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Exhibit 10.13
BioPro Pharmaceutical, Inc.
BioPro Pharmaceutical, Inc. hereby agrees that the License and
Distribution
Agreement between BioPro Pharmaceutical, Inc and Valera
Pharmaceutical, Inc.
dated as of January 28, 2005, shall only be effective when
Valera has received
the $300,000 milestone payment as provided in Article 1,
paragraph 7.1. Said
payment shall be received no later than the close of business in
New York on
February 1, 2005.
/s/ Huang TTS
----------------------------------------
Chairman and CEO
Dated January 28, 2005
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EXECUTION COPY
LICENSE AND DISTRIBUTION AGREEMENT
THIS LICENSE AND DISTRIBUTION AGREEMENT is entered into as of
the 28 day of
January 2005, by and between VALERA PHARMACEUTICALS, INC., a
corporation
incorporated under the laws of the state of Delaware with its
principal place of
business located at 8 Clarke Drive, Cranbury, New Jersey
08512-3617 ("VALERA"),
and BIOPRO PHARMACEUTICAL INC., a corporation incorporated under
the laws of the
Commonwealth of Virginia with its principal place of business
located at 21 Sky
Road, Mill Valley, California 94941 ("BIOPRO").
BACKGROUND
WHEREAS BioPro is engaged in the marketing, sale and
distribution of
various pharmaceutical products used in the treatment of cancer
in Asia;
WHEREAS Valera has developed and is the sole owner or exclusive
licensee of
certain Patent Rights (as defined below) and other Intellectual
Property (as
defined below) relating to a certain Product (as defined
below);
WHEREAS Valera wishes to appoint BioPro as the exclusive
licensee and
distributor of the Product in the Territory (as defined below)
for use in the
same indications for which Valera owns or controls an approval
from the United
States Food and Drug Administration or similar agency of a
foreign government,
the whole in accordance with the terms and conditions set forth
in this
Agreement;
WHEREAS BioPro desires Valera to supply BioPro with the Product
on an
exclusive basis in the Territory prior to Regulatory Approval
(as defined
below), and following receipt of Regulatory Approval, for
distribution and sale
in the Territory for use in the indications described above, the
whole in
accordance with the terms and conditions set forth in this
Agreement.
TERMS
NOW, THEREFORE, in consideration of the respective covenants,
agreements,
representations, warranties and indemnities contained in this
Agreement and for
other good and valuable consideration, BioPro and Valera hereby
covenant and
agree as follows:
ARTICLE 1 - DEFINITIONS AND INTERPRETATION
1.1 DEFINITIONS. For the purposes of this Agreement or any
notice,
consent, authorization or other communication required or
permitted to be given
under this Agreement, the following expressions shall have the
following
meanings, respectively, unless the context otherwise
requires:
(a) "AFFILIATE" shall mean any Person which directly or
indirectly
controls, is controlled by, or is under common control with
another Person,
provided that "control" shall mean ownership as to more than
fifty percent (50%)
of another Person or the power to direct decisions of another
Person, including,
without limitation, the power to direct
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management and policies of another Person, whether by reason of
ownership, by
contract or otherwise
(b) "AGREEMENT" shall mean this License and Distribution
Agreement, as
amended from time to time.
(c) "BIOPRO RELEASEES" shall be as defined in Section 10.2.
(d) "BUSINESS DAY" shall mean any day other than a Saturday,
Sunday or
other day on which the branches of the Federal Reserve Bank with
jurisdiction
over the then-current principal place of business by Valera is
not open for
business.
(e) "CALENDAR QUARTER" shall mean each three-month period
commencing
January 1, April 1, July 1 and October 1 of each year during the
term of this
Agreement.
(f) "CALENDAR YEAR" shall mean the period from January 1st to
December
31st in a given year.
(g) "CMC INFORMATION" shall mean the chemistry, manufacturing,
and
control information filed by Valera from time to time with the
FDA with respect
to the Product.
