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Exhibit 10.29
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| CONFIDENTIAL |
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EXECUTION COPY |
DEVELOPMENT,
LICENSE AND SUPPLY
AGREEMENT
dated as of May 7,
2001
among
ETHYPHARM, S.A.
194 Bureaux de la
Colline
92213 Saint Cloud
France
and
ETHYPHARM INDUSTRIES,
S.A.
194 Bureaux de la
Colline
92213 Saint Cloud
France
and
RELIANT PHARMACEUTICALS,
LLC
110 Allen Road
Liberty Corner, New Jersey
07938
United States
CONFIDENTIAL
THIS DEVELOPMENT, LICENSE
AND SUPPLY AGREEMENT , dated as of May 7, 2001, by and among
ETHYPHARM S.A., a corporation organized under the laws of France,
with its principal offices at 194 Bureaux de la Colline, 92213
Saint Cloud, France, ETHYPHARM INDUSTRIES S.A., a corporation
organized under the laws of France, with its principal offices at
194 Bureaux de la Colline, 92213 Saint Cloud, France (Ethypharm,
S.A., Ethypharm Industries, S.A., together with their respective
subsidiaries and Affiliates, collectively, “ ETHYPHARM
”), and RELIANT PHARMACEUTICALS, LLC, a limited liability
company organized under the laws of the State of Delaware, with its
principal offices at 110 Allen Road, Liberty Corner, New Jersey
07938, United States of America (“ RELIANT ”).
Capitalized terms used herein without definition shall have the
meanings specified in Section 1 hereof.
WITNESSETH
THAT:
WHEREAS, ETHYPHARM is engaged
in the development of new formulations of pharmaceutical
specialties and, in particular, is the owner of, and has the right
to grant licenses with respect to, certain Know-How and
Intellectual Property (as hereinafter defined) used in connection
with the development, formulation, manufacture, encapsulation,
packaging and otherwise related to the Product (as hereinafter
defined);
WHEREAS, ETHYPHARM wishes to
grant to RELIANT an exclusive license, with the right to
sublicense, to such Intellectual Property in the Territory (as
hereinafter defined) in relation with the Product developed by
ETHYPHARM, and RELIANT is willing to accept such a license on the
terms and conditions set forth hereinafter; and
WHEREAS, the parties desire
to set forth herein, among other things, certain agreements
regarding the product development, supply and manufacturing
obligations of
Initials:
ETHYPHARM to RELIANT in respect of the
Product and the clinical development, licensing, purchasing and
marketing obligations of RELIANT to ETHYPHARM in respect of the
Product, Intellectual Property and Know-How.
NOW, THEREFORE, in
consideration of the agreements and covenants hereinafter set forth
and intending to be legally bound hereby, the parties hereto
covenant and agree as follows:
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1.1 |
“ Act ” shall mean the United States Federal
Food, Drug and Cosmetic Act, 21 U.S.C. §301 et seq .,
and the regulations promulgated thereunder, in each case as
hereafter amended from time to time, and similar legislation in
other countries of the Territory. |
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1.2 |
“ Additional Manufacturing Facility ” shall
have the meaning specified in Section 5.4. |
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1.3 |
“
Affiliate ” means, with respect to any Person, any
other Person directly or indirectly controlling, controlled by, or
under common control with, such other Person. For purposes hereof,
the term “ controlling ” (including the terms
“ controlled by ” and “ under common
control with ”), as used with respect to any Person, will
mean the direct or indirect ability or power to direct or cause the
direction of management policies of such Person or otherwise direct
the affairs of such Person, whether through ownership of at least
fifty percent (50%) of the voting securities of such Person, by
contract or otherwise. In addition and not in limitation of the
foregoing, the following entities shall be deemed Affiliates of
RELIANT: (i) PharmBay Investors, LLC; (ii) Bay City Capital Fund
II, L.P.; and (iii) any of the lineal descendants of Nicholas J.
Pritzker, deceased, trusts
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primarily for the benefit
of such lineal descendants, entities controlled by such lineal
descendants and/or trust for their benefit.
