Exhibit 10.1
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote omissions.
AGREEMENT
between
ALTANA INC.
and
COLLAGENEX PHARMACEUTICALS, INC.
May 24, 2002
TABLE OF CONTENTS
PAGE
Article I DEFINITIONS 1
Article II LICENSE GRANTS 6
Section 2.01. Exclusive License Grant.................................6
Section 2.02. Non-Exclusive License Grant.............................6
Section 2.03. Disclosure of Information...............................6
Section 2.04. Extension of Patent Life................................7
Section 2.05. Improvements............................................7
Article III PAYMENTS AND ROYALTIES 7
Section 3.01. License Fee.............................................7
Section 3.02. Royalty Payments........................................7
Section 3.03. Reports, Exchange Rates.................................7
Section 3.04. Records and Audits......................................7
Section 3.05. Taxes...................................................8
Section 3.06. Payment Terms...........................................8
Section 3.07. Payment Method..........................................8
Section 3.08. No Assurances...........................................8
Article IV TERM AND TERMINATION 10
Section 4.01. Term...................................................10
Section 4.02. Termination By CollaGenex..............................10
Section 4.03. Termination By Altana..................................10
Section 4.04. Termination Upon Certain Events........................10
Section 4.05. Remedies...............................................10
Section 4.06. Effect of Termination..................................10
Article V COMMERCIALIZATION OF THE PRODUCT 11
Section 5.01. CollaGenex's Obligations...............................11
Article VI MANUFACTURE AND SUPPLY 12
Section 6.01. Agreement to Supply Products...........................12
Section 6.02. Quality Assurance......................................12
Section 6.03. Altana's Duties........................................12
Section 6.04. Failure to Supply......................................13
Article VII PURCHASE AND SALE 13
Section 7.01. Purchase Price and Payment.............................13
Section 7.02. Labeling...............................................13
Section 7.03. Purchase Forms.........................................14
Section 7.04. Forecasts and Orders...................................14
Section 7.05. Confirmation...........................................14
Section 7.06. Delivery...............................................14
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TABLE OF CONTENTS
PAGE
Section 7.07. Professional Samples...................................15
Section 7.08. Return of Products.....................................15
Article VIII WARRANTY, REJECTION AND INSPECTIONS OF SHIPMENTS 15
Section 8.01. Altana Warranty........................................15
Section 8.02. Rejection of Product or Professional Samples for
Failure to Conform to Specifications...................15
Section 8.03. CollaGenex Inspections.................................16
Article IX REGULATORY COMPLIANCE 16
Section 9.01. Maintenance of Regulatory Approvals....................16
Section 9.02. Adverse Drug Event Reporting...........................17
Section 9.03. Assistance.............................................17
Section 9.04. Compliance.............................................17
Article X PATENTS AND TRADEMARKS 18
Section 10.01. Maintenance of Patents or Marks.......................18
Section 10.02. Cooperation...........................................18
Section 10.03. Altana to Prosecute Infringement......................18
Section 10.04. Infringement Claimed by Third Parties.................18
Article XI REPRESENTATIONS AND WARRANTIES 19
Section 11.01. Corporate Power.......................................19
Section 11.02. Due Authorization.....................................19
Section 11.03. Binding Obligation....................................19
Section 11.04. Ownership of Patent Rights............................20
Section 11.05. Patent Proceedings....................................20
Section 11.06. Adverse Properties....................................20
Section 11.07. Governmental Approvals................................20
Section 11.08. Protection of the Marks...............................20
Section 11.09. SOP Conformance.......................................20
Section 11.10. Further Actions.......................................20
Section 11.11. Limitation of Liability...............................21
Article XII COVENANTS OF COLLAGENEX 21
Section 12.01. Limitation to the Territory...........................21
Section 12.02. Marketing and Instructional Materials.................21
Section 12.03. Marketing Expenses....................................21
Article XIII PRODUCT RECALL 21
Section 13.01. Product Recalls.......................................21
Section 13.02. Recall Costs..........................................22
Section 13.03. Notification of Complaints............................22
Section 13.04. Notification of Threatened Action.....................23
Article XIV INDEMNIFICATION AND INSURANCE 23
Section 14.01. CollaGenex Indemnified by Altana......................23
ii
TABLE OF CONTENTS
PAGE
Section 14.02. Altana Indemnified by CollaGenex......................23
Section 14.03. Prompt Notice Required................................23
Section 14.04. Indemnitor May Settle.................................24
Section 14.05. Insurance.............................................24
Article XV DISPUTE RESOLUTION 25
Section 15.01. Disputes..............................................25
Section 15.02. Mediation.............................................25
Section 15.03. Trial Without Jury....................................25
Section 15.04. Performance to Continue...............................25
Section 15.05. Provisional Remedies..................................26
Section 15.06. Determination of Patents and Other Intellectual
Property..............................................26
Article XVI CONFIDENTIALITY 26
Section 16.01. Confidentiality.......................................26
Section 16.02. Publicity Review......................................26
Article XVII MISCELLANEOUS 27
Section 17.01. Non-Solicitation and Non-Compete......................27
Section 17.02. Commercially Reasonable Efforts.......................28
Section 17.03. No Right to Use Names.................................28
Section 17.04. Notices...............................................28
Section 17.05. Section Headings......................................29
Section 17.06. Severability..........................................29
Section 17.07. Entire Agreement/Merger...............................30
Section 17.08. Amendment.............................................30
Section 17.09. Equitable Relief......................................30
Section 17.10. Counterparts..........................................30
Section 17.11. No Waiver of Rights...................................30
Section 17.12. Force Majeure.........................................30
Section 17.13. Further Assurances....................................30
Section 17.14. Assignment............................................30
Section 17.15. Expenses..............................................31
Section 17.16. Binding Effect........................................31
Section 17.17. Governing Law.........................................31
Section 17.18. No Strict Construction................................31
Section 17.19. US Dollars............................................31
Section 17.20. Independent Contractors...............................31
Exhibit A -- Patent Rights...........................................A-1
Exhibit B -- Standard Operating Procedures - Recall..................B-1
Exhibit C -- Specifications..........................................C-1
Exhibit D -- Marks...................................................D-1
Exhibit E -- Standard Operating Procedures - ADE.....................E-1
Exhibit F -- Product Fixed Price Schedule ...........................F-1
Exhibit G -- Standard Altana Production Quantities...................G-1
Exhibit H -- Memorandum..............................................H-1
iii
AGREEMENT
This Agreement ("Agreement") is made as of May 24, 2002, by and between
Altana Inc., a New York corporation ("Altana"), with its principal place of
business located at 00 Xxxxxx Xxxx, Xxxxxxxx, Xxx Xxxx 00000 and CollaGenex
Pharmaceuticals, Inc., a Delaware corporation ("CollaGenex"), with its principal
place of business located at 00 Xxxxxxxxxx Xxxxx, Xxxxxxx, Xxxxxxxxxxxx 00000.
Altana and CollaGenex are sometimes referred to collectively herein as the
"Parties" and individually as a "Party."
