<PAGE>
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
th
