Exhibit 10.13
[*] Confidential treatment requested
MANUFACTURING AND SUPPLY AGREEMENT
MANUFACTURING AND SUPPLY AGREEMENT ("Agreement") dated as of December 1, 1998
("Effective Date"), between Xxxxxx R&D Laboratories, Inc. with offices at 0000
Xxxxxxxxx Xxx, Xxxxx 00 0, Marina xxx Xxx, XX 00000, Xxxxxx Xxxxxx of America
("R&D"), on the one hand, and Xxxxx-Xxxxxxx Xxxxx Ltd, an English company with a
manufacturing facility at Xxxxxxx Xxxx Xxxxx, Xxxxxxxx, Xxxxx ("RPR") and Xxxxx-
Xxxxxxx Xxxxx GmbH, a German company with offices at Xxxxxxxxxxxxxxx 0, X 0000
Xxxx 00, Xxxxxxx ("RPR GmbH"), on the other hand.
Whereas, R&D and RPR GmbH have entered into a Distribution Agreement dated June
24, 1993, as amended to date (the "Distribution Agreement") and a Trademark
Agreement dated August 26, 1993, as amended to date, (the "Trademark Agreement")
(collectively the "Prior Agreements"), which grant R&D the exclusive right to
import the Product (as defined below) into, and to use and sell the Product in,
the Territory (as each term is defined below); and
Whereas, RPR GmbH and RPR (an affiliate of RPR GmbH), on the one hand, and R&D,
on the other hand, desire to enter into this Agreement under which RPR will
supply to R&D all of R&D's requirements of the Product, and R&D will purchase
all of its requirements of the Product from RPR.
Therefore, in consideration of the mutual covenants and consideration set forth
herein, the parties hereto, intending to be legally bound, agree as follows:
ARTICLE I. -- DEFINITIONS
-------------------------
1.1 "Product" shall mean Ferrlecit(R) Injection, a sodium ferric gluconate
complex in sucrose manufactured by RPR in accordance with the Specifications (as
defined below).
1.2 "Specifications" shall mean all conditions, processes, methods and
parameters as contained and approved in the NDA (as defined below), including
those release specifications set forth in Exhibit A, as may be amended by
written agreement of the parties.
1.3 "Labeling/Packaging Specifications" shall mean those specifications
provided pursuant to the provisions of Article II-C, but shall exclude those
labeling and/or packaging specifications required under the NDA.
1.4 "Regulatory Approval" shall mean, with respect to any country in the
Territory, all governmental and regulatory registrations and approvals
(including, but not limited to, approvals of all final Product labeling)
required for the marketing, distribution and sale of the Product in such
country.
1.5 "Territory" shall mean the United States of America and its possessions,
Canada, Greece, Argentina, Chile, Mexico, United Kingdom, Ireland, Japan, and
Singapore.
1.6 "NDA" shall mean the New Drug Application, as defined in the U.S. Federal
Food, Drug and Cosmetics Act (the "Act"), with respect to the Product, filed on
December 30, 1997 with the United States Food and Drug Administration ("FDA"),
as amended or supplemented from time to time.
1.7 "Date of Manufacture" shall mean the date on which the constituent
materials were first mixed.
1.8 Capitalized terms used but not defined in this Agreement shall have the
meaning attributed to them in the Distribution Agreement.
ARTICLE II. -- SUPPLY OF THE PRODUCT
------------------------------------
A. EXCLUSIVE SUPPLY OF THE PRODUCT. During the term of this Agreement, RPR
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shall supply R&D on an exclusive basis with all of its requirements of the
Product for the Territory, and R&D shall purchase all of its requirements of the
Product for the Territory from RPR, according to the terms of this Agreement,
including Exhibit B. RPR GmbH shall be jointly and severally liable with RPR for
the performance of all of RPR obligations under this Agreement.
B. FORECASTS, ORDERS, PRICES-AND TERMS
-----------------------------------
1. On or before execution of this Agreement and on the first day of each
calendar quarter thereafter, R&D shall provide RPR with a written [*] rolling
forecast, by calendar month, of R&D's requirements of Product. All forecasts
shall be prepared in good faith in order to facilitate RPR's manufacture and
shipment of the Product in compliance with this Agreement. The initial rolling
[*] forecast will cover the period from [*]. RPR hereby confirms that R&D has
provided RPR with this initial [*] forecast. Each month of each successive [*]
rolling forecast provided to RPR shall be firm and unchanged from the same month
in the previous [*] rolling forecast, except that:
a) R&D shall add an additional calendar quarter forecast by month to the
end of the quantities projected in the previous [*] rolling forecast; and
b) R&D may change the quantities that had been forecasted in months [*]
in the previous [*] rolling forecast, which months will now become months [*] in
the current [*] rolling forecast; provided, however, that the change in
previously projected quantities for months [*], as they become months [*], may
be no more than plus or minus [*] of the amounts that were previously projected
(when they were months [*] in the previous [*] rolling forecast).
2. The parties acknowledge that R&D has provided RPR with R&D's firm, binding
purchase orders for Product to be delivered by RPR during the initial [*] period
(the calendar year 1999). For all periods during the term of this Agreement
following such initial [*] period, firm purchase orders for Product shall be
placed by R&D with not less than [*] lead time prior to
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the shipment or other release date(s) requested by R&D, unless RPR agrees to and
accepts an order for shipment in less than [*].
During the term of this Agreement, R&D shall ensure that all of its orders for
shipment in any calendar month are, with respect to each of the first [*]
covered by each [*] rolling forecast, in a range of not less than [*]% and not
more than [*]% of the quantities forecast for such month, as set forth in such
rolling forecast. However, notwithstanding the foregoing, the parties have
agreed to a range of no less than [*]% and no more than [*]% of R&D's projected
orders for the initial [*] of production. The applicable acceptable range set
forth above will be referred to hereinafter as the "Relevant Band." RPR shall
not be obligated to accept orders outside the Relevant Band for any period.
Although RPR and R&D have agreed to discuss orders that fall outside the
Relevant Band, RPR shall be entitled to accept, or decline to accept, any
increase or decrease in such orders, in RPR's sole discretion.
R&D has an obligation to order a minimum annual quantity of [*] ampoules of
Product. Each purchase order shall include (a) the quantity of Product to be
purchased, (b) the requested shipping date(s) therefor; (c) any relevant
shipping instructions; and (d) any other information dictated by the
circumstances of the order. RPR may require R&D to place orders in full batch
size, e.g., approximately [*] ampoules, or multiples thereof. (The parties
acknowledge that although the normal batch size for the Product is [*] ampoules,
the demonstrated average yield per batch is approximately [*] ampoules. R&D
will only be responsible for paying RPR for the number of ampoules actually
shipped). To the extent of any conflict or inconsistency between the Agreement
and any purchase order, purchase order release, confirmation, acceptance or any
similar document, the provisions of this Agreement shall govern.
Notwithstanding any contrary provision herein, in the event a purchase order
submitted by R&D hereunder falls within the Relevant Band but does not meet the
requirement that it equals a full batch size or a multiple thereof, the quantity
of Product reflected on such purchase order shall be rounded down to the nearest
multiple of the full batch size, even if such nearest multiple does not fall
within the Relevant Band; provided, however, that R&D's orders for Product
reflected in such purchase order plus R&D's orders for Product either (i) to be
delivered during the [*] following the delivery date for such purchase order, or
(ii) reflected in the next [*] purchase orders submitted by R&D, if the latest
delivery dates for all such [*] purchase orders is earlier than such [*] shall
on an aggregate basis fall within the Relevant Band.
