EXHIBIT NO. 10.1
CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS.
LICENSE AGREEMENT
BETWEEN
ATRIX LABORATORIES, INC.
AND
COLLAGENEX PHARMACEUTICALS, INC.
AUGUST 24, 2001
TABLE OF CONTENTS
PAGE
Article I DEFINITIONS..........................................................1
Article II LICENSE AND PURCHASE................................................9
Section 2.01. License Grant.............................................9
Section 2.02. Trademarks................................................9
Section 2.03. Occurrence of First Commercial Sale by CollaGenex.........9
Article III PAYMENTS AND ROYALTIES.............................................9
Section 3.01. License Fee...............................................9
Section 3.02. Royalty Payments..........................................9
Section 3.03. Reports, Exchange Rates..................................10
Section 3.04. Records and Audits.......................................10
Section 3.05. Taxes....................................................10
Article IV PAYMENTS...........................................................11
Section 4.01. Payment Terms............................................11
Section 4.02. Payment Method.......................................... 11
Section 4.03. Late Payments............................................11
Section 4.04. CollaGenex's Contribution Margin.........................11
Article V ATRIX CO-MARKETING RIGHTS...........................................11
Section 5.01. Co-Marketing Rights......................................11
Article VI TERM AND TERMINATION...............................................12
Section 6.01. Term.....................................................12
Section 6.02. Termination By CollaGenex................................12
Section 6.03. Termination By Atrix.....................................12
Section 6.04. Termination Upon Certain Events..........................13
Section 6.05. Remedies.................................................14
Section 6.06. Effect of Termination....................................14
Section 6.07. License Following Expiration.............................16
Article VII COMMERCIALIZATION OF THE PRODUCT..................................16
Section 7.01. CollaGenex's Obligations.................................16
Section 7.02. Marketing Advisory Board.................................17
Section 7.03. Co-Promotional Activities of Atrix.......................18
Article VIII MANUFACTURE AND SUPPLY...........................................19
Section 8.01. Agreement to Supply Products.............................19
Section 8.02. Quality Assurance........................................19
Section 8.03. Atrix's Duties..........................................19
Section 8.04. Failure to Supply........................................20
Section 8.05. Allocation...............................................21
Article IX PURCHASE AND SALE..................................................21
Section 9.01. Purchase Price and Payment...............................21
Section 9.02. Purchase Price Adjustment................................21
Section 9.03. Labeling and Artwork.....................................21
Section 9.04. Purchase Forms...........................................22
Section 9.05. Confirmation.............................................22
Section 9.06. Delivery.................................................22
Section 9.07. Forecasts and Orders.....................................22
Section 9.08. Professional Samples.....................................23
Article X WARRANTY, REJECTION AND INSPECTIONS.................................24
Section 10.01. Atrix Warranty..........................................24
Section 10.02. Rejection of Product or Professional Samples for
Failure to Conform to Specifications....................24
Section 10.03. CollaGenex Inspections..................................25
Article XI REGULATORY COMPLIANCE..............................................25
Section 11.01. Maintenance of Marketing Authorizations.................25
Section 11.02. Adverse Drug Event Reporting and Phase IV Surveillance..25
Section 11.03. Phase IV Studies........................................26
Section 11.04. Assistance..............................................26
Section 11.05. Compliance..............................................27
Article XII PATENTS AND TRADEMARKS............................................27
Section 12.01. Maintenance of Patents or Marks.........................27
Section 12.02. Cooperation.............................................27
Section 12.03. Atrix to Prosecute Infringement.........................27
Section 12.04. Infringement Claimed by Third Parties...................28
Article XIII REPRESENTATIONS, WARRANTIES and COVENANTS........................28
Section 13.01. Corporate Power.........................................28
Section 13.02. Due Authorization.......................................28
Section 13.03. Binding Obligation......................................28
Section 13.04. Ownership of Atrix Patent Rights........................28
Section 13.05. Patent Proceedings......................................29
Section 13.06. Adverse Properties......................................29
Section 13.07. Preservation of Name and Reputation.....................29
Section 13.08. Debarment...............................................29
Section 13.09. Limitation on Warranties................................29
Section 13.10. Limitation of Liability.................................29
Article XIV COVENANTS OF COLLAGENEX AND ATRIX.................................29
Section 14.01. Covenant Not to Launch Competitive Product..............29
Section 14.02. Limitation to the Territory.............................30
Section 14.03. Marketing and Instructional Materials...................30
Section 14.04. A&S Spending Levels.....................................31
Section 14.05. Variances...............................................31
ii
Section 14.06. Cash Alternatives.......................................31
Section 14.07. Minimum Size of Detail Force............................31
Section 14.08. Detail Calls............................................31
Section 14.09. Access to Books and Records.............................31
Section 14.10. Marketing Expenses......................................32
Section 14.11. Protection of the Marks.................................32
Section 14.12. Distribution System.....................................32
Section 14.13. Further Actions.........................................32
Section 14.14. Equitable Relief........................................32
Article XV PRODUCT RECALL.....................................................33
Section 15.01. Product Recalls or Withdrawal...........................33
Section 15.02. Recall Costs............................................33
Section 15.03. Notification of Complaints..............................34
Section 15.04. Notification of Threatened Action.......................34
Article XVI INDEMNIFICATION AND INSURANCE.....................................34
Section 16.01. CollaGenex Indemnified by Atrix.........................34
Section 16.02. Atrix Indemnified by CollaGenex.........................34
Section 16.03. Prompt Notice Required..................................35
Section 16.04. Indemnitor May Settle...................................35
Section 16.05. Insurance...............................................35
Article XVII DISPUTE RESOLUTION...............................................36
Section 17.01. Disputes................................................36
Section 17.02. Mediation...............................................36
Section 17.03. Trial Without Jury......................................36
Section 17.04. Performance to Continue.................................36
Section 17.05. Provisional Remedies....................................37
Section 17.06. Determination of Patents and Other Intellectual
Property................................................37
Article XVIII CONFIDENTIALITY.................................................37
Section 18.01. Confidentiality.........................................37
Section 18.02. Publicity Review........................................37
Article XIX MISCELLANEOUS.....................................................38
Section 19.01. No-Solicitation.........................................38
Section 19.02. Commercially Reasonable Efforts.........................38
Section 19.03. No Right to Use Names...................................38
Section 19.04. Notices.................................................39
Section 19.05. Severability............................................39
Section 19.06. Entire Agreement/Merger.................................40
Section 19.07. Amendment...............................................40
Section 19.08. Counterparts............................................40
Section 19.09. No Waiver of Rights.....................................40
Section 19.10. Force Majeure...........................................40
Section 19.11. Further Assurances......................................40
iii
Section 19.12. Assignment and Sub-License..............................40
Section 19.13. Expenses................................................41
Section 19.14. Binding Effect..........................................41
Section 19.15. Governing Law...........................................41
Section 19.16. Survival of Representations and Warranties..............41
Section 19.17. No Strict Construction..................................41
Section 19.18. Independent Contractors.................................41
Exhibit A -- Atrix Patent Rights....................................A-1
Exhibit B -- Form of Certificate of Compliance......................B-1
Exhibit C -- Specifications.........................................C-1
Exhibit D -- Form of Stock Purchase.................................D-1
Exhibit E -- Atrix Marks............................................E-1
Exhibit F -- CollaGenex's Standard Operating Procedures.............F-1
Exhibit G -- Product Fixed Price Schedule ..........................G-1
iv
LICENSE AGREEMENT
This License Agreement is made as of August 24, 2001 (the "Effective
Date"), by and between Atrix Laboratories, Inc., a Delaware corporation
("Atrix"), with its principal place of business located at 0000 Xxxxxxxx Xxxxx,
Xxxx Xxxxxxx, Xxxxxxxx 00000-0000 and CollaGenex Pharmaceuticals, Inc., a
Delaware corporation ("CollaGenex"), with its principal place of business
located at 00 Xxxxxxxxxx Xxxxx, Xxxxxxx, Xxxxxxxxxxxx 00000. Atrix and
CollaGenex are sometimes referred to collectively herein as the "Parties" and
individually as a "Party."
WHEREAS, Atrix owns certain proprietary information, intellectual property,
Patents and Know-How, and possesses manufacturing capabilities for ATRIDOX(R),
ATRISORB(R) Free Flow and ATRISORB(R) Free Flow with Doxycycline, and subject to
the terms of this Agreement, Atrix desires to grant to CollaGenex an exclusive
license to market and sell ATRIDOX(R), ATRISORB(R) Free Flow and ATRISORB(R)
Free Flow with Doxycycline and any and all Improvements thereon for use in the
field of dentistry including all its specialties in the Territory; and
WHEREAS, CollaGenex desires to obtain from Atrix an exclusive license to
advertise, promote, market, distribute, detail and sell the Licensed Products
(defined below); and
WHEREAS, Atrix is willing to grant such rights and licenses to CollaGenex
under the terms and conditions hereinafter set forth.
NOW, THEREFORE, in consideration of the mutual promises, covenants and
agreements hereinafter set forth, the Parties mutually agree as follows:
ARTICLE I
DEFINITIONS
(a) The following terms as used in the Agreement shall, unless the
context clearly indicates to the contrary, have the meaning set forth
below:
"Act" means the United States Food, Drug and Cosmetic Act, as amended, and
all regulations thereunder.
"Affiliate" means any entity which directly or indirectly controls, is
controlled by or is under common control with either CollaGenex or Atrix. The
term "control" means the power to direct or control the affairs of such entity
by reason of ownership of at least 50% of such entity by voting stock, equity
interest, contract or otherwise.
"Agreement" means this License Agreement and any written amendments,
addendums or modifications hereto.
"Applicable Laws" means all applicable laws, rules, regulations and
guidelines within or without the Territory that may apply to the marketing or
sale of the Products in the Territory or the performance of either Party's
obligations under this Agreement including laws, regulations
1
and guidelines governing the marketing, distribution and sale of the Products in
the Territory, to the extent applicable and relevant, and including all cGMP or
current Good Clinical Practices standards or guidelines promulgated by the FDA
or the Governmental Authorities and including trade association guidelines.
"A&S" means CollaGenex's advertising and selling expenditures incurred in
and associated with the promotional support of the Products, including the
creation, development and acquisition of advertising and selling materials,
including expenditures for samples, detailing materials, journal advertising,
in-office waiting room materials, educational programs, convention booths,
direct mail, consumer support, Phase IV clinical trials for marketing purposes,
market research, market surveys, market analysis and training of the Dental
Detail Force and the telesales staff, and any additional staff members
specifically recruited in order to directly support the marketing of the
Products, all as recorded in CollaGenex's financial statements in accordance
with GAAP.
"ATRIDOX(R)" means the ATRIGEL(R) drug delivery system containing
doxycycline for the subgingival therapy of periodontal disease.
"ATRIGEL(R)" means Atrix's proprietary drug delivery system consisting of
flowable compositions (e.g., solutions, gels, pastes and putties) of
biodegradable polymers and biocompatible solvents.
"ATRISORB(R) Free Flow" means the biodegradable guided tissue regeneration
("GTR") barrier for periodontal surgery, based on the ATRIGEL(R) drug delivery
system.
"ATRISORB(R) Free Flow with Doxycycline" means the ATRISORB barrier
containing doxycycline, which aids in the regeneration and integration of tissue
components in GTR procedures and reduces bacterial colonization of the barrier
at the site of GTR surgery.
"ATRISORB(R) Products" means ATRISORB(R) Free Flow and ATRISORB(R) Free
Flow with Doxycycline.
"Atrix Know-How" means all Know-How, including that related to Atrix's
proprietary ATRIGEL(R) technology and which is under the Control of Atrix or is
created during the Term, which is not covered by the Atrix Patent Rights, but is
necessary or useful to develop, Manufacture and commercialize the Products in
the Territory for use in the Field.
"Atrix Manufacturing Cost" means the actual cost of the Manufacture by
Atrix of a Products under a Manufacturing Process, including the related quality
assurance and quality control activities as required by Applicable Laws, which
actual cost shall be comprised of the cost of goods produced as determined in
accordance with GAAP, and shall include direct labor, direct material, including
raw materials and packaging materials, and the allocable portion of the
manufacturing overhead of Atrix directly attributable to the Manufacture of such
Product. The allocable portion of the manufacturing overhead shall be determined
by taking the total facility cost for the period, less an adjustment for idle
capacity, and allocating the remaining facility cost by labor usage to each of
the products produced in the facility during the period. For example: if the
facility cost for the period was $1,000,000 and it was operating at 80%
capacity, the allocable facility cost would be $800,000. If a Product
represented 30% of labor usage during the period, the allocable portion of the
manufacturing overhead directly attributable to the Manufacture of such Product
would be $240,000. Atrix Manufacturing Cost shall exclude selling, general and
administrative, research and development, and interest expenses and any and all
debt service payments of Atrix.
"Atrix Marks" means "ATRISORB(R)," "ATRIGEL(R)" or "ATRIDOX(R)" or any
additional trademarks selected by Atrix to describe its proprietary drug
delivery technology and the Products, alone or accompanied by any logo or design
and any foreign language equivalents in sound or meaning, whether registered or
not.
2
"Atrix Patent Rights" means all Patent Rights including those that claim
Atrix's proprietary ATRIGEL(R) technology as of the Effective Date and at any
time during the Term, which are necessary or appropriate to advertise, sell,
market, promote and distribute the Products in the Territory for use in the
Field which are under the Control of Atrix as of the Effective Date, and
Improvements thereto developed during the Term. The Atrix Patent Rights as of
the Effective Date are set forth on Exhibit A.
"Atrix Technology" means the Atrix Patent Rights and the Atrix Know-How.
"Certificate of Compliance" means the certificate of compliance in the form
attached hereto as Exhibit B.
"cGMP" means current good manufacturing practices as defined in 21
CFRss.110 et. seq.
"Competitive Products" means:
(a) any non-surgical, professionally applied subgingival treatment of
the periodontal pocket for which the primary mechanism of action is the
reduction of bacterial load in the periodontal pocket.
(b) any product that would constitute barriers for GTR or barriers for
guided bone regeneration ("GBR"), whether or not such GTR and GBR barriers
contain antibiotics, which is used as an adjunct to surgical treatment for
periodontal disease.
"Confidential Information" means any confidential information (including
information related to the Atrix Technology) of a Party relating to any use,
process, method, compound, research project, work in process, future
development, scientific, engineering, manufacturing, marketing, business plan,
financial or personnel matter relating to the disclosing Party, its present or
future products, sales, suppliers, customers, employees, investors or business,
whether in oral, written, graphic or electronic form. Confidential Information
shall not include any information which the receiving Party can prove by
competent evidence:
(a) is now, or hereafter becomes, through no act or failure to act on
the part of the receiving Party, generally known or available;
(b) is known by the receiving Party at the time of receiving such
information, as evidenced by its written records maintained in the ordinary
course of business;
(c) is hereafter furnished to the receiving Party by a Third Party, as
a matter of right and without restriction on disclosure;
(d) is independently developed by the receiving Party, as evidenced by
its written records, without knowledge of, and without the aid, application
or use of, the disclosing Party's Confidential Information; or
(e) is the subject of a written permission to disclose provided by the
disclosing Party.
3
"Continental United States" means the 50 states and the District of
Columbia.
"Contribution Margin" means that percentage of Net Sales for all Products
sold by CollaGenex, its Affiliates or agents, which percentage represents the
dollar amount of Net Sales retained by CollaGenex as a result of such Product
sales, determined by a fraction, (i) the numerator of which is equal to (A) the
aggregate Net Sales for all Products sold by CollaGenex, its Affiliates or
agents during a given period of time, minus (B) the aggregate amount of Purchase
Price payments, royalty payments and Customer Service Costs attributible to all
such Products sold by CollaGenex, its Affiliates or agents during that period of
time, and (ii) the denominator of which is equal to the aggregate Net Sales for
all Products sold by CollaGenex, its Affiliates or agents during that period of
time.
"Control" means the possession of the ability to grant a license or
sublicense as provided for herein without violating the terms of any agreement
or other arrangement with any Third Party.
