Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment which has been filed separately with the SEC. STRATEGIC ALLIANCE AGREEMENT
EXHIBIT 10.8
*Certain portions of this exhibit have been omitted pursuant to a request for confidential
treatment which has been filed separately with the SEC.
treatment which has been filed separately with the SEC.
THIS AGREEMENT is made and entered into as of the 21st day of July, 2000.
BY AND BETWEEN:
CUMBERLAND PHARMACEUTICALS INC., a corporation organized and existing under the laws of Tennessee,
with its principal offices located at 000 Xxxxx Xxxxxx Xxxxx, Xxxxx 000, Xxxxxxxxx, Xxxxxxxxx,
00000 (hereinafter referred to as “CUMBERLAND”)
AND:
X.X. XXXXXXXX & CO. LIMITED (ABN 88 007 870 984), a corporation organized under the laws of South
Australia, with its principal place of business located at 000 Xxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxx
Xxxxxxxxx 0000 (hereinafter referred to as “FAULDING”);
WHEREAS, CUMBERLAND is the owner of intellectual property rights, formulations and know- how
related to intravenous formulations of a certain pharmaceutical product set forth in Schedule I;
WHEREAS, FAULDING has the expertise and the manufacturing facility suitable for the pharmaceutical
preparation and production of the Drug Product;
WHEREAS, CUMBERLAND wishes to have FAULDING manufacture the Drug Product and FAULDING wishes to
supply the Drug Product to CUMBERLAND;
WHEREAS, CUMBERLAND will appoint FAULDING as its preferred manufacturer for CUMBERLAND’s products;
WHEREAS, FAULDING and CUMBERLAND will explore opportunities to collaborate on the manufacture and
distribution of other pharmaceutical products of CUMBERLAND;
NOW, THEREFORE, in consideration of the premises and the undertakings, terms, conditions and
covenants set forth below, the parties hereto agree as follows:
1. DEFINITIONS
1.1 BUFFER SOLUTION shall mean the buffer solution selected by CUMBERLAND for the manufacture
of the Drug Product.
1.2 BULK DRUG SUBSTANCE shall mean the active ingredients in the Drug Product.
1.3 cGMP or GMP shall have the meaning set forth in Schedule I.
1.4 CONFIDENTIAL INFORMATION shall have the meaning set forth in Paragraph 9.
1.5 DEVELOPMENT shall mean all work necessary to develop a process to manufacture the Drug
Product in full accord with cGMP and to supply the Drug Product conforming to the Specifications.
Development activities shall include, but not be limited to, pilot batches, scale- up batches,
validation of the manufacturing process, and successful completion of the Drug Product manufacture
and delivery as defined in Schedule I attached hereto.
1.6 DRUG PRODUCT shall mean the Ibuprofen for injection pharmaceutical product developed by
Cumberland and marketed under the trade name AMELIOR™.
1.7 EXCIPIENT shall mean any inert substance selected by CUMBERLAND and used to give the Drug
Product proper consistency.
1.8 FDA shall mean the United States Food and Drug Administration (FDA).
1.9 IN-PROCESS SOLUTION shall mean all Buffer Solutions and Excipients needed to produce Drug
Product in the finished dosage form set forth in Schedule I.
1.10 INVENTION shall have the meaning set forth in Paragraph 9.4.
1.11 LABELING shall mean all labels and other written, printed, or graphic matter upon: (i)
the Drug Product or any container or wrapper utilized with the Drug Product or (ii) any written
material accompanying the Drug Product, including without limitation, package inserts.
1.12 MANUAL shall mean the Manufacturing Project Manual attached as Schedule II to this
Agreement and reviewed and accepted by CUMBERLAND and FAULDING, the terms and provisions of which
are incorporated by reference as though fully set forth herein.
1.13 SPECIFICATIONS shall mean those specifications set forth in Attachment I to the Manual.
2. DEVELOPMENT AND MANUFACTURING
2.1 Initiation: Upon request by CUMBERLAND, FAULDING shall proceed with the schedule for
completing Development of the Drug Product. Upon request by CUMBERLAND, FAULDING shall manufacture
the Drug Product in the batch size set forth in Schedule I in accordance with the terms hereof, the
Specifications, and all applicable laws and
regulations. Prior to distributing and selling the Drug Product, CUMBERLAND shall prepare and
file submissions to the FDA in order to obtain and maintain during the term hereof regulatory
approval of the Drug Product. FAULDING shall prepare and test the Drug Product in accordance with
cGMP.
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2.2 Processing and Manufacturing: FAULDING shall manufacture and package the Drug Product in
accordance with Schedules I and II hereto.
2.3 Documentation: Subject to CUMBERLAND’s prior consent pursuant to Paragraph 5.5 hereof to
reimburse FAULDING for all out-of-pocket expenses and reasonable internal costs, FAULDING shall
provide CUMBERLAND with required supporting documentation for the Development of the Drug Product
in a form suitable for CUMBERLAND’s submission to the FDA or applicable governmental authorities
for any country into which the Drug Product will be distributed with the prior written consent of
FAULDING, which consent shall not be unreasonably withheld or delayed.
2.4 Bulk Drug Substance Supply: FAULDING shall be responsible for the supply of all Bulk Drug
Substance in accordance with Schedules I and II hereto; provided that the supply of Bulk Drug
Substance shall be exclusively from such suppliers and in such grades as have been approved in
writing by CUMBERLAND as reflected on an approved list to be attached hereto as Schedule III, and
provided further that such suppliers and grades may not be changed without CUMBERLAND’s prior
written consent.
2.5 Supply of Components: FAULDING shall be responsible for the supply of all components in
accordance with Schedules I and II hereto; provided that the supply of components shall be
exclusively from such suppliers and in such grades as have been approved in writing by CUMBERLAND
as reflected on an approved list to be attached hereto as Schedule III, and provided further that
such suppliers and grades may not be changed without CUMBERLAND’s prior written consent.
