Exhibit 10.5
Confidential treatment has been requested for portions of this exhibit. The copy
filed herewith omits the information subject to the confidentiality request.
Omissions are designated as [Intentionally Redacted]. A complete version of the
exhibit has been filed separately with the Securities and Exchange Commission.
SUPPLY, DISTRIBUTION and MARKETING AGREEMENT
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THIS AGREEMENT made as of this 15th day of August, 2003, by and between
LANNETT COMPANY, INC., a Delaware corporation whose principal office is at 0000
Xxxxx Xxxx, Xxxxxxxxxxxx, XX 00000 (hereinafter referred to as "Lannett"), and
NEOJB LLC, a Delaware limited liability company (and a subsidiary of SPECTRUM
PHARMACEUTICALS, INC., a Delaware corporation), whose principal office is at 000
Xxxxxxxxxx Xxxxx, Xxxxxx, Xxxxxxxxxx 00000 (hereinafter referred to as
"Spectrum").
WITNESSETH
WHEREAS, Spectrum represents that it is engaged in the development, supply
and marketing of pharmaceutical products for human use, and that it is, subject
to receipt of all necessary governmental approvals, ready, willing and able to
supply Lannett CIPROFLOXACIN (hereinafter referred to and further defined as
"Product"); and
WHEREAS, Lannett desires to have available on a coordinated, continuing
basis the manufacture of Product; and
WHEREAS, Spectrum is willing to supply Product for Lannett's use on the
terms and conditions hereinafter set forth.
NOW, THEREFORE, in consideration of the premises and of the mutual
covenants and agreements set forth herein, the parties hereto covenant and agree
as follows:
1. Definitions. For all purposes of this Agreement (this
"Agreement"), the following terms shall have the following meanings:
1.1 "ANDA" shall mean abbreviated new drug application.
1.2 "cGMPs" shall mean the current Good Manufacturing Practices
as defined in regulations promulgated by the FDA under the Act and as generally
understood and interpreted by the pharmaceutical industry.
1.3 "FDA" shall mean the United States Food and Drug
Administration, any successor agencies or departments, or any other federal
agency serving in the same or similar function.
1.4 "Product" shall mean Ciprofloxacin Hydrochloride, as defined
in the latest edition of United States Pharmacopeia ("USP"), in tablet form, in
such dosages as may be set forth in Exhibit A hereto. The term "Product" shall
also include such other products as may be mutually agreed upon by the parties
from time to time.
1.5 "Reference Product" means the reference drug listed in the
FDA's Orange Book, as the same may change from time to time.
1.6 "Territory" shall mean the United States of America and its
territories, commonwealths and possessions.
2. Premises, Terms and Conditions of Development and Manufacture.
2.1 On and subject to the terms hereof, Spectrum hereby agrees to
supply Lannett all of the requirements of Lannett for the Product necessary to
supply its customers in the Territory in accordance with established business
practices of Lannett.
2.2 On and subject to the terms hereof, Lannett agrees to
purchase from Spectrum its entire requirements of the Product for the Territory
and, except as permitted hereunder, not to manufacture or cause to have
manufactured the Product for sale in the Territory, nor cause to have the
Product manufactured for marketing in the Territory during the term of this
Agreement. If Spectrum is unable to produce a sufficient quantity of Product to
meet the requirements of Lannett on the delivery dates requested by Lannett for
a period of four (4) consecutive months, then Lannett may obtain the same from
another supplier or manufacturer mutually acceptable to both Lannett and
Spectrum, provided that Lannett purchases all of the Product that Spectrum is
able to produce, subject to the terms of this Agreement. If the foregoing event
should occur and Spectrum subsequently increases its production after Lannett
has found an additional source, then the parties must mutually agree on the
phasing and timing of Spectrum's and the other supplier's additional production
in order to restore Spectrum's exclusivity as soon as reasonably possible.
2.3 Spectrum shall arrange to commence manufacture of all orders
within thirty (30) working days from receipt thereof (as raw material deliveries
permit).
2.4 Lannett will use commercially reasonable efforts to market
and sell an annual minimum amount of tablets or capsules per strength of each of
the Product(s), which amount shall be mutually agreed upon by Lannett and
Spectrum. Product(s) may only be shipped if the package configuration is in
compliance with the cGMP and FDA regulations.