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1.4 |
“ API ” or “ Active Pharmaceutical
Ingredient ” means the raw non-micronized fenofibrate
used in the Product manufactured by a party other than ETHYPHARM or
any of its Affiliates. |
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1.5 |
“ Applicable Laws ” means all laws,
statutes, codes, treaties, ordinances, judgments, decrees,
directives, injunctions, orders of any court, arbitrator or
Governmental Authority, rules, regulations, interpretations,
authorizations and Applicable Permits of any Governmental Authority
applicable to any of the parties hereto, the transactions
contemplated hereby and/or the Product. |
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1.6 |
“ Applicable Permits ” means any waiver,
exemption, variance, permit, license, authorization, consent,
certification, registration or similar approval (including, without
limitation, any NDA), including, without limitation, product
registrations by or of any Governmental Authority required to be
obtained or maintained under Applicable Laws in connection with the
formulation, development, registration, manufacture, packaging,
labeling, import, export, shipment, receipt, storage, use, pricing
or sale of the Product, regardless of the formulation or dosage
form thereof, and any ingredient thereof. |
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1.7 |
“ Approval Date ” means, with respect to a
particular country in the Territory, the date on which all
Applicable Permits necessary for the commercial sale and pricing of
the Product by or on behalf of RELIANT in such country have been
issued and are in effect. |
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1.8 |
“ Audit ” shall have the meaning specified
in Section 7.7. |
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1.9 |
“ Bulk Product Form ” shall mean the Product
in such form which is ready for incorporation by or on behalf of
RELIANT into Finished Dosage Form or such other form as may be sold
commercially by RELIANT in the Territory. |
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1.10 |
“ Business Day ” means any day except
Saturday, Sunday and any day which shall be a federal legal holiday
in the United States or a day on which banking institutions in the
State of New Jersey or Paris, France are authorized or required by
law or other government action to close. |
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1.11 |
“ cGMP ” shall mean current Good
Manufacturing Practices as in effect under the Act from time to
time and similar regulations in other countries under Applicable
Laws. |
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1.12 |
“ CMC ” shall mean the Chemistry and
Manufacturing Controls section of the IND or NDA, as applicable, as
then in effect. |
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1.14 |
“ Competing Dosage Form ” shall mean a
[***]. For the purposes of this Agreement, no Combination Product
shall be considered a Competing Dosage Form. |
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1.15 |
“ Confidential Information ” means, with
respect to any Person (including, without limitation, the parties
hereto), all proprietary or confidential information of such Person
(including such Person’s Affiliates and subsidiaries),
including, without limitation, any non-public Intellectual
Property, Know-How, financial information, procurement
requirements, purchasing, manufacturing, customer or supplier
information, business forecasts and plans, financing information,
detailing, sales and merchandising, and marketing plans and
information, pricing, |
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Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions. |
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and accounting policies
and procedures of or related to such Person; provided,
however , that Confidential Information shall not include and
information that (a) was or becomes generally available to the
public other than as a result of an unauthorized disclosure by a
party hereto or any of such party’s subsidiaries, Affiliates,
employees, agents or representatives; (b) was or becomes available
to a party hereto on a non-confidential basis from a source other
than (in the case of future information) any other party hereto (or
any of such party’s subsidiaries, Affiliates, employees,
agents or representatives), provided that such source was not known
be bound by any agreement to keep such information confidential or
otherwise prohibited from transmitting the information by a
contractual, legal or fiduciary obligation; or (c) is independently
developed by any party hereto without the use of or reference to
the Confidential Information of the other party hereto or any of
such other party’s subsidiaries or Affiliates.
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1.16 |
“ Contract Manufacturing Agreement ” shall
have the meaning specified in Section 5.5. |
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1.17 |
“ Delivery Forecast ” shall have the meaning
specified in Section 7.4. |
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1.18 |
“ DMF ” shall mean the Drug Master File
(together with all subsequent submissions, supplements and
amendments thereto, and any materials, documents or information
referred to or relied upon thereby) in the United States and any
similar files in other countries of the Territory that relate to
the Product. |
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1.19 |
“ ETHYPHARM ” shall have the meaning
specified in the Preamble. |
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1.20 |
“ ETHYPHARM Indemnified Claims ” shall have
the meaning specified in Section 6.4. |
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1.21 |
“ ETHYPHARM Indemnified Parties ” shall have
the meaning specified in Section 13.2. |
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1.22 |
“ ETHYPHARM Infringement Indemnitees ” shall
have the meaning specified in Section 6.5. |
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1.23 |
“ Event of Default ” shall have the meaning
specified in Section 12.1. |
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1.24 |
“ Exception Notice ” shall have the meaning
specified in Section 7.6. |
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1.25 |
“ FDA ” shall mean the Food and Drug
Administration in the United States and similar Governmental
Authorities in other countries within the Territory, including any
successor agencies performing comparable functions. |
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1.26 |
“ Finished Dosage Form ” means the Product
in the form of single dose capsules containing the formulation and
dosage of API as developed by ETHYPHARM and such quantity and type
of excipients specified in the Specifications, which shall be
labeled and packaged [***] such that it is ready for immediate
marketing, sale or other distribution by RELIANT. |
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1.27 |
“ Governmental Authority ” means any
international, national, domestic, foreign, regional, local or
other governmental or regulatory body, agency, authority, court or
other authorized Person, including, without limitation, all such
Persons having jurisdiction over the formulation, development,
registration, manufacture, packaging, labeling, import, export,
shipment, storage, use, pricing or sale of the Product, regardless
of the formulation or dosage form thereof, or health and safety
matters generally. |
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1.28 |
“ IND ” shall mean an Investigational New
Drug Application under the Act (together with all subsequent
submissions, supplements and amendments thereto, |
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Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions. |
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and any materials,
documents or information referred to or relied upon thereby)
seeking authorization to commence clinical trials of the Product in
humans, and similar applications or filings in the other countries
within the Territory.
