EXHIBIT 10.44
CO-PROMOTION AGREEMENT
BETWEEN
MILES INC.
AND
SCHEIN PHARMACEUTICAL, INC.
Co-Promotion Agreement
This Agreement is made and effective as of the 1st day of August, 1994,
(hereinafter referred to as the "Effective Date"), by and between Miles Inc., a
corporation of the State of Indiana (hereinafter"Miles") and Schein
Pharmaceutical, Inc. a corporation of the State of Delaware
(hereinafter"Schein").
WHEREAS, Schein is the holder of an NDA covering a pharmaceutical product
marketed by Schein under the brand name INFeD(R) (iron dextran injection, U.S.P.
50 mg/ml) (hereinafter "Product") indicated for treating iron deficiency, and
Schein desires to enhance market share of Product in the United States
pharmaceutical market place; and
WHEREAS, Miles has considerable knowledge in promoting, detailing and marketing
pharmaceutical products in the United States and has in place a large, well-
experienced detailing force; and
WHEREAS, Miles and Schein believe that a joint promotion and detailing
arrangement regarding Product would be desirable and fully compatible with each
party's business objectives.
NOW, THEREFORE, for and in consideration of the mutual covenants contained
herein, Miles and Schein hereby agree as follows:
Article 1: Definitions
----------------------
1.01 "Affiliate" shall mean:
(a) An organization which owns, directly or indirectly, a controlling
interest in Miles or Schein by stock ownership or otherwise; or
(b) An organization having its majority ownership directly or
indirectly common to the majority ownership of Miles or Schein.
1.02 "Product" shall mean iron dextran injectable.
1.03 "United States" shall mean the United States of America.
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1.04 "Net Sales" shall mean *** ******* ***** ****** ** *********** *****
******* ** ****** **** *** ********* ******** ******** ** ************
******* ****** *** *** *********** **** ******* ** *** ******* ** ***
****** ******* **** ***** ********** ************ ****** **************
***** ******* ** ********** ********* ***** ******* ** ******* ** *****
************ ******* ** ******** ** **** ******** ** *******
************* ***************
1.05 "Threshold Value" with respect to a Detailing Year shall mean the
dollar amount specified for such year under Article lil.
1.06 "Joint Detailing Years~' shall mean the period of time commencing on
the Effective Date of this Agreement and ending on the last day of the
Third Detailing Year, subject to extension or termination in accordance
with Section 4.12 and Article VIII. A "Detailing Year" shall be the
twelve (12) month period commencing on each August 1st of the Term.
1.07 "Promotional Costs" shall mean all out-of-pocket costs incurred by
Schein in the marketing and promotion of the Product, including without
limitation in the development and production of promotional materials,
but excluding costs associated with sales representatives and
administrative overhead.
1.08 "Standard Cost" shall mean ******** *** *** ************ *************
******** ****** ********* *** ** ********** **** **** **********
******* *** ********* ******** ********** ********** ************
******** ************ *** ** ********
1.09 "Confidential Information" shall mean information which relates to the
Product, including financial statements, costs and expense data,
production data, trade secrets, secret processes and formulae,
marketing and consumer data or any other information which is not
generally ascertainable from public or published information,
regardless of whether such information was provided pursuant to the
terms of this Agreement, by request of the other party or in any other
manner. Schein reserves the right to limit the disclosure to Miles of
any Confidential Information which, in the sole opinion of Schein. is
not necessary to achieve the purposes of this Agreement.
1.10 In the terms defined herein, the singular shall include the plural and
vice versa.
---- -----
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Article II: Grants and Obligations
----------------------------------
2.01 Schein hereby grants to Miles during the Joint Detailing Years the
right to promote and detail the Product in the United States jointly
with Schein in accordance with the provisions of this Agreement.
2.02 During the Joint Detailing Years, Schein shall not authorize, or grant
the right to, any third party to detail the Product in the United
States.
(a) During the Joint Detailing Years, Miles will be diligent in its
efforts consistent with its customary business practices and legal
requirements to deploy its sales force to promote and detail
throughout the United States the Product in such manner and with
such expedition as Miles itself would have adopted in promoting
and detailing a pharmaceutical product of its own invention.
During the Joint Detailing Years and for a period of one (1) year
thereafter, Miles will not promote or detail any pharmaceutical
product with indications similar to those of the Product.
(b) The Product will be presented in a primary position in at least
fifty percent (50%) of Miles' sales representative calls to
dialysis centers and nephrologists and in no less than a secondary
position in the remainder of such calls.
2.03 During the Joint Detailing Years, Schein will be diligent in its
efforts consistent with its customary business practices and legal
requirements to promote and market the Product throughout the United
States. Notwithstanding the foregoing, the parties acknowledge that it
is Schein's present intention that Schein's brand sales representatives
will continue to promote the Product, and Schein will reassign its
other sales representatives to promote products other than the Product.