"Customer Service Costs" means those direct customer service costs incurred
by CollaGenex in connection with (i) warehousing the Products, (ii) distributing
the Products to its customer accounts (including shipping and handling charges),
(iii) order processing, billing and collection activities for such customer
account, and (iv) bad debt expense incurred in connection thereto. "Customer
Service Costs" shall not include A&S or similar costs.
"Dental Detail Force" means CollaGenex's field force of dental consultants,
divisional and regional managers who make sales and product recommendation calls
on Dental Professionals (each a "Dental Consultant").
"Dental Professionals" means Dentists, dental practitioners, dental school
staffs and dental hygienists.
"Dentist" means any professional having a D.D.S. or D.M.D. degree,
including general practitioners, dental specialists, endodontists, oral surgeons
and periodontists.
"Detail Call" means a sales and product recommendation call by the Dental
Detail Force on Dental Professionals.
"Eighth Amendment" means the Eighth Amendment to Agreement between Atrix
and Block Drug Corporation, a New Jersey corporation ("Block").
"Evaluation Period" means the [**] periods preceding the month end of that
month that is approximately 45 days prior to an Adjustment Date (e.g. [**] with
respect to the Initial Adjustment Period), and shall refer to both the [**]
period and the [**] period, unless otherwise set forth in this Agreement.
"FDA" means the United States Food and Drug Administration.
"Field" means the field of dentistry, including all of its specialties.
"First Commercial Sale" means the first sale for use, consumption or resale
of a Product by CollaGenex or its Affiliates in the Territory (excluding any
sales for clinical trials or the distribution of Professional Samples). A sale
to an Affiliate shall not constitute a First Commercial Sale unless the
Affiliate is the end user of the Product.
"Fixed Price Schedule" means the Fixed Price Schedule as set forth in
Exhibit G, as amended in accordance with the terms of this Agreement.
"GAAP" means generally accepted accounting principles, consistently applied
in accordance with past practice.
4
"Good Clinical Practices" means good clinical practices as defined in 21
CFRss.50 et. seq. andss.312 et. seq.
"Governmental Approval" means all permits, licenses and authorizations,
including Marketing Authorizations, required by the FDA or any other
Governmental Authority as a prerequisite to the Manufacturing, packaging,
marketing and selling of the Products or the Units.
"Governmental Authority" means any federal, state, local or other
government, administrative or regulatory agency, authority, body, commission,
court, tribunal or similar entity.
"Improvements" means any and all developments, inventions or discoveries in
the Field relating to the Atrix Technology developed, or acquired by Atrix at
any time during the Term and shall include developments intended to enhance the
safety and/or efficacy of a Product.
"Know-How" means all know-how, trade secrets, inventions, data, processes,
techniques, procedures, compositions, devices, methods, formulas, protocols and
information, whether or not patentable, which are not generally publicly known,
including, without limitation, all chemical, biochemical, toxicological, and
scientific research information, whether in written, graphic or video form or
any other form or format.
"Manufacture" or "Manufacturing Process" means the production, processing
and packaging of a Product or a Professional Sample, in accordance with this
Agreement and Applicable Laws.
"Marketing Authorization" means all necessary and appropriate regulatory
approvals, including Pricing and Reimbursement Approvals, where applicable, to
put a Product on the market in the Territory.
"NDA" means a New Drug Application, and all amendments and supplements
thereto, filed or to be filed, with the FDA seeking authorization and approval
to manufacture, package, ship and sell a product as more fully defined in 21 CFR
ss. 314.5 et seq.
"Net Sales" means the invoice amounts [**] for sales of each Product by
CollaGenex or its Affiliates to Dental Professionals in bona fide arms length
transaction, less the following items, provided that they are bona fide
transactions designed to optimize the sales of Product (a) cash discounts and
trade allowances actually granted, (b) rebates and chargebacks required by
Applicable Laws or made pursuant to agreements with customers, (c) credits or
allowances actually granted upon the claims, damaged goods, outdated goods,
rejections or returns of such Product, including recalls, (d) taxes, tariffs and
similar obligations, duties or other governmental charges (other than income
taxes) levied on, absorbed or otherwise imposed on sales of such Product in the
Territory and shown separately on the invoice, (e) shipping charges and (f)
insurance costs related to shipping.
Components of Net Sales shall be determined in the ordinary course of
business in accordance with historical practice and using the accrual method of
accounting in accordance with GAAP.
In the event CollaGenex transfers a Product to a Third Party in a bona fide
arm's length transaction, for consideration, in whole or in part, other than
cash or to a Third Party in other than a bona fide arm's length transaction, the
Net Sales price for such Product shall be deemed to be the standard invoice
price then being invoiced by CollaGenex in an arms length transaction with
similar customers. In the event that CollaGenex includes one or more Products as
part of a bundle of products, CollaGenex agrees not to offer or sell any such
Product as a loss leader (i.e. sold at less than the invoice price at which any
such Product is sold when not part of a bundle of products) in determining the
price of the bundled products.
5
"Net Selling Price" means with respect to a given time period on a
Product-by-Product basis, Net Sales of a Product divided by the number of Units
sold for such Product during the applicable time period.
"Packaging Specifications" means the packaging and labeling specifications
for the Unit, as mutually determined by Atrix and CollaGenex from time to time,
and in compliance with Applicable Laws.
"Patent Rights" means all rights under patents and patent applications, and
any and all patents issuing therefrom (including utility, model and design
patents and certificates of invention), together with any and all substitutions,
extensions (including supplemental protection certificates), registrations,
confirmations, reissues, divisionals, continuations, continuations-in-part,
re-examinations, renewals and foreign counterparts of the foregoing and all
improvements, supplements, modifications or additions.
"Phase IV" means, as applicable, a study or program designed to obtain
additional safety or efficacy data, detect new uses for or abuses of a drug, or
to determine effectiveness for labeled indications under conditions of
widespread usage, which is commenced after regulatory approval of a Product.
"Pricing and Reimbursement Approvals" means any pricing and reimbursement
approvals which must be obtained before placing a Product on the market in the
Territory in which such approval is required.
"Prime Rate of Interest" means the prime rate of interest published from
time to time in The Wall Street Journal as the prime rate; provided, however
that if The Wall Street Journal does not publish the prime rate of interest,
then the term "Prime Rate of Interest" shall mean the rate of interest publicly
announced by Bank of America, N.A., as its prime rate, base rate, reference rate
or the equivalent of such rate, whether or not such bank makes loans to
customers at, above, or below said rate.
"Product" or "Products" means ATRIDOX(R), ATRISORB(R) Free Flow with
Doxycycline and ATRISORB(R) Free Flow, respectively, for use in the Field.
"Product Due Date" means the first day that CollaGenex is unable to supply
a Product to a customer account as a direct result of Atrix's failure to supply
the Product to CollaGenex in accordance with the terms of this Agreement.
"Professional Samples" means a carton containing one complete treatment kit
of ATRIDOX(R), consisting of a syringe of ATRIGEL(R) delivery system, a syringe
of doxycycline hyclate, a clear capillary tip and a cannula in a moisture proof
pouch and instructions for use (as such kit may be changed or reformulated by
Atrix from time to time), which may be used to demonstrate the manner in which
ATRIDOX(R) is prepared and used, and which shall be labeled "professional sample
for trial purposes only, not for resale."
"Shipment" or "Shipped" means each individual group of Product received by
CollaGenex from Atrix.
6
"Specifications" means the specifications for each Product attached hereto
as Exhibit C.
"Stock Purchase Agreement" means that certain Stock Purchase Agreement
dated as of the same date as this Agreement between Atrix and CollaGenex
attached hereto as Exhibit D.
"Territory" means the United States.
"Third Party" means any entity other than Atrix or CollaGenex or an
Affiliate of Atrix or CollaGenex.
"Unit" means (i) with respect to ATRIDOX(R), a carton containing six
complete treatment kits, each kit consisting of a syringe of ATRIGEL(R) delivery
system, a syringe of doxycycline hyclate, a clear capillary tip and a cannula in
a moisture proof pouch and instructions for use, as such kit may be changed or
reformulated by Atrix from time to time; (ii) with respect to ATRISORB(R) Free
Flow, a carton containing three complete treatment kits, each kit consisting of
a syringe containing the sterile ATRISORB(R) formulation, a cannula and
instructions for use, as such kit may be changed or reformulated by Atrix from
time to time; and (iii) with respect to ATRISORB(R) Free Flow with Doxycycline,
a carton containing three complete treatment kits, each kit consisting of a
syringe containing the sterile ATRISORB(R) formulation, a syringe containing
powdered doxycycline hyclate, a cannula and instructions for use, as such kit
may be changed or reformulated by Atrix from time to time. The trade or sample
package may be changed or reformulated by Atrix and CollaGenex from time to time
and the term "Unit" shall refer to the Product in such changed or reformulated
package. With respect to Professional Samples, a "Unit" shall mean one
Professional Sample.
"United States" means the Continental United States and all territories,
possessions and commonwealths of the United States, Puerto Rico, Guam and the
U.S. Virgin Islands.
(b) Each of the following terms is defined in the Section or under the
defined term set forth opposite such term below:
ADE....................................................Section 11.02(a)
Adjusted Product Repurchase Cost....................Section 6.06(d)(ii)
Adjustment Date.........................................Section 9.02(a)
Atrix Sales Force..........................................Section 7.03
Block................................................"Eighth Amendment"
Dental Consultant................................."Dental Detail Force"
Disputed Amount.........................................Section 6.03(a)
Effective Date.................................................Preamble
Force Majeure.............................................Section 19.10
Indemnitee................................................Section 16.03
Indemnitor................................................Section 16.03
Initial Adjustment Date.................................Section 9.02(a)
Initiating Group..........................................Section 19.01
Loss......................................................Section 16.01
Marketing Advisory Board................................Section 7.02(a)
Marketing Materials.......................................Section 14.03
7
Other Group...............................................Section 19.01
Product Repurchase Cost.............................Section 6.06(d)(ii)
Purchase Price.............................................Section 9.01
Recall....................................................Section 15.01
Representatives...........................................Section 18.01
Royalty Payment Date.......................................Section 4.01
Royalty Statement..........................................Section 3.03
SEC.......................................................Section 18.02
Service Cost Percentage.................................Section 9.02(a)
SOP....................................................Section 11.02(c)
Supplemental Royalty Statement..........................Section 9.02(a)
Target Contribution Margin.................................Section 4.04
Term.......................................................Section 6.01
Variance................................................Section 9.02(b)
(c) INTERPRETATION. The Section headings contained in this
Agreement are for reference purposes only and shall not affect the
meaning or interpretation of this Agreement. Except where the context
clearly requires to the contrary: (i) each reference in this Agreement
to a designated "Section" or "Exhibit" is to the corresponding Section
or Exhibit of or to this Agreement; (ii) instances of gender or
entity-specific usage (e.g., "his" "her" "its" "person" or
"individual") shall not be interpreted to preclude the application of
any provision of this Agreement to any individual or entity; (iii) the
word "or" shall not be applied in its exclusive sense; (iv)
"including" shall mean "including, without limitation"; (v) references
to laws, regulations and other governmental rules, as well as to
contracts, agreements and other instruments, shall mean such rules and
instruments as in effect at the time of determination (taking into
account any amendments thereto effective at such time without regard
to whether such amendments were enacted or adopted after the effective
date of this Agreement) and shall include all successor rules and
instruments thereto; (vi) references to "$" or "dollars" shall mean
the lawful currency of the United States; (vii) references to
"Federal" or "federal" shall be to laws, agencies or other attributes
of the United States (and not to any State or locality thereof);
(viii) the meaning of the terms "domestic" and "foreign" shall be
determined by reference to the United States; (ix) references to
"days" shall mean calendar days; (x) references to months or years
shall be to the actual calendar months or years at issue (taking into
account the actual number of days in any such month or year); (xi)
days, business days and times of day shall be determined by reference
to local time in Denver, Colorado; (xii) the English language version
of this Agreement shall govern all questions of interpretation
relating to this Agreement, notwithstanding that this Agreement may
have been translated into, and executed in, other languages; and
(xiii) the terms "Product" and "Products" shall refer to each
individual Product and all Products collectively, unless the context
clearly indicates otherwise.
8
ARTICLE II
LICENSE AND PURCHASE
Section 2.01. LICENSE GRANT. Subject to the terms of this Agreement, Atrix
hereby grants to CollaGenex an exclusive sublicense under the Atrix Technology
to use, market, advertise, promote, distribute, offer for sale and sell, but not
Manufacture, the Products in the Territory for use in the Field, without the
right to sublicense. This exclusive sublicense can only be transferred by
CollaGenex on the basis set forth in Section 19.13.
Section 2.02. TRADEMARKS.
(a) Subject to the terms and conditions of this Agreement, Atrix
hereby grants to CollaGenex an exclusive, royalty-free license in the
Territory and in the Field to use the Atrix Marks solely in connection with
the marketing, advertising, promotion, distribution, offering for sale and
sale, but not Manufacture, of the Products during the Term.
(b) CollaGenex acknowledges that the Atrix Marks being licensed to
CollaGenex under Section 2.02(a) belongs to Atrix and that CollaGenex shall
have no rights in such Atrix Marks except pursuant to such license.
CollaGenex shall use the Atrix Marks as depicted on Exhibit E or otherwise
in the exact form used by Atrix, including without limitation, the "(R)"
symbol or "(TM)" symbol, as applicable. Any other use of the Atrix Marks
shall be subject to the prior written approval of Atrix. All content or
other specific graphic elements provided by Atrix shall remain the property
of Atrix and shall be used only in the manner set forth in this Agreement
except as otherwise previously approved in writing by Atrix.
Section 2.03. OCCURRENCE OF FIRST COMMERCIAL SALE BY COLLAGENEX. The First
Commercial Sale of each Product, including ATRISORB(R) Free Flow with
Doxycycline, shall occur on or prior to November 1, 2001; provided Atrix has
Units available in commercial quantities ready for shipment to CollaGenex in
accordance with CollaGenex's forecasts as provided in Section 9.07.
ARTICLE III
PAYMENTS AND ROYALTIES
Section 3.01. LICENSE FEE. In partial consideration for the licenses
granted under Sections 2.01 and 2.02, CollaGenex shall pay to Atrix an initial
one-time non-refundable license fee equal to One Million Dollars ($1,000,000) on
the Effective Date by wire transfer of immediately available funds to an account
designated by Atrix to CollaGenex prior to the Effective Date. On the Effective
Date, Atrix shall purchase from CollaGenex Three Million Dollars ($3,000,000) of
CollaGenex's common stock, as provided in the Stock Purchase Agreement.
Section 3.02. ROYALTY PAYMENTS. CollaGenex will pay Atrix the following
royalties based on the aggregate Net Sales of the Products in each calendar
year:
9
(a) [**] on the first [**] of CollaGenex's combined Net Sales of the
Products during that calendar year; then
(b) [**] of that portion of CollaGenex's combined Net Sales of the
Products that are in excess of [**] but not more than [**] during that
calendar year; then
(c) [**] of that portion of CollaGenex's combined Net Sales of the
Products that are in excess of [**] during that calendar year.
Section 3.03. REPORTS, EXCHANGE RATES. CollaGenex shall furnish to Atrix a
quarterly written report (in sufficient detail to determine the relevant amounts
and dates specified in this Section 3.03) on a Product-by-Product basis, (a) the
calculation of Net Sales; (b) royalties payable in U.S. dollars, if any, which
shall have accrued hereunder based upon Net Sales; (c) withholding taxes, if
any, required by law to be deducted with respect to such sales; and (d) the
dates of the First Commercial Sale of any Product (the "Royalty Statement").
Reports shall be due on the 45th day following the close of each quarter.
