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Document Preview Development and Supply Agreement |
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Title: |
Development and Supply Agreement |
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Entities: |
Dr. Reddy’s Laboratories Ltd.; Par Pharmaceutical Companies, Inc. |
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Date: |
2002 |
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Size: |
Preview shows 20KB of 102KB total |
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Price: |
$61 |
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ID: |
#321314 |
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DEVELOPMENT AND SUPPLY AGREEMENT
AGREEMENT, dated April 17, 2001, is made between PAR PHARMACEUTICALS,
INC., a _____________ corporation, maintaining its principal place of business
at One Ram Ridge Road, Spring Valley, New York 10977 ("PAR"), DR. REDDY'S
LABORATORIES LIMITED, an Indian corporation, maintaining its principal offices
at 7-1-27 Ameerpet, Hyderabad - 500 016, India, and REDDY-CHEMINOR, INC., a New
Jersey corporation, maintaining its principal office at 66 S. Maple Avenue,
Ridgewood, New Jersey 07450, U.S.A. (collectively "REDDY").
WITNESSETH:
WHEREAS, REDDY has expertise in the development of generic
pharmaceutical products; and
WHEREAS, PAR has expertise in the development, marketing and sale of
such products in the United States; and
WHEREAS, REDDY and PAR desire to collaborate in the development, marketing
and sale of certain generic pharmaceutical products; and
WHEREAS, REDDY desires to manufacture and supply to PAR and PAR desires to
purchase exclusively from REDDY for sale in the Territory, as defined below, by
PAR all of PAR's requirements for the Reddy Finished Products, as defined below;
NOW, THEREFORE, in consideration of the mutual promises, covenants and
agreements hereinafter set forth, the parties agree as follows:
1. DEFINITIONS.
(a) "Affiliate" means any corporation or business entity controlled by,
controlling, or under common control with PAR or REDDY as the case may be. (For
{PAGE}
the purpose of this definition, "control" means direct or indirect beneficial
ownership of greater than fifty percent (50%) of the voting stock of such
corporation or other business entity, or a greater than fifty percent (50%)
interest in the income of such corporation or other business entity, or the
power to direct or cause the direction of the management and policies of such
corporation or other business entity whether by ownership of voting securities,
by contract or otherwise, or such other relationship as, in fact, constitutes
control.)
(b) "ANDA" means an Abbreviated New Drug Application filed with the FDA
for a Reddy Finished Product or Par Finished Product in the United States.
(c) Applicable Percentage" means [*********************]
(d) "Bulk Product" means either REDDY's or a third party's bulk
actives for Reddy Finished Product or PAR's or a third party's bulk actives for
Par Finished Product.
(e) "cGMP" means current good manufacturing practices for the methods to
be used in, and the facilities and controls to be used for, the manufacture,
storage and handling of each Reddy Finished Product and Par Finished Product,
all as set forth from time-to-time by the FDA pursuant to the FD&C Act and the
rules and regulations promulgated thereunder (including specifically, Title 21,
part 211 of the Code of Federal Regulations of the United States).
(f) "Commercial Expenses" means PAR's or REDDY's, as the case may be,
commercially reasonable costs and expenses for marketing, advertising,
promoting, and selling (including but not limited to costs and expenses for
launch, sales force training and materials, samples, conventions, symposia,
marketing, direct mailing, marketing research, public relations, printed
materials, medical information, regulatory activities and distribution) each
Reddy Finished Product or Par Finished Product, determined in accordance with
PAR's or REDDY's customary accounting policies and practices and in a manner
consistent with U.S. generally accepted accounting principles.
(g) "Competing Product" means, with respect to a particular Reddy Finished
Product or Par Finished Product, a generic pharmaceutical product which is in
2
{PAGE}
the same dosage form, has the same active ingredient, the same strength and is
for the same indication as the Reddy Finished Product or Par Finished Product
but which is manufactured and supplied by or purchased and acquired from any
Person other than REDDY or its Affiliates or PAR or its Affiliates, as the case
may be.
(h) "Development Costs" means the commercially reasonable costs and
expenses of REDDY or PAR, as the case may be, incurred in the preparation and
filing of a DMF for each Bulk Product and in obtaining the ANDA for each Reddy
Finished Product or Par Finished Product, including but not limited to:
allocated costs for manufacturing, personnel, packaging, stability, testing,
analytical, Bulk Product supplied for ANDA submission (calculated at
Manufacturing Cost) and all costs relating to the development of finished dosage
including R&D, preformulation, formulation, bio-equivalence, ANDA preparation,
validation, issuance and submission.
(i) "DMF" means the drug master file for each Bulk Product, as the same
may be amended or supplemented from time to time.
(j) "Exclusivity Period" means, with respect to any Reddy Finished Product
(or any strength or dosage form of a Reddy Finished Product) or Par Finished
Product (or any strength or dosage form of a Par Finished Product), the granting
of up to six (6) months of marketing exclusivity in the United States from the
FDA for being first to file an ANDA with a patent certification for the given
Reddy Finished Product or Par Finished Product enabling PAR to market such
product during such period in the U.S. with no other generic competitor.