2.6 Delivery Terms: All deliveries of Drug Product under this Agreement shall be made by
FAULDING to CUMBERLAND in the manner set forth in Schedule I. CUMBERLAND shall, within twenty (20)
working days after its receipt of any shipment, notify FAULDING in writing, of any claim relating
to a Drug Product not conforming to the Specifications, and, failing such notification,
notwithstanding Paragraph 5.1 of this Agreement, CUMBERLAND shall be deemed to have accepted the
Drug Product. If FAULDING disputes CUMBERLAND’s claim that the Drug Product is non-conforming, then
such dispute shall be resolved by an independent testing organization of recognized repute within
the pharmaceutical industry mutually agreed upon by FAULDING and CUMBERLAND, the appointment of
which shall not be unreasonably withheld by either party. In such event, CUMBERLAND shall ship the
testing organization representative samples of the Drug Product from the disputed production lot,
and the fees and costs of such testing organization and related shipping and supply costs shall be
borne by the party whose position is not sustained by the testing organization. CUMBERLAND’s sole
remedy for non-conforming product (other than indemnification under Paragraph 10.2) is to be
provided with replacement Drug Product free of charge, including compensation for all CUMBERLAND
inputs and all freight charges.
2.7 Payment for the Drug Product: At the time of each shipment, FAULDING shall invoice
CUMBERLAND for FAULDING’s manufacturing services at the cost per batch as set forth in Schedule I.
Payment shall be made in Australian dollars of the latter of the invoice date or
3
CUMBERLAND’s acceptance of
shipment of conforming Product at its designated receiving facility.
2.8
Price Variations:
(i) Prices are as set on Schedule I for the term hereof unless changed pursuant to Paragraph
2.8(ii).
(ii) A party may request not less than two months prior to the second anniversary of the
effective date of this Agreement and each anniversary thereof thereafter to renegotiate the price
per batch having regard to varying costs of manufacture. The requesting party shall provide the
other party with evidence of varying costs of manufacture if an increase or decrease in price is
sought. Any increase in price shall not exceed the twelve (12) month percent increase in the
Consumer Price Index as published by the Australian government and shall be further subject to a
maximum of [***] percent ([***]%) unless (a) CUMBERLAND consents in writing to an increase in excess
of such Consumer Price Index and (b) FAULDING provides CUMBERLAND with evidence that the proposed
increase in price per batch is equivalent to FAULDING’s increased cost of manufacturing per batch
(excluding non-manufacturing overhead) as calculated in accordance with generally accepted
accounting principles consistently applied. If CUMBERLAND does not consent in writing to an
increase in excess of such Consumer Price Index within thirty (30) days of written notification
thereof, then FAULDING may withdraw the proposed amount of the increase in excess of the Consumer
Price Index or may terminate this Agreement upon at least ninety (90) days prior written notice.
3. TERM AND TERMINATION
3.1 Term: This Agreement shall commence on the date first above written and will continue
until the fifth anniversary of the date on which the FDA grants approval to market and sell the
Drug Product, unless sooner terminated pursuant to Paragraph 3.2 herein. The Agreement shall be
automatically renewed for successive three-year terms unless either party notifies the other party
in writing at least twelve (12) months in advance of the expiration of the then current term that
the party is terminating the Agreement.
3.2 Termination: This Agreement may be terminated at any time upon the occurrence of any of
the following events:
(a) Default: Forty-five (45) days following written notice, by either party to the other
party, in the event that the other party breaches any provision of this Agreement, and such party
fails to remedy the breach prior to the expiration of the forty-five (45) day period.
(b) Insolvency: Written notice by either party to the other upon insolvency or bankruptcy of
the other party, and the failure of any such insolvency or bankruptcy to be dismissed within sixty
(60) days.
(c) If, as a result of causes described in Paragraph 7.1, either party is unable to fully
perform its obligations hereunder for a period of one hundred eighty (180) consecutive days, the
other party shall have the right to terminate this Agreement upon at least thirty (30) days prior
written notice; provided that if the required performance is met during that thirty-day period,
this Agreement shall continue in full force and effect as if the notice had not been given.
Termination, expiration, cancellation or abandonment of this Agreement, through any means and
for any reason, shall not relieve the parties of any obligation accruing prior thereto and shall be
without the prejudice to the rights and remedies of either party with respect to any antecedent
breach of any of the provisions of this Agreement or CUMBERLAND’s purchase order issued hereunder.
3.3 Survival: Paragraphs 5, 6, 9, and 10 shall survive the termination or cancellation of the
Agreement for any reason.
4. CERTIFICATES OF ANALYSIS AND MANUFACTURING COMPLIANCE
4.1 Certificates of Analysis: FAULDING shall perform, or cause to be performed, certain tests
requested by CUMBERLAND as indicated in the Specifications on each batch of the Drug Product
manufactured pursuant to this Agreement before delivery to CUMBERLAND.
4
A certificate of analysis
for each batch delivered shall be delivered with each batch and shall set forth the items tested,
specifications, and test results. FAULDING shall also indicate on the certificate of analysis that
all batch production and control records have been reviewed and approved by the appropriate quality
control unit. FAULDING shall send, or cause to be sent, such certificates to CUMBERLAND prior to
the shipment of the Drug Product. CUMBERLAND shall test, or cause to be tested, prior to final
release, each batch of the Drug Product as meeting the Specifications. As required by the FDA (see
Paragraph 5.2 below), CUMBERLAND shall assume full responsibility for final release of each lot of
the Drug Product.
4.2 Manufacturing Compliance: FAULDING shall advise CUMBERLAND immediately if an authorized
agent of any regulatory body visits FAULDING’s manufacturing facility and makes an inquiry
regarding FAULDING’s method of manufacture of the Drug Product for CUMBERLAND. Upon receipt of any
Form 483 Notice of Inspectional Observations issued by the FDA or notice of deficit from any other
regulatory inspection after a visit to FAULDING’s manufacturing facility, FAULDING shall
immediately send CUMBERLAND a copy thereof; provided that it may redact any language that is
subject to a legally enforceable confidentiality agreement between FAULDING and a third party.
