Exhibit 10.13
BioPro Pharmaceutical, Inc.
BioPro Pharmaceutical, Inc. xxxxxx 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 Xxxxxx 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/ Xxxxx XXX
----------------------------------------
Chairman and CEO
Dated January 28, 2005
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 0 Xxxxxx Xxxxx, Xxxxxxxx, Xxx Xxxxxx 00000-0000 ("VALERA"),
and BIOPRO PHARMACEUTICAL INC., a corporation incorporated under the laws of the
Commonwealth of Virginia with its principal place of business located at 00 Xxx
Xxxx, Xxxx Xxxxxx, Xxxxxxxxxx 00000 ("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 Xxxxxx 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 Xxxxxx 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 Xxxxxx 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 Xxxxxx 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 Xxxxxx 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 Xxxxxx'x 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 Xxxxxx 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. Xxxxxx'x 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 Xxxxxx 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 Xxxxxx 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, Xxxxxx 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 Xxxxxx 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
Xxxxxx 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 Xxxxxx.
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, Xxxxxx 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 Xxxxxx 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 Xxxxxx 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 Xxxxxx. In the event that any subcontracting by
Xxxxxx would have a material impact on BioPro's responsibilities to the
appropriate Regulatory Authority and to the extent reasonably possible, Xxxxxx
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 Xxxxxx'x 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. Xxxxxx, 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 Xxxxxx 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 Xxxxxx but not incorporated. In the event that Xxxxxx 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. Xxxxxx acknowledges that BioPro requested that the
Other Countries be part of the Territory. However, because of licensing
arrangements with third persons, Xxxxxx 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, Xxxxxx 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 Xxxxxx was successful. If Xxxxxx 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 Xxxxxx, 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 Xxxxxx 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 Xxxxxx'x 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 Xxxxxx'x ownership of the Trademarks. It is agreed by
the Parties that in the event that Xxxxxx 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 Xxxxxx'x 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 Xxxxxx 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 Xxxxxx shall be responsible for registering, as necessary, its own
trademarks, trade names, logos and trade dress. BioPro acknowledges that all use
of any of Xxxxxx'x trade names, trademarks, trade dress and logos and all of the
goodwill associated therewith shall inure solely to Xxxxxx'x benefit. Likewise,
Xxxxxx 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
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responsibility for manufacturing, assembling, packaging and labeling the Product
in such quantities as, in Xxxxxx'x 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 Xxxxxx'x 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 Xxxxxx and approved by BioPro, which approval shall not be
unreasonably withheld, conditioned, denied or delayed. If BioPro makes such an
election, Xxxxxx 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 Xxxxxx 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 Xxxxxx 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 Xxxxxx 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 Xxxxxx gave
BioPro notice of its desire to resume supply and cover periods no more than six
(6) months after the date that Xxxxxx gave BioPro notice of its desire to resume
supply. If and when Xxxxxx 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 manufacture and packaging of the
Product in a form
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suitable for BioPro's submission to the Regulatory Authorities. A certificate
of analysis and full set of batch manufacturing records shall be delivered with
each batch of the Product delivered to BioPro.
5.6 IMPROVEMENTS; NEW FORMULATION. Valera shall furnish BioPro with all
information pertinent to the marketing, sale and promotion of the Product
relating to any Improvements, which Valera may make from time to time to the
Product, or to any new formulation of the Product. To the extent reasonably
possible, Valera shall provide BioPro with six (6) months prior written notice
of any anticipated Improvements or new formulations.
5.7 SHELF LIFE. Each unit of the Product will have a remaining shelf life
of at least eighteen (18) months at the time of shipment to BioPro; provided
that it is understood that the Implant is intended to be inserted into a human
body for twelve (12) of such eighteen (18) months.
5.8 COMPLIANCE WITH LAWS. BioPro shall comply with all applicable Laws in
relation to the handling, storage, distribution and sale of the Product in each
country of the Territory and Xxxxxx'x then-current instructions relating to
handling, storage and shipment of the Products in each country of the Territory.
ARTICLE 6 - FORECASTS/ORDERING/TITLE AND RISK/RETURNS
6.1 ORDERING. BioPro may order units of the Product by issuing binding
purchase orders (each, a "PURCHASE ORDER") to Valera pursuant to the terms of
this Agreement. Each Purchase Order shall state the quantity of the Product to
be purchased, delivery date(s) and routing instructions, destination or
destinations. No different or additional terms or conditions on any purchase
order, acknowledgment or other transmittal, whether a standard business form or
otherwise, utilized by BioPro or Valera in connection with the sale of the
Product shall be construed or deemed to be an amendment of or supplement to this
Agreement or otherwise binding on either BioPro or Valera.
6.2 ACCEPTANCE OR REJECTION OF PURCHASE ORDERS. Valera shall indicate its
acceptance or rejection of each Purchase Order within ten (10) Business Days
after receipt; provided that Valera may reject a Purchase Order, in whole or in
part, only if: (a) the Purchase Order fails to comply with the terms and
conditions of this Agreement; (b) the delivery date is less than one hundred
fifty (150) days from the date of Xxxxxx'x receipt of such Purchase Order; or
(c) if the volume under the Purchase Order and all other accepted Purchase
Orders covering the applicable monthly period exceeds the volume set forth in
BioPro's then-current forecast (delivered pursuant to Section 6.3) by more than
ten percent (10%). If requested by BioPro following BioPro's receipt of Xxxxxx'x
rejection notice under clause (c) above, Xxxxxx will use commercially reasonable
efforts to deliver the excess volume of the Product specified in the rejected
Purchase Order, but Xxxxxx'x failure to so deliver the excess volume shall not
be a breach of this Agreement. Xxxxxx'x sole obligation in filling accepted
Purchase Orders shall be to use commercially reasonable efforts to fill BioPro's
orders for the Product. In no event shall Xxxxxx be liable to any third party
for Xxxxxx'x failure to deliver the Product to BioPro by any delivery due date
set forth in any Purchase Order.
VALERA CONFIDENTIAL
13
6.3 FORECASTS. BioPro shall provide Valera a non-binding twelve (12) month
rolling forecast (the "FORECAST") of BioPro's estimated requirements of the
Product. The Forecast shall be reviewed and updated by BioPro no later than
thirty (30) days before the start of each calendar quarter during the Term. Each
such Forecast shall reflect a good faith attempt by BioPro to estimate quantity
requirements of the Product, based on anticipated demand therefor.