Section 3.04. RECORDS AND AUDITS. During the Term and for a period of two
years thereafter or as otherwise required in order for Atrix to comply with
Applicable Law, CollaGenex shall keep complete and accurate records in
sufficient detail to permit Atrix to confirm the completeness and accuracy of:
(a) the information presented in each Royalty Statement and all payments due
hereunder; and (b) the calculation of A&S expenditures. CollaGenex shall permit
an independent, certified public accountant reasonably acceptable to CollaGenex
to audit and/or inspect those records of CollaGenex (including financial
records) that relate to Net Sales, Royalty Statements, A&S expenditures and
compliance with Sections 14.07 and 14.08 for the sole purpose of: (i) verifying
the completeness and accuracy of the Royalty Statements; (ii) verifying the
calculation of the Net Selling Price, the calculation of Net Sales and the
calculation of A&S expenditures; (iii) verifying CollaGenex's compliance with
Sections 14.07 and 14.08; and (iv) to confirm royalty payments and A&S
expenditures for the Products in each case, during the two preceding calendar
years. Such inspection shall be conducted during CollaGenex's normal business
hours, no more than once in any 12 month period and upon at least ten days prior
written notice by Atrix to CollaGenex. If such accounting firm concludes that
such payments were underpaid during the periods reviewed by such accountants,
CollaGenex shall pay Atrix the amount of any such underpayments, plus interest
at a rate equal to the Prime Rate of Interest, within 30 days of the date Atrix
delivers to CollaGenex such accounting firm's report so concluding that such
payments were underpaid. If such accounting firm concludes that such payments
were overpaid during such period, Atrix shall pay to CollaGenex the amount of
any such overpayments, without interest, within 30 days of the date Atrix
delivers to CollaGenex such accounting firm's report so concluding that such
payments were overpaid. Atrix shall bear the full cost of such audit unless such
audit discloses an underpayment by more than [**] of the amount due during such
period. In such case, CollaGenex shall bear the full cost of such audit.
Section 3.05. TAXES. All taxes levied on account of the payments accruing
to Atrix under this Agreement shall be paid by Atrix for its own account,
including taxes levied thereon as income to Atrix. If provision is made in law
or regulation for withholding, such tax shall be deducted from the payment made
by CollaGenex, paid to the proper taxing authority and a receipt of payment of
the tax secured and promptly delivered to Atrix.
10
ARTICLE IV
PAYMENTS
Section 4.01. PAYMENT TERMS. Royalties shall be due and payable [**] 45
days after [**] (each a "Royalty Payment Date"). CollaGenex may prepay, in whole
or in part, any royalties prior to the applicable Royalty Payment Date.
Section 4.02. PAYMENT METHOD. Except as otherwise agreed between the
Parties, all royalties and other payments due hereunder shall be paid in U.S.
dollars and shall be originated from an United States bank located in the United
States and shall be made by bank wire transfer in immediately available funds to
such account as Atrix shall designate before such payment is due.
Section 4.03. LATE PAYMENTS. Unless otherwise provided in this Agreement,
upon the failure of CollaGenex to pay any amount due under this Agreement within
five days after receipt of notice by CollaGenex that such amount has become due
and payable and has not been paid, CollaGenex shall pay interest to Atrix on
such amount from the date such amount is due under this Agreement at the Prime
Rate of Interest, plus 2%, or the highest rate permitted by applicable law,
calculated on the number of days such payment is delinquent, unless such payment
is being disputed by CollaGenex in good faith pursuant to Section 6.03.
Section 4.04. CollaGenex's Contribution Margin. The intent of the Parties
is that CollaGenex shall receive a Contribution Margin of [**] (the "Target
Contribution Margin") for the [**] period commencing [**] and [**] and for each
[**] period thereafter. The Parties acknowledge and agree that the Target
Contribution Margin is not an entitlement of CollaGenex. Further, if the Target
Contribution Margin is not obtained for any twelve month period or at all,
CollaGenex shall not be entitled to receive the dollar amount represented by the
difference between the actual Contribution Margin minus the Target Contribution
Margin, if negative, and Atrix shall not be entitled to receive the dollar
amount of such difference if positive; rather each Parties sole remedy for such
differences shall be through the adjustment mechanism set forth in Section 9.02.
ARTICLE V
ATRIX CO-MARKETING RIGHTS
Section 5.01. CO-MARKETING RIGHTS. Except as set forth in this Section
5.01, Atrix shall have no right to co-market the Products in the Territory
during the Term. Atrix may either directly or through a Third Party:
(a) Co-market ATRIDOX(R) in the United States in the event
CollaGenex's aggregate Unit sales of ATRIDOX(R) in the United States do not
equal or exceed [**] during months [**] following the Effective Date.
(b) Co-market the ATRISORB(R) Products in the United States in the
event CollaGenex's combined aggregate Unit sales of the ATRISORB(R)
Products do not equal or exceed [**] during months [**] following the
Effective Date.
(c) If Atrix exercises its right to co-market a Product in the
Territory the following shall occur, to the extent allowed by Applicable
Laws: (i) CollaGenex shall grant Atrix an irrevocable, exclusive, royalty
free license, except as against CollaGenex, with the right to sublicense,
under the license granted to CollaGenex under Section 2.01 (and no other
CollaGenex proprietary or intellectual property rights) to market,
advertise, promote, distribute, offer for sale and sell such Product in the
Territory; (ii) Atrix will be
11
solely responsible for its expenses related to marketing such Product in
the Territory and Atrix will retain all revenues from such Product that it
or its sublicensees sell in the Territory; (iii) Atrix or its sublicensee
shall market such Product under a trademark and a trade dress that are not
confusingly similar to the trademark and trade dress being used by
CollaGenex in the Territory; and (iv) the Marketing Advisory Board shall
automatically dissolve as of the date Atrix exercises its right to
co-market such Product.
(d) If Atrix exercises its co-marketing rights under this Section 5.01
and sublicenses such rights to a Third Party, Atrix agrees to sell the
Products to CollaGenex on terms no less favorable to CollaGenex than those
provided to such Third Party licensee.
ARTICLE VI
TERM AND TERMINATION
Section 6.01. TERM. This Agreement will take effect on the Effective Date
and will expire on a Product-by-Product basis upon the expiration of the last
applicable Atrix Patent Right or loss of patent protection for each Product in
the Territory (the "Term").
Section 6.02. TERMINATION BY COLLAGENEX. CollaGenex may terminate the
Agreement by notice to Atrix as follows:
(a) at any time with or without cause upon 12 months prior written
notice to Atrix;
(b) if Atrix shall commit any willful and material breach of the
provisions of this Agreement;
(c) if Atrix shall cease to Manufacture or supply the Products to
CollaGenex pursuant to this Agreement, except as otherwise set forth
herein;
provided however, that with respect to Sections 6.02(b) and (c) that: (i)
CollaGenex has first given Atrix notice specifying the details of the material
breach, and (ii) Atrix has not cured such material breach within 30 days of the
effective date of notice of the material breach.
Section 6.03. TERMINATION BY ATRIX. Atrix may terminate this Agreement by
notice to CollaGenex, upon any of the following conditions:
(a) if CollaGenex shall fail to make any payments to Atrix on the date
on which such payments are due hereunder and such failure continues for
more than ten business days after notice of such failure to pay; provided,
however, that this subsection (a) shall not apply to any payment, or
portion thereof, under this Agreement, which is the subject of a good faith
dispute (a "Disputed Amount") between CollaGenex and Atrix. Further,
CollaGenex shall pay interest on any Disputed Amount at a rate equal to the
Prime Rate of Interest to begin accruing on a daily basis from the date
such payment was due and continuing until such payment is received by
Atrix. Any Disputed Amount shall be resolved by the Parties within 30 days
from the date CollaGenex notifies Atrix of a
12
good faith dispute; provided, however, if the Disputed Amount cannot be
resolved to the mutual satisfaction of the Parties within such 30 day
period then either Party may request that the dispute be submitted to the
Chief Executive Officers of Atrix and CollaGenex, respectively, or their
designees, for joint resolution. If the Disputed Amount is not jointly
resolved by the Parties' Chief Executive Officers, or their designees,
within ten days after the submission thereto, then Atrix shall be entitled
to pursue any and all remedies at law available to it. In no event will the
dispute resolution period exceed a maximum of 60 days unless otherwise
agreed in writing by the Parties. Further, CollaGenex may in its discretion
elect to pay any such Disputed Amount and in the event such amount is
finally determined not to have been payable by CollaGenex, Atrix shall
reimburse CollaGenex for such amount, without interest;
(b) if CollaGenex shall fail to deliver to Atrix a Royalty Statement
by the Royalty Payment Date and shall fail to cure such default within 15
days after notice from Atrix with respect thereto; provided, however, that
Atrix shall be entitled to terminate this Agreement immediately if such
Royalty Statement is late on more than two occasions during a calendar year
or on more than three occasions during any period consisting of 12
consecutive calendar quarters, without regard to any cure period;
(c) if CollaGenex shall make any willful and material
misrepresentation or false statement in any Royalty Statement;
(d) if CollaGenex shall commit any willful and material breach of the
provisions of this Agreement;
(e) if CollaGenex shall cease to offer the Product for distribution to
its customers, except as may be provided for herein; or
(f) if CollaGenex markets, distributes or sells a Competitive Product.
provided however, that with respect to Sections 6.03(c) through (f) that: (i)
Atrix has first given CollaGenex notice specifying the details of the material
breach, and (ii) CollaGenex has not cured such material breach within 30 days of
the effective date of such notice.
Section 6.04. TERMINATION UPON CERTAIN EVENTS. This Agreement may be
terminated by the Party specified below forthwith upon prior written notice to
the other Party of the occurrence of either of the following events:
(a) by either Party upon a cessation of operations of the other Party
or the institution by or against such Party as debtor of any proceeding
(whether voluntary or involuntary) in bankruptcy or for dissolution,
liquidation, reorganization, arrangement or the appointment of a receiver,
trustee or judicial administrator (or the equivalent thereof in the
jurisdiction in question) or any other proceeding under the law for the
relief of debtors, if, in the case of an involuntary proceeding, the same
shall not have been dismissed or stayed within 45 days after its
institution; or
(b) by either Party if the other Party makes an assignment for the
benefit of, or arrangement with, its creditors or becomes unable to pay its
debts as they become due.
13
A Party's failure to terminate this Agreement for any of the reasons
specified in this Section 6.04 shall not in any way be deemed a waiver of such
Party's rights in respect thereof or otherwise limit its rights to enforce the
obligations hereunder.
Section 6.05. REMEDIES. All of the non-breaching Party's remedies shall be
cumulative, and the exercise of one remedy hereunder by the non-defaulting Party
shall not be deemed to be an election of remedies. These remedies shall include
the non-breaching Party's right to xxx for damages for such breach without
terminating this Agreement.
Section 6.06. EFFECT OF TERMINATION. Upon termination of this Agreement by
Atrix pursuant to Sections 6.03 or 6.04 or by CollaGenex pursuant to Sections
6.02 or 6.04 the following shall occur:
(a) CollaGenex shall have no right to practice within the Atrix Patent
Rights or use any of the Atrix Technology, all rights, title or interest
in, or other incidents of ownership under, the Atrix Technology and the
Atrix Marks shall revert to and become the sole property of Atrix, and the
licenses granted to CollaGenex under Sections 2.01 and 2.02 shall
terminate;
(b) except with respect to the termination of this Agreement under
Sections 6.02(b) or (c), CollaGenex shall reimburse Atrix for those costs
and expenses reasonably incurred or committed to by Atrix in anticipation
of meeting forecasted amounts for six months from the last firm order which
cannot reasonably be canceled, eliminated, re-deployed, or mitigated by
using reasonable and diligent efforts (but including any direct costs
incurred by Atrix in doing so). CollaGenex shall reimburse Atrix for such
costs and expenses within ten days after its receipt of an appropriately
detailed invoice setting forth those costs and expenses incurred by Atrix
pursuant to the terms of this subsection (b);
(c) notwithstanding subsection (a) above, CollaGenex may, in its sole
discretion, elect to sell off or distribute, as applicable, its existing
inventory of the Products and Professional Samples in accordance with the
terms set forth in subsection (d) below by notifying Atrix of its decision
within 30 days after the date it receives a notice of termination by Atrix
or the date it provides a notice of termination to Atrix;
(d) if CollaGenex elects to sell off or distribute, as applicable, its
existing inventory of the Products and Professional Samples, it shall not,
either directly or indirectly, use or permit the use of the Products or
Professional Samples except as set forth under this subsection (d) and
shall proceed as follows:
(i) continue to comply with its payment obligations to Atrix
under Articles III and IV;
(ii) continue to sell off or distribute, as applicable, existing
inventory of the Products and Professional Samples for six months
after the notice of termination. At the expiration of such six month
period CollaGenex shall, at Atrix's election, either (A) sell all
existing inventory of the Products and Professional Samples to Atrix
or (B) destroy all remaining inventory of the Products and
Professional Samples in accordance with Applicable Law and
14
provide Atrix with written proof of destruction sufficient to comply
with Applicable Laws. In either case, Atrix shall pay to CollaGenex
the full amount of the actual cost paid by CollaGenex to Atrix for
such remaining inventory of the Products and Professional Samples (the
"Product Repurchase Cost"); provided, however, that if Atrix
terminates this Agreement, Atrix shall be entitled to deduct from the
Product Repurchase Cost the costs incurred by Atrix to repackage such
Products or Professional Samples for sale or distribution,
respectively, by Atrix or a Third Party (the "Adjusted Product
Repurchase Cost");
(iii) if CollaGenex notifies Atrix that CollaGenex does not
intend to sell off or distribute, as applicable, any existing
inventory of the Products and Professional Samples, CollaGenex shall,
at Atrix's election, either:
(A) sell all existing inventory of the Products and
Professional Samples to Atrix; or
(B) destroy all remaining inventory of the Products and
Professional Samples in accordance with Applicable Law and
provide Atrix with written proof of destruction sufficient to
comply with Applicable Laws. In either case, Atrix shall pay to
CollaGenex the Product Repurchase Cost or the Adjusted Product
Repurchase Cost, as applicable;
(iv) if CollaGenex sells any inventory of the Products or
Professional Samples to Atrix pursuant to this subsection (d), it
shall warrant that such inventory of the Products and Professional
Samples has been stored in compliance with all Applicable Laws, has
not been adulterated and has otherwise been maintained according to
the requirements of Applicable Laws and Governmental Authorities; and
(v) any sales of the Products or Professional Samples made by
CollaGenex to Atrix pursuant to this subsection (d) shall be made by
CollaGenex within 30 days after the date it becomes obligated to do so
and shall be shipped to Atrix appropriately packaged and stored. All
transportation costs in connection with such sale, including without
limitation, insurance, freight and duties, shall be [**]. Amounts owed
by Atrix to CollaGenex pursuant to this subsection (d) for the
Products or Professional Samples shall be paid by Atrix within ten
days after receipt by Atrix of an appropriately detailed invoice from
CollaGenex for the amount so owing to it by Atrix under this
subsection.
(e) except as otherwise provided in this Agreement, expiration or
termination of this Agreement shall not relieve the Parties of any
obligation accruing prior to such expiration or termination. Except as set
forth below or elsewhere in this Agreement, the obligations and rights of
the Parties under Sections 13.07 and 13.08 and Articles XV, XVI, XVII,
XVIII and XIX and this Article VI shall survive expiration or termination
of this Agreement.
15
(f) subject to the provision of Section 6.07, within 30 days following
the expiration or termination of this Agreement, each Party shall return to
the other Party, or destroy, upon the written request of the other Party,
any and all Confidential Information of the other Party in its possession
and upon a Party's request, such destruction (or delivery) shall be
confirmed in writing to such Party by a responsible officer of the other
Party.
Section 6.07. LICENSE FOLLOWING EXPIRATION. Upon expiration of the Term,
CollaGenex shall have (a) an irrevocable, non-exclusive, royalty-free license,
with the right to sublicense, to market, advertise, promote, distribute, offer
for sale and sell, but not Manufacture, the Products in the Territory, and (b) a
non-exclusive, royalty-free license to use the Atrix Marks to market, advertise,
promote, distribute and sell the Products, subject to the provisions of Sections
2.02(b) and 2.02(c), which Sections shall survive the expiration of this
Agreement. Upon request by CollaGenex, Atrix shall continue to sell the Products
to CollaGenex upon terms mutually agreeable to the Parties pursuant to a
separate supply agreement to be negotiated in good faith between the Parties.