3. RPR shall accept purchase orders issued to it by R&D that are within the
Relevant Bands and other terms specified above by written notification to R&D
within [*] after receipt of such purchase order. If RPR cannot satisfy a
purchase order in full, either as to delivery schedule or as to quantities
ordered, it shall so inform R&D within such [*] period, detailing in writing the
extent to which that purchase order cannot be satisfied. If RPR is unable to
satisfy a purchase order in full it shall endeavor to make up the difference in
the next calendar quarter or allow R&D to add the difference to a future order
even though it would violate the Relevant Band. This make up window would be
suspended during periods when the RPR facility is not in operation.
4. RPR shall manufacture and ship Product pursuant to R&D's purchase orders
accepted by RPR. Delivery by RPR of quantities that are at least [*]% and no
more than [*]% of the
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quantities ordered shall be accepted by R&D as satisfactory performance under
this Agreement. However, in making a determination as to whether RPR has
satisfied these percentages, only the actual ampoules yielded from each batch
and shipped to R&D will be taken into account. For the purposes of this
Agreement, a timely shipment shall be a shipment made by RPR, through R&D's
carrier, a common carrier, or other method designated by and for the accounts
and at the expense of R&D no later than [*] from the shipment date set forth in
the applicable purchase order.
However, notwithstanding the foregoing, if RPR has provided R&D with between
[*]% and [*]% of the quantities ordered, R&D would have the option to reduce its
future orders by the amount of such excess. R&D would have to notify RPR of
R&D's intention in this regard within [*] of its receipt of such
excess Product.
5. The purchase price for each pack of [*] ampoules shall be [*] ex works RPR
(Incoterms 1990). R&D shall pay such purchase price to RPR GmbH as follows: R&D
shall arrange for an irrevocable and confirmed Letter of Credit at sight payable
to RPR GmbH and RPR shall make available Product as provided for in this
Agreement upon RPR GmbH's draw down under such Letter of Credit. These
shipments will be made available for R&D's carrier to pickup at RPR's factory
and, if the carrier selected by R&D is located on site at RPR, then RPR will
arrange the logistics of such shipment with R&D's carrier.
6. All shipments of the Product shall be shipped to a single R&D designated
site in the U.S., or in the case of orders for non-U.S. portions of North
America, South America, Europe or Asia, respectively, a single site within each
such geographic region. The parties will work together to develop mutually
acceptable procedures for packaging and other logistical issues relating to the
Product for marketing. All shipments shall be ex works RPR's manufacturing
facility (Incoterms 1990), and shall be accompanied by a certificate of
analysis, a statement of conformance with deviation reports, if applicable, and
a packing slip that describes the Product, the NDC number, date of manufacture,
the batch number(s), expiry date(s), batch quantities, the number of pallets per
batch, storage conditions the purchase order number and shows the shipment's
destination (as specified above). Title and risk of loss or damage to any
Product sold by RPR to R&D hereunder shall pass to R&D upon delivery by RPR to
the carrier at RPR's facility. R&D shall use its best efforts to designate a
carrier at the time of issuance of each purchase order to RPR, provided,
however, that if R&D fails to designate a carrier on its purchase order, RPR may
select a carrier for the account and risk of R&D.
C. LABELING AND PACKAGING
----------------------
1. The Product will be suitably packed for transit, each pallet or outer
package being labeled with:
a) the Product's approved name
b) RPR batch number(s)
c) RPR total batch number quantity (if it has been specified) and
individual pallet quantities
d) RPR name and address
e) NDC number and bar code on shipper
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f) Destination address(ees)
g) Product tariff code as provided to RPR by R&D
h) Partial pallet recognition (where applicable)
i) Storage conditions
Any change in packaging for transportation from those used on the ship test
performed in August, 1998, must first be approved in writing by R&D. Damage
caused to the Product, that is a direct result of RPR's negligence in packaging
the Product, shall be RPR's responsibility and RPR shall reimburse R&D for such
damage promptly.
2. R&D shall supply to RPR all labeling for the Product, including label
design and artwork (the "Labeling/Packaging Specifications"). Label design shall
include, but not be limited to, labeling for the ampoule, carton, foil and
package insert. When provided, the Labeling/Packaging Specifications shall
become part of the Specifications for the Product. R&D represents and warrants
that the Labeling/Packaging Specifications provided to RPR shall be in full
conformity with Regulatory Approvals and all applicable laws and regulations,
and RPR represents and warrants that it shall package and label the Product in
accordance with such Labeling/Packaging Specifications provided by R&D. RPR will
purchase ampoule labels as specified by R&D and overprint the applicable batch
numbers and expiration date. RPR will also print in-house all labels for the
corrugated cases (shippers) used to ship the Product. RPR will arrange to have
the foil (if printing is required) and the package insert printed by third
parties.
3. The accurate reproduction of the labeling in accordance with the
Packaging/Labeling Specifications provided by R&D is the responsibility of RPR.
On the packaging for the Product, R&D shall identify RPR as the manufacturer of
the Product as and to the extent permitted by applicable laws and regulations.
No changes shall be made to the artwork provided by R&D, or the label produced
therefrom, without R&D's written approval. R&D shall supply to RPR a printed
and/or electronic copy of the approved copy for all labels and labeling. R&D
will be provided with, and will promptly sign-off on, proofs for each label.
RPR shall maintain at all times sufficient inventories of labels and packaging
material to produce the Product, in accordance with the terms of the forecast
submitted by R&D. R&D shall reimburse RPR for RPR's costs of printing all
package inserts for the Product. RPR will separately invoice R&D for these
costs which are estimated at [*] per 1000 two-sided package inserts. To the
extent that RPR agrees to assist R&D in the logistics of the preparation of any
of the artwork necessary for labeling and packaging, R&D agrees to promptly
either directly pay for, or reimburse RPR for, any expenditure that RPR incurs
in connection with such work. R&D is responsible for all costs associated with
all changes to any labeling for the Product, including the costs of any obsolete
stock of any labeling or packaging. If R&D so requests, RPR will cooperate with
R&D in arranging for R&D to audit the printer(s) used by RPR to print R&D's
labels. All costs of such audit shall be borne exclusively by R&D.
4. The Product shall be packaged as follows.
a) Individual ampoules will be labeled and packed into a plastic tray,
which will hold [*] ampoules. The tray will be sealed with foil
lidstock.
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b) Two trays ([*] ampoules) will be packaged in a carton with one package
insert.
c) [*] cartons will be packed into a corrugated case (the shipper) that
will have a mutually agreed upon label.
d) [*] shippers will be stacked and cling film wrapped to each pallet,
except in the case where partial palletization is necessary.
e) The dimension of the pallet will be [*] mm x [*] mm, with nominal
thickness of [*] mm.
f) There will be approximately [*] pallets for each batch. Partial
pallets are acceptable, however, there shall be no mixing of batches
on a pallet.
D. INSPECTION OF SHIPMENTS
-----------------------
1. RPR will be responsible for quality control testing (except for the
molecular weight and sucrose testing that will be initially performed by R&D)
and release of the Product. RPR will provide R&D with a Certificate of
Analysis, packing slip and Statement of Conformance with the manufacturing
process as defined in the NDA for all batches of Product shipped to R&D.