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Article III: Payments
---------------------
3.01 (a) Schein shall pay to Miles in each Detailing Year amounts equal to
***** ******* ***** of the Incremental Net Profit.
Incremental Net Profit is calculated as:
*** ***** ** ******* **** ********* ***** **** ************ *****
******* *** *** ********** ********* **** **** *** *** ** ***
******** **** ********** ** *** ****** ** ***** ** *******
********** *** *********** ***** ****** *** **** ** ****** ***
************ ***** ***** ** *** ******* **** ** *** ***********
***** ****** *** ***** *** ******* ** **** ** *********** *****
**** **** *********** ******
*** ** ** ***** ** ******* *******
(b) The Threshold Value for each Detailing Year shall be as follows:
********* **** ********* ***** **** ***********
************** *************** ****************
***** ******** *****
************** *****
***** *********** **********
****** ********** *********
***** ********** *********
(c) Within sixty (60) days prior to the start of the second Detailing
Year and each Detailing Year thereafter, Schein and Miles will
meet for the purposes of reviewing the Threshold Value (and
applicable Base Promotional Costs) for the coming Detailing Year
and negotiating in good faith any appropriate adjustment to the
Threshold Value (and applicable Base Promotional Costs) for
reasons including, but not limited to, the effect of a competitive
product in the market, and additional indications or delivery
systems for the Product.
(d) Within thirty (30) days after the close of each quarter during
each Detailing Year, Schein shall remit to Miles all payments
accruing under this Article during such quarter. The payment shall
be accompanied by an accounting reporting for such quarter Net
Sales both as to aggregate quantities and dollar amounts of such
Net Sales of the Product subject to payments hereunder for such
quarter.
*redacted pursuant to confidential treatment request.
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Article IV: Cooperation. Rights and Responsibilities
----------------------------------------------------
It is among the objectives of the parties, to jointly promote and detail the
Product in the United States in the most effective and efficient fashion during
the Joint Detailing Years. To achieve this objective, the parties agree, during
the Joint Detailing Years, as follows:
4.01 The parties shall each appoint an authorized representative
("Coordinator") between whom communications will be directed. Each
party will notify the other as to the name of the individual so
appointed. Each party may replace its Coordinator at any time, upon
written notice to the other party.
4.02 (a) The Coordinators shall establish a team ("Team") directed by the
Coordinators and consisting of representatives of each party which
will meet from time to time, at mutually agreeable times and
locations, to discuss and coordinate the joint promotion and
detailing of the Product in the United States and the strategies
and programs that should be developed to maximize Net Sales of the
Product. Illustratively, the Team shall:
(i) guide all continuing joint promotion and detailing efforts
with respect to the Product in the United States. Schein will
have the final authority and responsibility, with the
cooperation and assistance of Miles, for developing
detailing, marketing and promotional strategies and other
matters with respect to the Product, and Schein shall have
the final right of approval for all such strategies and other
matters.
(b) From time to time, but in no event less than once a year, the Team
shall develop and formulate joint marketing plans for specified
periods (collectively the "Marketing Plan") which shall set forth
detailing, promotion and marketing strategies relating to the
Product. The marketing planning process shall be a joint effort
under the leadership and authority of Schein. The provisions of
the Marketing Plan shall be agreed to by the Coordinators, and if
the Coordinators cannot agree, then the matters in dispute shall
be referred to the President of Miles Pharmaceutical Division and
the Chairman of Schein. Schein, however, shall have xxx.xxxxx
responsibility for, and control over, and the final right of
approval for, the development and content of the Marketing Plan.
Schein retains the right to determine in its discretion the
appropriate manner and timing of execution of all marketing and
promotional plans and strategies, including without limitation the
selection of ad agencies, the development and production of
promotional materials.
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(c) A party shall have the right to comment upon and make
recommendations to the other party regarding the other party's
activities under this Agreement, which recommendations the-_ other
party shall thoroughly evaluate and consider.
(d) Each party shall bear its own costs associated with its
participation in the Team and associated with its detailing,
marketing and promotional activities under this Agreement, except
as provided in Section 3.01.
4.03 (a) During the Joint Detailing Years and subject to any other
provision of this Agreement, each party will provide the other
with all information which the disclosing party deems significant
and relevant to the detailing and promotion of the Product within
a reasonable time after such information becomes known to the
party, provided such information is not received under a secrecy
obligation. Within thirty (30) days after the close of each
quarter during each Detailing Year, Miles will provide to Schein a
report of Miles Product detail call activity by medical specialty
for the quarter then ended, along with a summary of feedback from
Miles sales representatives concerning their detailing efforts for
that quarter.
(b) During the Joint Detailing Years, each party shall promptly notify
the other party of all information coming into its possession
concerning unexpected side effects, injury, toxicity or
sensitivity reactions as provided in Appendix I hereto.