6.4 SHIPMENT. Xxxxxx will use diligent efforts to ship the Product ordered
by BioPro within one hundred and fifty (150) days after its acceptance of
BioPro's purchase order. The Products will be shipped EXW (Incoterms 2000)
Valera's or its Third Party designee's facilities. Valera shall ensure that the
Product is suitably packed for shipment in standard containers.
6.5 DELIVERY AND ACCEPTANCE.
6.5.1. ACCEPTANCE. BioPro shall not be obliged to accept delivery of
any lot or batch of the Product unless the lot or batch complies with the
warranties set forth in Section 8.1. Each lot or batch of the Product shall be
considered accepted by BioPro unless BioPro has rejected the same by delivering
written notice thereof to Valera as soon as is reasonably possible but in any
event no later than thirty (30) days after delivery of such lot or batch of the
Product. To the extent possible, BioPro shall verify counts and identify any
damages to Valera within five (5) Business Days of receipt. BioPro's sole and
exclusive remedy for any shortage in a shipment shall be for Valera to send
additional units of the Product as soon as reasonably possible.
6.5.2. REJECTION NOTICE. A written notice of rejection shall be
conclusive and binding upon Valera unless Xxxxxx notifies BioPro within
forty-five (45) Business Days after receipt by Xxxxxx of the written notice of
rejection that it denies responsibility for the problem in question. In the
event of such a notice by Xxxxxx, the claim shall be settled as set forth in
Sections 8.3 and 8.4.
6.6 VALERA'S PRODUCT LIABILITY INSURANCE. Xxxxxx agrees to maintain
product liability insurance consistent with its normal business practices to
cover risks related to the Product and, upon BioPro's request from time to time,
to provide BioPro with certificates of insurance attesting to the existence of
such insurance. Xxxxxx shall name BioPro as an additional insured under the
foregoing insurance policy.
6.7 BIOPRO'S PRODUCT LIABILITY INSURANCE. BioPro agrees to maintain
product liability insurance to cover risks related to its activities (or
activities undertaken on its behalf) with respect to the labeling, packaging,
storage, marketing, sales, and distribution of the Product in each country of
the Territory with a limit of liability of at least $5,000,000 in the aggregate.
Upon request by Xxxxxx, BioPro will provide Valera with a certificate of
insurance attesting to the existence of such insurance. BioPro shall name Xxxxxx
as an additional insured under the foregoing insurance policy. BioPro will cause
its sublicensees to comply with this Section 6.7 as if the sublicensee were
BioPro.
6.8 INSURANCE NOTIFICATION. Each Party agrees, upon request, to advise the
other Party of the status of the insurance required by this Article 6 and of any
change in such status. It
VALERA CONFIDENTIAL
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is understood and agreed that furnishing of such insurance coverage will not
relieve either Party of their obligations under this Agreement.
ARTICLE 7 - MILESTONE PAYMENTS; PRICING AND PAYMENT TERMS
7.1 MILESTONE PAYMENTS. BioPro shall pay Valera the following amounts in
immediately available funds within thirty (30) days after the first occurrence
of each of the following events, except that the first milestone payment must be
paid upon the execution of this Agreement by both parties:
MILESTONE AMOUNT
---------------------------------------------- --------
Upon execution of this Agreement $300,000
The filing of a Marketing Approval Application
for an Indication in any of South Korea,
Taiwan or China $100,000
The receipt of Regulatory Approval for an
Indication in any country of the Territory $200,000
7.2 PRICING. BioPro shall pay Valera for Xxxxxx'x supply and BioPro's
distribution of the Product under this Agreement in an amount equal to:
7.2.1. a transfer fee for each unit of the Product supplied by Valera
to BioPro or its Affiliates or sublicensees under this Agreement (the "TRANSFER
FEE"). Until twelve (12) months following the first Commercial Sale of the
Product in any country in the Territory, the Transfer Fee shall be USD$250 per
unit of the Product. After twelve (12) months following the first Commercial
Sale of the Product in any country in the Territory, Valera may adjust the
Transfer Fee once per Calendar Year by giving BioPro written notice of the
adjusted Transfer Fee, except that no increase shall exceed the aggregate
percentage increase in the Producer Price Index for Drugs and Pharmaceuticals
(Series WPU063), as reported by the Bureau of Labor Statistics of the United
States Department of Labor, during the period since the last price adjustment
(and for which data, preliminary or final, is available); plus
7.2.2. twenty-five percent (25%) of Net Sales.
7.2.3. Notwithstanding Section 7.2.1, the transfer fee for supply of
Product intended for use in clinical trials in China, South Korea, Taiwan or
India shall be Valera's cost of goods sold (as determined using Valera's normal
method of accounting), and the transfer fee for the supply of Product for use in
testing by Regulatory Authorities pursuant to Section 2.2 shall be zero.
7.3 PAYMENTS TO THE POPULATION COUNCIL. In addition to the amounts payable
pursuant to Sections 7.1 and 7.2, BioPro shall pay directly to The Population
Council, Inc., an amount equal to two percent (2%) of Net Sales (the "POPULATION
COUNCIL ROYALTY").
7.4 QUARTERLY REPORT. Within forty-five (45) days following the end of
each Calendar Quarter, BioPro shall render a written report to Valera setting
forth the following information and calculations for such Calendar Quarter,
segregated by BioPro, each Affiliate and each sublicensee: (a) each component
making up Net Sales for the Calendar Quarter and the
VALERA CONFIDENTIAL
15
calculation of Net Sales; (b) the actual number of Product sold (net of returns)
for the Calendar Quarter; and (c) the calculation of royalties payable to Valera
pursuant to Section 7.2.2 and the royalties payable to the Population Council
set forth in Section 7.3. No later than one hundred twenty (120) days after the
conclusion of each Calendar Year; BioPro shall supply to Valera and The
Population Council a report certified by its chief financial officer showing the
quantity, sales prices, product development costs and the amount of the
Population Council Royalty for such Calendar Year in respect of sales of the
Product by BioPro and its Affiliates and sublicensees.
