Document:

exv10w5

Exhibit 10.5

MANUFACTURING AGREEMENT

By and between

VINTAGE PHARMACEUTICALS, LLC.

And

CORNERSTONE PHARMACEUTICALS, INC.

Dated

July 20, 2004

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

 

 

MASTER MANUFACTURING AGREEMENT

     This contract is made this 20th day of July, 2004 (Effective Date) by and between
Cornerstone Pharmaceuticals, Inc. (“CORNERSTONE”) a corporation organized and existing under the
laws of the State of Nevada and having an office and place of business at 8000 Regency Parkway,
Suite 430 Cary, NC 27511, and Vintage Pharmaceuticals, LLC (“VINTAGE”), a limited liability company
organized and existing under the laws of the State of Alabama and having an office and place of
business at 130 VINTAGE Drive, Huntsville, AL 35811.

     1. RECITALS

          1.1 WHEREAS, CORNERSTONE and VINTAGE will have contemporaneously executed an Asset Purchase
Agreement, whereby CORNERSTONE will purchase certain rights of VINTAGE in the Propoxyphene
Napsylate/APAP 100/325mg Tablet (#76-743) and Propoxyphene Napsylate/APAP 100/500mg Tablet
(#76-750) owned by VINTAGE and

          1.2 WHEREAS, as additional consideration to the Asset Purchase Agreement, CORNERSTONE desires
to have VINTAGE manufacture and supply certain specified drugs, as referenced in Section 1.1 above,
according to the ANDA’s specifications and VINTAGE desires to manufacture and supply such drugs
under the terms hereof.

     NOW, THEREFORE, in consideration of the aforesaid premises, the parties agreeing to be
mutually bound, hereby agree as follows:

     2. DEFINITIONS

     The following terms, whether used in the singular or plural, shall have the respective
meanings set forth below:

          2.1 “Force Majeure” means, without limitation, inclement weather, strikes, lockouts,
inability to procure labor or materials or fuels due to shortages, fires, riots, incendiarism,
interference by civil or military authorities, compliance with the regulations or order of any
government authority, or the outbreak of war or insurgence, or acts of war (declared or undeclared)
and any other cause which is beyond the reasonable control of either Party.

          2.2 “cGMPs” means current good manufacturing practices for the methods to be used in,
and the facilities and controls to be used for, the Manufacture, packaging and holding of drugs,
all as set forth from time to time by the FDA.

          2.3 “Product(s)” means Propoxyphene Napsylate/APAP 100/325mg Tablet and Propoxyphene
Napsylate/APAP 100/500mg Tablet and “Product(s)” means either of them.

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          2.4 “Manufacture or Manufacturing” means the compounding, formulating, finishing,
quality control testing, filling, labeling and packaging of the Product(s) in accordance with the
terms of this Agreement.

          2.5 “Product(s) Price” means the price for each dosage and package size of the
Product(s) as set out in Exhibit A.

          2.6 “Business Day” means any day other than Saturday, Sunday, or Federal Holiday in
the USA.

          2.7 “FDA” means the Food and Drug Administration of the U.S.A.

          2.8 “Initial Supply Period” means the period five (5) years commencing of the date of
the First Commercial Sale.

          2.9 “First Commercial Sale” means the first arm’s length purchase by CORNERSTONE of
the Product(s) from VINTAGE.

          2.10 “Manufacturing Standards” means applicable cGMP regulations and other applicable
governmental requirements.

          2.11 “Market” means to promote, advertise, distribute, and sell.

          2.12 “Parties” means CORNERSTONE and VINTAGE, and “Party” means either of them.

          2.13 “Packaging” means packaging of liquid and tablets into bottles, and the
applications of any necessary labeling.

          2.14 “Term” means the period of time this Agreement will remain in force unless
earlier terminated.

     3. PRICE AND PAYMENT

          3.1 Supply Price: VINTAGE shall invoice CORNERSTONE for Product(s) manufactured
hereunder according to the Product(s) Prices as set forth in Exhibit A attached hereto.

          3.2 Payment: CORNERSTONE shall pay all amounts due to VINTAGE under the terms of this
Agreement, the net invoice amount, in U.S. Dollars within thirty (30) days from the date of
VINTAGE’S invoice; provided, however, that invoices pertaining to the first order of each of the
Product(s) shall be due and payable within ninety (90) days from the date of VINTAGE’S invoice. Net
invoice amount shall be defined as the number of units of the Product(s) shipped multiplied by the
Product(s) Price.

          3.3 Renegotiation of Supply Price: CORNERSTONE and VINTAGE acknowledge that business
operating conditions and/or volumes may change, resulting in

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changes in the cost structure compared to what is currently envisioned. Therefore, for any
subsequent twelve (12) month period, on or before the anniversary dates of the commencement of the
term, both parties agree to an annual business review, the result of which may require amendments
to the stated pricing in Exhibit A and/or volume rebates/discounts given to CORNERSTONE.
Furthermore, VINTAGE reserves the right to increase the invoice price based upon increases in raw
material and/or component cost, or based upon the Consumer Price Index, whichever is greater.

     4. DELIVERY AND RISK OF LOSS

          4.1 The Product(s) shall be shipped freight collect, F.O.B. VINTAGE plant. CORNERSTONE has the
option to designate a carrier of choice for transportation of Product(s) from VINTAGE to a location
so designated on the purchase orders of CORNERSTONE. In the event CORNERSTONE does not designate
such carrier, VINTAGE will select a carrier of its choice. CORNERSTONE will bear all risk of loss,
delay, or damage in transit as may occur from time to time, as well as all insurance associated
with transit.

     CORNERSTONE shall have a period of seven (7) Business Days from date of receipt of the
Product(s) to inspect and reject all or part of any shipment of Product(s) on the grounds it does
not comply with the provision of Article 10.1. VINTAGE shall have the opportunity to confirm or
dispute such non-compliance through generally accepted quality control procedures. Claims relating
to quantity, quality, weight, condition and loss to any of the Product(s) sold under this Agreement
shall be waived by CORNERSTONE unless made within seven (7) Business Days of receipt of Product(s)
by CORNERSTONE.

     5. PRODUCT(S) DEVELOPMENT & MANUFACTURING

          5.1 Grant of Manufacturing Rights: CORNERSTONE hereby grants to VINTAGE the exclusive
right to manufacture the Product(s) for sale to CORNERSTONE. VINTAGE agrees not to enter into any
subcontracts or other agreements for the Product(s) in order to satisfy its obligations under this
Agreement without prior written approval from the CORNERSTONE.

          5.2 Exclusivity: During the Term of this Agreement VINTAGE shall supply the Product(s)
to CORNERSTONE exclusively, and CORNERSTONE shall purchase the Product(s) from VINTAGE exclusively.
CORNERSTONE agrees not to enter into any agreement (written or oral) or any subcontract, directly
or indirectly, itself or through any of its affiliates or subsidiaries, for the manufacture or
production of the Products, except as may be specifically permitted by Vintage under the terms of
this Agreement.

          5.3 Authorized Generic: The parties agree VINTAGE or one of its affiliates have the
exclusive right to manufacture and market an authorized generic version of the Product(s) from time
to time after a competing product with identical active ingredients and concentrations or a product
which has been declared generic to the Product(s) has been approved by FDA and has been
commercially offered and/or marketed by a competing company. VINTAGE or its affiliate may market an
authorized generic sooner if mutually agreed upon in

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writing. VINTAGE must receive CORNERSTONE’S authorization in writing before manufacturing and
marketing an authorized generic. If and when VINTAGE manufactures and markets an authorized generic
version of the Product(s), VINTAGE and CORNERSTONE agree to divide the net profits derived from
such marketing efforts [***]% due VINTAGE and [***]% due CORNERSTONE. Net profits shall be defined
as the number of pieces invoiced (shipped), multiplied by the net dollar amount for which each
piece was sold, which equals gross dollars, from which the following shall be deducted: cash
discounts, contractual rebates, CMS rebates, returns, chargebacks, VINTAGE transfer fee, and
unsaleable, short-dated or out-dated product which must be destroyed.

          5.4 Place of Manufacture: The Product(s) shall be Manufactured at VINTAGE plants
located at 150 VINTAGE Drive, Huntsville, AL 35811, and/or 3241 Woodpark Blvd., Charlotte, NC
28206, unless otherwise permitted by this Agreement.

          5.5 Product(s) Scale-Up: After successful stability studies have been completed and as
required by cGMP’s, VINTAGE will manufacture and package three (3) consecutive production batches
of all Product(s). VINTAGE will be responsible for all process validation and testing, including
stability testing, as needed to assure the process will consistently produce the Product(s) meeting
the specifications and quality requirements.

          5.6 Purchase of Raw Materials: VINTAGE shall purchase at its own expense and for its
own account all raw materials, including active pharmaceutical ingredients and excipients,
packaging components and other items of any nature that VINTAGE may use to manufacture the
Product(s).

