Confidential
treatment has been requested for portions of this Exhibit. The copy
filed herewith omits the information subject to the confidentiality
request. Omissions are designated by ***. A complete version of
this exhibit has been filed separately with the Securities and
Exchange Commission.
DEVELOPMENT AND MARKETING
AGREEMENT
This
Development and Marketing Agreement (this
“Agreement”) is hereby entered into and effective as of
February 22, 2006 (the “Effective Date”) by and
between Spectrum Pharmaceuticals, Inc. (“Spectrum”), a
Delaware corporation, with offices located at 157 Technology Drive,
Irvine, California 92618 and Par Pharmaceutical, Inc.
(“Par”), a Delaware corporation with offices located at
300 Tice Boulevard, Woodcliff Lake, New Jersey 07677. Spectrum and
Par shall each be defined as a “Party” and together as
the “Parties” under this Agreement.
WHEREAS ,
Spectrum is engaged in the development of certain generic
pharmaceutical products and desires Par to market, sell and
distribute certain of Spectrum’s products in the
Territory;
WHEREAS ,
Par desires to market, sell and distribute certain of
Spectrum’s products in the Territory;
NOW
THEREFORE , for good and valuable consideration, the receipt
and sufficiency of which is hereby acknowledged, the Parties hereby
agree as follows:
1.1. “
Act ” means the United States Federal Food, Drug and
Cosmetic Act, as amended from time to time, and the rules,
regulations and guidelines promulgated thereunder.
1.2. “
Affiliate(s) ” means a Person that Controls, is
Controlled by or is under common Control with a Party.
1.3. “
ANDA ” means an Abbreviated New Drug Application
pursuant to 21 U.S.C. 355(j) and 21 C.F.R. § 314.3.
1.4. “
API ” means an active pharmaceutical ingredient used
in the manufacture of a Product.
1.5. “
Applicable Laws ” means all applicable laws, rules,
regulations and guidelines that may apply to the development,
manufacturing, exportation, importation, promotion, marketing, sale
or distribution of the Products and/or the performance of a
Party’s obligations under this Agreement, to the extent
applicable and relevant, and including specifically, but without
limitation, all cGMP or similar standards or guidelines of the FDA
and including trade association guidelines, where applicable, as
well as U.S. export control laws and the U.S. Foreign Corrupt
Practices Act.
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1.6. “
cGMP ” means all applicable standards relating to
manufacturing practices for fine chemicals, active pharmaceutical
ingredients, intermediates, bulk products or finished
pharmaceutical products, including the principles detailed in the
U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 210 and
211.
1.7. “
Commercial Launch ” means, on a product-by-product
basis, the first sale of such Product by Par, or its Affiliate, to
an unaffiliated Third Party after such Product has received all
necessary Regulatory Approvals.
1.8. “
Commercially Reasonable Efforts” means with respect to
each Party, efforts and commitment of resources in accordance with
such Party’s reasonable business, legal, medical, and
scientific judgment that are consistent with the efforts and
resources such Party would use for other products owned by it or to
which it has exclusive rights, which are of similar market
potential and at a similar stage in their life cycle, taking into
account the competitiveness of the market place, the regulatory
structure involved and other relevant factors.
1.9. “
Committee ” shall have the meaning set forth in
Section 4.1.
1.10. “
Competing Product ” means any Drug Product, excluding
the Products under this Agreement, which is a Therapeutic
Equivalent of a Reference Listed Drug listed on Schedules 1.18,
1.19, 1.20 or 1.37.