2.5 Subject to the terms of this Agreement, Spectrum shall be
solely responsible for all development costs and expenses associated with this
Agreement that it may incur or that may be incurred by its affiliates or
subsidiaries, including, but not limited to, stability determination, production
demonstration batches, and other scale up and laboratory costs and expenses, all
of which will be within Spectrum's sole discretion.
2.6 Lannett shall also perform the following services: a
commercially reasonable volume of advertising and promotional activities,
registering Product National Drug Codes ("NDCs") for the Product in national
databases and state formularies, and submitting pricing for the Product to the
Center for Medicaid Services for state reimbursement purposes, shipping product
to customers, paying freight charges for delivery to customers, billing
customers and servicing customer accounts receivable.
2.7 Any work that is to be done by either Lannett or Spectrum
under this Agreement may be subcontracted to a third party in accordance with
the approved ANDA, cGMP's and any applicable FDA guidelines which relate to the
work to be performed under the
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direction and supervision of Lannett or Spectrum, as the case may be; provided,
however, that, as between Lannett and Spectrum, the subcontracting party shall
be and remain responsible for all acts and omissions of any such subcontractor.
2.8 This Agreement shall serve as the master agreement between
the parties and, as such, sets forth all of the terms and conditions concerning,
and shall govern the purchase by each party, by whatever means of, of all
Product (and all components and ingredients thereof) from the other party
hereto. Specific orders of Product hereunder shall be made by purchase order
(written or electronically transmitted), setting forth the quantity and
description of Product, delivery dates and shipping instructions (if other than
as set forth herein). Unless agreed to in writing signed by both parties, any
and all terms and conditions which add to, vary from or conflict with the terms
and conditions of this Agreement shall be of no effect, whether such terms and
conditions are set forth in either party's purchase order, invoice, confirmation
(written or electronically transmitted), packing slip, xxxx of lading or any
other writing, and regardless of whether the Product shall have been shipped,
accepted or paid for. The parties further agree that no course of prior dealings
between the parties shall in any way modify, change or supersede the terms and
conditions of this Agreement.
2.9 Spectrum will use commercially reasonable efforts to process
an ANDA for the Product through the FDA. Spectrum's duties under this Agreement
are conditioned upon issuance and continued validity of FDA approvals necessary
for the performance of its duties hereunder including without limitation final
approval of the ANDA for the Product.
3. Additional Products.
3.1 If Spectrum desires to add one or more additional
pharmaceutical products to the Products covered by this Agreement, it shall send
written notice thereof to Lannett, setting forth its proposal in such detail as
may be appropriate under the circumstances (the "Product Proposal").
3.2 Lannett will respond to each Product Proposal by confirming
or rejecting Lannett's interest in marketing and distributing the subject of
such Product Proposal. If Lannett is interested in marketing and distributing
such Product, Lannett will submit to Spectrum its expected purchases, including
quantity and a desired transfer cost for, such Product. Spectrum will then
confirm or reject Lannett's proposal for purchases of such products.
3.3 For each additional Product added to this Agreement, Spectrum
will be solely responsible for developing or having developed the finished
dosage form of such Products, submitting appropriate ANDAs to the FDA with
respect thereto, and receiving approval from the FDA of such ANDAs for
distribution of such Products. The FDA approved finished dosage form will be
manufactured by or for Spectrum and will either be packaged in bottles or will
be shipped in bulk for Lannett for packaging into trade bottles of 100's and
1000's. After receipt of FDA approval, Spectrum will offer a reliable and
constant supply of the finished dosage Product to Lannett to meet Lannett's
needs under this Agreement. The terms of the transactions between Spectrum and
Lannett for such future finished dosage Products shall be negotiated on an
individual Product-by-Product basis.
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3.4 Any Products added to this Agreement under this Paragraph 3
shall be deemed to be a "Product" within the meaning of this Agreement and shall
be subject to all of the terms and conditions hereof that are applicable
thereto.
3.5 If Lannett agrees to distribute any Product manufactured by
or for Spectrum (other than Ciprofloxacin), Lannett shall not, without
Spectrum's prior written approval, such approval not to be unreasonably withheld
or delayed, market, distribute or sell a product that competes with such
Product. As used herein, one product "competes" with another if it is
therapeutically equivalent (AB or AA rated) to the same innovator drug to which
the Spectrum Product is AB or AA rated.
