sections 4.2, 4.3 and 4.4 the Parties agree that only the milestone payments for the
highest Region shall actually be due within thirty (30) days and the milestone payments for the
other Regions that are triggered by such event shall be deferred until twelve (12) months after the
date of the triggering event. For example, in the event a *
shall be due (if not already paid) within thirty (30) days, and
the *
shall be paid in full (if not already paid) within thirty
(30) days after twelve (12) months from
the *.
4.3
*. In further consideration of the rights and license granted by
MacroMed to Diatos under this Agreement,
4.3.1
*. Diatos agrees to pay MacroMed *
Dollars (US $*) within thirty (30) days after * by Diatos
or its Affiliates.
4.3.2
*. Diatos agrees to pay MacroMed * Dollars (US $*) within
thirty (30) days after * by Diatos or its Affiliates.
* confidential treatment requested
16
4.3.3
*. Diatos agrees to pay MacroMed * Dollars (US $*) within
thirty (30) days after the * by Diatos or its Affiliates.
4.3.4
*. In the event the * by
Diatos or its Affiliates is *, Diatos agrees to pay MacroMed *
Dollars (US $*) within thirty (30) days after such *. In the event such MAA is not
*, Diatos agrees to pay MacroMed * Dollars (US $*) within
thirty (30) days after such *, and an additional * Dollars (US $*)
within thirty (30) days after the * by Diatos or its
Affiliates. It is understood and agreed that the total amounts paid under this Section 4.3.4 shall
not exceed * Dollars (US $*).
4.3.5
*. In the event the * by Diatos or its
Affiliates *, Diatos agrees
to pay MacroMed * Dollars (US $*) within thirty (30) days after such
*. In the event such *, Diatos agrees to pay MacroMed * Dollars
(US $*) within thirty (30) days after such *, and an additional
* Dollars (US $*) within thirty (30) days after the first * by
Diatos or its Affiliates is *. It is understood
and agreed that the total amounts paid under this Section 4.3.5
shall not exceed * Dollars (US $*).
4.3.6
*. In the event the first * by Diatos or its Affiliates in *,
Diatos agrees to pay MacroMed * Dollars (US $*) within thirty
(30) days after such *. In the event such *, Diatos agrees
to pay MacroMed * Dollars (US $*) within thirty (30) days after
such *, and an additional * (US $*)
within thirty (30) days after the * by Diatos or
its Affiliates in *. It is understood and agreed that the total amounts paid under this Section
4.3.6 shall not exceed * Dollars (US $*).
4.3.7
*. Diatos agrees to pay MacroMed * Dollars (US $*) within
thirty (30) days after *
by Diatos or its Affiliates first * Dollars (US $*).
4.3.8
*. Diatos agrees to pay MacroMed * Dollars (US $*) within
thirty (30) days after *
by Diatos or its Affiliates first * Dollars (US
$*).
* confidential treatment requested
17
4.3.9
*. Diatos agrees to pay MacroMed * Dollars (US
$*) within thirty (30) days after the * by Diatos or its
Affiliates, * by Diatos or
its Affiliates.
4.3.10 Certain Conditions. For the avoidance of doubt, each milestone payment in this
Section 4.3 above shall be made no more than once, and Diatos shall owe not more than an aggregate
maximum of * Dollars (US $*) under this
Section 4.3. Certain other conditions with respect to the milestone payments of this Section 4.3
are set forth in Section 4.2.10 above.
4.4
*. In further consideration of the rights and license granted by MacroMed
to Diatos under this Agreement,
4.4.1
*. Diatos agrees to pay MacroMed * (US
$*) within thirty (30) days after * by Diatos or its
Affiliates.
4.4.2
*. Diatos agrees to pay MacroMed * Dollars (US
$*) within thirty (30) days after the *.
4.4.3
*. Diatos agrees to pay MacroMed * Dollars (US $*) within
thirty (30) days after the *.
4.4.4
*. Diatos agrees to pay MacroMed * Dollars
(US $*) within thirty (30) days after the *.
4.4.5
*. Diatos agrees to pay MacroMed * Dollars (US $*) within
thirty (30) days after the *.
4.4.6
*. Diatos agrees to pay MacroMed * Dollars (US $*) within
thirty (30) days after the *.
4.4.7
*. Diatos agrees to pay MacroMed * Dollars (US $*) within
thirty (30) days after * Dollars (US $*).
4.4.8
*. Diatos agrees to pay MacroMed *
Dollars (US $*) within thirty (30) days after * Dollars (US $*).
* confidential treatment requested
18
4.4.9
*. Diatos agrees to pay MacroMed *
Dollars (US $*) within thirty (30) days after the *.
4.4.10 Certain Conditions. For the avoidance of doubt, each milestone payment in this
Section 4.4 above shall be made no more than once, and Diatos shall owe not more than an aggregate
maximum of * Dollars (US $*) under this Section 4.4. Certain
other conditions with respect to the milestone payments of this Section 4.4 are set forth in
Section 4.2.10 above.
4.5
Sublicensees. In further consideration of the rights and license granted by
MacroMed to Diatos under this Agreement, Diatos shall pay MacroMed *
percent (*%) of
Sublicensee Fees received by Diatos (the “Sublicense Fee Share”) within thirty (30) days after
receipt thereof; provided however that, on a Region-by-Region basis at no time shall the Sublicense
Fee Share for a Region plus the Diatos Milestone Payments for such
Region be (a) greater than * percent (*%) or (b) less than
* percent (*%) of the Total
Deemed Milestones for such Region. For purposes of this Section 4.5, Sublicense Fees received for
more than one Region, e.g. up-front license fees received by Diatos from a Sublicensee whose
Sublicense covers countries in more than one Region, shall be allocated among such Regions in the
* proportion contemplated by Sections 4.2, 4.3 and 4.4 in regard to milestone payment
levels for Europe-Asia-ROW respectively.
4.5.1
“Diatos Milestone Payments.” for the Region(s) of Europe, Asia and/or ROW, shall mean
the amounts paid by Diatos under Sections 4.2, 4.3 and/or 4.4 above, respectively (including via
amounts credited pursuant to Section 4.5.4, 7.2 or 7.3 below or Exhibit A).
4.5.2
“Total Deemed Milestones.” for the Region(s) of Europe, Asia and/or
ROW, shall mean the total milestones that have or would have accrued under Sections 4.2, 4.3 and/or
4.4, respectively, assuming there were no Sublicenses, and the activities of the Sublicensees were
activities of Diatos.
4.5.3
Excess Sublicense Fee Share. In the event the * (*%)
threshold described in Section 4.5(a) above is exceeded with respect to a Region, the excess
Sublicense Fee Share for such Region shall be deferred and shall not be due, to the extent such
threshold continues to be exceeded for such Region. If such condition continues until the
expiration or termination of this Agreement, then such excess Sublicense Fee Share for such Region
shall not be due nor paid.
4.5.4 Shortfall in Sublicense Fee Share. In the event the condition specified in
Section 4.5(b) above exists, at any time, with respect to a Region, (including without limitation,
as the result of the achievement by a Sublicensee of a milestone specified in Sections 4.2, 4.3 or
4.4 hereof for such Region), Diatos shall pay MacroMed the difference
between (i) * percent (*%) of the Total Deemed Milestones for such Region, and (ii) the sum of the Sublicense
Fee Share if any, theretofore actually paid in respect of such Region and Diatos
* confidential treatment requested
19
Milestone Payments for such Region. Such payment shall be creditable against future payments
under Sections 4.2, 4.3 or 4.4 above for such Region or future payments of Sublicense Fee Share
under this Section 4.5 for such Region.
