Exhibit 24
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DEVELOPMENT AND LICENSE AGREEMENT
dated as of June 3, 2004
BY AND BETWEEN
BIOSPECIFICS TECHNOLOGIES CORP.
(a Delaware corporation)
AND
AUXILIUM PHARMACEUTICALS, INC.
(A DELAWARE CORPORATION)
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PLEASE TAKE NOTICE, SOME OF THE INFORMATION CONTAINED IN THE AGREEMENT HAS BEEN
REDACTED TO PRESERVE TRADE SECRETS.
SCHEDULES
SCHEDULE 1.7 BTC PATENTS
SCHEDULE 1.16 COST OF GOODS
SCHEDULE 1.21 ENZYME
SCHEDULE 3.2 CLINICAL TRIALS
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DEVELOPMENT AND LICENSE AGREEMENT
This DEVELOPMENT AND LICENSE AGREEMENT (this "Agreement") dated the 3rd
day of June, 2004 (the "June 3, 2004") is by and between BioSpecifics
Technologies Corp., a corporation organized and existing under the laws of
Delaware and having its principal office at ▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇
▇▇▇▇▇, and its Affiliates ("BTC"), and Auxilium Pharmaceuticals, Inc., a
corporation organized and existing under the laws of the State of Delaware and
having its principal office at ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇
19401("Auxilium"). BTC and Auxilium shall sometimes be referred to herein
individually as a "Party" and collectively as "Parties."
INTRODUCTION
WHEREAS, BTC controls certain BTC Patents and BTC Know-How (each as
defined below) related to the Enzyme and the Product (each as defined below),
and has the right to grant certain rights and licenses thereunder as set forth
herein, and
WHEREAS, Auxilium has certain expertise in the development and
commercialization of pharmaceutical products, and Auxilium wishes to obtain
certain licenses and options to develop and commercialize the Product for
certain therapeutic uses in humans, and
WHEREAS, BTC wishes to convey such licenses to Auxilium.
NOW, THEREFORE, in consideration of the mutual promises, covenants and
agreements hereinafter set forth, the sufficiency of which is hereby
acknowledged, the Parties to this Agreement mutually agree as follows:
ARTICLE 1
DEFINITIONS
For purposes of this Agreement, the following initially capitalized
terms in this Agreement, whether used in the singular or plural, shall have the
following meanings:
1.1 "Additional Indication" shall mean any Indication for a Product
outside of the Field.
1.2 "Additional Indication Option" has the meaning set forth in Section
2.2(b).
1.3 "Adverse Drug Experience" shall mean any of the following as such
terms are defined at either 21 C.F.R. ss. 312.32 or 21 C.F.R. ss. 314.80: an
"adverse drug experience," a "life-threatening adverse drug experience," a
"serious adverse drug experience," or an "unexpected adverse drug experience"
and the foreign counterparts thereof.
1.4 "Affiliate" shall mean any corporation, company, partnership, joint
venture or firm which controls, is controlled by, or is under common control
with a specified person or entity. For purposes of this Section 1.4, "control"
shall be presumed to exist if one of the following conditions is met: (a) in the
case of corporate entities, direct or indirect ownership of at least fifty
percent (50%) of the stock or shares having the right to vote for the election
of directors, and (b) in the case of non-corporate entities, direct or indirect
ownership of at least fifty percent (50%) of the equity interest with the power
to direct the management and policies of such non-corporate entities. The
Parties acknowledge that in the case of certain entities organized under the
laws of certain countries outside of the United States, the maximum percentage
ownership permitted by law for a foreign investor may be less than fifty percent
(50%), and that in such cases such lower percentage shall be substituted in the
preceding sentence, provided that such foreign investor has the power to direct
the management and policies of such entity.
1.5 "Auxilium Remaining Indication" shall mean an Additional Indication
for a Product that Auxilium believes has a reasonable probability of obtaining
Regulatory Approval and achieving commercial success, but for which BTC does not
wish to undertake Stage I Development.
1.6 "BTC Know-How" shall mean any proprietary information or materials
related to the Manufacture, preparation, formulation, use or development of the
Enzyme or the Product Controlled by BTC during the Term and shall include
formulations, processes, techniques, formulas, biological, chemical, assay
control and manufacturing, technical, pre-clinical, clinical or other data,
methods, know-how, and trade secrets.
1.7 "BTC Patents" shall mean those Patents Controlled by BTC with at
least one claim directed to the Enzyme or the Product (or processes,
improvements, uses and intermediates for the foregoing) including those listed
on Schedule 1.7 attached hereto as it may be amended from time to time.
1.8 "BTC Product" shall mean any pharmaceutical product that includes
Enzyme as an active ingredient and is under development for an Indication (or is
indicated for use) outside the Field.
1.9 "Business Day" shall mean any day on which banking institutions in
New York, New York are open for business.
1.10 "Clinical Trials" shall mean tests and studies in human subjects
or patients that are required to obtain, maintain, or sustain Regulatory
Approval in a country in the Territory.
1.11 "Commercialization" or "Commercialize" shall mean activities
directed to marketing, promoting, co-promoting, distributing, importing,
exporting, offering for sale and selling the Product. When used as a verb,
"Commercialize" means to engage in Commercialization.
1.12 "Commercially Reasonable Efforts" means, with respect to a Party,
the efforts and resources which would be used by that Party relating to a
certain activity or activities, consistent with its normal business practices,
which are consistent with the general level of effort and resources in the
pharmaceutical industry for a company similar in size and scope.
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1.13 "Competing Product" shall mean a product that contains Enzyme and
is sold in a country by a Person (other than Auxilium) in an Indication for
which Auxilium is marketing a Product in such country.
1.14 "Confidential Information" has the meaning set forth in Section
10.1
1.15 "Controlled" or "Controls", when used in reference to intellectual
property, shall mean the legal authority or right of a Party hereto (or any of
its Affiliates) to grant a license or sublicense of intellectual property rights
to another Party, or to otherwise disclose proprietary or trade secret
information to such other Party, without breaching the terms of any agreement
with a Third Party, infringing upon the intellectual property rights of a Third
Party, or misappropriating the proprietary or trade secret information of a
Third Party.
1.16 "Cost of Goods" shall mean the total cost of Product in Final
Packaging, including, but not limited to, the sum of the following actual costs:
(i) manufacturing, shipping and storage of Enzyme; (ii) manufacturing, shipping
and storage of Product, prior to sale to a Third Party; (iii) commercial
packaging and labeling; (iv) routine quality compliance and quality assurance
programs; and (v) customs or excise taxes, import duties, sales taxes and other
taxes or duties (other than those taxes resulting from sales to a Third Party of
Product in finished packaged and labeled form). In the event that BTC
manufactures Enzyme or Products, Cost of Goods shall be calculated in accordance
with Schedule 1.16.
1.17 "Develop" or "Development" shall mean Stage I Development and
Stage II Development. When used as a verb, "Developing" means to engage in
Development. For purposes of clarity, in no event shall Development include
Manufacture.
1.18 "Development Costs" shall mean costs associated with Development
activities.
1.19 "Effective Date" shall mean the date specified in the first
paragraph of this Agreement.
1.20 "EMEA" shall mean the European Medicines Evaluation Agency or any
successor agency thereto.
1.21 "Enzyme" shall mean the purified form of the enzyme currently
identified by BTC as Collagenase ABC, more particularly described on Schedule
1.21, and any variants or derivatives thereof.
1.22 "European Union" shall mean the countries of the European Union,
as it is constituted as of the Effective Date and as it may be expanded from
time to time.
1.23 "Exercised Indication" has the meaning set forth in Section
2.2(c).
1.24 "Exercised Indication Date" has the meaning set forth in Section
2.2(c).
1.25 "Exercise Period" has the meaning set forth in Section 2.2(c).
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1.26 "FDA" shall mean the U.S. Food and Drug Administration or its
successor agency.
1.27 "Field" shall mean, subject to expansion pursuant to Section 2.2,
the prevention or treatment of Dupuytren's Disease and Peyronie's Disease.
1.28 "Final Packaging" means the labeling and packaging to be used in
connection with the Product labeled for use in the Field in the Territory,
including the packaging of package inserts and components reasonably necessary
for sale of the finished Product to the ultimate consumer.
1.29 "Indemnified Party" has the meaning set forth in Section12.3.
1.30 "Indemnifying Party" has the meaning set forth in Section 12.3.
1.31 "Indication" shall mean a pharmaceutical application for the
Product.
1.32 "Infringement Claim" has the meaning set forth in Section 8.2(a).
1.33 "Law" shall mean any applicable statute, law, ordinance,
regulation, order, or rule of any federal, state, local, foreign, or other
governmental agency or body or of any other type of regulatory body (including
common law) or securities exchange, including those covering pharmaceutical
sales, environmental, pollution, energy, safety, health, transportation,
bribery, record-keeping, zoning, antidiscrimination, antitrust, wage and hour,
and price and wage control matters.
1.34 "Licensed Technology" shall mean the BTC Patents and the BTC
Know-How.
1.35 "Loss" has the meaning set forth in Section 12.1.
1.36 "Major Market Country" shall mean the United States, each country
of the European Union.
1.37 "MAA" shall mean an application seeking Regulatory Approval of the
Regulatory Authority in the European Union to market and sell a Product in the
Field in the European Union.
1.38 "MAA Acceptance" shall mean the written notification by the
applicable Regulatory Authority that the MAA has met all the criteria for filing
acceptance.
1.39 "Manufacture" or "Manufacturing" shall mean manufacturing,
filling, processing, testing, engineering, designing, redesigning, packaging,
storing, quality control, quality assurance, releasing, disposing, handling,
shipping, and all other activities undertaken or required to be undertaken in
order to manufacture and supply the Product in its Final Packaging and related
devices and apparatus for administration thereof, in the case of commercial
supplies, or packaged in accordance with Laws, in the case of clinical supplies.
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1.40 "NDA" or "New Drug Application" shall mean a new drug application
filed with the FDA pursuant to 21 C.F.R. ss.314, seeking permission to market
the Product for a particular Indication in the Field in interstate commerce in
the United States.
1.41 "NDA Filing Acceptance" shall mean the written notification by the
FDA that the NDA has met all the criteria for filing acceptance.
1.42 "Net Sales" shall mean the gross amount invoiced by Auxilium and
its Affiliates or Sublicensees on account of sales of the Product in Final
Packaging to Third Parties in the Territory, less the total of: (a) trade, cash
or quantity discounts not already reflected in the amount invoiced; (b) excise,
sales and other consumption taxes and customs duties to the extent included in
the invoice price; (c) freight, insurance and other transportation charges to
the extent specifically included in the invoice price; (d) returns or
retroactive price reductions; and (e) compulsory payments and rebates directly
related to the sale of the Product accrued, paid or deducted pursuant to
governmental regulations.
1.43 "Orphan Drug Designation" shall mean the special designation of
Product by FDA's Orphan Product Division which provides the Product with the
opportunity to obtain additional market exclusivity from the date the drug
receives FDA approval and also possible tax and regulatory approval benefits.
The term "Orphan Drug Designation" shall include any foreign counterparts of the
foregoing.
1.44 "Patents" shall mean any patents or patent applications and any
continuations, continuations-in-part, divisions, provisionals, substitutions,
patents of addition, reissues, reexamination, renewals or extensions thereof
(including any supplemental patent certificates) and any confirmation patent or
registration patent and all foreign counterparts of any of the foregoing.
1.45 "Person" shall mean any individual, corporation, partnership,
association, joint-stock company, trust, unincorporated organization or
government or political subdivision thereof.
1.46 "Phase II Clinical Trials" shall mean a Clinical Trial for the
Product on a number of patients, no fewer than the number required to allow for
the detection of statistical differences between the control and treated
patients, for the purposes of determining dose and evaluating safety and
efficacy in the proposed therapeutic indication, conducted in accordance with
current good clinical practices and in accordance with a protocol that has been
reviewed by the FDA and reflects any comments or concerns raised by the same.
1.47 "Phase III Clinical Trials" shall mean a Clinical Trial for the
Product on sufficient numbers of patients to generate safety and efficacy data
to support Regulatory Approval in the proposed therapeutic indication, conducted
in accordance with current good clinical practices and in accordance with a
protocol that has been reviewed by the FDA and reflects any comments or concerns
raised by the same.
1.48 "Product" shall mean pharmaceutical product containing Enzyme as
an active ingredient and any reformulation, improvement, enhancement,
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combination, refinement, or modification thereof; provided however, Product
shall specifically exclude dermal formulations labeled for topical
administration.