(h) "COMMERCIAL SALE" means any sale or distribution of the
Product by
BioPro or its Affiliates to a Third Party, other than
distribution in connection
with clinical trials of the Product conducted by BioPro.
(i) "COMPETING PRODUCT" shall be as defined in Section 3.5.
(j) "CONFIDENTIAL INFORMATION" shall be as defined in Section
12.1.
(k) "DEVELOPMENT PLAN" shall have the meaning set forth in
Section
2.3.
(l) "DOLLAR" and the symbol "$" shall mean lawful money of the
United
States.
(m) "EFFECTIVE DATE" shall mean the date first written
above.
(n) "EVENT OF FORCE MAJEURE" shall have the meaning set forth
in
Section 14.1.
(o) "FDA" means the United States Food and Drug Administration
and any
successor thereto.
(p) "FORECAST" shall be as defined in Section 6.3.
(q) "GMPS" shall mean then-current Good Manufacturing Practices
as
required under the rules and regulations of the FDA.
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(r) "GOVERNMENTAL BODY" shall mean (i) any national,
federal,
provincial, state, municipal or other government or body with
jurisdiction over
all or any part of the Territory, (ii) any subdivision,
ministry, department,
secretariat, bureau, agency, commission, board, instrumentality
or authority of
any of the foregoing governments or bodies, (iii) any
quasigovernmental or
private body exercising any regulatory, expropriation or taxing
authority under
or for the account of any of the foregoing governments or
bodies, or (iv) any
domestic or foreign judicial, quasi-judicial, arbitration or
administrative
court, grand jury, tribunal, commission, board or panel of any
of the foregoing
governments or bodies.
(s) "IMPLANT" means Valera's proprietary histrelin implant
marketed in the United States under the trademark
Vantas(TM).
(t) "IMPLANTATION DEVICE" means the TROCAR device that is used
to
insert the Implant into a human body.
(u) "IMPROVEMENTS" shall mean any re-formulations,
line-extensions or other advances in, modifications or
improvements to the
Product for use in an Indication.
(v) "INDEMNIFIED PARTY" shall be as defined in Section 10.3.
(w) "INDEMNIFYING PARTY" shall be as defined in Section
10.3.
(x) "INDICATION" shall mean an indication for which the
Implant
is approved for marketing and sale, the approval of which issued
by the FDA or
similar agency of a foreign government is owned or controlled by
Valera. As of
the Effective Date, the only indication for which the Implant
has been approved
for marketing and sale in the United States is the treatment of
hormone
responsive prostate cancer.
(y) "LABELS" shall mean (i) all labels and other written,
printed, or graphic matter upon the Product or any packaging,
container or
wrapper utilized with the Product, in each case when sold for
use in the United
States and (ii) any written material accompanying the Product,
including without
limitation, any package inserts, in each case when sold for use
in the United
States.
(z) "LAWS" shall mean:
(i) all constitutions, treaties, laws, statutes, codes,
ordinances, orders, decrees, rules, regulations, and municipal
by-laws, whether
domestic, foreign or international, including any such
constitutions, etc. of
any Governmental Body;
(ii) all judgments, orders, writs, injunctions, decisions,
rulings, decrees and awards of any Governmental Body; and
(iii) all policies, practices and guidelines of any
Governmental Body, in each case binding on or affecting the
Party or Person
referred to in the context in which such word is used; and "Law"
shall mean any
one of them.
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(aa) "Losses" shall mean liabilities, damages, costs or
expenses, including reasonable fees and expenses of attorneys
and other
professionals, as well as court costs.
(bb) "MARKETING APPROVAL APPLICATION" shall mean an
application or registration filed with a Regulatory Authority
seeking the
approval to market, distribute and sell the Product in the
jurisdiction
controlled by such Regulatory Authority.
(cc) "MARKETING PLAN" shall have the meaning set forth in
Section 3.9.
(dd) "MATERIAL BREACH" shall mean any breach of the terms of
this Agreement of such a nature as to have a material effect on
the
non-breaching Party.