4.04 Schein shall retain all proprietary and property interests in the
Product until the point of sale and in all supporting sales and
promotional material. Miles will not have nor represent that it has any
control or proprietary or property interests in the Product or in any
sales or promotional material. Nothing contained herein shall be deemed
to grant Miles, either expressly or impliedly, a license or other right
or interest in any patent, trademark or other similar property of
Sch,Xxxxx or its Affiliates except as may be necessary for Miles to
promote and detail the Product as provided in this Agreement. Miles
acknowledges that Schein shall retain all copyrights in and to all
sales, promotional and training materials created or used in connection
with the promotion of the Product.
4.05 (a) Miles shall not be required to distribute any sales and
promotional material which:
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(i) does not present Product to the Medical and paramedical
communities and to the trade as joining with Schein in the
detailing and promotion of the Product; and
(ii) does not mention the Product; or
(iii) includes reference to another Schein pharmaceutical in
addition to the Product. At Schein's request and at Miles'
sole option, Miles may distribute sales and promotion
material of the type identified in this subsection (a).
Should Miles elect to distribute such material, it shall be
supplied to Miles by Schein free of all charge. Schein shall
not be require to distribute any sales and promotion
material which contains a reference:
(1) to Miles (other than in connection with the joint
detailing and promotion of the Product in accordance
with this Agreement); or
(2) any Miles pharmaceutical. All materials distributed by
Schein promoting the Product during the Joint Detailing
years and intended to be part of the co-promotion
arrangement covered by this Agreement shall mention
Miles as the joint promoter of the Product.
(b) During the Joint Detailing Years, Schein shall also provide Miles,
at Schein's cost, with reasonable quantities of training materials
which have been created and developed by Schein relating to the
Product. Miles shall have the responsibility for, and control
over, the manner in which it trains its sales force with respect
to the Product.
4.06 In implementing the obligations contained in Article II, each party
shall have sole discretion as to the manner (which shall not be
inconsistent with the Marketing Plan, and provided that Miles will not
utilize any promotional materials not created by Schein) in which it
promotes and details (including any expenditure of funds in connection
therewith) the Product in the United States. Each party shall bear its
own costs incurred in the performance of any obligations hereunder,
subject to the provisions of Section 3.01. Neither party shall have any
responsibility for the hiring, firing or compensation of the other
party's employees or for any employee benefits. No employee or
representative of a party shall have any authority to bind or obligate
the other party to this Agreement for any sum or in any manner
whatsoever, or to create or impose any contractual or other liability
on the other party without said party's authorized written approval.
For all
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purposes, and notwithstanding any other provisions of this Agreement to
the contrary Miles' legal relationship under this Agreement to Schein
shall be that of independent contractor. Each party shall be
responsible for ensuring that its promotional activities under this
Agreement are in full compliance with all applicable laws, rules,
regulations and orders, including without limitation applicable FDA
regulations, and are consistent with the Product approval and package
insert.
4.07 (a) Schein shall use commercially reasonable efforts consistent with
Schein's overall business strategy, as determined by Schein, to
insure that sufficient stock of the Product will be available in
its inventory to promptly fill orders from the trade in the Joint
Detailing Years for sales of the Product in the United States.
All orders for Products are subject to acceptance by Schein, in
whole or in part.
(b) Prior to or upon the signing of this Agreement and at least
thirty (30) days prior to each calendar quarter during the Joint
Detailing Years, Miles and Schein will confer to establish a
forecast of anticipated sales of Product by month for the
succeeding twelve (12) month period. Such forecasts shall be made
to assist Schein in planning its Product production and shall be
non-binding.
4.08 (a) During the Joint Detailing Years, Miles and Schein will be
presented and described, by each party hereto, to the medical and
paramedical communities and to the trade as joining in the
detailing and promotion of the Product, and all written
information (including, but not limited to, journal
advertisements, direct mail, sales pieces and other promotional
material) and, to the extent practicable, all oral information,
disseminated or presented, respectively, to such communities and
trade regarding the detailing and promoting of the Product in the
United States will state this arrangement, if such information is
intended to be part of the co-promotion arrangement covered by
this Agreement. Neither party shall distribute or have
distributed any such information. ,, which bears the name of the
other without the prior written approval of the other, which
approval shall not be unreasonably withheld. Nothing herein
contained shall require the Miles name or logo to appear on the
Product's label, container label or package insert.
(b) Each party, at its option, may issue press releases or other
public announcements relating to the Product or the arrangement
contemplated by this Agreement, provided, however, that;
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(i) neither party shall issue a press release or public
announcement which has, as a major focus, either the joint
detailing and promotion of the Product in the United States
or such arrangement, without the prior written approval of
the other party, which approval shall not be unreasonably
withheld; and
(ii) all other press releases and public announcements will
describe the Product and the arrangement contemplated by
this Agreement in a manner consistent with those releases
and announcements previously approved by the other party.