4.3 Regulatory Agency Requirements: FAULDING shall prepare and test the Drug Product in
conformity with GMP. Subject to the allocation of responsibility for regulatory compliance as set
forth in Paragraph 5.2, each party shall consult with the other party hereto before implementing
additional regulatory agency requirements concerning the control of Drug Product components,
manufacture of the Drug Product, or storage and handling of the Drug Product. The full text of
regulatory agency requests or comments will be provided by the party receiving such requests or
comments to the other party hereto. The parties will mutually agree on how to respond to such
requests and comments and on the allocation of the costs thereof; provided that FAULDING shall be
liable only for its reasonable internal costs and not for any out-of-pocket expenses or
extraordinary costs required in connection with implementing such regulatory requirements other
than the ordinary costs of compliance with GMP.
4.4 Regulatory Documents: Each party will advise the other party hereto of its intention to
change any Drug Product regulatory documents prior to submission of the document to any regulatory
body. If the change affects the rights and obligations of a party hereto under this Agreement, such
party may seek to review or alter any part of the document at any time within ten (10) business
days after receipt of notification thereof; provided that if no alterations are submitted to the
other party within such ten-day period, each party will be deemed to have consented to the
alteration. CUMBERLAND shall reimburse FAULDING for all out-of-pocket expenses and reasonable
internal costs of changes to Drug Product regulatory documents, subject to CUMBERLAND’s prior
consent pursuant to Paragraph 5.5.
5. REPRESENTATIONS AND WARRANTIES
5.1 Conformity with Specifications: FAULDING warrants that, at the time of manufacture, the
Drug Product is prepared and tested in accordance with cGMP and meets the Specifications. Because
FAULDING has no control of the conditions under which the Drug Product is used, the diagnosis of
the patient before or after treatment with the Drug Product, the
5
method of use or administration of
the Drug Product, and handling of the Drug Product after delivery to CUMBERLAND, FAULDING does not
warrant either a good effect, or against an ill effect, following the use of the Drug Product. The
foregoing warranty is exclusive and in lieu of all other warranties either written, oral, or
implied. THERE ARE NO WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. No
representative of FAULDING may change any of the foregoing warranties and CUMBERLAND accepts the
Drug Product subject to all terms hereof.
5.2 Compliance: CUMBERLAND assumes responsibility for coordinating all contact with the FDA
and other regulatory bodies, pertaining specifically to Drug Product. FAULDING authorizes
CUMBERLAND’s representatives to supervise and inspect the methods used in and facilities used for
manufacturing, processing, packaging, and handling of the Drug Product, but CUMBERLAND shall have
no such obligation under this Agreement. Except as otherwise required by applicable regulations,
CUMBERLAND’s inspections shall be limited to two per year, each to occur upon seven days notice and
to be conducted during normal business hours; provided that CUMBERLAND may also inspect such
facilities promptly after any regulatory inspection thereof.
5.3 Debarring: FAULDING represents and warrants that it has not been debarred in the United
States within the meaning of 21 U.S.C. § 335a(a) and 335a(b), nor will it use in any capacity the
services of any person debarred pursuant to subsections 3.06(a) or 3.06(b) of the Federal Food,
Drug, and Cosmetic Act, 21 U.S.C. Section 335(a) and (b).
5.4 FDA Submission: FAULDING represents and warrants that it has submitted to the FDA
information about the manufacturing site to be used for the Drug Product and the facilities,
operating procedures, and personnel at such site.
5.5 Reimbursement: FAULDING shall not incur any development costs for which it intends to seek
reimbursement from CUMBERLAND for the manufacturing facility, equipment, or manufacturing method
unless FAULDING has the prior written consent of CUMBERLAND.
5.6 Exclusivity: FAULDING will not sell, give away, or deliver to any other person, firm, or
corporation any Drug Product without CUMBERLAND’s prior written consent while this Agreement is
effective and for two years after the termination of this Agreement. In the event of breach,
CUMBERLAND shall have the right, in addition to other rights, to seek injunctive relief.
6. DRUG PRODUCT RECALLS
6.1 Drug Product Recalls: In the event: (a) any government authority issues a request,
directive or order that the Drug Product be recalled, or (b) a court of competent jurisdiction
orders such a recall, (c) CUMBERLAND determines that the Drug Product should be recalled because
the Drug Product does not conform to Specifications, or (d) FAULDING
recommends to CUMBERLAND that a recall be initiated, the parties shall take all appropriate
corrective actions. In the event that FAULDING recommends a recall of Drug Product by CUMBERLAND,
such recommendation must take the form of a notice as per Paragraph 14.1, and CUMBERLAND shall
respond promptly indicating to FAULDING whether the Drug
6
Product will be recalled. In no event,
however, shall FAULDING have responsibility for regulatory compliance in connection with any
recall, except to the extent and under the circumstances set forth in the Manual or any other
written agreement between the parties hereto or as required by law. All costs and expenses incurred
in connection with such recall shall be the responsibility of CUMBERLAND unless caused by the
negligence of FAULDING.
7. FORCE MAJEURE; FAILURE TO SUPPLY
7.1 Force Majeure Events: Failure of either party to perform under this Agreement (except the
obligation to make payments) shall not subject such party to any liability to the other if such
failure is caused by acts such as, but not limited to, acts of God, fire, explosion, flood,
drought, war, riot, sabotage, embargo, strikes or other labor trouble, compliance with any order or
regulation of any government entity, or by any cause beyond the reasonable control of the parties,
provided that written notice of such event is promptly given to the other party.
7.2 Failure to Supply; Delivery Dates; Forecasts: FAULDING shall supply all of the Drug
Product ordered by CUMBERLAND within sixty (60) days of receipt of a written order from CUMBERLAND.