1.49 "Product Data" shall mean the physical embodiment, to the extent
available of: (a) the know-how, including relevant laboratory notebook
information, screening data and synthesis schemes, including descriptions in any
form, data and other information, and (b) all other data including Regulatory
Data and any other pre-clinical and clinical data and information, technical,
chemical, safety and scientific data, information and know-how, obtained or
generated in connection with Development of the Product in the Field.
1.50 "Product Details" shall mean a face-to-face meeting, in an individual or
group practice setting, between a healthcare professional with prescribing
authority who is a target prescriber of a Product in the Field and a
professional representative of the applicable Party during which the
key
attributes of a Product are verbally presented to such healthcare professional.
When used as a verb, "detail" or "detailing" shall mean to engage in a Detail.
1.51 "Regulatory Approval" shall mean, with respect to a country or
group of countries in the Territory, all authorizations by the appropriate
governmental entity or entities necessary for commercial sale of the Product in
the Field for a particular Indication in that country or group of countries
including, where applicable, approval of labeling, price, reimbursement and
manufacturing.
1.52 "Regulatory Authority" shall mean the FDA or any foreign
counterpart or additional governmental or regulatory agencies in the Territory
responsible for applicable Regulatory Approvals.
1.53 "Regulatory Data" shall mean any and all research data,
pharmacology data, chemistry, manufacturing, and control data, preclinical data,
clinical data or all other documentation submitted, or required to be submitted,
to Regulatory Authorities in association with regulatory filings for the Product
in the Field (including any Drug Master Files (DMFs), Chemistry, Manufacturing
and Control ("CMC") data, or similar documentation).
1.54 "Remaining Indication" shall mean an Additional Indication for
which Auxilium has not exercised an Additional Indication Option within the
Exercise Period.
1.55 "Stage I Development" shall mean pre-clinical and clinical drug
development activities reasonably necessary to completing all development
activities up to and including the completion of Phase II Clinical Trials for
the Product in the Field, including pre-clinical studies, test method
development, statistical analysis, Clinical Trials, regulatory affairs, and
activities directed to seeking Regulatory Approvals.
1.56 "Stage I Development Costs" shall mean costs associated with Stage
I Development activities.
1.57 "Stage II Development" shall mean non-clinical and clinical drug
development activities reasonably necessary to the development and submission of
Regulatory Data to a Regulatory Authority for the purpose of achieving
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Regulatory Approval, including non-clinical studies, test method development,
statistical analysis, Clinical Trials, regulatory affairs, and activities
directed to seeking Regulatory Approvals.
1.58 "Stage II Development Costs" shall mean costs associated with
Stage II Development activities.
1.59 "Standard Terms" has the meaning set forth in Section 6.4(d).
1.60 "Sublicense Income" shall mean (a) the upfront payment, if any,
actually received from a Sublicensee by Auxilium upon execution of an agreement
with such Sublicensee, and (b) any milestone payments actually received from a
Sublicensee by Auxilium in consideration for the grant of a sublicense to such
Sublicensee under the Licensed Technology in the Field; provided, however, that
Sublicense Income shall not include any such consideration received by Auxilium
from any such Sublicensee in return for, as payment for or otherwise in respect
of: (i) equity or debt of Auxilium (provided, however, that the exclusion
contained in this sub-clause (i) shall not apply to transactions between
Auxilium and its Affiliates), (ii) the manufacture or supply of ingredients or
products, (iii) the performance of services (including research and development
services other than screening services performed on behalf of a Sublicensee) or
other similar payments, (iv) reimbursement of Auxilium's out of pocket costs and
expenses, including patent expenses, or (v) the sale of Auxilium in whole or in
part.
1.61 "Sublicensee" shall mean a Person to whom Auxilium grants any
right or license to use the Licensed Technology to make, use or sell the Product
in the Field in the Territory.
1.62 "Supply Agreement" has the meaning set forth in Section 6.4.
1.63 "Term" has the meaning set forth in Section11.1(a).
1.64 "Territory" shall mean all the countries and territories of the
world.
1.65 "Third Party" shall mean any Person or other entity other than
Auxilium, BTC or their respective Affiliates.
1.66 "Vial" shall means a single dose unit of Product.
ARTICLE 2
LICENSE AND OPTION
2.1 License Grant to Auxilium
(a) Subject to the terms and conditions of this Agreement, on the
Effective Date, BTC hereby grants to Auxilium an exclusive license under the
Licensed Technology to research, Develop, use, Commercialize, market, sell and
distribute the Product for the Field in the Territory.
(b) Subject to the terms and condition of this Agreement, BTC
hereby grants to Auxilium a non-exclusive right and license under the Licensed
Technology to Manufacture or have Manufactured the Product for the Field in the
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Territory. Notwithstanding the foregoing provisions of this Section 2.1(b),
Auxilium shall not exercise its license pursuant to this Section 2.1(b) to
Manufacture the Product except as permitted by, and solely for the purposes set
forth in, Article 6.
(c) The licenses granted under Sections 2.1(a) and 2.2(b) shall
include the right to grant sublicenses (and in the case of Section 2.1(a),
distribution rights); provided, however, that all such sublicenses shall contain
terms and conditions which are consistent with the terms and conditions
contained in this Agreement.
2.2 Option to License Additional Indications
(a) Development of Additional Indications for Products. The Parties
shall cooperate in good faith in generating ideas and concepts for Additional
Indications for Products. BTC shall use Commercially Reasonable Efforts to
conduct Stage I Development for the use of the Product for the treatment of
Frozen Shoulder. BTC shall summarize such efforts in reports to be submitted to
the Joint Development Committee on a quarterly basis.
(b) Option Grant. Subject to the terms and conditions of this
Agreement, BTC hereby grants to Auxilium an exclusive option to an exclusive
license to Products in the Territory for each Additional Indication on the same
terms and conditions as provided for Indications in the Field (each, an
"Additional Indication Option").
(c) Exercise Period; Exercise of Option. The period during which
Auxilium may exercise an Additional Indication Option (the "Exercise Period")
shall commence on the date on which BTC submits a Phase II Clinical Trial report
to Auxilium for the Product for such Additional Indication and ends one hundred
and twenty (120) days thereafter. BTC shall provide Auxilium with a copy of a
Phase II Clinical Trial report and, any additional data or results in its
control. Auxilium may exercise the Additional Indication Option at any time
during the Exercise Period by delivering to BTC a written notice of exercise
with regard to such Additional Indication (each, an "Exercised Indication") that
sets forth the effective date of the exercise (the "Exercised Indication Date").
Upon receipt, BTC shall counter-sign the exercise notice which shall then be
appended to and incorporated by reference into this Agreement effective the
Exercised Indication Date.
(d) License Grant Upon Exercise of Option. Effective on the
Exercised Indication Date, the Field definition shall be amended and expanded to
include the relevant Exercised Indication.
(e) Auxilium Remaining Indications. Auxilium shall have the right
to Develop and Commercialize Auxilium Remaining Indications at its sole cost and
expense. Upon notification to BTC of Auxilium's intent to Develop and
Commercialize an Auxilium Remaining Indication, the Field definition shall be
amended and expanded to include such Auxilium Remaining Indication.
2.3 Remaining Indications BTC may offer Third Parties the right under
the Licensed Technology to research, Develop, use Commercialize, market, sell
and distribute the Product for any Remaining Indication (the "Remaining
Indication Rights"), provided that, prior to executing a definitive agreement
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with a Third Party for one or more Remaining Indications, BTC must (a) provide
Auxilium with a written summary of the material terms of the proposed agreement
(the "Offer Terms"), and (b) grant Auxilium an option, exercisable for
seventy-five (75) days after Auxilium's receipt of the written summary, to agree
to equivalent terms, in which case the Parties shall negotiate in good faith an
exclusive license agreement on such terms as promptly as possible thereafter. In
the event that Auxilium does not exercise an option to license a Remaining
Indication within such seventy-five (75) day period, the Remaining Indication
Rights may be licensed to such Third Party on terms and conditions no less
favorable to BTC than the Offer Terms.
2.4 Transfer of BTC Know-How Within forty-five (45) days of the
Effective Date, BTC shall, or shall cause its Affiliates to, transfer to
Auxilium all material Product Data relating to Dupuytren's Disease and
Peyronie's Diseases, including but not limited to preclinical, clinical data,
clinical trial protocols, study data tabulations, reports, the right of
cross-reference and permission to use in Auxilium Regulatory Data and regulatory
filings, investigator-generated data granted by the owners of such data, etc.,
in reasonably satisfactory form. Promptly, but in no event more than thirty (30)
days, after the Exercised Indications Date, BTC shall, or shall cause its
Affiliates to, transfer to Auxilium all Product Data relating to such Exercised
Indication, in reasonably satisfactory form.
2.5 Exclusivity During the Term and any extension thereof, and for two
years thereafter, neither BTC nor any of its Affiliates shall, except as
otherwise set forth and provided in this Agreement, (a) directly or indirectly
develop, manufacture, market, sell, detail or promote any Competing Product or
(b) encourage off-label use of a Competing Product that could affect labeled
usage of the Product in the Field. In addition, in the event that BTC markets a
BTC Product outside the Field within a country in the Territory where Auxilium
is promoting the Product within the Field, BTC shall promote the BTC Product
under a trademark different from the Auxilium Trademark, and will not knowingly
market, ship, distribute, promote, sell or otherwise put into circulation the
BTC Products within the Field in such country or in any other country within the
Territory. In the event that BTC enters into any agreements with its
distributors or wholesalers for the BTC Products in a country in the Territory,
it shall include in any and all said agreements appropriate provisions
providing, to the extent not prohibited by Law, that the BTC Products must be
distributed and sold solely outside the Field within such country in the
Territory. In the event that Auxilium enters into any agreements with its
distributors or wholesalers for the Product in the Field, it shall include in
any and all said agreements appropriate provisions providing, to the extent not
prohibited by Law, that the Product must be distributed and sold solely within
the Field within such country in the Territory.
ARTICLE 3
PRODUCT DEVELOPMENT
3.1 Joint Development Committee
(a) Formation. As soon as practicable after the execution of this
Agreement, BTC and Auxilium will establish a Joint Development Committee (the
"JDC") made up of two (2) representatives designated by each Party hereto to
assist in coordinating scientific interactions and resolving potential
disagreements between BTC and Auxilium during the course of the Development of
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Product. The JDC Chair will be appointed by Auxilium from among the members of
the committee designated by Auxilium. Each of BTC and Auxilium shall have one
vote on the JDC and, in the event of a deadlock with respect to any action, the
vote of Auxilium , rendered after reasonable and open discussion among the
members of the JDC, shall be final and controlling. BTC shall not take any
action with respect to Remaining Indications that would be detrimental to the
Product or damaging to Auxilium. Notwithstanding the foregoing, BTC will advise
the JDC of all Development and Commercialization of Remaining Indications. The
JDC shall have the right to discuss and comment on such activities but shall not
have the final vote with respect to such activities as they relate to Remaining
Indications.
(b) Quarterly Meetings. While a Product is under Development, the
JDC shall meet formally at least quarterly, or with such other frequency, and at
such time and location, as may be established by the JDC, for the following
purposes, among others: (i) to oversee and coordinate Development activities of
the Parties for Products; (ii) to receive and review reports by the Parties as
may be submitted to the JDC on a quarterly basis; and (iii) to discuss matters
relating to Patents related to the Product, including but not limited to issues
of inventorship and decisions relating to the filing, prosecution and
maintenance of such Patents, provided however, when the JCC is established, the
JCC and the JDC will coordinate responsibility on such matters. Meetings of the
JDC may be held in person or by teleconference, as may be determined by the JDC.
3.2 Auxilium's Stage II Development Activities.
(a) Dupuytren's Disease and Peyronie's Disease. As soon as it has
received the relevant Product Data pursuant to Section 2.4, Auxilium shall
assume all responsibility for (including financial responsibility), and have
sole discretion over, all continuing Development of the Product for Dupuytren's
Disease and Peyronie's Disease including all Clinical Trials underway as of the
Effective Date and listed on Schedule 3.2. Auxilium shall not have financial
responsibility for Development Costs or any other costs incurred in connection
with Development related to Dupuytren's Disease and Peyronie's Disease prior to
the Effective Date.
(b) Exercised Indications On each Exercised Indication Date,
Auxilium shall be entitled to assume responsibility for, and have sole
discretion over, all continuing Development activities for the Product for each
such Exercised Indication. Auxilium shall have one (1) year after the relevant
Exercised Indication Date to initiate Stage II Development for such Exercised
Indication, provided, however, that such obligations shall not be binding upon
Auxilium to the extent that BTC fails to (i) deliver material Product Data to
Auxilium in accordance with Section 2.4, or (ii) supply Auxilium with material
amounts of clinical supplies of the Product for use in the Field in accordance
with the delivery scheduled specified by Auxilium under the terms of Section
6.3.