4.09 (a) Schein shall have the sole right and responsibility for, and shall
bear all costs related to, obtaining and maintaining the
authorization and/or ability to market a pharmaceutical product in
the United States including, without limitation, the following:
(1) Responding to Product and medical complaints relating to the
Product. Miles agrees that it shall refer any such complaints
which it receives to Schein in accordance with Appendix I
hereto:
(2) All Product returns must be authorized by Schein. Miles shall
not solicit or accept any returns of Product and shall advise
the customer that Product is to be returned to Schein. If
despite the foregoing any Product is returned to Miles, then
it shall be shipped to Schein's nearest distribution facility
or, at Schein's option, may be handled through the One Box
return system. Costs of returns are to be included in the
computation of Net Sales as provided in Paragraph 1.04.
(3) Handling all recalls of the Product. At Schein's request and
Miles' option, Miles will assist Schein in receiving the
recalled Product and any direct documented costs incurred by
Miles with respect to participating in such recall shall be
reimbursed by Schein;
(4) Communicating with any governmental agencies and satisfying
their requirements regarding the authorization and/or
continued authorization to market the Product in commercial
quantities in the United States; provided, however, that
Miles shall be able to communicate with such agencies
regarding the Product if:
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(i) in the reasonable opinion of Miles' counsel, such
communication is necessary to comply with the terms of
this Agreement or the requirements of any law,
governmental order or regulation; and
(ii) Miles, if practical, made a request of such agency to
communicate with Schein instead, and such agency
refused such request; but in any such event, unless in
the reasonable opinion of Miles' counsel, there is a
legal prohibition against doing so, Schein shall be
immediately notified of such agency's request and of
Miles' intention to make such communication and Schein
shall be permitted to accompany Miles to any meeting
with such agency, take part in any such communications
and receive copies of all such communications provided
in no event shall Miles take any action which would
impose any liability or obligation on Schein, without
Schein's prior written consent; and
(5) Handling product distribution, inventory and receivables;
except that the costs thereof shall be governed by Section
3.01 (a).
(b) Each party shall respond to medical questions or inquiries
relating to the Product directed to such party. Within a
reasonable time from the date of this Agreement, but in no event
later than the Effective Date, Schein shall provide Miles with all
reasonably necessary information which would enable Miles to
respond properly and promptly to any such questions or inquiries.
Schein shall use its best efforts to keep such information
current. Schein and Miles shall coordinate responses to
anticipated inquiries and questions. Each party shall be
responsible for ensuring that its responses are in full compliance
with all applicable laws, rules, regulations and orders, including
without limitation applicable FDA regulations, and are consistent
with the Product approval and package insert.
4.10 Schein shall send to Miles, on a monthly basis, a copy of its monthly
ex-factory sales report for the preceding month showing ex-factory
sales of the Product.
Additionally, Schein shall authorize Miles to access, on a monthly
basis and at Miles' expense, its monthly DDD sales report on the
Product.
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4.11 Notwithstanding the Marketing Plan or any other provision herein to the
contrary, Schein will have the right and responsibility for
establishing and modifying the terms and conditions with respect to the
sale of the Product, including the price at which the Product will be
sold, any discount attributable to payments on receivables,
distribution of the Product and the like.
4.12 Subject to Article VII hereof, the joint promotion and detailing of the
Product shall cease at the end of the Third Detailing Year; provided
that the joint promotion and detailing of the Product and the term of
this Agreement shall automatically be extended for successive one (1)
year periods unless at least sixty (60) days before the expiration of
the then-current term-, either party gives written notice to the other
that it does not wish to extend this Agreement. At the end of the Third
Detailing Year (or, if later, at the end of any extension of the term
of this Agreement or on termination under any circumstance) Miles shall
have no further obligations to promote and detail the Product and, upon
request by Schein, shall return to Schein all sales, marketing,
training and other materials which it has in its possession relating to
Product. Schein shall have the right to continue to distribute
materials bearing the Miles name, until the inventories of such
materials are depleted.
Article V: Warranties and Indemnification
-----------------------------------------
5.01 Each party warrants and represents to the other that it has the full
right and authority to enter into this Agreement, and that it is not
aware of any impediment that would inhibit its ability to perform its
obligations under this Agreement.
5.02 Schein warrants and represents that, to the best of its knowledge, the
Product package insert adequately describes the toxicity and
sensitivity reactions associated with the Product when administered in
accordance with the package insert. Miles acknowledges that the Product
is a "black box" product, with significant known side effects,
including death.