1.11. “
Confidential Information ” means with respect to a
Party (as the “Disclosing Party”), all non-public
information of any kind whatsoever (including without limitation,
data, compilations, formulae, models, patent disclosures,
procedures, processes, projections, protocols, results of
experimentation and testing, specifications, strategies, techniques
and all non-public Intellectual Property Rights (defined below)),
and all tangible and intangible embodiments thereof of any kind
whatsoever (including without limitation, apparatus, compositions,
documents, drawings, machinery, patent applications, records and
reports), which is disclosed by the Disclosing Party to the other
Party (as the “Receiving Party”) and is acknowledged to
be confidential at the time of such disclosure. Notwithstanding the
foregoing, Confidential Information of a Disclosing Party shall not
include information which the Receiving Party can establish by
competent proof (a) to have been publicly known prior to
disclosure of such information by the Disclosing Party to the
Receiving Party, (b) to have become publicly known, without
fault on the part of the Receiving Party, subsequent to disclosure
of such information by the Disclosing Party to the Receiving Party,
(c) to have been received by the Receiving Party free of an
obligation of confidentiality from a source, other than the
Disclosing Party, rightfully having possession of and the right to
disclose such information free of an obligation of confidentiality,
(d) to have been otherwise known by the Receiving Party prior
to disclosure of such information by the Disclosing Party to the
Receiving Party, or (e) to have been independently developed
by employees or agents of the Receiving Party without the use of or
access to Confidential Information of the Disclosing
Party.
1.12. “
Control ” including, with correlative meaning, the
terms “Controlled by” or “under common Control
with” means the actual power, either directly or indirectly
through one or more intermediaries, to direct the management and
policies of such Person, whether by the ownership of at least fifty
percent (50%) of the voting interest of such Person (it
being
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understood that
the direct or indirect ownership of a lesser percentage of such
interest shall not necessarily preclude the existence of control),
or by contract or otherwise.
1.13. “
Drug Product ” means a drug product as defined in 21
C.F.R. § 314.3 for administration to human
subjects.
1.14. “
Development Costs and Expenses ” means the costs and
expenses relating to all research and development for each Product
for the Territory, including, without limitation, such costs and
expenses related to materials (e.g., API), analytical testing
(e.g., outside laboratory expenses), process development costs,
pre-clinical and clinical costs, bioequivalence or bioavailability
testing, exhibit batch and validation costs, processing and
conversion costs of materials required for regulatory filings but
excluding, costs and expenses associated with legal due diligence,
litigation, and ANDA submissions and prosecutions.
1.15. “
Direct Cost ” means (i) in the event a Party is
manufacturing a Product, the direct costs actually incurred for the
manufacturing, Labeling and Packaging of the Product including the
cost of all API and excipient raw material ingredients, packaging
components, and direct labor, including quality control and
assurance testing that are a necessary part of manufacturing or
(ii) in the event a Third Party is manufacturing a Product, the
out-of-pocket expenses actually paid by such Party to a Third Party
for Product. Direct Costs shall not include any Development Costs
and Expenses or any allocations for overhead (except as set forth
in the preceding sentence), depreciation, idle or excess capacity,
or other indirect costs.
1.16. “
Generic Products ” means collectively the Group A
Generic Products, the Group B Generic Products and the Group C
Generic Products.
1.17. “
Governmental Authority ” means any foreign, domestic,
federal, territorial, state or local governmental authority,
quasi-governmental authority, instrumentality, court, government or
self-regulatory organization, commission, tribunal or organization
or any regulatory, administrative or other agency, or any political
or other subdivision, department or branch of any of the
foregoing.
1.18. “
Group A Generic Products ” means the Drug Products
that are Therapeutically Equivalent to the Reference Listed Drugs
listed on Schedule 1.18 attached hereto including all listed
dosage strengths and Packaging forms thereof and for which Par is
under no conflicting or prohibiting contractual obligations. ***
The Parties acknowledge that Par is restricted from
commercialization of the Cipro Tablet Products listed on
Schedule 1.18 until March 11, 2006.
1.19. “
Group B Generic Products ” means the Drug Products
that are Therapeutically Equivalent to the Reference Listed Drugs
listed on Schedule 1.19 attached hereto including all listed
dosage strengths and Packaging forms thereof. The Parties
acknowledge that Par is restricted from commercializing the
Paraplatin Products listed on Schedule 1.19 until
Spectrum’s agreement with Cura Pharmaceutical Company, Inc.