(c) Cooperation The Parties agree to cooperate with respect to the
transfer of Development activities from BTC to Auxilium including transferring
Clinical Trials and making introductions of Auxilium to clinical investigators
and opinion leaders.
(d) Stage II Development Costs.
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(i) Dupuytren's Disease and Peyronie's Disease. Auxilium shall
be responsible for all the Development Costs related to the Product for
Dupuytren's Disease and Peyronie's Disease and incurred by Auxilium
after the Effective Date; provided, however, that BTC shall continue to
be responsible for all Development Costs which are which are incurred
prior to the Effective Date.
(ii) Exercised Indications. In the event Auxilium assumes
responsibility for Stage II Development of the Product for an Exercised
Indication, Auxilium shall be responsible for all Development Costs
related to the Product for such Exercised Indication and incurred by
Auxilium after the Exercised Indication Date; provided, however, that
BTC shall continue to be responsible for all Development Costs which
are incurred prior to the Exercised Indication Date.
(iii) Right of Set-Off. To the extent that Auxilium pays any
Stage I Development Costs resulting from additional Stage I Development
that is requested or required by a Regulatory Authority after assuming
responsibility for Development of the Product for any Indication,
Auxilium shall be entitled to set-off the amount of such Stage I
Development Costs against any amounts due to BTC pursuant to Section
7.1.
3.3 Data and Records
(a) Ownership of Data. Auxilium shall retain ownership of all
Product Data, information and results related to Development activities for the
Product, provided, however, that Auxilium hereby grants to BTC a right of
reference with respect to Remaining Indications to the Regulatory Data contained
in Regulatory Approvals Controlled by Auxilium for the Product in the Field.
Notwithstanding the foregoing, (a) if Auxilium's license rights to the Product
terminate with respect to an Indication within the Field, Auxilium shall assign
BTC its right, title and interest in and to the Product and Regulatory Data for
that Indication, and (b) if Auxilium's license rights to a Product hereunder
terminate entirely, Auxilium shall assign BTC its right, title and interest in
and to all such Product and Regulatory Data; provided, however, that Auxilium
may maintain a copy of such Regulatory Data for legal and archival purposes.
(b) Development Records. Each Party shall each maintain records in
sufficient detail and in good scientific manner appropriate for patent purposes
and as will properly reflect all work done and results achieved in the
performance of Development activities hereunder (including all Regulatory Data
in the form required to be maintained under any applicable governmental
regulations). Such records shall include books, records, reports, research
notes, charts, graphs, comments, computations, analyses, recordings,
photographs, computer programs and documentation thereof, computer information
storage means, samples of materials and other graphic or written data generated
in connection with the Development activities. Subject to the terms and
conditions of Article 10 below, each Party shall provide the other the right to
inspect (no more than once a year) such records upon reasonable request and
during normal business hours, and shall provide copies of all requested records,
to the extent reasonably required for the performance of the requesting Party's
obligations under this Agreement.
11
ARTICLE 4
REGULATORY MATTERS
4.1 Efforts Within twelve (12) months of filing for Regulatory Approval
in any Major Market Country, Auxilium will file for Regulatory Approval in all
the Major Market Countries. Notwithstanding the foregoing, if a different
dossier is required for any such other Major Market Country(ies), Auxilium will
exercise Commercially Reasonable Efforts to seek Regulatory Approval with
respect to such country(ies). Auxilium may develop additional formulations,
dosage forms or delivery systems for the Product in the Field as may be
commercially practicable at its own expense. For purposes of clarity, Remaining
Indications shall not be subject to this Article 4; provided, however, that BTC
shall not conduct Development or Commercialization of Product in such Remaining
Indication in a manner that jeopardizes Auxilium's Development or
Commercialization of Product in the Field.
4.2 Regulatory Matters in the Territory. As between the Parties,
Auxilium shall be responsible in the Territory for ensuring compliance with all
regulatory requirements relating to the Product labeled for use in the Field
(i.e., obtaining, maintaining, and updating all required any Regulatory
Approvals). Without limiting the foregoing, Auxilium shall (i) file all
regulatory filings and supporting documentation; (ii) serve as the designated
regulatory official for purposes of receiving communications from the Regulatory
Authority; and (iii) report any Adverse Drug Experience to Regulatory
Authorities.
4.3 Ownership. All Regulatory Approvals relating to the Products
labeled for use in the Field shall be the property of Auxilium and held in the
name of Auxilium or its designee. BTC shall promptly take whatever steps
necessary to transition any existing regulatory filings to Auxilium. As promptly
as possible after the Effective Date, BTC shall cause the Investigational New
Drug ("IND") # 5780 and IND # 5588, and all foreign counterparts thereof, to be
assigned to Auxilium.
4.4 Regulatory Interactions for Product.
(a) Communications with Regulatory Authority; Advice of Counsel.
BTC shall not communicate with Regulatory Authorities, or take any action
regarding an investigation or a request by a Regulatory Authority with respect
to a Product in the Field, except (i) with the prior written consent of
Auxilium, or (ii) upon the advice of legal counsel that such communication is
required by Law. BTC shall cooperate with Auxilium and provide all reasonable
assistance and take all actions reasonably requested by Auxilium that are
necessary to comply with any Law applicable to a Product in the Field. If BTC is
advised by its legal counsel that it must communicate with any Regulatory
Authority, then BTC shall promptly, but in no event more than two (2) Business
Days, advise Auxilium of the same and provide Auxilium in advance with a copy of
any proposed written communication with such Regulatory Authority and comply
with any and all reasonable requests of Auxilium concerning any such
communication with such Regulatory Authority.
(b) Receipt of Correspondence; Inspections. Each Party shall
promptly, but in any event within three (3) Business Days, (i) provide to the
other copies of any material documents or correspondence received from any
12
Regulatory Authority related to Development activities for a Product and (ii)
inform the other Party of any inspections, proposed regulatory actions,
investigations or requests for information or a meeting by any Regulatory
Authority with respect to a Product. In the event BTC does not have advance
notice of an inspection by a Regulatory Authority, it shall immediately notify
Auxilium of such inspection and it shall cooperate with such Regulatory
Authority.
(c) Recalls and Withdrawals. Subject to the terms and conditions of
the Supply Agreement, Auxilium shall have sole responsibility for and shall make
all decisions with respect to any recall, market withdrawals or any other
corrective action related to the Products labeled for use in the Field in the
Territory; provided however, (i) Auxilium shall immediately notify BTC of any
decision to initiate a recall or withdrawal of such Product; (ii) all costs and
expenses with respect to a recall, market withdrawal or other corrective action
for such Product shall be borne by Auxilium unless such recall, market
withdrawal or other corrective action was due to the negligence, willful
misconduct or material breach of this Agreement or the Supply Agreement by BTC;
and (iii) BTC shall immediately notify Auxilium of any decision to initiate a
recall or withdrawal of a Product outside of the Field. Each Party shall provide
the other Party with recall information received by it in sufficient detail to
allow the Parties to comply with Law.
(d) Notice. Each Party shall provide the other Party with notice,
in a sufficiently timely basis to enable the other Party to comply in all
material respects with Laws, of notification or other information which it
receives (directly or indirectly) from, any Regulatory Authority (and providing,
as soon as reasonably possible, copies of any associated written requests) that
(i) raises any material concerns regarding the safety or efficacy of a Product;
(ii) indicates or suggests a claim of a Third Party arising in connection with a
Product, or (iii) is reasonably likely to lead to a recall or market withdrawal
of a Product, provided that neither Party shall be obliged to disclose
information in breach of any contractual restriction which it could not
reasonably have avoided or which disclosure would waive any legal privilege.
4.5 Inquiries, Adverse Events, etc. As between the Parties, Auxilium
shall be responsible for the surveillance, receipt and evaluation of product
complaints for Product labeled for use in the Field in the Territory and
reporting to Regulatory Authorities Adverse Drug Experiences for the Products in
the Field. As between the Parties, BTC shall be responsible for the
surveillance, receipt and evaluation of product complaints for Product labeled
for use outside the Field and reporting to Regulatory Authorities Adverse Drug
Experiences for the Products outside the Field. Each Party shall ensure that, in
the Development or Commercialization of the Product, it will record,
investigate, summarize, notify, report and review all Adverse Drug Experiences
in accordance with Law. Each Party shall (i) adhere to all requirements of Laws
which relate to the reporting and investigation of Adverse Drug Experiences, and
(ii) keep the Parties informed of such events.
(a) Each Party shall submit reports of all Adverse Drug Experiences
associated with the use of the Product and other required safety information
(e.g., PSUR's or annual safety reports) to the Regulatory Authorities in
accordance with Law. Each Party shall submit a copy of each such report to the
other Party in advance of such submission to permit the other Party to comply
with legal requirements applicable to it and comment on such reports.
13
(b) Each Party shall submit reports of all Adverse Drug Experiences
associated with the use of Product for which Regulatory Approval has not been
achieved and other required safety information to the Regulatory Authorities in
accordance with Law. Each Party shall submit a copy of each such report to the
other Party in advance of such submission to permit the other Party to comply
with legal requirements applicable to it and comment on such reports.
(c) In order to accomplish the objectives of this Section and to
the extent required by Law, within one hundred and eighty (180) days of the
Effective Date, the Parties shall discuss and develop an agreement containing
mutually acceptable guidelines and procedures for the receipt, recordation,
communication, exchange and reporting of Adverse Drug Experiences for the
Product.
4.6 Approval of Labeling and Promotional Materials. Auxilium shall be
responsible to seek or obtain any necessary Regulatory Authority approvals of
any label, labeling, package inserts or outserts, monographs and packaging, and
promotional materials for use in connection with the Products labeled for use in
the Field and for determining whether the same requires approval from Regulatory
Authority. The Parties shall cooperate in such efforts to seek and obtain such
approvals.
4.7 Cooperation. The Parties shall cooperate to provide each other all
reasonable assistance and take all actions reasonably requested that are
necessary to comply with Laws, including safety updates, amendments, annual
reports, pharmacovigilance filings, investigator notifications, facility
inspections, and certifications and maintenance and updates for regulatory
filings and Regulatory Approvals. Unless otherwise provided under the terms of
this Agreement, the Parties will cooperate, communicate and provide reasonable
assistance to each other with regard to all CMC matters related to the Product.
ARTICLE 5
COMMERCIALIZATION
5.1 Joint Commercialization Committee.
(a) Formation. Not later than the commencement of Phase III
Clinical Trials for any Product, BTC and Auxilium will establish a Joint
Commercialization Committee (the "JCC") made up of two (2) representatives
designated by each Party hereto to assist in coordinating interactions and
resolving potential disagreements between BTC and Auxilium during the course of
the Commercialization of Product. The JCC shall meet each and every calendar
quarter. The JCC Chair will be appointed by Auxilium from among the members of
the committee designated by Auxilium. Auxilium and BTC shall each have one vote
on the JCC. The objective of the JCC shall be to reach agreement by consensus on
all matters falling within its authority hereunder. In the event of a deadlock
with respect to any action, the vote of Auxilium, after reasonable opportunity
for open discussion among the members of the JCC, shall control. Notwithstanding
the foregoing, the JCC shall not have authority to commit the financial
resources of either party.
14
(b) Patent Position. The JCC will coordinate with the JDC in
discuss matters relating to Patents related to the Product, including but not
limited to issues of inventorship and decisions relating to the filing,
prosecution and maintenance of such Patents.
(c) Coordinated Strategy. The JCC shall meet at least quarterly or
with such frequency and at such time and location as may be establishd by the
JCC and will monitor the overall strategy and oversee the global marketing of
all Products. The JCC will have the opportunity to review market research plans
and research results, clinical development results and similar items for each
Product, including Products Developed for Remaining Indications, for the purpose
of advising and assisting in communicating a unified global marketing strategy;
provided, however, that with respect to Remaining Indications, the JCC shall not
have the final vote.
5.2 Commercialization. Auxilium shall use Commercially Reasonable
Efforts to Commercialize the Product in the Field in each country in the
Territory. Subject to Section 5.4 below, Auxilium shall be responsible for and
have sole discretion over all aspects of Commercialization of the Product for
use in the Field in the Territory.
5.3 Orders, Booking Sales. Auxilium shall have the sole right and
responsibility for Product in the Field in each country in the Territory to (a)
receive, accept, and fill orders for such Product, (b) control invoicing, order
processing, and collection of accounts receivable for such Product sales, and
(c) record such Product sales in its books of account. If, for any reason, BTC
receives orders for such Product, BTC shall forward such orders to Auxilium (or,
if directed by Auxilium, to Auxilium' wholesalers) as soon as practicable. If
any quantities of such Product are returned to BTC, BTC shall immediately notify
Auxilium and ship them to the facility designated by Auxilium.