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1.29 |
“ Initial Term ” shall have the meaning
specified in Section 11.1. |
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1.30 |
“ Intellectual Property ” shall mean all
patents (including, without limitation, the Patents), copyrights,
trademarks, service marks, service names, trade names, internet
domain names, e-mail addresses, applications or registrations for
any of the foregoing, or extensions, renewals, continuations or
re-issues thereof, or amendments or modifications thereto,
brandmarks, brand names, trade dress, labels, logos, know-how
(including, without limitation, the Know-How), show-how, technical
and non-technical information, trade secrets, formulae, techniques,
sketches, drawings, models, inventions, designs, specifications,
processes, apparatus, equipment, databases, research, experimental
work, development, pharmacology and clinical data, software
programs and applications, software source documents, third-party
licenses, and any similar type of proprietary intellectual property
right vesting in the owner and/or licensee thereof pursuant to the
applicable laws or regulations of any relevant jurisdiction or
under any applicable license or contract, whether now existing or
hereafter created, together with all modifications, enhancements
and improvements thereto. |
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1.31 |
“
Know-How ” means any and all proprietary methods,
devices, technology, trade secrets, inventions, compositions,
designs, formulae, know-how, show-how, technical and training
manuals and documentation and other information, including, without
limitation, processes and analytical methodologies used
in
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development, testing,
analysis and manufacture, and medical, clinical and toxicological
testing as well as other scientific data of ETHYPHARM, which is
related to or used in connection with the Product or any ingredient
thereof, and/or the formulation, development, registration,
manufacture, packaging, labeling, import, export, receipt,
shipment, storage, use, pricing or sale thereof, whether now known
or hereafter developed.
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1.32 |
“ Launch Date ” shall mean, with respect to
each country in the Territory, the first date RELIANT [***] in such
country. |
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1.33 |
“ License ” shall have the meaning specified
in Section 3.1. |
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1.35 |
“ LET Notice ” shall have the meaning
specified in Section 3.2. |
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1.38 |
“ NDA ” shall mean any New Drug Application
under the Act (together with all subsequent submissions,
supplements and amendments thereto, and any materials, documents or
information referred to or relied upon thereby) seeking approval to
market, sell or otherwise distribute the Product, in any
formulation or dosage form, in the United States, and similar
applications or filings in the countries within the
Territory. |
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1.39 |
“ Net Royalties ” means royalties payable to
ETHYPHARM pursuant to the terms of this Agreement, net of any Taxes
required to be withheld therefrom. |
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1.40 |
“ Net Sales ” means the aggregate amounts
invoiced by RELIANT for sales of the Product produced using
ETHYPHARM Intellectual Property to independent and |
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Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions. |
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unrelated third-parties in
the Territory, less any and all (a) trade, quantity and cash
discounts; (b) commissions, discounts, refunds, rebates,
chargebacks, retroactive price adjustments and any other allowances
which effectively reduce the net selling price; (c) returns, bad
debts and uncollectible accounts; (d) Taxes collected, charged or
otherwise required to be paid by RELIANT in respect thereof; and
(e) insurance, freight, warehousing and other transportation and
storage costs related to shipment of the Product.
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1.41 |
“ Nonparticipating Party ” shall have the
meaning specified in Section 6.8. |
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1.42 |
“ Patents ” shall mean any issued patents
and patent applications (including, without limitation, any
applications or registrations therefor, extensions, renewals,
continuations or re-issues thereof, or amendments or modifications
thereto) that are currently owned or hereafter acquired or applied
for by ETHYPHARM, which would be infringed by the formulation,
development, registration, manufacture, packaging, labeling,
import, export, receipt, shipment, storage, use, pricing or sale of
the Product or any ingredient thereof in the Territory, but for the
rights granted to RELIANT by ETHYPHARM under this Agreement,
including but not limited to those patents and patent applications
set forth on Schedule 1.42 attached hereto (as may such
schedule shall be amended from time to time). |
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1.43 |
“ Person ” means any individual,
partnership, association, joint venture, corporation, limited
liability company, trust or Governmental Authority or other
entity. |
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1.44 |
“
Product ” means a product composed of or containing
micronized fenofibrate, in any dosage form, including encapsulated
or bulk beads, granules or similar
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presentations, including,
without limitation, the fenofibrate product developed by ETHYPHARM
for RELIANT pursuant to this Agreement and the Product Development
Program.