          5.7 Raw Material and Finished Product(s) Testing: VINTAGE shall perform applicable
tests on all raw materials and packaging components associated with the Product(s). Additionally,
VINTAGE will perform finished Product(s) analytical analysis of each batch of Product(s) in
accordance with standard compendia requirements including the USP, to determine if the batches meet
finished Product(s) release specifications. If so, Product(s) will be released for commercial
distribution. At time of shipment of Product(s) to CORNERSTONE, VINTAGE shall forward to
CORNERSTONE a certificate of analysis for each batch of Product(s) shipped. VINTAGE shall retain
records of all testing of Product(s) in accordance with all State and Federal laws, and will
provide copies to CORNERSTONE upon written request. VINTAGE will keep a file retention sample(s) as
required from each batch of Product(s) manufactured and shall be maintained as required by cGMP’s.
All testing provided for in this Section 5.7 shall be at the expense of VINTAGE.

          5.8 Inspection Rights: VINTAGE shall, on an annual basis during the Term of this
Agreement, upon reasonable notice and at mutually convenient times during normal Business Days,
grant access to CORNERSTONE’S manufacturing, quality control and compliance inspectors or their
designees and allow such inspectors to inspect the manufacturing and quality control testing
operations and compliance procedures relating to the Product(s) and all records reasonably related
thereto.

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

5

 

          5.9 Stability Testing: VINTAGE shall produce one stability batch per year for each
package presentation, to be used for stability testing, and CORNERSTONE agrees to purchase at least
one batch per year to allow VINTAGE to conduct such stability testing. In addition, a file
retention sample from each lot of package Product(s) shall be maintained for a period of not less
than the expiration period of the Product(s) plus one year. VINTAGE shall maintain all records and
samples reasonably necessary to support cGMPs and other regulatory requirements in the United
States. All records related to the packaging, stability and quality control of Product(s) shall be
retained for a period not less than the expiration period of the Product(s) plus one year.
Compliance with the Section 5.10 shall be at the expense of VINTAGE.

          5.10 D.E.A. Quota: VINTAGE shall secure all necessary quota from the United States
Drug Enforcement Agency necessary to supply CORNERSTONE with Product(s).

     6. CHANGES

          6.1 In the event CORNERSTONE seeks to amend and/or supplement the components or Product(s)
listed in Exhibit A, or the manufacturing procedures and controls for the purpose of either
complying with cGMPs, incorporating improvements or any other reasonable business purpose,
CORNERSTONE shall notify VINTAGE in writing of the proposed amendment or supplement.

          6.2 Once written notice is obtained from CORNERSTONE of the proposed amendment or supplement
pursuant to Section 6.1, above, that may affect the Manufacture of Product(s), VINTAGE shall
promptly respond in writing to CORNERSTONE’S notice. VINTAGE’S response shall state the nature of
the change to the Manufacturing required to comply with such amendment and/or supplement, whether
such change is feasible, the date by which the change can be made and the change, if any, in the
costs of Manufacturing. The parties shall negotiate in good faith and attempt to agree in writing
to any change in the Product(s) price related to the Manufacturing change before any Manufacturing
change or any Product(s) price change becomes effective.

          6.3 In the event that VINTAGE seeks to make any substantive change in the Manufacturing
Process, VINTAGE shall submit to CORNERSTONE a request to authorize such change which request shall
set forth the change, if any, proposed in the supply price as a result of the proposed change as
well as any necessary regulatory approvals incident to the proposed change. VINTAGE shall not
implement such change without the written authorization of CORNERSTONE, which authorization may not
be unreasonably withheld.

     7. ARTWORK AND LABELING

          7.1 All design artwork shall be supplied by and be the property of CORNERSTONE and must be
compatible with VINTAGE packaging equipment. VINTAGE shall provide the required technical
specifications pertaining to design artwork for its packaging equipment. All packaging and labeling
shall be provided by VINTAGE at VINTAGE expense.

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In the event the CORNERSTONE seeks any changes in design artwork, CORNERSTONE will 1) use all
existing components in VINTAGE inventory before implementing new artwork, or 2) reimburse VINTAGE
for all component inventory cost on hand at time of change.

     8. TERM

          8.1 This Agreement shall be effective as of the Effective Date and shall continue in full
force and effect until the date, which is five (5) years from the Effective Date. The Parties may
extend the Term of this Agreement upon mutual agreement reduced to writing and signed by an
authorized representative of each Party. This Agreement will automatically renew thereafter, under
the same terms and conditions, for periods of one (1) year each unless notice is given by either of
the Parties one to the other at least one (1) year prior to the renewal date that the Agreement
will not be renewed.

     9. FORECASTS AND PURCHASE ORDERS

          9.1 CORNERSTONE shall furnish VINTAGE, not later than sixty (60) days prior to the beginning
of each calendar quarter, with updated estimates of its requirements for the following four (4)
calendar quarters.

          9.2 CORNERSTONE agrees to submit to VINTAGE its binding purchase orders for the Product(s) at
least ten (10) weeks prior to the anticipated date of shipment of the Product(s) by VINTAGE.
CORNERSTONE’S purchase orders shall designate the desired quantities of Product(s) in increments of
single batches for each presentation, , the delivery dates and the destination. In the event that
CORNERSTONE does not require full batch sizes, CORNERSTONE shall notify VINTAGE and request that
VINTAGE split the packaging of the batch between quantities set forth in two or more binding
orders. VINTAGE, at its sole discretion, may decline such request. VINTAGE shall ship all orders of
Product(s) in accordance with CORNERSTONE’S instructions. Should Product(s) from the remainder of a
split batch Manufactured and packaged by VINTAGE to meet CORNERSTONE’S orders remain undelivered to
CORNERSTONE, CORNERSTONE shall remain obligated either to purchase such remainder of the batch or
pay to VINTAGE an invoice amount defined as the number of units of Product(s) that remain
undelivered multiplied by the Product(s) Price, within sixty (60) days from the date of VINTAGE’S
invoice, for such remainder of the batch regardless of the expiration date of such remainder.

          9.3 VINTAGE agrees to make commercially reasonable efforts to fill the orders placed by
CORNERSTONE for the Product(s), subject, however, to VINTAGE’S production capacities, supply of raw
materials and availability of labor and transportation (all of which VINTAGE shall use commercially
reasonable efforts to maintain). Accordingly, all orders for the Product(s) shall be subject to
acceptance by VINTAGE, which acceptance shall not be unreasonably withheld. Should Product(s) be
available, VINTAGE may ship Product(s) up to [***] days prior to a due date.

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

7

 

          9.4 VINTAGE will order all necessary raw materials and primary and secondary packaging
components based on the lead time required to fill CORNERSTONE’S forecasted requirements. Subject
to CORNERSTONE’S rights under Section 9.2, above, CORNERSTONE agrees to purchase from VINTAGE all
Product(s) manufactured for CORNERSTONE by VINTAGE in accordance with CORNERSTONE’S purchase
orders. In the event CORNERSTONE requests a change in artwork, or upon termination of this
Agreement, CORNERSTONE shall purchase any inventory of Product(s) Manufactured for it by VINTAGE
and remaining as of the date of termination along with any components, printed labeling, packaging
materials and containers, at VINTAGE’S cost, and without markup, that VINTAGE acquired and/or
prepared based upon forecasts provided by CORNERSTONE pursuant to this Agreement. CORNERSTONE shall
purchase from VINTAGE any inventory of packaging components rendered obsolete as a result of a
change. In the event of any such change or termination by VINTAGE, CORNERSTONE shall be relieved of
any payment obligation it may have to VINTAGE for any inventory at VINTAGE of Product(s),
components, printed labeling, packaging materials and containers rendered obsolete because of such
change or termination by VINTAGE.

     10. WARRANTIES

          10.1 VINTAGE warrants that it will Manufacture Product(s) in accordance with the Federal Food,
Drug and Cosmetic Act and cGMPs and that delivered Product(s): (a) will be in material compliance
with standard compendia and the quality and release criteria developed for each specific
Product(s), (b) will not be adulterated within the meaning of the Federal Food, Drug and Cosmetic
Act, and (c) will not be the subject to any notice directed specifically at VINTAGE from any court
or other competent governing body with respect to the Product(s) that such Product(s) is in
material violation of any law, regulation, order, decree or ruling of or restriction imposed by any
judicial, governmental or regulatory body or agency.

     11. LIMITATIONS ON DAMAGES

          11.1 Notwithstanding any other provisions of this Agreement, including but not limited to any
provisions of this Agreement pursuant to which one Party agrees to indemnify the other Party, in no
event shall either Party be liable to the other for any incidental, consequential or special
damages suffered by such Party, including without limitation, loss of profit or revenues, as a
result of any breach of this Agreement or arising in connection with this Agreement or any patent
or trademark of the Product(s).

     12. PATENT/TRADEMARK INDEMNITY

          12.1 VINTAGE shall indemnify and hold CORNERSTONE harmless from all costs, damages and
expenses (including reasonable attorney’s fees) arising out of any suit or action brought against
CORNERSTONE based upon a claim that any process or technical data furnished by VINTAGE infringes a
U. S. patent or any other proprietary rights.

          12.2 CORNERSTONE will indemnify and hold VINTAGE harmless from all costs, damages and expenses
(including reasonable attorney’s fees) arising out of any suit or

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action against VINTAGE based on a claim that the manufacturing process provided by CORNERSTONE
and the sale or distribution of the Product(s) by CORNERSTONE infringes a U.S. patent(s). VINTAGE
reserves the right to defend itself against such claims.