ARTICLE VII
COMMERCIALIZATION OF THE PRODUCT
Section 7.01. COLLAGENEX'S OBLIGATIONS.
(a) Marketing Efforts. CollaGenex agrees to use its commercially
reasonable efforts to timely promote the sale, marketing and distribution
of the Products in the Territory, consistent with accepted business
practices devoting the same level of efforts as it devotes to its own
products of comparable market potential. "Comparable market potential"
shall be fairly determined by CollaGenex in good faith and without
limitation may be based upon market size, price, competition, patent
rights, product liability issues and general marketing parameters.
Notwithstanding anything herein to the contrary, for the first 24 months
following the Effective Date, [**] of this subsection 7.01(a) [**] with the
[**]. CollaGenex shall promptly advise Atrix of any issues that materially
and adversely affect CollaGenex's ability to market the Products in the
Territory. In such event, senior executives of CollaGenex and Atrix shall
meet and in good faith discuss what actions should be taken in light of
such issues. Notwithstanding the foregoing or anything else in this
Agreement to the contrary, CollaGenex shall have no responsibility for
refunding money for customer returns of Product sold by Block or replacing
outdated Products sold by Block with free Product that CollaGenex has
purchased from Atrix.
(b) Trademarks. Subject to the terms of this Agreement, CollaGenex
shall be the exclusive licensee of the Atrix Marks in the Territory and
shall use the Atrix Marks in connection with the promotion, marketing and
sale of the Products. The Atrix Marks shall remain the sole property of
Atrix.
(c) Packaging. Packaging and labeling of the Products, the Units and
the Professional Samples shall comply with the Packaging Specifications and
Applicable Laws. Atrix, in consultation with CollaGenex, shall be
responsible for assuring that such
16
packaging and labeling conform with all Applicable Laws of the FDA for
selling the Products and distributing the Professional Samples in the
United States, and that the Units comply with the Packaging Specifications
and Applicable Laws where such Product is to be distributed for sale. For
purposes of clarity, Atrix shall be solely responsible for providing
initial packaging that includes CollaGenex's name, trade dress, logos,
contact information and other identifying insignia and information as may
be agreed between the Parties in the Packing Specifications. All additional
incremental costs resulting from changes to the Packaging Specifications,
including artwork and labeling (in accordance with Section 9.03), made at
the request of CollaGenex shall be borne by CollaGenex.
(d) Marketing Plans And Reports. Prior to January 15th of each
calendar year, CollaGenex shall submit to the Marketing Advisory Board in
writing the annual marketing, sales and distribution plan for the Territory
detailing CollaGenex's and its Affiliates' proposed marketing, sales and
distribution strategy and tactics for the sale and distribution of each
Product during such calendar year, or portion thereof, including the
expected selling price schedules for each Product in the Territory
(including any (i) prompt payment or other trade or quantity discounts
which CollaGenex expects to offer and (ii) commission rates or rebates
which CollaGenex expects to offer to distributors and agents). In addition,
upon the request of Atrix, CollaGenex shall provide the Marketing Advisory
Board with copies of any plans or market research reports relating to the
sale or marketing of the Product and/or Product competition which
CollaGenex or its Affiliates commission or otherwise obtain to the extent
permissible by the agency preparing the report. To the extent the foregoing
information is contained in plans or reports which contain information
about other products or markets, CollaGenex may provide the Marketing
Advisory Board only those excerpts from such plans or reports which relate
to the Products and Product competition.
Section 7.02. MARKETING ADVISORY BOARD.
(a) Formation and Function. Promptly after the Effective Date,
CollaGenex and Atrix will each appoint two senior representatives to a
committee (the "Marketing Advisory Board") that shall have oversight for
any activity under this Agreement for the Territory. CollaGenex will select
an individual to serve as chairman of the Marketing Advisory Board for the
initial 12 months. Thereafter, the chairmanship will rotate between an
Atrix member and a CollaGenex member every 12 months. Each of CollaGenex
and Atrix shall bear its own travel and lodging expenses incurred in
connection with the attendance of its representatives at meetings of the
Marketing Advisory Board. Except as set forth in Section 5.01(c), the
Marketing Advisory Board will be consulted by both Parties on all major
decisions in the marketing of each Product in the Territory, including,
without limitation, in the following areas as they relate to each Product:
(i) Product positioning in the marketplace;
(ii) quantity of direct selling efforts, including the number of
sales details to be made;
17
(iii) extent and degree of non-personal selling and promotional
efforts;
(iv) quantity and content of workshops and medical symposia;
(v) design and implementation of a Phase IV study program to
support the Product, if any;
(vi) design and implementation of a consumer awareness program;
(vii) selection of dentists for a medical advisory board and
speakers bureau;
(viii) dispute resolution regarding sales, marketing and
promotional activities related to the Product;
(ix) internet presence; and
(x) design and performance of other clinical studies in the
Territory.
CollaGenex, alone, will be responsible for making the final decisions
on the marketing of each Product regardless of the action or inaction
of the Marketing Advisory Board, except with respect to Phase IV
studies for which Atrix bears 100% of the cost, which shall be under
the sole direction and control of Atrix. CollaGenex agrees that in
making such decisions and taking such actions that it will consider
the effect of such decisions and actions on the marketing and sale of
such Product outside the Territory. Notwithstanding the foregoing, for
the avoidance of doubt, Atrix, alone, shall make the final decision on
all matters concerning the Manufacture of the Products.
(b) Meetings. The Marketing Advisory Board will meet every six
months and at such other times as a Party may request, alternating
between Newtown, Pennsylvania and Fort Xxxxxxx, Colorado and will
otherwise communicate regularly by telephone, facsimile and/or video
conference. The chairman of the Marketing Advisory Board shall prepare
minutes of all meetings. Each Party recognizes the importance of the
Marketing Advisory Board and will use diligent efforts to cause all of
its representatives on the Marketing Advisory Board to attend all
meetings of the Marketing Advisory Board. A Party may change any of
its appointments to the Marketing Advisory Board at any time upon
giving written notice to the other Party.
Section 7.03. Co-promotional activities of Atrix. Beginning on January 1,
2003, Atrix shall have the right, but not the obligation, subject to
CollaGenex's supervision of Atrix's sales, marketing and promotional activities,
to participate in the sales, marketing and promotion of the Products or Product.
If Atrix so elects, Atrix will provide additional field sales representatives
(the "Atrix Sales Force") and/or funding to augment the sales, marketing and
promotional activities of the Products by CollaGenex as the Parties may agree.
All costs associated with the Atrix Sales Force shall be borne solely by Atrix.
The Atrix Sales Force will report and be subject to the supervision of the
current CollaGenex field sales management system, and will carry out those
co-promotional tasks as directed by the Marketing Advisory Board. All revenues
from the sale of products realized by the efforts of the Atrix Sales Force will
be payable to CollaGenex and handled in the same manner and pursuant to the same
terms and conditions as all other revenues from the sale of Products are handled
by CollaGenex pursuant to this Agreement.
18
ARTICLE VIII
MANUFACTURE AND SUPPLY
Section 8.01. AGREEMENT TO SUPPLY PRODUCTS. Subject to the terms of this
Agreement, CollaGenex agrees to purchase exclusively from Atrix, and Atrix
agrees to Manufacture for, and sell exclusively to CollaGenex during the Term,
CollaGenex's total requirements for the Products and the Professional Samples in
the Territory on the terms and conditions set forth herein. Atrix may
subcontract any part of the Manufacturing Process for the Products and the
Professional Samples to Third Parties provided the Products, the Professional
Samples and the facilities continue to meet the requirements as defined in this
Agreement. If subcontracting is initiated by Atrix, Atrix will bear the cost of
validation and necessary stability work. To ensure an adequate supply of
Product, at all times during the Term Atrix shall maintain inventory for each
Product [**].
Section 8.02. QUALITY ASSURANCE. Atrix shall Manufacture the Products in
accordance with the Specifications. Atrix shall promptly notify CollaGenex in
writing of any changes required by a Governmental Authority in the
Specifications or Atrix's quality assurance procedures that would render Atrix
unable to supply a Product and/or Professional Samples in accordance with the
terms of this Agreement. The Parties agree to negotiate in good faith to develop
and execute an appropriate action plan in such situation. Any additional costs
or expenses shall be shared between the Parties in such proportion as is equal
to each Party's relative fault in causing such change or changes to occur;
provided, however, that if the Parties cannot reach an agreement in good faith
as to the relative fault of each Party or if neither Party is at fault, such
additional costs and expenses shall be born equally by the Parties.
Section 8.03. ATRIX'S DUTIES. Atrix agrees to furnish to CollaGenex with
every Shipment a written certificate of analysis and Certificate of Compliance
that confirms conformity of each Product and the Professional Samples to the
Specifications. In addition, Atrix shall:
(a) provide CollaGenex with written sampling and testing procedures
used by Atrix to assure that the Products and the Professional Samples
conform to the Specifications;
(b) retain a sample of each batch of Product and the Professional
Samples for a period equal to the greater of (i) one year after the date of
Manufacture of such batch of Product or Professional Samples or (ii) the
period required by Applicable Laws. Upon CollaGenex's request, Atrix shall
make such samples available for inspection to CollaGenex, or a Third Party
selected by CollaGenex and reasonably acceptable to Atrix. The retained
sample shall be sufficient in size to allow CollaGenex or such Third Party
to perform tests to determine whether the Product and the Professional
Samples meet the Specifications. Atrix shall store the retained Samples in
accordance with the Specifications;
(c) maintain records to ensure Atrix's ability to perform a complete
lot history via lot tracing of the Product and the Professional Samples;
(d) keep on file all manufacturing records and analytical results
pertaining to the Manufacture of each batch of Product and the Professional
Samples for a period expiring not earlier than one year after the
expiration date of the last lot of the last batch of Product and the
Professional Samples Manufactured and Shipped to CollaGenex. Atrix
19
shall make such records available to CollaGenex upon request, however,
Atrix shall be responsible for investigating any Manufacturing problems or
defects;
(e) consult on an ongoing basis with the Marketing Advisory Board on
all aspects of the Manufacture of the Products and the Professional
Samples, including the use of any subcontractors to perform part of the
Manufacturing Process;
(f) provide CollaGenex with notice within 48 hours of notification of
any scheduled inspection by any Governmental Authority of Atrix's
facilities, books or records, or of the facilities, books or records of any
subcontractor being utilized by Atrix to perform any portion or all of the
Manufacturing Process. Atrix shall inform such Governmental Authority that
CollaGenex may desire to be present at such inspection; provided that
CollaGenex's right to be present is subject to approval by such
Governmental Authority and subject to CollaGenex being available at the
time and date established by such Governmental Authority. Atrix shall use
reasonable efforts to secure a time and date for such inspection that is
reasonably acceptable to CollaGenex; provided, however, that Atrix alone
shall have the right to make the final decision on all such matters; and
(g) Atrix agrees not to change the Manufacturing Process, including
components and raw materials, without first notifying CollaGenex.
Section 8.04. FAILURE TO SUPPLY.
(a) Atrix shall immediately notify CollaGenex if Atrix is unable to
fill any order placed by CollaGenex pursuant to Section 9.07 and advise
CollaGenex of the revised delivery date. CollaGenex shall then have the
option of terminating the purchase order without obligation of payment or
of accepting the revised delivery date. If Atrix is unable to cure such
failure within [**] after such notice, Atrix may elect, in its sole
discretion, to utilize its [**] to satisfy CollaGenex's supply
requirements; provided, however, any consequent incremental costs which
result by reason of Atrix's use of its [**] under this Section 8.04(a)
[**].
(b) Notwithstanding the foregoing, Atrix shall not be deemed to be
unable to fill any order placed by CollaGenex as follows:
(i) if Atrix's inability to fill any order arises as a result of
a [**] in CollaGenex's order over CollaGenex's immediately prior
forecast. For example, if CollaGenex's forecast for [**] CollaGenex's
forecast for [**] CollaGenex [**] Atrix would not be deemed [**] or
(ii) in the event that Atrix must purchase additional equipment
or construct a new facility in order to expand its capacity in order
to meet purchase orders hereunder, Atrix will be deemed to have
satisfied this Section 8.04(b)(ii) by placing a purchase order for
such equipment or signing a contract for such construction within 60
days of Atrix's receipt of CollaGenex's purchase order showing firm
quantities in excess of Atrix's capacity; provided that Atrix
diligently pursues and completes within a reasonable time thereafter
such purchase or construction.
(c) Since the Parties agree that it would be difficult to correctly
and adequately determine the damages which CollaGenex may suffer in the
event Atrix fails to supply the Product and therefore it would not be
possible for CollaGenex to obtain an adequate remedy, in the event Atrix
fails to supply the Product to CollaGenex in accordance with the terms of
this Agreement, such that CollaGenex is unable to supply the Product to its
customers, then Atrix shall pay to CollaGenex the following amounts [**]:
(i) [**] if Atrix fails to supply the Product for a period of [**] or
less after the Product Due Date;
(ii) an additional [**] if Atrix fails to supply the Product for a
period exceeding [**] but less than or equal to [**] from the Product
Due Date; and
(iii) an additional [**] if Atrix fails to supply the Product for a
period exceeding [**] from the Product Due Date.
20
The above [**] are a [**]. In no event will the aggregate amounts payable
to CollaGenex under this Section 8.04(c) exceed [**] CollaGenex
acknowledges and agrees that the [**] set forth in this Section 8.04(c)
constitute CollaGenex's [**] for Atrix's failure to supply the Products in
accordance with the terms of this Agreement. The date on which Atrix shall
be deemed to have recommenced supply of the Product to CollaGenex under
this Section 8.04(c) shall be one day after the date CollaGenex or its
agent receives a Shipment of Product.
Section 8.05. ALLOCATION. If Atrix exercises its rights to co-market under
Article V and if Atrix is unable to supply all of the requirements for a
Product, and quantities ordered by CollaGenex in accordance with Section 9.07,
then Atrix shall allocate the resources available to it so that CollaGenex
receives at least its proportional share of available supplies as determined
based on reasonable forecasts (taking into consideration past sales and sales
performance against forecast) of CollaGenex and Atrix.
ARTICLE IX
PURCHASE AND SALE
Section 9.01. PURCHASE PRICE AND PAYMENT. Atrix shall sell, and CollaGenex
shall purchase, each Product at the price set forth on the Fixed Price Schedule,
which shall be subject to adjustment in accordance with Section 9.02 (the
"Purchase Price"). Atrix shall invoice CollaGenex monthly for all Products and
Professional Samples shipped by Atrix to CollaGenex and payment shall be due
[**], 30 days from receipt of the invoice.
Section 9.02. PURCHASE PRICE ADJUSTMENT.
(a) Timing and Information Requirements. The Purchase Price for each
Product shall be subject to adjustment (i) on [**] (the "Initial Adjustment
Date"), (ii) during the following [**] on each [**] anniversary of the
Initial Adjustment Date, and (iii) thereafter, on the [**] anniversary of
the Initial Adjustment Date (each, including the Initial Adjustment Date,
and "Adjustment Date"). On or prior to each Adjustment Date, CollaGenex
shall provide to Atrix a supplement to the Royalty Statement otherwise then
due ("Supplemental Royalty Statement") setting forth the following
information: (x) the aggregate [**] for that Evaluation Period and the [**]
as a percentage of Net Sales (the "Service Cost Percentage") for that
Evaluation Period; (y) for each Product, (A) the [**] and the net
percentage change in the [**] for that Evaluation Period, and (B) the
weighted average [**] for all Products and the net percentage change in the
weighted average [**] for all Products for that Evaluation Period; and (z)
the [**] for that Evaluation Period.
(b) When Adjustment is Required. Based on the Supplemental Royalty
Statement, the Parties will adjust the Purchase Price on a
Product-by-Product basis in accordance with the following provisions: (i)
no adjustment shall be made unless the difference between the [**] for the
preceding [**] Evaluation Period (or such shorter Evaluation Period in the
case of an Initial Adjustment Date) (as appropriately adjusted for any
changes arising as a result of [**] being in effect during such Evaluation
Period), minus the [**] results in a cumulative net change of plus or minus
[**] (the "Variance"), and then only to the extent that either (A) the net
percentage change in the weighted average [**] per Unit for all Products,
and/or (B) the difference between the [**] at the beginning and end of that
Evaluation Period, results in a net change of plus or minus [**] The
Purchase Price shall be adjusted upward, if the Variance is a positive
number, and downward, if the Variance is a negative number.