5.03 Schein warrants and represents that it has no knowledge of the
existence of any U.S. patent which would prevent Schein from making,
using or selling the Product in the United States or would prevent
Schein and Miles from jointly promoting or detailing the Product in the
United States. Miles acknowledges that neither Schein nor any of its
Affiliates holds any patent covering the Product.
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5.04 (a) One party shall indemnify, protect and hold the other party
harmless against any and all damages, costs, expenses, lawsuits
and liabilities directly or indirectly result,resulting from
claims, suits or judgments arising out of said one party's
negligence (as between Schein or Miles) with resect to the Product
or components thereof or the detailing, promoting or other
obligations of said party hereunder. The other party shall
promptly notify said one party of any claims or suits for which
the other party may assert indemnification from said one party
hereunder and the other party shall permit said one party, or its
insurer, at said one party's expense, to assume or participate in
the defense of any such claims or suits and the other party shall
cooperate with said one party or its insurer in such defense when
reasonably requested to do so.
(b) One party shall indemnify, protect and hold the other party
harmless against any and all damages, costs, expenses, lawsuits,
and liabilities directly or indirectly resulting from claims,
suits or judgments with respect to the Product or components
thereof or the detailing, promoting or other obligations of said
one party hereunder to the extent that such damages, costs,
expenses, lawsuits and liabilities are due to the contributory
negligence of said one party. The other party shall promptly
notify said one party of any such claims or suits for which the
other party may assert contribution or indemnification from said
one party and each party shall permit the other party or its
insurer at the other party's expense, to participate in the
defense of any and all such claims or suits and each party shall
reasonably cooperate with the other party or its insurer in such
defense when requested to do so.
(c) Without limitation, as between Miles and Schein, if an above-
described claim, suit or judgment (or any portion thereof) is
based solely on:
(i) the failure of the Product to meet any specifications in the
Schein New Drug Application approved by the U.S. Food and
Drug Administration ("FDA") or supplements thereto;
(ii) misrepresentations or deficiencies in or omissions from the
Product's package insert approved by the FDA;
then Miles shall not be deemed negligent with respect to such
matters and shall be fully and completely indemnified by Schein
under Section 5.04 (a) with respect to such claim, suit or judgment
(or portion thereof) which solely involved such matters, and Schein
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shall be permitted, at its sole cost, to assume full control over
the defense of any such claim or suit (or portion thereof)0.
(d) This Section 5.04 shall survive the termination of this Agreement.
Article VI: Reports
-------------------
6.01 Schein shall keep such records as are required to determine accurately
under United States generally accepted accounting principals the sums
due to under this Agreement. Such records shall be retained by Schein
and shall be made available for reasonable review and/or audit, at the
request and expense of Miles by an independent Certified Public
Accountant appointed by Miles and reasonably acceptable to Schein and
subject to appropriate confidentiality undertakings for the purposes of
verifying Schein' accounting reports hereunder and determining the
correctness of such reports during the one hundred and twenty (120) day
period following the close of the applicable Detailing Year, in respect
of New Sales for the Detailing Year then ended.
6.02 All sums due to Miles shall be payable to Miles in U.S. dollars by
Schein at the following address:
Miles Inc.
Pharmaceutical Division
000 Xxxxxx Xxxx
Xxxx Xxxxx, Xxxxxxxxxxx 00000
or at such other address within the United States that Miles may
designate in writing to Schein.
6.03 Notwithstanding anything in this Agreement to the contrary, in the
event that Schein' actual Net Sales of the Product in the United States
are reduced, due to Adjustments after such Net Sales have been accrued
pursuant to the terms of this Agreement, then Net Sales for the
Detailing Year in which such Adjustments occur shall: be reduced
accordingly and Miles shall return to Schein within sixty (60) days of
receipt of a notice from Schein requesting such return, any dollar
amounts which were paid to Miles in respect of Net Sales during such
Detailing Year which are in excess of the dollar amounts which would
have been paid to Miles if Net Sales for such period reflected the Net
Sales actually received by Schein, taking into account such
Adjustments.
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Article VII: Term and Termination
---------------------------------
7.01 Unless sooner terminated d as herein provided, or extended in
accordance with Paragraph 4. 12, this Agreement shall expire, subject
to Paragraph 7.03 below. after the Third Detailing Year.
7.02 Either party may terminate this Agreement at any time for any reason
whatsoever with one hundred and twenty (120) days written notice;
provided no such termination shall be effective prior to April 1, 1996,
unless the grounds for termination is Miles' or Schein's failure to
fulfill its obligations under Section 2.02 or 2.03, respectively.
7.03 Termination of this Agreement shall be without prejudice to either
party's right to obtain performance of any obligations provided for in
this Agreement which survive termination by their terms.