WHEREAS, Altana licenses certain proprietary information, intellectual
property, Patents Rights (as defined below) and Know-How (as defined below), and
possesses manufacturing capabilities for the Product (as defined below), and
subject to the terms of this Agreement, Altana desires to grant to CollaGenex an
exclusive sublicense to market and sell the Product for use in the Territory (as
defined below); and
WHEREAS, CollaGenex desires to obtain from Altana an exclusive sublicense
to advertise, promote, market, distribute, detail and sell the Products.
NOW, THEREFORE, in consideration of the mutual promises, covenants and
agreements hereinafter set forth, the Parties mutually agree to be legally bound
as follows:
ARTICLE I
DEFINITIONS
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.
"ADE" means any serious or unexpected adverse event (including adverse drug
experiences, as defined in Applicable Laws) involving the Product or the
Professional Samples.
"Affiliate" means any entity which directly or indirectly controls, is
controlled by or is under common control with either CollaGenex or Altana. The
term "control" means the power to direct or control the affairs of such entity
by reason of ownership of at least fifty percent (50%) of such entity by voting
stock, equity interest, contract or otherwise.
"Agreement" means this Agreement and any written amendments, addendum or
modifications hereto.
"Applicable Laws" means all applicable laws, including but not limited to
the Act, rules, regulations and guidelines within or outside the Territory that
may apply to the import, export, development, manufacturing, storage, marketing
or sale of the Product or the performance of either Party's obligations under
this Agreement including all cGMP or current Good Clinical Practices standards
or guidelines promulgated by the FDA or the Governmental Authorities and
1
including trade association guidelines, where applicable, as well as U.S. export
control laws and the U.S. Foreign Corrupt Practices Act.
"Altana Technology" means the Patent Rights and the Know-How.
"Collaboration" means the activities of the Parties carried out in
performance of, and the relationship between the Parties established by, this
Agreement.
"Generic Products" means any compound or treatment with identical or
similar structure that would substitute for, eliminate the need for, which
competes with or which would constitute barriers for the Product.
"Confidential Information" means any confidential information 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.
"Effective Date" means the date specified above in the preamble.
"FDA" means the United States Food and Drug Administration.
"First Commercial Sale" means the first sale for use, consumption or resale
of the Product by CollaGenex in the Territory (excluding providing the Product
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.
"GAAP" means generally accepted accounting principles, consistently applied
in accordance with past practice.
2
"Good Clinical Practices" means good clinical practices as defined in 21
CFR ss.50 et. seq. and ss.312 et. seq., as may be amended.
"cGMP" means current good manufacturing practices as defined in 21
CFR ss.110 et. seq., as may be amended.
"Governmental Approval" means all permits, licenses and authorizations,
including but not limited to a NDA and other Regulatory Approvals, required by
the FDA or any other Governmental Authority as a prerequisite to the
Manufacturing, packaging, marketing and selling of the Product or Professional
Samples.
"Governmental Authority" means any foreign, federal, state, local or other
government, administrative or regulatory agency, authority, body, commission,
court, tribunal or similar entity within the Territory.
"Improved Product" means Products which are derived from or arise out of
any Improvements.
"Improvement" means any enhancements, reformulations or modifications to
the Altana Technology or Product, which include but not limited to, preparation,
presentation, means of delivery, dosage, packaging or any new or expanded
therapeutic indications and which are made by CollaGenex or any agent of
CollaGenex.
"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 storage, handling,
production, processing and packaging of the Product or a Professional Sample, in
accordance with this Agreement and Applicable Laws.
"Marks" means any trademark(s) proposed, chosen, used, owned, licensed or
controlled by Altana in connection with the Product, alone or accompanied by any
logo or design and any foreign language equivalents in sound or meaning, whether
registered or not.
"Net Sales" means the invoice amounts actually received for sales of each
Product and/or Improved Product by CollaGenex or its Affiliates to a Third Party
in a bona fide arm's length transaction, less the following items (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 claims, damaged goods, outdated
goods, rejections or returns of such Product and/or Improved 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 and/or Improved Product in the Territory.
Components of Net Sales shall be determined in the ordinary course of
3
business in accordance with historical practice and using the accrual method of
accounting in accordance with GAAP.
"NDA" means a New Drug Application, as defined in the Act, that is required
to be approved by the FDA before marketing a Product and which is held under the
name of Savage Laboratories.
"Packaging Specifications" means the packaging and labeling specifications
for the Product or Professional Sample as mutually determined by Altana 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. The Patent Rights as of
the Effective Date are set forth in Exhibit A, which is incorporated by
reference.
"Product" means Pandel(R) Cream. The Product shall include all three sizes
of the Pandel(R) Cream which is comprised of, fifteen (15) grams, forty five
(45) grams and eighty (80) grams.
"Professional Samples" means samples used to demonstrate the manner in
which Product is prepared and used, and which are labeled "professional sample
for trial purposes only, not for resale."
"Regulatory Approval" means all necessary and appropriate regulatory
approvals to place the Product on the market in the Territory.
"Shipment" or "Shipped" means each individual group of Product received by
CollaGenex from Altana.
"Specifications" means the specifications for each Product attached hereto
as Exhibit C, which is incorporated by reference.
"Standard Operating Procedure" or "SOP" means Altana's company policies and
procedures which have been implemented by Altana detailing Altana's response,
responsibilities and obligations in day to day management of Altana and in the
event of certain occurrences, including but not limited to ADE reporting and
Recalls.
"Taisho" means Taisho Corporation, a Japanese corporation with its
headquarters located at 00-0, Xxxxxx 0-xxxxx, Xxxxxxx-xx, Xxxxx 000, Xxxxx.
"Territory" means the United States and Puerto Rico.
"Third Party" means any entity other than Altana or CollaGenex or an
Affiliate of Altana or CollaGenex.
4
Each of the following terms is defined in the Section set forth opposite
such term below:
Force Majeure..........................................Section 17.12
Indemnitee.............................................Section 14.03
Indemnitor.............................................Section 14.03
Initiating Group.......................................Section 17.01
Inventory Stock.........................................Section 7.06
Loss...................................................Section 14.01
Marketing Materials....................................Section 12.02
Purchase Price..........................................Section 7.01
Other Group............................................Section 17.01
Recall.................................................Section 13.01
Representatives........................................Section 16.01
Royalty Payment Date....................................Section 3.06
Royalty Statement.......................................Section 3.03
SEC....................................................Section 16.02
Supply Failure..........................................Section 6.04
Term....................................................Section 4.01
(a) 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 Newtown, Pennsylvania; (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 formulation of the Product and all formulations of the Product
collectively, unless the context clearly indicates otherwise.
5
ARTICLE II
LICENSE GRANTS
SECTION 2.01. EXCLUSIVE LICENSE GRANT.
(a) Subject to the terms of this Agreement, Altana hereby grants to
CollaGenex an exclusive sublicense (exclusive even as to Altana) under the
Altana Technology to create Improvements, use, market, advertise, promote,
distribute, offer for sale and sell the Product in the Territory.
(b) Subject to the terms and conditions of this Agreement, Altana
hereby grants to CollaGenex an exclusive royalty-free sublicense to use the
Marks solely in connection with the use, detail and sale of the Product.