5.4 BTC Co-Promotion Rights. In the event that BTC provides written
notice of its intent within ninety (90) days after an NDA Acceptance for a
Product in the Field in the Territory indicated for use for any Exercised
Indication, BTC will be allowed to provide up to ten percent (10%) of the
Product Details for such Indication. In addition, in the event that BTC provides
written notice of its intent within ninety (90) days after an NDA Acceptance for
Frozen Shoulder, BTC will be allowed to provide up to ten percent (10%) of the
Product Details for Dupuytren's Disease. Notwithstanding Section 13.10, BTC's
co-promotion rights granted pursuant to this Section shall not be assignable or
transferable to any other Person.
ARTICLE 6
MANUFACTURE AND SUPPLY
6.1 Joint Manufacturing Committee.
(a) Within forty-five (45) days after the Effective Date, BTC and
Auxilium will establish a Joint Manufacturing Committee (the "JMC") made up of
two (2) representatives designated by each Party hereto to which shall oversee
the manufacturing of Product on a worldwide basis, including the planning,
manufacturing and supply (including supply chain management). The JMC Chair will
be appointed by BTC from among the members of the committee designated by BTC.
Each of BTC and Auxilium shall have one vote on the JMC. The objective of the
JMC shall be to reach agreement by consensus on all matters falling within its
15
authority hereunder. In the event of a deadlock with respect to any action, the
vote of BTC, after reasonable opportunity for open discussion among the members
of the JMC, shall control.
(b) Specific Responsibilities of the JMC. In support of its
responsibility for overseeing the Manufacturing of Product on a worldwide
basis the JMC shall meet at least quarterly or with such higher frequency, and
at such time and location as may be established by the JMC, and the JMC shall
perform the following activities:
(i) delineate requirements and responsibilities for development
and licensure of manufacturing processes and facilities for Product and
for supply of Product in the Territory;
(ii) together with the Joint Development Committee, develop a
manufacturing strategy to enable development and licensure of
manufacturing processes and facilities for Product in the Territory
that includes all aspects of manufacture and release, including but not
limited to formulations, intermediate, dosage form, devices, product
characterization studies, stability studies and manufacturing plans and
forecasts;
(iii) review quality assurance efforts, including but not
limited to those efforts with respect to the establishment of
specifications and quality standards for Product;
(iv) together with the Joint Development Committee review and
comment on the process for Product Development and the drafting and
contents of the CMC section of a Drug Approval Application for Product;
(v) review technology transfer plans for any changes in
manufacturing sites, testing sites, and responsibilities in the supply
chain for Product, it being understood that decisions regarding the
selection of which of a Party's own manufacturing and testing sites
shall be used to manufacture any component of a Product, if a Party
manufactures any component of a Product pursuant to this Agreement or
any related supply agreement, shall remain in the sole control of such
Party;
(vi) prepare for regulatory inspections and ensure adherence to
compliance standards with respect to Product; and
(vii) review quality compliance and manufacturing related
regulatory issues concerning the Product or any component thereof as
important issues arise through meetings and review of relevant written
material produced by Auxilium, BTC or any Regulatory Authority.
6.2 Development and Scale-Up. BTC shall, at its own cost and expense,
develop the formulation and the finished dosage form and scale-up the
Manufacture for commercial supply of the Enzyme and the Product for each
Indication for use in the Field, including the lyophilized injection
formulation, to be registered with Regulatory Authorities in accordance with Law
and in sufficient time prior to anticipated commercial launch of a Product to
provide for sufficient supply of Product for use in the Field. Notwithstanding
16
the foregoing, Auxilium will have the sole right and responsibility for
selecting the finished dosage form and presentation for the Product in the
Field.
6.3 Clinical Supply.
(a) Supply by BTC. BTC shall be responsible for supplying or
arranging for the supply of the Product suitable for use by Auxilium in Clinical
Trials. All the Product shall be Manufactured in accordance with applicable
specifications, all Laws, and shall be subject to the Standard Terms set forth
in below. BTC will supply Auxilium, free of charge, with bulk vials containing
sufficient quantities of the Product to treat up to five hundred (500) patients
per year in Clinical Trials. If Auxilium requires additional clinical supplies,
BTC will supply Auxilium with such clinical supplies at its Cost of Goods.
Auxilium will be entitled to qualify a back up supplier for the Manufacture of
clinical and commercial supplies of Product in the Field (the "Back-Up Supplier
") at any time after the Effective Date. BTC will use Commercially Reasonable
Efforts to ensure that such Back-Up Supplier has sufficient know-how to
Manufacture Product, including (i) providing all protocols, registration
applications and other substantive regulatory documents, including, but not
limited to, all data, scientific dossiers and governmental authorizations; (ii)
providing access and reference to all regulatory dossiers and filings produced
by BTC, its Affiliates and sublicensees relating to the Product; (iii) providing
access to BTC Know-How in reasonably satisfactory form, and (iv) providing all
technical assistance reasonably requested by the Back-Up Supplier related to the
Manufacture of the Product. Auxilium will require that the Back-up Supplier
execute a written confidentiality agreement with both Auxilium and BTC, in a
form consistent with industry standards, which includes, among other things, an
undertaking by the Back-up Supplier to keep confidential the manufacturing
information and know-how disclosed to the Back-up Supplier by BTC. In the
manufacturing information and know-how disclosed to the Back-up Supplier by BTC.
In addition, Auxilium will use reasonable commercial efforts to seek the
cooperation of the Back-up Supplier in sharing with BTC and Auxilium information
concerning the Manufacture of the Product that Back-up Supplier may acquire in
connection with such Manufacture.
(b) Notification of Requirements. Auxilium will provide BTC with
XXXX days notice of its requirements for clinical supplies of Product including
a delivery schedule and address. BTC will provide notice within three (3)
Business Days of receipt of such notice if BTC is unable to supply Auxilium with
the quantities of clinical supplies of Product in accordance with the delivery
schedule. In such event, the Parties shall cooperate but BTC shall be primarily
responsible, at its sole cost and expense, for procuring such quantities of
Product from the Back-Up Supplier as are necessary to compensate for any such
deficiency.
(c) Late Delivery of Clinical Supply. In the event that BTC is more
than thirty (30) days late in delivering such material amount of clinical
supplies, in addition to any other remedies Auxilium may have in Law or equity,
BTC will forgive Auxilium XXXX per day for each additional day, such amounts to
be creditable against any milestone payments due to BTC under Article 7.
6.4 Commercial Supply; Supply Agreement. BTC will supply or arrange for
the supply of all necessary commercial quantities of the Product in the
17
Territory. No later than three (3) months after the Effective Date, the Parties
shall enter into a commercial supply agreement on customary and reasonable terms
and conditions (the "Supply Agreement"), such Supply Agreement shall include the
following:
(a) Royalty. Auxilium will pay BTC on a country-by-country and
Product by Product basis a royalty payment of X percent (X%) of Net Sales of
Products in the Field for the Term. Such royalty may be reduced as follows:
(i) Competing Product Sales. If a Competing Product is sold in
a country in the Territory with a unit based market share of X% or
greater, then there shall be no royalty due for sales in that country
in the Territory.
(ii) Third Party Royalties. If the Manufacturing, Development
or Commercialization of the Product by the Parties in accordance with
this Agreement would, but for a license from such Third Party, infringe
on such Third Party Patents, any royalties or other payments due to
Third Parties pursuant to a license acquired by Auxilium then the
royalty may be reduced by up to X% by such the royalty amounts to a
floor of not less than X percent (X%) in any case.
(b) Supply Price.
(i) Basic Supply Price. Subject to the adjustments set forth
below, the "Supply Price" for the Product shall be calculated as a
percentage of Net Sales as follows:
XXXX
Provided, however, the Supply Price shall not equal less than X percent
(X%) of BTC's Cost of Goods for the Product as provided in Schedule
1.16 (the "Minimum Supply Price").
(ii) Adjustments to Supply Price.
(A) Most Favored Customer. Notwithstanding anything in
this Agreement to the contrary, if at any time during the Term BTC
sells or provides products including Enzyme as an active ingredient
to any customer for commercial use at rates more favorable than
those accorded to Auxilium, BTC shall promptly offer Auxilium the
benefit of such more favorable terms and conditions or rates,
which, upon acceptance, shall be retroactive to the date that such
more favorable terms and conditions were first effective for such
other customer. In order for Auxilium to receive more favorable
cost rates, Auxilum must accept the same basic business deal
conditions as those provided to a party receiving the more
favorable rates. Upon Auxilium's reasonable request, BTC shall
18
provide written confirmation that it is in compliance with the
requirements of this Section.
(B) Reduction In Cost of Goods. If BTC is successful in
reducing the Cost of Goods, the Supply Price to Auxilium will be
reduced by fifty percent (50%) of such dollar reduction.
(C) Supply of Samples. Product samples shall be provided
at no charge to Auxilium for use in post-market clinical trials and
for selected use as commercial samples for dispensing to patients
by an appropriate health care provider, but in no event for direct
distribution to patients. The number of Product samples to be
provided to Auxilium shall be set forth in the Supply Agreement.
(D) Delay in Delivery. If, for any reason other than a
force majeure, the BTC delivers any shipment of Product in
accordance with this Article later than the date of delivery set
out in the purchase order as agreed by the Parties pursuant to the
Supply Agreement then:
(1) a X% reduction in the Supply Price of Product if
the shipment is delivered more than thirty (30) days but less than sixty (60)
days late;
(2) a X% reduction in the Supply Price of Product if
the shipment is delivered more than sixty (60) days but less than ninety (90)
days late; and
(3) a X% reduction in the Supply Price of Product if
the shipment is delivered more than ninety (90) days late.
(4) Once the price has been reduced in accordance with
this Section, it will not revert to the original price unless and until the
deliveries are no longer delayed.
(c) Stand-By Rights; Back Up Supplier.
(i) Standby Rights. Auxilium will be entitled to seek from the
Back-Up Supplier the greater of (a) X% its requirements and (b) that
quantity of Product that BTC is unable to provide, for a period of XX
following the occurrence of any of the events set forth in
(A), (B) or (C) below (the "Standby Rights"). In the event that
Auxilium exercises its Standby Rights, the amount of Product that
Auxilium is obligated to source from BTC pursuant to the Supply
Agreement shall be reduced by such quantity for such one (1) year
period.
(A) Failure to Meet Firm Order. If, for any reason,
including, without limitation, as a result of a force majeure, BTC
is unable to supply at least 75% of the amount of Product specified
under a Firm Order, then Auxilium may exercise its Standby Rights
by providing written notice; provided, however, that in the event
that BTC is unable to supply the full amount specified in
Auxilium's Firm Order for two consecutive quarters (regardless of
the amount of such material shortfall), Auxilium may exercise its
Standby Rights by providing written notice to BTC. In addition,
19
Auxilium shall be permitted to seek supply of any shortfall
(regardless of amount of such shortfall or the number of times BTC
has fulfill some or all of an Auxilium Firm Order) from the Back-Up
Supplier on a per event basis without specifically invoking its
Stand-By Rights.
(B) Egregious Delivery Delay. If, for any reason, other
than a force majeure, BTC delivers any quantity of any Product more
than X days after the date such delivery was due, then
Auxilium may exercise its Standby Rights by providing written
notice.
(C) Nonconforming Product. If any X consecutive
shipments contain nonconforming Product and BTC (1) fails to
replace any nonconforming Product with conforming Product in a
timely manner or (2) fails to replace nonconforming Product within
fifteen (15) Business Days after a dispute regarding whether any
rejected quantity of any Product constitutes nonconforming Product
is decided in Auxilium's favor, then Auxilium may exercise its
Standby Rights by providing written notice.
(ii) Offset. Auxilium will be entitled to offset any royalties
owed to BTC by the amount represented by the difference between the
Back Up Supplier's supply price and BTC's supply price.
(iii) BTC's Use of the Back Up Supplier. If BTC opts to use the
Back Up Supplier to provide Product to Auxilium, then BTC will either
reimburse Auxilium for half of the documented costs and expenses
Auxilium incurred in qualifying, sourcing and maintaining such Back Up
Supplier or BTC will not be entitled to receive a royalty from Auxilium
for the Product sourced from such Back Up Supplier.
(d) Maintenance of Inventory. The Supply Agreement will require
that by the time of Commercialization of the Product, BTC will maintain at least
a six (6) month supply of API Enzyme and such reserve supply of Product as may
be set forth in the Supply Agreement.