7.5 FAILURE TO ACHIEVE MINIMUM NET SALES.
7.5.1. If BioPro fails to achieve the Minimum Net Sales in a given
Calendar Year, then BioPro shall:
(a) pay to Valera an amount equal to (i) the difference of
Minimum Net Sales for such Calendar Year minus the actual amount of Net Sales
for such Calendar Year multiplied by (ii) twenty five percent (25%); and
(b) pay to the Population Council, Inc. an amount equal to (i)
the difference of Minimum Net Sales for such Calendar Year minus the actual
amount of Net Sales for such Calendar Year multiplied by (ii) two percent (2%).
7.5.2. Notwithstanding Section 7.5.1, BioPro may notify Valera no
later than forty five (45) days after the completion of the Calendar Year that
it will not pay the amounts required by Section 7.5.1 for the just completed
Calendar Year, in which case: (a) BioPro shall be relieved from its obligation
to pay the amount required by Section 7.5.1 for such Calendar Year; but (b)
Valera shall have the option of (i) converting all of the exclusive rights
granted to BioPro in this Agreement into non-exclusive rights effective as of
the date of BioPro's notice to Valera or such later date as Valera may specify
or (b) terminating this Agreement effective as of the date of BioPro's notice to
Valera or such later date as Valera may specify. If BioPro does not send a
notice permitted by this Section 7.5.2 or does so after the period specified in
this Section 7.5.2, BioPro shall not be relieved of its obligations under
Section 7.5.1.
7.6 PAYMENT. BioPro shall pay Xxxxxx'x invoices for Transfer Fees no later
than forty five (45) days after receipt of each shipment of the Product. BioPro
shall pay the amounts due under Sections 7.2.2 and 7.3 no later than forty-five
(45) days following the completion of each Calendar Quarter and the amounts due
under Section 7.5 no later than forty-five (45) days following the completion of
each Calendar Year. BioPro shall pay all amounts due under this Agreement by
check or wire transfer in Dollars to such bank as Valera and The Population
Council, as the case may be, may direct from time to time. BioPro shall send
Valera evidence of the payment of the amounts payable under Section 7.3 no later
than two (2) Business Day after each such payment. Overdue amounts shall bear
interest at a rate equal to the lower of 1.5% per month or the highest rate
permitted by law from the due date until the date paid. All expenses incurred by
BioPro in making such transfers shall be borne by BioPro. To the extent that Net
Sales includes amount collected by BioPro in currency other than Dollars, such
amounts shall be converted to Dollars using the exchange ratio set forth in the
Wall Street Journal on the last day of the relevant Calendar Quarter. Unless
otherwise agreed by Xxxxxx, BioPro shall obtain a confirmed, irrevocable letter
of credit in favor of Xxxxxx in an amount set by Xxxxxx from time to
VALERA CONFIDENTIAL
16
time, against which Xxxxxx may draw if BioPro fails to pay any amount due under
this Agreement. Such letter of credit shall be in form and substance acceptable
to Valera, shall be issued by a bank acceptable to Valera and shall be payable
in Dollars upon presentation of the documentation recited in the letter of
credit.
7 7 RECORDS. BioPro shall record all sales of Product and shall keep full
and true books of account and other records in accordance with the requirements
of generally accepted accounting principles in the United States, consistently
applied, and other good business practice so that details of sales for the
Product, the calculation of Net Sales and BioPro's payment obligations in
respect thereof may be properly ascertained.
7.8 AUDIT. BioPro agrees, at the request of Xxxxxx and at Xxxxxx'x
expense, to permit an independent accounting firm selected by Xxxxxx or The
Population Council to have access, upon reasonable notice, during ordinary
business hours and no more frequently than once in any Calendar Year, to such
books of account and other records as may be necessary to determine the
correctness of any report by BioPro made in accordance with this Article 7. If
such independent certified public accountant shall determine that an amount is
due and owing by one Party to the other, then the owing Party shall promptly pay
the amount due and owing; provided that if the Party owing the amount is BioPro
and such amount is five percent (5%) or more of the total amount that should
have been paid under this Agreement in respect of the audited period, then
BioPro shall also reimburse Valera for the cost of the audit.
ARTICLE 8 - PRODUCT WARRANTIES
8.1 LIMITED WARRANTY FOR THE PRODUCTS. Valera warrants to BioPro that: (a)
each Product will be manufactured and packaged in accordance with GMPs; (b) each
of the Products, when delivered to the carrier, will conform to the
Specifications; and (c) each of the Products shall be free from defects in
materials, workmanship and packaging at the time of delivery to the carrier.
8.2 DISCLAIMER. THE EXPRESS LIMITED WARRANTY FOR THE PRODUCTS SET FORTH IN
SECTION 8.1 AND THE ADDITIONAL REPRESENTATIONS AND WARRANTIES SET FORTH IN
SECTION 9.1 ARE IN LIEU OF ALL OTHER REPRESENTATIONS AND WARRANTIES, WHETHER
EXPRESS OR IMPLIED. XXXXXX XXXXXX DISCLAIMS ANY AND ALL OTHER REPRESENTATIONS
AND WARRANTIES OF ANY KIND, EXPRESSED OR IMPLIED, WHETHER ARISING FROM A COURSE
OF DEALING OR USAGE OF TRADE, INCLUDING, WITHOUT LIMITATION, THE IMPLIED
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND
NON-INFRINGEMENT.