Article VIII: Force Majeure
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8.01 The performance by either party of any covenants or obligations on its
part to be performed hereunder (other than an obligation of either to
pay money to the other) shall be excused by floods, strikes or other
labor disturbances, riots, fires, accidents, wars, embargoes, delays of
carriers, inability to obtain materials from sources of supply, acts,
injunctions, or restraints of governments (whether or not now
threatened), or any cause preventing such performance whether similar
or dissimilar to the foregoing beyond the reasonable control of the
party bound by such covenant or its obligation, provided, however, that
the party affected shall exert its reasonable diligent efforts to
eliminate or cure or overcome any of such causes and to resume
performance of its covenants with all possible speed.
Article IX: Dispute Resolution
------------------------------
9.01 Both parties are obligated to undertake all reasonable efforts in order
to solve in an amicable way any controversy arising in connection with
this Agreement. However, in the event that disputes arise that cannot
be resolved at the immediate level, the dispute shall be referred to
the President of Miles Pharmaceutical Division and the chairman of
Schein.
Article X: Miscellaneous Provisions
-----------------------------------
10.01 This Agreement shall be governed by and interpreted under the laws of
the United States and of the State of New Jersey.
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10.02,(a) For a period of ten (10) years from the Effective Date of this
Agreement or five (5) years from the termination hereof, whichever
occurs later:
(i) each party agrees not to use Confidential Information
furnished by the other party for any purpose inconsistent
with this Agreement; and
(ii) each party will treat Confidential Information furnished by
the other party as if it were its own proprietary
information and will not disclose it to any third party
other than its Affiliates or consultants without the prior
written consent of the other party who furnished such
information.
(iii) Miles shall not have the right for a period of five (5)
years from the termination of this Agreement to disclose,
publish and/or use for its benefit or for the benefit of any
third party any Confidential Information, sales, marketing,
training or other information provided to Miles by or on
behalf of Schein or its Affiliates received under this
Agreement to promote, achieve and/or maintain the sale and
use of the Product or any other pharmaceutical specialty
with indications similar to those of Product without the
prior written consent of Schein.
10.03 A party shall be relieved of any and all of the obligations of Section
11.02(a) with respect to Confidential Information if:
(a) such Confidential Information was known to the party receiving the
Confidential Information prior to receipt from the disclosing
party; or
(b) such Confidential Information was at the time of disclosure to the
party receiving the Confidential Information generally available
to the public or which became generally available to the public
through no fault attributable to the party receiving the
Confidential Information;
(c) such Confidential Information was made available to the party
receiving the Confidential Information for its use or disclosure
from any third person who was at the time of transmitting such
Confidential Information not under a non-disclosure obligation to
the other party.
10.04 This Agreement shall be binding upon, and shall inure to the benefit of
successors to a party hereto, but shall not otherwise be assignable
without the prior written consent of both parties.
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10.05 Any notice required to be given hereunder shall be considered properly
given if sent by certified mail, return receipt requested to the
respective address of each party as follows:
Office of the President
Miles Inc.
Pharmaceutical Division
000 Xxxxxx Xxxx
Xxxx Xxxxx. Xxxxxxxxxxx 00000
and
Chairman of the Board
Schein Pharmaceutical, Inc.
000 Xxxxxx Xxxxx
Xxxxxxx Xxxx, XX 00000
or to such other address as the addressee shall have last furnished in
writing in accord with this provision to the addresser.
10.07 If any provision of this Agreement is held to be invalid, such invalidity
shall not affect the validity of the remaining provisions.
10.08 All captions herein are for convenience only and shall not be interpreted
as having any substantive meaning.
10.09 All covenants, agreements, representations and warranties made hereunder
shall be deemed to have been relied upon notwithstanding any investigation
heretofore or hereafter made and shall survive the execution of this
Agreement.
10.10 This Agreement constitutes the entire agreement between the parties hereto
with respect to the within subject matter and supersedes all previous
agreements, whether written or oral. It may be changed only in writing
signed by properly authorized representatives of Miles and Schein.
10.11 Neither party shall be entitled to assign its rights hereunder without the
express written consent of the other party hereto.
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IN WITNESS WHEREOF, Miles and Schein have caused this Agreement to be duly
executed by their authorized representatives, in duplicate on the dates written
hereinbelow.
Attest: Miles Inc.
By /s/ By /s/ Xxxxx X. X. Xxxxxxxx
___________________________ ___________________________
Xxxxx X. X. Xxxxxxxx,
Executive Vice President
Miles Inc. and
President
Pharmaceutical Division
Date November 11, 1994
--------------------------
Attest: Schein Pharmaceutical, In,
By /s/ X. X. XxXxxxxxxx By /s/ Xxxxxx Xxxxxxx
___________________________ ___________________________
Xxxxxx Xxxxxxx
Chairman of the Board and
Chief Executive Officer
Date Dec 9, 1994
--------------------------
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APPENDIX I
COMPLAINT HANDLING PROCEDURES
The purpose of this appendix is to establish written procedures for the
communication and processing of Product complaints received by Miles.