          12.3 CORNERSTONE will indemnify and hold VINTAGE harmless from all damages, costs and expenses
(including reasonable attorneys’ fees) arising out of any claim, suit or action brought against
VINTAGE based on a claim that the trademark appearing on the labeled packaging materials, or the
use, sale, advertising or distribution of the Product(s) infringes a trademark, trade name, or
trade dress of others. CORNERSTONE shall promptly assume responsibility for the defense of any
claim, suit or action brought against VINTAGE pursuant to this subsection. VINTAGE reserves the
right to defend itself against any such action.

     13. GENERAL INDEMNITIES

          13.1 VINTAGE will indemnify and hold CORNERSTONE harmless from any and all liability, damage,
loss, cost or expenses (including reasonable attorney’s fees) resulting from any third party claims
made or suits brought against CORNERSTONE which arise from VINTAGE’S negligence in the manufacture
of Product(s) hereunder or VINTAGE’S breach of the warranty set forth in Article 10.1 hereof. Upon
filing of any such claim or suit, CORNERSTONE shall immediately notify VINTAGE.

          13.2 CORNERSTONE will indemnify and hold VINTAGE harmless from any and all liability, damage,
loss, cost or expense (including reasonable attorney’s fees) resulting from any third party claims
made or suits brought against VINTAGE which arise from CORNERSTONE’S formulation, handling,
distribution or sale of Product(s). Upon filing of any such claim or suit, VINTAGE shall
immediately notify CORNERSTONE.

          13.3 The applicable provisions of Sections 13.1 and 13.2, and the Limitations on Damages set
forth in Section 11.1, above, shall also apply to VINTAGE’S production and CORNERSTONE’S use of the
Product(s) produced from batches manufactured pursuant to Section 5.8, above.

     14. REGULATORY FILINGS AND APPROVALS

          14.1 CORNERSTONE will be responsible for filing any and all annual product reports, quarterly
and annual adverse drug events, field alerts, supplements, and any other reports or filings as may
be required from time to time by the FDA.

     15. FORCE MAJEURE

          15.1 CORNERSTONE and VINTAGE shall not be considered in default of their obligations
hereunder, except for obligations with respect to payment, to the extent that performance of such
obligations is delayed, hindered or prevented by Force Majeure.

     16. TERMINATION

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          16.1 In the event that either Party hereto shall at any time commit a material breach of any
of its obligations hereunder, the non-breaching Party may, at its option, terminate this Agreement
by giving the other Party at least ninety (90) calendar days prior written notice. Unless the
breaching Party cures the breach and provides written notice of such cure within the aforesaid
notice period, this Agreement shall be deemed terminated.

          16.2 Any termination of this Agreement shall not release the Parties from liabilities and
obligations accrued as of the date thereof including but not limited to CORNERSTONE’S reimbursement
of VINTAGE’S cost of materials purchased for the Product(s) prior to notice of termination,
including but not limited to active pharmaceutical ingredient purchased by VINTAGE in accordance
with Section 5.1, above.

     17. NON-WAIVER OF RIGHTS

          17.1 Failure by VINTAGE or CORNERSTONE at any time to enforce any of the terms or conditions
of this Agreement shall not affect or impair such terms or conditions in any way, or the right of
VINTAGE or CORNERSTONE at any time to avail itself of such remedies as it may have for any breach
of such terms or conditions under the provisions of this Agreement, in equity or at law.

     18. TRADEMARKS AND TRADE NAMES

          18.1 Each Party hereby acknowledges that it does not have, and shall not acquire, any interest
in any of the trademarks or trade names of the other Party unless otherwise expressly agreed upon
in writing by the parties.

          18.2 CORNERSTONE agrees not to use any trade names or trademarks of VINTAGE including but
without limitation the trade name and trademark “VINTAGE,” except as specifically authorized by
VINTAGE in writing both as to the names or marks, which may be used, and as to the manner and
prominence of use. Without limiting the generality of the foregoing, CORNERSTONE agrees not to
identify the name VINTAGE or the name of any affiliated company thereof on the label of the
Product(s) except as the manufacturer or otherwise without the express written consent of VINTAGE.

     19. CONFIDENTIALITY

          19.1 VINTAGE and CORNERSTONE realize that that information disclosed by one Party to the other
pursuant to this Agreement may be confidential. It is therefore agreed that all information
disclosed by one Party to the other, which is oral or in writing shall not be disclosed by the
receiving Party to any third party and shall not be used by the receiving Party for purposes other
than those contemplated by this Agreement, from the date this Agreement is signed, during the Term
of this Agreement and for a period of five (5) years from and after the date of termination or
expiration of this Agreement. For purposes of this Article 19.1, all such information which a Party
is obligated to retain in confidence shall be called “Information.”

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          19.2 The obligations set forth above shall not apply to any information disclosed by one Party
to the other, either in anticipation of or pursuant to this Agreement,

               (a) which was in the public domain at the time of the disclosure to the receiving Party, or
which thereafter fell into the public domain without any fault of the receiving Party;

               (b) which the receiving Party rightfully had in its possession prior to the disclosure by the
disclosing Party;

               (c) which is developed by the receiving Party independently;

               (d) which is inherently or necessarily disclosed to the public by the display or commercial
sale of Product(s), by the issuance of a related patent by judicial order, or in compliance with
the lawful requirements of the Department of Health and Human Services of the United States; or

               (e) which the receiving Party finds it reasonably necessary or appropriate to disclose to its
consultants or outside contractors in order to fulfill its obligations or to exercise its rights
hereunder on condition that such entities or persons agree (i) to keep the information confidential
for the same period and to the same extent as the receiving Party is required to keep such
Information.

     In the event that a Party is required by a court or governmental agency or pursuant to
subpoena or other compulsory process to disclose the disclosing Party’s Information, it shall
notify the disclosing Party prior to disclose and use reasonable efforts to obtain a protective
order or otherwise protect the confidentiality of such Information.

          19.3 Confidentiality of Terms. Except to the extent otherwise provided by law or the
terms of this Agreement or mutually agreed upon by the parties hereto, each Party shall treat as
confidential the existence of, and the terms and conditions set forth in, this Agreement.

     20. NOTICES

          20.1 Any notice required to be given herein shall be deemed to have been sufficiently given to
either Party for all of the purposes hereof if given by telephone or telefax and confirmed by
registered mail, postage prepaid, addressed as follows:

	 	 	 
	TO VINTAGE:

	 	Vintage Pharmaceuticals, LLC.
	 

	 	130 VINTAGE Drive
	 

	 	Huntsville, AL 35811
	 

	 	Attn: William S. Propst, Jr., President
	 

	 	Facsimile No.: (256) 859-2903

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	TO CORNERSTONE:

	 	Cornerstone Pharmaceuticals, Inc.
	 

	 	8000 Regency Parkway, Suite 430
	 

	 	Cary, NC 27511
	 

	 	Attn: Craig A. Collard, President
	 

	 	Facsimile No.: (919) 462-0565
	 

	 	(919) 462-0566.

or to such other address as either of the parties shall designate by notice given as herein
required. Notices shall be effective upon receipt.

     21. AMENDMENTS AND WAIVER

          21.1 This Agreement cannot be amended in any respect except in writing duly executed by both
Parties. No waiver or compliance with any provisions or conditions of this Agreement and no
approvals provided for in this Agreement shall be effective unless evidenced by a written
instrument executed by the Party to be charged.

     22. ASSIGNMENT

          22.1 Neither Party hereto shall assign this Agreement or any part thereof or any interest
herein without the written approval of the other Party hereto except (i) that VINTAGE may assign
this Agreement to Qualitest Pharmaceuticals, Inc., QV Pharmaceuticals, Inc. or any other entity
affiliated with VINTAGE or successor to VINTAGE.

     23. GOVERNING LAW

          23.1 This Agreement shall be construed in accordance with the laws of the State of Alabama,
without regard to the conflicts of law, rules or principles thereof.

     24. ENTIRE AGREEMENT

          24.1 This Agreement constitutes the entire understanding between the Parties and shall
supersede any prior agreements between the Parties hereto. Each Party acknowledges that mere are no
other understandings, which relate to the matters covered herein or which are inconsistent with any
provisions of this Agreement.

     25. DISPUTE RESOLUTION

          25.1 In the event that a dispute arises between the Parties as to the interpretation or
performance of any of the provisions of this Agreement, the President of VINTAGE and President of
CORNERSTONE shall consult initially to try and resolve the matter amicably. If they cannot resolve
the dispute within thirty (30) days of it being referred to them, the matter shall be submitted to
binding arbitration before a single arbitrator pursuant to Delaware law and the then prevailing
rules of the American Arbitration Association for the Arbitration of Commercial Disputes in an
arbitration held in Huntsville, Alabama.

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     26. EXHIBITS INCORPORATED BY REFERENCE

          26.1 All exhibits to this Agreement are hereby incorporated by reference, and made a part
hereof, as if fully set forth in this Agreement.