On the date that CUMBERLAND makes its first order, CUMBERLAND will supply FAULDING with a
non-binding forecast of its future orders of Drug Product for each of the eleven calendar months
following the month in which the initial order is made. CUMBERLAND will update the forecasts on the
first day of the calendar month and on a monthly basis thereafter throughout the term of this
Agreement. The quantity of any Drug Product ordered pursuant to this Agreement shall not be less
than seventy percent (70%) nor more than one hundred thirty percent (130%) of the quantity
indicated in the most recent monthly forecast provided hereunder for the month in which the order
is placed. If CUMBERLAND fails to provide orders, or forecasts by agreed dates, FAULDING shall not
be required to deliver the quantity ordered by CUMBERLAND within sixty (60) days. The provisions of
this Paragraph 7.2 shall be without prejudice to CUMBERLAND’s rights under Paragraph 3.2 and
remedies provided for thereunder.
8. IMPROVEMENTS
8.1 Changes by CUMBERLAND:
When CUMBERLAND seeks to change the Drug Product Specifications, such change shall be
incorporated within the Specifications only with the prior written consent of FAULDING, such
consent not to be unreasonably withheld or delayed. The price of the Drug Product may be adjusted
for such change, and CUMBERLAND shall pay FAULDING the agreed costs associated with such change,
including any development work, if necessary, based upon FAULDING’s then-prevailing development
rates. Such prices and costs shall be set forth in a written amendment to this Agreement. It is the
responsibility of CUMBERLAND to ensure that proper regulatory agencies approve the suggested
changes. CUMBERLAND will notify
FAULDING if it intends to change the process or test specifications related to the preparation
of the Bulk Drug Substance.
8.2 Changes by FAULDING:
7
FAULDING shall inform CUMBERLAND in writing of all proposed changes in the manufacturing
facility, equipment, or manufacturing methods and labeling of the Drug Product, each as approved by
applicable regulatory authorities, including the FDA, in advance of the time such changes are
intended to be made to allow CUMBERLAND sufficient time to provide any notice required by FDA
regulations. FAULDING shall not implement any such changes without prior written authorization by
the FDA or other applicable regulatory authorities and the prior written consent of CUMBERLAND,
which consent shall not be unreasonably withheld or delayed. FAULDING shall be liable only for its
reasonable internal costs and not for extraordinary costs in connection with such manufacturing
changes.
9. CONFIDENTIALITY
9.1 Confidential Information: “Confidential Information” means collectively Confidential
Information of CUMBERLAND (as defined herein) and Confidential Information of FAULDING (as defined
herein).
9.2 Confidential Information of CUMBERLAND: “Confidential Information of CUMBERLAND” means all
information obtained or developed by FAULDING or any third party which related to CUMBERLAND’s
business or the Drug Product, regardless of the form in which such information is transmitted. The
following shall not be considered Confidential Information of CUMBERLAND for purposes hereof:
(a) Information that is already in the possession of FAULDING at the time it is received from
CUMBERLAND or developed on CUMBERLAND’s behalf, if FAULDING notifies CUMBERLAND of its belief that
the information is excepted under the terms of this subsection;
(b) Information received by FAULDING from a person which has the right to disclose the same,
when FAULDING notifies CUMBERLAND of its belief that the information is excepted under the terms of
this subsection;
(c) Information that is or becomes published, or is or becomes otherwise publicly available
without the fault of FAULDING; or
(d) An Invention as defined in Paragraph 9.4.
In the event of a dispute regarding the applicability of the above exceptions to the
definition of Confidential Information of CUMBERLAND, FAULDING shall have the burden of producing
clear and convincing proof that the information should be excepted from the definition of
Confidential Information of CUMBERLAND. FAULDING shall not use or permit the use of the
Confidential Information of CUMBERLAND other than for the limited purposes
expressly permitted by or consistent with this Agreement. Recipients of Confidential
Information of CUMBERLAND shall be granted access thereto strictly on a “need-to-know” basis.
FAULDING shall take all reasonable steps to ensure that recipients comply with the terms of this
Agreement, including all restrictions on use, disclosure and dissemination of Confidential
8
Information of CUMBERLAND. FAULDING shall notify CUMBERLAND immediately upon becoming aware of any
breach hereof and shall take all reasonable steps to prevent any further disclosure or unauthorized
use.
Upon termination or expiration of this Agreement, FAULDING shall deliver to CUMBERLAND all
Confidential Information of CUMBERLAND, all copies thereof, and all documents or data storage media
containing such Confidential Information of CUMBERLAND, except as expressly set forth herein or in
any other written agreement between the parties.
9.3 Confidential Information of FAULDING: “Confidential Information of FAULDING” means all
information obtained by CUMBERLAND which relates to FAULDING’s business, regardless of the form in
which such information is transmitted. The following shall not be considered Confidential
Information of FAULDING for purposes hereof:
(a) Information that is already in the possession of CUMBERLAND at the time it is received
from FAULDING, if CUMBERLAND notifies FAULDING of its belief that the information is excepted under
the terms of this subsection; or
(b) Information received by CUMBERLAND from a person which has the right to disclose the same,
when CUMBERLAND notifies FAULDING of its belief that the information is excepted under the terms of
this subsection; or
(c) Information that is or becomes published, or is or becomes otherwise publicly available
without the fault of CUMBERLAND.
In the event of a dispute regarding the applicability of the above exceptions to the
definition of Confidential Information of FAULDING, CUMBERLAND shall have the burden of producing
clear and convincing proof that the information should be excepted from the definition of
Confidential Information of FAULDING. CUMBERLAND shall not use or permit the use of the
Confidential Information of FAULDING other than for the limited purposes expressly permitted by or
consistent with this Agreement. Recipients of Confidential Information of FAULDING shall be
granted access thereto strictly on a “need-to-know” basis. CUMBERLAND shall take all reasonable
steps to ensure that recipients comply with the terms of this Agreement, including all restrictions
on use, disclosure and dissemination of Confidential Information of FAULDING. CUMBERLAND shall
notify FAULDING immediately upon becoming aware of any breach hereof and shall take all reasonable
steps to prevent any further disclosure or unauthorized use.