8.3 WARRANTY CLAIM PROCEDURE. Unless otherwise agreed by Xxxxxx, to make a
warranty claim, BioPro shall at BioPro's expense return the allegedly defective
the Products(s), or a representative sample thereof, together with a description
of the alleged defect. Valera shall, promptly after receipt and as required,
inspect the alleged defective Products(s). If such inspection results reasonably
confirm the Products do not conform with the warranties set forth in Section 8.1
and the non-conformance did not arise from misuse, mishandling, storage in a
manner inconsistent with Xxxxxx'x directions, neglect, modification or unusual
physical or
VALERA CONFIDENTIAL
17
chemical stress after delivery to the carrier, BioPro shall return any remaining
the Products(s) in BioPro's inventory with the same defect at Valera's expense,
and the sole and exclusive warranty remedies set forth in Section 8.4 shall
apply. If such test results fail to confirm the Products' non-conformance to the
warranties set forth in Section 8.1, or if the parties fail to otherwise resolve
the dispute, the parties shall submit the Products, or a representative sample
thereof, along with a reference batch which has previously been shown by BioPro
to conform to the warranties set forth in Section 8.1, to a mutually acceptable
independent laboratory along with mutually agreeable interrogatories to be
answered by such laboratory. The determination of the Products' conformance or
non-conformance to the warranties set forth in Section 8.1 shall be binding upon
the Parties. If the laboratory determines that the Products conform to the
warranties set forth in Section 8.1, BioPro shall pay all independent laboratory
and shipping costs incurred by Xxxxxx, and if such laboratory confirms that the
Products do not conform with the warranties set forth in Section 8.1, Xxxxxx
shall pay all independent laboratory costs and the sole and exclusive warranty
remedies set forth in Section 8.4 shall apply.
8.4 BIOPRO'S WARRANTY REMEDIES. BioPro must make a claim for breach of any
other warranties set forth in Section 8.1 no later than one (1) year after
shipment of the unit of Product to BioPro claimed to be defective (the "WARRANTY
PERIOD"). Valera shall replace, at Xxxxxx'x expense, or at BioPro's option,
refund or credit the Transfer Fee for, any of the Products that do not comply
with Xxxxxx'x limited warranty set forth in Section 8.1 and reported, to Valera
during the Warranty Period (and confirmed to be defective pursuant to Section
8.3). Xxxxxx'x obligation to replace defective Product or to refund or credit
the purchase price paid for such the Products pursuant to this Section 8.4 shall
not apply to any Product that has been subjected to misuse, mishandling, storage
in a manner inconsistent with Xxxxxx'x directions, neglect, modification or
unusual physical or chemical stress after delivery to the carrier. Other than
with respect to third party claims for which Xxxxxx must indemnify BioPro
pursuant to Section 10.2, this Section 8.4 states BioPro's sole and exclusive
remedy for failure of any the Products to comply with the limited warranties set
forth in Section 8.1.
ARTICLE 9 - REPRESENTATIONS AND ADDITIONAL WARRANTIES
9.1 REPRESENTATIONS AND WARRANTIES OF VALERA. Valera hereby makes the
following representations and warranties to BioPro and does so in full
understanding and acknowledgement that BioPro is relying on such representations
and warranties in entering into this Agreement, notwithstanding any due
diligence investigation done or information obtained by BioPro prior to the
Effective Date:
(a) STATUS. Valera is a corporation organized and existing under
the Laws of the State of Delaware, U.S.A. No action has been taken by the
directors, officers or shareholders of Valera to dissolve the corporation.
Xxxxxx has the corporate power and authority to enter into this Agreement and to
perform all its obligations under this Agreement.
(b) ALL NECESSARY PROCEEDINGS. The execution and delivery by
Xxxxxx of this Agreement, the performance by Xxxxxx of all the terms and
conditions thereof to be performed by it and the consummation of the
transactions contemplated hereby have been duly authorized by all necessary
corporate actions and proceedings, and no other act or approval of any Person is
required to authorize such execution, delivery, and performance.
VALERA CONFIDENTIAL
18
(c) NO VIOLATION. The execution, delivery and performance of
this Agreement by it: (i) does not violate or conflict with any provision of Law
or any provision of its articles of incorporation or by-laws; and (ii) does not
and will not, with or without the passage of time or the giving of notice,
result in the breach of, or constitute a default, cause the acceleration of
performance, or require any consent under, or result in the creation of any
lien, charge or encumbrance upon any of its property or assets pursuant to any
material instrument or agreement to which it is a party or by which it or its
properties may be bound or affected. Without limiting the generality of the
foregoing, Xxxxxx has not made any written or oral agreement or undertaking with
any other Person regarding the rights to promote, distribute or sell the Product
or to seek Regulatory Approval for the Product in any country of the Territory,
(d) THIRD PARTY CLAIMS. To Xxxxxx'x knowledge, as of the
Effective Date, there is no outstanding or threatened claim or allegation that
the marketing, distribution or sale of the Product or use of the Trademarks in
accordance with this Agreement infringe upon any rights of a Third Party in each
country of the Territory.
(e) RIGHT TO GRANT LICENSES. To Xxxxxx'x knowledge, Valera is
the sole and exclusive owner or licensee of all Intellectual Property needed to
market, distribute and sell the Product in each country of the Territory in
accordance with this Agreement. Xxxxxx has the full right, power and authority
to grant the rights granted to BioPro under this Agreement.
(f) REGULATORY APPROVAL. As of the Effective Date of this
Agreement, Xxxxxx is not aware of any facts that would reasonably lead it to
conclude that the Product will be unable to receive Regulatory Approval in any
country of the Territory.
9.2 REPRESENTATIONS AND WARRANTIES OF BIOPRO. BioPro hereby makes the
following representations and warranties to Valera and does so in full
understanding and acknowledgement that Xxxxxx is relying on its said
representations and warranties in entering into this Agreement, notwithstanding
any due diligence investigation done or information obtained by Xxxxxx prior to
the Effective Date:
(a) STATUS. BioPro is a limited company organized and existing
under the Laws of the Commonwealth of Virginia. No action has been taken by the
directors, officers or shareholders of BioPro to dissolve the corporation.
BioPro has the corporate power and authority to enter into the present
Agreement.
(b) ALL NECESSARY PROCEEDINGS. The execution and delivery by
BioPro of this Agreement, the performance by BioPro of all the terms and
conditions thereof to be performed by it and the consummation of the
transactions contemplated hereby have been duly authorized by all necessary
corporate actions and proceedings, and no other act or approval of any Person is
required to authorize such execution, delivery, and performance.
(c) NO VIOLATION. BioPro warrants that the execution, delivery
and performance of this Agreement by it: (i) does not violate or conflict with
any provision of Law or any provision of its articles of incorporation or
by-laws; and (ii) does not and will not, with or without the passage of time or
the giving of notice, result in the breach of, or constitute a default, cause
the acceleration of performance, or require any consent under, or result in the
creation of
VALERA CONFIDENTIAL
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any lien, charge or encumbrance upon any of its property or assets pursuant to
any material instrument or agreement to which it is a party or by which it or
its properties may be bound or affected.