ARTICLE 5
ROYALTIES
5.1 Net Sales of Diatos and its Affiliates. In further consideration of the
rights and license granted by MacroMed to Diatos under this Agreement, Diatos agrees to pay
MacroMed a running royalty as set forth in the table below of the Net Sales of Products during the
Royalty Term by Diatos and its Affiliates (but not their Sublicensees, which are separately
addressed in Section 5.3 below), in accordance with Section 5.5 below. As used herein, “Annual Net
Sales” of a Product shall mean the Net Sales of such Product sold in the Diatos Territory by Diatos
and its Affiliates (but not their Sublicensees) during each successive twelve (12) month period
after the First Commercial Sale of Products during the Royalty Term (each, a “Royalty Year”).
|
|
|
|
|
|
|
ROYALTY |
NET SALES |
|
PERCENTAGE |
With
respect to that portion of Annual Net Sales of such Product,
equal to or less than US $* Dollars (US $*) |
|
|
* |
% |
|
|
|
|
|
With respect
to that portion of Annual Net Sales of such Product,
greater than US $* Dollars(US $*) and less than or
equal to US $* Dollars (US $*) |
|
|
* |
% |
|
|
|
|
|
With respect
to that portion of Annual Net Sales of such Product,
greater than US $* Dollars (US $*) |
|
|
* |
% |
5.2 Adjustments to Royalties.
5.2.1 No Exclusivity. On a country-by-country and Product-by-Product basis, in the event of
expiration of, or if there are no, Valid Claims in a country covering the sale of a Product in such
country, the royalties payable thereafter under this Article 5 on the Net Sales of such Product in
such country shall be reduced by * percent (*%), prior to the application of any credits.
Similarly, on a country-by-country basis, in the event there is a Subject Infringement in such
country, wherein the alleged infringing product is sold or used for any same tumor type as
a Product sold or used by or under authority of Diatos, and the Parties make a Decision Not to
Enforce (as defined in Section 7.3.1 below) against such Subject Infringement, the royalties
payable thereafter under this Article 5 on the Net Sales of Products in such country shall be
reduced by * percent (*%), prior to the application of any credits, until such Subject
Infringement is otherwise abated and either Party has notified the other Party thereof. In the
event that, in any reporting period, there are Net Sales that are
subject to a * percent (*%)
reduction as set forth in this Section 5.2.1 and Net Sales that
are not subject to such a *
percent (*%) reduction, the Net Sales subject to such a * percent (*%) reduction shall be
* confidential treatment requested
20
allocated, to the extent applicable, among the three royalty categories set forth in the
table above (each a “Royalty Band”), proportionally with the Net Sales not subject to such
a fifty percent (50%) reduction.
5.2.2 Third Party Royalties.
(a) In the event that Diatos or its Affiliates believe that they are
obligated to pay a third party royalties or other amounts for patent rights or technologies (“Third
Party IP”) in connection with a Product or the development or commercialization thereof in the
Diatos Territory, or that the payment of such royalties or other amounts is necessary or
appropriate in order to so develop and commercialize Licensed Technology (“Third Party
Payments”), Diatos shall give MacroMed written notice thereof. Within thirty (30) days of the
date of such written notice, MacroMed will discuss with Diatos, in good faith, the Third Party IP
and the proposed Third Party Payments specified in such written notice.
(b) In the event (i) MacroMed agrees that the proposed Third Party IP is necessary or
appropriate (which agreement MacroMed shall not unreasonably withhold or delay), or (ii)
the Third Party Payments are ordered by final order of a court of competent jurisdiction, Diatos
may deduct the Third Party Payments from the royalties due to MacroMed under Section 5.1 and from
its payment of the Sublicense Royalty Share under Section 5.3 below. In the event conditions (i) or
(ii) are not met, then Diatos may still license or otherwise acquire such Third Party IP for the
Products in the Diatos Territory, but Diatos may only deduct *
percent (*%) of such Third
Party Payments from the royalties due to Macromed under Section 5.1 and from its payment of the
Sublicensee Royalty Share under Section 5.3 below.
(c) MacroMed shall be deemed to have agreed that a license of Third
Party patent rights or technologies for the Product is necessary or appropriate for the Diatos
Territory (i.e. condition (i) in Section 5.2.2(b) above is deemed to be met) if MacroMed obtains a
corresponding license for Products in the United States or another country in the MacroMed
Territory.
(d) In the event MacroMed fails to respond within thirty (30) days after written notice
required by Section 5.2.2(a), or affirmatively notifies Diatos that it agrees that such Third Party
IP is necessary or appropriate, then MacroMed shall irrevocably be deemed to have approved the
Third Party IP which are the subject of such notice.
5.2.3 Combination Products. In the event that a Product is sold for a single combined
price in combination with other products, components (including active ingredients) or services for
which no amounts would be payable to MacroMed if sold separately, amounts invoiced for such
combination sales for purposes of calculating Net Sales on the sales of the Product in such
combination shall be allocated in a pro rata basis between the value(s) of such Product and of such
other products, components or services, provided that in no event shall the Net Sales of the
Product in such combination be less than the average arms-length price of such Product, if being
sold separately.
* confidential treatment requested
21
5.3
Net Sales by Sublicensees. In further consideration of the rights and license
granted by MacroMed to Diatos under this Agreement, Diatos shall pay
MacroMed * percent (*%)
of Sublicensee Royalties received by Diatos (the “Sublicense Royalty Share”) in accordance
with Section 5.5 below; provided however that, on a Region-by-Region basis, at no time shall the
Sublicense Royalty Share for a Region plus the Diatos Royalty Payments for such Region be (a)
greater than * percent (*%) of the Deemed High-End Royalties or (b)
less than * percent (*%) of the Deemed Low-End Royalties for such Region.
5.3.1 “Diatos Royalty Payments” for a Region shall mean the amounts paid by Diatos
pursuant to Sections 5.1 and 5.2 on the Net Sales in such Region by Diatos and its Affiliates,
including via amounts credited pursuant to Sections 5.3.4, 7.2 or 7.3 below or Exhibit A.
5.3.2 “Deemed High-End Royalties” for the Region shall mean the royalties that
have or would have accrued pursuant to Sections 5.1 and 5.2 with respect to the activities of the
Sublicensee, assuming there were no sublicense, the activities of the Sublicensee were activities
of Diatos, and such royalties were charged at the highest Royalty
Band (i.e. at *%, subject to
the adjustments set forth in Section 5.2). It is understood and agreed that any costs incurred by
the Sublicensee for Third Party patent rights, patent prosecution or enforcement, if reported to
Diatos and affecting the amounts received by Diatos from the Sublicensee, shall be deemed such
costs incurred by Diatos for purposes of calculating Deemed High-End Royalties; provided that the
portion of such costs for Third Party Patent rights which may be deducted will be determined pursuant to
the provisions of Section 5.2.2 above.
5.3.3 “Deemed Low-End Royalties” for the Region shall mean the royalties that have or
would have accrued pursuant to Sections 5.1 and 5.2 with respect to the activities of the
Sublicensee, assuming there were no sublicense, the activities of the Sublicensee were activities
of Diatos, and such royalties were charged at the lowest Royalty Band
(i.e. at *%, subject to the
adjustments set forth in Section 5.2). It is understood and agreed that any costs incurred by the
Sublicensee for Third Party patent rights, patent prosecution or enforcement, if reported to Diatos
and affecting the amounts received by Diatos from the Sublicensee, sha|l be deemed such costs
incurred by Diatos for purposes of calculating Deemed Low-End Royalties; provided that the portion
of such costs for Third Party patent rights which may be deducted by Diatos will be determined
pursuant to the provisions of Section 5.2.2 above.
5.3.4
Excess Sublicense Royalty Share. In the event the *
(*%) threshold described in Section 5.3(a) above is met with respect to a Region, the excess
Sublicense Royalty Share for such Region shall be deferred and shall not be due, to the extent
condition specified in Section 5.3 (a) continues to be met for such Region. If such condition
continues until the expiration or termination of this Agreement, then such excess Sublicense
Royalty Share for such Region shall not be due nor paid.
5.3.5 Shortfall in Sublicense Royalty Share. In the event.the condition specified in
Section 5.3(b) above is met with respect to a Region, Diatos shall pay the difference between (i)
* percent (*%) of the Deemed Low-End Royalties for such Region and (ii) the sum
* confidential treatment requested
22
of the Sublicense Royalty Share and Diatos Royalty Payments for such Region. Such payment
shall be creditable against future payments made pursuant to Sections 5.1 and 5.2 for such Region
or future payments of the Sublicense Royalty Share under this Section 5.3 for such Region.
5.4 Single Royalty. Only one royalty shall be paid with respect to each unit of
Product that is subject to royalties under this Article 5, without regard to whether more than one
claim in the Licensed Patents is applicable to such Product or the number of transfers. In no event
shall more than one royalty be due under this Article 5 with respect to any Product unit.
5.5 Reports. Commencing upon the First Commercial Sale of a Product in the Diatos
Territory, within sixty (60) days after each March 31, June 30, September 30 and December 31
thereafter, Diatos shall deliver to MacroMed a true and accurate report, giving such particulars of
the business conducted by Diatos, its Affiliates and its Sublicensees during the preceding three (3) calendar months, as are pertinent to account for payments under this Article 5.