Upon termination or expiration of this Agreement, CUMBERLAND shall deliver to FAULDING all
Confidential Information of FAULDING, all copies thereof, and all documents or data storage media
containing such Confidential Information of FAULDING, except as expressly set forth herein or in
any other written agreement between the parties.
9.4 Invention: CUMBERLAND owns all intellectual property rights in any improvement to or
derived from the Drug Product and any existing or further developments or modifications of the Drug
Products (“Invention”), except to the extent that a manufacturing
9
process used therewith is
developed exclusively by FAULDING, in which case the intellectual property rights for such process
shall be retained by FAULDING.
9.5 Disclosure: The parties agree that the existence of this Agreement may be disclosed to
third parties but that the contents of this Agreement shall not be disclosed to any third party
except (i) the controlling companies of the parties, (ii) the companies controlled by the parties,
(iii) individuals and entities providing paid services to either of the parties, and (iv)
governmental regulatory agencies, including, but not limited to, environmental protection
authorities, without prior written consent of the other party.
9.6 Retention of Records: Notwithstanding the restrictions set forth in this Agreement,
FAULDING shall retain production records (a) for batches of Drug Products manufactured prior to
establishment by CUMBERLAND of an expiry date (CTM and validation batches) for three (3) years
after (i) issuance of regulatory approval of the Drug Product necessary for distribution thereof or
(ii) withdrawal of the IND (Notice of Claimed Investigational Exemption for a New Drug) and (b) for
batches of Drug Product manufactured after establishment by CUMBERLAND of an expiry date for a
period of at least one year after the respective expiry date for each batch. These records will be
stored by appropriate means, including without limitation, optical disk or microfilm in a secure
manner in compliance with current GMP with duplicate copies submitted to CUMBERLAND promptly after
the creation thereof and shall be made available on request of the FDA or any other authorized
regulatory body.
9.7 Confidential Information Upon Termination: Upon termination of this Agreement for whatever
reason, FAULDING shall return to CUMBERLAND originals, copies, and derivative forms of disclosed or
developed information relating to the purpose of this Agreement; except that one copy of such
information may be retained as required by regulation or law for future reference. The Confidential
Information shall remain confidential and not be disclosed by either party for a period of ten (10)
years following the date of expiration or termination of this Agreement.
10. INDEMNIFICATION
10.1 Indemnification by CUMBERLAND: CUMBERLAND shall indemnify and hold FAULDING (and any
parent, subsidiary, or affiliate company or corporation, and their officers, directors,
shareholders, agents, and the employees and insurers of any of them and/or their successors and
assigns thereto), free and harmless from any and all claims, demands, liability, actions or causes
of actions, and any and all expenses associated therewith (including, without limiting the
generality of the foregoing, attorney’s fees), arising out of or in connection with, as a result
of, or otherwise related to any third party claims arising from: (i) any negligence or recklessness
of CUMBERLAND, its agents, or employees; (ii) the promotion, distribution, use, misuse or sale or
effects of the Drug Product except to the extent the alleged Drug Product
defects were caused by FAULDING; (iii) CUMBERLAND’s non-compliance with any applicable FDA or
other applicable regulations; or, (iv) any failure of CUMBERLAND to perform, in whole or in part,
any of its obligations hereunder in each case, unless caused by the acts or omissions of FAULDING.
Beginning prior to use of the Drug Product in humans and
10
continuing until the third anniversary of
termination of this Agreement, CUMBERLAND shall maintain products liability insurance with limits
of liability of not less than [***] and shall name
FAULDING as additional insured under said policy.
10.2 Indemnification by FAULDING: FAULDING will indemnify and hold CUMBERLAND (and any parent,
subsidiary, or affiliate company or corporation, and their officers, directors, shareholders,
agents, and the employees and issuers of any of them and/or their successors and assigns thereto),
free and harmless against any and all claims, demands, actions or causes of action, and any and all
expenses associated therewith (including, without limiting the generality of the foregoing, defense
costs and attorney’s fees), arising out of or in connection with, as a result of, or otherwise
related to any third party claims arising from (i) any negligence or recklessness of FAULDING, its
agents or employees; (ii) personal injury (including death) or property damage arising out of or in
connection with FAULDING’s manufacture or handling of the Drug Product otherwise than in accordance
with the Specifications and CUMBERLAND’S written directions; (iii) FAULDING’s non-compliance with
any applicable FDA or other applicable regulations; provided that CUMBERLAND perform its
obligations under Paragraph 2.1, or (iv) any failure of FAULDING to perform any of its obligations
hereunder, unless caused by the acts or omissions of CUMBERLAND. Beginning prior to delivery of the
first order for Drug Product pursuant to this Agreement and continuing until the third anniversary
of termination of this Agreement, FAULDING shall maintain products liability insurance with limits
of liability of not less than [***] and shall name CUMBERLAND as additional insured under
said policy.
10.3 Patent Indemnity: Subject to Paragraph 5.1, CUMBERLAND further warrants that importation,
manufacture (excluding manufacturing not specific to the manufacture of the Drug Product to be
performed by FAULDING for CUMBERLAND), use, supply, and sale of the Drug Product and Bulk Drug
Substance will not infringe any patent rights or any other third-party intellectual property rights
and that CUMBERLAND will indemnify, defend, and hold FAULDING free and harmless from any damage,
judgment, liability, loss, cost or expense, including legal expenses, arising from claims that the
Drug Product and Bulk Drug Substance infringe patent rights of a third party or any third-party
intellectual property rights.
10.4 Conditions of Indemnification: If either party seeks indemnification from the other under
Paragraphs 10.1, 10.2, or 10.3, it shall promptly give written notice to the other party of any
such claim or suit threatened, made or filed against it, which forms the basis for such claim of
indemnification and shall cooperate fully with the other party in the defense of all such claims or
suits. No settlement or compromise shall be binding on a party hereto without its prior written
consent.