(“Cura”) has been amended to become a non-exclusive
agreement. Spectrum shall promptly notify Par when such agreement
has been
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amended. After
Spectrum notifies Par, the Paraplatin Products will be considered a
Group B Generic Product and notwithstanding anything in the
Agreement to the contrary, Par shall have semi-exclusive rights to
Carboplatin (i.e. only Cura and Par shall have the right to market
Spectrum’s Paraplatin Products), and everywhere in this
Agreement where it refers to exclusive rights to the Products,
there shall only be semi-exclusive rights for the Paraplatin
Products. ***
1.20. “
Group C Generic Products ” means the Drug Products
that are Therapeutically Equivalent to the Reference Listed Drugs
listed on Schedule 1.20 attached hereto including all listed
dosage strengths and Packaging forms thereof.
1.21. “
FDA ” means the United States Food and Drug
Administration or any successor agency thereto.
1.22. “
First-to-File Opportunity ” means an opportunity to
license or purchase the right to market, distribute, sell or have
sold a Competing Product under a first filed ANDA pursuant 21
U.S.C. § 355(j)(2)(vii)(IV) against a Reference Listed
Drug.
1.23. “
Intellectual Property ” means without limitation all
of the following: (i) patent applications, continuation
applications, continuation in part applications, divisional
applications, any foreign patent applications corresponding to any
of the foregoing, and any patents that may grant or may have been
granted on any of the foregoing, including without limitation
reissues, re-examinations and extensions thereof; (ii) all
know-how, trade secrets, inventions (whether patentable or
otherwise), data, processes, techniques, procedures, compositions,
devices, methods, formulas, protocols and information, whether
patentable or not; (iii) copyrightable works, copyrights and
applications, registrations and renewals; (iv) logos,
trademarks, service marks, and all applications and registrations
relating thereto; (v) other proprietary rights; and
(vi) copies and tangible embodiments of any one or more of the
foregoing.
1.24. “
Label ,” “ Labeled ” or “
Labeling ” means all labels and other written, printed
or graphic matter, (i) upon the Product or any container or
wrapper utilized with the Product, or (ii) accompanying the
Product, including without limitation, package inserts, which in
either case may be subject to FDA review.
1.25. “
Marketing Fee ” means the dollar amount equal to ***
percent (***%) of Net Sales.
1.26. “
Material Adverse Event ” means an event, change or
occurrence that has or would reasonably likely cause a material
adverse effect on the financial position, business, properties,
operations or assets of Spectrum.
1.27. “
NDA ” means a new drug application filed with the FDA
pursuant to and under 21 U.S.C. § 355(b) of the Act, together
with the FDA’s implementing rules and regulations.
1.28. “
Net Profit ” means the Net Sales of each Product less
***
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1.29. “
Net Sales ” means the dollar amount determined by
deducting from the gross amount invoiced for the Product sold by
Par, or by an Affiliate of Par, or by a permitted sub-licensee, as
the case may be, in the Territory the following to the extent they
relate directly to the sale of the Products by Par: (i) all
applicable sales credits accrued in accordance with accounting
principles generally accepted in the United States,
(ii) payments or rebates incurred pursuant to federal, state
and local government assistance programs, whether in existence now
or enacted at any time hereafter, (iii) costs for transit
insurance, freight, handling or other transportation, (iv) customs
duty, sales, use or excise taxes, and (v) the write-off of any
bad debt. Sales credits accrued in accordance with accounting
principles generally accepted in the United States include credits
or discounts related to the following: (i) customer returns,
returned goods allowances, billing and shipping errors, rejected
goods and damaged goods, (ii) cash or terms discounts, (iii)
customer rebate programs, (iv) chargebacks and administration
fees or similar credits or payments granted to customers pursuant
to contract or other purchases, (v) sales promotions, trade
show discounts and stocking allowances, (vi) price
adjustments, including those on customer inventories following
price changes, and (vii) Product recall.
1.30. “
Packaging ” means all primary containers, including
bottles, cartons, shipping cases or any other like matter used in
packaging or accompanying the Product.
1.31. “
Person ” means an individual, corporation,
partnership, limited liability company, firm, association, joint
venture, estate, trust, governmental or administrative body or
agency, or any other entity.
1.32. “
Proceedings ” means, without limitation, governmental,
judicial, administrative or adversarial proceedings (public or
private), litigation, suits, arbitration, disputes, claims, causes
of action or investigations.
1.33. “
Products ” means both Generic Products and the
Sumatriptan Products.