(e) Allocation of Supply. In the event of a shortage of raw
materials necessary to Manufacture the Product, BTC shall allocate X
percent (X%) of the total available supply of raw materials and Product to
Auxilium.
(f) Continuous Improvement and Reduction of Cost of Goods. BTC
shall use reasonable efforts to continuously improve its performance, and any
Product suppliers' performance in the supply of the Product, including but not
limited to, reducing Cost of Goods, increasing yield, and optimizing delivery
timing.
(g) Standard Terms of Supply. With respect to the supply of the
Product, BTC shall make the following representations, warranties, and covenants
(the "Standard Terms"):
(i) The Product shall be Manufactured in accordance with all
Laws and, at the time of delivery of the Product, such the Product will
20
comply with the specifications, shall be free from defects in materials
and workmanship, shall be fit for the purpose for which it is intended,
and shall not be adulterated or misbranded within the meaning of the
Act, and shall not constitute an article which may not, under the Act,
be introduced into interstate commerce. BTC provides no other
warranties, express or implied, regarding the Product and disclaims all
other express or implied warranties, including the implied warranties
of merchantability and fitness for a particular purpose.
(ii) The Product sold and shipped shall be Manufactured in
accordance with all Laws in effect at the time and place of Manufacture
of the Product, and all waste, including all hazardous waste, generated
at the time of Manufacture of the Product shall be disposed of in
accordance with all Laws;
(iii) All records as are necessary and appropriate to
demonstrate compliance with Laws shall be maintained by BTC and such
Manufacture of the Product shall be performed in a facility maintaining
a current drug establishment registration with the FDA as set forth in
21 C.F.R. ss. 207;
(iv) BTC shall ensure that it, its Affiliates, and its
subcontractors maintain all Governmental Permits that may be necessary
to Manufacture and ship the Product;
(v) BTC shall advise Auxilium of any information which arises
out of BTC's, its Affiliates, and its subcontractors, as applicable,
Manufacturing, relating to the Product, which have adverse regulatory
compliance or reporting consequences concerning such the Product;
(vi) BTC shall provide to Auxilium any information reasonably
requested by Auxilium and shall consult Auxilium before providing any
information to any Regulatory Authority in connection with Manufacture
of the Product. BTC shall as promptly as possible, but in no event
later than within ten (10) days, advise Auxilium of any requests by any
Regulatory Authority for inspections at the premises of BTC or any of
its Affiliates or subcontractors with respect to the Product;
(vii) In the event BTC, its Affiliates, or its subcontractors
are inspected by the FDA or any similar or related Regulatory Authority
relating to the Product, BTC agrees to notify Auxilium of any such
inspection and will use Commercially Reasonable Efforts to ensure that
Auxilium shall have the right to be present during such inspection. BTC
shall promptly notify Auxilium of any alleged violations or
deficiencies relating to a Manufacturing facility at which the Product
are Manufactured, packaged, or stored, and shall promptly disclose to
Auxilium all relevant portions of any notice of observations or
potential violations as well as a copy of its response thereto;
(viii) Neither BTC, its Affiliates nor subcontractors shall
use, in the Manufacture of any the Product, in any capacity the
services of any person, including any firm or individual, debarred or
subject to debarment under the Generic Drug Enforcement Act of 1992,
amending the Act at 21 U.S.C. ss. 335a. BTC agrees to notify Auxilium
immediately in the event any person providing services to BTC, its
21
Affiliates, or subcontractors relating to this Agreement is debarred or
becomes subject to debarment; and
(ix) For the purpose of permitting a quality and compliance
audit, BTC, its Affiliates, and subcontractors shall grant to
authorized representatives of (or a Third Party hired on behalf of
Auxilium who is reasonably acceptable to BTC), in general not more than
once per month, upon reasonable notice, access to areas of each of its
plants to the extent permitted by Law. Auxilium shall have the right,
subject to any Third Party confidentiality obligations and at its sole
expense, to examine those technical records made by BTC, its Affiliates
or subcontractors that relate to the Manufacture of the Product.
(h) Customary Terms. The Supply Agreement shall also include
provisions for: forecasting and ordering, inventory maintenance requirements;
packaging obligations; back-up suppliers, compliance with applicable regulatory
requirements, Auxilium guidelines, and specifications, and all Laws.
ARTICLE 7
PAYMENTS
7.1 Milestone Payments by Auxilium.
(a) Amount of Milestone Payments.
----------------------------------------------------------------------------------------------------------------
# MILESTONE UNITED STATES DOLLARS
----------------------------------------------------------------------------------------------------------------
1 The Effective Date $2.5 million
----------------------------------------------------------------------------------------------------------------
2 The delivery to Auxilium of the Product Data relating to $2.5 million
Dupuytren's Disease and Peyronie's Disease in accordance
with Section 2.4 of this Agreement.
----------------------------------------------------------------------------------------------------------------
3 The one (1) year anniversary of the Effective Date $X
----------------------------------------------------------------------------------------------------------------
4 Upon first of either NDA Acceptance or MAA Acceptance for Dupuytren's $X
the following Indications on an Indication by Indication Disease
basis: -----------------------------------------
Peyronie's Disease $X
----------------------------------------------------------------------------------------------------------------
5 Receipt by Auxilium or its Affiliate of first Regulatory Dupuytren's $X
Approval in the United States or three or more of the United Disease
Kingdom, Spain, Germany, France or Italy with labeling -----------------------------------------
approved for the following Indications on an Indication by Peyronie's Disease $X
Indication basis:
----------------------------------------------------------------------------------------------------------------
(b) Timing of Milestone Payments. For milestones 1, 2 and 3,
payment shall be made within ten (10) Business Days after the occurrence of the
event giving rise to a payment obligation hereunder. For milestones 4 and 5,
payment shall be made within thirty (30) days after the occurrence of the event
giving rise to a payment obligation hereunder. All payments shall be made by
22
wire transfer in United States Dollars to the credit of such bank account as may
be designated, from time to time, by BTC in writing.
7.2 Process Development Milestones Within thirty (30) days following
the Effective Date, BTC will provide Auxilium with a plan for the scale-up of
Manufacturing for clinical and commercial supplies of Product (the
"Manufacturing Plan") which is acceptable to Auxilium. The Manufacturing Plan
shall contain, among other things, a schedule setting forth a timeline for the
achievement of certain manufacturing process development milestones (the
"Process Development Milestones"). Auxilium shall pay to BTC the amount of
$X monthly upon achieving the Process Development Milestones (the "Process
Development Payments"); provided, however, that Auxilium may suspend the Process
Development Payments at anytime if it determines, in its reasonable judgement
that BTC has not consistently met the Process Development Milestones. For
purposes of clarification, in no event will the Process Development Payments
exceed $X in the aggregate.
7.3 Payments for Exercised Indications.
(a) Upon Exercise of Option. Within ten (10) Business Days of the
inclusion on Exercised Indications in the Field, Auxilium shall make the
following one-time license fee payments to BTC on a per Indication basis:
Amount Indication
------ ----------
$X Cellulite reduction
$X Frozen Shoulder
$X Each Additional Indication
(b) Upon Approval. Within ten (10) Business days of receipt by
Auxilium of the first Regulatory Approval from the FDA for an Exercised
Indication, Auxilium shall make the following milestone payments to BTC on a per
Indication basis:
Amount Labeling Approved for the following Indication
------ ----------------------------------------------
$X Cellulite reduction
$X Treatment of keloids
$X Treatment of lipomas
$X Frozen Shoulder
$X Each Additional Indication
7.4 Payments Related to Sublicense Income. Within thirty (30) Business
Days of receiving Sublicense Income, Auxilium shall make a payment to BTC in the
following amount:
7.3.1 If Auxilium has not conducted a Clinical Trial for Product in
the relevant Indication prior to the effective date of the relevant sublicense,
then Auxilium will remit X percent (X%) of the Sublicense Income actually
received.
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7.3.2 If Auxilium has conducted Clinical Trials for a Product in
the relevant Indication prior to the date of the relevant sublicense, then
Auxilium will remit X percent (X%) of Sublicense Income actually received.
7.3.3 Auxilium has obtained Regulatory Approval for a Product in
the relevant Indication prior to the date of the relevant sublicense, then
Auxilium will remit X percent (X%) of Sublicense Income actually received.
7.3.4 If the field of use of the sublicense to the Product is
non-human use, then Auxilium will remit X percent (X%) of the Sublicense
Income actually received for that field of use.
7.5 Currency. All payments shall be payable in United States Dollars.
7.6 Books and Records. Auxilium agrees to maintain and retain, in
accordance with generally accepted accounting practices, complete and accurate
records showing all transactions and information relating to this Agreement for
a period of three (3) years from the date of entry to which they pertain.
7.7 Audit Rights. Upon the written request of BTC and not more than
once in each calendar year, Auxilium shall permit an independent certified
public accounting firm (other than on a contingency fee basis) selected by BTC
and acceptable to Auxilium (which acceptance by Auxilium shall not be
unreasonably withheld) to have access during normal business hours to such
records of Auxilium as may be reasonably necessary to verify Auxilium's
compliance with the payment terms of this Article 7. The accounting firm shall
enter into an acceptable and customary confidentiality agreement with Auxilium
obligating the accounting firm to retain in confidence all information of
Auxilium which it obtains in performing such audits hereunder, and such audit
shall be subject to Auxilium's third Party confidentiality obligations. Any
audit under this Section 7.7 shall be at the expense of BTC, unless a particular
audit reveals an underpayment of five percent (5%) or more of the amount that
should have been paid to BTC for the period audited, in which case, Auxilium
shall bear the expense of such audit.
7.8 Taxes. Auxilium shall be entitled to deduct from its payments to
BTC the amount of any withholding taxes required to be withheld by Auxilium or
its Affiliates or sublicensees to the extent BTC or sublicensees pay to the
appropriate governmental authority on behalf of BTC such taxes. Auxilium shall
deliver to BTC, upon BTC's request, proof of payment of all such taxes. Each
Party shall provide assistance to the other Party in seeking any benefits
available to such Party with respect to government tax withholdings by any
relevant law or double tax treaty.
7.9 Interest. Any payments payable by either party which are not paid
on or before the date such payments are due under this Agreement (other than
such payments which are the subject of a good faith dispute between the Parties)
shall bear interest at the prime rate of interest plus 1%, calculated on the
number of days that payment is delinquent.
7.10 Blocked Payments. In the event that, by reason of Laws or
regulations in any country, it becomes impossible or illegal for Auxilium or an
Affiliate or sublicensee of Auxilium, to transfer, or have transferred on its
24
behalf, distribution fees or other payments to BTC, Auxilium shall promptly
notify BTC of the conditions preventing such transfer and such distribution fees
or other payments shall be deposited in local currency in the relevant country
to the credit of BTC in a recognized banking institution designated by BTC or,
if none is designated by BTC within a period of thirty (30) days, in a
recognized banking institution selected by Auxilium or its Affiliate or
sublicensee, as the case may be, and identified in a notice given to BTC.
ARTICLE 8
INTELLECTUAL PROPERTY
8.1 BTC Patentable Inventions and Know-How.
(a) BTC Patent Prosecution.
(i) During the term of the Agreement, BTC shall, diligently and
in the reasonable exercise of its commercial discretion, prepare, file,
prosecute, maintain, renew and defend BTC Patents in the countries
where such BTC Patents are filed as of the Effective Date; provided,
however, that BTC shall select patent counsel with Auxilium's consent,
such consent not to be unreasonably withheld.
(ii) If BTC does not intend to file for patent protection or
does not wish to continue preparation, prosecution, or maintenance of a
BTC Patent, then it shall give at least thirty (30) days advance
notice, and in no event less than a reasonable period of time for
Auxilium to act in its stead.
(A) In such case, Auxilium may elect at its sole
discretion to continue preparation, filing and prosecution or
maintenance of the discontinued BTC Patent at its sole expense.
(B) Ownership of any such discontinued BTC Patent shall at
the request of Auxilium be assigned to Auxilium and BTC shall
execute such documents and perform such acts as may be reasonably
necessary for assigning such ownership to Auxilium.
(C) Discontinuance may be elected on a country-by-country
basis or for a patent application or patent series in total.
(b) Cooperation. BTC will consult Auxilium and will keep Auxilium
continuously informed of all matters relating to the filing, prosecution and
maintenance of BTC Patents including, but not limited to, disclosing to Auxilium
the complete text of all such BTC Patents.