Simultaneously with the delivery of each such report, Diatos shall pay to MacroMed the total
amounts, if any, due to MacroMed pursuant to this Article 5 for the period of such report.
5.6 Records. Diatos and its Affiliates shall keep complete
and accurate records in sufficient detail to enable the amounts payable hereunder to be determined.
Upon MacroMed’s written request, but not more frequently than once per calendar year, Diatos and
its Affiliates shall permit representatives or agents of MacroMed at
MacroMed’s expense, to examine such records during regular business hours for the purpose of verifying any report required
under this Agreement made not more than three (3) years prior to the date of MacroMed’s request.
Diatos agrees to either (a) require each of its Sublicensees to maintain similar books and records
and to open such records for inspection by a designee of MacroMed, on behalf of, and as required
by, MacroMed for the purpose of verifying payments hereunder, or (b) obtain such audits rights from
the Sublicensee for itself and exercise such audit rights on behalf of MacroMed upon MacroMed’s
request and disclose the results thereof to MacroMed. Any examinations conducted by MacroMed under this Section 5.6 shall be at the expense of MacroMed, unless a
variation or error producing an underpayment exceeding five percent (5%) of the amount owed during
the audited period is established in the course of any such inspection, whereupon all out-
of-pocket costs of such audit of such period will be at the expense of Diatos.
5.7 U.S. Dollars; Payment Method; Currency Conversion. All dollar amounts set
forth in the Agreement are set forth in United States Dollars. All payments due hereunder shall be
made in United States Dollars by bank wire transfer in immediately available funds to an account
designated by MacroMed in a written notice to Diatos. If any currency conversion shall be required
in connection with the payment of royalties hereunder, such conversion shall be made by using the
averaged buying and selling exchange rate for conversion of the foreign currency into United States
Dollars, quoted for current transactions reported in The Wall Street Journal for the last
business day of the quarter to which such payment pertains.
5.8 Withholding Taxes. Any withholding or other tax that is required by law to be
withheld with respect to payments owed by Diatos, its Affiliates or their Sublicensees pursuant to
this Agreement shall be deducted from such payment prior to remittance. Diatos, its Affiliates
23
and their Sublicensees shall promptly furnish MacroMed evidence of any such taxes withheld. If
any currency conversion shall be required in connection with the calculation of taxes hereunder,
such conversion shall be made by using the averaged buying and selling exchange rate for conversion
of the foreign currency into United States Dollars, quoted for current transactions reported in
The Wall Street Journal for the last business day of the quarter to which such payment
pertains.
ARTICLE 6
MANUFACTURE AND SUPPLY OF THE EXISTING PRODUCT
Subject to the terms and conditions herein, MacroMed shall supply Diatos with up to one
hundred percent (100%) of Diatos’s requirements for the Existing Product upon and subject to the
terms and conditions set forth in Exhibit A hereto, which is incorporated herein by reference. Upon
and subject to the terms and conditions herein and in Exhibit A, Diatos agrees to obtain at least
eighty percent (80%) of its requirements for the Existing Product from MacroMed.
ARTICLE 7
INTELLECTUAL PROPERTY
7.1 Ownership of Inventions. Title to all inventions and other intellectual property
made solely by MacroMed personnel in connection with this Agreement shall be owned by MacroMed.
Title to all inventions and other intellectual property made solely by Diatos personnel in
connection with this Agreement which inventions would not necessarily
infringe (i.e. are not
dominated by) any claim of one or more patent listed in Exhibit B, shall be owned by Diatos. Title
to all inventions and other intellectual property made solely by Diatos personnel in connection
with this Agreement, which inventions would necessarily infringe (i.e. are dominated by) any
claim of one or more patents listed in Exhibit B, shall be jointly owned by MacroMed and Diatos. It
is understood that a particular patent shall not be deemed to “necessarily infringe” nor be
“dominated by” a patent listed in Exhibit B if products or processes under such patent can be
substantially made, used, sold or practiced without infringing a patent listed in Exhibit B. Title
to all inventions and other intellectual property made jointly by personnel of MacroMed and Diatos
in connection with this Agreement shall be jointly owned by MacroMed and Diatos. Prosecution of any
patent applications and patents with respect to jointly owned inventions and intellectual property
described in this Section 7.1 shall be solely conducted as mutually agreed. If an agreement cannot
be reached as to how to conduct prosecution of a jointly owned patent or application under this
Section 7.1 that is dominated by a patent listed on Exhibit B, MacroMed shall have the sole right
to appoint counsel and make other decisions related to such prosecution. Except as expressly
provided in this Agreement, it is understood that neither party shall have any obligation to
account to the other for profits, or to obtain any approval of the other party to exploit, license
or assign any such jointly owned inventions or intellectual property, by reason of joint ownership
thereof.
7.2 Prosecution. MacroMed shall control, and agrees to use Commercially
Reasonable Efforts to undertake the filing, prosecution and maintenance, including conducting
interferences, re-examinations, reissues and oppositions, if any, (collectively, the
“Prosecution”) of the Licensed Patents in the Diatos Territory, using counsel acceptable to
Diatos (which
24
acceptance shall not be unreasonably withheld or delayed). MacroMed shall keep Diatos informed as
to such Prosecution, including using Commercially Reasonable Efforts to provide Diatos drafts of
patent applications, responses and other filings in advance of their
submission to their respective
patent offices), and providing Diatos copies of any correspondence with or notices from the
respective patent offices. MacroMed shall duly consider and follow any reasonable comments
provided by Diatos with respect to the Prosecution of the Licensed Patents in the Diatos Territory.
In the event MacroMed desires to abandon its efforts to Prosecute any
Licensed Patents in the Diatos Territory, it shall notify Diatos at
least thirty (30) days prior to any required action (or such shorter period as is reasonably practicable for non-extendable
deadlines). In such event, Diatos shall have the right, but not the obligation, to Prosecute such
Licensed Patents using counsel reasonable acceptable to MacroMed, in its discretion. However, if
Diatos exercises its right to prosecute, the exercise of this right shall in no way modify the
ownership rights set forth in Section 7.1. The exercise of Diatos right to prosecute will be solely
in protecting their position as an exclusive licensee. Diatos may
credit * percent (*%) of
its actual and reasonable cost of Prosecution of such Licensed Patents in the Territory, against
any payments under Articles 4 and 5 above.
7.3 Enforcement. Subject to the provisions of this Section 7.3, in the event that
Diatos or MacroMed reasonably believes that any Licensed Technology is being infringed or
misappropriated in the Diatos Territory by a Third Party or is subject to a declaratory judgment
action arising from either of such type of infringement in the Diatos Territory, in each case
pertaining to Formulated Taxoids in the Diatos Territory, or any Licensed Marks is being infringed
or diluted in the Diatos Territory (collectively, “Subject Infringements”), such Party
shall promptly notify the other Party. Promptly after such notice the Parties shall meet to discuss
the course of action to be taken with respect to an Enforcement Action (as defined below) with
respect to such infringement or misappropriation, including the control thereof and sharing of
costs and expenses related thereto, for the purposes of entering into a litigation agreement
setting forth the same (“Litigation Agreement”).
7.3.1 Right to Enforce. If the Parties do not enter such Litigation Agreement, Diatos
shall have the initial right (but not the obligation) to enforce the Licensed Technology and
Licensed Marks in the Diatos Territory with respect to the Subject Infringement, or defend any
declaratory judgment action with respect thereto (an “Enforcement Action”); provided that
any settlement of such Enforcement Action shall be subject to the approval of MacroMed if such
settlement admits the invalidity or unenforceability of the Licensed Patents or Licensed Marks. It
is understood and agreed that the foregoing shall not limit Diatos’s freedom to sublicense its
rights hereunder in accordance with Section 2.2. The Parties agree that Diatos shall be entitled
to credit * percent(*%) of its actual and reasonable costs of such Enforcement Action against
any payments under Articles 4 and 5 above. In the event Diatos does not notify MacroMed that it intends to enforce or defend the Licensed Technology or Licensed Marks againts a Subject Infringement within one hundred and twenty (120) days
after notice by either Party of an alleged Subject Infringement in the Diatos Territory, or
notifies MacroMed at any time that it does not desire to enforce or defend the Licensed Technology
or Licensed Marks with respect to such alleged Subject Infringement, then MacroMed shall have the
right (but not the obligation) to enforce or defend against such alleged Subject Infringement,
provided that any settlement of such Subject Infringement shall be subject to the approval of Diatos,
if such settlement would not
* confidential treatment requested
25
terminate all further use by the alleged infringer of the Licensed Technology and Licensed Marks in
the Diatos Territory. If MacroMed does not file suit to enforce against the alleged Subject
Infringement within sixty (60) days after such time, then the Parties shall be deemed to have made
a “Decision Not to Enforce.”