(c) Amount of Adjustment. Any required adjustment: (i) shall only be
made in the minimum amount necessary to delete any Variance at the end of
the subsequent [**] Evaluation Period and not in a shorter period of time,
(ii) shall be based on the assumption that the [**] and the weighted
average [**] for all Products as of the end of the most recent [**]
Evaluation Period shall remain in effect for the next [**] Evaluation
Period and (iii) shall in no event reduce the Purchase Price for any
Product below the Atrix Manufacturing Cost for such Product plus [**] The
Parties shall share equally in any adjustment resulting from a change in
the [**] (e.g., an adjustment of $0.50 instead of $1.00 to the Purchase
Price).
(d) Related Issues. After consultation with CollaGenex, Atrix shall
determine the amount of the adjustment and the Products to which such
Purchase Price adjustment shall be made. Any adjustment shall take effect
with respect to all [**] made after the applicable [**] and the [**] shall
automatically be revised to reflect the adjusted Purchase Price. No
adjustment shall apply retroactively. If CollaGenex disagrees with any
action or inaction taken by Atrix under this Section 9.02 such disagreement
shall be resolved in accordance with Article XVII.
Section 9.03. LABELING AND ARTWORK.
21
(a) After execution of this Agreement, CollaGenex shall have the right
to review and comment upon any labeling and proposed changes to the
labeling of the Products and to participate in discussions with the
Governmental Authorities concerning any labeling or proposed labeling
change. Notwithstanding the above, Atrix shall make the final decision with
regard to any labeling or labeling revisions.
(b) Both Parties will approve all artwork developed for inclusion in
the Product packaging, including carton labels, package inserts, etc.,
which approval will not be unreasonably withheld, conditioned or delayed by
either Party. For the avoidance of doubt, Atrix will be solely responsible
for the initial conversion of the current artwork to artwork bearing the
CollaGenex name and trade dress, as applicable. The Parties acknowledge
that other significant changes from currently approved packaging and
labeling may require FDA approval prior to marketing. If CollaGenex wishes
to institute changes in labeling artwork, after the Parties have agreed to
and implemented the first labeling artwork bearing the CollaGenex name and
information, both Parties will develop a mutually acceptable implementation
schedule. The actual cost of implementing such change will be at
CollaGenex's sole cost and expense, including any materials made obsolete
by CollaGenex's changes to the artwork. Neither Party shall alter, change
or in any way modify the artwork, which has previously been approved, for
any reason, without prior written authorization from the other Party, which
approval will not be unreasonably withheld, conditioned or delayed, and
provided that such approved artwork shall conform to all Applicable Laws.
Section 9.04. PURCHASE FORMS. Purchase orders, purchase order releases,
confirmations, acceptances and similar documents submitted by a Party in
conducting the activities contemplated under this Agreement are for
administrative purposes only and shall not add to or modify the terms of the
Agreement. To the extent of any conflict or inconsistency between this Agreement
and any such document, the terms of this Agreement shall govern.
Section 9.05. CONFIRMATION. Atrix shall confirm each purchase order within
ten business days from the date of receipt of a purchase order and shall supply
the Products within a maximum of 60 days from the date of acceptance of a
purchase order, or later if so specified in the purchase order. Failure of Atrix
to confirm any purchase order shall not relieve Atrix of its obligation to
supply Products ordered by CollaGenex in conformity with this Agreement.
Section 9.06. DELIVERY. Delivery terms for the Products and Professional
Samples shall be FOB Atrix's manufacturing facility at Fort Xxxxxxx, Colorado.
Atrix shall ship the Products and Professional Samples in accordance with
CollaGenex's purchase order form or as otherwise directed by CollaGenex in
writing. Title to any Product or Professional Samples purchased by CollaGenex
shall pass to CollaGenex or its agent upon the earlier of (a) a common carrier
accepting possession or control of such Product or Professional Samples, as
applicable, or (b) passage of such Product or Professional Samples, as
applicable, from the loading dock of Atrix's facilities to CollaGenex or its
agent. When delivered to a common carrier, the Products shall have an expiration
date of no less than 18 months.
Section 9.07. FORECASTS AND ORDERS.
22
(a) On or prior to the Effective Date, CollaGenex will provide Atrix
with a 12 month forecast of CollaGenex's requirements for each Product, on
a Product-by-Product basis, including Professional Samples, as follows:
(i) During the first four calendar quarters following the First
Commercial Sale of each Product, the forecasts shall be provided
quarterly, no less than 45 days prior to the beginning of each
quarter. Said requirements will be based on standard production
planning parameters including sales forecasts, sales demand forecasts,
promotional forecasts, inventory requirements, and the like. The first
two quarters of the 12 month forecast will be stated in monthly
requirements. The second two quarters of the 12 month forecast will be
total requirement by stock keeping unit and will be stated as
quarterly requirements. The first 3 months of the 12 month forecast
will be firm orders to purchase. The second 3 months will be allowed
to be flexed from the previous forecast by plus or minus [**] until
fixed by the subsequent forecast; provided that the aggregate
adjustment from the quantity set forth in the previous forecast for
such 3 month period shall not exceed [**] during that 3 month period.
For example, if CollaGenex's forecast for [**] was for [**] and its
forecast for [**] was for [**] the maximum number of Units CollaGenex
could order at the time [**] becomes fixed would be [**]. The [**] of
any [**] will be [**].
(ii) After the first four calendar quarters following the First
Commercial Sale of a Product, CollaGenex will provide to Atrix a
rolling 12 month forecast for each Product with the first 3 months of
the rolling 12 month forecast a firm order to purchase. Each forecast
under this subsection (ii) shall be provided monthly, no less than 20
days prior to the beginning of each month. All orders will be for full
batch quantities.
(b) CollaGenex agrees to purchase a sufficient amount of each Product
to enable CollaGenex to carry sufficient inventory to allow for
fluctuations in sales demand so as to allow Atrix reasonable lead time to
meet increased demand. All forecasts will be made by CollaGenex to Atrix in
good faith based upon standard commercial parameters. From time to time
after the Effective Date, the Parties shall consider whether, in light of
market demand, manufacturing capacity, inventory levels and other pertinent
factors, to revise the schedule for delivery of forecasts and, if
appropriate, negotiate in good faith to revise such schedule.
Section 9.08. PROFESSIONAL SAMPLES. Pursuant to the provisions of Section
9.07, for so long as CollaGenex retains a license pursuant to Section 2.01 in
the Territory, Atrix shall supply to CollaGenex Professional Samples in such
amount as the Parties may mutually agree. For a period of [**] following the
Effective Date, Atrix shall provide at [**] the Professional Samples to
CollaGenex, up to a maximum amount of [**] during any [**] period and up to a
maximum aggregate amount of [**] during such [**] period. Except as otherwise
set forth in this Agreement, [**] Professional Samples to CollaGenex at [**]
CollaGenex (a) shall only use the Professional Samples for marketing and
promotional activities (e.g., as professional or trial samples to be left
following Detail Calls, or in association with other marketing activities such
as workshops, symposia or trade shows), (b) shall not sell the Professional
Samples and (c) shall not use the Professional Samples other than for the
primary intent of inducing future sales of ATRIDOX(R).
23
ARTICLE X
WARRANTY, REJECTION AND INSPECTIONS
Section 10.01. ATRIX WARRANTY. Atrix represents and warrants to CollaGenex
that the Products and Professional Samples delivered pursuant to this Agreement
(a) shall comply with the Specifications and conform to the certificate of
analysis for such Product; (b) are not adulterated or misbranded under
Applicable Laws; and (c) at the time of Manufacture and delivery to CollaGenex,
will be free from any failure or defects.
EXCEPT AS OTHERWISE SET FORTH HEREIN, ATRIX MAKES NO OTHER WARRANTIES OF
ANY OTHER KIND, INCLUDING BUT NOT LIMITED TO ANY WARRANTY OF MERCHANTABILITY OR
FITNESS OF THE PRODUCTS AND PROFESSIONAL SAMPLES FOR ANY PURPOSE, AND ATRIX
EXPRESSLY DISCLAIMS ANY SUCH OTHER WARRANTIES WITH RESPECT TO THE PRODUCTS AND
PROFESSIONAL SAMPLES, EITHER EXPRESSED OR IMPLIED.
Section 10.02. REJECTION OF PRODUCT OR PROFESSIONAL SAMPLES FOR FAILURE TO
CONFORM TO SPECIFICATIONS. Each Shipment shall be considered accepted by
CollaGenex based on its reliance on the Certificate of Analysis and its
appropriate physical inspection of the Product, subject to CollaGenex's right to
test or have a Third Party test any Shipment to determine conformity of the
Shipment to the Specifications and/or Applicable Laws. If CollaGenex exercises
such right, it shall promptly notify Atrix of its decision and shall have 45
days after the receipt of any Shipment to conduct such testing. If testing of
such Shipment shows a failure of the Shipment to meet the Specifications and/or
Applicable Laws, CollaGenex may return the entire Shipment, or any portion
thereof, to Atrix at Atrix's expense within a reasonable time following the
above described testing, provided that notice of non-conformity is received by
Atrix from CollaGenex within 45 days of CollaGenex's receipt of said Shipment.
CollaGenex shall have the right to request that Atrix provide to CollaGenex,
within 30 days after such notice is received by it, Product or Professional
Samples that meet the Specifications and Applicable Laws or to promptly provide
CollaGenex with full credit for the Purchase Price paid by CollaGenex for the
returned Product or Professional Samples. The cost of freight and handling to
return or replace the Products or Professional Samples shall be at the expense
of Atrix. If CollaGenex does not notify Atrix of the non-conformity of the
Product or Professional Samples within 45 days of receipt of said Shipment, the
Product or Professional Samples shall be deemed to meet the Specifications, the
Packaging Specifications and Applicable Laws. Notwithstanding anything in this
Agreement to the contrary, the Parties may agree to a return of the Product or
Professional Samples or an adjustment in the Purchase Price in the event of any
failure or defect in the Product or Professional Samples. Should there be a
discrepancy between CollaGenex's test results and the results of testing
performed by Atrix, such discrepancies shall be finally resolved by testing
performed by an independent Third Party mutually agreed upon by CollaGenex and
Atrix. The costs of such testing shall be borne by the Party against whom the
discrepancy is resolved. In the event the Product or Professional Samples have
been previously returned to Atrix and an independent Third Party determines that
the Product or Professional Samples meet the Specifications, CollaGenex shall be
responsible for all costs associated with the return.
24
Section 10.03. COLLAGENEX INSPECTIONS. Atrix shall upon reasonable (but not
less than ten days) prior written notice by CollaGenex and during normal
business hours, allow CollaGenex to inspect and audit Atrix's facilities used to
Manufacture the Products and the Professional Samples, no more than twice
annually, to confirm that the Atrix's facilities and the equipment, personnel
and operating and testing procedures used by Atrix in the Manufacture, testing,
storage and distribution of the Products are in compliance with Applicable Laws
and the Governmental Approvals; provided that such inspection does not interfere
with Atrix's normal operations or cause Atrix to violate or be in breach of any
confidentiality agreements with any Third Parties.
ARTICLE XI
REGULATORY COMPLIANCE
Section 11.01. MAINTENANCE OF MARKETING AUTHORIZATIONS. [**] will own all
Marketing Authorizations in the Territory. [**] agrees, [**], to maintain the
Marketing Authorizations including obtaining any variations or renewals thereof,
including all fees and licenses, including user fees, related to the Manufacture
of the Products by Atrix. Each Party agrees that neither it nor its Affiliates
will do anything to adversely affect a Marketing Authorization.
Section 11.02. ADVERSE DRUG EVENT REPORTING AND PHASE IV SURVEILLANCE.
(a) Each Party, including its permitted sublicensees, shall advise the
other Party, by telephone or facsimile, immediately but in no event later
than the next business day after a Party, or its sublicensees, becomes
aware of any potentially serious or unexpected adverse event (including
adverse drug experiences, as defined in Applicable Laws) (an "ADE")
involving the Products or the Professional Samples. Such advising Party
shall provide the other Party with a written report delivered by confirmed
facsimile of any adverse reaction, stating the full facts known to such
Party, including customer name, address, telephone number, batch, lot and
serial numbers, and other information as required by Applicable Laws. For
so long as CollaGenex has an exclusive license to market, promote and sell
the Products the Territory for use in the Field, CollaGenex shall have full
responsibility for data collection activities that occur between CollaGenex
and the patient or medical professional, as appropriate, including any
follow-up inquiries which CollaGenex deems necessary or appropriate. Atrix
shall have responsibility for medical monitoring of, and final medical
sign-off on, ADEs.
If Atrix exercises its right to co-market as set forth in Article V,
then upon the occurrence of an ADE the Parties shall promptly meet, in
person or by telephone, as appropriate, to discuss and determine how to
mutually handle and resolve any issues relating to or arising from any such
ADE.
(b) In the event either Party requires information regarding adverse
drug events with respect to reports required to be filed by it to comply
with Applicable Laws, including obligations to report ADEs to the
Governmental Authorities, each Party agrees to provide such information to
the other on a timely basis. For the avoidance of doubt, Atrix shall be
responsible for all trend and ADE reporting to Governmental Authorities,
25
and for the maintenance of the file of original ADE forms. CollaGenex shall
have access on request to the worldwide Atrix database of ADEs related to
the Products.
(c) Subject to Atrix's exercise of its Co-Marketing rights under
Article V, the Parties agree to follow CollaGenex's standard operating
procedure for reporting and identifying adverse drug reactions (the "SOP")
a copy of which is attached hereto as Exhibit F. In the event the SOP is
modified or amended during the Term, CollaGenex shall provide Atrix with
copies of any such modification or amendment to the SOP for Atrix's prior
approval, which will not be unreasonably withheld, conditioned or delayed,
at least five business days prior to such amendment taking effect.
CollaGenex shall designate a qualified person under Applicable Laws to be
responsible for ADE reporting in the Territory. In order to facilitate the
development of the customer response procedures for the Products, Atrix
shall supply to CollaGenex: (i) all professional and patient materials used
for responding to professional and consumer inquirers (including but not
limited to procedural, standard response letters, literature search
findings and references used in the evaluation, documentation and
communication with healthcare professionals and consumers), (ii) NDA
summaries and general technical reports relevant to the processing and
response to customer inquiries, (iii) the historical electronic database of
professional and consumer inquiries and responses for the last 12 months
(iv) a copy of the responses to each inquiry and (v) an historical
electronic database of Adverse Events, provided in each such case Atrix has
Control of such information.
(d) If the report of an ADE causes a Governmental Authority to request
labeling revision as a result of an ADE or that a Phase IV surveillance
program be conducted, then the Parties shall promptly enter into
discussions and shall mutually agree on all of the material terms and
conditions of such labeling revision or Phase IV surveillance program;
provided, however the costs of such labeling revision or Phase IV
surveillance program shall be borne 100% by Atrix. Atrix shall make all
final decisions with regard to any labeling revisions and the development,
design and implementation of such Phase IV study. CollaGenex agrees that
should Applicable Laws require that any such interim data and results from
such Phase IV surveillance programs be prepared in written form, CollaGenex
shall comply with such requirements and provide all such information in
writing to Atrix and the Governmental Authorities in accordance with
Applicable Laws. CollaGenex further agrees that Atrix shall have the right
to incorporate, refer to and cross-reference such results and underlying
data in any regulatory filing or any other filing or requirement Atrix is
required to undertake with respect to the Products.
Section 11.03. PHASE IV STUDIES. In the event a Governmental Authority
requires Atrix to conduct a Phase IV study, Atrix shall develop, design and
implement such Phase IV study and the costs shall be borne 100% by Atrix.