4. Forecasts.
4.1 [Intentionally Redacted]
4.2 [Intentionally Redacted]
5. Product Description and Regulatory Materials.
5.1 The Product and all components and ingredients thereof shall
be produced in strict accordance with cGMPs and the formulae specifications
which have been developed to meet the specifications set forth in Exhibit A for
dosage strength, and in accordance with quality control procedures and
associated test methods for the manufacturing process as developed by or for
Spectrum, and acceptance specifications and test methods for the Product as
jointly approved by Spectrum and Lannett.
5.2 Spectrum shall supply to Lannett the protocol of assay of all
controlled tests performed on the Product and shall, for each batch of Product
delivered hereunder, supply Lannett with the results thereof. Spectrum shall
test raw materials and Product, and further, will use no raw materials in the
manufacture of the Product which fail to meet or exceed the current National
Formulary/United States Pharmacopoeia compendia standards for such materials,
where such standards are established.
5.3 Spectrum agrees that the stability data for the Product as
packaged for the existing ANDA will be obtained by Spectrum and will be provided
to Lannett. Stability is guaranteed by Spectrum for the Product in finished
package form, for the period supported by the stability data. Following the
execution of this Agreement, Lannett will commence sales of the Product in the
ANDA approved packages, which will provide the Product with an expiration date
of not less than twenty-four (24) months. If, thereafter, Lannett chooses a
package size different than those approved in the ANDA, Lannett may request that
Spectrum undertake a 90-day stability test, which may provide the Product with
an expiration date of not less than two (2) years. Upon receipt of such request,
Spectrum will promptly commence or arrange for such a 90-day stability test at
Lannett's expense and will promptly provide the results thereof to Lannett.
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[Intentionally Redacted] Certain information on this page has been omitted and
filed separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions.
5.4 Spectrum agrees to validate all manufacturing, packaging and
testing procedures under the Act.
5.5 The package labels for the Product will be jointly developed
by Spectrum and Lannett. The labels will contain the Lannett logo and the
Spectrum Pharmaceuticals, Inc. logo in equal prominence in all, and such other
marketing information as the parties may mutually agree upon.
6. Inspection of Manufacturing Site and Product Approval.
6.1 Lannett shall have the right to inspect at reasonable times,
during normal business hours, on reasonable prior notice, the operations and
facilities wherein the Product is being manufactured, packaged, tested, labeled
and/or stored for shipping.
6.2 The Product manufactured by or for Spectrum shall be subject
to approval by Lannett's quality assurance group or such other technical
representatives as Lannett may select, with respect to whether or not each batch
of Product meets the specifications referred to in Paragraph 5.1.
6.3 Lannett shall, as promptly as reasonably practicable,
normally within fifteen (15) working days after receipt but not exceeding thirty
(30) days, notify Spectrum of its approval or disapproval of samples of each
batch of Product tested.
6.4 Spectrum warrants that the manufacturer's plant for
manufacture of the Product is and shall be in compliance with cGMPs and that the
manufacturer's plant(s) is and shall continue to be available for FDA inspection
if and when the FDA so requests.
7. Product Materials and Shipment.
7.1 All boxes, labels, inserts, droppers and other components of
the Product, as well as all shipping containers for the Product, shall be
provided by Spectrum. The Product will be palletized in corrugate boxes or other
form approved in advance by Lannett.
7.2 All orders for Product shall be placed by means of a purchase
order issued by Lannett to Spectrum. Spectrum shall notify Lannett in writing
within fifteen (15) business days of its receipt of Lannett's purchase order if
Spectrum is unable to make any scheduled delivery and state the reasons
therefor. The absence of such notice constitutes acceptance of the purchase
order.
7.3 Spectrum shall deliver Product in accordance with the
delivery dates contained in the purchase order or on such other dates as the
parties may agree. Lannett may return non-conforming shipments at Spectrum's
sole risk and expense.