10.5 Disclaimer of Warranties; Limited Liability: Under no circumstances shall either party be
liable to the other on account of any claim (whether based upon principles of
contract, warranty, negligence, or other tort, breach of any statutory duty, principles of
indemnity, the failure of any expressly limited remedy to achieve its essential purpose) for any
special, consequential, incidental or exemplary damages, or including but not limited to lost
profits.
11
11. APPOINTMENT AS PREFERRED MANUFACTURER
Until the expiration or earlier termination of this Agreement, CUMBERLAND agrees to provide
FAULDING with the first opportunity to negotiate to manufacture each CUMBERLAND pharmaceutical
product to be sold anywhere in the world in addition to the Drug Product; provided that the
foregoing shall not apply to pharmaceutical products in respect of which CUMBERLAND is unable to
enter into a manufacturing arrangement with FAULDING, due to contractual obligations applicable to
CUMBERLAND or where to enter into such an arrangement with FAULDING would adversely affect any
existing regulatory approval or application for regulatory approval for the product, in either case
as reasonably determined by CUMBERLAND having regard to documented evidence which CUMBERLAND shall
provide to FAULDING or FAULDING’s advisers for review at FAULDING’s request. Except as set forth to
the contrary in the preceding sentence, CUMBERLAND agrees not to manufacture, or to have
manufactured, such a product anywhere in the world unless CUMBERLAND first notifies FAULDING of the
opportunity hereunder and unless CUMBERLAND negotiates in good faith with FAULDING for sixty (60)
days after providing such notice in an attempt to enter into a written agreement on substantially
the same terms as this Agreement with respect to such additional product.
12. LICENSING AND DISTRIBUTION OF CUMBERLAND PRODUCTS
Until the expiration or earlier termination of this Agreement, CUMBERLAND agrees to provide
FAULDING with the first opportunity to negotiate to license and distribute each pharmaceutical
product of CUMBERLAND in Xxxxxxxxx, Xxx Xxxxxxx, Xxxxxx, and mutually agreed Southeast Asian and
Latin American countries; provided that the foregoing shall not apply to pharmaceutical products in
respect of which CUMBERLAND is unable to enter into a license and distribution arrangement with
FAULDING, due to contractual obligations applicable to CUMBERLAND as reasonably determined by
CUMBERLAND having regard to documented evidence which CUMBERLAND shall provide to FAULDING or
FAULDING’s advisers for review at FAULDING’s request, and further provided that CUMBERLAND shall
use good faith efforts to initiate such negotiations with FAULDING as soon as such a product is
reasonably available for license and distribution in such territory. Except as set forth to the
contrary in the preceding sentence, CUMBERLAND agrees not to license or distribute such a product
in such territory unless CUMBERLAND first notifies FAULDING of the opportunity hereunder and unless
CUMBERLAND negotiates in good faith with FAULDING for sixty (60) days after providing such notice
in an attempt to enter into a written agreement with respect to the services that are being
negotiated.
13. REGULATORY SUPPORT
If requested by CUMBERLAND, and at CUMBERLAND’S cost at reasonable fees to be agreed
by the parties, FAULDING shall provide CUMBERLAND with reasonable assistance in relation to the
Development of, and applications for regulatory approval for, pharmaceutical products other than
the Drug Product which are identified by CUMBERLAND, including but not limited to the preparation
of development reports, stability reports, manufacturing documentation and
12
instructions for use
necessary to support applications for regulatory approval.
14. GENERAL PROVISIONS
14.1 Notices: Any notice permitted or required by this Agreement may be sent by facsimile with
the original document being sent by certified (or registered) mail, return receipt requested, or
overnight delivery and shall be effective when received (or refused) via facsimile or mail or
overnight if faxed and sent and addressed as follows (or to such other facsimile number or address
as may be designated by a party in writing):
| If to CUMBERLAND: | Cumberland Pharmaceuticals Inc. | |||||
| 000 Xxxxx Xxxxxx Xxxxx, Xxxxx 000 | ||||||
| Xxxxxxxxx, Xxxxxxxxx 00000 | ||||||
| Attn: Chief Executive Officer | ||||||
| Telephone: | 000-000-0000 | |||||
| Facsimile: | 000-000-0000 | |||||
| If to FAULDING: | X.X. Xxxxxxxx & Co. Limited | |||||
| 000 Xxxxxxxx Xxxxxx | ||||||
| Xxxxxxxxx, Xxxxx Xxxxxxxxx 0000 | ||||||
| Attn: Company Secretary | ||||||
| Telephone: | 00-0-0000-0000 | |||||
| Facsimile: | 00-0-0000-0000 | |||||
14.2 Entire Agreement: Amendment: The parties hereto acknowledge that this Agreement sets
forth the entire agreement and understanding of the parties and supersedes all prior written or
oral agreements or understandings with respect to the subject matter hereof; provided that the
Confidentiality Agreement dated August 1, 1999, between FAULDING and CUMBERLAND shall remain in
effect and that the terms thereof shall supersede any conflicting term of Paragraph 9 hereof. No
modification of any of the terms of this Agreement, or any amendments thereto, shall be deemed to
be valid unless in writing and signed by both parties hereto. No course of dealing or usage of
trade shall be used to modify the terms and conditions herein.
14.3 Waiver: None of the provisions of the Agreement shall be considered waived by any party
hereto unless such waiver is agreed to, in writing, by both parties. The failure of a party to
insist upon strict conformance to any of the terms and conditions hereof, or failure or delay to
exercise any rights provided herein or by law shall not be deemed a waiver of any rights of any
party hereto.
14.4 Obligations to Third Parties: Each party warrants and represents that this Agreement is
not inconsistent with any contractual obligations, expressed or implied, undertaken
with any third party.