1.34. “
Product Specifications ” means the specification for
each Product as approved in the Regulatory Approval for such
Product, including (as applicable) statements of pharmaceutical
manufacturing, labeling, filling, packaging, storage and quality
control procedures, and Labeling and Packaging specifications (as
such may be revised from time to time in accordance with Applicable
Law) together with any additional specifications that may be agreed
to between the Parties.
1.35. “
Reference Listed Drug ” shall have the meaning set
forth at 21 C.F.R § 314.3.
1.36. “
Regulatory Approvals ” means, with respect to each
Product, any approvals, product and/or establishment licenses,
registrations, permits or authorizations, including without
limitation approvals under ANDAs which are necessary for the
commercial manufacture, use, storage, importation, transport,
promotion, pricing, distribution or sale of each Product in the
Territory or other applicable locations.
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1.37. “
Sumatriptan Products ” means all dosage and/or
Packaging forms of the Drug Products listed on Schedule 1.37
that are Therapeutically Equivalent to the Reference Listed Drug
Imitrex (sumatriptan) ***
1.38. “
Territory ” means the United States, its territories,
possessions, protectorates and the Commonwealth of Puerto
Rico.
1.39. “
Therapeutic Equivalent ” including, with correlative
meaning, the term “Therapeutically Equivalent” shall
have the meaning given to it by the FDA in the edition of the
“Approved Drug Products with Therapeutic Equivalence
Evaluations” which was current as of the Effective Date (the
“Orange Book”).
1.40.
“Third Party” or “Third
Parties” shall mean any Person or entity other than a
Party or its Affiliates
1.41. “
Transfer Price ” means the dollar amount equal to the
Direct Cost for each Product.
2.1. General
Development Obligations . Spectrum shall use Commercially
Reasonable Efforts to develop each Product, for all applicable
dosage strengths and Packaging forms listed on Schedules 1.18,
1.19, 1.20 and 1.37. For future products, it is the intent of both
Parties for Spectrum to develop all approved dosage strengths and
Packaging forms, however, the Committee shall decide which dosage
strengths and Packaging forms will be developed. Spectrum’s
development responsibilities shall include, without limitation, the
following: !
2.1.1. Spectrum
shall develop a stable final dosage form of each Product, which
does not infringe any Third Party Intellectual Property that shall
be Therapeutically Equivalent to the corresponding Reference Listed
Drug. ***
2.1.2. Spectrum
shall manufacture, or ensure that a Third Party manufactures, all
supplies of the Products required for Regulatory Approval in
facilities that meet the Applicable Laws.
2.1.3. Spectrum
shall be responsible for, and maintain, materials, facilities and
personnel reasonably necessary to fulfill its obligations under
this Agreement.
2.1.4. Spectrum
shall keep Par informed of the progress of the development of the
Products and shall cooperate with Par and its legal counsel in
assessing and avoiding infringement of Third Party Intellectual
Property ***, including, but not limited to, providing Par and its
legal
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counsel with
proposed and final formulations, results of all testing and
analytical studies, API processing and synthesis information,
manufacturing processes and access to Spectrum’s technical
personnel involved in the development of a Product.
2.1.5. Spectrum
shall conduct all reasonable testing and analytical studies
required by the FDA to support an ANDA for each Product as
applicable.
2.2.
Development Compliance . Spectrum shall comply with, and
shall require compliance by its Third Party contractors with, all
Applicable Laws in the conduct of all activities associated with
the development and manufacture of the Products including all
associated analytical methods and cGMP requirements.
2.3.
Development Costs and Expenses . Spectrum shall be
responsible for all Development Costs and Expenses for each
Product, including any bioequivalence or bioavailability studies
that are needed for the filing and approval of an ANDA for a
Product. In the event Spectrum requests that Par reasonably assist
in the development of any Product, Spectrum shall reimburse Par for
all of its reasonable costs and expenses associated with such
assistance that are approved in writing in advance by
Spectrum.
2.4. Future
Products. The Parties desire that their collaboration with
respect to the development and commercialization of generic
pharmaceutical products be extended to additional brand name
products and generic products in addition to the Products. In view
of that desire, the Parties shall work together to develop
additional products over a mutually acceptable period of
time.