(c) CollaGenex acknowledges that the Marks being sublicensed to
CollaGenex belong to Altana or Taisho and that CollaGenex shall have no
rights in such Marks except pursuant to the sublicense. CollaGenex shall
use the Marks as depicted on Exhibit D, which is incorporated by reference,
or otherwise in the exact form used by Altana, including without
limitation, the (R) symbol or (TM) symbol, as applicable. Any other use of
the Marks shall be subject to the prior written approval of Altana.
(d) CollaGenex shall have the right to use Third Party distributors
and sales force organizations under this Agreement and such Third Party
distributors and sales force organizations shall not be considered
CollaGenex's sublicensees but independent Third Party service providers.
Further, CollaGenex shall have a right to use the services of Third Parties
to create Improvement and such Third Parties shall not be deemed
CollaGenex's sublicensees but independent Third Party service providers.
SECTION 2.02. NON-EXCLUSIVE LICENSE GRANT.
In the event that the use, advertising, distribution, marketing, promotion,
offering for sale or sale of the Product would infringe a claim of an issued
patent, and/or any patent rights which Altana or Taisho own or have the rights
to license or sublicense, as applicable, and which patents are not covered by
the grant in Section 2.01, Altana hereby grants a non-exclusive, royalty-free
sublicense in the Territory under such issued patents or patent rights to use,
market, advertise, promote, distribute, offer for sale and sell the Product or
shall ensure that Taisho grants CollaGenex the same.
SECTION 2.03. DISCLOSURE OF INFORMATION.
Upon CollaGenex's request, but not more than once per year, Altana shall
disclose to CollaGenex in writing, or via electronic media acceptable to
CollaGenex, sales information, marketing information, protocols, processes,
formulation information, or scientific information that might assist CollaGenex
in the marketing of the Product or in the development of an Improved Product.
6
SECTION 2.04. EXTENSION OF PATENT LIFE
The Parties agree to use commercially reasonable efforts to work together
to extend the life of the Patent Rights under the Altana Technology.
SECTION 2.05. IMPROVEMENTS
Altana agrees to discuss payment of license fees to CollaGenex, or a
reduction in CollaGenex's Pandel royalty payment on sales of the Improved
Product, for the rights to market Improved Product made by CollaGenex, if any,
for Altana and/or Third Party licensees of the Product. Taisho also agrees to
discuss with CollaGenex the payment of license fees or royalties to CollaGenex
for the rights to market Improved Product made by CollaGenex, if any, so long as
the fees or royalties are consistent with the terms set forth in the Memorandum
by Taisho and Altana, referenced herein under Exhibit H.
ARTICLE III
PAYMENTS AND ROYALTIES
SECTION 3.01. LICENSE FEE.
In partial consideration for the sublicenses granted under Section 2.01,
CollaGenex shall pay to Altana two (2) sublicense fee payments totaling One
Million Seven Hundred Thousand Dollars ($1,700,000) by wire transfer of
available funds to an account designated by Altana to CollaGenex prior to the
initial payment date and in accordance with the following schedule: a payment of
Eight Hundred Thousand Dollars ($800,000) on May 31, 2002 and payment of Nine
Hundred Thousand Dollars ($900,000) on May 31, 2003.
SECTION 3.02. ROYALTY PAYMENTS.
During the Term, CollaGenex will pay Altana a royalty of (i) [**] percent
([**]%) of the Net Sales on the Product. CollaGenex shall make such payments in
accordance with this Article III.
SECTION 3.03. REPORTS, EXCHANGE RATES.
CollaGenex shall furnish to Altana a quarterly written report (in
sufficient detail to determine the relevant amounts and dates specified in this
Section 3.03) on (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 date of the First Commercial Sale of the Product (the
"Royalty Statement"). Reports shall be due on the sixtieth (60) day following
the close of each quarter.
SECTION 3.04. RECORDS AND AUDITS.
During the Term and for a period of two (2) years thereafter, CollaGenex
shall keep complete and accurate records in sufficient detail to permit Altana
to confirm the completeness and accuracy of: (i) the information presented in
each Royalty Statement and all payments due
7
hereunder; and (ii) the calculation of Net Sales. 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 and Royalty Statements for the sole purpose of: (A)
verifying the completeness and accuracy of the Royalty Statements; and (B)
verifying the calculation of Net Sales. Such inspection shall be conducted
during CollaGenex's normal business hours, no more than once in any twelve (12)
month period and upon at least fifteen (15) days prior written notice by Altana
to CollaGenex. If such accounting firm concludes that such payments were
underpaid for the preceding year, CollaGenex shall pay Altana the amount of any
such underpayments for the preceding year within thirty (30) days of the date
Altana delivers to CollaGenex such accounting firm's report so concluding that
such payments were underpaid for the preceding year. If such accounting firm
concludes that such payments were overpaid for the preceding year, Altana shall
pay to CollaGenex the amount of any such overpayments for the preceding year
within thirty (30) days of the date Altana delivers to CollaGenex such
accounting firm's report so concluding that such payments were overpaid for the
preceding year. Altana shall bear the full cost of such audit unless such audit
discloses an underpayment by more than ten percent (10%) of the amount due for
the preceding year. In such case, CollaGenex shall bear the full cost of such
audit. In the event CollaGenex receives royalty payments from Altana pursuant to
Section 4.06(a), CollaGenex shall be entitled to perform audits of Altana's
records pursuant to this Section 3.04.
SECTION 3.05. TAXES.
All taxes levied on account of the payments accruing to Altana under this
Agreement shall be paid by Altana for its own account, including taxes levied
thereon as income to Altana. 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 Altana. Each Party agrees to assist the other Party in
claiming exemption from such deductions or withholdings under any double
taxation or similar agreement or treaty from time to time in force.
SECTION 3.06. PAYMENT TERMS.
Royalties shown to have accrued by each Royalty Statement provided for
under Section 3.03 shall be due and payable sixty (60) days after the end of
each calendar quarter (each a "Royalty Payment Date").
SECTION 3.07. 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 available funds to such account as Altana shall designate
before such payment is due.
SECTION 3.08. NO ASSURANCES
COLLAGENEX MAKES NO REPRESENTATION OR WARRANTY, EITHER EXPRESS OR IMPLIED,
THAT (i) IT WILL BE ABLE TO SUCCESSFULLY
8
COMMERCIALIZE ANY PRODUCT OR IMPROVED PRODUCTS, OR (ii) THAT THE PRODUCTS OR
IMPROVED PRODUCTS, IF ANY, WILL ACHIEVE ANY PARTICULAR SALES LEVEL.
ARTICLE IV
TERM AND TERMINATION
SECTION 4.01. TERM.
This Agreement will take effect on the Effective Date and shall continue
until terminated in accordance with the terms contained herein (the "Term").
SECTION 4.02. TERMINATION BY COLLAGENEX.
CollaGenex may terminate the Agreement by notice to Altana as follows:
(a) at any time, without cause, upon twelve (12) months prior written
notice to Altana;
(b) if Altana shall commit any willful or material breach of the
provisions of this Agreement; or
(c) if Altana shall cease to Manufacture or supply the Product to
CollaGenex pursuant to this Agreement, except as otherwise set forth
herein;
provided however, that with respect to Sections 4.02(b) and (c) that: (i)
CollaGenex has first given Altana notice specifying the details of the breach,
and (ii) Altana has not cured such breach within ninety (90) days of the receipt
of notice of such breach.