(i) BTC shall provide Auxilium with a copy of any BTC Patents
relating to Enzyme or Product withing thirty (30) days of the Effective
Date. Prior to filing the first of any new Patents in any jurisdiction,
BTC shall provide Auxilium with a copy of any such Patent applications
and copies of all material correspondence with the relevant patent
office pertaining to the BTC Patents and directly relating to Enzyme or
Product.
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(ii) BTC shall consider all of Auxilium's comments in good
faith and take all steps reasonably necessary to optimize the patent
position for the Product.
(iii) In no event shall BTC relinquish control of the
prosecution of BTC Patents to a Third Party.
8.2 Infringement Claims by Third Parties.
(a) Notice. If the manufacture, use or sale of the Product under
the BTC Patents results in a claim or a threatened claim by a Third Party
against a Party hereto for patent infringement or for inducing or contributing
to patent infringement ("Infringement Claim"), the Party first having notice of
an Infringement Claim shall promptly notify the other in writing. The notice
shall set forth the facts of the Infringement Claim in reasonable detail.
(b) Third Party Licenses. In the event that practicing under the
BTC Patents in connection with manufacture, use or sale of the Product in a
country would infringe a Third Party Patent and a license to such Third Party
Patent is available and Auxilium in its sole discretion seeks such a license,
the Parties agree:
(i) Auxilium will be responsible for all costs associated with
acquiring any Third Party license to the extent required for Auxilium
to continue to make, use and sell the Product and the Enzyme, provided
however, Auxilium may offset such costs against the Royalty, with a
minimum floor of three percent (3%) in accordance with Section 6.4 or,
prior to commercial launch, offset such costs against any milestones
due to BTC pursuant to Article 7; and
(ii) Auxilium will use Commercially Reasonable Efforts to
obtain any such required licenses under the Third Party's Patents with
a right to sublicense to BTC and if requested by BTC will grant such
sublicense, under reasonable sublicense terms mutually acceptable to
both BTC and Auxilium.
(c) Litigation. In the event of the institution of any suit by a
Third Party against Auxilium as a result of Auxilium's Development or
Commercialization of the Product or the Enzyme, Auxilium shall have the right
but, not the obligation, to defend such suit at its expense; BTC shall cooperate
and assist Auxilium in any such litigation at Auxilium' expense. In the event of
the institution of any suit by a Third Party against BTC as a result of BTC's
Manufacture of the Product or the Enzyme, BTC shall have the right but, not the
obligation, to defend such suit at its expense. Auxilium shall cooperate and
assist BTC in any such litigation at BTC's expense. For purposes of clarity,
notwithstanding anything to the contrary in Article 12, to the extent
applicable, Auxilium will be entitled to seek indemnification from BTC for
Losses arising in connection with such suit.
8.3 Infringement Claims Against Third Parties.
(a) Cooperation. BTC and Auxilium each agree to take reasonable
actions to protect BTC Patents from infringement. If one Party brings any such
action or proceeding, the second Party may be joined as a Party plaintiff if
26
necessary for the action or proceeding to proceed and, in case of joining, the
second Party agrees to give the first Party reasonable assistance and authority
to file and to prosecute such suit.
(b) Notice. If any BTC Patents are infringed by a Third Party, the
Party to this Agreement first having knowledge of such infringement, or
knowledge of a reasonable probability of such infringement, shall promptly
notify the other in writing. The notice shall set forth the facts of such
infringement in reasonable detail.
(c) Institution of Proceedings. BTC, shall have the primary right,
but not the obligation, to institute, prosecute, and control with its own
counsel at its own expense any action or proceeding with respect to infringement
of the claims of such BTC Patents and Auxilium shall have the right, but not the
obligation at its own expense, to be represented in such action by its own
counsel.
(d) Failure to Institute Proceedings. If BTC fails to institute,
prosecute, and control such action or prosecution and fails to do so within a
period of one hundred twenty (120) days after receiving notice of the
infringement, Auxilium shall have the right to bring and control any such action
by counsel of its own choice, and BTC shall have the right, at its own expense,
to be represented in any such action by counsel of its own choice.
(e) Division of Damages Award. Any recovery made in connection with
such infringement claim shall be divided as follows:
(i) the Party that initiated and prosecuted such action shall
recoup all of its costs and expenses (including reasonable attorney's
fees) incurred in connection with such action, whether the recovery is
by settlement or otherwise;
(ii) the other Party then shall, to the extent possible,
recover its costs and expenses (including reasonable attorney's fees)
incurred in connection with such action;
(iii) if BTC initiated and prosecuted the action, the amount of
any recovery remaining shall be retained by BTC; and
(iv) if Auxilium initiated and prosecuted the action, the
amount of any recovery remaining shall be retained by Auxilium, except
that BTC shall receive a portion equivalent to the amount it would have
received in accordance with the terms of Section 6.4 as if such amount
were Net Sales of Auxilium.
(f) Settlement. The Parties shall keep each other informed of the
status of and of their respective activities regarding any litigation or
settlement thereof concerning Product; provided, however, that no settlement or
consent judgment or other voluntary final disposition of a suit under this
Section may be undertaken without the consent of the other Party if such
settlement would require the other Party to be subject to an injunction or to
make a monetary payment or would otherwise adversely affect the other Party's
rights under this Agreement or the validity of BTC Patents.
27
8.4 Notice of Certification. BTC and Auxilium each shall immediately
give notice to the other of any certification filed under the "U.S. Drug Price
Competition and Patent Term Restoration Act of 1984" (or its foreign equivalent)
claiming that a BTC Patent is invalid or that infringement will not arise from
the manufacture, use or sale of any Product by a Third Party.
(a) If BTC decides not to bring infringement proceedings against
the entity making such a certification, BTC shall give notice to Auxilium of its
decision not to bring suit within twenty one (21) days after receipt of notice
of such certification.
(b) Auxilium may then, but is not required to, bring suit against
the Party that filed the certification; provided, however, that the costs
incurred by Auxilium in connection with such suit shall be creditable against
milestone payments payable by Auxilium in accordance with Article 7.
(c) Any suit by Auxilium or BTC shall either be in the name of
Auxilium or in the name of BTC, or jointly in the name of Auxilium and BTC, as
may be required by law.
(d) For this purpose, the Party not bringing suit shall execute
such legal papers necessary for the prosecution of such suit as may be
reasonably requested by the Party bringing suit.
8.5 Patent Term Extensions. The Parties shall cooperate in good faith
with each other in gaining patent term extension wherever applicable to BTC
Patents covering Enzyme or Product.
(a) Auxilium and BTC shall jointly determine which BTC Patents
shall be extended.
(b) All filings for such extension shall be made by the Party
responsible for prosecution and maintenance of the BTC Patent, provided,
however, that in the event that the Party who is responsible for prosecution and
maintenance of the BTC Patent elects not to file for an extension, such Party
shall (i) inform the other Party of its intention not to file and (ii) grant the
other Party the right to file for such extension.
8.6 Trademarks.
(a) Each Party and its Affiliates shall retain all right, title and
interest in and to its and their respective corporate names and logos.
(b) Auxilium shall be solely responsible for selecting a trademark
(the "Auxilium Trademark") to use for each country in the Territory. The Product
shall be promoted and sold, in accordance with the provisions of this Agreement,
in the Territory under the Auxilium Trademark. Auxilium (or its local
Affiliates, as appropriate) shall own and retain all rights to Auxilium
Trademark, and all goodwill associated therewith throughout the Territory.
Auxilium shall also own rights to any internet domain names incorporating the
Auxilium Trademark or any variation or part of Auxilium Trademark as its URL
address or any part of such address.
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ARTICLE 9
REPRESENTATIONS AND WARRANTIES
9.1 BTC Represents and Warrants. BTC hereby represents and warrants to
Auxilium that:
(a) This Agreement has been duly executed and delivered by BTC and
constitutes the valid and binding obligation of BTC, enforceable against BTC in
accordance with its terms except as enforceability may be limited by bankruptcy,
fraudulent conveyance, insolvency, reorganization, moratorium and other laws
relating to or affecting creditors' rights generally and by general equitable
principles. The execution, delivery and performance of this Agreement have been
duly authorized by all necessary action on the part of BTC, its officers and
directors;
(b) As of the Effective Date BTC owns or possesses adequate
licenses or other rights necessary to make, use and sell all technology covered
by the BTC Patents, and to grant the licenses herein and the granting of the
licenses to Auxilium hereunder does not violate any right known to BTC of any
Third Party;
(c) BTC represents that to the best of its knowledge, as of the
Effective Date it is not aware that the development, manufacture, use or sale of
the Enzyme or the Product pursuant to this Agreement may infringe or conflict
with any Third Party right or Patent, and BTC is not aware of any pending patent
application that, if issued, would be infringed by the development, manufacture,
use or sale of the Enzyme or the Product pursuant to this Agreement;
(d) The execution, delivery and performance of this Agreement by
BTC 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, and, to the best of
its knowledge, does not violate any material law or regulation of any court,
governmental body or administrative or other agency having authority over it;
(e) BTC has disclosed to Auxilium all material information in its
control pertaining to the suitability of Enzyme as a pharmaceutical candidate;
(f) The Product has valid and effective Orphan Drug Designation
under the applicable FDA statutes, rules or regulations, effective, May 23,
1996, and March 12, 1996 BTC has no reason to believe such Orphan Drug
Designation shall be terminated prior to the Effective Date.
(g) BTC is not currently a Party to, and during the Term will not
enter into, any agreements, oral or written, that are inconsistent with its
obligations under this Agreement;
(h) BTC is duly organized and validly existing under the laws of
the state of Delaware and has full legal power and authority to enter into this
Agreement; and
(i) BTC is not subject to any order, decree or injunction by a
court of competent jurisdiction which prevents or materially delays the
consummation of the transactions contemplated by this Agreement.
29
9.2 Auxilium Represents and Warrants. Auxilium hereby represents and
warrants to BTC that:
(a) The execution, delivery and performance of this Agreement by
Auxilium 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, and, to the best
of its knowledge, does not violate any material law or regulation of any court,
governmental body or administrative or other agency having authority over it;
(b) Auxilium is not currently a Party to, and during the Term will
not enter into, any agreements, oral or written, that are inconsistent with its
obligations under this Agreement;
(c) Auxilium is duly organized and validly existing under the laws
of the state of Delaware and has full legal power and authority to enter into
this Agreement; and
(d) Auxilium is not subject to any order, decree or injunction by a
court of competent jurisdiction which prevents or materially delays the
consummation of the transactions contemplated by this Agreement.
9.3 Disclaimer of Warranties. THE LIMITED WARRANTIES CONTAINED IN THIS
ARTICLE ARE THE SOLE WARRANTIES GIVEN BY THE PARTIES AND ARE MADE EXPRESSLY IN
LIEU OF AND EXCLUDE ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, TITLE, INFRINGEMENT OR OTHERWISE, AND ALL OTHER EXPRESS OR
IMPLIED REPRESENTATIONS AND WARRANTIES PROVIDED BY COMMON LAW, STATUTE OR
OTHERWISE ARE HEREBY DISCLAIMED BY BOTH PARTIES.
ARTICLE 10
CONFIDENTIALITY
10.1 Confidentiality. During the Term, and for a period of five (5)
years thereafter, each Party hereto will maintain in confidence all information
disclosed, and reasonably believed by the other party to be confidential whether
orally or in writing, by the other Party hereto ("Confidential Information").
Neither Party shall use, disclose or grant use of such Confidential Information
except as required under 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 its and its Affiliates' employees, agents, consultants, and clinical
investigators only make use of Confidential Information for the purpose of this
Agreement and do not disclose or make any unauthorized use of such Confidential
Information. Each Party shall promptly notify the other upon discovery of any
unauthorized use or disclosure of Confidential Information. Confidential
Information shall not include any information which and to the extent:
(a) was already known to the receiving Party, other than under an
obligation of confidentiality, at the time of disclosure by the other Party;
(b) was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the other Party;
30
(c) becomes generally available to the public or otherwise part of
the public domain after its disclosure and other than through any act or
omission of the receiving Party in breach of this Agreement;
(d) was disclosed to the receiving Party, other than under an
obligation of confidentiality, by a Third Party who had no obligation to the
other Party not to disclose such information; or
(e) was independently developed by the receiving Party without
reference to the disclosure by the other Party, as documented by written
records.
10.2 Terms of Agreement. The Parties agree that the material financial
terms of the Agreement shall be considered the Confidential Information of both
Parties.
10.3 Permitted Disclosure. Each Party may disclose the Confidential
Information to the extent such disclosure is reasonably necessary in filing or
prosecuting patent applications, prosecuting or defending litigation, or
complying with any applicable statute or governmental regulation provided such
Party has given the disclosing Party prompt written notice allowing it to limit
such disclosure. In addition, either Party may disclose Confidential Information
to its Affiliates and to its Sublicensees; provided, however, in connection with
any such disclosure the disclosing Party shall secure confidential treatment of
such Confidential Information.