7.4 All Product provided by Spectrum under this Agreement shall
be subject to inspection and approval by Lannett for a five (5) business days
after receipt, notwithstanding prior payments therefor, and may be rejected, in
whole or in part, by Lannett, as if it had never been accepted, if any such
Product is found not to be in compliance with Paragraphs 5.1, 5.2, 5.3 and/or
5.4. Lannett may also reject any Product not ordered if Spectrum
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has substituted a different quantity, quality or type of product for the Product
ordered by Lannett. If so rejected by Lannett, such Product (and in the case of
Product shipped in excess of any order, the excess) shall be subject to return
to Spectrum with charges for return transportation, insurance, labor and other
costs of unloading and reloading, payable by Spectrum, with full credit to
Lannett. Product so rejected may not be reshipped except upon receipt of written
instructions from Lannett. Neither the payment of any invoice nor any delay in
the return of Product shall constitute acceptance of such Product or be deemed a
waiver of Lannett's right to reject or return such Product under this Paragraph
even if such Product was subsequently sold and then returned by the purchaser
thereof to Lannett.
8. Product Price, Payment and Transfer cost Adjustments.
8.1 For the finished Product, manufactured and packaged and
delivered to Lannett hereunder, Lannett shall pay Spectrum the transfer costs
set forth in Exhibit A hereto.
8.2 Payment for the transfer cost of any Product purchased
hereunder shall be made by Lannett no later than thirty-five (35) days after the
date of invoice. If Product has been rejected at a time after payment is made,
and is found not to be in compliance with the guarantees as stated in Paragraphs
5.1, 5.2, 5.3 and 5.4, Spectrum will issue a check or credit to be applied to
the next scheduled delivery for the amount of the Product so found to be in
non-compliance with these terms.
8.3 [Intentionally Redacted]
8.4 [Intentionally Redacted]
9. Term and Termination.
9.1 The initial term of this Agreement shall begin as of the date
first set forth above and shall expire eighteen (18) months after the date upon
which Spectrum is first legally allowed to sell the Product in the United
States. If so desired, this Agreement may be renewed by the written, mutual
agreement of both parties. Such a renewal may be executed before or after the
last day of the initial term of this Agreement.
9.2 Lannett shall also have the right to terminate this Agreement
and/or suspend further performance under this Agreement without terminating this
Agreement, without liability except for unpaid prior delivered Product, if: (a)
Spectrum breaches any of its obligations under this Agreement in any material
respect and fails to cure such breach within thirty (30) days of Lannett's
written notice to Spectrum of such breach; or (b) Spectrum becomes insolvent,
makes an assignment for the benefit of creditors or files or has filed against
it a petition in bankruptcy, or has a receiver, marshal or trustee placed in
possession of all or substantially all of Spectrum's assets, plant(s),
equipment, inventory or raw or finished materials; or (c) Spectrum loses any
approval(s) from the FDA required to perform its obligations under this
Agreement because of felonious or fraudulent reasons or is otherwise involved in
involved in felonious or fraudulent activities.
9.3 If Lannett decides to terminate this Agreement after receipt
of FDA approval to market for any reason other than as a result of one of the
events described in Paragraph 9.2, or if Spectrum terminates this Agreement
pursuant to Paragraph 9.4 below, then, at Spectrum's election, Lannett shall
have the obligation to purchase all of Spectrum's components, materials and
finished goods inventory of the Product on hand at the time of the
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[Intentionally Redacted] Certain information on this page has been omitted and
filed separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions.
termination of this Agreement. Such purchase must be completed within thirty
(30) days of the date of termination and shall be accompanied by a transfer to
Lannett from Spectrum of ownership of the components, materials and Product so
purchased, including, but not limited to, all records, documents,
correspondence, data and other pertinent information regarding the Product that
is then in the possession or under the control of Spectrum and necessary for
Lannett to distribute the Products as herein contemplated. The purchase price
for finished goods shall be the then existing transfer price hereunder and the
purchase price for such components and materials shall be Spectrum's documented
cost thereof.
9.4 Spectrum shall also have the right to terminate this
Agreement and/or suspend further performance under this Agreement without
terminating this Agreement, without liability, if: (a) Lannett breaches any of
its obligations under this Agreement in any material respect and fails to cure
such breach within thirty (30) days of Spectrum's written notice to Lannett of
such breach; or (b) Lannett becomes insolvent, makes an assignment for the
benefit of creditors or files or has filed against it a petition in bankruptcy
or has a receiver, marshal or trustee placed in possession of all or
substantially all of Lannett's assets, plant(s), equipment, inventory or raw or
finished materials; or (c) Lannett is involved in felonious or fraudulent
activities; or (d) Lannett diverts any Product beyond the Territory without
prior written approval from Spectrum or amendment of this Agreement.