     IN WITNESS WHEREOF, the parties hereto have executed this Agreement in duplicate effective as
of the date of the latest of the signatures hereto.

	 	 	 	 	 	 	 	 	 
	Cornerstone Pharmaceuticals, Inc.	 	 	 	Vintage Pharmaceuticals, LLC
	 
	 	 	 	 	 	 	 	 
	By:

	 	/s/ Craig Collard
 

	 	 
	 	By: /s/ William S. Propst, Jr.
 

	 	 
	Title:

	 	President and CEO
	 	 	 	Title: President	 	 
	Date:

	 	7/20/04
	 	 	 	Date: 7-20-2004	 	 

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Exhibit A 

Product(s) Pricing

	 	 	 	 	 	 	 	 	 
	Product	 	Size	 	Invoice Price
	Propoxyphene Napsylate/APAP 100/325mg Tablet
	 	 	100	 	 	 	[***]	 
	Propoxyphene Napsylate/APAP 100/325mg Tablet
	 	 	500	 	 	 	[***]	 
	Propoxyphene Napsylate/APAP 100/325mg Tablet
	 	 	1000	 	 	 	[***]	 
	Propoxyphene Napsylate/APAP 100/500mg Tablet
	 	 	100	 	 	 	[***]	 
	Propoxyphene Napsylate/APAP 100/500mg Tablet
	 	 	500	 	 	 	[***]	 
	Propoxyphene Napsylate/APAP 100/500mg Tablet
	 	 	1000	 	 	 	[***]	 

Other sizes to be mutually agreed upon

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.exv10w6

Exhibit 10.6

LICENSE AND SUPPLY AGREEMENT

THIS AGREEMENT is made and entered into as of this 12th day of October, 2006 by and between:

Meiji Seika Kaisha, Ltd., a company organized and existing under the laws of Japan and having its
principal place of business at 4-16, Kyobashi 2-chome, Chuo-ku, Tokyo 104-8002 Japan (hereinafter
referred to as “Licensor”), and

Cornerstone BioPharma Inc., a company organized and existing under the law of Nevada and having its
principal place of business at 2000 Regency Parkway, Suite 255 Cary, North Carolina, 27518 USA
(hereinafter referred to as “Licensee”).

WITNESSETH:

WHEREAS, Licensor has developed a cephalosporin antibiotic known as Cefditoren Pivoxil; and

WHEREAS, Licensor and Purdue Pharmaceutical Products L.P. (“Purdue”) entered into the License
Agreement dated March 20, 2003 (“Purdue License Agreement”) wherein Licensor granted to Purdue a
license to manufacture and commercialize the product containing Cefditoren Pivoxil in the United
States, Puerto Rico and Canada; and

WHEREAS, under the Purdue License Agreement, Purdue has acquired and owns certain registrations for
the product containing Cefditoren Pivoxil in the United States and has conducted marketing
activities for such product in the United States; and

WHEREAS, Licensor and Purdue entered into the Settlement Agreement dated March 31, 2006, pursuant
to which, the Purdue License Agreement will terminate effective upon the earlier to occur of the
date on which Licensor and a new partner introduced by Purdue enter into a license
agreement with respect to the product containing Cefditoren Pivoxil in the United States or October
31, 2006; and

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

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WHEREAS, Licensee is a new partner introduced by Purdue; and

WHEREAS, Licensor and Licensee entered into the Confidentiality Disclosure Agreement dated
September 1, 2006 (the “Confidentiality Disclosure Agreement”) to enable Licensee to evaluate its
interest in obtaining a license from Licensor for commercializing the product containing Cefditoren
Pivoxil in the United States; and

WHEREAS, as a result of the said evaluation, Licensee has indicated its desire to obtain an
exclusive license to commercialize the product containing Cefditoren Pivoxil in the United States
with benefits of the transfer of the registrations for such product from Purdue, and Licensor is
willing to grant such license to Licensee; and

WHEREAS, Licensor and Licensee entered into the Letter of Intent dated September 13, 2006 (“Letter
of Intent”) to confirm their intent to enter into a license and supply agreement for the product
containing Cefditoren Pivoxil in the United States and to set forth basic terms and conditions for
such agreement; and

WHEREAS, after further discussion and negotiation, Licensor and Licensee have reached agreement on
detailed terms and conditions for such license and supply agreement.

NOW, THEREFORE, it is hereby agreed by the parties hereto as follows:

Article 1. Definitions

For the purpose of this Agreement, the following terms shall have the following meanings:

	(a)	 	The term “API” shall mean Compound in amorphous powder form ready to be formulated.

	(b)	 	The term “API Specifications” shall mean the specifications and analytical method relating to
the API attached hereto as Annex A.

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	(c)	 	The term “Compound” shall mean a cephalosporin antibiotic known as Cefditoren Pivoxil (INNM)
developed and invented by Licensor.
	 
	(d)	 	The term “Launching Date” shall have the meaning as set forth in Paragraph 2 of Article 4.
	 
	(e)	 	The term “Net Sales” shall mean the amount invoiced by Licensee for the sale of the Product
to customers in the Territory less: (i) cash, trade and quantity discounts allowed; (ii)
credits and allowances for returns, rejections and chargebacks; (iii) costs incurred for
freight, insurance and transportation; (iv) sales and use taxes, duties or other government
tariffs and other similar taxes incurred and government mandated rebates; and (v) estimated
contract rebates and bid rebates (which shall be adjusted to reflect actual rebates on a
periodic basis); all of which shall be determined in accordance with U.S. generally accepted
accounting practices.
	 
	(f)	 	The term “Patents” shall mean (i) all U.S. patents listed in Annex B attached hereto and (ii)
all other patents relating to the Compound and/or the Product which Licensor may obtain in the
Territory during the term of this Agreement.
	 
	(g)	 	The term “Product” shall mean the pharmaceutical product containing the Compound as an active
ingredient in the finished form suitable for use by ultimate customers, as identified by the
Product Registrations.
	 
	(h)	 	The term “Product Registrations” shall mean the registrations of the Product granted by the
United States Food and Drug Administration, as listed in Annex C attached hereto.
	 
	(i)	 	The term “Technical Information” shall mean pre-clinical and clinical data and other
technical and scientific data, know-how and information pertaining to the Compound and the
Product which are available to Licensor as of the date of this Agreement or will subsequently
be available to Licensor during the term of this Agreement and which are

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	 	 	useful or necessary for due performance of this Agreement, including all data, know-how and
information heretofore furnished to Licensee by Licensor under the Confidentiality
Disclosure Agreement. Technical Information shall not include any technical information and
know-how pertaining to the manufacturing process or method of the Compound.
	 
	(j)	 	The term “Territory” shall mean the United States, its territories and possessions, including
Puerto Rico.
	 
	(k)	 	The term “Trademark” shall mean “SPECTRACEF®” owned by Licensor in the Territory.

Article 2. Grant of License

1. Subject to the terms and conditions set forth below, Licensor hereby grants Licensee, and
Licensee hereby accepts from Licensor, an exclusive license to manufacture or have manufactured the
Product from the API supplied by Licensor and to offer to sell, sell, and have sold such Product in
the Territory under the Patents, the Technical Information and the Product Registrations.

2. Licensee shall have the right to co-promote the Product in the Territory with a third party
approved by Licensor in writing and in advance. In the event that Licensee desires to enter into
co-promotion arrangements with any third party, Licensee shall notify Licensor of details of such
third party including information showing such third party’s ability to co-promote the Product and
shall seek Licensor’s written approval, such approval not to be unreasonably withheld or delayed.

Article 3. Supply of Technical Information

1. Within thirty (30) days after the execution of this Agreement, Licensor shall furnish Licensee
with the Technical Information which Licensor deems useful or necessary for due

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performance of this Agreement. The information will be updated from time to time during the term of
this Agreement.

2. Further, from time to time during the term of this Agreement, Licensor shall furnish Licensee
with additional Technical Information then available to Licensor to the extent that such Technical
Information is deemed by Licensor as useful or necessary for due performance of this Agreement.

3. Should, during the term of this Agreement, it become evident that any data or information not
then available to Licensor is necessary for due performance of this Agreement, then the parties
hereto shall, in good faith, consult with each other with respect thereto.

4. During the term of this Agreement, Licensee shall furnish Licensor without charge, for
unrestricted use by Licensor and/or its licensees, with all data and information obtained or
acquired by Licensee relating to or necessary for use of the Compound and the Product as a
pharmaceutical product.

Article 4. Transfer of Product Registrations — Launch

1. Promptly upon execution of this Agreement, Licensor shall instruct Purdue to transfer the holder
status of the Product Registrations to Licensee free of charge. If the holder status of the Product
Registrations has already been transferred from Purdue to Licensee prior to execution of this
Agreement as permitted by the Letter of Intent, Licensor shall admit that the holder status of the
Product Registrations has been transferred from Purdue to Licensee.

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2.

	(a)	 	Within sixty (60) days after completion of transfer of the holder status of the Product
Registrations from Purdue to Licensee or, if the holder status of the Product Registrations
has already been transferred from Purdue to Licensee prior to execution of this Agreement,
then within sixty (60) days after execution of this Agreement, Licensee shall commence
promotion of the Product in the Territory.
	 