10.4 Employee Obligations . The Parties shall undertake to ensure that
all their employees who have access to Confidential Information of the other
Party are under obligations of confidentiality fully consistent with those
provided in this Article.
10.5 Publication. No Party may publish confidential or proprietary
information of the other Party, without the consent of the other Party. The
reviewing Party shall have thirty (30) days from receipt of the proposed oral
disclosure or written publication to provide comments or proposed changes to the
disclosing Party. The review period may be extended for an additional two (2)
months to permit the reviewing Party to file one or more patent applications as
it deems appropriate. This Section 10.5 shall be inapplicable to the publication
of information presented in substantially the same form in which was previously
published or disclosed to the public, and to any other disclosures which, on the
advice of counsel, are required by law to be disclosed.
10.6 Prior Agreements. The obligations of Confidentiality and
Nondisclosure set forth in this Section 10 supersede any and all prior and
contemporaneous communications, representations, agreements or understandings,
whether oral or written concerning the subject matter of this Section 10.
ARTICLE 11
TERM AND TERMINATION
11.1 Term.
(a) Term.Unless earlier terminated as provided herein, the Term
shall commence as of the Effective Date and shall remain in full force and
effect on a Product by Product and country by country basis until the later of
31
(i) the last to expire valid claim of a patent covering such Product, (ii) the
expiration of the regulatory exclusivity period conveyed by Orphan Drug
Designation with respect to such Product, and (iii) twelve (12) years (the
"Term").
(b) Accrued Obligations. Except where explicitly provided
elsewhere herein, termination of this Agreement for any reason, or expiration of
this Agreement, will not affect: (i) obligations, including the payment of any
royalties or other sums which have accrued as of the date of termination or
expiration, and (ii) rights and obligations which, from the context thereof, are
intended to survive termination or expiration of this Agreement.
11.2 Termination for Insolvency. Either Party may terminate this
Agreement immediately upon delivery of written notice to the other Party (a)
upon the institution by or against the other Party of insolvency, receivership
or bankruptcy proceedings or any other proceedings for the settlement of the
other Party's debts; provided, however with respect to involuntary proceedings,
that such proceedings are not dismissed within one hundred and twenty (120)
days; (b) upon the other Party's making an assignment for the benefit of
creditors; or (c) upon the other Party's dissolution or ceasing to do business.
11.3 Material Breach. Either Party may terminate this Agreement upon
ninety (90) days prior written notice to the other Party upon the material
breach by the other Party of any of its obligations under this Agreement;
provided, however, that such termination shall become effective only if the
other Party shall fail to remedy or cure the breach within such ninety (90) day
period.
11.4 Termination by Auxilium. Auxilium may terminate this Agreement in
its entirety or on a country-by-country basis or on an Indication by Indication
basis or on a Product by Product basis at any time upon ninety (90) days prior
written notice to BTC.
11.5 Effect Of Termination.
(a) Effect On License. Upon the expiration or earlier termination
of this Agreement, the rights licensed under this Agreement shall be treated as
follows:
(i) Upon the expiration of the Term or the termination of this
Agreement by Auxilium pursuant to Section 11.2 or Section 11.3,
Auxilium shall have a fully paid-up, perpetual, irrevocable,
royalty-free, transferable, worldwide, non-exclusive right and license
under the Licensed Technology existing as of the date of such
expiration to make, have made, use, offer to sell, and sell the Product
in the Territory.
(ii) Upon termination of this Agreement by BTC pursuant to
Section 11.2 or 11.3, or by Auxilium pursuant to Section 11.4 all
rights to Product shall revert to BTC.
(b) Ongoing Obligations.
(i) Upon expiration or termination of this Agreement for any
reason, each Party shall no later than thirty (30) days after such
termination return to the other Party or destroy any Confidential
Information disclosed by the other Party, except for one copy which may
be retained in its confidential files.
32
(ii) Upon termination of this Agreement by BTC pursuant to
Sections 11.2 or 11.3 or by Auxilium pursuant to Section 11.4, Auxilium
shall assign and deliver to BTC all Regulatory Data and information
(including registration dossiers) obtained for or in pursuing
Regulatory Approvals, and all Regulatory Approvals (e.g., to BTC;
designee in the Territory as permitted under the Law) for Product in
the Territory received as of such termination date.
11.6 Inventory. Notwithstanding the foregoing, upon early termination
of this Agreement pursuant to Section 11.2, 11.3 or 11.4, Auxilium shall have
the right to sell all remaining Product in its inventory within six (6) months
after the date of termination, but shall be bound to the royalty payments
provided by Article 7.4 herein.. Thereafter, Auxilium agrees to destroy any
remaining supply of Product or return it to BTC at BTC's request and direction.
ARTICLE 12
INDEMNIFICATION
12.1 Auxilium. Auxilium shall defend BTC at Auxilium' cost and expense,
and will indemnify and hold BTC and their respective directors, officers,
employees, consultants, contractors, representatives, and agents harmless from
and against any and all losses, costs, damages, fees, or expenses (including
reasonable attorney's fees and expenses) ("Losses") incurred in connection with
or arising out of any Third Party claim (a "Third Party Claim") directly
relating to (i) any material breach by Auxilium of its representations or
warranties or obligations pursuant to this Agreement, (ii) any gross negligence
or willful misconduct of Auxilium, its Affiliates, or their respective
directors, officers, employees, contractors, consultants, agents,
representatives, or sublicensees in the exercise of any of Auxilium' rights or
the performance of any of Auxilium' obligations under this Agreement, and (iii)
the handling, packaging, storage, or Commercialization by Auxilium or any of its
Affiliates or sublicensees of any Product in the Territory (excluding all
intellectual property infringement or related claims, which are covered in
Section 12.2); provided that notwithstanding the foregoing, in all cases
referred to in this Section 12.1, Auxilium shall have no liability to BTC for
any Losses to the extent that such Losses were caused by any item for which BTC
is required to indemnify Auxilium pursuant to Section 12.2.
12.2 BTC. BTC shall defend Auxilium and its Affiliates at BTC's cost
and expense, and will indemnify and hold Auxilium and its Affiliates and their
respective directors, officers, employees, consultants, contractors,
representatives, and agents harmless from and against any and all Losses
incurred in connection with or arising out of any Third Party Claim directly
relating to (i) material breach by BTC of any of its representations, warranties
or obligations pursuant to this Agreement, (ii) gross negligence or willful
misconduct of BTC in the exercise of any of its rights or the performance of any
of its obligations under this Agreement, (iii) personal injury and other product
liability resulting from BTC's Development, Manufacture, or Commercialization of
any Product, (iv) intellectual property infringement or related claims,
including any Third Party Claim and trade secret misappropriation liability
relating to the Development, Manufacture, or Commercialization of any Product,
(v) any liability or other claims from the Manufacture, handling, packaging,
storage, sale, or other disposition of any Product by BTC or any of its
Affiliates or sublicensees, and (vi) any liability or claims arising from
Product supplied by or on behalf of BTC to Auxilium that was not Manufactured in
accordance with current Good Manufacturing Practices, Good Clinical Practice and
33
Good Laboratory Practices, the specifications or all Laws and regulations except
for such Losses that are indemnified pursuant to the Supply Agreement; provided
that notwithstanding the foregoing, in all cases referred to in this Section
12.2, BTC shall have no liability to Auxilium for any Losses to the extent (and
only to the extent) that such Losses were caused by any item for which Auxilium
is required to indemnify BTC pursuant to Section 12.1.
12.3 Claims Procedures. Each Party entitled to be indemnified by the
other Party (an "Indemnified Party") pursuant to Section 12.1 or 12.2 hereof
shall give notice to the other Party (an "Indemnifying Party") promptly after
such Indemnified Party has actual knowledge of any threatened or asserted claim
as to which indemnity may be sought, and shall permit the Indemnifying Party to
assume the defense of any such claim or any litigation resulting therefrom;
provided:
(a) That counsel for the Indemnifying Party, who shall conduct the
defense of such claim or any litigation resulting therefrom, shall be approved
by the Indemnified Party (whose approval shall not unreasonably be withheld) and
the Indemnified Party may participate in such defense at such Party's expense
(unless (i) the employment of counsel by such Indemnified Party has been
authorized by the Indemnifying Party; or (ii) the Indemnified Party shall have
reasonably concluded that there may be a conflict of interest between the
Indemnifying Party and the Indemnified Party in the defense of such action, in
each of which cases the Indemnifying Party shall pay the reasonable fees and
expenses of one law firm serving as counsel for the Indemnified Party, which law
firm shall be subject to approval, not to be unreasonably withheld, by the
Indemnifying Party).
(b) The failure of any Indemnified Party to give notice as
provided herein shall not relieve the Indemnifying Party of its obligations
under this Agreement to the extent that the failure to give notice did not
result in harm to the Indemnifying Party.
(c) No Indemnifying Party, in the defense of any such claim or
litigation, shall, except with the approval of each Indemnified Party which
approval shall not be unreasonably withheld, consent to entry of any judgment or
enter into any settlement which (i) would result in injunctive or other relief
being imposed against the Indemnified Party; or (ii) does not include as an
unconditional term thereof the giving by the claimant or plaintiff to such
Indemnified Party of a release from all liability in respect to such claim or
litigation.
(d) Each Indemnified Party shall furnish such information
regarding itself or the claim in question as an Indemnifying Party may
reasonably request in writing and shall be reasonably required in connection
with the defense of such claim and litigation resulting therefrom.
12.4 Escrow. In the event of any Third Party Claim against Auxilium for
which BTC is obligated to indemnify Auxilium in accordance with Section 12.2,
Auxilium shall be entitled, until a final un-appealable decision has been
rendered or a settlement has been reached (a "Final Decision"), to pay an amount
equal to fifty percent (50%) of all amounts due to BTC on Net Sales of Products
(such aggregate amount, the "Escrowed Amount") into an escrow account maintained
by a Third Party reasonably acceptable to BTC. To the extent that Auxilium
incurs any Losses in connection with such Third Party Claim, an amount equal to
34
the amount of any such Losses shall be distributed to Auxilium out of such
escrow account, with the remainder (if any) to be paid to BTC. In the event that
the Escrow Amount is less than the amount of such Losses, BTC shall pay the
difference to Auxilium within thirty (30) days of such Final Decision.
12.5 Insurance. During the Term, each of Auxilium and BTC shall
maintain general liability and product liability insurance in the following
amounts: (i) at all times prior to approval of a NDA for a Product, $3,000,000
per occurrence, and (ii) at all times after approval of a NDA for a Product,
$5,000,000.
12.6 Compliance. The Parties shall comply fully with all Laws and
regulations in connection with their respective activities under this Agreement.
ARTICLE 13
MISCELLANEOUS PROVISIONS
13.1 Dispute Resolution. In the event of any controversy or claim
arising out of relating to or in connection with any provision of this
Agreement, or the rights or obligations hereunder, the Parties shall try to
settle their differences amicably between themselves. Either Party may initiate
such informal dispute resolution by sending written notice of the dispute to the
other Party, and within ten (10) business days after such notice appropriate
representatives of the Parties shall meet for attempted resolutions by good
faith negotiations. If such representatives are unable to resolve such disputed
matters, it shall be referred to the Chief Executive Officers of BTC and
Auxilium, for discussion and resolution. If they are unable to resolve the
dispute within thirty (30) days of initiating such negotiations, the Parties
agree first to submit the dispute to non-binding mediation before resorting to
litigation or other mutually agreed dispute resolution mechanism. The dispute
resolution procedures set forth herein shall not limit a court from granting a
temporary restraining order or a preliminary injunction in order to preserve the
status quo of the Parties pending arbitration or to protect a Party's trademark
or confidential or proprietary information.
13.2 Construction. Unless the context of this Agreement clearly
requires otherwise, (a) references to the plural include the singular, the
singular the plural, the part the whole, (b) references to any gender include
all genders, (c) "or" has the inclusive meaning frequently identified with the
phrase "and/or," (d) "including" has the inclusive meaning frequently identified
with the phrase "including but not limited to" or "including", and (e)
references to "hereunder" or "herein" relate to this Agreement. The section and
other headings contained in this Agreement are for reference purposes only and
shall not control or affect the construction of this Agreement or the
interpretation thereof in any respect. Section, subsection, and Schedule
references are to this Agreement unless otherwise specified. Each accounting
term used herein that is not specifically defined herein shall have the meaning
given to it under GAAP.