(ee) "MINIMUM NET SALES" means an amount of Net Sales from
the Territory for a given Calendar Year that must be achieved by
BioPro,
expressed as an aggregate amount of Dollars. Minimum Net Sales
for 2006 is
$225,000, $1,477,500 in 2007, $4,260,000 in 2008, $6,655,500 in
2009 and
$9,112,500 in 2010. For Calendar Years beginning in 2011,
Minimum Net Sales
shall equal the greater of (a) ninety five percent (95%) of the
actual Net Sales
for the immediately prior Calendar Year or (b) $9,112,500.
(ff) "NET SALES" shall mean the gross amount actually
collected by BioPro and its Affiliates or sublicensees with
respect to the
Commercial Sale of the Product in the Territory, less the
aggregate of: (i)
customers' returns for Product that fails to comply with the
warranties set
forth in Section 8.1; (ii) rebates pursuant to any governmental
programs or
Laws; (iii) trade and/or promotional allowances actually allowed
or taken; (iv)
amounts collected for freight, transport and delivery, including
insurance, for
shipping from BioPro's or its designee's facilities to a
customer (but only to
the extent of the actual cost of such freight, transport and
delivery charges);
and (v) any sales tax, value added tax, goods and services tax
or any other tax
that may be imposed on the sale of the Product, which taxes are
included in
gross amount collected by BioPro and its Affiliates.
(gg) "OTHER COUNTRIES" means Bangladesh, Myanmar and Sri
Lanka.
(hh) "PARTIES" shall mean BioPro and Valera collectively.
(ii) "PARTY" shall mean either Valera or BioPro, as the
context requires.
(jj) "PERSON" shall mean an individual, corporation, limited
liability company, co-operative, partnership, organization or
any similar
entity.
(kk) "PLAN" shall be as defined in Section 2.3.
(ll) "POPULATION COUNCIL ROYALTY" shall be as defined in
Section 7.3.
(mm) "PRODUCT" shall mean all dosage strengths and forms of
the Implant in its final finished form along with the
Implantation Device,
together with all Labels and any and all Improvements. As of the
Effective Date,
the dosage of the Implant for use in the treatment of hormone
responsive
prostate cancer is 50mg of histrelin.
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(nn) "PROMOTIONAL MATERIALS" shall mean all promotional
materials, detail aids and pieces, journal ads, films, artwork
and graphics, and
any other marketing literature and information relating to the
marketing,
distribution or sale of the Product for use in the Primary
Indication outside of
the Territory.
(oo) "PURCHASE ORDER" shall be as defined in Section 6.1.
(pp) "Purpose" shall be as defined in Section 12.2.
(qq) "REGULATORY APPROVAL" shall mean, with respect to a
particular country in the Territory and an Indication, the
approval by all
Regulatory Authorities of the Marketing Approval Application and
the receipt by
BioPro of the other approvals, licenses, registrations and
authorizations of all
Regulatory Authorities necessary for the marketing, distribution
and sale of the
Product in such Territory for use in such Indication.
(rr) "REGULATORY AUTHORITY" shall mean each and every
Governmental Body from which approvals are required for the
marketing,
distribution or sale of the Product in a country in the
Territory.
(ss) "SPECIFICATIONS" shall mean the specifications for the
Product approved by the FDA for use in the relevant
Indication.
(tt) "TERM" shall mean the time period from the Effective
Date until the expiration or earlier termination of this
Agreement.
(uu) "TERRITORY" shall mean: (a) Brunei, Cambodia, China
(including Hong Kong), Laos, India, Indonesia, Malaysia, the
Philippines,
Singapore, South Korea, Taiwan, Thailand and Vietnam; and (b)
such of the Other
Countries that are added to the Territory pursuant to Section
3.11.
(vv) "THIRD PARTY" means any Person other than a Party or an
Affiliate of a Party.
(ww) "TRADEMARKS" shall mean, subject to Article 4, all
trademarks and trade names and trade dresses (whether registered
or not) owned
by Valera or its Affiliates and approved by Valera for use in
the marketing,
distribution and sale of the Product in a country in the
Territory for use in a
particular Indication.