ARTICLE 10 - INDEMNIFICATION
10.1 BY BIOPROS. BioPro shall indemnify Valera, its affiliates and their
respective directors, officers, shareholders, employees or agents (collectively,
the "VALERA RELEASEES"), and hold it harmless from and against any and all
Losses (including personal injury, death or property damage) arising from any
and all Third Party claims against the Valera Releasees: (a) relating to the
marketing, distribution or sale of the Product in each country of the Territory;
(b) of any nature whatsoever relating to any processing or repackaging of the
Product after delivery to the carrier in accordance with Section 6.4; or (c)
caused by a breach or misstatement by BioPro of its representations and
warranties under this Agreement; except, in each case, to the extent such Third
Party claims result from the fault, negligence or willful misconduct of the
Valera Releasees or its or their material failure to comply with the terms of
this Agreement. BioPro shall not be liable under this Section 10.1 in the event
that the Valera Releasees admit or settle any such claim without the prior
written consent of BioPro, which consent shall not be unreasonably withheld,
conditioned, delayed or denied.
10.2 BY XXXXXX. Valera shall indemnify BioPro, its Affiliates and their
respective directors, officers, shareholders, employees or agents (collectively,
the "BIOPRO RELEASEES"), and hold it harmless from and against any and all
Losses (including personal injury, death or property damage) arising from any
and all Third Party claims against the BioPro Releasees: (a) that the
manufacture, use or sale of the Product in accordance with this Agreement
infringes the intellectual property rights of a third party in each country of
the Territory; (b) of any nature whatsoever relating to the manufacture of the
Product; or (c) caused by a breach or misstatement by Xxxxxx of its
representations and warranties in Section 9.1; except, in each case, to the
extent such Third Party claims result from the fault or negligence of the BioPro
Releasees, or its or their material failure to comply with the terms of this
Agreement. Valera shall not be liable under this Section 10.2 in the event that
the BioPro Releasees admit or settle any such claim without the prior written
consent of Valera, which consent shall not be unreasonably withheld, delayed or
denied.
10.3 INDEMNIFICATION PROCEDURE. A Party seeking indemnification (the
"INDEMNIFIED PARTY") shall notify, in writing, the other Party (the
"INDEMNIFYING PARTY") within fifteen (15) Business Days after the assertion of
any claim or discovery of any fact upon which the Indemnified Party intends to
base a claim for indemnification. An Indemnified Party's failure to so notify
the Indemnifying Party shall not, however, relieve such Indemnifying Party from
any liability under this Agreement to the Indemnified Party with respect to such
claim except to the extent that such Indemnifying Party suffers or otherwise
incurs additional liquidated or other readily quantifiable damages as a result
of being denied, during the period of delay in notice, the opportunity to remedy
or otherwise mitigate the event or activity giving rise to the claim for
indemnification or the damages therefrom or is materially prejudiced in the
defense of the claims giving rise to the right to indemnification.
VALERA CONFIDENTIAL
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10.4 DEFENDING CLAIMS. The Indemnifying Party, while reserving the right
to contest its obligations to indemnify the Indemnified Party under this
Agreement, shall be responsible for the defense of any claim, demand, lawsuit or
other proceeding in connection with which the Indemnified Party claims
indemnification hereunder. The Indemnified Party shall have the right, at its
expense, to participate jointly with the Indemnifying Party in the defense of
any such claim, demand, lawsuit or other proceeding, but with respect to any
issue involved in such claim, demand, lawsuit or other proceeding with respect
to which the Indemnifying Party has acknowledged its obligation hereunder, the
Indemnifying Party shall have the right to select counsel, settle, try or
otherwise dispose of or handle such claim, demand, lawsuit or other proceeding
on such terms as the Indemnifying Party shall deem appropriate, subject to any
reasonable written objection of the Indemnified Party.
ARTICLE 11 - INTELLECTUAL PROPERTY MATTERS
11.1 INTELLECTUAL PROPERTY INFRINGEMENT.
11.1.1. Without limiting the obligations and requirements of Sections
10.2 through 10.4, each Party will notify the other Party if it receives any
notice that the activities engaged in under this Agreement infringe or may
infringe any Third Party's intellectual property rights. If BioPro establishes
to Xxxxxx'x reasonable satisfaction that license(s) under such Third Party's
intellectual property rights is necessary or advisable for purposes of enabling
BioPro to market, use or sell the Products in each country of the Territory,
Valera and BioPro shall cooperate to obtain such license(s) for the benefit of
Valera and BioPro, in accordance with the following provisions:
11.1.2. Xxxxxx shall be primarily responsible for obtaining any such
third party license. The matter shall be deemed resolved if Valera is granted a
license, whether royalty-free or royalty-bearing, under the relevant
intellectual property rights that would make the continued marketing, use or
sale of the Products in each country of the Territory for use in the Primary
Indication non-infringing with respect to such Third Party's intellectual
property rights.
11.1.3. However, in the event that Xxxxxx is unable to resolve the
matter in accordance with Section 11.1.2 in spite of good faith efforts and/or
upon terms that are commercially reasonable to Valera, then BioPro shall be
entitled to negotiate a license in favor of BioPro under such Third Party's
intellectual property rights, provided that BioPro shall not enter into such
license without the prior written consent of Valera, such consent not to be
unreasonably withheld or delayed. In the event that such license requires BioPro
to pay the Third Party royalties, BioPro may deduct such royalties from the
amounts due to Valera under Section 7.2.2, such deduction not to exceed an
amount equal to two percent (2%) of Net Sales during the applicable Calendar
Quarter.
11.1.4. Should any claim or suit that the Product infringes any Third
Party's intellectual property rights in each country of the Territory be upheld
by a final, non-appealable order of a court such that BioPro is prevented from
marketing, using and selling the Product in each country of the Territory and no
license that permits BioPro to market, use and sell the Product in each country
of the Territory in accordance with this Agreement is obtained by either Valera
or BioPro pursuant to Sections 11.1.2 and 11.1.3, Xxxxxx shall repurchase from
BioPro, at
VALERA CONFIDENTIAL
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cost, all of the Product currently in BioPro's stock that have not been sold
and, if commercially reasonable to Valera, change the Product so as to make it
non-infringing. If changing the Product so as to make it non-infringing is not
commercially reasonable to Xxxxxx, Xxxxxx may terminate this Agreement effective
upon giving BioPro notice of termination without any liability to BioPro.