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1.45 |
“ Product Development Program ” shall have
the meaning specified in Section 2.1. |
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1.46 |
“ Recall ” shall have the meaning specified
in Section 7.9. |
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1.47 |
“ Regulatory Applications ” shall have the
meaning specified in Section 2.4. |
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1.48 |
“ RELIANT ” shall have the meaning specified
in the Preamble. |
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1.49 |
“ RELIANT Clinical Data ” shall have the
meaning specified in Section 2.2. |
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1.50 |
“ RELIANT Indemnified Claims ” shall have
the meaning specified in Section 6.5. |
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1.51 |
“ RELIANT Indemnified Parties ” shall have
the meaning specified in Section 13.1. |
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1.52 |
“ RELIANT Infringement Indemnitees ” shall
have the meaning specified in Section 6.4. |
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1.53 |
“ Specifications ” means the pharmaceutical
formulation, manufacture, delivery, packaging, labeling, import,
export, storage, receipt and shipment specifications for the
Product (including Product in Bulk Product Form and Finished Dosage
Form) and any excipients set forth on Exhibit A attached
hereto (which Exhibit A may be amended or changed from time
to time upon the agreement of the parties). |
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1.54 |
“
Tax(es) ” means, with respect to any Person, all
federal, state, local, county, foreign and other taxes, assessments
or other government charges, including, without limitation, income,
estimated income, gross receipts, profits, business, license,
occupation, franchise, capital stock, real or personal property,
sales use, transfer, value added, employment or unemployment,
social security, disability,
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alternative or add-on
minimum, customs, duty, excise, stamp, environmental or withholding
taxes, including interest, penalties and additions in connection
therewith for which such Person may be liable (including any such
tax related to any other Person for which such Person is liable, by
contract, as transferee or successor, by law, treaty or
otherwise).
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1.55 |
“ Term ” shall have the meaning specified in
Section 11.1. |
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1.56 |
“ Territory ” means: (a) the United States
of America, its territories and possessions including without
limitation, Puerto Rico; (b) the Caribbean (including, without
limitation, The Bahamas); (c) Mexico; and (d) Canada. |
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1.57 |
“ Third Party Infringement ” shall have the
meaning specified in Section 6.8. |
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PRODUCT DEVELOPMENT PROGRAM; CLINICAL DATA; PRODUCT
REGISTRATION |
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2.1 |
Product Development Program; Dosages . During the Term
of this Agreement, ETHYPHARM and RELIANT shall develop the Product
consistent with the terms of this Agreement in accordance with
product development program set forth on Exhibit B attached
hereto (the “ Product Development Program ”),
which Exhibit B specifies the proposed development timetable
and each party’s respective responsibilities related to the
development of the Product for sale in the Territory, including,
without limitation, the preparation and filing of an NDA and the
conduct of clinical trials related to the Product. As part of the
Product Development Program, [***], however, RELIANT, at its
option, may develop in collaboration with ETHYPHARM and conduct
clinical trials in respect of other formulations and/or dosage
forms of the Product. ETHYPHARM shall develop the formulations and
dosage forms of the Product and manufacture the Product
in |
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Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions. |
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such formulations and
dosage forms as shall be requested by RELIANT or otherwise required
to comply with the Act and any applicable NDA and in compliance
with the Product Development Program.
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2.2 |
Ownership of Clinical Data . Subject to the provisions
of Section 2.3, all preclinical, clinical, technical and other
information relative to the clinical program, data, analyses,
studies or similar information (including, without limitation, all
Intellectual Property) generated or developed by or on behalf of
the parties after the date hereof as a result of or in connection
with the Product Development Program and the clinical trials
conducted by [***] hereunder and thereunder (collectively, the
“ RELIANT Clinical Data ”), shall be owned
exclusively by [***]. |
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2.3 |
ETHYPHARM’s Right to RELIANT Clinical Data . The
parties agree, that following the issuance of an NDA for the
purpose of licensing the Product and subject to the terms and
conditions of this Agreement, ETHYPHARM shall have access to the
RELIANT Clinical Data for use outside the Territory on the basis of
terms and conditions to be negotiated in good faith between the
parties; provided, however , as consideration for providing
ETHYPHARM access to such RELIANT Clinical Data, such terms and
conditions shall provide that RELIANT shall be entitled to receive
[***] received by, ETHYPHARM by or from any third party licensee of
the Product. For the avoidance of doubt, the parties acknowledge
and agree that ETHYPHARM shall have no rights in or to any RELIANT
Clinical Data until the issuance of the final NDA or in the event
that that the NDA is |
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Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions. |
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revoked, cancelled,
withdrawn or otherwise impaired as a result of any act or omission
by or behalf of ETHYPHARM of the types described in Section
4.4.
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2.4 |
Regulatory Applications and Related Filings . Provided
that ETHYPHARM satisfies its obligations under Section 2.5 and the
Product Development Program in a timely manner, RELIANT shall
exercise its commercially reasonable efforts to prepare, file and
prosecute all necessary applications, submissions and regulatory
filings (together with all documentation, correspondence and other
supporting materials related thereto, collectively, the “
Regulatory Applications ”) to obtain any Applicable
Permits required to market the Product in the United States
promptly following completion of the Product Development Program
and in any event within a maximum period of [***] from completion
of the Product Development Program. Upon the completion of those
portions of the Product Development Program applicable to [***],
RELIANT shall use its commercially reasonable efforts to file
Regulatory Applications in those countries and in any event within
a maximum period of [***] from completion of those portions of the
Product Development Program applicable to these countries of the
Territory. All Regulatory Applications shall be filed and submitted
in RELIANT’s name and shall be owned exclusively by RELIANT,
and all Applicable Permits issued pursuant thereto shall be in the
name of and owned exclusively by RELIANT. RELIANT shall be
responsible for obtaining any and all necessary regulatory
approvals from any Governmental Authority under any Applicable Law
or Applicable Permit as a result of any changes to the
Specifications requested by RELIANT and for reporting any such
modifications to the Specifications to the |
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Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions. |
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applicable Governmental
Authority as appropriate. In the event that the submission of the
Regulatory Applications does not take place within the time periods
specified in this Section 2.4 as a result of RELIANT’s breach
of this Agreement or other refusal to submit such Regulatory
Applications, then ETHYPHARM, [***]; provided, however ,
that RELIANT shall have the option, but not the obligation, for a
period [***] to make an additional payment of [***] with respect to
the [***],[***]
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2.5 |
ETHYPHARM’s Development Responsibilities .