7.3.2 Cooperation. Absent a Litigation Agreement, the Party controlling the
enforcement shall keep the other Party reasonably informed of the progress of any Enforcement
Action, and the other Party shall have the right to participate with counsel of its own choice at
its own expense, and shall reasonably cooperate with the Party initiating the Enforcement Action
(including joining as a party plaintiff to the extent necessary and
requested by the other Party).
7.3.3 Allocation of Recoveries. Unless otherwise agreed, all amounts recovered in the
Enforcement Action, after reimbursing each Party for its costs and expenses incurred in such
Enforcement Action (including reimbursing MacroMed for the *
percent (*%) credit described in
Section 7.3.1), shall be shared between the Parties as follows: (a) if such Enforcement Action is
initiated by Diatos, * percent (*%) to Diatos and * (*%) to MacroMed and (b) if such
Enforcement Action is initiated by MacroMed, * percent (*%) to
MacroMed and * percent
(*%) to Diatos.
7.4 Defense of Third Party Infringement Claims. If the development, manufacture, sale
or use of any Product anywhere in the world under a Licensed Xxxx results in a claim alleging
patent or trademark infringement against either Party (or its respective Affiliates or
Sublicensees), such Party shall promptly notify the other Party hereto in writing. MacroMed (if the
claim is brought against Products made sold or used in the MacroMed Territory) and Diatos (if the
claim is brought against Products made, sold or used in the Diatos Territory) shall have the
exclusive right to defend and control the defense of any such claim using counsel of its own
choice; provided, however, that the other Party shall be kept informed of all material developments
in connection with any such claim. The controlling Party shall not enter into any settlement
relating to the Licensed Patents or Licensed Marks that admits the invalidity or unenforceability
of any Licensed Patents or Licensed Xxxx, nor the infringement of any third party patent rights,
trademark or other intellectual property rights by the Licensed Patents or Licensed Marks without
the other Party’s approval, which shall not be withheld or delayed unreasonably. Any Liabilities
shall be borne by the controlling Party; provided that Diatos may treat its Liabilities as
pre-approved Third Party Payments under Section 5.2.2 above (i.e. meeting condition (i) in Section
5.2.2(b)).
7.5 Patent Marking. Each Party agrees to xxxx and have its Affiliates and their
Sublicensees xxxx all Products in accordance with the applicable statutes or regulations in the
country or countries of manufacture and sale thereof.
7.6 Licensed Marks. MacroMed hereby grants to Diatos an exclusive license, to use the
Licensed Marks solely in connection with marketing, promoting, distributing and selling the Product
in the Diatos Territory in accordance with this Agreement. The ownership and all goodwill from the
use of the Licensed Marks shall vest in and inure to the benefit of MacroMed. Diatos agrees to file
and maintain, at its own cost and discretion, any registration for the Licensed Marks in each
country of the Diatos Territory in which Diatos is commercializing the
* confidential treatment requested
26
Products. MacroMed will cooperate with Diatos with respect to the filing of any trademark
applications within the Diatos Territory. In those countries where a trademark license must be
recorded, MacroMed will, upon the request of Diatos, provide and record a separate trademark
license for the Product, and Diatos shall cooperate in the preparation and execution of such documents.
7.7 Grant-back. It is the intent of the Parties that this Agreement not block MacroMed’s
freedom to operate regarding the practice and commercialization of the Licensed Technology (subject
to the exclusive rights as may be granted to Diatos under this Agreement). Diatos hereby grants to
MacroMed a non-exclusive, irrevocable, fully-paid up license, with the right to grant and authorize
sublicenses, under any Improvements made by Diatos arising from use of the Licensed Technology, to
make, use, sell, offer for sale or import any products of MacroMed and to practice the Improvements
in connection with the foregoing. As used herein, “Improvements” shall mean any modification of
the Product, so long as it remains a Formulated Taxoid, including modifications of the type or
amount of the Taxoid drug, modification of the type or amount of the polymer matrix (i.e. the
ReGel®), or modifications of or additional additives.
ARTICLE 8
CONFIDENTIALITY
8.1 Confidential Information. Except as expressly provided in this Article 8, each Party
shall keep completely confidential and shall not use, publish nor otherwise disclose the
Confidential Information of the other Party. Notwithstanding the foregoing, each Party hereto may
use or disclose Confidential Information of the other party to the extent such use or disclosure is
reasonably necessary (a) in the exercise of the rights granted to it hereunder (including the right
to grant sublicenses), provided that the recipient of such Confidential Information agrees in
writing to be bound by confidentiality terms and conditions at least substantially, equivalent to
those set forth in this Agreement, (b) in prosecuting or defending litigation, complying with
applicable governmental laws, regulations or court order to otherwise submitting information to tax
or other governmental authorities, (c) in submissions to regulatory authorities, or (d) as a part
of patent applications filed on inventions made under this Agreement; provided that if a Party is
required by law to make any such disclosure, other than pursuant to a confidentiality agreement, it
will give reasonable advance notice to the other party of such disclosure and, save to the extent
inappropriate in the case of patent applications or the like, will use its reasonable efforts to
secure confidential treatment of such information.
8.2 Terms of this Agreement. The Parties agree that each Party shall have the right to
disclose the existence of this Agreement but not the specific terms of license of financial
details hereof; provided, however, that each Party may disclose such terms and details (a) as
required by law or regulation of any state or country or any agency thereof, (b) to the SEC, IRS
and other federal, state or other governmental entities, or (c) in confidence to such Party’s
attorneys, advisors, actual or potential investors, merger or
acquisition partners, sublicensees and others who have a need to know.
27
8.3 Press Release. Each Party shall provide prior written notice to the other Party of
any press release pertaining to this Agreement intended for public disclosure, and can disclose it
only when the other Party consents to the conditions and contents of such disclosure, which consent
shall not be unreasonably withheld and shall be deemed given if such other Party does not respond
within seven (7) days. Notwithstanding the foregoing, the Parties have agreed upon the substance of
information that can be used to describe this transaction and the terms and conditions of this
Agreement, as set forth in Exhibit C hereto, and each Party acknowledges and agrees that the other
Party may disclose the information specified in Exhibit C at any time and from time to time without
the consent of the other Party. In addition, subject to Section 8.4 below, each Party shall retain
the right to publicly disclose information as to its own activities hereunder, without having to
obtain the consent of the other Party under this Section 8.3, provided that such disclosure does
not reference the name of the other Party nor this Agreement.
8.4 Publications. The Parties further agree that each Party shall consult with the
other Party prior to the submission of any manuscript for publication or making any public
presentation, including speeches and conference posters, if such publication or presentation
contains any Confidential Information of the other Party. Such consultation shall include providing
a copy of the proposed manuscript or presentation at least sixty (60) days prior to the proposed
date of submission of such manuscript to a publisher or the proposed date of presentation,
incorporating appropriate changes proposed by the other Party as to its Confidential Information
into the manuscript submission or presentation, and deleting all Confidential Information of the
other Party as it may request. In addition, each Party shall consult with the other Party prior to
first publishing the results of any Clinical Trial of the Products conducted by such Party. Such
consultation shall include using Commercially Reasonable Efforts to provide such other Party with a
copy of the proposed disclosure of Clinical Trial results at least fifteen (15) days prior to the
date of first publication. The Parties agree, however, that each Party retains the right to publish
any results of its Clinical Trial of the Products, after such fifteen (15) day period, or at any
time if it reasonably determines that a public disclosure is required by applicable law or
regulations. In-addition, once any results of a Clinical Trial has been published by either Party
in accordance with this Section 8.4, each Party shall retain the right to re-publish such results
without further consultation under this Section 8.4.