(xx) "TRANSFER FEE" shall be as defined in Section 7.2.1.
(yy) "VALERA RELEASEES" shall be as defined in Section 10.1.
(zz) "WARRANTY PERIOD" shall be as defined in Section 8.4.
1.2 INTERPRETATION. The division of this Agreement into Articles
and the
insertion of headings are for convenience of reference only and
shall not affect
the interpretation of this Agreement. In this Agreement, words
importing the
singular number only shall include the plural and vice versa and
words importing
gender shall include all genders.
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ARTICLE 2 - PRODUCT DEVELOPMENT AND REGULATORY APPROVAL
2.1 REGULATORY APPROVAL. In accordance with the terms and
subject to the
conditions herein specified, BioPro shall apply for each
Regulatory Approval for
the Product in each country of the Territory for use in each
Indication. BioPro
hereby agrees to use commercially reasonable efforts in applying
for each such
Regulatory Approval, which shall be held in the name of BioPro
or an Affiliate
of BioPro. Valera's only obligations in regards to the
Regulatory Approval
effort shall be for Valera to: (a) provide to BioPro the
information and data
required by Section 2.2; (b) make personnel available for
telephone calls with
BioPro and Regulatory Authorities as Valera determines in its
sole discretion;
and (c) supplying a reasonable quantity of the Product for use
in clinical
trials as set forth in this Agreement. If BioPro desires or
requires more
assistance or resources from Valera in relation to the
Regulatory Approval
effort, it may request such resources and Valera will determine
in its sole
discretion whether it will provide such resources and the cost
to BioPro of
providing such resources.
2.2 FURNISHING DATA. Valera shall supply BioPro with all data
and
information in its possession or control as is necessary for the
purpose of
obtaining Regulatory Approval for the Product in each country of
the Territory
for use in each Indication, including, but not limited, to
clinical and
non-clinical study data, results and reports (including
toxicology reports)
and/or CMC information including, where required, a reasonable
number of samples
for actual testing by Regulatory Authorities. Without limiting
the generality of
the foregoing and to the extent legally permitted, Valera shall
provide BioPro
with access to and the right to cross-reference existing
regulatory filings for
the Product submitted by it and/or its Affiliates or designated
nominees in any
jurisdiction outside of the Territory. At the request of BioPro
and to the
extent legally permitted, Valera shall notify the Regulatory
Authority in each
country of the Territory of BioPro's right to reference any such
regulatory
filings in any application filed by BioPro in accordance with
the terms of this
Agreement.
2.3 DEVELOPMENT AND REGULATORY APPROVAL PLAN FOR THE PRIMARY
INDICATION.
Within sixty (60) Business Days after the Effective Date, BioPro
shall prepare a
plan outlining all pre-clinical, clinical and regulatory
activities that are
necessary for receiving Regulatory Approval for the use of the
Product in the
prostate cancer Indication in each country of the Territory and
estimated time
schedules for the completion of all such activities (the
"PLAN"). Generally, the
Plan shall allocate responsibility for pre-clinical and clinical
activities and
regulatory activities in each country of the Territory
(including development
and approval of Territory-specific labeling for the Product) to
BioPro and shall
not allocate any responsibility to Valera other than provision
of the data and
information required by Section 2.2 and the supply of the
Product. The Plan
shall be subject to the review and approval of Valera, which
will not be
unreasonably withheld or delayed. As new Indications become
available-during the
Term, BioPro shall develop a Plan for receiving Regulatory
Approval from each
Regulatory Authority in the Territory for the Product for use in
such Indication
no later than sixty (60) Business Days after Valera notifies
BioPro of the
approval of the Product for marketing, sale and use in the
United States in such
Indicaion. Each such Plan shall be subject to the review and
approval of Valera,
which approval shall not be unreasonably withheld or
delayed.