11.2 THIRD PARTY INFRINGEMENT.
11.2.1. In the event that either Party determines that a Third Party
(other than a permitted licensee, transferee or distributor of either Party) is
making, using, or selling a product or process that may infringe any of the
Intellectual Property relating to the Product, including later issued and
acquired patents covering the Product, or any uses or processes pertaining
thereto, it will promptly notify the other Party in writing.
11.2.2. Xxxxxx shall be responsible for, in its sole discretion,
obtaining a discontinuance of any infringement or bringing suit against a Third
Party infringer relating to the Product. Notwithstanding anything contained
herein to the contrary, Xxxxxx shall have the right, but not the obligation, to
bring such a suit. Valera shall bear all the expenses of any such suit brought
by it and shall, after retaining for itself an amount equal to such expenses,
split equally the remaining balance of any and all recovery and damages
therefrom with BioPro. BioPro agrees to be named as a co-plaintiff if Xxxxxx
brings suit and shall cooperate with Xxxxxx (which shall include providing any
necessary assistance and executing any necessary documents, with any reasonable,
receipted out-of-pocket expenses being reimbursed to BioPro by Xxxxxx to the
extent such expenses were previously approved in writing by Xxxxxx), and shall
have the right to consult with Xxxxxx and to participate in and be represented
by independent counsel in such litigation at its own expense. Except as
otherwise specifically provided herein, Xxxxxx shall have control over any such
suit, and decisions as to settlement, methods and/or terms and conditions for
resolving the suit shall be made by Xxxxxx (after consultation with BioPro,
should BioPro be joined as a party to such suit).
ARTICLE 12 - CONFIDENTIALITY
12.1 CONFIDENTIAL INFORMATION. For the purposes of this Agreement,
"CONFIDENTIAL INFORMATION" means all verbal, written, electronically transmitted
and/or machine reproduced information, chemical structures, data, documents,
methods and Intellectual Property of or relating to the business of either Party
or its Affiliates, already provided or disclosed by it or its Affiliates to the
other Party, or which will be provided to the other Party under this Agreement,
and all materials, data, results, reports and other documents generated by or on
behalf of the other Party containing or regarding such information, data,
documents, methods and Intellectual Property.
12.2 OBLIGATIONS. During the Term, each Party may supply to the other
Party such Confidential Information as is considered useful solely for the
purpose of enabling the other Party to perform its obligations hereunder (the
"PURPOSE"). The other Party shall not use or allow the use of the Confidential
Information for any purpose other than the Purpose or to enforce its rights
under this Agreement.
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12.3 EXCEPTIONS. Neither Party shall have any obligation of non-disclosure
or non-use hereunder with respect to any Confidential Information which:
(a) at the time of disclosure to the other Party is already
available or known, to the public;
(b) after disclosure to the other Party becomes available or
known to the public through no breach of this Agreement;
(c) is already lawfully in the possession of the other Party at
the time disclosure hereunder was made and such possession is documented by
written evidence and not subject to any obligation of non-disclosure or non-use;
or
(d) is received from a Third Party having the right to disclose
same and who is not bound by obligations of non-disclosure and/or non-use.
12.4 COMPELLED DISCLOSURE. If a Party shall become compelled by any
requirement of law or pursuant to any legal, regulatory or investigatory
proceeding before any court, tribunal or other governmental entity, agency or
commission to disclose Confidential Information of the other Party, such Party
shall give the other Party prompt written notice of its receipt of the order or
notice requiring the disclosure so that the other Party may seek a protective
order or other remedy to protect the confidentiality of the Confidential
Information and/or waive the compelled Party's obligations under this Article
12. If such protective order, other remedy or waiver is not obtained or granted
by the time the compelled Party is required to comply, the compelled Party may
furnish only that portion of the Confidential Information of the disclosing
Party that it is compelled to disclose and no more.
12.5 UNAUTHORIZED USE. In case either Party becomes aware or has knowledge
of any unauthorized use or disclosure of Confidential Information, it shall
promptly notify the other Party of such unauthorized use or disclosure and,
thereafter, shall take all reasonable steps to assist the other Party in
attempting to minimize any potential or actual damages or losses resulting from
such unauthorized use or disclosure.
12.6 RETURN OF DOCUMENTS. Each Party, upon receipt of a written request
from the other Party following the expiration or termination of this Agreement,
shall promptly return to the other Party all Confidential Information of such
other Party, including all reproductions and copies thereof together with all
internal material and documents generated by it containing Confidential
Information or references thereto or from which references the substance of the
Confidential Information can be implied or understood and shall delete all
references thereto stored electronically.
12.7 OWNERSHIP RIGHTS. Each Party agrees that it shall not claim to have
any rights, title or ownership in the Confidential Information of the other
Party or any discoveries or inventions based on or derived from the Confidential
Information, and that rights, title and ownership in the Confidential
Information or any discoveries or inventions based on or derived from said
Confidential Information shall, as between the Parties, rest in the disclosing
Party. Each party agrees to promptly disclose to the disclosing Party any
discoveries or inventions based on or derived from the Confidential Information.
Each Party further agrees to assign (and
VALERA CONFIDENTIAL
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does hereby assign) to the disclosing Party, the sole and exclusive ownership in
all such discoveries and inventions and to sign all documents and do all things
required to give effect thereto.
12.8 TERM. The provisions of this Article 12 shall survive the expiration
or termination of the Agreement until all of the Confidential Information has
fallen within one of the exceptions set forth in Sections 12.3.
ARTICLE 13 - TERM AND TERMINATION
13.1 TERM. This Agreement shall commence upon the Effective Date and shall
continue for ten (10) years after the date on which the first Regulatory
Approval that allows sales to proceed in any country of the Territory is issued
unless sooner terminated as provided elsewhere in this Agreement. This Agreement
shall automatically renew for additional periods of one (1) year each unless a
Party gives notice to the other Party at least six (6) months prior to the
completion of the then-current term.