Notwithstanding RELIANT’s obligations under Section 2.4 to
the contrary, ETHYPHARM shall prepare and deliver, and shall cause
each applicable supplier or other third party (other than RELIANT)
involved with the manufacture and packaging of the Product to
prepare and deliver, to RELIANT and, as applicable, file or cause
to be filed with the appropriate Governmental Authority: (a) the
DMF, which shall be filed with FDA for the manufacture of the
Product; and (b) the CMC section of the IND and the NDA, all of
which shall be in accurate and complete, and in form and substance
reasonably satisfactory to RELIANT and suitable for inclusion in
the applicable filing. ETHYPHARM shall, at its own cost, cooperate
with and assist RELIANT in the preparation, filing and prosecution
of the Regulatory Applications, and shall prepare and deliver such
other documents, and take such other actions, as may be necessary
or appropriate to apply for, prosecute or obtain any Applicable
Permits. All materials to be prepared by or on behalf of ETHYPHARM
hereunder shall be prepared and delivered and, as applicable,
filed, in timely manner in accordance with timetable established by
the parties |
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Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions. |
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hereunder. ETHYPHARM shall
provide RELIANT with sufficient opportunity to review and comment
upon all Regulatory Applications or portions thereof prepared by or
on behalf of ETHYPHARM prior to their submission to any
Governmental Authority. In the event that RELIANT requests any
modifications to the Regulatory Applications or portions thereof
required to be prepared by ETHYPHARM hereunder, the parties shall
discuss such modifications in good faith; provided, however
, that the party in whose name the Regulatory Application is being
made shall retain the ultimate right to determine the contents
thereof. In connection with this Agreement, ETHYPHARM shall also
provide RELIANT with full access to all of its information and
records, including, without limitation, its Intellectual Property
and Confidential Information, related to the Product and its
formulation, manufacture and packaging (including, without
limitation, formulation, development, pharmacology and clinical
data regarding the Product, any ingredient thereof (including
fenofibrate)) in order that RELIANT may obtain and maintain the
Applicable Permits contemplated by this Agreement and comply with
Applicable Law.
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2.6 |
Compliance of Specifications . The Specifications shall
at all times be in compliance with the requirements of the Act and,
in particular, an NDA applicable to the Product, such that RELIANT
shall be entitled to market, sell and distribute the Product in the
Territory, and the parties agree to make any changes to the
Specifications as may be required to ensure such
compliance. |
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3.1 |
Grant of
License; License Exclusion . Subject to the terms set forth
herein and in consideration for the payments set forth in Sections
4, 8 and 9 hereof,
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ETHYPHARM hereby grants to
RELIANT [***]
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3.2 |
RELIANT Right of First Refusal Regarding License Exclusion
Transactions . In the event that ETHYPHARM desires to enter
into or consummate [***], ETHYPHARM agrees that it shall first
provide RELIANT with at least sixty (60) days prior written notice
of such proposed [***]. Following delivery of any LET Notice,
ETHYPHARM shall provide RELIANT with such information as RELIANT
may reasonably request in order to allow RELIANT to evaluate the
proposed License Exclusion Transaction described therein. Within
[***] following its receipt of the [***], RELIANT shall have the
right, but not the obligation, upon delivery of written notice to
ETHYPHARM to [***]. In the event that RELIANT notifies ETHYPHARM in
writing that it [***], |
| [***]: |
Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions. |
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ETHYPHARM shall [***];
provided, however , that ETHYPHARM [***]; provided,
further , that in the event ETHYPHARM shall not have entered
into a binding agreement with such third party within [***]
following the date of the [***],[***].
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3.3 |
Sublicenses . RELIANT shall have the right to sublicense
any and all of the rights granted pursuant to this Agreement, in
whole or in part, to one or more Persons; provided, however
, that RELIANT shall promptly (a) advise ETHYPHARM of the identity
of any such sublicensee; and (b) provide ETHYPHARM with a copy of
the sublicense agreement to establish that such sublicensee has
been informed of the obligations under this Agreement.