8.5 Residual Know-how. Notwithstanding Section 8.1 above, the Parties agree that use of
ideas, concepts and know-how abstracted from the Confidential Information received hereunder, which
are retained in the unaided memories of the receiving Party’s employees who had access to such
Confidential Information, shall not be deemed a breach of this Agreement. This Section 8.5 shall
not be deemed to extend to any patent rights in such ideas, concepts and know-how.
ARTICLE 9
REPRESENTATIONS AND WARRANTIES
9.1 General Warranties. Each Party represents and warrants to the other Party
that it is a corporation duly organized and validly existing under the laws of the state or country
of its incorporation, the execution, delivery and performance of this Agreement by such party has
been
28
duly authorized by all requisite corporate action, and it has the power and authority to execute
and deliver this Agreement and to perform its obligations hereunder.
9.2 Intellectual Property. MacroMed represents, warrants and covenants to Diatos
that:
9.2.1 As of the Effective Date, MacroMed solely owns all right, title and interest in and to
the Licensed Technology and Licensed Marks free of any liens or restrictions (except as set forth
in that certain Amended and Restated Intellectual Property Security Agreement, dated as of April
15, 2004, by and among MacroMed and Xxxxxxx Xxxxxxx, Ph.D., Sun Xxx Xxx, Ph.D., Samyang
Corporation, Samyang Genex Corporation and JG Consulting AG, provided to Diatos), and MacroMed has
the right to grant to Diatos all of the Licenses and other rights with respect to the Licensed
Technology and Licensed Marks granted to Diatos under this Agreement. MacroMed has not and will not
enter into any agreement nor grant any third party any rights with respect to the Licensed
Technology and Licensed Marks that are inconsistent with the rights granted to Diatos under this
Agreement or which would limit the scope of, or otherwise materially adversely affect Diatos’s
rights to practice, the Licensed Technology and Licensed Marks hereunder or which would limit
MacroMed’s ability to perform all of the obligations undertaken by MacroMed hereunder. MacroMed is
not a party to, nor otherwise bound by, any contract that will result in any person or entity
obtaining any interest in, or which would give any third party any right to assert any claim in or
with respect to, Diatos’s rights under this Agreement. MacroMed shall not suffer or permit any
liens or restrictions to be imposed on the Licensed Technology and Licensed Marks without the prior
written consent of Diatos, unless the lien holder agrees to take the Licensed Technology and
Licensed Marks subject to Diatos’s rights therein.
9.2.2 Exhibit B accurately and completely identifies all patents and patent applications that
are related to and which are believed to provide patent coverage of the Licensed Technology as of
the Effective Date.
9.2.3 As of the Effective Date, no item of Licensed Technology is in-licensed by MacroMed from
an Affiliate or Third Party. With respect to each item of Licensed Technology licensed by MacroMed
from an Affiliate or Third Party after the Effective Date: MacroMed shall not take or authorize any
action that would allow its rights under such Licensed Technology to lapse or otherwise terminate;
MacroMed has provided to Diatos a true, correct and complete copy of each license agreement by
MacroMed with such Affiliate or Third Party for such Licensed
Technology (each, an “In-License
Agreement”); such In-License Agreements are in full force and effect; as of the Effective Date,
neither MacroMed nor, to the knowledge of MacroMed, such Affiliate or Third Party are in breach of
any provision of such In-License Agreements, and MacroMed has neither given to, nor received from,
such Affiliate or Third Party notice of any such breach.
9.2.4 To MacroMed’s knowledge as of the Effective Date, except for that disclosed by MacroMed
to Diatos prior to the Effective Date in a writing referencing this Section 9.2.4: (a) MacroMed is
not aware of any patents or patent applications (including international and provisional
applications) not within the Licensed Patents that cover or claim the Product or
29
its manufacture, use or sale as part of any Product in the Field, (b) Diatos’s practice of the
Licensed Technology hereunder will not infringe the patent rights or other intellectual property
rights of a Third Party, (c) none of the Licensed Patents are invalid, unenforceable, have been
infringed or misused, and (d) there are no existing actions, suits or proceedings, and MacroMed
has not received any written claim or demand from a Third Party, that challenges MacroMed’s rights
with respect to the Licensed Technology, and/or Products or MacroMed’s rights to enter into this
Agreement or that asserts that development, manufacture or sale of Products would infringe the
intellectual property rights of a third party.
9.3 Development and Regulatory Activities. MacroMed represents, warrants
and covenants to Diatos that:
9.3.1
MacroMed will and has conducted or will and has caused its contractors or consultants to
conduct its preclinical and clinical studies for Products, in accordance with (i) laws or
regulations, (ii) the known or published standards of the Regulatory Authority, and (iii)
scientific standards applicable to the conduct of such studies and activities; in each case of the
country in which such studies are conducted, and to the extent not inconsistent therewith, such
laws, regulations and standards of the United States and any ICH guidelines. Neither MacroMed, any
officer, employee of MacroMed, nor to MacroMed’s knowledge, any subcontractor of MacroMed, has
made an untrue statement of a material fact to any Regulatory Authority with respect to the
Products, or has knowingly failed to disclose a material fact required to be disclosed to any
Regulatory Authority with respect to Product. During the term of this Agreement, MacroMed shall
not, and shall cause its officers, employees and subcontractors not to, make any untrue statement
of material fact to any Regulatory Authority with respect to the Products, or knowingly fail to
disclose a material fact required to be disclosed to any Regulatory Authority with respect to the
Product.
9.3.2 In the course of its development of the Product, MacroMed will not
conduct and has not conducted any development activities in violation of applicable laws and
regulations, including current Good Laboratory Practices (“GLP”), current Good Clinical Practices
(“GCP”), and current Good Manufacturing Practices (“GMP”). To the knowledge of
MacroMed as of the Execution Date, there are no problems that would reasonably require that
any current development activities be materially delayed, suspended or abandoned before their
completion.
9.3.3 To its knowledge, MacroMed has not employed and will not employ any personnel, and has
not knowingly used and will not knowingly use a contractor or consultant, debarred by the FDA (or
subject to a similar sanction of a Regulatory Authority outside the United States), or who is
subject of an FDA debarment investigation or proceeding (or similar proceeding of a Regulatory
Authority outside the United States).
9.3.4 As of the Execution Date, neither MacroMed nor its Affiliates, nor, to MacroMed’s
knowledge, its subcontractors, has received any notice in writing or otherwise has knowledge of
any facts which have led MacroMed to believe that any of the regulatory filings relating to
Product are not currently in good standing with, the FDA or any other
Regulatory Authority. As of
the Execution Date, there are no inquiries, actions or other proceedings pending
30
before or, to MacroMed’s knowledge, threatened by, any Regulatory Authority or other government
agency with respect to Product or any facility where Products are
manufactured, and neither MacroMed
nor, to the knowledge of MacroMed its subcontractors, has received written notice threatening any
such inquiry, action or other proceeding.
9.3.5 MacroMed has all regulatory approvals that are required to manufacture Product for the
conduct of clinical trials being conducted as of the Execution Date, and to its knowledge, such
manufacture is in compliance with the terms and conditions of such regulatory approvals. All
current regulatory approvals are valid and in full force and effect. As of the Execution Date, to
MacroMed’s knowledge, no suspension, revocation, cancellation or withdrawal of any such regulatory
approval is threatened and no cause exists such suspension, revocation, cancellation or withdrawal.
9.4 Full Disclosure. MacroMed has not omitted to furnish Diatos any information
requested by Diatos in writing prior to the Effective Date, and has not intentionally concealed
from Diatos, any material information in its possession concerning the Licensed Technology, Licensed
Marks, the Existing Product, any Second Generation Products or the transactions contemplated by
this Agreement. Nor has MacroMed failed to disclose to Diatos any information which makes the
information disclosed misleading. Without limiting the foregoing,
MacroMed has disclosed to Diatos any information MacroMed has that indicates a substantial
likelihood that the Product will not prove to be safe in animals or humans. In addition, as of the
Effective Date, there are no Second Generation Products.
9.5 Diatos. Diatos represents, warrants and covenants to MacroMed that:
9.5.1 Diatos will and will cause its contractors or consultants to conduct its preclinical and
clinical studies for Products, in accordance with (i) laws or
regulations, (ii) the known or published
standards of the Regulatory Authority, and (iii) scientific standards applicable to the conduct of
such studies and activities; in each case, of the country in which
such studies are conducted, and to the extent not inconsistent
therewith, any ICH guidelines.