SECTION 4.03. TERMINATION BY ALTANA.
Altana may terminate this Agreement by notice to CollaGenex, upon any of
the following conditions:
(a) if CollaGenex shall fail to make any payments to Altana on the
date on which such payments are due hereunder and such failure continues
for more than thirty (30) business days after notice;
(b) if CollaGenex shall fail to deliver to Altana a Royalty Statement
by the Royalty Payment Date and shall fail to cure such default within
thirty (30) days after notice from Altana with respect thereto;
(c) if CollaGenex shall commit any willful or material breach of the
provisions of this Agreement;
9
(d) if CollaGenex shall cease to offer the Product for distribution to
its customers, except as may be provided for herein; or
(e) at any time, without cause, upon twelve (12) months prior written
notice to CollaGenex;
provided however, that with respect to Sections 4.03(c) and (d), Altana has
first given CollaGenex notice specifying the details of the breach, and
CollaGenex has not cured such breach within ninety (90) days of the receipt of
notice of such breach.
SECTION 4.04. 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 sixty (60) 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.
A Party's failure to terminate this Agreement for any of the reasons
specified in this Section 4.04 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 4.05. 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 4.06. EFFECT OF TERMINATION.
(a) In the event CollaGenex terminates this Agreement prior to the
expiration of the US patent for the Product pursuant to Section 4.02 (other
than according to subsection 4.02(a)) or Section 6.04 or Altana terminates
pursuant to Section 4.03(e), all monies paid by CollaGenex to Altana (other
than royalty payments pursuant to Section 3.02) shall immediately be
refunded to CollaGenex, including the fees paid by CollaGenex in Section
3.01. In the event CollaGenex terminates this agreement prior to the
expiration of the US patent for the Product pursuant to 4.02 (a), none of
the monies paid by CollaGenex to Altana, pursuant to Sections 3.01 and
3.02, shall be refunded to CollaGenex.
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(b) In the event Altana terminates this Agreement under Section
4.03 (other than pursuant to subsection 4.03(e)) or CollaGenex
terminates pursuant to Section 4.02(a), all rights to the Altana
Technology shall revert to Altana; provided, however, CollaGenex may,
in its sole discretion, elect to sell off or distribute, as
applicable, its existing inventory of Product and Professional Sample
in accordance with the terms of this Agreement, including CollaGenex's
payment obligation to Altana; provided, however, Altana shall have a
first right to purchase all of the existing inventory at fair market
value.
(c) In the event CollaGenex terminates this Agreement under
Section 4.04 or this Agreement is otherwise terminated under Section
4.04, the Parties agree that CollaGenex, as a licensee of rights to
"intellectual property" under this Agreement, shall retain and may
fully exercise all of its rights and obligations under this Agreement.
(d) 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 3.03, 3.06, 10.04 and Articles
IV, VIII, IX, XI, XII, XIII, XIV, XV, XVI and XVII shall survive
expiration or termination of this Agreement.
(e) Subject to the provision of Article XVI, within thirty (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.
ARTICLE V
COMMERCIALIZATION OF THE PRODUCT
SECTION 5.01. COLLAGENEX'S OBLIGATIONS.
(a) Marketing Efforts. CollaGenex agrees to use commercially
reasonable efforts to timely promote the sale, marketing and distribution
of the Product 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.
CollaGenex shall promptly advise Altana of any issues that materially and
adversely affect CollaGenex's ability to market the Product in the
Territory. In such event, senior executives of CollaGenex and Altana shall
meet and in good faith discuss what actions should be taken in light of
such issues.
(b) Packaging. Packaging and labeling of the Product and the
Professional Samples shall comply with the Packaging Specifications and
Applicable Laws. Altana
11
shall be responsible for assuring that such packaging and labeling conform
with all Applicable Laws of the FDA for selling the Product and
distributing the Professional Samples in the United States, and that the
Professional Samples comply with the Packaging Specifications and
Applicable Laws where such Product is to be distributed for sale. All
additional incremental costs resulting from changes to the Packaging
Specifications, including artwork and labeling made at the request of
CollaGenex shall be borne by CollaGenex.
(c) Customer Leads. Promptly after the Effective date, Altana shall
provide to CollaGenex all customer lists for the Product and all known
customer leads. To the extent practical, Altana shall assign to CollaGenex
any customer contracts and purchase orders for the Product as soon as
reasonably practical after the Effective Date. During the Term, Altana
shall promptly forward to CollaGenex any customer leads Altana develops or
receives related to the Product.
ARTICLE VI
MANUFACTURE AND SUPPLY
SECTION 6.01. AGREEMENT TO SUPPLY PRODUCTS.
Subject to the terms of this Agreement, CollaGenex agrees to purchase
exclusively from Altana, and Altana agrees to Manufacture for, and sell
exclusively to CollaGenex during the Term, CollaGenex's total requirements for
the Product and the Professional Samples in the Territory on the terms and
conditions set forth herein. Altana may subcontract any part of the
Manufacturing Process for the Product and the Professional Samples to Third
Parties provided the Product, the Professional Samples and the facilities
continue to meet the requirements as defined in this Agreement. Altana will bear
the cost of validation and necessary stability work for all such subcontracting.
SECTION 6.02. QUALITY ASSURANCE.
Altana shall Manufacture the Product in accordance with the Specifications.
Altana shall promptly notify CollaGenex in writing of any changes required by a
Governmental Authority in the Specifications or Altana's quality assurance
procedures that would render Altana unable to supply the Product and/or
Professional Samples in accordance with the terms of this Agreement. The Parties
agree to develop and execute an appropriate action plan in such situation.
Altana shall be solely responsible for the costs of any changes required by such
Governmental Authority.
SECTION 6.03. ALTANA'S DUTIES.
Altana agrees to furnish every Shipment of Product and the Professional
Samples in accordance with all Applicable Laws and all other regulatory
requirements specified in the NDA.
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SECTION 6.04. SECOND MANUFACTURING SOURCE
Altana shall have the right to validate, qualify and obtain all requisite
Government Approvals for a Third Party as a second source (the "Second Source")
to manufacture and label the Product for sale in the Territory. Upon prior
written notice to Altana, CollaGenex shall have the right, at its sole cost and
expense, to inspect and audit the Second Source's facilities used to manufacture
the Product to confirm that such facilities are in compliance with Applicable
Laws and Governmental Approvals. Altana, at its sole cost and expense, may have
a representative(s) accompany CollaGenex's representative(s) on any such
inspection or audit.
SECTION 6.05. FAILURE TO SUPPLY.
Altana shall immediately notify CollaGenex if Altana is unable to fill any
order placed by CollaGenex pursuant to Section 7.05 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 Altana is unable to cure such failure within fifteen (15)
business days after such notice, Altana may outsource to the Second Source to
satisfy CollaGenex's supply requirements. If Altana elects to use the Second
Source, Altana shall, within five (5) business days after the expiration of such
cure period, make arrangements with the Second Source to take commercially
reasonable steps to commence the manufacture of the Product and to sell to
Altana (for resale to CollaGenex) the Product until such time as Altana is again
able to Manufacture the Product; provided however any consequent incremental
costs which result by reason of the use of the Second Source under this Article
6 shall be the sole cost and liability of Altana.