	(b)	 	If Licensee has purchased or subsequently purchases the Product from Purdue, Licensee may
immediately initiate sale of such Product in the Territory. Licensee shall have no liability
for and no obligation to accept any return of Product sold by Purdue or any other party prior
to the effective date of this Agreement.
	 
	(c)	 	The “Launching Date” means the earlier of (i) January 1, 2007 or (ii) the date that Licensee
receives samples of the Product in form and quantity suitable for detailing physicians. The
Launching Date shall be confirmed in writing between Licensor and Licensee promptly upon
occurrence thereof.

Article 5. License Fee and Royalty Payment

1. In consideration for the licenses granted to Licensee under Article 2, Licensee shall pay to
Licensor a non-refundable license fee (hereinafter referred to as the “License Fee”) in the total
amount of US$6,000,000 payable in the following installments:

1st
payment: US$250,000 within thirty (30) days after execution of this Agreement,

2nd payment: US$1,000,000 on the first anniversary date of this Agreement,

3rd payment: US$1,000,000 on the second anniversary date of this Agreement,

4th payment: US$1,000,000 on the third anniversary date of this Agreement,

5th payment: US$1,250,000 on the fourth anniversary date of this Agreement,

6th payment: US$1,500,000 on the fifth anniversary date of this Agreement.

If, at any time until the fifth anniversary date of this Agreement, a generic Cefditoren is
launched in the Territory, then Licensee shall be released from the obligation to pay the portion
of the

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License Fee that comes due after such generic launch and the minimum purchase requirements under
Article 8 shall no longer apply.

2. In consideration for the licenses granted to Licensee under Article 2, Licensee shall pay to
Licensor a running royalty of [***] percent ([***] %) of the Net Sales of the Product for a period
often (10) years from the Launching Date. If Licensee sells the Product before the Launching Date,
Licensee shall pay to Licensor a running royalty of [***] percent ([***] %) of the Net Sales of the
Product generated from such sales as well.

3. Licensee shall pay the running royalty to Licensor in the currency of United States Dollar
within sixty (60) days after the end of each calendar quarter. Each payment of the running royalty
shall be accompanied by a statement which sets forth the gross sales, the Net Sales, the quantity
of the Product sold and the running royalty payable for the applicable calendar quarter.

4. Licensee shall keep and maintain books and records relating to sales of the Product made under
this Agreement so that the running royalty payable and the royalty statement may be verified. Upon
thirty (30) days’ prior written notice to Licensee, on a day and at a time reasonably acceptable to
Licensee during normal business hours, Licensor may audit such books and records through an
independent certified public accountant selected by Licensor and accepted by Licensee, which
approval shall not be unreasonably withheld. Such certified public accountant shall execute a
written non-disclosure agreement reasonably acceptable to Licensee. Such audit shall occur no more
often than once any calendar year and shall be limited to such of Licensee’s records as may be
necessary to determine, in respect of any calendar quarter ending not more than three years prior
to the date of such request, the correctness of any report and/or payment made under this
Agreement. Expenses for such certified public accountant shall be borne by Licensor, provided that
if such audit reveals more than five percent (5%) underpayment of the running royalty payable,
expenses for said accountant shall be borne by Licensee.

5. The License Fee and the running royalty due Licensor hereunder shall be paid by remitting to the
bank account designated by Licensor.

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

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Article 6. Notice of Adverse Reactions

With respect to details of the mechanism and procedures for notice of adverse reactions regarding
the Product, Licensor and Licensee shall enter into a separate agreement in writing.

Article 7. Supply of API

1. Subject to the terms and conditions of this Agreement, Licensor shall sell the API to Licensee,
and Licensee shall purchase the API exclusively from Licensor during the term of this Agreement.

	2.	 	Supply Price of API
	 
	(a)	 	For the first year from the Launching Date, the supply price of API shall be [***]/kg
(potency) C.I.P. San Juan, or such other destination as may be agreed by Licensor and Licensee
(which agreement shall not be unreasonably withheld), by air and shall be subject to the
adjustment based on the foreign exchange fluctuation set forth in (c) below.
	 
	(b)	 	On or before the first date of each and every six (6) month period after the first year from
the Launch Date, Licensee shall provide Licensor with an updated Licensee’s ex-factory price
of the Product. Effective on the first date of each and every such six (6) month period, the
supply price of subsequent purchases of API shall be revised to be the greater of (i) [***]/kg
(potency) or (ii) the supply price of API calculated in accordance with the following formula,
subject to the adjustment based on the foreign exchange fluctuation set forth in (c) below:

Future Supply Price of API = {{[0.5] x [(the updated Cornerstone’s ex-factory price
of the Product divided by the previous Cornerstone’s ex-factory price of the
Product) – (1)]} + 1} x {current supply price of API}

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

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	(c)	 	In the event that the exchange rate of the US$ to the Japanese Yen as of the date on which
any firm written order for the API is placed by Licensee (the “Exchange Rate”) fluctuates more
than [***] above or below the exchange rate of US$l=Japanese Yen

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

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[***], then the supply price of API in respect of such order shall be adjusted in accordance
with the following formula:

Supply Price of API Adjusted by Exchange Rate={[(current supply price of API x
Japanese Yen [***]/US$) + (current supply price of API x the Exchange Rate)] divided
by 2} divided by the Exchange Rate

(d) In the event that the transactions of API are not feasible for Licensor and/or Licensee from an
economical reason(s) with the supply price of API which is generated from the calculation method
described in above (b) and/or (c) and it is deemed that Licensor and/or Licensee is unable to
continue the transactions of API from the said reason(s), Licensor and Licensee shall discuss in
good faith measures to be taken to cope with such situation, such measures may include sourcing API
from third-party manufacturers.

(e) The payment terms for the API for one-year period from the Launching Date shall be advance
payment by T.T. remittance to the bank designated by Licensor. Thereafter, the payment terms for
the API shall be by Letter of Credit confirmed by a first-class bank within thirty (30) days after
B/L date.

3. Licensee shall place a firm order for the API at least three (3) months prior to a desired
shipping date for the API. Licensor shall use commercially reasonable efforts to ship API within
five (5) days of the desired shipping date and in amounts not less than ninety five percent (95%)
of the amount ordered. By the first day of each month, Licensee shall submit to Licensor a
non-binding six (6) months rolling purchasing forecast of the API which shall be the best estimates
of Licensee but which shall not be binding upon Licensee.

4. One quantity unit for an order for the API shall be 320kg (potency).

Article 8. Minimum Purchase of AP

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

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For each year during the five (5) year period from the Launching Date, Licensee shall agree to
purchase the API from Licensor sufficient to support the targeted gross sales of the Product listed
below.

Year
1 - $8,000,000

Year 2 - $11,000,000

Year 3 - [***]

Year 4 - [***]

Year 5 - [***]

The minimum purchase quantity in each year shall be set at 80% of the quantity of API required to
produce the Product in the quantity equivalent to the respective targeted sales above. However,
with respect to Year 1, if Licensee purchases the Product of 60ct 200mg tablets/bottle from Purdue,
the quantity of API equivalent to such Product purchased from Purdue shall be deducted from the
minimum purchase quantity in Year 1. If Licensee’s purchases of API are less than the annual
minimum purchase quantity defined above, Licensee shall pay to Licensor an amount calculated in
accordance with the following formula:

(Minimum Purchase Quantity — Actual Purchase Quantity) x Then Current API price x
50%

In addition to the above mentioned payment, in case it is deemed that Licensee is not able to
achieve the above targeted gross sales in any year of the above five (5) year period, Licensor and
Licensee shall discuss in good faith measures to be taken to cope with such situation, which may
include Licensee changing an existing co-promotion agreement or entering into a new co-promotion
arrangement to co-promote the Product with Licensee.

Article 9. Sales Promotion

1. Licensee agrees to do all reasonable efforts to obtain the largest possible sales turnover of
the Product in the Territory.

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

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2. Licensee shall promote at its own expense the sale of the Product efficiently and continuously
by, for example, distributing scientific literature and samples, by advertising in professional
publications, by detailing doctors and hospitals, and by any other suitable means.

Article 10. Sales Report

Licensee shall, within thirty (30) days after the end of each quarter, submit to Licensor a
quarterly sales report showing quantity of the Product sold during the preceding quarter and
quantity of stock of the Product.

Article 11. Trademark

1. Subject to the terms and conditions set forth below, Licensor hereby grants Licensee an
exclusive and non-transferable (except as permitted pursuant to Paragraph 2(a) of Article 15)
license to use the Trademark for or in connection with sale and promotion of the Product in the
Territory, and Licensee agrees to use the Trademark for such purpose. Notwithstanding the
foregoing, Licensee shall be permitted to grant co-promotion partners (approved by Licensor under
Paragraph 2 of Article 2) the right to use the Trademark in connection with the sale and promotion
of the Product. Licensor represents that as of the date of this Agreement, Licensor has no actual
knowledge that use of the Trademark in connection with the sale and promotion of the Product by
Licensee in the Territory will infringe any third party rights. In addition, Licensee shall be
permitted to use any Uniform Resource Identifier (“URI”) or domain names that correspond to the
Product in the Territory, and to control the content of any resources intended for viewing in the
Territory accessed under such URI or domain names on the World Wide Web, provided that in respect
of the use of each URI or domain name, Licensee shall obtain prior written approval from Licensor.