9.5 If Spectrum decides to terminate this Agreement as a result
of any of the events described in Paragraph 9.4, then Lannett shall immediately
transfer to Spectrum ownership of all records, documents, data, correspondence
and other pertinent information regarding the sales and marketing of the Product
to Spectrum.
9.6 Notwithstanding any other term of this Agreement but subject
to Paragraph 9.1, Spectrum shall have the right to terminate this Agreement by
giving at least one-hundred eighty (180) days advance notice of termination to
Lannett in order to provide Lannett with the opportunity to replace Spectrum as
a supplier without interruption to Lannett's sales efforts.
9.7 In no event shall any expiration or termination of this
Agreement excuse either party from any breach or violation of this Agreement and
full legal and equitable remedies shall remain available therefor, nor shall it
excuse either party from making any payment due under this Agreement with
respect to any period prior to the date of expiration or termination.
Notwithstanding any provision of this Agreement to the contrary, Paragraphs 9.7,
10, 11, 13, 15, 17, 18, 19, 20 and 21 hereof shall survive any expiration or
termination of this Agreement.
10. Insurance.
10.1 Spectrum shall maintain in full force during the term hereof
a comprehensive general liability insurance policy including Products Liability
coverage with minimum limits of Two Million Dollars ($2,000,000) for bodily
injury including death.
10.2 On or before the date on which Lannett begins to sell the
Product, Spectrum shall deliver to Lannett a Certificate of Insurance with a
broad form vendors
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endorsement naming Lannett as an additional insured to verify the coverage
provided in Paragraph 10.1, which endorsement provides a thirty (30) day written
notice to Lannett of cancellation or non-renewal; and Spectrum shall maintain
such endorsement in effect for so long as Spectrum manufactures or processes (or
has manufactured or processed for it) any Product for Lannett and for a period
of one (1) year thereafter, provided that such insurance coverage is available
to Spectrum at a cost reasonable to Spectrum. Spectrum agrees to promptly renew
all insurance policies in a timely manner and so notify Lannett with
certificates evidencing same. Spectrum further agrees that Spectrum shall notify
Lannett at least thirty (30) days in advance of any proposed cancellation of any
policies so that negotiations for continuous coverage may be held between
Lannett and Spectrum.
10.3 If Spectrum breaches its obligation with respect to
maintaining insurance pursuant to the foregoing, then Lannett may procure such
insurance and either charge the cost of the same to Spectrum or offset the cost
of such insurance against sums owed by Lannett to Spectrum under this Agreement.
10.4 Lannett shall maintain in full force during the term hereof
a comprehensive general liability insurance policy including Products Liability
coverage with minimum limits of Two Million Dollars ($2,000,000) for bodily
injury including death.
10.5 On or before the date on which Lannett begins to sell the
Product, Lannett shall deliver to Spectrum a Certificate of Insurance with a
broad form vendors endorsement naming Spectrum and Spectrum Pharmaceuticals,
Inc. as additional insureds to verify the coverage provided in Paragraph 10.4,
which endorsement provides a thirty (30) day written notice to Spectrum of
cancellation or non-renewal; and Lannett shall maintain such endorsement in
effect for so long as Spectrum manufactures or processes (or has manufactured or
processed for it) any Product for Lannett and for a period of one (1) year
thereafter, provided that such insurance coverage is available to Lannett at a
cost reasonable to Lannett. Lannett agrees to promptly renew all insurance
policies in a timely manner and so notify Spectrum with certificates evidencing
same. Lannett further agrees that Lannett shall notify Spectrum at least thirty
(30) days in advance of any proposed cancellation of any policies so that
negotiations for continuous coverage may be held between Lannett and Spectrum.
10.6 If Lannett breaches its obligation with respect to
maintaining insurance pursuant to the foregoing, then Spectrum may procure such
insurance and charge the cost of the same to Lannett.
11. Warranty.
11.1 For the purpose of Section 303 (c) of the U.S. Food, Drug
and Cosmetic Act, as amended, each of Spectrum and Lannett warrant and guarantee
to the other that each article shipped by them hereunder: (a) will not, on the
date of shipment, be adulterated or misbranded (i) within the meaning of such
Act, or (ii) within the meaning of any applicable state law in which the
definitions of "adulteration" and "misbranding" are substantially the same as
those contained in the such Act, as such laws are constituted and effective at
the time of such shipment or delivery, and (b) will not be an article which may
not under the provisions of Section 404 or 505 of such Act be introduced into
interstate commerce.