ARTICLE VII
PURCHASE AND SALE
SECTION 7.01. PURCHASE PRICE AND PAYMENT.
Altana shall sell and CollaGenex shall purchase the Product at the prices,
including possible price increases, set forth on the Price Schedule, attached
hereto as Exhibit F (the "Purchase Price"). Altana shall invoice CollaGenex upon
shipment for all Products and Professional Samples shipped by Altana to
CollaGenex and payment, without cash discounts, shall be due sixty (60) days
from the receipt of the invoice.
SECTION 7.02. LABELING.
Altana will be solely responsible for generating all prescribing
information included with the Product and labeling of the Product and artwork
included on the Product and/or packages. Altana will be solely responsible for
obtaining all Governmental Approval for prescribing information, artwork and
labeling. The prescribing information and labeling shall comply with all
Applicable Laws. CollaGenex shall have a right to modify the prescribing
information, artwork and labeling and shall inform Altana of such modifications.
Altana shall obtain all Governmental Approvals for such modifications, at
CollaGenex' expense Upon expiration of the
13
Term, CollaGenex shall have a fully paid and perpetual right to use such
prescribing information, artwork and labeling.
SECTION 7.03. 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 7.04. FORECASTS AND ORDERS.
(a) All Product and Professional Sample forecasts will be made by
CollaGenex to Altana in good faith based upon standard Altana production
batch sizes, as set forth in Exhibit G, attached hereto and incorporated
herein by reference. On or prior to the Effective Date, CollaGenex will
provide Altana with 2-year forecasts of CollaGenex's requirement of the
Product, on a formulation-by-formulation basis, including Professional
Samples. The 2-year forecasts shall be provided quarterly, no later than 7
days after the start of each calendar quarter. Calendar quarters begin on
January 1, April 1, July and October 1. Changes to the forecast can be made
more frequently than every quarter , as needed, to meet demand. Any changes
to the forecast and corresponding purchase orders must accommodate the
9-month (270-day) lead time needed by Altana to acquire Product and
Professional sample manufacturing components. Although Altana will attempt
to fill purchase order changes that are submitted by CollaGenex with less
than a 9-month (270-day) lead time, Altana is under no obligation to do so.
Said requirements will be based on standard production planning parameters
including sales forecasts, sales demand forecasts, promotional forecasts,
inventory requirements, and the like.
(b) It is understood that Altana will not maintain Product or
Professional Sample inventory, but will produce Products or Professional
Sample upon receipt of that portion of CollaGenex's forecasts that
constitute firm orders to purchase.
SECTION 7.05. CONFIRMATION.
Altana shall confirm each purchase order within ten (10) business days from
the date of receipt of a purchase order and shall supply the Product within a
maximum of two hundred seventy (270) days from the date of acceptance of a
purchase order, or later if so specified in the purchase order. Failure of
Altana to confirm any purchase order shall not relieve Altana of its obligation
to supply Products ordered by CollaGenex in conformity with this Agreement.
SECTION 7.06. DELIVERY.
Delivery terms for the Product and Professional Samples shall be FOB
Melville, NY, in the relevant purchase order. Altana shall ship the Product and
Professional Samples in accordance with CollaGenex's purchase order form, plus
or minus ten percent (10%) of the
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original purchase order quantity, 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 delivery of such Product to the
facility requested by CollaGenex in the relevant Purchase Order. When delivered
to a common carrier, the Product shall have an expiration date of no less than
twenty one (21) months. Within three (3) months after the Effective Date, Altana
shall, free of charge, provide all Product that was manufactured for sale in the
Territory and which is in Altana's and its Affiliates' and agent's inventory
("Inventory Stock"). CollaGenex shall accept the Inventory Stock; provided,
however, acceptance shall be subject to Sections 8.01 and 8.02 and all units of
the Product have at least a one (1) year expiration date from the date of
receipt of the Product by CollaGenex.
SECTION 7.07. PROFESSIONAL SAMPLES.
Altana shall supply to CollaGenex free of charge Fourteen Thousand Nine
Hundred (14,900) packets of Professional Samples on a yearly basis to be used
solely for promotional purposes (and not for sale). CollaGenex shall specify the
percentage of each sample that will comprise the aforementioned quantity.
Professional Samples in excess of the aforementioned quantity shall be sold by
Altana to CollaGenex at the price specified in Exhibit F. CollaGenex shall not
use the Professional Samples for any purpose other than as set forth in this
Section 7.07.
SECTION 7.08. RETURN OF PRODUCTS.
Each party shall be liable for the costs associated with the return of any
Product sold by such party to its customers, wholesalers, distributors or other
entities to whom such party has sold the Product. CollaGenex shall be
responsible for the costs associated with refunds of any Product sold by
CollaGenex after the Effective Date, including any sales of the Inventory Stock.
Altana shall be responsible for the costs associated with the refunds of any
Product sold by Altana prior to the Effective Date. This Section 7.08 applies to
all sales made within the Territory only.
ARTICLE VIII
WARRANTY, REJECTION AND INSPECTIONS OF SHIPMENTS
SECTION 8.01. ALTANA WARRANTY.
Altana represents and warrants to CollaGenex that (i) the Product delivered
pursuant to this Agreement shall comply with the Specifications, Governmental
Approval, Applicable Laws and conform to the certificate of analysis for such
Product; (ii) are not adulterated or misbranded under Applicable Laws; (iii) at
the time of Manufacture and delivery to CollaGenex, the Product and Professional
Samples will be free from any failure or defects; and (iv) Altana has not
received the right from Taisho to permit Altana's sublicensees to grant further
sublicenses to the Altana Technology and Marks.
SECTION 8.02. REJECTION OF PRODUCT OR PROFESSIONAL SAMPLES FOR FAILURE TO
CONFORM TO SPECIFICATIONS.
15
CollaGenex shall have a 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
Altana of its decision and shall have forty-five (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 Altana at
Altana's expense within a reasonable time following the above described testing,
provided that notice of non-conformity is received by Altana from CollaGenex
within forty-five (45) days of CollaGenex's receipt of said Shipment. CollaGenex
shall have the right to request that Altana provide to CollaGenex, within thirty
(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 goods shall be at the expense of Altana. If CollaGenex
does not notify Altana of the non-conformity of the Product or Professional
Samples within forty-five (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 Altana, such discrepancies shall be finally resolved by testing
performed by an independent Third Party mutually agreed upon by CollaGenex and
Altana. 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 Altana 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.
SECTION 8.03. COLLAGENEX INSPECTIONS.
Altana shall upon reasonable (but not less than ten (10) days) prior
written notice by CollaGenex and during normal business hours, allow CollaGenex
to inspect and audit Altana's facilities used to Manufacture the Product and the
Professional Samples, twice annually, to confirm that the Altana's facilities
and the equipment, personnel and operating and testing procedures used by Altana
in the Manufacture, testing, storage and distribution of the Product are in
compliance with Applicable Laws and Governmental Approvals; provided that such
inspection does not interfere with Altana's normal operations.
ARTICLE IX
REGULATORY COMPLIANCE
SECTION 9.01. MAINTENANCE OF REGULATORY APPROVALS.
