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LICENSE AND DISTRIBUTION AGREEMENT

Distribution Agreement

LICENSE AND DISTRIBUTION AGREEMENT | Document Parties: BioPro Pharmaceutical, Inc | Valera Pharmaceutical, Inc | Valera Pharmaceuticals, Inc You are currently viewing:
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Title: LICENSE AND DISTRIBUTION AGREEMENT
Date: 3/14/2005
Industry: Biotechnology and Drugs     Sector: Healthcare

LICENSE AND DISTRIBUTION AGREEMENT, Parties: biopro pharmaceutical  inc , valera pharmaceutical  inc , valera pharmaceuticals  inc
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Exhibit 10.13

BioPro Pharmaceutical, Inc.

BioPro Pharmaceutical, Inc. hereby agrees that the License and Distribution

Agreement between BioPro Pharmaceutical, Inc and Valera Pharmaceutical, Inc.

dated as of January 28, 2005, shall only be effective when Valera has received

the $300,000 milestone payment as provided in Article 1, paragraph 7.1. Said

payment shall be received no later than the close of business in New York on

February 1, 2005.

 

/s/ Huang TTS

----------------------------------------

Chairman and CEO

Dated January 28, 2005

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EXECUTION COPY

LICENSE AND DISTRIBUTION AGREEMENT

THIS LICENSE AND DISTRIBUTION AGREEMENT is entered into as of the 28 day of

January 2005, by and between VALERA PHARMACEUTICALS, INC., a corporation

incorporated under the laws of the state of Delaware with its principal place of

business located at 8 Clarke Drive, Cranbury, New Jersey 08512-3617 ("VALERA"),

and BIOPRO PHARMACEUTICAL INC., a corporation incorporated under the laws of the

Commonwealth of Virginia with its principal place of business located at 21 Sky

Road, Mill Valley, California 94941 ("BIOPRO").

BACKGROUND

WHEREAS BioPro is engaged in the marketing, sale and distribution of

various pharmaceutical products used in the treatment of cancer in Asia;

WHEREAS Valera has developed and is the sole owner or exclusive licensee of

certain Patent Rights (as defined below) and other Intellectual Property (as

defined below) relating to a certain Product (as defined below);

WHEREAS Valera wishes to appoint BioPro as the exclusive licensee and

distributor of the Product in the Territory (as defined below) for use in the

same indications for which Valera owns or controls an approval from the United

States Food and Drug Administration or similar agency of a foreign government,

the whole in accordance with the terms and conditions set forth in this

Agreement;

WHEREAS BioPro desires Valera to supply BioPro with the Product on an

exclusive basis in the Territory prior to Regulatory Approval (as defined

below), and following receipt of Regulatory Approval, for distribution and sale

in the Territory for use in the indications described above, the whole in

accordance with the terms and conditions set forth in this Agreement.

TERMS

NOW, THEREFORE, in consideration of the respective covenants, agreements,

representations, warranties and indemnities contained in this Agreement and for

other good and valuable consideration, BioPro and Valera hereby covenant and

agree as follows:

ARTICLE 1 - DEFINITIONS AND INTERPRETATION

1.1 DEFINITIONS. For the purposes of this Agreement or any notice,

consent, authorization or other communication required or permitted to be given

under this Agreement, the following expressions shall have the following

meanings, respectively, unless the context otherwise requires:

(a) "AFFILIATE" shall mean any Person which directly or indirectly

controls, is controlled by, or is under common control with another Person,

provided that "control" shall mean ownership as to more than fifty percent (50%)

of another Person or the power to direct decisions of another Person, including,

without limitation, the power to direct

VALERA CONFIDENTIAL

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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.

VALERA CONFIDENTIAL

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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

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responsibility for manufacturing, assembling, packaging and labeling the Product

in such quantities as, in Valera's opinion, are required to fill all orders and

for maintaining such inventory levels of raw materials and packaging components

as are required to meet BioPro's then-current forecast for the Product (as

delivered pursuant to Section 6.3). BioPro shall be responsible for supplying

camera-ready proofs of all Labels and other artwork to be included with the

Product.

5.2 LABELING. The Product supplied under this Agreement will be the

Product packaged for use in the United States including all Labels for use in

the United States. BioPro shall be responsible for making changes to the

labeling and packaging necessary to comply with all Regulatory Approvals

(including, without limitation, oversticking labels on the Labels or repackaging

the Product using labels, package inserts and documentation other than or in

addition to the Labels) and bear all costs related to the same. From time to

time, and in any event promptly following Valera's request, BioPro shall notify

Valera of all labeling and repackaging activities undertaken by or on behalf of

BioPro to comply with all Regulatory Approvals in the Territory.

5.3 FAILURE TO SUPPLY. In the event that Valera or its Affiliates are

unable to supply the Product in specified quality or in quantities sufficient to

meet forecast demand for a successive period of ninety (90) Business Days, then

BioPro may elect to have the Product made by a Third Party manufacturer

designated by Valera and approved by BioPro, which approval shall not be

unreasonably withheld, conditioned, denied or delayed. If BioPro makes such an

election, Valera shall grant the Third Party manufacturer a non-exclusive,

royalty-free license under the Intellectual Property for the sole purpose of

manufacturing and selling to BioPro the quantity of the Product that Valera is

unable to supply.

5.4 SUPPLY RESUMPTION. If BioPro exercises its rights to have a Third

Party manufacturer manufacture the Product pursuant to Section 5.3 and

thereafter during the Term Valera desires to resume supplying BioPro with the

Product (whether by Valera or otherwise), then Valera shall notify BioPro of

such desire. BioPro shall then resume purchasing Product exclusively from Valera

for the remainder of the Term as soon as Valera demonstrates to BioPro's

reasonable satisfaction that Valera (whether by Valera or otherwise) is capable

of reestablishing a satisfactory supply of the Product; provided that BioPro

shall not be required to cancel any purchase orders for the Product issued to

the Third Party manufacturer that were issued in accordance with the Forecasts

provided to Valera pursuant to Section 6.3 prior to the date that Valera gave

BioPro notice of its desire to resume supply and cover periods no more than six

(6) months after the date that Valera gave BioPro notice of its desire to resume

supply. If and when Valera resumes supplying the Product pursuant to this

Section 5.4, the Third Party manufacturer shall be required to return to Valera

all information provided to the Third Party manufacturer pursuant to Section 5.3

and any license granted to the Third Party manufacturer shall terminate.

Notwithstanding anything in this Agreement to the contrary, upon the termination

of this Agreement for any reason, the Third Party manufacturer shall be required

to return to Valera all information provided to Third Party manufacturer

pursuant to Section 5.3 and any license granted to the Third Party manufacturer

shall terminate.

5.5 DOCUMENTATION AND CERTIFICATE OF ANALYSIS. Valera shall provide BioPro

with required supporting documentation for the ma


 
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