13.3 Governing Law; Jurisdiction. This Agreement shall be construed and
the respective rights of the Parties determined according to the substantive
laws of the State of New York notwithstanding the provisions governing conflict
of laws under such New York law to the contrary, except matters of intellectual
property law which shall be determined in accordance with the intellectual
property laws relevant to the intellectual property in question.
35
13.4 Post-Closing Access to Information. BTC shall afford to
representatives of Auxilium reasonable access to offices, plants, properties,
books and records of BTC relating to the Product, during normal business hours,
in order that Auxilium may have an opportunity to make such reasonable
investigations as it desires with respect to Product. At all times after the
Effective Date, each Party will permit the other Party and its representatives
(including its counsel and auditors) during normal business hours, for a proper
purpose to have reasonable access to and examine and make copies of, at the
expense of the copying Party, all books, records, files and documents in its
possession which relate to the Product.
13.5 Section 365(n) of the Bankruptcy Code. All rights and licenses
granted under or pursuant to any section of this Agreement are, and shall
otherwise be deemed to be, for purposes of Section 365(n) of the Bankruptcy
Code, licenses of rights to "intellectual property" as defined under Section
101(35A) of the Bankruptcy Code. The Parties shall retain and may fully exercise
all of their respective rights and elections under section 365(n) of the
Bankruptcy Code.
13.6 Waiver. The failure on the part of Auxilium or BTC to exercise or
enforce any rights conferred upon it hereunder shall not be deemed to be a
waiver of any such rights nor operate to bar the exercise or enforcement thereof
at any time or times thereafter. The observance of any Term may be waived
(either generally or in a particular instance and either retroactively or
prospectively) by the Party entitled to enforce such term, but any such waiver
shall be effective only if in writing signed by the Party against whom such
waiver is to be asserted.
13.7 Force Majeure. Neither Party shall be held liable or responsible
to the other Party nor be deemed to have defaulted under or breached this
Agreement for failure or delay in fulfilling or performing any Term, other than
an obligation to make a payment, when such failure or delay is caused by or
results from fire, floods, embargoes, government regulations, prohibitions or
interventions, war, acts of war (whether war be declared or not), insurrections,
riots, civil commotions, strikes, lockouts, acts of God, or any other cause
beyond the reasonable control of the affected Party.
13.8 Severability. It is the intention of the Parties to comply with
all Laws domestic or foreign in connection with the performance of its
obligations hereunder. In the event that any provision of this Agreement, or any
part hereof, is found invalid or unenforceable, the remainder of this Agreement
will be binding on the Parties hereto, and will be construed as if the invalid
or unenforceable provision or part thereof had been deleted, and the Agreement
shall be deemed modified to the extent necessary to render the surviving
provisions enforceable to the fullest extent permitted by law.
13.9 Government Acts. In the event that any act, regulation, directive,
or law of a government, including its departments, agencies or courts, should
make impossible or prohibit, restrain, modify or limit any material act or
obligation of Auxilium or BTC under this Agreement, the Party, if any, not so
affected shall have the right, at its option, to suspend or terminate this
Agreement as to such country, if good faith negotiations between the Parties to
make such modifications to this Agreement as may be necessary to fairly address
the impact thereof, after a reasonable period of time are not successful in
producing mutually acceptable modifications to this Agreement.
36
13.10 Assignment. This Agreement may not be assigned or otherwise
transferred by either Party without the prior written consent of the other
Party; provided, however, that either Party may assign this Agreement, without
the consent of the other Party, in connection with the transfer or sale of all
or substantially all of its assets or business or in the event of its merger or
consolidation with another company. In all cases the assigning Party shall
provide the other Party with prompt notice of any such assignment. Any purported
assignment in contravention of this Section shall, at the option of the
nonassigning Party, be null and void and of no effect. No assignment shall
release either Party from responsibility for the performance of any accrued
obligation of such Party hereunder.
13.11 Counterparts. This Agreement may be executed in duplicate, both
of which shall be deemed to be originals, and both of which shall constitute one
and the same Agreement.
13.12 No Agency. Nothing herein contained shall be deemed to create an
agency, joint venture, amalgamation, partnership or similar relationship between
BTC and Auxilium. Notwithstanding any of the provisions of this Agreement,
neither Party shall at any time enter into, incur, or hold itself out to third
Parties as having authority to enter into or incur, on behalf of the other
Party, any commitment, expense, or liability whatsoever, and all contracts,
expenses and liabilities undertaken or incurred by one Party in connection with
or relating to the development, manufacture or sale of Enzymes or Product shall
be undertaken, incurred or paid exclusively by that Party, and not as an agent
or representative of the other Party.
13.13 Notice. All communications between the Parties with respect to
any of the provisions of this Agreement will be sent to the addresses set out
below, or to other addresses as designated by one Party to the other by notice
pursuant hereto, by internationally recognized courier or by prepaid certified,
air mail (which shall be deemed received by the other Party on the seventh
business day following deposit in the mails), or by facsimile transmission or
other electronic means of communication (which shall be deemed received when
transmitted), with confirmation by letter given by the close of business on or
before the next following business day:
If to BTC, at:
-------------
Biospecifics Technologies Corp.
▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇
Attn: ____________________
with a copy to:
--------------
▇▇▇▇▇ Raysman ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ & ▇▇▇▇▇▇▇ LLP
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇.▇. ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇
Attn.: ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ Restaino, Esq.
If to Auxilium at:
-----------------
Auxilium Pharmaceuticals Inc.
▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attn: __________________
37
with a copy to:
--------------
▇▇▇▇▇▇, ▇▇▇▇▇ & ▇▇▇▇▇▇▇ LLP
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attn: ▇▇▇▇▇ ▇. ▇▇▇▇▇, Esq.
13.14 Headings. The paragraph headings are for convenience only and
will not be deemed to affect in any way the language of the provisions to which
they refer.
13.15 Assurances. Neither Party will take any action, or fail to act in
a manner, which would prejudice the rights intended to be granted to the other
Party pursuant to this Agreement.
13.16 Entire Agreement. This Agreement contains the entire
understanding of the Parties relating to the matters referred to herein, and may
only be amended by a written document, duly executed on behalf of the respective
Parties.
[SIGNATURE PAGE FOLLOWS]
38
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be
executed by their duly authorized representatives as of the Effective Date.
AUXILIUM PHARMACEUTICALS, INC.
By:
-----------------------------------
Name:
Title:
BIOSPECIFICS TECHNOLOGIES CORP.
By:
-----------------------------------
Name:
Title:
SCHEDULE 1.7 BTC PATENTS
BIOSPECIFICS TECHNOLOGIES CORP. AND SUBSIDIARIES
PATENT APPLICATIONS AND EXISTING PATENTS
1. U.S. Patent 5,393,792, patented February 28, 1995, inventors ▇▇. ▇▇▇▇▇▇ ▇▇▇▇▇
and Dr. ▇▇▇▇▇ ▇▇▇, title: High Dosage Topical Forms of Collagenase
2. U.S. Patent 5,422,103, patented June 6, 1995, inventors ▇▇. ▇▇▇▇▇▇ ▇▇▇▇▇ and
Dr. ▇▇▇▇▇ ▇▇▇, title: High Dosage Topical Forms of ▇▇▇▇▇▇▇▇▇▇▇
▇. U.S. Patent 5,514,370, patented May 7, 1995, inventors ▇▇. ▇▇▇▇▇▇ ▇▇▇▇▇ and
Dr. ▇▇▇▇▇ ▇▇▇, title: High Dosage Forms of Collagenase (Method of Treatment
with...). Note: Foreign patent applications corresponding to the above U.S.
applications have been filed in 14 foreign countries (Australia, Canada, 9
countries of the European patent convention, (Austria, France, Germany, Ireland,
Italy, Netherlands, Spain, Switzerland, United Kingdom, Hungary, Japan, Russia).
Patents have issued in all countries except Japan, where the application is
pending.
4. U.S. application inventors ▇▇▇▇▇ ▇. ▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, and ▇▇▇▇▇ ▇.
▇▇▇▇▇, title: Reduction of Adipose Tissue. US Patent Application # 10/172601
pending.
5. U.S. Patent 6.086.872, patented July 11, 2000, inventor ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇,
Amelioration of Dupuytren's Disease.
Note: Foreign patents corresponding to the above patent have been granted in 4
countries. France (2,772,273 granted 4/25/03), Australia (733,208 granted
8/23/01), UK (98050503 granted 10/10/01) and Sweden (9800806-3 granted 3/2/04).
Patents have been filed in Denmark, and , Norway.
6. U.S. Patent 6.022,539, patented February 8, 2000, inventor ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇,
Amelioration of Peyronie's Disease. Note: Foreign patent application
corresponding to the above application have been filed in 9 countries.
Australia, Canada, Denmark, France, Germany, Iceland, Norway, Sweden, United
Kingdom. Corresponding patent French Patent 0006863 has issued.
7.U.S. Patent 5,173,295, patented December 22, 1992, inventor ▇▇▇▇▇ ▇▇▇▇▇▇▇,
title: Method of Enhancing the Regeneration of Injured Nerves and Adhesive
Pharmaceutical Formulation Therefor.
8. U.S. Patent 5,279,825, patented January 18, 1994, inventor ▇▇▇▇▇ ▇▇▇▇▇▇▇,
title: Method of Enhancing the Regeneration of Injured Nerves and Adhesive
Pharmaceutical Formulation Therefor.
Note: Foreign patent application corresponding to the above two cases filed in
the European Patent Office (5 countries) For France, Germany, Italy, Spain, UK
foreign application in European Patent Office.
9. European Patent Office Patent EPO721781B1 June 2002 - inventors ▇▇▇▇▇ ▇.
▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, and ▇▇▇▇▇ ▇. ▇▇▇▇▇, title: Reduction of Adipose Tissue
Using Collagenase. This patent is being extended into 12 additional countries.
PATENTS LICENSED TO ADVANCE BIOFACTURES CORP.
10. US Patent 5,851,522, patented December 22, 1998 inventor Dr. I. M ▇▇▇▇▇▇
titled "Enhancing Keratinocyte Migration. EPO, (9 countries), Canada
11. US Patent 5,718,897, patented on February 17, 1998. Inventor ▇▇. ▇▇▇ ▇▇▇▇▇▇,
Title: Enhancing Keratinocyte Migration and Proliferation.
Note: Foreign patent application corresponding to the above case has been filed
in Australia, Canada, EPO (12 countries).
Updated: May 24, 2004
SCHEDULE 1.16
COST OF GOODS
The cost of Enzyme or a Product manufactured by BTC shall mean the fully
allocated cost of manufacturing, which shall include:
1. Materials cost, which means the price paid for raw material components and
finished goods which are purchased from outside vendors as well as any freight
and duty where applicable.
2. Direct labor costs, which means the employment costs including, salary and
employee benefits within the relevant manufacturing operating unit.
3. Direct and factory overheads, which means the cost of specific activities
that are provided by support functions. Overhead costs includes expenses
associated with quality assurance testing, batch review, equipment maintenance
costs, manufacturing energy and utilities, waste removal, storage,
transportation, insurance, management and administrative expenses, general
facilities costs, environmental engineering, interest expense and property
taxes.
Cost of Goods shall be calculated in accordance with U.S. Generally Accepted
Accounting Principles. BTC's Cost of Goods for Enzyme or Product shall in no
event exceed 110% of the cost of Enzyme or Product as supplied, or as could be
supplied, by a Third Party, as measured at the request of Auxilium and no more
frequently than once per calendar year.
SCHEDULE 1.21
ENZYME
Schedule 1.2.1 Enzyme
The enzyme is collagenase obtained by fermentation of Clostridium histolyticum,
purified by chromatography, lyophilized and substantially free from other
proteinases.
SCHEDULE 3.2
CLINICAL TRIALS
SCHEDULE 3.2 CLINICAL TRIALS
DUPUYTREN'S DISEASE
▇▇▇▇ 303a and ▇▇▇▇ 303b Double Blind, Randomized, Placebo Controlled Study of
the Relative Safety and Efficacy of Collagenase Therapy in the Treatment of
Residual Type Dupuytren's Disease 11/21/03
▇▇▇▇ 299 An Open Label Training Study for the Use of Collagenase Therapy for the
Use of Collagenase Therapy in the Treatment of Residual Type Dupuytren's Disease
4/4/03
▇▇▇▇ 404 An Open Label Study of the Relative Safety and Efficacy of Collagenase
Therapy in the Treatment of Residual Type Dupuytren's Disease 4/4/03
PEYRONIE'S DISEASE
1035-PEY An Open Label Study To Evaluate the Efficacy and Safety of Collagenase
Therapy in the Treatment of Peyronie's Disease 1/2/03