Notwithstanding the foregoing, RELIANT shall not be required to
disclose to ETHYPHARM the amount or structure of any royalty or
other payments due to RELIANT from any such sublicensees. RELIANT
agrees that it shall require any sublicensees of any of its rights
hereunder to preserve the confidentiality of any ETHYPHARM
Intellectual Property or Confidential Information to the extent
RELIANT is required to do so under this Agreement. |
| [***]: |
Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions. |
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3.4 |
Minimum Annual Sales Requirement; Conversion to
Non-Exclusive License . In order to maintain exclusivity of the
License granted in Section 3.1, RELIANT shall be required to reach
minimum annual sales of capsules containing Product (“
Minimum Annual Sales ”) in the United States and
Canada as set forth immediately below for the year ending on the
anniversary of the applicable Launch Date in such country (subject
to adjustment for introduction of generic competing products in the
Territory as described below): |
Minimum Annual Sales
– United States
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[***] |
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Launch Date
Anniversary
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[***]
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[***] |
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[***]
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[***] |
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[***]
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[***] |
Minimum Annual Sales
– Canada
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[***]
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[***] |
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[***]
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[***] |
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[***]
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[***] |
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[***]
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[***] |
No Minimal Annual Sales
requirements shall apply after the [***] anniversary of the
applicable Launch Date or in respect of any sales of the Product in
outside of the United States and Canada. Should RELIANT fail to
reach the applicable Minimum Annual Sales target during any
applicable year, ETHYPHARM, as its sole remedy hereunder, may, upon
at least [***] prior written notice to RELIANT, [***]; provided,
however , that RELIANT shall have the option, but not the
obligation, [***], in addition to any other payments due to
ETHYPHARM under Section 9.1 in respect of sales of the Product in
such country for said year, such that ETHYPHARM receives [***], in
which case ETHYPHARM shall have no right to convert the License to
a non-exclusive license in such country. For the purpose of [***],
RELIANT shall use the [***]. For the avoidance of doubt, the
parties agree and acknowledge that sales of the Product by
RELIANT’s sublicensees shall be included for the purposes of
determining whether the applicable Minimum Annual Sales target has
been satisfied. [***].
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3.5 |
Competing Dosage Forms . RELIANT may not, within [***]
of the first Launch Date in the Territory, develop, have developed,
promote, distribute or market any |
| [***]: |
Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions. |
18
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[***] within the
Territory, without the prior written consent of ETHYPHARM;
provided, however , that the foregoing restriction shall not
prevent RELIANT from developing, having developed, promoting,
distributing or marketing any Competing Dosage Form within the
Territory provided that RELIANT [***]; provided, further ,
that should RELIANT decide to develop or have developed any [***]
within the Territory, RELIANT shall send ETHYPHARM a written
notification of such decision in order to enable ETHYPHARM to
propose within a [***] from receipt of the written notification a
similar or comparable product to the Competing Dosage Form;
provided, further , RELIANT agrees to give ETHYPHARM [***]
of RELIANT’s decision to promote, distribute or market any
existing any [***] within the Territory. For the avoidance of
doubt, the parties agree and acknowledge that the restrictions in
this Section 3.5 shall not apply to any [***].
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| 4. |
COMPENSATION – LICENSE FEES AND MILESTONE
PAYMENTS |
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4.1 |
License Fees . In consideration of the services by
ETHYPHARM to research and develop the Product, pursuant to the
License and other rights granted hereunder, RELIANT shall pay to
ETHYPHARM license fees, up to an aggregate amount of [***], as
follows: |
(a) [***] upon full execution
by the parties of this Agreement;
(b) [***] within five (5)
Business Days of the acceptance for filing by the FDA of
RELIANT’s NDA for the marketing and sale by RELIANT of the
Product in the United States, which NDA shall contain all sections
thereof and other supporting documentation required to be prepared
and delivered by ETHYPHARM pursuant to Section 2.5
hereof;
| [***]: |
Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions. |
19
(c) [***] if and when
cumulative Net Sales (measured from the first Launch Date) exceed
[***], which amount shall be payable at such time as the next
payment is due to ETHYPHARM in respect of Net Sales pursuant to
Section 9.1 hereof.