Delivery of any Product by RPR to R&D, or its carrier, shall constitute a
certification by RPR that the Product conforms at the time of such delivery to
the Specifications. R&D, or its agent, and RPR shall store all Product in
controlled conditions as specified in the Product Specifications and
Labeling/Packaging Specifications. RPR accepts responsibility for the
manufacture of Product to the Specifications.
2. Upon receipt of each shipment of Product by R&D at the destination
specified in the shipping instructions, R&D agrees to inspect promptly each
shipment to determine whether any portion of it failed to conform with the
applicable Purchase Order or the Specifications. R&D will positively identify
all batches of the Product received. In the event that any portion of any
shipment failed to conform to the applicable Purchase Order or Specifications at
the time of delivery to R&D's carrier in accordance with the terms of Article
II.B.6, R&D may reject the non-conforming portion of the Product by giving
written notice to RPR within [*] of R&D's receipt of such shipment. Such notice
shall specify the manner in which the Product fails to meet the applicable
purchase order or Specifications. Failing such notification, R&D shall be deemed
to have accepted the shipment of Product, unless there is a later discovery of
latent non-conformance not reasonably detectable by R&D's inspection, so long as
such non-conformance is, after appropriate investigation, shown to be
attributable to RPR, as opposed to a subsequent act or omission by R&D, or its
agents.
3. The following release procedures shall be followed:
After all quality control testing (including molecular weight and sucrose
initially performed by [*]) has been satisfactorily performed, RPR will prepare
a Certificate of Analysis and a document package for each batch of Product and
release such batch for shipment. RPR will forward 10 ampoules of each batch
together with the corresponding paperwork to R&D and simultaneously arrange for
dispatch of the Product to R&D's carrier at the Dagenham facility. After the
Product has been physically received at the designated address in the United
States (or
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at the address designated for non-US shipments) R&D, or its agents, would have
[*] to perform a visual inspection and a product identification test and to
reject any allegedly non-conforming product in accordance with the terms of
Article II.D.2. above.
4. In the event of rejection for non-conformance in accordance with the terms
of Article II.D.2, upon giving RPR such notification of non-conformance, R&D
shall provide RPR with a reasonable opportunity, within [*] of such
notification, to inspect the Product and make any appropriate adjustment or
replacement. In all cases in which the parties agree that there is a shortage
or non-conformance, RPR shall, at its own cost, endeavor to replace any shortage
or non-conforming Product in the next quarter or allow R&D to add such shortage
to a future order even though it would violate the Relevant Band; provided,
however, that in the event any such nonconformance that triggers a rejection is
attributable to a matter reflected in the Certificate of Analysis, packing slip
or Statement of Conformance for the applicable shipment such that had R&D had a
copy of such documents prior to shipment it would have caused the shipment to be
aborted, RPR will refund to R&D the purchase price for such rejected Product
pending replacement of the non-conforming Product.
Any such non-conforming Product shall, at RPR's direction, be destroyed by R&D
at RPR's expense (and certified as so destroyed by R&D). Any dispute regarding
the proper rejection of a shipment shall be submitted for testing to an
independent laboratory to be mutually agreed upon. If the independent
laboratory finds that the shipment in question or any part of it did not comply
in all material respects with the Specifications at the time of delivery to
R&D's carrier in accordance with the terms of Article II.B.6, RPR shall replace
such supply of non-conforming Product in accordance with the terms hereof.
RPR's supply of substitute Product which conforms to the Specifications shall
satisfy and discharge any claims or potential claims of R&D against RPR with
respect to such nonconforming Product.
5. During the pendency of a dispute that requires settlement by an independent
laboratory, pending the resolution of such dispute RPR shall endeavor to replace
the portion of the shipment under dispute and if it is not able to do so will
allow R&D to add such amount to future relevant manufacture.
6. The parties agree to be bound by the determination of an independent
laboratory as to whether the Product conformed to Specifications at the time of
delivery to R&D's carrier in accordance with the terms of Article II.b.6. Costs
of the independent laboratory's activities shall be borne by R&D if the Product
in question is found to have conformed with the Specifications, and by RPR, if
such Product is found not to have conformed with the Specifications.
E. RECALLS
-------
In the event any governmental agency having applicable jurisdiction shall order,
or it shall otherwise become necessary to perform, any corrective action or
market action with respect to the Product supplied hereunder, including any
recall, field correction, market withdrawal, stock recovery, customer notice or
restriction, if the cause of such corrective action or market action is due
solely to RPR's failure to manufacture Product that conforms to the
Specifications, then RPR shall reimburse R&D for the reasonable out-of-pocket
costs incurred by R&D or its sub-distributor in notifying its customers of such
action, conducting any required retrieval of Product
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and replacing any retrieved Product. If the cause of such corrective action is
due to any other reason, then R&D will be fully liable for the costs of such
action. R&D, or its agents, will be exclusively responsible for handling all
customer complaints, inquiries, and the like in the Territory, and RPR will
appropriately cooperate with R&D concerning the same.
Upon being notified of the necessity for any corrective or market action with
respect to the Product, including any recall, field correction, market
withdrawal, stock recovery, customer notice or restriction, R&D shall promptly
notify RPR in writing and provide RPR with any material details of which R&D is
aware at the time of such notification.
F. RPR MANUFACTURING CAPABILITIES
------------------------------
Within ninety (90) days of the date of the Agreement, RPR will submit to R&D its
one and two year manufacturing capability plan for producing the Product in
conformity with the terms and conditions of this Agreement. R&D shall promptly
review the capability plan and confer with RPR respecting any mutually agreeable
revisions to the plan. Notwithstanding R&D's review of such procedures, it is
expressly acknowledged that RPR shall be responsible for complying with its
obligations under this Agreement.
ARTICLE III. -- GENERAL TERMS AND CONDITIONS
--------------------------------------------
A. CONFIDENTIALITY. All confidential and proprietary information of either RPR
---------------
and/or RPR GmbH, on the one hand, or R&D, on the other hand, disclosed to the
other party hereunder or in connection herewith shall be governed by the
confidentiality provisions of Article 9 of the Distribution Agreement.
B. REPRESENTATIONS, WARRANTIES AND COVENANTS
-----------------------------------------
1. Each of RPR GmbH and RPR, on the one hand, and R&D, on the other hand,
represents and warrants to the other as follows:
a) It has full corporate power and authority to enter into this Agreement
and consummate the transactions contemplated hereby.
b) It has obtained or applied for such permits, licenses and
authorizations of governmental or regulatory authorities as are
necessary to own its respective properties, conduct its business and
consummate the transactions contemplated hereby.
2. RPR represents and warrants to R&D that:
a) All Product supplied by RPR to R&D under this Agreement shall be
manufactured, tested and stored in accordance with the Specifications
and the Technical Agreement attached hereto as Exhibit B and shall at
the time of delivery to R&D's carrier in accordance with the terms of
Article II.B.6 conform to the Specifications and the Technical
Agreement attached hereto as Exhibit B;
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b) All Product supplied by RPR to R&D under this Agreement shall be
manufactured in accordance with all current Good Manufacturing
Practices as defined under the Act;
c) No Product supplied by RPR to R&D under this Agreement shall at the
time of delivery to R&D's carrier in accordance with the terms of
Article II.B.6 be adulterated or misbranded within the meaning of
Sections 303/304 of the Act; and
d) All Product supplied by RPR to R&D's carrier in accordance with the
terms of Article II.B.6, will be so supplied no more than four months
after the applicable Date of Manufacture (as defined in Article 1.7)
of such Product.