13.2 TERMINATION. This Agreement may be terminated:
(a) By a Party if the other Party commits a Material Breach and
(i) fails to remedy the breach within thirty (30) Business Days of being
required by the first Party to do so; or (ii) where remedy of the breach is not
reasonably possible within thirty (30) Business Days, fails to propose a plan
within twenty (20) Business Days which, in the opinion of the first Party acting
reasonably, is capable of providing a remedy of the breach within ninety (90)
Business Days.
(b) If either Party shall commence as debtor any proceedings
under any bankruptcy, insolvency, readjustment of debt, dissolution or
liquidation Law or any such proceeding shall be commenced against either Party,
or any trustee or receiver shall be appointed therefor, and either Party shall
by any act or failure to act indicate approval of or consent to, or acquiescence
in such proceedings or in the appointment of any such trustee or receiver; or if
any such proceedings brought against either Party shall be approved by any court
and shall remain undismissed for thirty (30) Business Days after its levy, then
in any such case, the Party not involved in such proceedings shall have the
option to terminate this Agreement in its entirety by written notice of such
termination to the Party involved in such proceedings and upon the giving of
such notice this Agreement shall immediately terminate.
(c) By either Party, upon at least thirty (30) days prior written
notice to the other Parry, if, as a result of an Event of Force Majeure, the
other Party is unable to fully perform its obligations hereunder for a period of
one hundred fifty (150) consecutive days; provided that if the required
performance is met during the thirty (30) day period, this Agreement shall
continue in full force and effect as if the notice had not been given.
(d) By a Party, on a country-by-country and
Indication-by-Indication basis, if the Regulatory Authority for such country has
finally denied Regulatoiy Approval (or any material part thereof) for the
Product with respect to such Indication.
VALERA CONFIDENTIAL
24
(e) By Xxxxxx, on a country-by-country basis, in accordance with
Section 7.5.2.
(f) By Xxxxxx, on a country-by-country basis and Indication-by-
Indication, if BioPro fails to file all Marketing Approval Applications
necessary to allow the marketing and sale of the Product in the given country
for use in the given Indication within thirty (30) days after the deadline
stated in the Plan for such country for the filing of all such Marketing
Approval Applications for such Indication.
13.3 PARTIAL TERMINATION. In the event that any termination of this
Agreement is limited to one (1) or more, but not all forms or dosages of the
Product, or to a country or Indication, then the effects of such termination
shall only apply to the affected form(s), dosage(s), country (ies) or
Indication(s), but shall not affect in any way the validity of this Agreement
with respect to any other form, dosage, country or Indication.
13.4 REMEDIES NOT LIMITED. The termination of this Agreement by either
Party shall not limit remedies that may be otherwise available.
13.5 SURVIVAL. Expiration or termination of this Agreement for any reason
shall not relieve either party for any breach of this Agreement occurring prior
to the expiration or termination of this Agreement. Article 1, Article 7,
Article 8, Article 10, Article 12 and Article 15 and Sections 3.3, 3.5, 4.5,
4.6, 4.7, 11.1, 13.4, 13.5, 13.6 and 13.7 shall survive expiration or
termination of this Agreement for any reason in accordance with their respective
terms.
13.6 POST-TERMINATION. Unless Valera terminates this Agreement pursuant to
Sections 13.2(a) or 13.2(b), during the six (6) month period following the
expiration or termination of this Agreement, BioPro may sell out its stock on
hand of the Product. All applicable provisions of this Agreement shall survive
termination as necessary to give effect to this Section 13.6.
13.7 OTHER CONSEQUENCES OF TERMINATION. Upon termination or expiration of
this Agreement (whether in whole or in part), BioPro shall within thirty (30)
days from the date of receipt of a request from Valera submit all necessary
paperwork to all Regulatory Authorities to request assignment to Valera or
designee of all Marketing Approval Applications and all related registrations
and product numbers for the Product and any other Regulatory Approval held with
respect to the Product (in each case whether in BioPro's name or the name of any
Affiliate of BioPro); provided that if this Agreement is only terminated as to a
particular country or Indication, then only the assignment of all Marketing
Approval Applications and all related registrations and product numbers for the
Product and any other Regulatory Approval held with respect to the Product (in
each case whether in BioPro's name or the name of any Affiliate of BioPro) for
such country or Indication shall be required.
ARTICLE 14 - FORCE MAJEURE
14.1 DEFINITION. For the purposes of this Agreement, an "EVENT OF FORCE
MAJEURE" means any one or more of the following:
(a) acts of God;
VALERA CONFIDENTIAL
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(b) expropriation, confiscation or requisitioning of facilities,
compliance with any Law not presently existing, or change in the interpretation
of any presently existing Law which affects to a degree not presently existing
the supply, availability, export or use of the Product, materials or labour;
(c) acts or inaction on the part of any Governmental Body or
Person purporting to act therefor;
(d) embargoes, or acts of war or the public enemy, whether war be
declared or not;
(e) strikes, public disorder, insurrection, rebellion, riots or
violent demonstrations;
(f) floods, earthquakes, lightning, hail, inclement weather
conditions or other natural calamities; and
(g) any circumstances whether or not of the class or kind
specifically named above not within the reasonable control of a Party and which,
despite the exercise of reasonable diligence, such Party is unable to prevent,
avoid or remove including demand that exceeds Xxxxxx'x supply of the Product.
14.2 PROCEDURE. If any Party wishes to invoke an Event of Force Majeure,
then it shall (i) promptly following the commencement of such Event of Force
Majeure notify the other Parties of the occurrence of such Event of Force
Majeure, the reasonably estimated date and time on which it commenced and the
nature of the Event of Force Majeure, and (ii) as soon as reasonably practicable
thereafter, submit to the other Parties proof of the Event of Force Majeure.
14.3 SUSPENSION OF OBLIGATIONS. If one of the Parties is unable to perform
its obligations under this Agreement because of an Event of Force Majeure, then
such Party shall be excused from performance of its obligations under this
Agreement until the Event of Force Majeure terminates and the obligations of
such Party, which cannot be met due to the Event of Force Majeure, shall be
suspended during the pendency of the Event of Force Majeure; provided that such
Party uses all reasonable efforts to attempt to prevent, avoid or remove the
Event of Force Majeure within the shortest possible delay. Nevertheless, an
Event of Force Majeure has no effect on the obligation to pay a sum of money
owing for the purchase of the Product.