| |
4.2 |
Milestone Payments . In addition to the license fees set
forth above, RELIANT shall pay to ETHYPHARM milestone payments
following the delivery and acceptance of materials necessary for
clinical development of the Product, the filing of the Regulatory
Applications and the issuance of the Applicable Permits required
for RELIANT to market and sell the Product in the Territory, up to
an aggregate amount of [***], as follows: |
(a) [***] within five (5)
Business Days following receipt and acceptance by RELIANT of the
first delivery of [***] from ETHYPHARM pursuant to Section 5.1
hereof;
(b) [***] following receipt
and acceptance by RELIANT of [***] from ETHYPHARM necessary to
satisfy the requirements of the Act (including, without limitation,
the NDA and other applicable permits) and to obtain regulatory
approval to commence marketing of the Product in the United States,
said sum being payable in three (3) installments as
follows:
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(i) |
[***] within five (5) Business Days of RELIANT’s receipt
and acceptance of the first delivery of the Product in Finished
Dosage Form pursuant to Section 5.2 hereof; |
| [***]: |
Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions. |
20
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(ii) |
[***] within five (5) Business Days of issuance to RELIANT of
the NDA by the FDA for marketing the Product in the United States;
and |
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(iii) |
[***] within five (5) Business Days of the six (6) month
anniversary of the first Launch Date in the Territory. |
| |
4.3 |
ETHYPHARM Failure to Abide by Product Development
Program . In the event that ETHYPHARM either (a) fails to
prepare, deliver and, as applicable, file with the appropriate
Governmental Authorities any of the materials required to be so
prepared, delivered and/or filed by or on behalf of ETHYPHARM
pursuant to the Product Development Program or any provision
hereof, including, without limitation, Section 2.5 hereof, by the
applicable deadline, or (b) fails to deliver to RELIANT any Product
required to conduct any clinical trials, file any Regulatory
Applications or that is otherwise required to be delivered by
ETHYPHARM under this Agreement or the Product Development Program
by the applicable deadline, then the amount of the payments due to
ETHYPHARM pursuant to Sections 4.1 and 4.2 hereof shall be reduced
by the amount of [***] for each day or portion thereof after such
deadline with respect to which ETHYPHARM failed to make such
delivery or file such materials. The parties agree that this
provision is in addition to any other rights or remedies either of
the parties may have under this Agreement. Notwithstanding the
foregoing, the parties agree (a) to meet and discuss in good faith
any revised deadlines under the Product Development Program, and
(b) to provide each other with notice of, and a
reasonable |
| [***]: |
Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions. |
21
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opportunity to resolve or
mitigate, any problem or other issue that arises with respect to
the Product Development Program and/or the NDA.
|
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4.4 |
Refund . Any payments made to ETHYPHARM pursuant to
Sections 4.1 or 4.2 above which are made prior to the Approval Date
for the marketing and sale of the Product by RELIANT in the United
States shall be [***] within five (5) Business Days following
RELIANT’s notice to ETHYPHARM of the rejection of the NDA by
the FDA, or an order of “non-approval” or similar FDA
comment, if such rejection order or comment is due to any acts or
omissions of ETHYPHARM or any of its suppliers, employees, agents
or Affiliates, including, but not limited, to any acts or omissions
that consist of or result in one or more of the
following: |
(a) lack of Product
stability;
(b) lack of documentation
regarding Product stability;
(c) inadequacies in the DMF,
the CMC or any other materials prepared or provided by or on behalf
of ETHYPHARM that are included in the Regulatory Applications;
and/or
(d) failure to comply with
any Applicable Laws or Applicable Permits regarding the manufacture
or packaging of the Product, in any formulation or dosage form,
including, without limitation, failure to comply with cGMP
requirements, or properly maintain any documentation required under
Applicable Law.
In the event of any of the
foregoing, RELIANT shall promptly notify ETHYPHARM of any such
rejection of the NDA and the reason therefor, and
| [***]: |
Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions. |
22
shall provide to ETHYPHARM
copies of relevant documents in support of its request for a refund
as may reasonably be requested by ETHYPHARM. The parties agree
that, in the event that, following a rejection of the NDA, RELIANT
continues to intend to market the Product outside of the United
States they shall negotiate in good faith a reduction of the refund
( i.e. , the amount entitled to be retained by ETHYPHARM)
under this Section 4.4.
| |
4.5 |
Method of Payment . All payments required to be paid
under this Agreement by RELIANT to ETHYPHARM, or ETHYPHARM to
RELIANT, shall be paid in United States dollars by wire transfer of
immediately available funds to a dollar-denominated account located
in the United States pursuant to written payment instructions,
which shall be delivered to by the party entitled to such payment
at least five (5) Business Days prior to the date such payment is
due. Such payment shall be deemed to have been made upon the
issuance of a federal reference number for the wire transfer of
said funds. |
| 5. |
DELIVERY OF PRODUCT FOR CLINICAL AND REGULATORY PURPOSES;
PRODUCT LAUNCH; ADDITIONAL MANUFACTURING
FACILITY |
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5.1 |
Clinical
Formulations and Placebos . ETHYPHARM shall manufacture,
deliver and sell to RELIANT such quantities of validated clinical
formulations of the Product, in such formulations and dosage forms
as requested by RELIANT, together with matching quantities of
placebos, to enable RELIANT to conduct all clinical trials to be
conducted pursuant to the Product Development Program established
hereunder. All Product, regardless of formulation or dosage form,
and placebos for use by RELIANT in clinical trials shall be: (a)
sold to RELIANT at ETHYPHARM’s actual cost as determined in
accordance with Exhibit D attached
|
23
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hereto; and (b) delivered
by ETHYPHARM within thirty (30) days of ETHYPHARM’s receipt
of RELIANT’s order therefor.