2.4 CLINICAL TRIAL DATA. All clinical and/or marketing data
developed by
the Parties during the Term shall remain the property of the
Party developing
such data, and any data to
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which both Parties have contributed to or on which both Parties
have worked
shall remain the property of both jointly and severally
worldwide; provided that
Valera shall have a perpetual, irrevocable, royalty-free, fully
paid-up license
to copy, disclose and use in any manner any and all clinical
and/or marketing
data developed in the course of such trials and not otherwise
owned by Valera.
The Parties agree that they will promptly share with one another
all information
and reports regarding the results of any trials.
2.5 PHASE IV CLINICAL STUDIES. BioPro shall have the
non-exclusive right
(but not the obligation) to conduct Phase IV clinical trials
relating to the use
of the Product in the Primary Indication in each country of the
Territory, but
only with the prior written consent of Valera, which consent
shall not be
unreasonably withheld or delayed,
2.6 MAINTAINING REGULATORY APPROVAL. BioPro undertakes to use
commercially
reasonable efforts to maintain each Regulatory Approval for the
Product for use
in each Indication in each country of the Territory. All
reasonable direct
out-of-pocket expenses incurred by BioPro and/or Valera in
maintaining the
registrations shall be borne or reimbursed by BioPro.
2.7 COPIES OF CORRESPONDENCE; NOTICE. Copies of all
pertinent
correspondence related to the promotion, sale and use of the
Product for use in
each Indication to and from all Regulatory Authorities and all
submissions, or
pertinent excerpts thereof, to the Regulatory Authorities
connected to the
Product for use in each Indication will be furnished by the
corresponding Party
to the other Party in a timely manner.
2.8 REIMBURSEMENT. BioPro shall, at its own expense, make all
submissions
and filings to each Government Body and all other Third Parties
necessary or
desirable to establish unit prices for the Product for use in
each Indication in
each country of the Territory.
ARTICLE 3 - EXCLUSIVE DISTRIBUTION; PROMOTION AND SALES
3.1 APPOINTMENT OF DISTRIBUTOR. Subject to the terms and
conditions of
this Agreement, Valera hereby appoints BioPro during the Term,
and BioPro hereby
accepts its appointment, as the exclusive distributor of the
Product in each
country of the Territory for use in each Indication.
3.2 EXCLUSIVE SUPPLY. During the Term, Valera shall not supply
the Product
for distribution or sale in any country of the Territory for use
in any
Indication to any Person other than BioPro, it being understood
between the
Parties that Valera shall not directly or indirectly sell, or
otherwise make
available, the Product in any country of the Territory for use
in any Indication
other than through BioPro in accordance with the terms of this
Agreement. Valera
shall refer to BioPro all orders or inquiries received by it
from sources in any
country of the Territory in connection with the Product for use
in any
Indication.
3.3 RESERVATION OF RIGHTS. In no event shall this Agreement be
construed
to prevent Valera from directly or indirectly: (a)
manufacturing, using,
marketing, promoting, distributing and selling the Product
outside the Territory
for use in any indication; or (b) entering into and performing
agreements with
third parties regarding the foregoing.
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3.4 SALES WITHIN EACH COUNTRY OF THE TERRITORY. BioPro shall
not, and
BioPro shall cause its Affiliates not to, directly or
indirectly, without the
prior written consent of Valera, sell the Product outside the
Territory, or
knowingly sell the Product to any Person within any country of
the Territory for
resale or use outside of the Territory.
3.5 COMPETING PRODUCT. BioPro shall not, and shall cause its
Affiliates
not to, directly or indirectly, jointly or in conjunction with
any other Person,
whether as principal, agent, shareholder, employee, independent
contractor, or
in any other manner whatsoever, develop, market, distribute or
sell in any
country of the Territory any products that contain the same
active ingredient as
that which is contained in the Product, or any products similar
to or
competitive with the Product, that are used in any Indication
(each, a
"COMPETING PRODUCT"), during the Term and for a period of three
(3) years
following the expiry or termination of this Agreement. The
Parties acknowledge
that a product that is indicated for use in the treatment of
hormone resistant
prostate cancer is not a Competing Product.