14.4 RESOLUTION. If either Party is excused from performance under this
Agreement because of an Event of Force Majeure, then the Parties agree to
promptly meet and to work in good faith together in an attempt to find
appropriate solutions and to shorten the duration of the Event of Force Majeure,
to the extent reasonably feasible.
ARTICLE 15 - MISCELLANEOUS
15.1 LIMITATIONS OF LIABILITY. EXCEPT IN RESPECT OF XXXXXX'X
INDEMNIFICATION OBLIGATIONS UNDER THIS AGREEMENT, IN NO EVENT SHALL VALERA'S
LIABILITY TO KEY FOR DAMAGES UNDER OR IN RESPECT OF THIS
VALERA CONFIDENTIAL
26
AGREEMENT EXCEED, IN THE AGGREGATE, THE TOTAL AMOUNT PAID TO VALERA UNDER THIS
AGREEMENT DURING THE TWELVE (12) MONTHS PRECEDING THE EVENT GIVING RISE TO THE
DAMAGE, WHETHER SUCH DAMAGES ARISE IN TORT, CONTRACT OR OTHERWISE. IN ADDITION,
IN NO EVENT SHALL VALERA BE LIABLE FOR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR
INDIRECT DAMAGES, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY. THIS LIMITATION
WILL APPLY EVEN IF XXXXXX HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
15.2 NOTICES. Any notice or other communication required or permitted to
be given hereunder shall be in writing and shall be delivered in person,
transmitted by facsimile or sent by internationally-recognized overnight courier
mail, charges prepaid, addressed as follows:
If to Valera: Valera Pharmaceuticals, Inc.
0 Xxxxxx Xxxxx
Xxxxxxxx, Xxx Xxxxxx 00000-0000
Attention: President
Telephone: 000-000-0000
Fax: 000-000-0000
If to BioPro: BioPro Pharmaceutical Inc.
00 Xxx Xxxx
Xxxx Xxxxxx, Xxxxxxxxxx 00000
Attention: Chairman & CEO
Telephone: 000-000-0000
Fax: 000-000-0000
Any such notice or other communication shall be deemed to have been given and
received on the day on which it was delivered or successfully transmitted (or,
if such day is not a Business Day, on the next following Business Day) or, if
sent by nationally-recognized overnight courier, on the date on which it was
received or first-attempted delivery. Either Party may change its address for
service from time to time by giving notice thereof to the other Party in
accordance with this Section 15.2.
15.3 AMENDMENTS. No amendment or waiver shall be binding on either Party
unless consented to in writing by such Party. No waiver of any provision of this
Agreement shall constitute a waiver of any other provision, nor shall any waiver
constitute a continuing waiver unless otherwise expressly provided.
15.4 EXCLUSIVE JURISDICTION. The court with jurisdiction over the
then-current headquarters of Valera shall have exclusive jurisdiction over any
dispute, controversy or claim arising out of or relating to this Agreement
including any question regarding its existence, interpretation, validity, breach
or termination. Notwithstanding the foregoing, a party may seek injunctive and
other equitable relief in any court of competent jurisdiction. The prevailing
party's reasonable attorneys' and accountants' fees, expenses and disbursements)
shall be borne by the party against whom judgment is rendered.
VALERA CONFIDENTIAL
27
15.5 ASSIGNMENT. The rights and obligations under this Agreement may not
be assigned by BioPro (except to an Affiliate) without the prior written consent
of Valera, which consent shall not be unreasonably withheld or delayed. Valera
may assign this Agreement in its sole discretion.
15.6 FURTHER ASSURANCES. Each Party will, from time to time subsequent to
the date hereof, at the request and expense of any other Party, execute and
deliver all such documents and do all such other acts and things as that other
Party, acting reasonably, may from time to time request be executed or done in
order to better evidence or perfect or effectuate any provision of this
Agreement or any of the respective obligations intended to be created hereby or
thereby.
15.7 PUBLICITY. Neither Party shall issue any press release or other
public announcement relating to existence or terms of this Agreement without the
prior written consent of the other Party (which consent shall not be
unreasonably withheld or delayed), except where such announcements are required
by law or regulation, in which event the Parties will use all reasonable efforts
to consult with each other and cooperate with respect to the wording of any such
announcement. The Parties shall cooperate in issuing an initial public release
with respect to the signing of this Agreement, either separately or as a joint
release.
15.8 COUNTERPARTS. This Agreement may be executed in counterparts, each of
which shall constitute an original and all of which taken together shall
constitute one and the same instrument in effect as of the date first above
mentioned.
15.9 GOVERNING LAW. This Agreement shall be governed by and interpreted in
accordance with the Laws in effect in the State of New Jersey, U.S.A. applicable
to contracts entered into by residents of New Jersey and wholly performed within
New Jersey.
15.10 LANGUAGE. The Parties confirm that it is their wish that this
Agreement as well as all other documents relating to this Agreement, including
notices, have been and shall be drawn up in the English language only.
15.11 ENTIRE AGREEMENT. This Agreement constitutes the entire agreement
between the Parties with respect to the subject matter of this Agreement and
supersedes all prior and contemporaneous agreements, understandings, letters of
intent, negotiations and discussions, whether written or oral. There are no
conditions, covenants, agreements, representations, warranties or other
provisions, express or implied, collateral, statutory or otherwise, relating to
the subject matter of this Agreement, except as provided in this Agreement. This
Agreement shall not be changed or modified except in writing.
(SIGNATURE PAGE FOLLOWS)
VALERA CONFIDENTIAL
IN WITNESS WHEREOF, this Agreement has been executed by the Parties on the
date first set forth above.
VALERA PHARMACEUTICALS, INC.
By: /s/ Xxxxx X. Xxxxxxx Date: 1/27/2005
---------------------------------
Xxxxx X. Xxxxxxx, CEO
BIOPRO PHARMACEUTICAL INC.
By: /s/ Xxxxx X. X. Xxxxx Date: 1/28/2005
---------------------------------
Name: Xxxxx X. X. Xxxxx
Title: Chairman & CEO
VALERA CONFIDENTIAL