CollaGenex shall pay 100% of the costs of any Phase IV study conducted solely
for marketing purposes; provided, however, that Atrix shall supply to CollaGenex
up to [**] to conduct a Phase IV seeding study, [**] (other than shipping costs)
to CollaGenex. In exchange for providing [**] to be used in such Phase IV
seeding study, Atrix shall have the rights to use the results of such Phase Iv
seeding study outside of the Territory. Upon completion of such Phase IV seeding
study, CollaGenex shall provide Atrix with a detailed list of the number of [**]
used by CollaGenex in such Phase IV seeding study in the next Royalty Statement.
If CollaGenex used its existing inventory of [**] to conduct such Phase IV
seeding study, CollaGenex may offset the cost to CollaGenex for [**] excluding
shipping and handling costs, from future payments to Atrix. The costs of any
Phase IV study conducted solely for marketing purposes shall be included in
CollaGenex's aggregate A&S expenditures for purposes of Section 14.04.
Section 11.04. ASSISTANCE. Each Party shall provide reasonable assistance
to the other at the other's request, in connection with their obligations
pursuant to this Article XI, subject to reimbursement of all of its
out-of-pocket costs by the requesting Party.
26
Section 11.05. COMPLIANCE. CollaGenex shall be responsible for compliance
with Applicable Laws and the Government Approvals relating to the possession,
promotion, marketing, sale, advertising and distribution of the Products and
Units and distribution of the Professional Samples, as applicable, including (a)
obtaining all necessary permits, licenses and any other requirements relating to
the sale and distribution of the Products and Professional Samples, (b)
arranging for the warehousing and distribution of the Products, which
warehousing facility and distributor shall be reasonably satisfactory to Atrix,
and (c) all billing and collection activities with respect to the Products.
Atrix shall be responsible for compliance with Applicable Laws and Government
Approvals relating to the Manufacture, design and production of the Products,
Units and the Professional Samples, as applicable, and with cGMP relating to the
Manufacture and testing of the Products and the Professional Samples, as
applicable. CollaGenex and Atrix shall comply with all Applicable Laws within
the Territory as set forth in this Agreement, including the provision of
information by CollaGenex and Atrix to each other necessary for Atrix and
CollaGenex to comply with any applicable reporting requirements. Each Party
shall promptly notify the other Party of any comments, responses or notices
received from, or inspections by, the FDA, or other applicable Governmental
Authorities, which relate to or may impact the Product or the Manufacture of the
Product or the sales and marketing of the Product, and shall promptly inform the
other Party of any responses to such comments, responses, notices or inspections
and the resolution of any issue raised by the FDA or other Governmental
Authorities.
ARTICLE XII
PATENTS AND TRADEMARKS
Section 12.01. MAINTENANCE OF PATENTS OR MARKS. Atrix shall, at Atrix's
expense, maintain and protect the Atrix Patent Rights and the Atrix Marks in the
Territory for so long as CollaGenex markets the Products or has provided a
marketing plan and forecast for Product requirements; provided however, that
upon written request by Atrix, CollaGenex shall, at no cost or expense to
CollaGenex, provide such assistance as may be necessary to enable Atrix to
comply with the administrative formalities necessary to maintain any Atrix
Patent Rights or the Atrix Marks.
Section 12.02. COOPERATION. CollaGenex shall, at no cost or expense to
CollaGenex, make available to Atrix or its authorized attorneys, agents or
representatives, its employees, agents or consultants necessary or appropriate
to enable Atrix to file, prosecute and maintain patent applications for a period
of time sufficient for Atrix to obtain the assistance it needs from such
personnel.
Section 12.03. ATRIX TO PROSECUTE INFRINGEMENT. During the Term, each Party
shall give prompt notice to the other of any Third Party act which may infringe
the Atrix Patent Rights and shall cooperate with each other to terminate such
infringement without litigation. Atrix shall, at its sole expense, prosecute the
judicial or administrative proceedings against such Third Party infringement.
CollaGenex shall provide such assistance and cooperation to Atrix as may be
necessary to successfully prosecute any action against Third Party infringement
at Atrix's expense and may deduct the expenses thereof from any amounts payable
to Atrix under this Agreement.
27
In the event Atrix fails to institute proceedings and terminate any Third
Party infringement of the Atrix Patent Rights, CollaGenex may take such action
as it deems appropriate, including without limitation, the filing of a lawsuit
against such Third Party. In such event Atrix will provide such assistance and
cooperation to CollaGenex as may be necessary, at CollaGenex's expense, and
CollaGenex may deduct all costs and expenses of such actions against any amount
payable to Atrix under this Agreement and retain all amounts awarded in such
action. CollaGenex may settle any such claim so long as the terms of such
settlement do not impair Atrix's rights hereunder or Atrix's rights in the Atrix
Technology.
Section 12.04. INFRINGEMENT CLAIMED BY THIRD PARTIES. In the event a Third
Party commences, or threatens to commence, a judicial or administrative
proceeding against a Party to this Agreement and such proceeding claims that the
Atrix Technology or the Atrix Marks infringes such Third Party's intellectual
property rights, the Party against whom such proceeding is threatened or
commenced shall give prompt notice to the other Party. Atrix shall, at its sole
expense, defend such claims or proceedings and CollaGenex shall provide such
assistance and cooperation to Atrix as may be necessary to successfully defend
any such claim or proceeding at Atrix's expense. Atrix may settle any such claim
so long as the terms of such settlement do not impair CollaGenex's rights
hereunder, or increase the costs to CollaGenex hereunder. Notwithstanding the
above, if such claim or proceeding relates to or arises from the actions,
activities or omissions of CollaGenex other than the use by CollaGenex of the
Atrix Technology or the Atrix Marks, then CollaGenex shall defend such claims or
proceedings, at CollaGenex's sole expense, and CollaGenex shall indemnify Atrix
for any liabilities, costs and expenses, including, without limitation,
attorneys' fees, incurred with respect to such claim or proceeding.
ARTICLE XIII
REPRESENTATIONS, WARRANTIES and COVENANTS
Section 13.01. CORPORATE POWER. Each Party hereby represents and warrants
that such Party is duly organized and validly existing under the laws of the
state of its incorporation and has full corporate power and authority to enter
into this Agreement and to carry out the provisions hereof.
Section 13.02. DUE AUTHORIZATION. Each Party hereby represents and warrants
that such Party is duly authorized to execute and deliver this Agreement and to
perform its obligations hereunder.
Section 13.03. BINDING OBLIGATION. Each Party hereby represents and
warrants that this Agreement is a legal and valid obligation binding upon it and
is enforceable in accordance with its terms. The execution, delivery and
performance of this Agreement by such Party does not conflict with any
agreement, instrument or understanding, oral or written, to which it is a party
or by which it may be bound, nor violate any law or regulation of any court,
governmental body or administrative or other agency having authority over it.
Section 13.04. OWNERSHIP OF ATRIX PATENT RIGHTS. As of the Effective Date,
Atrix represents and warrants that (a) it has all right, title and interest in
and to the Atrix Patent Rights and the Atrix Marks necessary to grant CollaGenex
the licenses hereunder; (b) except for those
28
rights granted to Block under the Eighth Amendment and except with respect to
CollaGenex, it has not granted any license under the Atrix Patent Rights or the
Atrix Marks for any Product in the Territory for use in the Field to any Third
Party and is under no obligation to grant any such license; (c) except for the
security interest granted to Block in the Atrix Marks under the Eighth Amendment
and such other rights of Block thereunder, there are no outstanding liens,
encumbrances, agreements or understanding of any kind, either written, oral or
implied, regarding either the Atrix Patent Rights or the Atrix Marks which are
inconsistent or in conflict with this Agreement; and [**] Atrix, [**] Atrix[**]
(ii) that Block shall sell to Atrix all unsold Product held by Block as of
October 31, 2001.
Section 13.05. PATENT PROCEEDINGS. Atrix represents and warrants that (a)
no patent application within the Atrix Patent Rights is the subject of any
pending interference, opposition, cancellation or other protest proceeding, and
(b) to the best of its knowledge, the Atrix Technology does not infringe the
intellectual property rights of any Third Party.
Section 13.06. ADVERSE PROPERTIES. Atrix represents and warrants that it
knows of no adverse effects or other properties that may raise objections from
the FDA or other health registration authorities or may affect the use,
effectiveness or merchantability of the Products.
Section 13.07. PRESERVATION OF NAME AND REPUTATION. During the Term, each
of the Parties shall endeavor to preserve the good name and reputation of the
other Party and shall conduct itself in a manner as to maintain the good name
and reputation of the other Party.
Section 13.08. DEBARMENT. During the term, neither of the Parties shall
utilize any employee, representative, agent, assistant or associate who has been
debarred pursuant to the Act in connection with any of the activities to be
carried out under this Agreement.
Section 13.09. LIMITATION ON WARRANTIES. Except as expressly set forth in
this Agreement, nothing herein shall be construed as a representation or
warranty by Atrix to CollaGenex that the Atrix Technology is not infringed by
any Third Party, or that the practice of such rights does not infringe any
published intellectual property rights of any Third Party. Neither Party makes
any warranties, express or implied, concerning the success or commercial utility
of the Products.
Section 13.10. LIMITATION OF LIABILITY. EXCEPT FOR WILLFUL MISCONDUCT,
GROSS NEGLIGENCE OR INFRINGEMENT OF THIRD PARTY PROPRIETARY RIGHTS, NEITHER
PARTY SHALL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY SPECIAL, INCIDENTAL,
CONSEQUENTIAL OR PUNITIVE DAMAGES IN CONNECTION WITH THIS AGREEMENT OR ANY
LICENSE GRANTED HEREUNDER.
ARTICLE XIV
COVENANTS OF COLLAGENEX AND ATRIX
Section 14.01. COVENANT NOT TO LAUNCH COMPETITIVE PRODUCT.
(a) CollaGenex hereby covenants and shall cause its Affiliates to
agree not to develop, in-license, market, sell, distribute or have
marketed, have sold or have
29
distributed any Competitive Product in the Territory during the Term
without the prior written approval of Atrix, such approval not to be
unreasonably withheld. Notwithstanding the foregoing, if CollaGenex or any
Affiliate acquires an entity or all or substantially all of the assets of
an entity and such entity distributes or such assets include a Competitive
Product, CollaGenex or such Affiliate shall have 120 days in which to
divest itself of such Competitive Product or to otherwise cease
distribution of such Competitive Product, and CollaGenex shall not be in
breach of this Section 14.01 if it or the Affiliate, as the case may be, so
divests or ceases distribution within such 120 day period;
(b) All of the covenants in this Section 14.01 shall be construed as
an agreement independent of any other provision in this Agreement, and the
existence of any claim or cause of action of CollaGenex, its designee or
its Affiliates against Atrix, whether predicated on this Agreement or
otherwise, shall not constitute a defense to the enforcement by Atrix of
such covenants; and
(c) CollaGenex and Atrix hereby agree that the covenants set forth in
this Section 14.01 are a material and substantial part of the transactions
contemplated by this Agreement.
Section 14.02. LIMITATION TO THE TERRITORY.
(a) CollaGenex hereby covenants that it will not, without the prior
written authorization of Atrix: (i) promote or actively solicit sale of the
Products or advertise the Products, outside of the Territory; (ii) contact
any of Atrix's suppliers or vendors of the Products or components relating
to the Products (except as required by law); (iii) contact the Governmental
Authorities or other entity about the Products, except as required by
Applicable Laws or as may be necessary or appropriate to carry out its
obligations hereunder; (iv) knowingly sell or distribute for resale the
Products purchased hereunder to a Third Party who intends to sell outside
of the Territory; and (v) prior to October 31, 2001, market, promote,
advertise, distribute, commercialize or sell the Products to the customers
set forth on the Block customer list provided to CollaGenex by Atrix.
(b) to the extent allowed by Applicable Laws, and except with respect
to Atrix's exercise of its Co-Marketing rights under Section 5.01, Atrix
hereby covenants that any agreement under which it licenses the Products to
a Third Party shall contain provisions that prohibit such Third Party from
directly or indirectly selling or otherwise distributing the Products in
the Territory.
Section 14.03. MARKETING AND INSTRUCTIONAL MATERIALS. Atrix shall cooperate
with CollaGenex in the creation of instructional materials for the customers of
CollaGenex to enable the customers of CollaGenex to use the Products correctly.
Atrix also agrees to assist CollaGenex in the training of its Dental Detail
Force. In addition, on the Effective Date, Atrix shall transfer to CollaGenex
all marketing, promotional and advertising materials ("Marketing Materials") for
the Products in Atrix's control. The copyright for all materials developed by
CollaGenex shall be owned exclusively by CollaGenex; however, Atrix shall retain
the exclusive copyright to all Marketing Materials transferred to CollaGenex.
Upon (a) termination of this
30
Agreement, (b) breach or default by CollaGenex under this Agreement or (c) in
the event, pursuant to the terms of this Agreement, Atrix has the right to
Manufacture and sell the Products to persons other than CollaGenex, then to the
extent required, CollaGenex hereby grants to Atrix a perpetual, royalty-free
license to such copyrighted materials in order that Atrix may use the substance
of such materials (other than any tradename, trademark or similar device) for
use in instructional materials accompanying the Products. In addition,
CollaGenex grants Atrix a perpetual, royalty free license under such copyrighted
materials in order that Atrix may use such materials in all other countries
outside the Territory. Atrix grants CollaGenex a non-exclusive royalty free
license to use the Marketing Materials transferred to CollaGenex by Atrix under
this Section 14.03 in the Territory during the Term.
Section 14.04. A&S SPENDING LEVELS. CollaGenex's aggregate direct A&S
spending level in the Territory for the fiscal year beginning January 1, 2002,
for all Products shall be no less than $2,000,000 which amount shall include
CollaGenex's retention of additional representatives for its Dental Detail Force
specifically for the Products. From the Effective Date through December 31,
2001, CollaGenex shall attend all major relevant industry recognized dental
trade shows, immediately commence detailing the Products to Atrix's and
CollaGenex's existing customers and make such other A&S expenditures as mutually
agreed to by the Parties. For each fiscal year commencing on and after January
1, 2003, CollaGenex's aggregate A&S spending level in the Territory shall:
(a) for [**] be the lesser of 30% of CollaGenex's Contribution Margin
for [**] in the Territory or $4,000,000.00.
(b) for the [**] Products, be the lesser of 30% of CollaGenex's
Contribution Margin for the [**] Products in the Territory or
$2,000,000.00.
(c) Atrix shall have the right to review CollaGenex's plan for A&S
spending levels prior to the implementation thereof; provided, however that
final approval and implementation of such plan shall be CollaGenex's
responsibility.
Section 14.05. Variances. In the event A&S expenses in the immediately
preceding year are less than the minimum required A&S requirements for that
year, CollaGenex shall make up the difference by adding the amount of the
shortfall to the minimum A&S requirements for the [**] and shall satisfy the
revised minimum aggregate A&S expenditure amount in the [**].
Section 14.06. Cash Alternatives. In the event CollaGenex determines it is
advisable to spend less than the A&S commitment as set forth in Section 14.04,
CollaGenex will notify Atrix of the proposed underspending whereupon Atrix shall
have the option of causing CollaGenex to spend the required amount or receive
from CollaGenex in cash [**] of the amount proposed to be underspent.
Section 14.07. MINIMUM SIZE OF DETAIL FORCE. On the Effective Date and at
all times during the first 24 months of the Term, CollaGenex shall have and
maintain a Dental Detail Force consisting of no less than 90 fulltime Dental
Consultants calling on Dentists in the Continental United States.
Section 14.08. DETAIL CALLS.
(a) [**] will be the subject of [**].
(b) [**] will be the subject of [**].
(c) Thereafter, CollaGenex will make [**] Detail Calls in the
Continental United States. The Parties agree to renegotiate in good faith
the number of Dental Consultants and Detail Calls then required if adverse
market conditions for the Products make the current numbers not
commercially viable.
Section 14.09. ACCESS TO BOOKS AND RECORDS. CollaGenex shall permit Atrix,
at Atrix's expense and during normal business hours, to exercise the inspection
rights granted to Atrix by CollaGenex under Section 3.04.