2. Licensee acknowledges that the Trademark shall always remain the property of Licensor. Licensor
shall be exclusively responsible for the payment of the maintenance costs of the Trademark.
Licensee shall not do anything which is likely to diminish or impair the image and

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value of the Trademark. With respect to use of the Trademark, Licensee shall comply with all
instructions given by Licensor.

3. Licensee shall furnish Licensor with copies of its representative promotional materials,
packages and package insertions to be used for the Product for Licensor’s inspection and approval
in advance of the distribution by Licensee in the Territory. If within five (5) business days after
receipt of such materials by Licensor or its designee, Licensor does not inform Licensee in writing
of its decision, such material shall be considered as approved by Licensor.

The inspection and approval referred to in the previous paragraph shall be limited to verifying the
correct use of the Trademark in the promotional materials and shall not be unreasonably withheld.

4. Should it come to the knowledge of Licensee that the Trademark is disputed or infringed by any
third party in the Territory, Licensee shall promptly inform Licensor thereof and shall give
Licensor, when so requested by Licensor, every reasonable assistance, at Licensor’s expense, in
taking appropriate steps as deemed necessary by Licensor to protect the Trademark.

5. If any legal proceedings are brought or threatened against Licensee or its customers in the
Territory alleging that the use of the Trademark for sale and promotion of the Product in the
Territory infringes any rights of a third party, Licensor agrees to indemnify and hold harmless
Licensee against such proceedings on condition that:

(i) Licensee shall promptly notify Licensor of the institution or threat of such proceedings in
order that Licensor may have the maximum amount of time to prepare a proper response or defense;

(ii) Licensor shall have the right to manage and control all aspects of responding to and defending
such proceedings or threatened proceedings including selection of lawyers in all phases of
litigation;

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(iii) Licensee shall, upon Licensor’s request and at Licensor’s expense, fully cooperate with
Licensor in responding and defending such proceedings or threatened proceedings;

(iv) Licensee shall not without Licensor’s written consent:

	 	(A)	 	make any admission of liability to the third party in respect of such
proceedings or threatened proceedings; and
	 
	 	(B)	 	make or purport to make any settlement of such proceedings or threatened
proceedings; and

(v) If either Licensor or Licensee concludes on the basis of an opinion provided by its legal
counsel that continued use of the Trademark would violate a third party’s rights, Licensor shall
designate a different trademark for use by Licensee. If Licensee agrees to use such substitute
trademark designated by Licensor, the license granted to Licensee under Paragraph 1 of Article 11
shall be understood to apply to the substitute trademark. If Licensee does not agree to use such
substitute trademark designated by Licensor, then each of Licensor and Licensee shall have the
right to terminate this Agreement, provided that upon termination by either party, Licensor shall
buy back the Product and the API then remaining in Licensee’s stock in good conditions at the cost
price.

Further, in the event of such proceedings or threatened proceedings, if Licensee agrees to continue
sales of the Product under a substitute trademark designated by Licensor, Licensor shall be
responsible for all costs required for such change of trademark.

Article 12. Patent

1. Licensor makes no warranty that purchase, possession, use or sale of the Product by Licensee in
the Territory will not infringe any third party patents. However, Licensor represents that as of
the date of this Agreement, Licensor has no actual knowledge that purchase, possession,
manufacture, use or sale of the Product by Licensee in the Territory will infringe any

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third party patents. If any legal proceedings are brought or threatened against Licensee or its
customers in the Territory alleging that the sale or offer for sale by Licensee in the Territory of
the Product infringes any patent of a third party, Licensor agrees to indemnify and hold harmless
Licensee against such proceedings on condition that;

(i) Licensee shall promptly notify Licensor of the institution or threat of such proceedings in
order that Licensor may have the maximum amount of time to prepare a proper response or defense;

(ii) Licensor shall have the right to manage and control all aspects of responding to and defending
such proceedings or threatened proceedings including selection of lawyers in all phases of
litigation. Licensee shall be entitled to participate in such proceedings or threatened proceedings
through counsel of its own choosing and at its own expense, but shall not control the defense of
such proceedings or threatened proceedings;

(iii) Licensee shall, upon Licensor’s request and at Licensor’s expense, fully cooperate with
Licensor in responding to and defending such proceedings or threatened proceedings;

(iv) Licensee shall not without Licensor’s written consent:

	 	(A)	 	make any admission of liability to the third party in respect of such
proceedings or threatened proceedings; and
	 
	 	(B)	 	make or purport to make any settlement of such proceedings or threatened
proceedings.

If any legal proceedings are brought or threatened against Licensee or its co-promoter or their
customers in the Territory alleging that the sale or offer for sale by Licensee in the Territory of
the Product infringes any patent of a third party, and Licensee and Licensor cannot resolve the
matter to their mutual satisfaction within six (6) months, then each of Licensor and Licensee shall
have the right to terminate this Agreement, provided that upon termination Licensor shall

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buy back the Product and the API then remaining in Licensee’s stock in good conditions at the cost
price.

2. Should it come to the knowledge of either party that any of the Patents is disputed or infringed
by any third party in the Territory, the party learning of the infringement or dispute shall
promptly inform the other party. Licensee shall give Licensor, when so requested by Licensor, every
assistance in taking appropriate steps as deemed necessary by Licensor to protect the Patents.
Licensor shall have the first right, but not the obligation, to initiate an action to terminate
infringement of the Patents at its expense. If Licensor does not initiate such infringement action
within sixty (60) days after being informed by Licensee of infringement, Licensee shall have the
right, but not the obligation, to initiate such infringement action. The party who does not
initiate such infringement action shall fully cooperate with the initiating party in pursuing such
infringement action. Any damages or other monetary awards recovered from an infringer by the
Licensor in such infringement action shall, after deducting therefrom reasonable out-of-pocket
expenses incurred by Licensor (including attorney’s fees), be shared equally by the parties. Any
damages or other monetary awards recovered from an infringer by Licensee in such infringement
action shall be retained by Licensee.

3. The parties shall cooperate with each other in connection with any claim, suit or proceeding
brought under either Paragraph 1 or Paragraph 2 above, and shall keep each other reasonably
informed of all material developments in connection with any such claim, suit or proceeding.

4. Licensor shall have the sole right and discretion to file, prosecute and maintain the Patents,
provided, however, that if Licensor desires to abandon the prosecution of any patent application or
the maintenance of any patent in the Patents, Licensor shall, upon Licensee’s request, assign such
patent application or patent to Licensee so that Licensee may prosecute such patent application or
maintain such patent in its name and at its expense. Any such patent application or patent assigned
to Licensee shall be excluded from the Patents.

Article 13. Warranty and Limited Liability for the API

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1. Licensor shall warrant that the API supplied by it is manufactured in accordance with applicable
cGMP Rules and, when delivered to San Juan or such other destination agreed by Licensor and
Licensee, conforms to the API Specifications.

2. Licensor shall submit to Licensee with each consignment of the API supplied a certificate signed
by the quality assurance director of the Licensor setting out the results of the analysis of that
consignment confirming that it is in conformity with the API Specifications and has been
manufactured in accordance with applicable cGMP.

3. Within thirty (30) days after receiving the API, Licensee shall conduct diligent inspection of
the API. If Licensee, upon such inspection, finds that the API does not conform to the API
Specifications, Licensee shall so notify Licensor in writing with detailed reasons accompanied by
samples of the defective API within the said thirty (30) days period. In the event that the
non-conformance of the API with the API Specifications is confirmed by Licensor upon its inspection
of the said samples, Licensor shall, at its expense, replace the non-conforming API or, if
replacement API is not then available, refund the purchase price paid for the non-conforming API,
at no additional cost to Licensee. Should there arise disputes between Licensor and Licensee with
respect to the conformance or non-conformance of the API with the API Specifications, both parties
shall jointly analyze, or if such joint analysis is not practical, shall have a third party
acceptable to Licensor and Licensee, whose determination shall be binding and
conclusive upon the Parties, analyze to see if the API actually fails to conform to the API
Specifications. In the event that the non-conformance of the API to the API Specifications is
finally confirmed by such joint analysis, or as the case may be, third party analysis, Licensor
shall replace the non-conforming API or, if replacement API is not then available, refund the
purchase price paid for the non-conforming API. Costs arising from the third party analysis shall
be borne by the party whose results were found incorrect.

4. In the event that Licensee does not notify Licensor of non-conformance of the API to the API
Specifications within the thirty (30) days period as provided for in Paragraph 3 above, Licensor
shall be released from any claim with respect to non-conformance to the API

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Specifications for the API supplied. Notwithstanding the foregoing, with respect to a claim for a
“latent defect”, the Licensee may make a claim for a period of one (1) year after receipt of the
API. The term “latent defect” used herein shall mean a defect in the API that results in the API
not conforming to the API Specifications and that was not discoverable with reasonable and diligent
inspection of the API, excluding a defect that was caused by improper storage or mishandling of the
API by Licensee or any third party after receipt of the API by Licensee.