Neither Diatos, any officer, employee of Diatos, nor to Diatos’s knowledge, any subcontractor of
Diatos, has made an untrue statement of a material fact to any Regulatory Authority with
respect
to the Products, or has knowingly failed to disclose a material fact required to be disclosed to
any Regulatory Authority with respect to Product. During the term of this Agreement, Diatos, shall
not, and shall cause its officers, employees and subcontractors not to, make any untrue statement
of material fact to any Regulatory Authority with respect to the
Products, or knowingly fail to
disclose a material fact required to be disclosed to any Regulatory Authority with respect to the
Product.
9.5.2 In the course of its Development of Product, Diatos will not conduct any Development
activities in violation of applicable laws and regulations, including GLP, GCP, and GMP.
9.5.3
To its knowledge, Diatos has not employed and will not employ any personnel, and has
not knowingly used and will not knowingly use a contractor or consultant, debarred by the FDA (or
subject to a similar sanction of a Regulatory Authority), or who is
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subject of an FDA debarment investigation or proceeding (or similar proceeding of a Regulatory
Authority).
9.6 Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS ARTICLE 9,
NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES TO THE OTHER PARTY OF ANY
KIND, EITHER EXPRESS OR IMPLIED, REGARDING PATENT RIGHTS, KNOW-HOW OR DATA INCLUDING, BUT NOT
LIMITED TO, NO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NO INFRINGEMENT,
NOR VALIDITY.
ARTICLE 10
INDEMNIFICATION; INSURANCE
10.1 Indemnification of MacroMed. Subject to Section 10.4 below, Diatos shall
indemnify each of MacroMed and its directors, officers, and employees
(MacroMed’s
“Indemnitees”), and hold each MacroMed Indemnitee
harmless from and against any and all
liabilities, damages, settlements, claims, actions, suits, penalties, fines, costs or
expenses (including, without limitation, reasonable attorneys’ fees and other expenses of
litigation)
(“Liabilities”) incurred by any MacroMed Indemnitee, arising from, or occurring as a
result of any claim, action, suit, or other proceeding brought by
third parties (“Claim”)
against a MacroMed Indemnitee arising from or occurring as a result of (a) gross negligence,
willful misconduct or failure to comply with Laws by Diatos, (b) the breach of its
representations and warranties set forth in Article 9 above, and (e) subject to Section 10.3
below, product liability claims relating to any Products used, sold or otherwise distributed
by Diatos, its Affiliates or their Sublicensees; except in each case to the extent such claim
is caused by factors described in clauses (a) through
(d) of Section 10.2 below.
10.2
Indemnification of Diatos. Subject to Section 10.4 below, MacroMed shall
indemnify each of Diatos and its directors, officers, and employees (Diatos’s
“Indemnitees”), and hold each Diatos Indemnitee harmless from and against any and all
Liabilities arising from or occurring as a result of any Claim against a Diatos Indemnitee
arising from or occurring as a result of (a) gross negligence, willful misconduct or failure
to comply with Laws by MacroMed, (b) the breach of its representations and warranties set
forth in Article 9 above, (c) the supply by MacroMed to Diatos of Products that fail to
comply with Section A.6.1 of Exhibit A, (d) product liability claims relating to any Products
used, sold or otherwise distributed, or the conduct of clinical trials of Product, by
MacroMed, its Affiliates or their Sublicensees, and (e) subject to Section 10.3 below,
product liability claims relating to any Products used, sold or otherwise distributed by
Diatos, its Affiliates or their Sublicensees; except in each case to the extent such claim is
caused by factors described in clauses (a) or (b) of Section 10.1 above.
10.3 Product Liability Claims in the Diatos Territory. The Parties shall share the
Liabilities of each Party’s Indemnitees arising from or occurring as a result of any Claims
against each Party’s Indemnitees under Sections 10.1
(c) or 10.2(e) (“Product Liability Claims”)
so that Diatos shall bear * percent (*%) of such Liabilities and MacroMed shall bear
* percent (*%) of such Liabilities, but excluding any Liabilities to the extent
attributable to clauses (a) and (b) of Section 10.1 or clauses (a) through (d) of Section 10.2.
* confidential treatment requested
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10.4 Procedure. A Party that intends to claim indemnification hereunder (the
“Indemnitee”) shall promptly notify the indemnifying
Party (the “Indemnitor”) in writing of any
Claim for which such Party’s Indemnitees intend to claim indemnification hereunder. As between the
parties, the Indemnitor shall have the right to control the defense and settlement of such claim,
action, suit, or other proceeding (other than Product Liability Claims, for which Diatos shall have
the right to control the defense and settlement thereof); provided that the other Party shall have
the right to participate in such defense or settlement with counsel of its own choosing at its
expense. Notwithstanding the foregoing, the indemnity agreement in this Article 10 shall not apply
to amounts paid in settlement of any Claim if such settlement is effected without the prior consent
of the Indemnitor, to the extent such consent is not withheld unreasonably or delayed. The failure
to deliver written notice to the indemnitor within a reasonable time after the commencement of any
such action, if prejudicial to its ability to defend such action, shall relieve such Indemnitor of
any liability to the Indemnitee under this Article 10 but the omission so to deliver written notice
to the Indemnitor shall not relieve the Indemnitor of any liability that it may have to any
Indemnitee otherwise than under this Article 10. Without limiting the foregoing, the party
controlling the defense and/or settlement of a Claim under this Section 10.4 shall keep the
Indemnitee fully informed of the progress of such defense and/or
settlement.
10.5 Insurance. Each Party further agrees to obtain and maintain, during the term of
this Agreement and for five (5) years thereafter, Comprehensive General Liability Insurance,
including products liability insurance, with reputable and financially secure insurance carrier, to
cover its indemnification obligations under this Article 10 in a form and at levels commensurate
with standard and customary practices in the biopharmaceutical industry. Such liability insurance
shall be maintained on a claims-made basis. Each party shall furnish to the other party on request
certificates issued by the insurance company setting forth the amount of the liability insurance
and a provision that the other party hereto shall receive thirty (30) days’ written notice prior
to termination, reduction or modification of coverage.
ARTICLE 11
TERM AND TERMINATION.
11.1 Term. The term of this Agreement shall commence on the Effective Date and on a
Product-by-Product and country-by-country basis, unless earlier terminated as provided in this
Article 11, shall continue in full force and effect until the expiration of the Royalty Term for
such Product and country.
11.2 Termination for Breach. Either Party may terminate this Agreement upon written
notice in the event that the other Party shall have materially breached this Agreement, and such
breach is not cured within thirty (30) days after receiving written notice of such breach.
Notwithstanding the foregoing, if either Party is unable to remedy such breach for causes beyond
its reasonable control within such thirty (30) day period, then this Agreement may not be
terminated so long as such Party has presented prior to the end of the aforementioned thirty (30)
day period a plan for curing such breach, and thereafter is pursuing in accordance with such plan a
cure of such breach in a timely manner and can demonstrate that it is taking all diligent actions
possible to cure such breach. In addition, if during such thirty (30) day period, the allegedly
33
breaching Party disputes that it has materially breached this Agreement, then the other Party shall
not have the right to terminate this Agreement until it has been finally determined in accordance
with Article 12 below that the allegedly breaching Party has materially breached this Agreement,
and such Party fails to comply herewith within thirty (30) days thereafter.
11.3 Termination by Diatos. Diatos may terminate this Agreement, in whole or in part,
upon ninety (90) days written notice.
11.4 Effect of Termination.
11.4.1 Accrued Obligations. Expiration or any termination of this Agreement shall not
release either Party hereto from any liability which at the time of such expiration or termination
has already accrued to such Party or which is attributable to a period prior to such expiration or
termination, nor preclude either Party from pursuing any rights and remedies it may have hereunder
or at law or in equity which accrued to it prior to such expiration or termination; in each case,
subject to the terms of this Agreement.
11.4.2 Stock on Hand. In the event this Agreement is terminated (but
excluding
termination caused by Diatos’s breach or pursuant to Section 11.3 above), Diatos shall have the
right to sell or otherwise dispose of all Products in the process of manufacture, testing, in use
or in stock, provided that Diatos shall remain obligated to make payment of royalties to MacroMed
for such Products in accordance with Article 5 hereof.