2.4.1. From
time to time during the term of this Agreement either Party may
nominate additional product for collaboration through the
Committee, which the other Party shall duly consider.
2.4.2. The
Parties agree to either incorporate any additional products into
this Agreement through amendment or to negotiate in good faith a
new agreement. With respect to additional generic products, such an
agreement shall be on substantially similar terms and with
substantially similar financial terms as those relating to the
Generic Products and/or Sumatriptan Products, as applicable, set
forth in this Agreement, with the understanding that such terms and
conditions may be different from those described herein.
2.4.3. Any
information or materials shared by either Party during the course
of any discussions or negotiations relating to the collaboration on
any additional products shall be deemed Confidential Information
and subject to Article 10 of this Agreement.
3.1. ANDA
Ownership . The ANDA for each Product shall be owned
exclusively by
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Spectrum.
Spectrum shall maintain all Regulatory Approvals during the term of
this Agreement.
3.2.1. The
Parties acknowledge that Spectrum has filed a number of ANDAs for
the Products prior to the Effective Date and with respect to such
Products Spectrum shall diligently continue to pursue Regulatory
Approval of such Product.
3.2.2. With
respect to the Products not covered under Section 3.2.1,
Spectrum shall use Commercially Reasonable Efforts to file ANDAs
for such Products as soon as possible and shall thereafter continue
to diligently pursue Regulatory Approval.
3.2.3. Par
shall be provided with the opportunity to review and comment on all
future material submissions to the FDA, including any ANDAs,
relating to the Products.
3.2.4. Spectrum
will provide copies of all material information related to the
Products in its possession or control and all submissions made to
the FDA related to the Products, including any accompanying
material data, to Par upon Par’s request. Notwithstanding the
foregoing, regarding Third Party information, Spectrum shall use
Commercially Reasonable Efforts to obtain consent from such Third
Parties to provide such information to Par. For future agreements
with Third Parties regarding Products, Spectrum shall use
Commercially Reasonable Efforts to negotiate a three-way CDA with
Spectrum, Par and the Third Party to allow Spectrum to share the
Third Party’s confidential information with Par.
3.3.
Expenses . Spectrum shall bear all costs and expenses
associated with gaining and maintaining Regulatory Approval for
each Product.
3.4. Progress
Updates . Spectrum shall keep Par informed of the progress of
the prosecution of each ANDA, including providing good faith
projections of the approximate time at which approval of the ANDA
may be expected and providing notice of any negative communications
from the FDA which could affect approval timing or otherwise affect
the supply of Product.
ARTICLE 4. COLLABORATION
COMMITTEE
4.1.
Establishment of the Committee . The Parties each hereby
agree to work together in good faith in the collaboration under
this Agreement and to keep each other reasonably informed of its
activities under this Agreement. Additionally, and in support of
the foregoing, promptly after the Effective Date, the Parties will
form a committee comprised of six (6) people in total to
facilitate communication between the Parties and to administer the
collaboration (the “Committee”). Each Party shall have
equal representation in the Committee. Each Party shall have the
right from time to time to substitute new members, on a permanent
or temporary basis, for any of its previously designated members of
the Committee. Each Party
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shall bear its
own costs associated with participation in the
Committee.
4.2. Purpose
and Responsibilities of the Collaboration Committee . The
Committee shall generally oversee the development and the
commercialization of the Products and facilitate communication
between the Parties, including as follows:
4.2.1. The
Committee shall coordinate the exchange of information, technology
and know-how as applicable to the collaboration;
4.2.2. The
Committee shall establish approximate timelines for the development
of the Products including timing of bioequivalence or
bioavailability studies and the filing of the ANDAs;
4.2.3. The
Committee shall establish approximate timelines associated with the
commercialization of the Products including the timing of supply
and manufacturing commitments, the timing of the Commercial Launch,
and marketing of the Products such as achieving certain sales
targets;
4.2.4. The
Committee shall oversee the development of each formulation and the
associated legal assessments including those of risks associated
with Third Party Intellectual Property;
4.2.5. The
Committee shall facilitate communication regarding, and resolution
of, any disputes between the Parties;
4.2.6. The
Committee shall also address such other matters as are referred to
the Committee from time to time by mutual agreement of the
Parties;
4.2.7. The
Committee shall discuss and the Parties shall mutually agree to add
new products as set forth in Section 2.4;
4.2.8. The
Committee shall discuss and the Parties shall mutually agree to add
new dosage strengths and Packaging forms for the Products to the
appropriate Schedule; and
4.2.9. The
Committee shall discuss pricing of the Products, and in addition,
Spectrum may request pricing information from a representative of
Par on the Committee at any time.