31
Section 14.10. MARKETING EXPENSES. CollaGenex covenants and agrees that,
except as otherwise specified in this Agreement, CollaGenex shall be solely
responsible for the cost and implementation of all marketing, sales, promotional
and related activities concerning the marketing, sale and promotion of the
Products and the distribution of the Professional Samples.
Section 14.11. PROTECTION OF THE MARKS. The Parties covenant and agree that
neither Party nor their Affiliates shall publish, employ nor cooperate in the
publication of, any misleading or deceptive advertising material with regard to
the Parties, or the Atrix Marks or CollaGenex's trademarks for the Products.
Section 14.12. DISTRIBUTION SYSTEM. CollaGenex shall enter into an
arrangement with a Third Party, reasonably acceptable to Atrix, to warehouse and
distribute the Product on or prior to October 1, 2001.
Section 14.13. FURTHER ACTIONS. Upon the terms and subject to the
conditions hereof, each of the Parties hereto shall use its commercially
reasonable efforts to (a) take, or cause to be taken, all appropriate action and
do, or cause to be done, all things necessary, proper or advisable under
Applicable Law or otherwise to consummate and make effective the transactions
contemplated by this Agreement, (b) obtain from Governmental Authorities any
consents, licenses, permits, waivers, approvals, authorizations or orders
required to be obtained or made by the Parties in connection with the
authorization, execution and delivery of this Agreement and the consummation of
the transactions contemplated by this Agreement and (c) make all necessary
filings, and thereafter make any other required submissions, with respect to
this transaction under (i) the Securities Exchange Act of 1934, as amended and
the Securities Act of 1933, as amended, and the rules and regulations thereunder
and any other applicable federal or state securities laws and (ii) any other
Applicable Law. The Parties hereto shall cooperate with each other in connection
with the making of all such filings, including by providing copies of all such
documents to the other Party's counsel (subject to appropriate confidentiality
restrictions) prior to filing and, if requested, by accepting all reasonable
additions, deletions or changes suggested in connection therewith. Without
limiting the generality of the foregoing, each Party shall take or omit to take
such action as the other Party shall reasonably request to cause the Parties to
obtain any material Governmental Approvals and/or the expiration of applicable
waiting periods, provided that the foregoing shall not obligate either Party to
take or to omit to take any action (including, without limitation, the
expenditure of funds or any holding separate and agreeing to sell or otherwise
dispose of assets, categories of assets or businesses) as in the good faith
opinion of such Party, would cause a material adverse effect on a Party.
Section 14.14. EQUITABLE RELIEF. The Parties understand and agree that
because of the difficulty of measuring economic losses to the non-breaching
Party as a result of a breach of the covenants set forth in this Article XIV,
and because of the immediate and irreparable damage that may be caused to the
non-breaching Party for which monetary damages would not be a sufficient remedy,
the Parties agree that the non-breaching Party will be entitled to seek specific
performance, temporary and permanent injunctive relief, and such other equitable
remedies to which it may then be entitled against the breaching Party. This
Article XIV shall not limit any other legal or equitable remedies that the
non-breaching Party may have against the breaching Party for violation of the
covenants set forth in this Article XIV. The Parties agree that the
non-breaching Party shall have the right to seek relief for any violation or
threatened violation of this
32
Article XIV by the breaching Party from any court of competent jurisdiction in
any jurisdiction authorized to grant the relief necessary to prohibit the
violation or threatened violation of this Article XIV. This Article XIV shall
apply with equal force to the breaching Party's Affiliates.
ARTICLE XV
PRODUCT RECALL
Section 15.01. PRODUCT RECALLS OR WITHDRAWAL. If at any time or from time
to time any Governmental Authority in the Territory requests a Party to recall a
Product or if a voluntary recall of a Product is contemplated by either Party
(collectively, a "Recall"), then the Party to whom such request is made or the
Party contemplating such Recall, as the case may be, shall immediately notify
the other Party. Neither Party shall carry out a voluntary Recall in the
Territory without the prior written approval of the other Party, which approval
shall not be unreasonably withheld, conditioned or delayed by either Party. Any
Recall in the Territory shall be carried out by CollaGenex in as expeditious a
manner as reasonably possible to preserve the goodwill and reputation of the
Product and the goodwill and reputation of the Parties. CollaGenex shall in all
events be responsible for conducting any Recall in the Territory, market
withdrawals or corrections with respect to the Products in the Territory.
CollaGenex shall maintain records of all sales and distribution of Product and
customers sufficient to adequately administer a Recall, market withdrawal or
correction for the period required by Applicable Law.
Section 15.02. RECALL COSTS. CollaGenex shall be responsible for conducting
any Recall in the Territory and the cost and expense of a Recall shall be
allocated as follows:
(a) if such Recall is a voluntary Recall or shall be due to tampering
or other cause, other than a manufacturer's defect, but not due to the
negligence or misconduct of the Parties, or the breach by a Party of its
warranties or obligations hereunder, then CollaGenex and Atrix shall each
bear 50% of the costs and expenses incurred by CollaGenex in connection
with such Recall, including, without limitation, all product credits and
returns, freight and shipping costs and product disposal expenses. In such
event, Atrix agrees to pay CollaGenex within ten days after its receipt
from CollaGenex of any invoice(s) assessing Atrix its 50% share of these
said costs, as listed above;
(b) if such Recall shall be due to manufacturer's defect or the
negligence or the breach by Atrix of its warranties or obligations
hereunder or the misconduct of Atrix, all such costs and expenses shall be
borne and paid solely by Atrix and Atrix will reimburse CollaGenex for any
such costs and expenses paid by CollaGenex within ten (10) days of receipt
of an invoice for such costs and expenses from CollaGenex, and if not so
paid CollaGenex shall have the right to offset such amounts against amounts
otherwise due by CollaGenex to Atrix hereunder; and
(c) if such Recall is due to the negligence or the breach by
CollaGenex of its warranties or obligations hereunder or the misconduct of
CollaGenex, all such costs and expenses shall be borne and paid solely by
CollaGenex and CollaGenex will reimburse Atrix for any such costs and
expenses paid by Atrix within 30 days of receipt of an invoice and
appropriate documentation for such costs and expenses from Atrix.
33
Section 15.03. NOTIFICATION OF COMPLAINTS. Each Party agrees that
throughout the Term, and with respect to all Products or Professional Samples
supplied or purchased under this Agreement, after the termination of this
Agreement, it will (a) notify the other Party immediately of all available
information concerning any complaint, Product defect reports, and similar
notices received by either Party with respect to the Products or Professional
Samples, whether or not determined to be attributable to the Products or
Professional Samples and (b) with respect to an ADE, comply with the provisions
of Section 11.02. CollaGenex, in consultation with Atrix, shall define and
implement regulatory compliance procedures, including, without limitation,
action plans and an SOP for Product defect reporting and will handle all Product
complaints in the Territory. In connection with any such Product complaint Atrix
shall cooperate as reasonably requested by CollaGenex including performing any
testing and follow-up investigations mutually agreed upon by the Parties, within
a commercially reasonable time frame.
Section 15.04. NOTIFICATION OF THREATENED ACTION. Throughout the duration
of this Agreement and with respect to all Products or Professional Samples
supplied or purchased under this Agreement, after the termination of this
Agreement, each Party shall immediately notify the other Party of any
information it receives regarding any threatened or pending action, inspection
or communication by or from a concerned Governmental Authority which may affect
the safety or efficacy claims of a Product or Professional Samples or the
continued marketing of a Product or distribution of the Professional Samples.
Upon receipt of such information, the Parties shall consult with each other in
an effort to arrive at a mutually acceptable procedure for taking appropriate
action.
ARTICLE XVI
INDEMNIFICATION AND INSURANCE
Section 16.01. COLLAGENEX INDEMNIFIED BY ATRIX. Atrix shall indemnify and
hold CollaGenex harmless from and against any liabilities or obligations,
damages, losses, claims, encumbrances, costs or expenses (including attorneys'
fees) (any or all of the foregoing herein referred to as "Loss") insofar as a
Loss or actions in respect thereof, whether existing or occurring prior to, on
or subsequent to the Effective Date, arises out of or is based upon (a) any
misrepresentation or breach of any of the warranties, covenants or agreements
made by Atrix in this Agreement; (b) the Manufacture of any Product or
Professional Sample that is identifiable as having been Manufactured by or on
behalf of Atrix; (c) any claims that a Product (as a result of the use of the
Atrix Technology therein) or its Manufacture (as a result of the use of Atrix
Technology therein), use or sale infringes the patent, trademark or proprietary
right of a Third Party.
Section 16.02. ATRIX INDEMNIFIED BY COLLAGENEX. CollaGenex shall indemnify
and hold harmless Atrix from and against any Loss insofar as such Loss or
actions in respect thereof occurs subsequent to the Effective Date, whether
existing or occurring prior to, on or subsequent to the date hereof, arises out
of or is based upon (a) any misrepresentation or breach of any of the
warranties, covenants or agreements made by CollaGenex in this Agreement; (b)
CollaGenex's use of the Marketing Authorizations in the marketing, sale,
distribution or promotion of the Products or the Professional Samples; (c)
CollaGenex's marketing, sale, distribution or promotion of the Products or the
Professional Samples (except if such Loss arises as a result of
34
matters described in Section 16.01); (d) the use of CollaGenex's name and
trademark in the packaging and labeling of the Products or Professional Samples
and in the marketing, sale, distribution or promotion of the Products or
Professional Samples where it is alleged that such name or trademark infringes
the proprietary rights of a Third Party.
Section 16.03. PROMPT NOTICE REQUIRED. No claim for indemnification
hereunder shall be valid unless notice of the matter which may give rise to such
claim is given in writing by the (the "Indemnitee") to the persons against whom
indemnification may be sought (the "Indemnitor") as soon as reasonably
practicable after such Indemnitee becomes aware of such claim; provided that the
failure to notify the Indemnitor shall not relieve it from any liability which
it may have to the Indemnitee otherwise than under this Article XVI. Such notice
shall state that the Indemnitor is required to indemnify the Indemnitee for a
Loss and shall specify the amount of Loss and relevant details thereof. The
Indemnitor shall notify Indemnitee no later than 60 days from such notice of its
intention to assume the defense of any such claim. In the event the Indemnitor
fails to give such notice within that time the Indemnitor shall no longer be
entitled to assume such defense.
Section 16.04. INDEMNITOR MAY SETTLE. The Indemnitor shall at its expense,
have the right to settle and defend, through counsel reasonably satisfactory to
the Indemnitee, any action which may be brought in connection with all matters
for which indemnification is available. In such event the Indemnitee of the Loss
in question and any successor thereto shall permit the Indemnitor full and free
access to its books and records and otherwise fully cooperate with the
Indemnitor in connection with such action; provided that this Indemnitee shall
have the right fully to participate in such defense at its own expense. The
defense by the Indemnitor of any such actions shall not be deemed a waiver by
the Indemnitor of its right to assert a claim with respect to the responsibility
of the Indemnitor with respect to the Loss in question. The Indemnitor shall
have the right to settle or compromise any claim against the Indemnitee without
the consent of the Indemnitee provided that the terms thereof: (a) provide for
the unconditional release of the Indemnitee; (b) require the payment of
compensatory monetary damages by Indemnitor only; and (c) expressly state that
neither the fact of settlement nor the settlement agreement shall constitute, or
be construed or interpreted as, an admission by the Indemnitee of any issue,
fact, allegation or any other aspect of the claim being settled. No Indemnitee
shall pay or voluntarily permit the determination of any liability which is
subject to any such action while the Indemnitor is negotiating the settlement
thereof or contesting the matter, except with the prior written consent of the
Indemnitor, which consent shall not be unreasonably withheld or delayed. If the
Indemnitor fails to give Indemnitee notice of its intention to defend any such
action as provided herein, the Indemnitee involved shall have the right to
assume the defense thereof with counsel of its choice, at the Indemnitor's
expense, and defend, settle or otherwise dispose of such action. With respect to
any such action which the Indemnitor shall fail to promptly defend, the
Indemnitor shall not thereafter question the liability of the Indemnitor
hereunder to the Indemnitee for any Loss (including counsel fees and other
expenses of defense).
Section 16.05. INSURANCE. Each Party shall, at its sole cost and expense,
obtain and keep in force comprehensive general liability insurance, including
any applicable self-insurance coverage, with bodily injury, death and property
damage limits of $5,000,000 per occurrence and $10,000,000 in the aggregate,
including contractual liability and product liability coverage. Upon execution
of this Agreement, each Party shall furnish the other with a certificate of
insurance
35
signed by an authorized representative of such Party's insurance underwriter
evidencing the insurance coverage required by this Agreement and providing for
at least 30 days prior written notice to the other Party of any cancellation,
termination or reduction of such insurance coverage.
ARTICLE XVII
DISPUTE RESOLUTION
Section 17.01. DISPUTES. The Parties recognize that disputes as to certain
matters may from time to time arise during the Term, which relate to either
Party's rights and/or obligations hereunder. It is the objective of the Parties
to establish procedures to facilitate the resolution of disputes arising under
this Agreement in an expedient manner by mutual cooperation and without resort
to litigation. To accomplish this objective, the Parties agree to follow the
procedures set forth in this Article XVII if and when a dispute arises under
this Agreement.
Unless otherwise specifically recited in this Agreement, disputes among the
Parties will be resolved as recited in this Article XVII. Any disputes relating
to the Collaboration hereunder shall be first referred to the Marketing Advisory
Board by either Party at any time after such dispute has arisen, and such Party
believes that there has been sufficient discussion of the matter at the current
level. If the Marketing Advisory Board is unable to resolve such a dispute
within 15 days of being requested by a Party to resolve the dispute or the
Marketing Advisory Board is unable to resolve a dispute among its members, the
matter shall be presented to the chief executive officers of Atrix and
CollaGenex, or their respective designees, for resolution. In the event that the
chief executive officers of Atrix and CollaGenex, or their respective designees,
cannot resolve the dispute within ten days of being requested by a Party to
resolve a dispute, either Party may, by written notice to the other, invoke the
provisions of Section 17.02.
Section 17.02. MEDIATION. If a dispute under this Agreement is not resolved
in accordance with Section 17.01, the Parties agree to submit the dispute to
mediation in accordance with the Commercial Mediation Rules of the American
Arbitration Association. The Parties will jointly appoint a mutually acceptable
mediator, seeking assistance in such regard from the American Arbitration
Association, if they have been unable to agree to upon such appointment within
ten days from the conclusion of the negotiation period (as provided in this
Agreement). The Parties agree to participate in good faith in the mediation and
the negotiations related thereto for a period of 30 days. The costs of the
mediation, including fees and expenses, shall be borne equally by the Parties.
Section 17.03. TRIAL WITHOUT JURY. If the Parties fail to resolve the
dispute through negotiation and mediation in accordance with Sections 17.01 or
17.02, each Party shall have the right to pursue any of the remedies legally
available to resolve the dispute; provided, however, that the Parties expressly
waive any right to a jury trial in any legal proceedings under this Section
XVII.
Section 17.04. PERFORMANCE TO CONTINUE. Each Party shall continue to
perform its obligations under this Agreement pending final resolution of any
dispute arising out of or related
36
to this Agreement; provided, however, that a Party may suspend performance of
its obligations during any period in which the other Party fails or refuses to
perform its obligations.
Section 17.05. PROVISIONAL REMEDIES. Although the procedures specified in
this Article XVII are the sole and exclusive procedures for the resolution of
disputes arising out of or related to this Agreement, either Party may seek a
preliminary injunction or other provisional equitable relief, if, in its
reasonable judgment, such action is necessary to avoid irreparable harm to
itself or to preserve its rights under this Agreement.
Section 17.06. DETERMINATION OF PATENTS AND OTHER INTELLECTUAL PROPERTY.
Notwithstanding the foregoing, any dispute relating to the determination of
validity of claims, infringement or claim interpretation relating to a Party's
patents shall be submitted exclusively to federal court.