14.5 Assignment: This Agreement shall be binding upon and inure to the benefit of the
successors or permitted assigns of each of the parties and may not be assigned, transferred, or
13
subcontracted by either party without the prior written consent of the other, which consent will
not be unreasonably withheld or delayed, except that no consent shall be required in the case of a
transfer to a wholly-owned subsidiary or transaction involving the merger, consolidation or sale of
substantially all of the assets of the party seeking such assignment or transfer and such
transaction relates to the business covered by this Agreement and the resulting entity assumes all
the obligations under this Agreement.
14.6 Independent Contractor: FAULDING shall act as an independent contractor for CUMBERLAND in
providing the services required hereunder and shall not be considered an agent of or joint venturer
with CUMBERLAND. Unless otherwise provided herein to the contrary, FAULDING shall furnish all
expertise, labor, supervision, machining and equipment necessary for performance hereunder and
shall obtain and maintain all building and other permits and licenses required by public
authorities.
14.7 Governing Law: This Agreement is subject to and shall be governed by the laws of the
State of Tennessee. The parties hereby submit to the jurisdiction of the courts of the State of
Tennessee in respect to all disputes arising out of or in connection with this Agreement and waive
any and all objections to such venue.
14.8 Severability: In the event that any term or provision of this Agreement shall violate any
applicable statute, ordinance, or rule of law in any jurisdiction in which it is used, or otherwise
be unenforceable, such provision shall be ineffective to the extent of such violation without
invalidating any other provision hereof.
14.9 Headings, Interpretation: The headings used in this Agreement are for convenience only
and are not part of this Agreement.
14.10 Conflict: In the event of conflict between the terms and provisions of this Agreement
and the terms and provisions of the Manual, the terms of this Agreement shall control.
IN WITNESS WHEREOF, the parties hereto have each caused this Agreement to be executed by their
duly authorized representatives effective as of the date first above written.
| X.X. XXXXXXXX & CO. LIMITED | ||||||
/s/ X.X. Xxxxxx
|
/s/ Xxxx Xxxx | |||||
Printed Name
|
Printed Name | |||||
X.X. Xxxxxx
|
Xxxx Xxxx | |||||
Printed Name
|
Printed Name | |||||
| Title | ||||||
CEO
|
V.P. Tech Ops. | |||||
Title |
14
SCHEDULE I
DEVELOPMENT ACTIVITIES AND PRICING
Development of the Drug Product for use in Clinical Studies and for sale will consist of the
following:
Product -
|
Amelior™. Ibuprofen for intravenous injection. | |
Timing -
|
CUMBERLAND shall provide FAULDING with non-binding forecasts of its requirements in the manner set forth in Paragraph 7.2 of this Agreement. FAULDING shall manufacture the number of batches of Drug Product corresponding to each purchase order therefor within 60 days of receipt of any such order. | |
Special Issues -
|
All product contact components must be dedicated or disposed of after use. CUMBERLAND may be present for manufacturing. The initial batches are for an FDA submission, and may subsequently be used in clinical studies or sold. FAULDING shall provide process validation (scale-up and three validation batches) in accordance with this Agreement and the Schedules thereto. | |
cGMP or GMP -
|
GMP or cGMP shall mean the current good manufacturing practices as defined from time in regulations promulgated under the Federal Food, Drug and Cosmetic Act of the United States or any successor laws or regulations governing the manufacture of the Drug Product. | |
Storage - |
| 1. | FAULDING shall store and handle Bulk Drug Substance and finished Drug Product at 20E to 25E C. |
Composition, Process & Container
[***]
15
Preparation -
|
Additional details regarding preparation shall be incorporated herein upon adoption thereof by written agreement of FAULDING and CUMBERLAND. | |
[***] |
||
Disposal -
|
Method of disposal is incineration. Any disposal costs incurred by FAULDING will be charged back to CUMBERLAND; provided that CUMBERLAND shall not be required to reimburse FAULDING for such costs if the Drug Product is disposed of because of FAULDING’s negligence or breach of this Agreement. FAULDING shall prepare and provide CUMBERLAND with complete documentation of disposal throughout the chain of custody. |
Documentation by FAULDING –
| 1. | Master batch record for review and approval by FAULDING and CUMBERLAND. | |
| 2. | Product specific validation summaries. | |
| 3. | Executed batch records. | |
| 4. | Analytical records. | |
| 5. | Inventory records. | |
| 6. | Disposal records. |
Compensation -
|
The price to be paid by CUMBERLAND to FAULDING for the satisfactory performance of its obligations under this Agreement are as follows: | |
[***] |
Reimbursement of Development Costs -
|
CUMBERLAND shall reimburse FAULDING for development costs incurred and approved as agreed by the parties. | |
Reimbursement of Regulatory Costs -
|
CUMBERLAND shall reimburse FAULDING for regulatory costs incurred and approved as agreed by the parties. | |
Reimbursement of Inspection and Audit
Costs - |
CUMBERLAND shall reimburse FAULDING for inspection and audit costs incurred and approved as agreed by the parties. |
16
SCHEDULE II
MANUFACTURING PROJECT MANUAL
(To be expanded by mutual written consent of X.X. Xxxxxxxx & Co., Limited (“FHF”) and
Cumberland Pharmaceuticals, Inc. (“CPI”))