3.6 SUBCONTRACTING. The Parties acknowledge and agree that,
subject to
prior written notification to and acceptance from the
appropriate Regulatory
Authority, each Party shall have the right, at its sole expense,
to subcontract
with Third Parties or Affiliates for the performance of its
obligations
hereunder, upon prior written approval of the other Party where
the
subcontractor is a Third Party (which approval shall not be
unreasonably
withheld or delayed) provided, however, that each Party shall
remain responsible
to the other Party for (a) assuring that each subcontractor
complies with all
applicable provisions of this Agreement and all applicable Laws
and (b)
fulfilling all of its obligations hereunder; and provided
further that BioPro
shall have no right to approve or disapprove of any contract
manufacturer or
contract package engaged by Valera. In the event that any
subcontracting by
Valera would have a material impact on BioPro's responsibilities
to the
appropriate Regulatory Authority and to the extent reasonably
possible, Valera
will inform BioPro at least six (6) months prior to arranging
for any such
subcontracting.
3.7 PRODUCT PROMOTION. BioPro shall employ its best efforts to
market,
distribute and sell the Product in each country of the Territory
for use in each
Indication and shall bear all costs and expenses incurred in
connection with
such efforts. The Parties agree to meet at either Party's
request in order to
discuss any marketing, distribution and sales issues.
3.8 PROMOTIONAL MATERIALS. Valera shall provide BioPro, at no
additional
cost, with samples of all Promotional Materials owned by Valera
to market the
Product for use in each Indication outside of the Territory;
provided that
BioPro reimburses Valera for all additional advertising agency
costs, if any,
associated with supplying any artwork and graphics. Valera
hereby grants to
BioPro the right to use such Promotional Materials and, subject
to Article 4, to
modify any artwork and graphics for its purpose.
3.9 MARKETING PLAN. Commencing in the year in which BioPro
submits a
Marketing Approval Application to a Regulatory Authority within
a particular
country for a particular Indication, BioPro shall prepare,
develop and submit to
Valera an annual marketing plan in relation to use of the
Product for such
Indication in such country (each, a "MARKETING PLAN") for
Valera's review and
approval by no later than the 15th of February of each year
during the Term for
the then-current Calendar Year. The Marketing Plan will outline
plans for the
promotion and
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sale of the Product in such country for such Indication, and
will also include
recommendations for Product pricing, reimbursement status and
activities,
positioning, and a description of the promotional programs, if
any, planned for
the relevant Calendar Year. Valera, acting in good faith, shall
have thirty (30)
Business Days from the date of receipt to review each Marketing
Plan and suggest
commercially reasonable changes. BioPro shall make commercially
reasonable
efforts to include any changes in the Marketing Plan suggested
by Valera and
shall advise, in writing, within fifteen (15) Business Days
which changes it has
incorporated together with an explanation as to any changes that
were suggested
by Valera but not incorporated. In the event that Valera does
not respond to
BioPro within thirty (30) Business Days of the receipt of a
Marketing Plan, such
Marketing Plan will be deemed to be acceptable to Valera.
Notwithstanding
anything else contained herein to the contrary, at the request
of either Party,
the Parties shall meet semi-annually to review proposed
marketing plans for the
Product.
3.10 SUBLICENSING. BioPro may sublicense the distribution rights
granted
pursuant to Section 3.1 on the express conditions that: (a)
BioPro enters into a
written agreement with the sublicensee that binds the
sublicensee to compliance
with all the terms and conditions of this Agreement applicable
to BioPro; and
(b) no later than ten (10) days after sublicensing, BioPro also
provides Valera
with a full copy of the agreement referred to in clause (a).
Sublicensing shall
not relieve BioPro of any of its obligations under this
Agreement. BioPro shall
be liable for any sublicensee's failure to perform any term or
condition of this
Agreement as if BioPro itself breached the applicable term or
condition of this
Agreement.