5. Licensor shall indemnify, defend and hold Licensee harmless against any and all actions, suits,
claims, demands, prosecutions, product liabilities, costs and expenses, arising out of breach of
this Agreement by Licensor or out of any claims or suits by any third party due to a defect in the
API if and to the extent that such a defect is attributable to Licensor in the manufacture of the
API.

6. Except for the case provided in paragraph 5 above (or as otherwise provided in this Agreement,
including in Paragraph 5 of Article 11 and Paragraph 1 of Article 12), Licensee shall indemnify,
defend and hold Licensor harmless against any and all actions, suits, claims, demands,
prosecutions, product liabilities, costs and expenses, arising out of breach of this Agreement by
Licensee or out of any claims or suits by any third party based on or resulting from use of the API
and manufacture, use, marketing, distribution or sale of the Product by Licensee. Notwithstanding
the foregoing, if any third party claims that the Product caused adverse reactions or other
personal injury notwithstanding that the Product was manufactured in strict compliance with the API
Specifications, the specifications approved by the FDA and applicable cGMP and was not adulterated,
misbranded, mishandled or otherwise deteriorated by acts or omissions of Licensee or other parties,
Licensee shall have no obligation to indemnify Licensor for such claims and Licensee shall have the
right to deduct fifty percent (50%) of any costs incurred by Licensee in connection with such
claims from the License Fee and a running royalty otherwise payable to Licensor under this
Agreement.

7. In the event of any recall of the Product sold by Licensee, Licensee shall have primary
responsibility for such recall. Licensor shall cooperate with Licensee in connection with any such

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recall. Costs incurred in connection with such a recall shall be allocated by the parties
consistent with the preceding Paragraphs 5 and 6.

8. IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT OR SPECIAL
DAMAGES SUFFERED BY THE OTHER PARTY; provided, however, that this Paragraph shall not be construed
to limit either party’s indemnification obligations under Paragraph 5 or 6 above.

Article 14. Secrecy

1. During the term of this Agreement and for a period often (10) years after the expiration or
termination of this Agreement or the expiration of the last-to-expire of the Patents, whichever
comes later, Licensee shall keep as strictly confidential all parts of the Technical Information
furnished by Licensor under this Agreement including all data, know-how and information which have
heretofore been furnished under the Confidentiality Disclosure Agreement and shall not disclose any
of them to any third party without the prior written consent of Licensor; provided, however, that
the disclosure to clinicians, government officials, Licensee’s employees in charge and a
co-promoter approved by Licensor shall be allowed insofar as such disclosure is specifically
required for due performance of this Agreement and such disclosure is limited within a reasonable
extent, and provided that in the event of disclosure to such co-promoter, Licensee shall ensure
that such co-promoter shall comply with secrecy obligations not less stringent than those set forth
herein.

2. The secrecy obligations set forth in Paragraph 1 above shall not be applicable to any
information which (a) is now or later becomes, through no fault of Licensee, published or otherwise
generally available to the public, (b) was known to Licensee from sources other than Licensor or
its affiliates prior to disclosure by Licensor if such prior knowledge is evidenced by written
records made by Licensee prior to such disclosure or (c) is lawfully acquired by Licensee from a
third party without a duty of confidentiality to Licensor or its affiliates.

19

 

3. The secrecy obligations under the Confidentiality Disclosure Agreement, shall be superseded by
the secrecy obligations set forth in this Article 14.

4. Notwithstanding anything herein to the contrary, Licensee shall have the right to disclose the
existence and terms of this Agreement on a confidential basis to actual and prospective investors,
funding sources, merger partners and professional advisers in connection with any such transaction,
provided that Licensee shall obtain from those parties written undertaking to keep the existence
and terms of this Agreement confidential.

Article 15. Termination

	1.	 	This Agreement may be terminated by either party as follows:

	(a)	 	In the event of any payment default or any other default, or failure to perform any, of the
material terms or provisions of this Agreement by either party, the aggrieved party shall be
entitled to terminate this Agreement forthwith if such default or failure remains unremedied
for sixty (60) days after the aggrieved party has sent to the defaulting party a written
notice specifying such default or failure and requiring the same to be remedied. Termination
right set forth herein shall be in addition to any other remedies available at law, including
recovery of damages suffered as a result of the breach.

	(b)	 	In the event that relevant procedures shall be commenced for bankruptcy, insolvency,
receivership, liquidation or winding up of either party, the other party may forthwith
terminate this Agreement by a written notice to that effect.

2. Licensor shall be entitled to immediately terminate this Agreement by written notice in any of
the following events:

	(a)	 	If all or substantially all of the assets of Licensee related to this Agreement are
transferred to an unaffiliated third party or if the majority of the voting shares in Licensee
shall be acquired by an unaffiliated third party or if Licensee shall be merged or

20

 

	 	 	consolidated with an unaffiliated third party (hereinafter referred to as the “Change of
Control”), without written consent of Licensor, provided, however, that Licensor shall not
unreasonably withhold giving such written consent to the Change of Control if (A) Licensee
shall provide Licensor a written summary in reasonable details of the expected effect of the
Change of Control on this Agreement, (B) such unaffiliated third party who acquires the
assets or voting shares of Licensee or with whom Licensee is merged or consolidated shall
provide Licensor with a written undertaking agreeing to assume and succeed to all of
Licensee’s rights and obligations under this Agreement, (C) Licensee provides Licensor with
audited financial statements that reflect that such unaffiliated third party is in a sound
financial status at least equal to that of Licensee or otherwise sufficient to perform this
Agreement, and (D) Licensee provides Licensor with written certification that such
unaffiliated third party is not then selling directly or through its affiliate(s) any oral
cephalosporin product in the Territory. Licensor shall provide written notice of either
consent or objection within thirty (30) days of Licensee’s request for consent. If Licensor
does not provide either consent or a notice of objection within such 30-day period, Licensor
shall be deemed to have granted consent. If Licensor provides a notice of objection
notwithstanding that the conditions (A) through (D) set forth above are all met, then (1)
the parties shall discuss in good faith if the objection identified by Licensor in the said
notice is reasonable and (2) unless otherwise agreed by the parties within thirty (30) days,
each of Licensor and Licensee shall have the right to terminate this Agreement.

	(b)	 	If there shall be discontinuance for any reason of the commercial sale of the Product by
Licensee for a period of sixty (60) days or more unless such discontinuance is due to a force
majeure event, or due to a failure or delay in supplying the API by Licensor; or

	(c)	 	If Licensee and/or its co-promoter promotes, markets or sells in the Territory any
pharmaceutical product of the same IMS therapeutic class as the Product (USC 5 15130
(cephalosporins and related)), except for the pharmaceutical products which have already been
marketed in the Territory by Licensee and/or its subsidiaries as of the date of this
Agreement.

21

 

3. If a generic Cefditoren is launched in the Territory and Licensee’s sales amount of the Product
is substantially lessened as a result of such generic launch, Licensee may terminate this Agreement
by giving Licensor written notice at least two hundred seventy (270) days prior to such
termination. Notwithstanding the preceding sentence, Licensee may not terminate this Agreement
within five (5) years from the Launching Date.

	4.	 	Upon termination of this Agreement:

	(a)	 	Licensee shall immediately cease to sell the Product in compliance with the regulatory
regulations in the Territory. Provided, however, that should this Agreement be terminated by
Licensee for causes attributable to the responsibility of Licensor set forth in Paragraph 1
above or due to Licensor’s refusal to grant consent pursuant to Paragraph 2(a) above, Licensee
shall have the right to continue to sell the Product then remaining in its stock and/or
manufacture the Product from the API then remaining in its stock and sell such Product, in
each case for a period of one hundred eighty (180) days after termination of this Agreement
and to use the Trademark in connection with such sales of the Product.

	(b)	 	Licensee shall forthwith return to Licensor all the Technical Information and other
information supplied by Licensor under this Agreement and all copies thereof, and Licensee
shall not retain any copies thereof and shall not thereafter make use of any such information
in any manner or for any purpose.

	(c)	 	Licensee shall, as Licensor may direct, transfer the Product Registrations to Licensor or its
nominee, free of charge, on request of Licensor.

	(d)	 	Any obligation to pay the unpaid portion of the License Fee ends, except where this Agreement
is terminated by Licensor due to a breach of this Agreement by Licensee under Paragraph 1 of
Article 15.

Article 16. Term

22

 

This Agreement shall come into full force and effect upon execution hereof by both parties and
shall, unless earlier terminated pursuant to Article 15, continue to be in full force and effect
until expiration often (10) years form the Launching Date. Thereafter, this Agreement shall be
automatically renewed for subsequent one (1) year periods each unless either party gives to the
other party a written notice not to renew at least six (6) months prior to the expiration of the
initial term or, as the case may be, the renewal term(s).