|
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5.2 |
Registration Batches . ETHYPHARM shall manufacture,
deliver and sell to RELIANT such quantities of full commercial
scale batches of the Product, in such formulations and dosage forms
as requested by RELIANT, determined by RELIANT to be necessary to
satisfy requirements under Applicable Law or Applicable Permit
(including, without limitation, in connection with the filing and
approval of an NDA with the FDA) to market the Product in the
United States. All Product, in whatever formulation, for use by
RELIANT to satisfy such requirements shall be: (a) sold to RELIANT
at [***] as determined in accordance with Exhibit D attached
hereto; and (b) delivered by ETHYPHARM within thirty (30) days of
ETHYPHARM’s receipt of RELIANT’s order
therefor. |
| |
5.3 |
Launch and Promotion of the Product . RELIANT shall use
its commercially reasonable efforts to commence commercial sales of
the Product in the United States within a reasonable time [***]
after receipt of the Applicable Permits are issued. For a period of
[***] following the first Launch Date in the United States, RELIANT
shall use its commercially reasonable efforts to promote the
Product utilizing [***]. In the event that RELIANT does not use its
commercially reasonable efforts to commence commercial sales of the
Product within [***] period specified herein, then ETHYPHARM, as
its sole remedy hereunder, may, upon at least sixty (60) days prior
written notice to RELIANT, convert the exclusive license granted to
RELIANT pursuant to Section 3.1 to a non-exclusive license solely
in that country of the Territory where RELIANT failed to use
its |
| [***]: |
Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions. |
24
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commercially reasonable
efforts to commence commercial sales of the Product within the six
(6) month period specified herein; provided, however , that
RELIANT shall have the option, but not the obligation, [***] to
[***] payable monthly in arrears, in which case ETHYPHARM shall not
have the right to convert the License to a non-exclusive license in
said country (it being agreed that such payments shall be made
until such time as commercial sales of the Product commence in the
country in question).
|
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5.4 |
Additional Manufacturing Facility . On or prior to the
first Launch Date of the Product in the Territory, ETHYPHARM shall
establish, validate and certify an additional manufacturing
facility for the Product, which facility may be owned by ETHYPHARM
or a third party contract manufacturer (such facility, the “
Additional Manufacturing Facility ”). ETHYPHARM shall
certify in writing to RELIANT that the Additional Manufacturing
Facility (and, as applicable, any third party contract
manufacturer): (i) has the requisite capacity to satisfy
ETHYPHARM’s production, packaging and delivery obligations,
and to meet RELIANT’s order requirements, hereunder with
respect to the Product in accordance with the Specifications and
the terms and conditions of this Agreement; (ii) complies and will
comply with all Applicable Laws and holds all Applicable Permits
necessary for the manufacture and packaging of the Product in
compliance with cGMP; and (iii) has and will have the irrevocable
right to use all Intellectual Property and Confidential Information
of ETHYPHARM necessary to manufacture and package the Product in
any formulation or dosage form required |
| [***]: |
Certain information on this page has been omitted and filed
separately with the Commission. Confidential treatment has been
requested with respect to the omitted portions. |
25
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hereunder, in accordance
with the Specifications and the terms and conditions of this
Agreement.
|
| |
5.5 |
RELIANT Third-Party Beneficiary Rights . In the event
that ETHYPHARM contracts with any third party (other than RELIANT
or any of RELIANT’s Affiliates) to establish the Additional
Manufacturing Facility and to provide the manufacturing services
required under Section 5.4 hereof (such contract, a “
Contract Manufacturing Agreement ”): (a) ETHYPHARM
shall deliver to RELIANT a true and complete copy of such Contract
Manufacturing Agreement promptly following the execution thereof;
(b) such Contract Manufacturing Agreement shall explicitly provide
that RELIANT is a third party beneficiary thereof with the right to
enforce the provisions thereof for its benefit; and (c) such
Contract Manufacturing Agreement shall contain such terms and
conditions that are consistent with those contained herein
(including, without limitation, the obligation to manufacture,
package, sell and deliver Product to RELIANT, and the right of
RELIANT to conduct an audit an inspection of the Additional
Manufacturing Facility pursuant to Section 7.10 hereof). The
parties agree and acknowledge that the foregoing requirements are
necessary in order that RELIANT may be assured that it will
continue to be supplied with the Product in accordance with the
terms and conditions of this Agreement, and meet its contractual
obligations to various third-parties. Notwithstanding the
foregoing, RELIANT shall not be required to make any payment or
render any performance hereunder to any Person other than
ETHYPHARM, except as RELIANT may agree in writing. |
26
| 6. |
OWNERSHIP AND USE OF INTELLECTUAL PROPERTY; DEVELOPMENT
OF COMBINATION PRODUCTS |
| |
6.1 |
Ownership . Subject to the terms hereof, including,
without limitation, the License and other rights granted by
ETHYPHARM to RELIANT hereunder, all existing and future
Intellectual Property of the parties with respect to the Product
shall be owned as follows: |
(a) other than as provided
below or elsewhere in this Agreement, all Intellectual Property
owned by any party hereto on the date hereof shall continue to be
owned by such party;
(b) any Intellectual Property
developed, created or discovered solely by ETHYPHARM and subject to
the license granted hereunder during the Term of this Agreement
relating to the Product and its manufacturing shall be owned by
ETHYPHARM; and
(c) any Intellectual Property
developed, create
|