Altana will own all Regulatory Approvals in the Territory. Altana agrees,
at its sole cost and expense, to maintain the Regulatory Approvals including
obtaining any variations or renewals thereof, including all fees and licenses,
including user fees, related to the Manufacture
16
of the Product by Altana. Each Party agrees that neither it nor its Affiliates
will do anything to adversely affect a Regulatory Approval.
SECTION 9.02. ADVERSE DRUG EVENT REPORTING.
The Parties agree that Altana Inc. will be responsible for reporting
Pandel-related adverse drug events (ADE) to the FDA and that CollaGenex will be
responsible for communicating in a reasonable time to Altana Inc. any customer
complaints or ADE reports that CollaGenex may receive, according to the
procedures attached hereto as Exhibit E, which is incorporated by reference.
SECTION 9.03. ASSISTANCE.
Each Party shall provide reasonable assistance to the other at the other's
request, in connection with their obligations pursuant to this Article IX,
subject to reimbursement of all of its out-of-pocket costs by the requesting
Party; provided, however, Altana shall free of charge, upon CollaGenex's
request, provide CollaGenex's personnel with training regarding Altana's
policies and procedures specified in the SOP regarding an ADE, including but not
limited to reporting and filing for an ADE.
SECTION 9.04. 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 Product and distribution of the Professional
Samples, as applicable, including (i) obtaining all necessary permits, licenses
and any other requirements relating to CollaGenex's sale and distribution of the
Product and Professional Samples, (ii) arranging for CollaGenex's warehousing
and distribution of the Product, and (iii) all billing and collection activities
with respect to the Product. Altana shall be responsible for compliance with
Applicable Laws and Government Approvals relating to the Regulatory Approval,
clinical trials, Manufacture, design and production of the Product and the
Professional Samples, as applicable, and with cGMP relating to the Manufacture
and testing of the Product and the Professional Samples, as applicable.
CollaGenex and Altana shall comply with all Applicable Laws, including the
provision of information by CollaGenex and Altana to each other necessary for
Altana 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.
17
ARTICLE X
PATENTS AND TRADEMARKS
SECTION 10.01. MAINTENANCE OF PATENTS OR MARKS.
Altana shall, at Altana's expense, (i) maintain and protect the Patent
Rights and the Marks in the Territory, or (ii) ensure that Taisho maintains and
protects the Patent Rights and Marks in the Territory; provided however, that
upon written request by Altana, CollaGenex shall, at no cost or expense to
CollaGenex, provide such assistance as may be necessary to enable Altana to
comply with the administrative formalities necessary to maintain any Patent
Rights or the Marks.
SECTION 10.02. COOPERATION.
CollaGenex shall, at Altana's expense, reasonably make available to Altana
or its authorized attorneys, agents or representatives, its employees, agents or
consultants necessary or appropriate to enable Altana to file, prosecute and
maintain patent applications for a period of time sufficient for Altana to
obtain the assistance it needs from such personnel.
SECTION 10.03. ALTANA TO PROSECUTE INFRINGEMENT.
During the Term, each Party shall give prompt notice to the other of any
Third Party act which may infringe the Patent Rights or Marks and shall
cooperate with each other to terminate such infringement without litigation.
Altana shall, at its sole expense, (i) prosecute the judicial or administrative
proceedings against such Third Party infringement, or (ii) ensure that Taisho
prosecutes the judicial or administrative proceedings against such Third Party
infringement. CollaGenex shall provide such assistance and cooperation to Altana
as may be necessary to successfully prosecute any action against Third Party
infringement at Altana's expense and may deduct the expenses thereof from any
amounts payable to Altana under this Agreement.
In the event Altana fails or cannot compel Taisho to institute legal
proceedings to terminate any Third Party infringement of the Patent Rights or
Marks, CollaGenex may take such action as it deems appropriate, including
without limitation, the filing of a lawsuit against such Third Party, in
CollaGenex's own name and at its own cost and expense. Should CollaGenex file
any such suit, Altana will cooperate fully in the prosecution of such suit and
any damages awarded or costs recovered in connection with such suit will be for
the account of CollaGenex.
SECTION 10.04. 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 Altana Technology or the 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. Altana
shall, at its sole expense, defend, indemnify and hold CollaGenex harmless
against such claims or proceedings and CollaGenex shall provide such assistance
and cooperation to Altana as may be necessary to successfully defend, indemnify
and hold
18
CollaGenex harmless against any such claim or proceeding at Altana's expense.
Altana 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.
ARTICLE XI
REPRESENTATIONS AND WARRANTIES
SECTION 11.01. 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 11.02. 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 11.03. 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 11.04. OWNERSHIP OF PATENT RIGHTS.
As of the Effective Date, Altana represents and warrants that (a) it is the
exclusive licensee of all right, title and interest in and to the Altana
Technology and Marks in the Territory, (b) except to CollaGenex, Altana has not
granted any sublicense under the Altana Technology or Xxxx in the Territory to
any Third Party and is under no obligation to grant any such sublicense, (c)
Taisho has not granted any licenses other than to Altana, to the Altana
Technology and Marks in the Territory, and (d) there are no outstanding liens,
encumbrances, agreements or understanding of any kind, either written, oral or
implied, regarding the Altana Technology or Marks which are inconsistent or in
conflict with this Agreement. As of the Effective Date and to the best of
Altana's knowledge, Taisho is the sole owner of all right, title and interest in
and to the Altana Technology and Marks.
SECTION 11.05. PATENT PROCEEDINGS.
Altana represents and warrants that (a) no patent application within the
Altana Technology is the subject of any pending interference, opposition,
cancellation or other protest proceeding, and (b) the Altana Technology or Marks
do not infringe the intellectual property rights of any Third Party.
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SECTION 11.06. ADVERSE PROPERTIES.
Altana 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
Product.
SECTION 11.07. GOVERNMENTAL APPROVALS.
Altana represents and warrants that it has obtained all required and
necessary Governmental Approvals for the use, marketing and sale of the Product
in the Territory.
SECTION 11.08. 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 Marks or
CollaGenex's trademarks for the Product.
SECTION 11.09. SOP CONFORMANCE.
Altana represents and warrants that the SOPs will be in conformance with
all Applicable Laws and be in conformance with all Governmental Approvals.
SECTION 11.10. FURTHER ACTIONS.
Upon the terms and subject to the conditions hereof, each of the Parties
hereto shall use its commercially reasonable efforts to (i) 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, (ii) 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 (iii)
make all necessary filings, and thereafter make any other required submissions,
with respect to this transaction under any Applicable Law, including the Xxxx
Xxxxx Xxxxxx Act. 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.
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SECTION 11.11. LIMITATION OF LIABILITY.
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 SUBLICENSE GRANTED HEREUNDER.
ARTICLE XII
COVENANTS OF COLLAGENEX
SECTION 12.01. LIMITATION TO THE TERRITORY.
CollaGenex hereby covenants that it will not, without the prior written
authorization of Altana: (i) promote or actively solicit sale of the Product or
advertise the Product, outside of the Territory; (ii) contact the Governmental
Authorities or other entity about the Product, except as required by Applicable
Laws or as may be necessary or appropriate to carry out its obligations
hereunder; and (iii) knowingly sell or distribute for resale the Product
purchased hereunder to a Third Party who intends to sell outside of the
Territory.