3. EXCEPT FOR THE EXPRESS WARRANTIES AND REPRESENTATIONS CONTAINED IN THIS
AGREEMENT, THE DISTRIBUTION AGREEMENT OR TRADEMARK AGREEMENT, NONE OF RPR, RPR
GmbH OR R&D MAKES ANY WARRANTIES OR REPRESENTATIONS, EXPRESS OR IMPLIED, IN FACT
OR IN LAW, INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, OR NON INFRINGEMENT.
4. CERTAIN COVENANTS
-----------------
a) During the Term, RPR shall provide to R&D as they become available
copies of all Product-related correspondence from the FDA or any other
applicable regulatory authority, and all inspection reports with respect to the
Product issued by the FDA or any such other regulatory authority and related
correspondence to the extent it concerns the Product.
b) During the Term, R&D shall provide to RPR as they become available
copies of all Product-related correspondence from the FDA or any other
applicable regulatory authority in the Territory, and all inspection reports
with respect to the Product issued by the FDA or any such other regulatory
authority and related correspondence to the extent it concerns the Product.
c) RPR shall inform R&D in writing, at least six (6) months in advance of
any proposed change to the Specifications set forth herein, or the manufacturing
process with respect to the Product, that may affect any Regulatory Approval for
the Product. No such changes shall be made without the advance written approval
of R&D, such approval not to be unreasonably withheld or delayed, and without
all necessary regulatory submissions and approvals having been made and/or
obtained.
d) R&D shall receive, store and distribute the Product in accordance with
all applicable regulatory requirements, will engage in no conduct that renders
the Product adulterated or misbranded within the meaning of Sections 303/304 of
the Act, shall promote and distribute Product only in full compliance with
applicable laws and regulations, and shall be solely responsible for the failure
of itself, its Affiliates, agents and/or distributors, to comply with said laws
and regulations.
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C. STANDARD COMPLAINT HANDLING PROCEDURES
--------------------------------------
1. R&D and/or its relevant subdistributors shall be responsible in the
Territory for receiving, recording and responding to all customer inquiries
and/or complaints and all reports of alleged adverse drug experiences relating
to Product. In this regard, R&D and/or its relevant subdistributors shall be
responsible in the Territory for providing all medical information and for
responding to all inquiries and complaints relating to medical information
regarding the Product. R&D shall provide notice to RPR's Director of Quality
Assurance at the Dagenham facility of all Products complaints received. RPR
will investigate all complaints associated with the manufacturing and packaging
of the Product, including any inactive ingredients or the container/closure
system and all other packaging components for the Product. Upon completion of
the necessary investigation, RPR will provide a written summary to R&D. R&D
and/or its relevant subdistributors will be responsible for review of the
complaint investigation information and preparation of a written response to the
complainant. R&D will provide RPR with a copy of this written response.
Furthermore, RPR shall be responsible for performing all necessary testing which
should be performed under applicable current Good Manufacturing Practice
regulations in the U.S. as a result of any customer complaint relating to the
manufacturing of the Product. RPR shall, upon request, provide to R&D (subject
to Article III.A hereof) such technical information related to formulation,
manufacture, or stability of Product as is available to RPR to the extent
necessary to assist R&D with its obligations hereunder. R&D shall be solely
responsible for reporting to the FDA and all other government agencies in the
Territory all post-marketing adverse drug experience reports with respect to the
Product.
2. Each of RPR GmbH and R&D shall report to the other potentially serious
alleged adverse drug experiences (whether labeled or unlabelled) with respect to
the Product of which it becomes aware promptly and in no event later than five
(5) working days after initial receipt of the information by such party. Each
such report shall identify lot numbers and customers affected, if known. Each
of RPR GmbH and R&D will provide to the other party at the end of each calendar
half-year a summary of all other adverse drug experiences with respect to the
Product of which it is aware.
D. TERM
----
1. The term of this Agreement shall commence on the Effective Date and shall
continue until the expiration or termination of the Distribution Agreement.
E. FORCE MAJEURE
-------------
No party shall be responsible or liable to the other hereunder for any failure
or delay in its performance under this Agreement caused by war, fire, accident
or other casualty, labor disturbance, Act of God or the public enemy, or any
other contingency beyond such party's reasonable control. In the event of the
applicability of this Article, the party affected by such Force Majeure event
shall use commercially reasonable efforts to eliminate, cure and overcome such
event and resume performance of its obligations hereunder.
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F. RESPONSIBILITIES/ PRODUCT LIABILITY
-----------------------------------
1. R&D shall hold each of RPR and RPR GmbH harmless from any product liability
claims or from any product liability damages arising from the Territory in
relation to R&D's or its Distributing Partners (as defined in the Distribution
Agreement) use of the Product. It is agreed that R&D promptly notifies RPR and
RPR GmbH of any such claims and that R&D cooperates with RPR and RPR GmbH in
defending against such claims, and provided also that such claims or damages do
not result in whole or in part from any negligence or defects attributable to
RPR and RPR GmbH (as to which RPR or RPR GmbH, jointly indemnities R&D), and
provided that RPR or RPR GmbH promptly notifies R&D of preclinical and clinical
data relating to any serious or previously unknown side effects of or adverse
reaction to the Product. RPR and RPR GmbH will not (except as provided in
parenthesis above) have to bear any damages or financial indemnity for R&D, its
distributors or a third party.
2. Neither RPR nor RPR GmbH is responsible in case the Dagenham production
site is not approved by the FDA.
3. This article and the obligations contained herein shall survive the
expiration of this Agreement, or the termination of this Agreement for any
reason whatsoever, until the applicable statutes of limitations have all
expired.
ARTICLE IV. -- MISCELLANEOUS
----------------------------
A. INDEPENDENT CONTRACTOR
----------------------
In making and performing this Agreement, the parties are acting and shall act as
independent contractors. Nothing in this Agreement shall be deemed to create an
agency, joint venture, or partnership relationship between the parties hereto.
No party shall have the authority to obligate any other party in any respect,
and no party shall hold itself out as having any such authority except RPR as to
RPR GmbH, and RPR GmbH as to RPR. All personnel of RPR and RPR GmbH shall be
solely employees of RPR and RPR GmbH, respectively, and shall not represent
themselves as employees of R&D. All personnel of R&D shall be solely employees
of R&D and shall not represent themselves as employees of RPR or RPR GmbH.
B. ASSIGNMENT
----------
1. This Agreement and all rights and obligations hereunder are personal to the
parties hereto and may not be assigned, other than to Affiliates as defined
herein, without the express prior written consent of the other parties. Any
assignment or attempt at same in the absence of such prior written consent shall
be void and without effect. However, no such assignment shall relieve the
assigning party of its obligations hereunder.
2. RPR GmbH hereby represents that RPR is an Affiliate of RPR GmbH as such
term is defined in the Distribution Agreement.
11
C. AMENDMENTS
----------
This Agreement may only be modified, amended, or supplemented by an instrument
in writing executed by RPR, RPR GmbH & R&D.