(k) "FDA" means the United States Food and Drug Administration.
(l) "FD&C Act" means the Federal Food, Drug and Cosmetic Act of 1938,
as amended, and the regulations thereunder, including current good manufacturing
practice regulations, as the same may be amended or revised.
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{PAGE}
(m) "Form 483" means the written notice of objectionable practices or
deviations from the regulations that is prepared by the FDA investigator at the
end of an inspection.
1.
(n) "Group 2 Term" means, for each Reddy Group 2 Product, the date
commencing upon the execution of this Agreement and ending on December 31, 2004.
(o) "Indemnified Party" has the meaning set forth in Section 15(c)
hereof.
(p) "Indemnifying Party" has the meaning set forth in Section 15(c)
hereof.
(q) "Intellectual Property Costs" means REDDY's or PAR's, as the case may
be, out-of-pocket payments to patent counsel (or other experts, including
outside laboratories) in connection with pre- or post-marketing patent work,
including patent litigation.
(r) "Know-How" means all Reddy Finished Product or Par Finished Product,
as the case may be, related technical knowledge, manufacturing procedures,
expertise, methods, protocols and current and accumulated experiences which any
party hereto acquires in connection with this Agreement and/or has acquired as a
result of scientific research, practical experiences and otherwise which have a
demonstrated usefulness in manufacturing, obtaining and maintaining Regulatory
Approval, including but not limited to (i) plant validation protocols and
specifications; (ii) process validation procedures; (iii) quality control
procedures; (iv) analytical methods and procedures; (v) bio-equivalence testing
protocols and procedures; (vi) cleaning validation protocols and procedures;
(vii) procedures for preparation of applications for Regulatory Approval; (viii)
ongoing regulatory compliance procedures; and (ix) galenical formulations and
processes.
(s) "Launch Date" means, with respect to each Reddy Finished Product or
Par Finished Product, the date on which PAR makes its first commercial sale of
such Reddy Finished Product or Par Finished Product in the Territory to an
unrelated third party in an arm's length transaction but no later than the later
of: thirty (30) days after the date on which all regulatory and governmental
approvals for the manufacture, delivery, sale and distribution in the Territory
have been obtained (including Regulatory Approval); thirty (30) days after
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{PAGE}
applicable patent expiration (including General Agreement on Trade and Tariffs
extensions) or thirty (30) days after product exclusivity expiration.
(t) "Manufacturing Cost" means the sum of (i) the [*******************]
for either each Reddy Finished Product (other than Group 3 Products) incurred by
REDDY and its Affiliates, or each Par Finished Product incurred by PAR and its
Affiliates, as the case may be, calculated separately for each Reddy Finished
Product or Par Finished Product, in each case determined in accordance with
REDDY's or PAR's customary cost accounting policies and practices and in a
manner consistent with U.S. generally acceptable accounting principles; (ii)
[*******************] of such [*******************] (to cover
[*******************]); and (iii) all transportation and related costs to
deliver the Reddy Finished Product or Par Finished Product to its destination
under Section 8 of this Agreement. Manufacturing Cost for Reddy Group 3 Product
means the Manufacturing Cost as described above plus an additional
[*******************] of such Manufacturing Cost. If the manufacturing of any
Reddy Finished Product or Par Finished Product or any component thereof
(including Bulk Product) is performed for REDDY or PAR, as the case may be, by a
third party (which is not an Affiliate), then amounts paid to such third party
in connection with the manufacturing of such Reddy Finished Product or Par
Finished Product or any component thereof (including Bulk Product) shall be
[*******************] .
(u) "Net Margin" means [*********************].
(v) "Net Profit" means [*********************].
(w) "Net Sales" means that dollar amount determined by deducting the
following items from the [*******************] billed for that particular Reddy
Finished Product or Par Finished Product, as the case may be, sold by PAR and
its Affiliates or REDDY and its Affiliates, as the case may be, in the Territory
to unaffiliated third parties in arms length transactions:
(i) trade, quantity or cash discounts, service allowances;
(ii) credits or allowances for the Reddy Finished Product
or Par Finished Product, if any, given or made on
account of [*******************], returns, bad debts,
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{PAGE}
off-invoice promotional discounts, [******************],
[*******************], any and all federal, state or
local government rebates or discounts whether in
existence now or enacted at any time hereafter, volume
reimbursements, and the gross amount billed for that
rejected Reddy Finished Product or Par Finished Product
or that Reddy Finished Product or Par Finished Product
recalled, seized or destroyed (voluntarily or at the
request of any government agency, subdivision or
department);
(iii) any tax, excise or other government charge upon or
measured by the production, sale, transportation,
delivery or use of that Reddy Finished Product or Par
Finished Product; and
(iv) any surcharge, levy, tax or assessment mandated by any
federal, state or local government or administrative
agency to fund a compensation program or reserve for
persons injured by that Reddy Finished Product or Par
Finished Product;
in each case determined in accordance with PAR's, REDDY's or any third party's
customary accounting policies and practices in a manner consistent with U.S.
generally accepted accounting principles.