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11.2 The warranty contained in Paragraph 11.1 shall be binding
upon Spectrum with respect to all Product or Product components shipped or
delivered to Lannett by or on behalf of Spectrum (including without limitation
goods in transit).
11.3 Lannett warrants that if any packaging is performed by
Lannett then neither the packaging nor the Product will be adulterated or
misbranded within the meaning of the Act or any applicable state law.
11.4 The warranty contained in Paragraph 11.3 shall be binding
upon Lannett with respect to all Product or Product components shipped or
delivered to Spectrum by or on behalf of Lannett (including without limitation
goods in transit).
12. Force Majeure. Either party shall be excused from failure to
perform any of its obligations hereunder to the extent such failure is caused by
acts of God, fires, floods, wars, acts of terrorism, sabotage, unavailability of
raw materials, governmental laws or regulations, labor disputes or strikes or
similar occurrences, or any other circumstance or causes beyond the reasonable
control of the non-performing party.
13. Indemnity and Contribution.
13.1 Spectrum shall protect, defend, indemnify, and hold Lannett
harmless from and against any and all damages, losses, claims, expenses
(including without limitation reasonable attorneys' fees), judgments, demands or
causes of action of every kind and character arising in favor of any person,
including without limitation Spectrum's employees, on account of personal
injuries, illness or death, or damages to property occurring, growing out of,
incident to, or resulting directly or indirectly from the manufacture,
processing or packaging by or for Spectrum of the Product, including components
thereof but excluding claims associated with the pharmacology of the active
components of the Product and excluding claims covered by Paragraph 13.5.
13.2 Spectrum shall have no liability for damages or the costs
incident thereto caused by negligence or misuse of Lannett.
13.3 Spectrum will indemnify, defend and hold Lannett harmless
from and against all damages, losses, claims, expenses (including without
limitation reasonable attorneys' fees), judgments, demands or causes of action
of every kind and character arising in favor of any person growing out of,
incident to, or resulting directly or indirectly from any claim of patent,
copyright or other intellectual property infringement resulting from the
manufacturing, processing or packaging processes or the composition of the
Product, if such procedures differ from those specified in the ANDA. If the
Product is held, or is believed by Spectrum, to infringe, then Spectrum shall
have the option, at its expense, to obtain a license or other right to continue
using the Product. If, in Spectrum's sole discretion, it is not economically or
commercially reasonable to obtain such rights then Spectrum may terminate this
Agreement without further liability. This Paragraph states Spectrum's entire
liability and Lannett's sole and exclusive remedy for infringement.
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13.4 Both Spectrum and Lannett will promptly notify the other of
any actual or threatened judicial or other proceedings which could involve
either or both parties. Spectrum and Lannett each reserve the right to defend
themselves in any such proceedings, provided however, if indemnity is sought
then the party from whom indemnity is sought shall have the right to control the
defense of the claim, and the indemnified party may participate with counsel of
its choice at its own expense. Spectrum and Lannett shall cooperate with each
other to the extent reasonably necessary in the defense of all actual or
potential liability claims and in any other litigation relating to the Product
supplied pursuant to this Agreement. Each party will supply information to the
other relevant to any product liability claims and litigation affecting the
Product.
13.5 Lannett shall protect, defend, indemnify, and hold Spectrum
harmless from and against any and all damages, losses, claims, expenses
(including without limitation reasonable attorneys' fees), judgments, demands or
causes of action of every kind and character arising in favor of any person,
including without limitation Lannett's employees, on account of personal
injuries, illness or death, or damages to property occurring, growing out of,
incident to, or resulting directly or indirectly from the processing, packaging,
marketing, distribution or sale by Lannett of the Product, including components
thereof but excluding claims associated with the pharmacology of the active
components of the Product and excluding any claims covered by Paragraphs 13.1 or
13.3.
13.6 Spectrum and Lannett shall have a contractual right of
contribution against one another equivalent to the currently existing rights of
contribution among joint tortfeasors under Pennsylvania law with respect to any
damages, losses, claims, expenses (including reasonable attorneys' fees),
judgments, demands or causes of action of every kind and character arising in
favor of any person associated with the pharmacology of the active components of
the Product(s).