D. WAIVERS
-------
No term or provision hereof will be considered waived by any party, and no
breach excused by any party, unless such waiver or consent is in writing signed
on behalf of the party against whom the waiver is asserted. No consent by any
party to, or waiver of a breach by any party, whether expressed or implied, will
constitute a consent to, waiver of, or excuse of any other, different, or
subsequent breach by any party.
E. NOTICES
-------
Any notice or communication required or permitted to be given or made under this
Agreement by one of the parties hereto to the other shall be in writing and
shall be deemed to have been sufficiently given or made for all purposes (1) on
the day of dispatch if sent on a business day (in the county of the recipient's
location) by telecopier to the indicated number (with confirmation of receipt);
(2) three days after dispatch if sent by express courier (such as DHL) to the
indicated address below; and (3) seven days after dispatch if sent by registered
mail, postage prepaid, to the indicated address below:
Xxxxxx R&D Laboratories, Inc.
0000 Xxxxxxxxx Xxx
Xxxxx 000
Xxxxxx xxx Xxx, XX 00000
U.S.A.
Attention: General Counsel
Telecopier No. (000) 000-0000
Xxxxx-Xxxxxxx Xxxxx GmbH
Xxxxxxxxxxxxxxx 0
X-0000 Xxxxxxx 30
Germany
Attention: Geschaftsleitung
Telecopier No. 011-49-221-509-2711
Xxxxx-Xxxxxxx Xxxxx Ltd.
Xxxxxxx Xxxx Xxxxx
Xxxxxxxx, Xxxxx, XX 00 7XS U.K.
Attention: Customer Service Manager for the Sterile Business Stream
Telecopier No.: 011-44-181-919-2006
F. COUNTERPARTS
------------
This Agreement shall become binding when any one or more counterparts hereof,
individually, or taken together, shall bear the signatures each of the parties
hereto. This Agreement may be
12
executed in any number of counterparts each of which shall be deemed an
original, but all of which taken together shall constitute but one and the same
instrument.
G. HEADINGS
--------
The article and section headings contained in this Agreement are for reference
purposes only and shall not affect in any way the meaning or interpretation of
this Agreement.
H. ARBITRATION AND GOVERNING LAW
-----------------------------
This Agreement shall be construed, and the rights of the parties determined, in
accordance with Swiss law. All disputes, controversies, or differences which
may arise between the parties out of, or in relation to, or in connection with,
this Agreement or for the breach thereof, shall be finally settled by
arbitration held under Swiss law and by which each party hereto is bound. The
arbitration proceedings with the application of Swiss law shall take place in
Zurich, Switzerland and will be conducted in the English language.
I. SEVERABILITY
------------
Any of the provisions of this Agreement which are determined to be invalid or
unenforceable in any jurisdiction shall be ineffective to the extent of such
invalidity or unenforceability in such jurisdiction, without rendering invalid
or unenforceable the remaining provisions hereof or affecting the validity or
enforceability of any of the provisions of this Agreement in any other
jurisdiction.
J. ENTIRE AGREEMENT
----------------
This Agreement, the Prior Agreements and the contents of the February 3, 1997
letter of RPR GmbH to R&D regarding Schein Pharmaceutical constitute the entire
understanding and agreement of the parties with respect to the subject matter
hereof and thereof and supersede all prior agreements, express or implied, oral
or written with respect thereto.
K. INTERPRETATION
--------------
To the extent of any conflict or inconsistency, of any nature, between the
Agreement and the Prior Agreements, the provisions of the Prior Agreements shall
exclusively govern. If and when any such conflicts or inconsistencies (between
this Agreement and the Prior Agreements) are identified by any party, the
parties hereto will work together to promptly resolve such conflicts or
inconsistencies and, if material, incorporate the resulting resolution into an
amendment to this Agreement.
In the event that any material provision of this Agreement needs to be changed
during the term hereof, all parties hereto agree to negotiate in good faith to
consider such a proposed change, irrespective of which party initiated the
change and, if adopted and material, the resulting change would be included in
an amendment to this Agreement.
13
IN WITNESS WHEREOF, duly authorized representatives of the parties hereto have
duly executed this Agreement, including exhibits, as of the Effective Date.
Xxxxxx R&D Laboratories, Inc.
By: ____________________________
Name: Xxxxxx X. Xxxxxxxx
Title: Chief Financial Officer
Xxxxx-Xxxxxxx Xxxxx GmbH Xxxxx-Xxxxxxx Xxxxx Ltd
By: ____________________________ By: __________________________
Name: ____________________________ Name: C.C.B. Waights
Title: ____________________________ Title: V.P. & General Mgr.-Deg.
14
EXHIBIT A
FERRLECIT(R) INJECTION SPECIFICATIONS
Test Method Specification
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[*] [*] [*]
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[*] [*] [*]
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[*] [*] [*]
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[*] [*] [*]
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[*] [*] [*]
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[*] [*] [*]
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[*] [*] [*]
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[*] [*] [*]
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[*] [*] [*]
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[*] [*] [*]
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[*] [*] [*]
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[*] [*] [*]
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[*] [*] [*]
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[*] [*] [*]
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[*] [*] [*]
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[*] [*] [*]
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[*]
15
EXHIBIT B
TECHNICAL AGREEMENT
This agreement defines the steps to be taken to ensure that European Community
Guidelines and U.S. Food and Drug Administration Guidelines concerning Good
Pharmaceutical Manufacturing Practices (GMP) are being followed when product is
made by RPR for sale by R&D.
1. Product
The Product (Ferrlecit(R) Injection) is as listed in Appendix I.
2. Materials
All Product supplied by RPR will meet the most recent version of the release
specifications listed in Appendix I, as such specifications may be amended from
time to time to comply with applicable regulatory standards.
3. Manufacture - General
3.1 The good manufacturing practices for drug product detailed in The Rules
Governing Medicinal Products in the European Community, volume IV, and in the
then-current U.S. Code of Federal Regulations, will govern the manufacture of
the Product.
3.2 RPR will manufacture, package and test (except for sucrose and molecular
weight) (subject to Section 3.4 below) the Product at its plant at Xxxxxxx Xxxx
Xxxxx, Xxxxxxxx, Xxxxx, Xxxxxxx.
3.3 RPR will not use any new manufacturing or testing operations for the
Product, or transfer any manufacturing or testing operations for the Product to
any third parties or other sites until after any required FDA approval has been
obtained. In any such case, RPR will provide written information to R&D with
respect to the proposed change, and R&D will seek expeditiously the required FDA
approval on RPR's behalf However, R&D makes no assurances that such approval
would be forthcoming from the FDA and, furthermore, R&D has no responsibility to
RPR or RPR GmbH if such approval was not granted by the FDA by a particular
time, or any time at all.
3.4 R&D through [ * ] will be responsible for testing of Molecular Weight and
Sucrose until such time as validated assay methodologies can be transferred to
and incorporated by RPR.
3.5 Any significant change in the process, test procedures, change in the
source of starting materials, equipment or facilities required by RPR must be
approved in writing by R&D before the change can be implemented. However, in
any event, no change may be made that is not in compliance with FDA regulations.
4. Rework
There shall be no reworking of the Product.
16
5. Documents
5.1 The Product will be manufactured and packaged in accordance with the RPR
manufacturing and packaging procedures as included in the latest version of the
approved NDA for the Product.
5.2 Any deviation from the process during manufacture must be carefully
investigated, explained and documented in the batch records, justified and
approved by RPR Quality Assurance and Production Managers and included in the
document package.