4.3.
Decision-Making; Limitations on Authority . Decisions of the
Committee shall be made by unanimous agreement. In the event that
unanimity is not achieved within the Committee, the matter will be
referred to Par’s and Spectrum’s CEOs, who shall
promptly meet and endeavor in good faith to resolve such matter in
a timely manner. The Committee shall not have any authority to
impose financial, cost or other obligations on either Party in
excess of those expressly set forth in this Agreement, unless
expressly consented to in writing by such Party.
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4.4.
Collaboration Committee Meetings . During the term of this
Agreement, the Committee shall meet at least twice each calendar
year or at such other frequency as the Committee determines. The
Parties shall meet on a date and at a time and location determined
by the Committee; the Parties anticipate alternating meetings
between the Party’s respective sites. Upon written notice by
either Party to the other that a meeting is required or requested,
a meeting will be held within thirty (30) calendar days of
such notice on a date and time and at a location to be agreed upon
by the Parties, or sooner if warranted by the circumstances. Notice
requesting such a meeting shall include adequate information
describing the activity to be reviewed. Any meetings of the
Committee may be held in person at a location to be agreed to by
the Parties, or by videoconference or teleconference. A reasonable
number of additional representatives of either Party including
outside consultants and legal counsel, subject to the other
Party’s reasonable consent, may attend meetings of the
Committee in a non-voting capacity. At least one week prior to any
meeting of the Committee, each Party shall provide the other with a
proposed agenda of the matters to be discussed at such meeting. A
Committee Chairperson shall be selected for a one-year term and
shall alternate between designees of the Parties, commencing with a
designee of Spectrum. Within thirty (30) days after each
meeting, the Committee Chairperson will provide the Parties with a
written report describing, in reasonable detail, a summary of the
meeting and a summary of the results and progress to date, the
issues requiring resolution and the agreed resolution of previously
reported issues.
ARTICLE 5.
COMMERCIALIZATION
5.1. License
Grant . Spectrum hereby grants to Par an exclusive (even as to
Spectrum) royalty-free, irrevocable license under its rights in and
to the Regulatory Approvals and under its Intellectual Property
rights associated with the Products to market, promote, distribute,
sell and have sold the Products in the Territory. The foregoing
license shall include the right for Par to grant sublicenses and
appoint sub-contractors to market, distribute and sell the Products
within the Territory on Par’s behalf.
5.2. Promotion,
Marketing, Sales and Distribution Obligations .
5.2.1. Par, at
its sole expense, shall use Commercially Reasonable Efforts to
launch, market, promote, distribute and sell the Products in the
Territory consistent with Par’s efforts in regards of the
other generic products that it distributes, as applicable. Ultimate
responsibility and decision-making control with regard to marketing
and pricing of the Products shall belong solely to Par. Nothing in
this Agreement shall require Par to sell any Product at a
loss.
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5.2.3. The
label for the Products shall be a Par label in accordance with
Par’s customary practices and with the Applicable Law.
However, Spectrum’s name shall be included on the label in
accordance with the Applicable Law.
5.3. Launch
Timing . Subject to Par’s evaluation of any legal issues,
regulatory issues, and any supply problems not resulting from a
breach of Par’s supply obligations under this Agreement (a
“Launch Problem”), the Commercial Launch of each
Product shall take place no later than *** after receipt of the
Regulatory Approvals necessary to sell, market and distribute such
Product. The above notwithstanding, with regards to Products that
have received Regulatory Approval prior to the Effective Date, or
receive Regulatory Approval within one hundred and twenty
(120) days of the Effective Date, the Parties agree to work
together to set an appropriate time for the Commercial Launch of
such Products. Nothing in this Section shall be construed as
requir
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