(x) "Par Applicable Percentage" means [*********************].
(y) "Par Change in Control" means the acquisition by any third party
individual or entity (other than by Merck KGaA (but not a successor or assign)
or an Affiliate of Merck KGaA (but not a successor or assign)) of more than 50%
(in any one transaction or in any series of transactions) of the outstanding
shares of capital stock of Pharmaceutical Resources, Inc. or PAR having the
right to vote or generally to participate, in a manner similar to equity shares,
in the profits and losses of Pharmaceutical Resources, Inc. or PAR.
(z) "Par Finished Products" means [*********************].
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{PAGE}
(aa) "Par Group 1 Products" means [*********************].
(bb) "Par Group 4 Products" means [*********************].
(cc) "Person" means an individual, partnership, joint venture,
association, corporation, company and any other form of business organization,
government regulatory or governmental agency, commission, department or
instrumentality.
(dd) "Promotional Expenses" means promotional payments or fees directly
related to a Reddy Finished Product or Par Finished Product paid to REDDY's or
PAR's customers, as the case may be.
(ee) "Reddy Applicable Percentage" means [*********************].
(ff) "Reddy Change in Control" means the acquisition by any third party
individual or entity of more than 50% (in any one transaction or in any series
of transactions) of the outstanding shares of capital stock of REDDY having the
right to vote or generally to participate, in a manner similar to equity shares,
in the profits and losses of REDDY.
(gg) "Reddy Finished Product" means [*********************].
(hh) "Reddy Group 1 Products" means [*********************].
(ii) "Reddy Group 2 Products" means [*********************].
(jj) "Reddy Group 3 Products" means [*********************].
(kk) Reddy Group 4 Products means [*********************].
(ll) "Reddy Group 5 Products" means [*********************].
(mm) "Reddy Group 6 Products" means [*********************].
(nn) "Regulatory Approval" means any ANDAs or other approvals,
supplements, amendments, pre- and post-approvals, marketing authorizations based
upon such approvals (including any prerequisite manufacturing approvals or
authorizations related thereto) and labeling approval(s), technical, medical and
scientific licenses, registrations or authorizations of any national, regional,
state or local regulatory agency, department, bureau, commission, council or
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{PAGE}
other governmental entity, necessary for the manufacture, distribution, use,
import, or sale of Reddy Finished Products or Par Finished Products.
(oo) "Specifications" means the specifications required to obtain the
ANDA of each Reddy Finished Product or Par Finished Product based on the NDA
specifications of the innovator product and as contained in the DMF for Bulk
Product unless changes are required as described in the United States
Pharmacopoeia, as such specifications may be amended at the request of the FDA
or by mutual agreement of the parties from time to time.
(pp) "Technical Information" means all information and expertise which
REDDY or PAR, as the case may be, acquires in connection with this Agreement
and/or has acquired which have a demonstrated usefulness in manufacturing,
packaging and labeling and/or obtaining and maintaining Regulatory Approval of
the Reddy Finished Products or the Par Finished Products pursuant to this
Agreement, including, but not limited to, all specifications, manuals and
computer programs relating to manufacturing and similar materials and access to
the DMF of Bulk Product.
(qq) "Term" means, for each Reddy Finished Product (other than a Reddy
Group 2 Product) or Par Finished Product, the later to occur of (i) the date
commencing upon execution of this Agreement and ending seven (7) years after the
date of execution of this Agreement or (ii) the date commencing on the Launch
Date of each Reddy Finished Product or Par Finished Product and ending three (3)
years after the Launch Date of such product.
(rr) "Territory" means the United States, its territories, possessions
and the Commonwealth of Puerto Rico.
(ss) "Third Party Bulk Product" means a Bulk Product manufactured by an
entity other than REDDY or PAR, as the case may be.
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{PAGE}
2. DEVELOPMENT OF PRODUCTS.
(a) REDDY shall be responsible for the development of all Reddy
Finished Products to be supplied by REDDY to PAR under this Agreement. REDDY
shall use commercially reasonable efforts to develop each of the Reddy Finished
Products. All Development Costs and Intellectual Property Costs, including, but
not limited to, initiation, preformulation development, formulation development,
scale-up and any legal costs and expenses incurred in connection with a Reddy
Finished Product shall be the sole responsibility of REDDY. Nothing contained
herein shall constitute a guarantee or warranty of REDDY that development of any
Reddy Finished Product will be commenced or continued, that a submission for
Regulatory Approval for such Reddy Finished Product will be filed within any
specific time period, or that a Regulatory Approval for any Reddy Finished
Product will be obtained.
(b) REDDY shall prepare each application for Regulatory Approval for
each Reddy Finished Product and shall use commercially reasonable efforts to
obtain Regulatory Approval. REDDY shall hold all ANDAs for the Reddy Finished
Product in its own name, provided that such ownership shall be subject to the
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