5.3 A full document package will be provided by RPR to R&D for the first three
batches. Contents of the full document package is listed in Appendix II.
Thereafter, a reduced document package for each batch will be provided along
with each batch as it is made available to R&D with a full package available
yearly. R-PR will, however, supply a full package if needed for a particular
purpose (e.g., regulatory inspection, or potential regulatory exposure, such as
a recall or complaint) to be notified in writing by R&D to RPR. Contents of the
various document packages are listed in Appendix II.
5.4 RPR will promptly provide R&D all FDA and similar authorities outside of
the U.S. reports, notices, and the like issued to RPR in respect of the Product.
RPR will also provide R&D with any FDA reports on the Dagenham facility if they
could in any way affect the Product. RPR will also provide R&D with RPR's
responses to the foregoing.
5.5 R&D will provide RPR with copies of all FDA and similar authorities
outside of the U.S. correspondence as well as all reports, notices, and the
like, issued to R&D in respect of the Product.
6. Batch Number
The RPR batch number will be used for numbering each batch of Product. This
number will appear on all documents relating to the particular batch of the
Product.
7. Dates of Manufacture and Expiry
The shelf-life for the Product is given in Appendix II RPR will assign the Date
of Manufacture based on the day of first mixing of constituent materials. RPR
will calculate the expiration date for each batch of product based on the
(i) date of manufacture and (ii) shelf life..
8. Quality Assurance/Quality Control
8.1 Quality Control of materials and components supplied by RPR will be
undertaken by RPR in accordance with the suppliers' procedures, test methods,
Specifications and conditions contained in the approved NDA for the Product.
RPR will follow FDA rules/guidelines for any changes and will first notify R&D
of any changes in writing.
8.2 In process testing as defined in the approved RPR Manufacturing Procedure,
will be undertaken by RPR in accordance with the procedures, methods and
Specifications contained in
17
the approved NDA for the Product. RPR will follow FDA rules/guidelines for any
changes and will first notify R&D of any changes in writing.
8.3 RPR and R&D will agree on the finished product specifications and methods
of analysis to be used in each laboratory, as provided in the NDA. RPR will
follow FDA rules/guidelines for any changes and will first notify R&D of any
changes in writing.
8.4 RPR will fully test the Product to the finished product Specifications as
agreed to by both par-ties. An exception to this is Molecular Weight and
Sucrose - see 3.4 above.
8.5 R&D, or its agent will positively identify all batches of the Product
received using a suitable physical test. Release of Product to the market is
the responsibility of R&D, or its agent based on R&D's, or its agent's physical
testing and the document package provided by RPR.
8.6 RPR will allow Quality Assurance representatives from R&D to have access
to its manufacturing, warehousing, and laboratory premises at reasonable times
for audit purposes, once per year or as is reasonably needed to adequately
assure compliance upon extenuating circumstances (e.g., a follow -up audit after
----
a negative FDA 483 inspection). Access for subdistributors' Quality Assurance
representatives and/or representatives from R&D is at the sole discretion of
RPR.
8.7 There will be no carry over with production of the Product and R&D will be
supplied with full batches, assuming that R&D orders in full batch quantity
multiples.
9. Rejection
9.1 Any patent problem likely to cause rejection of the Product by R&D will be
communicated to the RPR Head of Quality Control by fax as soon as possible, but
in any case, within 45 days of transfer of title to R&D.
9.2 Rejection caused by incorrect information or materials supplied by R&D
will be the responsibility of R&D.
9.3 Rejection, regardless of when discovered, caused by incorrect
manufacturing or by incorrect monitoring of processes, or by incorrect materials
supplied by RPR, will be the responsibility of RPR.
9.4 Any problems thought to be due to manufacture or stability, which are
found during the sale of the Product will be communicated by R&D to RPR. RPR
will investigate and report results to R&D which is responsible for conducting
any Product recalls. If, as the result of the investigation, it is determined
that the problems identified are the result of manufacturing, then RPR shall be
responsible to replace the Product in the next quarter or allow R&D to add the
amount to a future order even though it would violate the Relevant Band and pay
all related costs associated therewith (see Article IIE of the Agreement
entitled "Recalls").
9.5 Any problems thought to be due to manufacture or stability, which are
found by RPR during normal monitoring of retained batches, shall be communicated
by RPR to R&D's Head of Quality promptly after results have been confirmed by
laboratory testing conducted within a
18
reasonable length of time. RPR and R&D will fully define the parameters of a
field alert requirement prior to the first commercial shipment.
10. Retained Samples
10.1 RPR will, where feasible, retain sufficient samples of the raw materials
used to carry out the full specification tests in duplicate for five (5) years
from date of receipt.
10.2 RPR will retain, at minimum, sufficient samples of the final stage Product
to carry out the full specification tests in duplicate for the expiry period of
the Product plus one (1) year.
11. Stability Testing
11.1 RPR Quality Assurance will be responsible for maintaining a stability
testing program for the Product, and will provide an annual stability report to
R&D or information to R&D earlier if results of stability testing indicate any
failure. Annual reports to the FDA or other regulatory authorities in the R&D
territories are the responsibility of R&D, although the information required
with respect to stability will be supplied promptly by RPR on request. All
efforts will be made by RPR to assure that any requested information is promptly
provided.
11.2 The details of the stability testing program to be maintained is that
required and approved under the most current version of the NDA in the
possession of R&D the parameters of which are defined in Appendix III. R&D will
ensure that RPR is provided promptly with any FDA mandated changes that will
affect the stability program parameters.
19
Xxxxxx R&D Laboratories, Inc.
By:_____________________________________
Name: Xxxxxx X. Xxxxxxxx
Title: Chief Financial Officer
Xxxxx-Xxxxxxx Xxxxx GmbH Xxxxx-Xxxxxxx Xxxxx Ltd
By:_____________________________________ By:___________________________________
Name:___________________________________ Name: C.C.B. Waights
Title:__________________________________ Title: V.P. & General Mgr.-Deg.
20
APPENDIX I
Product Name 869323 Specification Ref. Shelf Life Manufacturing
Nos. (Months) Document No.
---------------------------------------------------------------------------------------------------------
Ferrlecit(R) Injection [*] ml. x [*] RPR/R[*]
USA Ampoules
---------------------------------------------------------------------------------------------------------
RPR will make any changes in the specification reference number, if
necessary, and will incorporate the shelf life and manufacturing document
number into this appendix, consistent with the latest version of the
Ferrlecit NDA once R&D has received final FDA approval.
21
APPENDIX II
THE DOCUMENT PACKAGE
Each document will bear the Batch Number.
Full Document Package:
----------------------
Certificate of Analysis
Batch Manufacturing Record (BMR) including all dispensing details
Manufacturing Procedure
In-Process Results
Batch Yields
Finished Product Microbiological & Analytical Results
Deviation Reports
Date of Manufacture
Expiry Date
Packaging Record
Packing Slip (Product description, NDC number, date of manufacture, batch
number(s), expiry date(s), batch quantities, the number of pallets per batch,
storage conditions, purchase order number, and destination)
Reduced Document Package:
------------------------
Certificate of Analysis
Statement of Conformity with Agreed Procedures
Packing Slip
STATEMENT OF CONFORMANCE
------------------------
This confirms that Product ______________________________ Batch No._____________
has been manufactured to BNM No. _________________________ on (date)____________
in conformance with the agreed manufacturing and control procedures.