Acting in accord with this Agreement will facilitate compliance with Federal
Requirements as set forth in 21 CFR 211.198 (complaint files) and 21 CFR
310.305/21 CFR 314.80 (postmarketing reporting of adverse drug reactions).
A. Complaint Reporting:
1. Complaints reported directly to Miles will be summarized and forwarded
to the Supervisor of Clinical Affairs at Schein.
2. All adverse drug experience complaints reported to Miles will be
communicated to Schein within three working days of report receipt.
Schein will be responsible for completion and submission to the Food
and Drug Administration of Form FDA-3500A where appropriate .
3. Complaint reports which may meet NDA-Field Alert Report Criteria t21
CFR 314.81 (b) (1)] will be promptly communicated to Schein enabling
FDA notification by Schein within three working days. Schein will
advise Miles of NDA Field Alert Report submission and forward a copy
of any such report to the Complaint Coordinator (see A.1 above) of
Miles.
B. Complaint Investigation:
1. Schein will investigate all complaints, including complaints
associated with Product's active or inactive ingredients,
container/closure system, general Product quality, distribution or
handling.
C. Communications with Complainant:
1. Schein will be responsible for review of complaint evaluation
information and preparation of a written response.
2. In situations requiring submission of adverse drug experience reports,
Schein will be responsible for any follow-up communications which may
be required in order to facilitate timely completion and submission of
FDA
D. Product Recall:
1. In carrying out a recall, both parties will fully cooperate in
notifying customers to follow instructions as read upon by the
parties.
AMENDMENT NUMBER 1 TO CO-PROMOTION AGREEMENT
--------------------------------------------
This Amendment to Co-Promotion Agreement (the "Amendment") is entered into
as of the 1st day of January 1997 between Miles, Inc., an Indiana corporation,
now known as Bayer Corporation ("Bayer"), and Schein Pharmaceutical, Inc., a
Delaware corporation ("Schein").
Introduction
------------
X. Xxxxx and Xxxxxx entered into a Co-Promotion Agreement, dated August
1, 1994 (the "Agreement").
B. Pursuant to the terms of the Agreement Bayer and Schein agreed to
jointly promote and detail the Product (as defined in the Agreement) in the
United States.
C. The parties wish to amend the Agreement in accordance with the terms
of this Amendment.
NOW, THEREFORE, in consideration of the mutual covenants and promises
herein contained, and for other good and valuable consideration, it is agreed as
follows:
1. Definitions In This Amendment and Incorporation. Unless otherwise
-----------------------------------------------
defined, all terms used herein shall have the meaning ascribed to them in the
Agreement, and the terms and provisions of the Agreement are incorporated herein
by reference as though set forth in full.
2. Definitions. The following is added to the end of Section 1.06 of the
-----------
Agreement: "Effective as of December 29, 1996, a 'Detailing Year' shall be the
twelve (12) month period commencing on the last Sunday in December of the Term".
3. Grants and Obligations.
----------------------
The second paragraph of Article II, Section 2.01 of the Agreement is
hereby deleted in its entirety and replaced by the following:
"During the Joint Detailing Years, Schein shall not authorize, or
grant the right to, any third party to detail the Product in
the United States in the field of Nephrology: provided, however,
that Schein may authorize, or grant the right to, any third party
to detail and promote the Product in the United States in a field
other than Nephrology.
4. Payments.
--------
Article III, Subsections 3.01 (a), (b), (c) and (d) of the Agreement
are hereby deleted in their entirety and replaced by the following:
"3.01 (a) Effective January 1, 1997, Schein shall pay to Bayer in
each Detailing Year the following: (i) the aggregate amount of
********** ******* ** **** ***** ************ ** ******** ****,
within sixty (60) days after the close of each fiscal quarter
during a Detailing Year, plus (ii) an amount equal to *** *****
** *** ***** ****** *** ********* ********* *** **** **** ******
*** ******* ****** in each Detailing Year, payable annually
within sixty (60) days after the end of such Detailing Year. The
annual payment relating to *** ***** shall be accompanied by an
accounting of such *** ***** indicating aggregate quantities and
dollar amounts of the Product. For purposes of this Agreement,
***** **** ******* ***** **** *** ********** *** *********** for
the Detailing Year commencing December 29, 1996, and (ii) for
each Detailing Year thereafter, Schein and Bayer shall meet
within sixty (60) days prior to the start of such Detailing Year
for the purposes of reviewing the Base Line Figure for such
****** ********* **** *** *********** ** **** ***** ***
*********** ********** ** *** **** **** ****** *** *******
********** *** *** ******* *** *** ****** ** * ***********
******* ** *** ******* *** ********** *********** ** ********
******* *** *** ******** ******* ** ** ** **** ** **** ********
*** ****** ***** ***** *** *** ********** ************** ********
** ****** ******* *********** **** ******** **** ****** ********
** *** ******* ** *** ********** **** ******* ** *** ** **** ***
***** ********* ** ********
5. Reaffirmation of Agreement and Other Document. Except as modified
---------------------------------------------
herein, all of the covenants, terms and conditions of the Agreement remain in
full force and effect and are hereby ratified and reaffirmed in all respects. In
the event of any conflict, inconsistency or incongruity between the terms and
conditions of this Amendment and the covenants, terms and conditions of the
Agreement the terms and conditions of this Amendment shall govern and control.