11.4.3 Expiration. In the event of expiration (but not termination) of this
Agreement with respect to a Product in a country, Diatos’s license under the Licensed Know-how
under Article 2 for such Product in such country shall become
fully paid and irrevocable. Upon
expiration of this Agreement, unless otherwise mutually agreed, MacroMed shall continue supplying
Product to Diatos in accordance with Article 6 and Exhibit A, for so long as Diatos and/or its
Sublicensees continue commercializing the Product.
11.4.4 Return of Rights. Except as reasonably necessary for each Party’s surviving
rights or obligations under this Article 11, in the event of any termination (but not expiration)
of this Agreement other than due to MacroMed’s material breach
hereof, (a) all of Diatos’s license
rights with respect to the Licensed Technology shall terminate, and (b) each Party shall promptly
destroy, or if requested by the other Party within forty-five (45) days after such termination
return, all Confidential Information of the other Party then in such
Party’s possession or
control; provided that each Party also may retain one (1) copy of such Confidential Information in
its legal files for purposes of determining the scope of its rights and obligations hereunder;
provided that such copy shall remain subject to the non-use and
non-disclosure provisions hereof.
11.4.5 Coordination with Abandonment under Section 2.5. A notice by Diatos under
Section 2.5.1 with respect to a country(ies) shall be deemed a notice of termination under Section
11.3 with respect to such countries, and such country shall be removed from the definition of
Diatos Territory hereunder upon the effective date of such
termination. In the event there are no
countries remaining in the Diatos Territory after such termination, this Agreement
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shall be deemed terminated in whole. Likewise, in the event of a notice of termination of this
Agreement pursuant to Section 11.3, Diatos shall be deemed to have made an affirmative company
decision that it does not desire to develop or commercialize the Products in the terminated
countries and so notified MacroMed thereof, and Section 2.5 above shall apply with respect to such
countries.
11.4.6 Transfer of Marketing Approvals.
(a) Breach. In the event this Agreement is terminated by MacroMed pursuant to
Section 11.2 due to the material breach of Diatos, Diatos shall promptly transfer to MacroMed all
of its right, title and interest in and to the XXXx, Marketing Approvals and other regulatory
filings or approvals for the Products filed or obtained by Diatos.
(b) Voluntary
Termination. In the event of termination of this Agreement pursuant to Section 11.3 above (including pursuant to Section 2.5), in whole or in part,
on an Abandoned Market-by-Abandoned Market basis, provided that the Parties have agreed on terms
under Section 2.5 or such terms have been established pursuant to Section 12.3 for such Abandoned
Market, Diatos shall promptly transfer to MacroMed all of its right, title and interest in and to
the XXXx, Marketing Approvals and other regulatory filings or approvals for the Products filed or
obtained by Diatos in such Abandoned Market.
11.4.7
Survival. In addition, Articles and Sections 1 (except 1.31.1), 3.5 (to the extent necessary to comply with each Party’s obligations under law), 5.6 (for three (3) years
following expiration or termination), 7.1,7.3, 7.4 (7.3 and 7.4 only with respect to defense of
claims made prior to expiration or termination), 7.5 (with respect to Products sold under Section
11.4.2), 7.7, 8, 9 (only with respect to claims made prior to expiration or termination), 10, 11,
12, 13 of this Agreement and Articles and Sections A.1, A.3.3, A.5.5, A.6.1 of Exhibit A and
Exhibit B shall survive the expiration and any termination of this Agreement for any reason other
than due to material breach of MacroMed. All other Articles and Sections of this Agreement shall
terminate in the event of expiration or termination of this Agreement. Upon the termination of this
Agreement for any reason, any sublicense granted by Diatos hereunder shall survive, provided that
upon request by MacroMed, each Sublicensee promptly agrees in writing to be bound by the applicable
terms of this Agreement.
11.4.8
Breach of MacroMed. In the event this Agreement is terminated by Diatos pursuant to
and in accordance with Section 11.2 hereof due to the material breach of MacroMed hereof, (a)
Diatos shall retain all of its license rights with respect to the Licensed Technology, (b)
Sections 2.3 and 2.5 shall terminate with respect to the obligations of Diatos, (c) Diatos shall no
longer be obligated to, but may at its discretion, continue the Collaboration Committee under
Section 3.1 and the coordination of sublicense activities and other activities under Section 3.2,
(d) Diatos shall no longer be obligated to, but may at its discretion, continue to purchase some or
all of its requirements of Products from MacroMed in accordance with Article 6 and Exhibit B, and
Diatos shall have the right to have an Alternate Source manufacture up to one hundred percent
(100%) of its requirements, (e) Diatos shall not be obligated to provide to MacroMed nor ensure
MacroMed access to, copies of or rights to reference any Data under Section 3.3, and Section 9.5
shall terminate, and (f) the milestones and royalties set forth
35
in Articles 4 and 5 shall be reduced by fifty percent (50%) prior to any other reductions. In
the event of such termination, (i) Articles and Sections 1
(except 1.31.1), 3.5 (to the extent
necessary to comply with each Party’s obligations under law),
7.1, 7.7, 8, 9, 10, 11, 12, 13 of
this Agreement and Articles and Sections A. 1, A.3.3, A.5.5, A.6.1 of Exhibit A and Exhibit B
shall survive such termination, (ii) subject to clauses
(a) through (f) and clause (i) above,
Articles and Xxxxxxxx 0.00.0, 0, 0, 0, 0, 0, 0 (xxxxx than 7.1 and 7.7), 13.3 (only with respect
to MacroMed’s obligations) and Exhibit A shall survive only until the expiration of the
respective Royalty Term, and upon expiration of such Royalty Term,
Section 11.4.3 shall apply
as if this Agreement had expired, and (iii) all other Articles and Sections of this Agreement
(including the Exhibits) shall terminate upon such termination.
ARTICLE 12
DISPUTE RESOLUTION
12.1 Disputes. The Parties recognize that disputes as to certain matters may
from time to time arise during the term of this Agreement which relate to either Party’s
rights and/or obligations hereunder. It is the objective of the Parties to establish
procedures to facilitate the resolution of disputes arising under this Agreement in an
expedient manner by mutual
cooperation and without resort to litigation. To accomplish this objective, prior to filing or
initiating any legal proceeding under Section 12.2, each Party agrees to have such dispute
referred, upon written notice to the other Party, to the Chief Executive Officers of Diatos
and MacroMed, who shall attempt to resolve such dispute by good faith negotiations within
thirty (30) days of such referral. In the event the Parties should resolve such dispute or
claim, a memorandum setting forth their agreement will be prepared and signed by both Parties
if requested by either Party. In the event that such officers are not able to resolve such
dispute within such thirty (30) day period, then either Party may pursue arbitration in
accordance with Section 12.2 below.
12.2
Arbitration. All disputes that may arise under or in relation to this
Agreement (other than those disputes described in Section 2.5,
or Section A.7.3(b) or Section
A.3.2(a) of Exhibit A which shall be subject to Section 12.3 below) shall be settled by
binding arbitration. The place of arbitration shall be, unless otherwise agreed between the
parties hereto, held in San Francisco,
California, and arbitration shall be held under the
Rules of Arbitration of the American Arbitration Association by one or more
arbitrators appointed in accordance with the said Rules. The decision and/or award rendered
by the arbitrator(s) shall be written, final and non-appealable, and judgment on such decision
and/or award may be entered in any court of competent jurisdiction. The costs of any
arbitration, including administrative fees and fees of the arbitrator(s), shall be shared
equally by the Parties, unless otherwise determined by the arbitrator(s). Each Party shall
bear the cost of its own attorneys’ and expert fees.