ARTICLE XVIII
CONFIDENTIALITY
Section 18.01. CONFIDENTIALITY. During the Term and for a period of [**]
thereafter, each Party shall maintain all Confidential Information of the other
Party as confidential and shall not disclose any such Confidential Information
to any Third Party or use any such Confidential Information for any purpose,
except (a) as expressly authorized by this Agreement, (b) as required by law,
rule, regulation or court order (provided that the disclosing Party shall first
notify the other Party and shall use commercially reasonable efforts to obtain
confidential treatment of any such information required to be disclosed), or (c)
to its Affiliates and its employees, agents, consultants and other
representatives ("Representatives") to accomplish the purposes of this
Agreement, so long as such persons are under an obligation of confidentiality no
less stringent than as set forth herein. Each Party may use such Confidential
Information only to the extent required to accomplish the purposes of this
Agreement. Each Party shall use at least the same standard of care as it uses to
protect its own Confidential Information to ensure that it and its Affiliates
and Representatives do not disclose or make any unauthorized use of the other
Party's Confidential Information. Each Party shall be responsible for any breach
of this Agreement by its Representatives. Each Party shall promptly notify the
other Party upon discovery of any unauthorized use or disclosure of the other
Party's Confidential Information.
Section 18.02. PUBLICITY REVIEW. The Parties agree that the public
announcement of the execution of this Agreement shall be in the form of press
releases issued by each of the Parties to be agreed upon on or before the
Effective Date and thereafter each Party shall be entitled to make or publish
any public statement consistent with the contents thereof. Thereafter, the
Parties will jointly discuss and agree, based on the principles of this Section
18.02, on any statement to the public regarding this Agreement or any aspect of
this Agreement, and the results of clinical studies conducted hereunder, subject
in each case to disclosure otherwise required by law or regulation as determined
in good faith by each Party. When a Party elects to make any such statement it
will give the other Party at least three days notice to review and comment on
such statement. In the event of a public disclosure required by law prior to the
end of such three day period, the Party required to make such disclosure, if it
legally may, shall give the other Party at least two business days to review and
comment on such disclosure. If a Party was not legally
37
able to give notice under the previous sentence, it will furnish the other Party
with a copy of its disclosure as soon as practicable after the making thereof.
The Parties acknowledge the importance of supporting each other's efforts to
publicly disclose results and significant developments regarding the Products.
The principles to be observed by Atrix and CollaGenex in such public disclosures
will be: accuracy, the requirements for confidentiality under Section 18.01,
compliance with FDA regulations and other FDA guidance documents, the advantage
a competitor of Atrix or CollaGenex may gain from any public statements under
this Section 18.02, and the standards and customs in the biotechnology and
pharmaceutical industries for such disclosures by companies comparable to Atrix
and CollaGenex. The terms of this Agreement may also be disclosed to: (a)
government agencies where required by law, including filings required to be made
by law with the United States Securities and Exchange Commission ("SEC"),
national securities exchanges or the Nasdaq Stock Market, (b) Third Parties with
the prior written consent of the other Party, which consent shall not be
unreasonably withheld, or (c) lenders, investment bankers and other financial
institutions of its choice solely for purposes of financing the business
operations of such Party, so long as such disclosure in (b) and (c) above is
made under a binder of confidentiality at least as restrictive as the
confidentiality provisions in Section 18.01, so long as highly sensitive terms
and conditions such as financial terms are extracted from the Agreement
(including in any disclosure required by law or the SEC) or deleted upon the
request of the other Party, and so long as the disclosing Party gives reasonable
advance notice of the disclosure under the circumstances requiring the
disclosure.
ARTICLE XIX
MISCELLANEOUS
Section 19.01. NO-SOLICITATION. Neither Party nor its Affiliates
(collectively, the "Initiating Group") shall, directly or through its
representatives, solicit for employment any officer, director, employee or
consultant of the other Party or its subsidiaries or controlled affiliates
(collectively, the "Other Group") with whom the Initiating Group has had contact
in connection with, or who otherwise participates in, the transactions
contemplated by this Agreement. The Initiating Group shall not be precluded from
hiring any such person who has been terminated by the Other Group at least 90
days prior to commencement of employment discussions between such person and the
Initiating Group or its representatives. "Solicitation" shall not include any
generalized public advertisement or any other solicitation by the Initiating
Group or its representatives that is not specifically directed toward any such
employee of the Other Group or toward any group of such employees of the Other
Group.
Section 19.02. COMMERCIALLY REASONABLE EFFORTS. Each Party shall use
commercially reasonable and diligent efforts to perform its responsibilities
under this Agreement. As used herein, the term "commercially reasonable and
diligent efforts" means, unless the Parties agree otherwise, those efforts
consistent with the exercise of prudent scientific and business judgment, as
applied to other products of similar scientific and commercial potential within
the relevant product lines of the Parties.
Section 19.03. NO RIGHT TO USE NAMES. Except as otherwise provided herein,
no right, express or implied, is granted by the Agreement to use in any manner
the name "Atrix,"
38
"CollaGenex" or any other trade name or trademark of the other Party or its
Affiliates in connection with the performance of the Agreement.
Section 19.04. NOTICES. All notices, requests and other communications to
any party hereunder shall be in writing and shall be deemed to have been given
if delivered personally, mailed by certified mail (return receipt requested) or
sent by cable, telegram or recognized overnight delivery service to the parties
at the following addresses or at such other addresses as, specified by the
parties by like notice:
If to CollaGenex: Senior Vice President, Commercial Development
CollaGenex Pharmaceuticals, Inc.
00 Xxxxxxxxxx Xxxxx
Xxxxxxx, Xxxxxxxxxxxx 00000
Facsimile: (000) 000-0000
Telephone: (000) 000-0000
With a copy to: Xxxx and Xxxx LLP
000 Xxxxxxx Xxxx Xxxx
Xxxxxxxxx, Xxx Xxxxxx 00000
Facsimile: (000) 000-0000
Telephone: (000) 000-0000
Attention: Xxxxx X. Xxxxx, Esq.
If to Atrix: Senior Vice President, Corporate Development
Atrix Laboratories, Inc.
0000 Xxxxxxxx Xxxxx
Xxxx Xxxxxxx, Xxxxxxxx 00000-0000
Facsimile: (000) 000-0000
Telephone: (000)-000-0000
With a copy to: Xxxxxxxx & Xxxxxxxx LLP
000 Xxxxxxxxxxx Xxxxxx, Xxxxx 0000
Xxxxxx, Xxxxxxxx 00000
Facsimile: (000) 000-0000
Telephone: (000) 000-0000
Attention: Xxxxxx X. Xxxxxx, Esq.
Notice so given shall be deemed given and received (i) if by mail on the
fourth day after posting; (ii) by cable, telegram, telex or personal delivery on
the date of actual transmission, with evidence of transmission acceptance, or
(as the case may be) personal or other delivery; and (iii) if by overnight
delivery courier, on the next business day following the day such notice is
delivered to the courier service.
Section 19.05. SEVERABILITY. Whenever possible, each clause, subclause,
provision or condition of this Agreement shall be interpreted in such manner as
to be effective and valid under applicable law, but if any clause, subclause,
provision or condition of this Agreement should be prohibited or invalid under
applicable law, such clause, subclause, provision or
39
condition shall be considered separate and severable from this Agreement to the
extent of such prohibition or invalidity without invalidating the remaining
clauses, subclauses, provisions and conditions of this Agreement.
Section 19.06. ENTIRE AGREEMENT/MERGER. This Agreement sets forth the
entire agreement between the Parties hereto pertaining to the subject matter
hereof and supersedes all negotiations, preliminary agreements, memoranda or
letters of proposal or intent, discussions and understandings of the Parties
hereto in connection with the subject matter hereof. All discussions between the
Parties have been merged into this Agreement, and neither Party shall be bound
by any definition, condition, understanding, representation, warranty, covenant
or provision other than as expressly stated in or contemplated by this Agreement
or as subsequently shall be set forth in writing and executed by a duly
authorized representative of the Party to be bound thereby.
Section 19.07. AMENDMENT. No amendment, change or modification of any of
the terms, provisions or conditions of this Agreement shall be effective unless
made in writing and signed on behalf of the Parties hereto by their duly
authorized representatives.
Section 19.08. COUNTERPARTS. This Agreement may be executed in one or more
counterparts, each of which shall be deemed to be an original document, but all
such separate counterparts shall constitute only one and the same instrument.
This Agreement may be signed and delivered to the other Party by facsimile
signature; such transmission shall be deemed a valid signature.
Section 19.09. NO WAIVER OF RIGHTS. No waiver of any term, provision, or
condition of this Agreement, whether by conduct or otherwise, in any one or more
instances, shall be deemed to be or construed as a further or continuing waiver
of any such term, provision, or condition of this Agreement.
Section 19.10. FORCE MAJEURE. Neither Party shall be liable hereunder to
the other Party nor shall be in breach for failure to deliver, provided failure
to deliver is no greater than the delay in time caused by circumstances beyond
control for either Party, including acts of God, fires, floods, riots, wars,
civil disturbances, sabotage, accidents, labor disputes, shortages, government
actions (including priorities, requisitions, allocations and price adjustment
restrictions) and inability to obtain material, equipment, labor or
transportation (collectively, "Force Majeure").
Section 19.11. FURTHER ASSURANCES. The Parties hereto shall each perform
such acts, execute and deliver such instruments and documents and do all such
other things as may be reasonably necessary to accomplish the transactions
contemplated in this Agreement.
Section 19.12. ASSIGNMENT AND SUB-LICENSE. Neither this Agreement nor any
of the rights, interests, options or obligations hereunder may be assigned,
sublicensed or delegated by either of the Parties without the prior written
consent of the other Party, provided, however, that either CollaGenex or Atrix
may, without such consent, assign this Agreement and its rights and obligations
hereunder in connection with the transfer or sale of all or substantially all of
its business pertaining to this Agreement, or in the event of its merger or
consolidation or change in control or similar transaction. Any permitted
assignee shall assume all obligations of its assignor
40
under this Agreement or that Party may assign or sublicense any and all of its
rights, interests, options, and delegate all obligations hereunder, to any
Affiliate of such Party (and such Affiliate may further assign or sublicense
this Agreement to such Party or any other Affiliate of such Party) without the
consent of the other Party. In the event of an assignment or sublicense to an
Affiliate, the assigning Party shall guarantee the performance of such assignee
or sub-licensee. The assignment or sublicense to an Affiliate shall not operate
to discharge the assignor or sub-licensor from any obligation under this
Agreement. Any assignment which contravenes this Section 19.12 shall be void ab
initio.
Section 19.13. EXPENSES. The Parties hereto shall each bear their own costs
and expenses (including attorneys' fees) incurred in connection with the
negotiation and preparation of this Agreement and consummation of the
transactions contemplated hereby.
Section 19.14. BINDING EFFECT. This Agreement, and all of the terms,
provisions and conditions hereof, shall be binding upon and shall inure to the
benefit of the Parties hereto and their respective permitted successors and
assigns.
Section 19.15. GOVERNING LAW. This Agreement shall be construed and
interpreted accordance with the laws of the State of Delaware.
Section 19.16. SURVIVAL OF REPRESENTATIONS AND WARRANTIES. All statements
contained herein, or in any schedule hereto, shall be considered a
representation, warranty or covenant of the Party making such statement. All
representations, warranties, covenants contained herein, or in any schedule
hereto, shall survive the closing of this transaction.
Section 19.17. NO STRICT CONSTRUCTION. This Agreement has been prepared
jointly and shall not be strictly construed against either Party.
Section 19.18. INDEPENDENT CONTRACTORS. The status of the Parties under
this Agreement shall be that of independent contractor. No Party shall have the
right to enter into any agreements on behalf of the other Party nor shall it
represent to any Person that it has such right or authority.
41
IN WITNESS WHEREOF the Parties hereto have caused this Agreement to be duly
executed by their respective authorized officers as of the Effective Date.
COLLAGENEX PHARMACEUTICALS, INC.
By: /s/ Xxxxx X. Xxxxxxxxx
-----------------------
Xxxxx X. Xxxxxxxxx, Ph.D., Chairman and Chief
Executive Officer
ATRIX LABORATORIES, INC.
By: /s/ Xxxxx X. Xxxxxxx
--------------------
Xxxxx X. Xxxxxxx, Chairman and Chief Executive
Officer
42
A-1
EXHIBIT A
ATRIX PATENT RIGHTS
--------------------------------------------------------------------------------
[**] [**] [**]
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
[**] [**] [**]
--------------------------------------------------------------------------------
[**] [**] [**]
--------------------------------------------------------------------------------
[**] [**] [**]
--------------------------------------------------------------------------------
[**] [**] [**]
--------------------------------------------------------------------------------
[**] [**] [**]
--------------------------------------------------------------------------------
[**] [**] [**]
--------------------------------------------------------------------------------
[**] [**] [**]
--------------------------------------------------------------------------------
[**] [**] [**]
--------------------------------------------------------------------------------
[**] [**] [**]
--------------------------------------------------------------------------------
[**] [**] [**]
--------------------------------------------------------------------------------
[**] [**] [**]
--------------------------------------------------------------------------------
[**] [**]
--------------------------------------------------------------------------------
[**] [**]
--------------------------------------------------------------------------------
A-1
EXHIBIT B
FORM OF CERTIFICATE OF COMPLIANCE
Issue Date:
--------------------
CERTIFICATE OF COMPLIANCE
FOR
-----------------------------------------------------------------------------
CUSTOMER
------------------------------------------------------------------------
LOT NUMBER
-------------------------------------------------------------
FILL DATE PREP/EX DATE
----------------------------------------- ------------------
DOSAGE
--------------------------------------------------------------------------
QUANTITY OF RELEASABLE VIALS
----------------------------------------------------
The batch production record for this product has been reviewed for accuracy,
completeness, and compliance with established written standard procedures and in
accordance with cGMP requirements. Any deviations/abnormal occurrences from the
aforementioned requirements have been appropriately documented, reviewed, and
approved.
Reviewed By:
Batch Record Auditor
Date:
------------------------------------------
Approved By:
-----------------------------------
Acting Supervisor Manager, Documentation
Date:
------------------------------------------
cc: All Customers
B-1
EXHIBIT C
SPECIFICATIONS
[**]
C-1
EXHIBIT D
FORM OF STOCK PURCHASE
[STOCK PURCHASE AGREEMENT FILED SEPARATELY AS EXHIBIT 10.2]
D-1
EXHIBIT E
ATRIX MARKS
Trademark Roster (01) (Grouped by Trademark)
ATRIDOX
COUNTRY CLASSES APP. # APP. DT REG. # REG. DATE REGISTERED. OWNER CURRENT STATUS
------- ------- ------ ------- ------- --------- ----------------- --------------
Canada 850,064 07/07/1997 530,394 00/00/0000 Xxxxx Xxxx Xxxxxxxxxxx* Xxxxxxxxxx
Xxxxxx Xxxxxx 5 75080259 28/03/1996 2219251 19/01/1999 Block Drug Corporation* Registered
ATRISORB
COUNTRY CLASSES APP. # APP. DT REG. # REG. DATE REGISTERED. OWNER CURRENT STATUS
------- ------- ------ ------- ------ --------- ----------------- --------------
Canada 824,209 25/09/1996 511,768 00/00/0000 Xxxxx Xxxx Xxxxxxxxxxx* Xxxxxxxxxx
Xxxxxx Xxxxxx 10 75081223 29/03/1996 2135253 00/00/0000 Xxxxx Xxxx Xxxxxxxxxxx* Xxxxxxxxxx
Xxxxxx Xxxxxx 5 74102606 02/10/1990 1912165 15/08/1995 Block Drug Corporation* Sec. 8/15 Accepted
-------------------------
* On the Effective Date, Block will transfer and assign to Atrix all of its
right, title and interest in these trademarks. Atrix will then file the
appropriate assignment form with United States Patent and Trademark office
making Atrix the registered owner of these trademarks.
E-1
EXHIBIT F
COLLAGENEX'S STANDARD OPERATING PROCEDURES
INFORMATION TO BE PROVIDED BY COLLAGENEX.
F-1
EXHIBIT G
PRODUCT FIXED PRICE SCHEDULE
[**] [**]
[**] [**]
[**] [**]
G-1