3.11 OTHER COUNTRIES. Valera acknowledges that BioPro requested
that the
Other Countries be part of the Territory. However, because of
licensing
arrangements with third persons, Valera is unable to include any
of the Other
Countries as part of the Territory under the terms and.
conditions of this
Agreement as of the Effective Date, Valera will use commercially
reasonable
efforts to amend its licensing arrangements such that it can
include one or more
of the Other Countries within the Territory under the same terms
and conditions
of this Agreement and, to the extent Valera is successful in so
doing, Valera
will notify BioPro of the same and the Territory will be deemed
to include the
Other Countries with respect to which Valera was successful. If
Valera is not
able to amend its licensing arrangements so as to include one or
more of the
Other Countries within the Territory under the same terms and
conditions of this
Agreement, Valera will notify BioPro, and Valera and BioPro will
promptly meet
to discuss potential changes to this Agreement (particularly the
arrangements
set forth in Article 7) with respect to such Other
Countries.
ARTICLE 4 - BRANDING; TRADEMARKS
4.1 LICENSE GRANT; BRANDING. Subject to the terms and conditions
of this
Agreement, Valera hereby grants BioPro an exclusive license to
use the
Trademarks in connection with the marketing, distribution, and
sale of the
Product in each country of the Territory for use in each
Indication. The
Product shall bear a product name owned by Valera, which product
name shall, if
possible, be the same as the product name used in the United
States (but may
vary by Indication), as well as certain other trademarks of
Valera and
trademarks of BioPro (other than a product name of BioPro) and
use the trade
dress identified by Valera from time to time and approved by
BioPro; provided,
however, that all packaging shall ensure that the
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distinctiveness of the trademarks of each party is maintained
and include a tag
line that indicates the ownership of each Party's
trademarks.
4.2 OBLIGATIONS AND CONDITIONS. No Promotional Materials bearing
the
Trademarks may be used without Valera's prior written approval,
which consent
shall not be unreasonably withheld or delayed but shall be
conditioned upon
maintaining the distinctiveness of the trademarks of each Party
and including a
tag line that indicates Valera's ownership of the Trademarks. It
is agreed by
the Parties that in the event that Valera does not respond to
BioPro's
submission of the new Promotional Materials or labeling within
ten (10) Business
Days, consent shall be deemed to be granted. Notwithstanding
anything to the
contrary, BioPro's use of the Trademarks shall be conditioned
upon BioPro's
compliance with Valera's then-current quality standards, which
standards Valera
may update from time to time by written notice to BioPro, it
being understood
that BioPro may use up any packaging, labeling or Promotional
Materials that it
has at the time of the update, either in stock or in
process.
4.3 BIOPRO'S TRADEMARKS. BioPro hereby, for itself and on behalf
of its
Affiliates, grants Valera the right to affix BioPro's
trademarks, trade names,
logos and trade dress on labeling of the Product approved by
BioPro.
4.4 CHANGES. Each Party may discontinue, alter or add new
trademarks to be
used in connection with the labeling and marketing of the
Product in each
country of the Territory for use in the Primary Indication;
provided that: (a)
the foregoing shall not be deemed to allow BioPro to use or
place a product name
owned by BioPro or licensed by BioPro from a Third Party on the
Product; and (b)
each Party may use up any packaging, labeling or Promotional
Materials that it
has at the time of the discontinuance, alteration or addition,
either in stock
or in process.
4.5 NO OTHER RIGHTS; ALLOCATION OF GOODWILL. Except for the
licenses
granted by each of Valera and BioPro to the other under this
Agreement, neither
Party shall acquire any right, title, or interest in any
trademark, trade name,
logo or trade dress of the other Party by reason of this
Agreement. Each of
BioPro and Valera shall be responsible for registering, as
necessary, its own
trademarks, trade names, logos and trade dress. BioPro
acknowledges that all use
of any of Valera's trade names, trademarks, trade dress and
logos and all of the
goodwill associated therewith shall inure solely to Valera's
benefit. Likewise,
Valera acknowledges that all use of any of BioPro's trademarks,
trade dress,
trade names, and logos, and all of the goodwill associated
therewith shall inure
solely to BioPro's benefit.