14. Delivery and Freight.
14.1 Delivery of the Product shall be on notice to Lannett within
twelve (12) weeks of receipt of a purchase order, following receipt of FDA
approval to market (if applicable), for the first [Intentionally Redacted]
batches of Product in accordance with Lannett's instructions. Thereafter, on
prior notice, the Product shall be delivered at a rate of not less than
[Intentionally Redacted] bottles in finished package form per delivery and
Spectrum shall maintain a capability of delivering at least [Intentionally
Redacted] bottles of 500 mg per month for the first year of this Agreement.
Lannett will provide Spectrum with forecasts for subsequent years in accordance
with Paragraph 4 so that Spectrum can accommodate Lannett's needs.
14.2 Delivery will be made prepaid to all distribution locations
designated by Lannett, by such means as may be designated by Lannett, and all
freight charges shall be added to the invoice. In the alternative, the orders
may be picked up by Lannett's truck.
15. Notice.
15.1 Any notice expressly provided for under this Agreement shall
be in writing, and shall be deemed sufficiently given when delivered in person
or upon mailing by registered or certified mail, postage prepaid, or upon
sending by reputable overnight courier, charges prepaid, to the addresses set
forth in the preamble to this Agreement, addressed to the President and one
other designated officer as well as a designated attorney or law firm chosen by
each party under this Agreement.
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[Intentionally Redacted] Certain information on this page has been omitted and
filed separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions.
15.2 Either party may, by written notice to the other, change its
address for receiving such notices. In the event Spectrum desires to change the
location of its manufacturing facility for the Product, it will not do so
without advance written notice to Lannett.
16. Assignment. Neither this Agreement nor any interest therein may
be assigned, in whole or in part, by either party without the prior written
consent of the other, which consent shall not be unreasonably withheld or
delayed, except that Lannett may assign its rights and obligations under this
Agreement to an affiliate, division, or subsidiary, in which event such assignee
shall assume Lannett's obligations hereunder. However, notwithstanding any such
assignment, Lannett shall remain liable in addition to the assignee unless such
liability is specifically waived in writing by Spectrum. Subject to the
foregoing, this Agreement shall be binding upon and inure to the benefit of the
parties hereto, and their respective successors and permitted assigns. Either
party may subcontract any of its duties hereunder as contemplated in Paragraph
2.7.
17. Entire Agreement. This Agreement constitutes the full
understanding of the parties hereto regarding the subject matter hereof and may
not be affected by any course of prior oral or written representations,
agreements or dealings that are not expressly contained in this Agreement. This
Agreement may not be modified orally, but only by an instrument in writing,
signed by the parties hereto. Any waiver of any provision of this Agreement
shall be written form signed by both parties.
18. Governing Law, Waiver of Jury Trial and ADR. This Agreement shall
be construed in accordance with, and governed by, the laws of the Commonwealth
of Pennsylvania. The parties waive any and all rights to have any dispute, claim
or controversy arising out of or relating to this Agreement tried before a jury.
All disputes, claims or controversies arising out of or relating to this
Agreement that are not resolved by the parties' good faith attempt to negotiate
a resolution shall be submitted to final and binding arbitration before
JAMS/Endispute, or its successor, in Wilmington, Delaware, USA, pursuant to the
United States Arbitration Act, 9 U.S.C. Sec. 1 et seq. The arbitration will be
conducted in accordance with the provisions of JAMS/Endispute's Streamlined
Arbitration Rules and Procedures in effect at the time of filing of the demand
for arbitration. The parties will cooperate with JAMS/Endispute and each other
in selecting a single arbitrator who shall be a former judge or justice with
substantial experiences in resolving business disputes with particular
experience in resolving disputes involving the pharmaceuticals industry. The
costs of arbitration will be shared equally by the parties. The provisions of
this Paragraph may be enforced by any court of competent jurisdiction. The
arbitrator shall not be empowered to award damages in excess of, or inconsistent
with, the liability limitations contained in this Agreement. The prevailing
party, however, shall be entitled to an award of all costs, fees and expenses,
including expert witness fees and attorneys' fees, to be paid by the party
against whom enforcement is ordered.