* There were no deviations from the agreed procedure, or
* Deviations from the agreed procedure are described in the attached reports.
The number of units which were passed as satisfactory were __________________.
_______________________________________
Quality Control Manager
Xxxxx-Xxxxxxx Xxxxx
22
APPENDIX III
The first three production batches of Ferrlecit(R) Injection released for U.S.
distribution upon approval of the NDA will be placed on stability in accordance
with the stability conditions, time points, and test requirements listed below.
Thereafter, one additional production batch each year will also be placed into
the room temperature stability program and tested annually until the expiration
date is reached.
Stability test conditions: [*](degrees)C and [*]% relative
humidity.
Stability time points: [*] months and annually thereafter until
the desired expiration date is reached.
Stability test requirements: At each test point, testing will be
conducted as per all regulatory
specifications and methods as provided
in the NDA section B.7.2 (volume test
and ID test for benzyl alcohol
excluded). Sterility, bacterial
endotoxin and particulate testing will
be performed initially and at expiration
date (end of shelf life).
23
AMENDMENT NO. 1 TO
MANUFACTURING AND SUPPLY AGREEMENT
This Amendment to the Manufacturing and Supply Agreement dated as of
December 1, 1998, between Xxxxxx R&D Laboratories, Inc., doing business as R&D
Laboratories, Inc. ("R&D"), on one hand and Xxxxx-Xxxxxxx Xxxxx GmbH ("RPR
GmbH") and Xxxxx-Xxxxxxx Xxxxx Ltd. ("RPR Ltd."), on the other hand is being
entered into as of.............. 2000.
WHEREAS, A. Nattermann & Cie. GmbH, an affiliate of RPR GmbH, owns the
rights, including the trademark, to Ferrlecit(R), an iron gluconate product (the
"Product");
WHEREAS, R&D and RPR GmbH entered into a Distribution Agreement dated June
24, 1993, as amended to date (the "Distribution Agreement") and a Trademark
Agreement dated August 26, 1993, as amended to date (the "Trademark Agreement"),
which grant R&D the right to distribute the Product in the R&D Territory (as
defined in the Distribution Agreement), on the terms and conditions that are set
forth in those Agreements;
WHEREAS, R&D on the one hand, and RPR GmbH and RPR Ltd. on the other hand,
entered into a Manufacturing and Supply Agreement dated as of December 1, 1998
(the "R&D/RPR" M&S Agreement"), which sets forth the terms and conditions
pursuant to which RPR Ltd. has agreed to supply all of R&D's requirements of the
Product for distribution in the R&D Territory;
WHEREAS, as of January 1, 1999, R&D transferred all of its right, title and
interest in the Distribution and Trademark Agreements and the R&D/RPR M&S
Agreement to its wholly owned subsidiary, R&D Ferrlecit Capital Resources, Inc.;
WHEREAS, RPR GmbH, A. Nattermann & Cie. GmbH and RPR Ltd. are affiliates of
Aventis S.A., France, a life science group of companies, with Aventis Pharma AG,
Germany, as holding company for the pharmaceutical division of Aventis S.A.,
France;
WHEREAS, R&D on one hand and RPR GmbH and RPR Ltd. on the other hand
(hereinafter referred to as "Aventis") are desirous of amending certain terms
and conditions of the R&D/RPR M&S Agreement; and
WHEREAS, R&D and Aventis shall be hereinafter referred to in this Amendment
individually as a Party, or collectively as the Parties.
NOW, THEREFORE, in consideration of the foregoing recitals and of the
mutual promises and covenants contained herein, the Parties agree as follows:
Section A. Changes to the R&D/RPR M&S Agreement: Other than those provisions
---------- ------------------------------------
of the R&D/RPR M&S Agreement that are expressly and specifically amended herein,
the remaining terms and conditions of the R&D/RPR M&S Agreement shall not be
amended by this Amendment and will remain in full force and effect.
For the purpose of this Amendment the term "Purchase Order" shall mean a firm
and binding purchase order.
24
Section B. Order Forecasting Method: The Parties agree to modify the method by
---------- ------------------------
which R&D provides Aventis with its order forecasts for the Product, as set
forth below in this Section B.
1. Effective January, 2001, R&D shall provide Aventis with a [*] rolling
order forecast (the "Rolling Forecast") by calendar months of the
Product that it requires, instead of the current [*] Rolling Forecast.
The [*] Rolling Forecast will be updated quarterly, with the update
due on, or before, the first day of each calendar quarter.
The first such R&D [*] Rolling Forecast will be due on, or before,
[*]. However, since Purchase Orders for the period from [*] will be
provided to Aventis by R&D prior to [*] (see Section B.4.d. below),
the first R&D [*] Rolling Forecast for [*] will include additional
Purchase Orders for the period from [*].
2. The Rolling Forecast shall be presented to Aventis with batches being
the unit of measure of the Product being ordered by R&D. The
demonstrated average yield for these batches of Product is [*]
ampoules.
3. Beginning with the first quarter of 2001, at the end of each calendar
quarter, R&D shall update the Rolling Forecast by providing Aventis
with an additional [*] of forecasted requirements of the Product.
These additional [*] shall become months [*] through [*] of the
updated version of the Rolling Forecast.
4. The Rolling Forecast shall contain four (4) bands:
a. The most current [*] of the Rolling Forecast shall be referred to
herein as Band 1. No change shall be made in the number or timing
of the forecasted batches, once the first day of a calendar
quarter becomes part of Band 1.
b. The next [*] of the Rolling Forecast shall be referred to herein
as Band 2. No change shall be made in the number or timing of
the forecasted batches, once a calendar quarter becomes part of
Band 2. However, a [*]-time increase or decrease of up to a
maximum of [*]% may be made when a calendar quarter moves from
Band 2 (as months [*] - [*]), to Band 1 (as months [*] - [*]).
Notwithstanding any contrary provision herein, in the event a
Purchase Order submitted by R&D hereunder does not meet the
requirement that it equals a full batch size or a multiple
thereof, the quantity of Product reflected on such Purchase Order
shall be rounded down to the nearest multiple of the full batch
size.
c. The next [*] of the Rolling Forecast shall be referred to herein
as Band 3. No change shall be made in the number or timing of
the forecasted batches, once a calendar quarter becomes part of
Band 3. However, a one-time increase or decrease of up to a
maximum of [*]% may be made when a calendar quarter moves from
Band 3 (as months [*] - [*]) to Band 2 (as months [*] - [*]).
Notwithstanding any contrary provision herein, in the
25
event a Purchase Order submitted by R&D hereunder does not meet
the requirement that it equals a full batch size or a multiple
thereof, the quantity of Product reflected on such Purchase Order
shall be rounded down to the nearest multiple of the full batch
size.
d. The last [*] of the Rolling Forecast shall be referred to herein
as Band 4. No change shall be made in the number or timing of
the forecasted batches, once a calendar quarter Is added to Band
4. However, a one-time increase or decrease of up to a maximum
of [*]% may be made when a calendar quarter moves from Band 4 (as
months [*] - [*]), to Band 3 (as months [*] - [*]). No partial
batches shall be allowed when such increase or decrease occurs.
e. [*] Promptly after execution of this Amendment, R&D shall provide
Aventis with Purchase Orders for the Product that it is ordering
for the period from [*], as set forth below in Section C.
f. In the event that the Parties agree to a change in the delivery
system of the Product and such a change materially modifies the
Rolling Forecast mechanism described hereinabove, the Parties
agree to meet and confer in good faith to make the necessary
modifications in the process described herein.
g. Aventis shall not be obligated to accept Purchase Orders above
the number of the batches in Band 1; provided that Aventis shall
accept any Purchase Order required hereunder to be submitted by
R&D pursuant to Section C hereinbelow.