6. Counteparts. This Amendment may be executed in two or more
-----------
counterparts each of which together shall constitute an original but which,
when taken together, shall
* redacted pursuant to confidential treatment request.
2
constitute but one instrument and shall become effective when copies hereof,
when taken together, bear the signatures of all required parties and persons.
IN WITNESS WHEREOF, this Amendment is executed as of the day and year first
above written.
BAYER CORPORATION
By: /s/ Xxxxxx X. Xxxxxxxxx
----------------------------
Name: Xxxxxx X. Xxxxxxxxx
--------------------------
Title: Senior Vice President and General Manager
-----------------------------------------
SCHEIN PHARMACEUTICAL, INC.
By: /s/ Xxxxxxx X. Xxxxx
-------------------------
Name: Xxxxxxx X. Xxxxx
-----------------------
Title: President Retail Specialty Product Division
-------------------------------------------
3
AMENDMENT NO. 2 TO CO-PROMOTION AGREEMENT
-----------------------------------------
This Amendment Number 2 to Co-Promotion Agreement (the "Amendment") is
entered into as of the 1st day of January 1997 between Bayer Corporation,
formerly known as Miles, Inc. ("Bayer") and Schein Pharmaceutical, Inc.
("Schein").
Introduction
------------
X. Xxxxx and Xxxxxx entered into a Co-Promotion Agreement, dated August 1,
1994 which was amended by Amendment Number 1 to Co-Promotion Agreement dated
January 1, 1997 (collectively, the "Agreement").
B. Pursuant to the terms of the Agreement, Bayer and Schein agreed to jointly
promote and detail the Product (as defined in the Agreement) in the United
States.
X. Xxxxx Puerto Rico Inc. ("Bayer Puerto Rico") and Schein entered into a
Promotion Agreement, dated February 1, 1995 (the "Puerto Rico Agreement").
D. Pursuant to the terms of the Puerto Rico Agreement, Bayer Puerto Rico and
Schein agreed to jointly promote and detail the Product (as defined in the
Agreement) in Puerto Rico.
X. Xxxxx and Xxxxxx wish to amend the Agreement to include Bayer Puerto Rico's
obligations with respect to promotion of the Product in Puerto Rico in the
Agreement. Bayer Puerto Rico and Schein simultaneously herewith have terminated
the Puerto Rico Agreement.
NOW, THEREFORE, in consideration of the mutual covenants and promises
herein contained, and for other good and valuable consideration, it is agreed as
follows:
1. Definitions In This Amendment Number 2 and Incorporation. Unless
--------------------------------------------------------
otherwise defined, all terms used herein shall have the meaning ascribed to them
in the Agreement, and the terms and provisions of the Agreement are incorporated
by reference as though set forth in full.
2. Definitions.
-----------
(a) Section 1.03 is deleted in its entirety and replaced with the following:
" `Territory' shall mean the United States and Puerto Rico."
(b) Except for Section 10.01 of the Agreement, in all places where the defined
term "United States" appears it is hereby replaced with the defined term
"Territory."
3. Addition of Bayer Puerto Rico as Party to the Agreement. With respect
-------------------------------------------------------
to its promotion of the Product in Puerto Rico, Bayer Puerto Rico agrees to the
terms and conditions in the Agreement.
4
4. Reaffirmation of Agreement and Other Documents. Except as modified
----------------------------------------------
herein, all of the covenants, terms and conditions of the Agreement remain in
full force and effect and are hereby ratified and reaffirmed in all respects. In
the event of any conflict, inconsistency or incongruity between the terms and
conditions of this Amendment and the covenants, terms and conditions of the
Agreement the terms and conditions of this Amendment shall govern and control.
5. Counterparts. This Amendment may be executed in two or more
------------
counterparts, each of which together shall constitute an original but which,
when taken together, shall constitute but one instrument and shall become
effective when copies hereof, when taken together, bear the signatures of all
required parties and persons.
IN WITNESS WHEREOF, this Amendment is executed as of the day and year first
above written.
BAYER CORPORATION BAYER PUERTO RICO INC.
By:________________ By:________________
Name:______________ Name:______________
Title:_____________ Title:_____________
SCHEIN PHARMACEUTICAL, INC.
By:________________
Name:______________
Title:_____________
5