SECTION 12.02. MARKETING AND INSTRUCTIONAL MATERIALS.
Altana shall cooperate with CollaGenex in the creation of instructional
materials for the customers of CollaGenex to enable the customers of CollaGenex
to use the Product correctly. Altana also agrees to assist CollaGenex in the
training of CollaGenex's sales force. In addition, on the Effective Date, Altana
shall transfer to CollaGenex all marketing, promotional and advertising
materials ("Marketing Materials") for the Product in Altana's control. The
copyright for all materials developed by CollaGenex shall be owned exclusively
by CollaGenex; however, Altana or Taisho, as applicable, shall retain the
exclusive copyright to all Marketing Materials transferred to CollaGenex.
SECTION 12.03. MARKETING EXPENSES.
CollaGenex acknowledges 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 Product and the distribution
of the Professional Samples.
ARTICLE XIII
PRODUCT RECALL
SECTION 13.01. PRODUCT RECALLS.
If at any time or from time to time any Governmental Authority of any
country within the Territory requests a Party to recall the Product or if a
voluntary recall of the 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
21
other Party. A voluntary recall of Product shall be Altana's sole decision. Any
Recall in the Territory shall be carried out pursuant to Altana's SOP regarding
Recalls and 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. A copy of the Recall SOP is attached hereto as Exhibit B. Altana shall
free of charge, upon CollaGenex's request, and at a time convenient for Altana's
personnel, provide CollaGenex's personnel with one (1) training session
regarding Altana's policies and procedures specified in the SOP regarding any
Recall.
SECTION 13.02. RECALL COSTS.
Unless otherwise specified in the SOP, 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 Altana shall each
bear fifty percent (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, Altana agrees to pay CollaGenex within ten (10)
days after its receipt from CollaGenex of any invoice(s) assessing Altana
its 50% share of these said costs, as listed above;
(b) if such Recall shall be due to Manufacturing defect or the
negligence or the breach by Altana of its warranties or obligations
hereunder or the misconduct of Altana, all such costs and expenses shall be
borne and paid solely by Altana and Altana 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 Altana 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 Altana for any such costs and
expenses paid by Altana within thirty (30) days of receipt of an invoice
and appropriate documentation for such costs and expenses from Altana.
SECTION 13.03. 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 (i) 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
Product or Professional Samples, whether or not determined to be attributable to
the Product or Professional Samples and (ii) with respect to an ADE, comply with
the provisions of Section 9.02.
22
SECTION 13.04. 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 the Product or Professional Samples
or the continued marketing of the 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 XIV
INDEMNIFICATION AND INSURANCE
SECTION 14.01. COLLAGENEX INDEMNIFIED BY ALTANA.
Altana shall indemnify and hold CollaGenex harmless from and against any
liabilities or obligations, damages, losses, claims, encumbrances, costs or
expenses (including reasonable 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 Altana in this Agreement; (b) the
Manufacture of any Product or Professional Sample that is identifiable as having
been Manufactured by or on behalf of Altana; (c) not limiting Section 14.01(a),
any claims that the Product (as a result of the use of Altana Technology
therein) or its Manufacture (as a result of the use of Altana Technology
therein), use or sale infringes the patent, trademark or proprietary right of a
Third Party.
SECTION 14.02. ALTANA INDEMNIFIED BY COLLAGENEX.
CollaGenex shall indemnify and hold harmless Altana 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 marketing, sale, distribution or promotion of the
Product or the Professional Samples (except if such Loss arises as a result of
matters described in Section 14.01); (c) the use of CollaGenex's name and
trademark in the (i) packaging and labeling of the Product or Professional
Samples; and (ii) marketing, sale, distribution or promotion of the Product or
Professional Samples.
SECTION 14.03. 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 practical after such Indemnitee becomes
aware of such claim; provided that the failure to notify the Indemnitor
23
shall not relieve it from any liability which it may have to the Indemnitee
otherwise than under this Article XIV. 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 sixty (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 14.04. INDEMNITOR MAY SETTLE.
The Indemnitor shall at its expense, have the right to settle and defend
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 14.05. INSURANCE.
Each Party shall, at its sole cost and expense, obtain and keep in force
comprehensive liability insurance, with bodily injury, death and property damage
limits of Five Million and 00/100 ($5,000,000.00) per occurrence and Ten Million
and 00/100 Dollars ($10,000,000.00) 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 signed by an
authorized representative of such Party's insurance underwriter evidencing the
insurance coverage required by this Agreement and providing for at least thirty
(30) days prior written notice to the other Party of any cancellation,
termination or reduction of such insurance coverage.
24
ARTICLE XV
DISPUTE RESOLUTION
SECTION 15.01. 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 XV 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 XV. Any disputes relating to
the Collaboration hereunder shall be first referred to the Director Business
Development of each Party at any time after such dispute has arisen. If the Vice
Presidents are unable to resolve such a dispute within fifteen (15) days of
commencement of discussions, the matter shall be presented to the chief
executive officers of Altana and CollaGenex, or their respective designees, for
resolution. In the event that the chief executive officers of Altana and
CollaGenex, or their respective designees, cannot resolve the dispute within ten
(10) 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 15.02.
SECTION 15.02. MEDIATION.
If a dispute under this Agreement is not resolved in accordance with
Section 15.01, 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 (10) 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 thirty (30) days. The costs of the
mediation, including fees and expenses, shall be borne equally by the Parties.
SECTION 15.03. TRIAL WITHOUT JURY.
If the Parties fail to resolve the dispute through negotiation and
mediation in accordance with Sections 15.01 or 15.02, 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 Article XV.
SECTION 15.04. 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 to this
Agreement; provided, however, that a
25
Party may suspend performance of its obligations during any period in which the
other Party fails or refuses to perform its obligations.
SECTION 15.05. PROVISIONAL REMEDIES.
Although the procedures specified in this Article XV 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 15.06. 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 XVI
CONFIDENTIALITY
SECTION 16.01. CONFIDENTIALITY.
During the Term and for a period of five (5) years 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 16.02. PUBLICITY REVIEW.
The Parties agree that the public announcement of the execution of this
Agreement shall be in the form of a press release 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 16.02, on any statement to the public regarding this Agreement or any
aspect of this
26
Agreement, 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 (3) 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 (3) day period, the
Party required to make such disclosure, if it legally may, shall give the other
Party at least two (2) business days to review and comment on such disclosure.
If a Party was not legally able to give notice under the previous sentence, it
will furnish the other Party with a copy of its disclosure as soon as practical
after the making thereof. The Parties acknowledge the importance of supporting
each other's efforts to publicly disclose results and significant developments
regarding the Product. The principles to be observed by Altana and CollaGenex in
such public disclosures will be: accuracy, the requirements for confidentiality
under Section 16.01, compliance with FDA regulations and other FDA guidance
documents, the advantage a competitor of Altana or CollaGenex may gain from any
public statements under this Section 16.02, and the standards and customs in the
biotechnology and pharmaceutical industries for such disclosures by companies
comparable to Altana 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 16.01, 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 XVII
MISCELLANEOUS
SECTION 17.01. NON-SOLICITATION AND NON-COMPETE.