5. Before a calendar quarter has moved into Band 1 (and become part of
the first [*] of the most recent version of the Rolling Forecast), R&D
shall provide Aventis with a Purchase Order for the quantities of the
Product to be supplied, during that particular calendar quarter. Once
such a Purchase Order has been provided to Aventis, R&D may not change
the amounts set forth therein. On the other hand, once a Purchase
Order has been received by Aventis, Aventis is obligated to supply
such Product to R&D, in the quantities and on the timetable set forth
in the Purchase Order. This provision regarding Purchase Order
placement, supersedes any contrary provision in the R&D/RPR M&S
Agreement.
In the event that Aventis cannot satisfy a Purchase Order full, either
as to delivery schedule or as to quantities ordered, the procedure set
forth in Article IIB3 of the R&D/RPR M&S Agreement shall be applied to
the new band approach set forth herein. Therefore, in such event, R&D
shall be allowed to add the amount of the shortfall in supply from
Aventis to a future order, even though by doing so it would cause such
future order to exceed the band provisions set forth herein.
26
6. For purposes of clarification, the provisions of the R&D/RPR M&S
Agreement, which allow for a Relevant Band (as defined therein) of [*]
at the time of the issuance of a Purchase Order, are hereby
specifically rescinded.
7. The provisions of the R&D/RPR M&S Agreement, that allowed for a [*]%
adjustment when forecasted batches became months [*] in the most
recent Rolling Forecast, are hereby specifically rescinded and
superseded.
8. The R&D/RPR M&S Agreement described "satisfactory performance" by RPR
Ltd. (now Aventis) as supplying R&D with batches that contained at
least [*]% and no more than [*]% of its projected batch size of [*]
ampoules (the "Demonstrated Yield"). The Parties agree to increase
this acceptable range to at least [*]% and no more than [*]% of the
Demonstrated Yield. The provisions of the R&D/RPR M&S Agreement are
hereby changed accordingly. Although Aventis will notify R&D of the
availability of batches that fall outside of this acceptable range,
R&D shall have no obligation to accept such batches.
Section C. Product Orders-for the Period Beginning August, 2000 through
---------- ------------------------------------------------------------
December 31,1002: The Parties hereto agree to the following orders:
----------------
1. For the balance of 2000:
a. At the present time, R&D has ordered a total of [*] batches from
Aventis for delivery in 2000 and has provided Aventis with
Purchase Orders for same. The Parties hereby agree to change
such order from a total of [*] batches to be delivered to R&D for
2000, to a target total of [*] batches to be delivered to R&D for
2000.
b. Aventis agrees to use its commercially reasonable efforts to
provide R&D with [*] batches for 2000.
c. Promptly after execution hereof, Aventis shall provide R&D with a
delivery schedule for the target total of [*] batches referenced
above for 2000.
d. Promptly after execution hereof, R&D shall Provide Aventis with a
Purchase Order requesting a minimum of [*] additional batches for
2000 (from [*] batches).
2. For 2001: R&D's current forecast for Product to be delivered by
Aventis to R&D in 2001, is hereby superseded with the following:
a. R&D shall order a total of [*] batches for 2001.
b. Aventis hereby agrees to supply R&D with a total of [*] batches
for 2001. It is Aventis' intention to provide such batches to R&D
ratably throughout 2001. By no later than the execution of this
Agreement, Aventis shall
27
provide R&D with a delivery schedule which sets forth the
projected delivery dates for the [*] batches in 2001.
c. Promptly after execution hereof, R&D shall provide Aventis with a
Purchase Order for a total of [*] batches for 2001. The delivery
dates for such batches shall be left open, pending receipt by R&D
of the Aventis Pharma 2001 delivery schedule.
3. For 2002: R&D's partial year current forecast for Product to be
delivered by Aventis to R&D in 2002, is hereby superseded with the
following:
a. R&D shall order a total of [*] batches for 2002.
b. Aventis hereby agrees to supply R&D with a total of [*] batches
for 2002. It is Aventis' intention to provide such batches to
R&D ratably throughout 2002. By no later than September 30,
2001, Aventis shall provide R&D with a delivery schedule which
sets forth the projected delivery dates for the [*] batches in
2002.
c. Promptly after execution hereof, R&D shall provide Aventis with a
Purchase Order for a total of [*] batches for 2002. The delivery
dates for such batches shall be left open, pending receipt by R&D
of the Aventis Pharma 2002 delivery schedule, which is due
September 30, 2001, as set forth above.
Section D. Method of Payment: The Parties agree to change the method of payment
---------- -----------------
from R&D to Aventis for the batches of Product supplied by Aventis as follows:
1. From time to time, R&D will advance Aventis funds as a prepayment
against future deliveries of the Product to R&D. Such advances shall
be wired to Aventis in EURO by R&D. The amount of each of these
advances in the future, shall be between [*].
2. Aventis shall give R&D credit for the fends transferred in the
Deutsche Xxxx equivalent of the EUROs wired. R&D shall endeavor to
keep the outstanding pre-payment balance with Aventis to no greater
than [*] of future deliveries of the Product.
3. In the future, when the EURO replaces the Deutsche Xxxx, all amounts
in the R&-D/RPR M&S Agreement will be automatically restated from
Deutsche Marks to their EURO equivalents.
4. Aventis shall keep contemporaneous records of all cash advances, and
amounts charged against same for deliveries of Product to R&D.
5. At the end of each calendar quarter, Aventis shall accrue an "in lieu
of" amount of interest based on the net average prepayment balance
that was outstanding for such quarter.
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a) From January 1, 2000 through September 30, 2000 - This in lieu of
amount of interest shall be based on the average US weekly
treasury xxxx rate during the calendar quarter.
b) Beginning October 1, 2000 - This in lieu of amount of interest
shall be based on the one month Euribor rate.
c) At the end of each calendar quarter, R&D and Aventis shall
reconcile their respective balances, including the accrued
Interest
6. The Parties agree that the requirement for R&D to maintain a letter of
credit in favor of Aventis, is hereby eliminated.
In the event that any material provision of this Amendment needs to be changed
during the term of the Distribution and Trademark Agreements, and the R&D/RPR
M&S Agreement, the Parties hereto agree to negotiate in good faith to consider
such a proposed change, irrespective of which party initiated the change and, if
adopted and material, the resulting change will be included as an additional
amendment to the R&D/RPR M&S Agreement.
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IN WITNESS WHEREOF, duly authorized representatives of the Parties have
duly executed this Amendment, as of the date first set forth hereinabove.
AGREED AND ACCEPTED:
Xxxxxx R&D Laboratories, Inc. and its wholly owned subsidiary
R&D Ferrlecit Capital Resources, Inc.
_______________________________________
By: Xxxxx Xxxxxx, Ph.D.
Its: President/CEO
RPR GmbH
_______________________________________
By: Xxxxxxxxx
Its: Managing Director
RPR Ltd.
_______________________________________
By: Xxxx Xxxxxx
Its: Site Director
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