12.3 Short-Form Arbitration. With respect to (a) the establishment of
commercially reasonable terms for granting the non-Abandoning Party rights to develop and/or
commercialize Products in an Abandoned Market under Section 2.5 above, or (b) the
determination of reasonable measures to remedy a Product supply shortage under Section A.7.3(b), or (c) determining reasonable forecasting and order procedures under Section A.3.2(a)
any matters that cannot be mutually agreed by the Parties as set forth in such Sections, shall
(i) upon the request
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of the
non-Abandoning Party in the case of Section 2.5, or (ii) upon the request of Diatos in
the case of Section A.7.3(b), or (iii) or (ii) upon request of either Party in the case of
Section A.3.2(a), be determined by binding arbitration conducted
pursuant to this 12.3 by one
(1) arbitrator. In such arbitration, the arbitrator shall be an independent expert (including
in the area of the dispute) with at least five (5) years of experience in the pharmaceutical
or biotechnology industry mutually acceptable to the Parties. If the Parties are unable to
agree on an arbitrator, the arbitrator shall be an independent expert as described in the
preceding sentence selected in accordance with the Rules of Arbitration of the American
Arbitration Association. In an arbitration conducted under this Section 12.3, each Party shall
prepare a written report setting forth its position with respect to the substance of the
dispute and THE ARBITRATOR SHALL SELECT ONE OF THE PARTY’S POSITIONS AS HIS DECISION, BASED ON
THE CRITERIA, IF ANY, SET FORTH IN THE RELEVANT SECTIONS 2.5, A.3.2(a) or A.7.3(b), AND SHALL
NOT HAVE AUTHORITY TO RENDER ANY SUBSTANTIVE DECISION OTHER THAN TO SO SELECT THE POSITION OF
EITHER MACROMED OR DIATOS. The arbitrator shall establish reasonable additional procedures to
facilitate such arbitration, including preliminary meetings between
the Parties to discuss
potential terms. Except as provided in this Section 12.3, such arbitration shall be conducted
in all respects under the Rules of Arbitration of the American Arbitration Association. Each
Party shall bear its own costs of arbitration under this Section 12.3 and its own expenses in
connection with such arbitration. The Parties shall use diligent efforts to cause the
completion of any such arbitration within sixty (60) days following the initiation of such
arbitration.
ARTICLE 13
MISCELLANEOUS
13.1
Governing Law. This Agreement shall be interpreted and construed in
accordance with the laws of State of
California, the United States of America without regard
to conflicts of law principles.
13.2 No Waiver. It is agreed that no waiver by any Party of any breach or default
of any of the covenants or agreements herein set forth shall be deemed a waiver as to any
subsequent and/or similar breach on default.
13.3
No Assignment. Neither this Agreement nor any right or obligation hereunder may be
assigned or delegated in whole or part, by either Party without the prior written consent of
the other; provided, however, that each Party may, without the written consent of the other
Party, assign this Agreement to any entity which has acquired all or substantially all of the
business or assets of such Party pertaining to this Agreement, whether by merger,
consolidation, sale or otherwise. The terms and conditions of this Agreement shall be binding
on and inure to the benefit of the permitted successors and assigns of each Party. Any
assignment in contravention of this Section 13.3 shall be null and void.
13.4 Independent Contractors. The relationship of the Parties hereto is that
of independent contractors. The Parties hereto are not deemed to be agents, partners or
joint venturers of the other Party for any purpose as a result of this Agreement or the
transactions contemplated hereby.
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13.5 Compliance with Laws. In exercising their rights under this license, the
Parties shall fully comply with the requirements of any and all applicable laws, regulations,
rules and orders of any governmental body having jurisdiction over the exercise of rights
under this Agreement.
13.6 Notices. All notices, requests and other communications hereunder shall be
in writing and shall be personally delivered or sent by registered or certified airmail,
return receipt requested, postage prepaid; facsimile transmission (receipt verified prior to 5
p.m. local time of the receiving Party, on a business day); or express courier service
(signature required), in each case to the respective address specified below, or such other
address or fax number as may be specified in writing to the other Party:
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13.7
English Language. This Agreement and all notices and other documents issued
pursuant hereto shall be in the English language. Any translation of this Agreement into any
other language shall not be an official version thereof, and in the event of any conflict in
interpretation between the English version of this Agreement and such translation, the English
version shall control.
13.8 Bankruptcy. All rights and licenses granted to each Party under or pursuant
to this Agreement are, and shall be deemed to be, for purposes of Section 365(n) of the
United States Bankruptcy Code, licenses to rights of “intellectual property” as defined thereunder,
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Notwithstanding any provision contained herein to the contrary, if either Party is under any
proceeding under the Bankruptcy Code and the trustee in bankruptcy of such Party, or such.
Party, as a debtor in possession, rightfully elects to reject this Agreement, the other Party
may, pursuant to 11 U.S.C. Section 365(n) (1) and (2) retain any and all of such other Party’s
rights hereunder, to the maximum extent permitted by law, subject to the payments specified
herein.
13.9
Security Interests. If, during the Royalty Term, MacroMed grants, creates or
otherwise permits to exist any security interest, lien, or other
encumbrance (a “Security
Interest”) in or upon the Licensed Technology (other than (a) those Security Interests which
MacroMed has disclosed to Diatos are outstanding as of the Effective Date and (b) inchoate
liens arising in the ordinary course of business which do not represent any material risk of
loss or forfeiture), MacroMed will cause and require the holder of any such Security Interest
(the “Holder”) to agree, in writing, that (i) in the event such Holder exercises any remedy
under its Security Interest which would result in all or a portion of the ownership of the
Licensed Technology being transferred to such Holder or to any third party, such transfer will
not effect Diatos’ rights to . utilize the Licensed Technology hereunder, and Diatos shall
have the uninterrupted right to exercise the license granted to it pursuant to this Agreement
so long as Diatos continues to perform its duties and obligations hereunder (including without
limitation its duties to make royalty, sublicense fee and milestone payments), and(ii) such
Holder shall cooperate fully with Diatos to protect Diatos’s license rights hereunder in the
event of any bankruptcy of MacroMed.
13.10 Export Laws. Notwithstanding anything to the contrary contained herein, all
obligations of MacroMed and Diatos are subject to prior compliance with the export regulations
of the United States and the country of export and such other laws and regulations of the
United States and the country of export as may be applicable, and to obtaining all necessary
approvals required by the applicable agencies of the government of the United States and the
country of export.
13.11 Severability. In the event that any provision of this Agreement
becomes or is declared by a court of competent jurisdiction to be illegal,
unenforceable or void, this Agreement shall continue in full force and effect without
said provision and the Parties shall discuss in good faith appropriate revised
arrangements. In the event a Party (the “Asserting Party”) seeks to avoid a provision
of this Agreement by asserting such provision is invalid, illegal or otherwise
unenforceable, the other Party shall have the right to terminate this Agreement upon
sixty (60) days’ prior written notice to the Asserting Party, unless such assertion
is eliminated and the effect of such assertion cured within such sixty (60) day period.
Such termination shall be deemed termination by such other Party for the material
breach of the Asserting Party.
13.12 Force Majeure. Nonperformance of any Party (except for those
provisions specifying obligations or rights in the event of Force Majeure) shall be
excused to the extent that performance is prevented by Force Majeure.
13.13 Employees. During the first two (2) years after the Effective Date,
neither Party shall solicit for employment, or employ, any person who is then-currently
(or was during the immediate prior three (3) month period) employed by the other Party,
without the prior written consent of such other Party.
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13.14
Complete Agreement; Amendment. It is understood and agreed between MacroMed
and Diatos that this Agreement, together with the letter agreement dated December 15,2004 from
Sun Xxx Xxx, Ph.D., Xxxxxxx Xxxxxxx, Ph.D., Sanyang Corporation, Samyang Genex Corporation and
X.X. Consulting AG and the letter agreement dated December 15,2004 from MacroMed, Inc.,
constitute the entire agreement, both written and oral, between the Parties with respect to the
subject matter hereof, and shall supersede and cancel all prior agreements respecting the
subject matter hereof, either written or oral, expressed or implied, including, without
limitation, that certain document entitled “Non-Binding Term Sheet for a License Agreement
between Diatos SA and MacroMed, Inc,” dated August 4th, 2004, and the letter dated
August 4th, 2004 between the Parties regarding the same (“Exclusivity Letter”). No amendment or
change hereof or addition hereto shall be effective or binding on either of the Parties hereto
unless reduced to writing and executed by the respective duly authorized representatives of
MacroMed and Diatos.
3.15 Counterparts. This Agreement may be executed in counterparts,
each of which shall be deemed to be an original and both together shall be deemed to be one and
the same agreement.
13.16 Headings. The captions to the several Articles and Sections hereof are not a
part of this Agreement, but are included merely for convenience of reference only and shall not
affect its meaning or interpretation.
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MACROMED, INC |
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DIATOS SA |
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By:
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/s/ Xxxxxx Xxxxxxx
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By:
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/s/ Xxxx Xxxxxxxxxxxxx, Ph.D. |
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Name:
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Name:
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Xxxx Xxxxxxxxxxxxx, Ph.D. |
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Title:
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Chief Executive Officer
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President and Chief Executive Officer |
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Date:
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Dec - 15 - 2004
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