Cumberland Pharmaceuticals, Inc. (“CPI”))
| Responsibility | ||||||
| Documentation/Activity | FHF | CPI | Comments | |||
GMP certificate and other permits
|
/ | |||||
Active Pharmaceutical Ingredient
(“API”) |
||||||
Supply of API
|
/ | CPI to identify source | ||||
Provide specifications
|
/ | |||||
Approval of API specifications
|
/ | / | ||||
Provide sampling and testing
methods
|
/ | |||||
Approval of sampling and testing
methods
|
/ | / | ||||
Sampling and testing
|
/ | |||||
Release
|
/ | |||||
Storage of samples
|
/ | |||||
Storage of documents
|
/ | / | ||||
Starting Materials (except API) |
||||||
Supply of starting materials
|
/ | CPI to identify arginine source | ||||
Provide specifications of starting
materials
|
/ | |||||
Approval of starting materials
specifications
|
/ | / | ||||
Providing sampling and testing
methods
|
/ | |||||
Approval of sampling and testing
materials
|
/ | / | ||||
Sampling and testing
|
/ | |||||
Release
|
/ | |||||
Storage of samples
|
/ | |||||
Storage of documentation
|
/ | / | ||||
Manufacturing Formula |
||||||
Development of manufacturing
formula
|
/ | / | ||||
Approval of manufacturing formula
|
/ | / | ||||
Processing Instructions |
||||||
Development of processing
instructions
|
/ | |||||
Approval of processing instructions
|
/ | / | ||||
17
| FHF | CPI | Comments | ||||
Bulk Product |
||||||
Supply of Bulk Product
|
/ | |||||
Provide specifications of Bulk Product
|
/ | / | ||||
Approval of Bulk Product specifications
|
/ | / | ||||
Providing sampling and testing methods
|
/ | |||||
Approval of sampling and testing methods
|
/ | / | ||||
Sampling and testing
|
/ | |||||
Release
|
/ | |||||
Storage of samples
|
/ | |||||
Prepare stability data for Bulk Product
|
/ | |||||
Storage of documentation
|
/ | |||||
Packaging |
||||||
Supply of packaging materials
|
/ | |||||
Provide packaging materials specifications
|
/ | |||||
Approval of specifications
|
/ | |||||
Providing sampling and testing methods
|
/ | |||||
Approval of sampling and testing methods
|
/ | / | ||||
Sampling and testing
|
/ | |||||
Release
|
/ | |||||
Storage of samples
|
/ | |||||
Storage of documentation
|
/ | / | ||||
Batch Processing Records |
||||||
Preparation of batch processing records
|
/ | |||||
Review of batch processing records
|
/ | |||||
Release of batch processing records
|
/ | / | ||||
Storage of batch processing records
|
/ | / | ||||
Product |
||||||
Providing sampling and testing methods
|
/ | |||||
Approval of sampling and testing methods
|
/ | / | ||||
Sampling and testing
|
/ | |||||
Release
|
/ | |||||
Storage of samples
|
/ | |||||
Storage of documentation
|
/ | / | ||||
Prepare stability data for Product
|
/ |
18
Supply of Materials
| Supplier (check one): | ||||||
| Documentation/Activity | FHF | CPI | Comments | |||
Starting Materials |
||||||
Active Pharmaceutical Ingredient |
/ | CPI will identify source | ||||
Other Starting Materials |
||||||
(Auxiliaries, fluids, gases, etc.): |
||||||
Excipients |
/ | |||||
WFI |
/ | |||||
N2 |
/ | |||||
Packaging Materials |
||||||
Vials |
/ | |||||
Stoppers |
/ | |||||
Seals |
/ | |||||
Boxes |
/ | |||||
Shippers |
/ | |||||
Labeling |
/ | |||||
Quality Control
Distribution of responsibilities:
X.X. Xxxxxxxx & Co. (FHF) shall ensure that all quality control measures follow the applicable cGMP
guidelines. The responsibilities shall be distributed between FAULDING and CPI as follows:
| Supplier (check one): | ||||||
| Documentation/Activity | FHF | CPI | Comments | |||
Active Pharmaceutical Ingredient |
||||||
Providing sampling and testing methods
|
/ | / | ||||
Approval of sampling and testing methods
|
/ | / | ||||
Sampling and testing
|
/ | |||||
Release
|
/ | |||||
Storage of samples
|
/ | |||||
Storage of documentation
|
/ | / | ||||
Starting Materials (except API) |
||||||
Providing sampling and testing methods
|
/ | / | ||||
Approval of sampling and testing methods
|
/ | / | ||||
19
| Supplier (check one): | ||||||
| Documentation/Activity | FHF | CPI | Comments | |||
Sampling and testing
|
/ | |||||
Release
|
/ | |||||
Storage of samples
|
/ | |||||
Storage of documentation
|
/ | |||||
Bulk Product |
||||||
Providing sampling and testing methods
|
/ | |||||
Approval of sampling and testing methods
|
/ | / | ||||
Sampling and testing
|
/ | |||||
Release
|
/ | |||||
Storage of samples |
||||||
Storage of documentation
|
/ | / | ||||
Prepare stability data for Bulk Product
|
/ | / | ||||
Packaging Materials |
||||||
Providing sampling and testing methods
|
/ | |||||
Approval of sampling and testing methods
|
/ | / | ||||
Sampling and testing
|
/ | |||||
Release
|
/ | |||||
Storage of samples
|
/ | |||||
Storage of documentation
|
/ | / | ||||
| FHF | CPI | Comments | ||||
Batch Documentation |
||||||
Assignment of batch numbers
|
/ | |||||
Preparation of batch processing records
|
/ | |||||
Review of batch processing records
|
/ | |||||
Release of batch processing records
|
/ | |||||
Storage of batch processing records
|
/ | / | ||||
Product |
||||||
Providing sampling and testing methods
|
/ | |||||
Approval of sampling and testing methods
|
/ | / | ||||
Sampling and testing
|
/ | |||||
Release
|
/ | |||||
Storage of samples |
||||||
Storage of documentation
|
/ | / | ||||
Prepare stability data for Product
|
/ |
20
ATTACHMENT I
BULK DRUG SUBSTANCE
AND DRUG PRODUCT SPECIFICATIONS
AND PROCEDURES
AND DRUG PRODUCT SPECIFICATIONS
AND PROCEDURES
Bulk Drug Substance -
To be agreed.
To be agreed.
Drug Product Specifications and Procedures -
To be decided.
To be decided.
21
SCHEDULE 3
Ibuprofen Injection 100mg/ml
[***]
22