(a) 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 contact in connection with, or
who otherwise is known by the Initiating Group to participate 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 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.
27
(b) Altana agrees, during the Term and for a period of two (2) years
thereafter, not to, directly or indirectly, Manufacture, market, advertise,
promote, distribute, offer for sale, import or export any Generic Product
in the Territory.
SECTION 17.02. 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 17.03. 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 "Altana," "CollaGenex" or
any other trade name or trademark of the other Party or its Affiliates in
connection with the performance of the Agreement.
SECTION 17.04. 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: Mr. Xxxx Xxx
CollaGenex Pharmaceuticals, Inc.
00 Xxxxxxxxxx Xxxxx
Xxxxxxx, Xxxxxxxxxxxx 00000
Facsimile: (000) 000-0000
Telephone: (000) 000-0000
If to Altana: Mr. Xxxxxx Xxxx
Altana Inc.
00 Xxxxxx Xxxx
Xxxxxxxx, Xxx Xxxx 00000
Facsimile: (000) 000-0000
Telephone: (000) 000-0000, extension 2002
Notice so given shall be deemed given and received (i) if by international
mail on the seventh (7th) 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 international courier, on the fourth (4th) business day following
28
the day such notice is delivered to the international courier service, or such
earlier delivery date as may be confirmed to the sender by such courier service.
SECTION 17.05. SECTION HEADINGS.
The titles, headings or captions of sections and paragraphs in this
Agreement do not define, limit, extend, explain or describe the scope or extent
of this Agreement or any of its terms or conditions and therefore shall not be
considered in the interpretation, construction or application of this Agreement.
SECTION 17.06. 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 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 17.07. 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. In the event of any conflict between the terms of
this Agreement and any attachment hereto, the terms of this Agreement shall
govern.
SECTION 17.08. 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 17.09. 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 Article XVI and Section 17.01, 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 Section 17.09
shall not limit any other legal or
29
equitable remedies that the non-breaching Party may have against the breaching
Party for violation of the covenants set forth in Article XVI and Section 17.01.
The Parties agree that the non-breaching Party shall have the right to seek
relief for any violation or threatened violation of Article XVI and Section
17.01 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 Article XVI and Section 17.01. This Section 17.09
shall apply with equal force to the breaching Party's Affiliates.
SECTION 17.10. 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 17.11. 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 17.12. 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 17.13. 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 17.14. ASSIGNMENT.
Neither this Agreement nor any of the rights, interests, options or
obligations hereunder may be assigned or delegated by either of the Parties
without the prior written consent of the other Party, provided, however, that
either CollaGenex or Altana 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
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
30
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 sublicensee.
The assignment or sublicense to an Affiliate shall not operate to discharge the
assignor or sublicensor from any obligation under this Agreement. Any assignment
which contravenes this Section 17.14 shall be null and void.
SECTION 17.15. 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 17.16. 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 17.17. GOVERNING LAW.
This Agreement shall be construed and interpreted accordance with the laws
of the State of New York, without regard to conflicts of law provisions.
SECTION 17.18. NO STRICT CONSTRUCTION.
This Agreement has been prepared jointly and shall not be strictly
construed against either Party.
SECTION 17.19. US DOLLARS.
All dollar amounts referred to in this Agreement are United States dollars.
SECTION 17.20. 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.
********
31
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. ALTANA INC.
By:/s/ Xxxxxxx Xxx By: /s/ Xxxxxx Xxxx
------------------------------ ---------------------------
Name: Xxxxxxx Xxx Name: Xxxxxx Xxxx
--------------------------- --------------------------
Title: Vice President Dermatology Title: President
-------------------------- ------------------------
/s/ Xxxxxxxxxxx Xxxxxx /s/ Xxxxxx Xxxxx
Senior Director Senior Vice PResident
32
EXHIBIT A
PATENT RIGHTS
U.S. Patent 4,794,106
A-1
EXHIBIT B
STANDARD OPERATING PROCEDURES - RECALLS
To be provided.
B-1
EXHIBIT C
SPECIFICATIONS
To be provided.
X-0
XXXXXXX X
XXXXX
XXXXXX XXXXXX PATENT AND TRADEMARK OFFICE
PANDEL
Word Xxxx XXXXXX
Translations THE FOREIGN CHARTERS IN THE XXXX TRANSLITERATE TO PANDEL.
Goods and IC 005. US 018.G & S: TOPICAL CORTICOSTEROID PREPARATIONS FOR
Services USE AS ANTI-INFLAMMATORY AGENTS SOLD ONLY ON PRESCRIPTION
Xxxx Drawing
Code (3) DESIGN PLUS WORDS, LETTERS, AND/OR NUMBERS
Design Search
Code 280103
Serial Number 73506106
Filing Date October 29, 1984
Published for
Opposition April 9, 1985
Registration
Number 1439767
Registration
Date May 19, 1987
Owner (REGISTRANT) TAISHO PHARMACEUTICAL CO., LTD. CORPORATION
JAPAN XX. 00-0 XXXXXX 0-XXXXX XXXXXXX-XX, XXXXX XXXXX
Attorney of XXXX X. XXXXXX
Record
Section 44 SECT44
Indicator
Type of Xxxx TRADEMARK
Register PRINCIPAL
Affidavit Text SECT 8 (6-YR)
Live/Dead
Indicator LIVE
D-1
EXHIBIT E
STANDARD OPERATING PROCEDURES - ADE
To be provided.
E-1
EXHIBIT F
PRODUCT FIXED PRICE SCHEDULE
PRODUCT PURCHASE PRICE
Strength Price
15g $[**]/tube
45g $[**]/tube
80g $[**]/tube
PROFESSIONAL SAMPLE PURCHASE PRICE
Strength Price
2g X 36 tubes $[**]/box
These Pandel prices to CollaGenex are based directly [**]. Price
increases to CollaGenex, if any, will be based on any increases [**],
if any, not to exceed [**]% per year. Pandel price increases to
CollaGenex may [**], on a percentage basis, than the increases [**].
Altana agrees to provide CollaGenex with Pandel standard cost
information, including the bases on which the Pandel standard costs
were calculated.
X-0
XXXXXXX X
XXXXXXXX XXXXXX PRODUCTION QUANTITIES
PRODUCT ORDER QUANTITIES
The minimum order quantity for Product, whether for a single size or for
any combination of the three (3) Product sizes, is based on a 1000kg batch size.
They yields from a 1000kg batch for each of the three (3) Product sizes are as
follows:
15g: [**] tubes
45g: [**] tubes
80g: [**] tubes
Purchase orders by CollaGenex to Altana must be in quantities for each
Product size such that the total amount of Product ordered in any single
purchase order is based on a 1000kg batch size, or a 2000kg batch size.
PROFESSIONAL SAMPLE ORDER QUANTITIES
The minimum order quantity for Professional Samples is based on a 1000kg
batch size. The yield from a 1000kg batch size for the Professional Sample is as
follows:
2g X 36 tubes: [**] Boxes
Purchase orders by CollaGenex to Atlanta must be in quantities of [**]
boxes for Professional Samples.
G-1
EXHIBIT H
MEMORANDUM
To be provided.
H-1