19. EXCLUSION OF CERTAIN DAMAGES. NOTWITHSTANDING ANY PROVISION OF
THIS AGREEMENT TO THE CONTRARY, IN NO EVENT SHALL EITHER PARTY, NOR ANYONE ELSE
WHO HAS BEEN INVOLVED IN THE CREATION, PRODUCTION OR DELIVERY OF THE PRODUCT,
INCLUDING SPECTRUM'S SUPPLIERS, BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL,
PUNITIVE OR CONSEQUENTIAL DAMAGES, WHETHER IN AN ACTION IN
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CONTRACT OR TORT, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH
DAMAGES. BECAUSE SOME STATES AND JURISDICTIONS DO NOT ALLOW THE EXCLUSION OR
LIMITATION OF LIABILITY, PORTIONS OF THE ABOVE LIMITATION MAY NOT APPLY IN
CERTAIN CIRCUMSTANCES.
20. Trademarks. Lannett shall advertise, promote, market and sell the
Product under any trademark of its choosing. Spectrum shall have no right, title
or interest in and to any such trademark. If a joint label is used including the
respective trademarks of either Spectrum or Lannett, then those trademarks
remain the property of the respective companies.
21. Confidentiality, Employees Rights.
21.1 Neither party shall disclose or appropriate to its own use,
or to the use of any third party, at any time during or subsequent to the term
of this Agreement, any secret or confidential information of the other party or
any of the other party's affiliates or subsidiaries of which either becomes
informed during such period, whether or not developed by the other, if based on
information supplied by the other.
21.2 During the term of this Agreement, Spectrum shall not supply
Ciprofloxacin for any other party in the Territory.
21.3 Neither party is granted any right or authority to assume or
create any obligation or responsibility, express or implied, on behalf of, or in
the name of the other party, or to bind the other party in any manner or with
respect to anything, whatsoever.
22. Severability.
22.1 Each provision of this Agreement is intended to be severable
from the others, so that if any provision or term hereof is illegal or invalid
for any reason whatsoever, such illegality or invalidity shall not affect the
validity of the remaining provisions of the terms hereof.
22.2 The parties to this Agreement specifically acknowledge the
drafting of this Agreement to be the product of both parties. Neither party may
attempt to claim the other party was the sole drafting party due to any
ambiguity in the language in this Agreement.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
executed by their respective representatives thereunto duly authorized as of the
day and year first above written.
LANNETT COMPANY, INC. NEOJB LLC
By: /s/ Xxxxxxxx Xxxxxxxxxx By: /s/ Xxxxxx X. Xxxxxxxxx
------------------------------ ----------------------------------
Xxxxxxxx Xxxxxxxxxx, Title: CEO
Title: Chief Financial Officer ---------------------------
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JOINDER/GUARANTEE
The undersigned, a Delaware corporation, intending to be legally bound
hereby, for good and valuable consideration, the receipt and sufficiency of
which are hereby acknowledged, does hereby agree to be bound by all of the terms
and conditions of the Supply, Development and Marketing Agreement, dated as of
August 15, 2003, entered into by and between LANNETT COMPANY, INC., a Delaware
corporation (hereinafter referred to as "Lannett"), and NEOJB LLC, a Delaware
limited liability company (hereinafter referred to as "Spectrum"), relating to
the development, supply and marketing of certain pharmaceutical products (the
"Agreement").
In particular, the undersigned corporation agrees that, if Spectrum should
fail or refuse to perform any of its duties, obligations or responsibilities
under the Agreement, the undersigned shall be obligated to perform any such
duty, obligation and/or responsibility.
SPECTRUM PHARMACEUTICALS, INC.
By: /s/ Xxxxxx X. Xxxxxxxxx
--------------------------------
Title: CEO
--------------------------------
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EXHIBIT A
1. Product: Ciprofloxacin Hydrochloride, in tablet form, in the following
dosages: 250 mg, 500 mg and 750 mg.
2. Transfer Costs:
Potency Primary Config.(A) Annual Forecast(B) Transfer Cost
------- -------------- --------------- -------------
250 mg 100's [Intentionally Redacted] [Intentionally Redacted]
500 mg 100's [Intentionally Redacted] [Intentionally Redacted]
750 mg 50's [Intentionally Redacted] [Intentionally Redacted]
NOTES:
-----
(A): [Intentionally Redacted]
(B): [Intentionally Redacted]
(C): [Intentionally Redacted]
[Intentionally Redacted] Certain information on this page has been omitted and
filed separately with the Securities and Exchange Commission. Confidential
treatment has been requested with respect to the omitted portions.