4.6 CONFUSINGLY SIMILAR MARKS. BioPro shall not authorize or
undertake any
use of any mark that is confusingly similar to the Trademarks in
each country of
the Territory.
4.7 EFFECT OF TERMINATION. Upon termination of this Agreement
both parties
shall immediately cease all use of the other party's trademarks,
trade names,
logos and trade dress, except as set forth in Section 13.7
ARTICLE 5 - MANUFACTURE AND SUPPLY
5.1 MANUFACTURING. Valera shall, directly or through an
Affiliate or Third
Party designee (including contract manufacturers and contract
packagers), have
the sole right and
VALERA CONFIDENTIAL
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responsibility for manufacturing, assembling, packaging and
labeling the Product
in such quantities as, in Valera's opinion, are required to fill
all orders and
for maintaining such inventory levels of raw materials and
packaging components
as are required to meet BioPro's then-current forecast for the
Product (as
delivered pursuant to Section 6.3). BioPro shall be responsible
for supplying
camera-ready proofs of all Labels and other artwork to be
included with the
Product.
5.2 LABELING. The Product supplied under this Agreement will be
the
Product packaged for use in the United States including all
Labels for use in
the United States. BioPro shall be responsible for making
changes to the
labeling and packaging necessary to comply with all Regulatory
Approvals
(including, without limitation, oversticking labels on the
Labels or repackaging
the Product using labels, package inserts and documentation
other than or in
addition to the Labels) and bear all costs related to the same.
From time to
time, and in any event promptly following Valera's request,
BioPro shall notify
Valera of all labeling and repackaging activities undertaken by
or on behalf of
BioPro to comply with all Regulatory Approvals in the
Territory.
5.3 FAILURE TO SUPPLY. In the event that Valera or its
Affiliates are
unable to supply the Product in specified quality or in
quantities sufficient to
meet forecast demand for a successive period of ninety (90)
Business Days, then
BioPro may elect to have the Product made by a Third Party
manufacturer
designated by Valera and approved by BioPro, which approval
shall not be
unreasonably withheld, conditioned, denied or delayed. If BioPro
makes such an
election, Valera shall grant the Third Party manufacturer a
non-exclusive,
royalty-free license under the Intellectual Property for the
sole purpose of
manufacturing and selling to BioPro the quantity of the Product
that Valera is
unable to supply.
5.4 SUPPLY RESUMPTION. If BioPro exercises its rights to have a
Third
Party manufacturer manufacture the Product pursuant to Section
5.3 and
thereafter during the Term Valera desires to resume supplying
BioPro with the
Product (whether by Valera or otherwise), then Valera shall
notify BioPro of
such desire. BioPro shall then resume purchasing Product
exclusively from Valera
for the remainder of the Term as soon as Valera demonstrates to
BioPro's
reasonable satisfaction that Valera (whether by Valera or
otherwise) is capable
of reestablishing a satisfactory supply of the Product; provided
that BioPro
shall not be required to cancel any purchase orders for the
Product issued to
the Third Party manufacturer that were issued in accordance with
the Forecasts
provided to Valera pursuant to Section 6.3 prior to the date
that Valera gave
BioPro notice of its desire to resume supply and cover periods
no more than six
(6) months after the date that Valera gave BioPro notice of its
desire to resume
supply. If and when Valera resumes supplying the Product
pursuant to this
Section 5.4, the Third Party manufacturer shall be required to
return to Valera
all information provided to the Third Party manufacturer
pursuant to Section 5.3
and any license granted to the Third Party manufacturer shall
terminate.
Notwithstanding anything in this Agreement to the contrary, upon
the termination
of this Agreement for any reason, the Third Party manufacturer
shall be required
to return to Valera all information provided to Third Party
manufacturer
pursuant to Section 5.3 and any license granted to the Third
Party manufacturer
shall terminate.
5.5 DOCUMENTATION AND CERTIFICATE OF ANALYSIS. Valera shall
provide BioPro
with required supporting documentation for the ma
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