Article 17. Survival

Termination or expiration of this Agreement shall not release either party hereto from any
obligations or liabilities which have already accrued to the other party at the time of termination
or expiration. For clarification, no part of the License Fee that would be due after expiration or
termination shall be payable after expiration or termination, except that if this Agreement is
terminated by Licensor due to the breach of this Agreement by Licensee under Paragraph 1 of Article
15, Licensee shall continue to be obligated to pay the unpaid portion of the License Fee. Further,
provisions set forth in Paragraph 5 of Article 11 (Trademark), Paragraph 1 of Article 12 (Patent),
Article 13 (Warranty and Limited Liability for the API), Article 14 (Secrecy), Paragraph 4 of
Article 15 (Termination), and Article 21 (Arbitration and Governing Law) shall survive and continue
to be effective after termination or expiration of this Agreement.

Article 18. Representations and Warranties

	1.	 	Licensor represents and warrants that:
	 
	(a)	 	Licensor has the authority to grant to Licensee the licenses set forth in this Agreement and
to enter into this Agreement and to perform Licensor’s obligations hereunder;
	 
	(b)	 	This Agreement has been duly executed and delivered by Licensor and constitutes a legal,
valid and binding obligation enforceable against Licensor in accordance with its terms; and

23

 

	(c)	 	Licensor is not a party to any outstanding agreements, assignments, covenants or encumbrances
in existence inconsistent with the provisions of this Agreement and Licensor shall not enter
into such agreements, assignments, covenants or encumbrances during the term of this
Agreement.

	2.	 	Licensee represents and warrants that:

	(a)	 	Licensee has the authority to enter into this Agreement and to perform Licensee’s obligations
hereunder;

	(b)	 	This Agreement has been duly executed and delivered by Licensee and constitutes a legal,
valid and binding obligation enforceable against Licensee in accordance with its terms; and

	(c)	 	Licensee is not a party to any outstanding agreements, assignments, covenants or encumbrances
in existence inconsistent with the provisions of this Agreement and Licensee shall not enter
into such agreements, assignments, covenants or encumbrances during the term of this
Agreement.

Article 19. Non-assignability

This Agreement and any rights and obligations thereunder shall not be assignable or transferable by
either party, except as permitted pursuant to Paragraph 2 (a) of Article 15, to any third party
without prior written consent of the other party.

Article 20. Force Majeure

There shall be no breach or violation of this Agreement if either party is delayed or prevented
from fulfilling its obligations hereunder due to war, revolution, strike, labor conflict, riot,
fire, flood, earthquake, explosion, natural calamity, embargo, compliance with any law or

24

 

governmental order, Act of God and any other causes beyond its reasonable control, provided that
such impeded party shall promptly notify the other party of the nature and expected duration of
such force majeure event and shall use its reasonable endeavor to remove such force majeure event.
If Licensor fails to supply the API due to force majeure event, then the quantity of the API which
Licensor fails to supply shall be reduced from the annual minimum purchase quantity for the purpose
of the minimum purchase requirements pursuant to Article 8. If such force majeure event preventing
Licensor from supplying the API continues for more than four (4) months, Licensor and Licensee
shall discuss in good faith measures to be taken to cope with such situation, such measures may
include sourcing the API from third-party manufacturers. If Licensee is required to obtain API from
another source, Licensor shall cooperate to facilitate such arrangement.

Article 21. Arbitration and Governing Law

All disputes, controversies or differences which may arise between the parties in relation to or in
connection with this Agreement, or the breach thereof, shall be finally settled by arbitration to
be conducted in English in accordance with the Arbitration Rules of the International Chamber of
Commerce by a single arbitrator appointed in accordance with the said Rules. The arbitration shall
be held in Geneva, Switzerland and the governing law shall be the laws of Switzerland. The award
rendered by the arbitrator shall be final and binding upon both parties.

Article 22. Severability

If any provision of this Agreement is held invalid or unenforceable by a court or other
governmental authorities of competent jurisdiction, then such provision shall be construed, to the
extent feasible, so as to render such provision valid and enforceable, and if no feasible
interpretation would save such provision, it will be severed from the remainder of this Agreement.
The remainder of this Agreement shall remain in full force and effect, unless the severed provision
is essential and material to the rights or benefits received by either party. In such event, the
parties shall negotiate, in good faith, and substitute a valid and enforceable provision that most
nearly implements the parties’ intent in entering into this Agreement.

25

 

Article 23. Entire Agreement

This Agreement constitutes the entire agreement of the parties hereto with respect to the subject
matter hereof and supersedes all prior agreements and understandings, either oral or written,
including the Confidentiality Disclosure Agreement and the Letter of Intent. This Agreement may be
amended only by a written instrument duly signed by both parties.

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their duly
authorized representatives as of the day and year first above written.

	 	 	 	 	 
	Meiji Seika Kaisha, Ltd.

	 	Cornerstone BioPharma Inc.	 	 
	 
	 	 	 	 
	/s/ Ryuzo Asada
 

Ryuzo Asada

	 	/s/ Craig Collard
 

Craig Collard
	 	 
	Vice President

	 	President and CEO	 	 
	International Headquarters
	 	 	 	 
	Pharmaceuticals
	 	 	 	 

26

 

Annex A

Specifications and Analytical Methods of the API

[1207]-0945-V3

MEIJI SEIKA KAISHA, LTD.

	 	 	 
	Bulk Cefditoren Pivoxil (RCF)

	 	Page 1 of 14
	 

	 	Date of issue October 29, 1999
	 
	 	 
	SPECIFICATIONS AND TEST METHOD

	 	Original doc. No.
	 

	 	     40-23-023-CFB0000-00-V01

	1.	 	SPECIFICATION

	 	 	 	 	 
	Description:

	 	 	 	 
	Color

	 	a light yellow color	 	 
	Form

	 	powder	 	 
	 
	 	 	 	 
	[***]
	 	 	 	 

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

27

 

[1207]-0945-V3

MEIJI SEIKA KAISHA, LTD.

	 	 	 
	Bulk Cefditoren Pivoxil (RCF)

	 	Page 2 of 14
	 

	 	Date of issue October 29, 1999
	 
	 	 
	SPECIFICATIONS AND TEST METHOD

	 	Original doc. No.
	 

	 	     40-23-023-CFB0000-00-V01

[***]

2. TEST METHOD

[***]

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

28

 

[1207]-0945-V3

MEIJI SEIKA KAISHA, LTD.

	 	 	 
	Bulk Cefditoren Pivoxil (RCF)

	 	Page 3 of 14
	 

	 	Date of issue October 29, 1999
	 
	 	 
	SPECIFICATIONS AND TEST METHOD

	 	Original doc. No.
	 

	 	     40-23-023-CFB0000-00-V01

[***]

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

29

 

[1207]-0945-V3

MEIJI SEIKA KAISHA, LTD.

	 	 	 
	Bulk Cefditoren Pivoxil (RCF)

	 	Page 4 of 14
	 

	 	Date of issue October 29, 1999
	 
	 	 
	SPECIFICATIONS AND TEST METHOD

	 	Original doc. No.
	 

	 	     40-23-023-CFB0000-00-V01

[***]

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

30

 

[1207]-0945-V3

MEIJI SEIKA KAISHA, LTD.

	 	 	 
	Bulk Cefditoren Pivoxil (RCF)

	 	Page 5 of 14
	 

	 	Date of issue October 29, 1999
	 
	 	 
	SPECIFICATIONS AND TEST METHOD

	 	Original doc. No.
	 

	 	     40-23-023-CFB0000-00-V01

[***]

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

31

 

[1207]-0945-V3

MEIJI SEIKA KAISHA, LTD.

	 	 	 
	Bulk Cefditoren Pivoxil (RCF)

	 	Page 6 of 14
	 

	 	Date of issue October 29, 1999
	 
	 	 
	SPECIFICATIONS AND TEST METHOD

	 	Original doc. No.
	 

	 	     40-23-023-CFB0000-00-V01

[***]

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

32

 

[1207]-0945-V3

MEIJI SEIKA KAISHA, LTD.

	 	 	 
	Bulk Cefditoren Pivoxil (RCF)

	 	Page 7 of 14
	 

	 	Date of issue October 29, 1999
	 
	 	 
	SPECIFICATIONS AND TEST METHOD

	 	Original doc. No.
	 

	 	     40-23-023-CFB0000-00-V01

[***]

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

33

 

[1207]-0945-V3

MEIJI SEIKA KAISHA, LTD.

	 	 	 
	Bulk Cefditoren Pivoxil (RCF)

	 	Page 8 of 14
	 

	 	Date of issue October 29, 1999
	 
	 	 
	SPECIFICATIONS AND TEST METHOD

	 	Original doc. No.
	 

	 	     40-23-023-CFB0000-00-V01

[***]

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

34

 

[1207]-0945-V3

MEIJI SEIKA KAISHA, LTD.

	 	 	 
	Bulk Cefditoren Pivoxil (RCF)

	 	Page 9 of 14
	 

	 	Date of issue October 29, 1999
	 
	 	 
	SPECIFICATIONS AND TEST METHOD

	 	Original doc. No.
	 

	 	     40-23-023-CFB0000-00-V01

[***]

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

35

 

[1207]-0945-V3

MEIJI SEIKA KAISHA, LTD.

	 	 	 
	Bulk Cefditoren Pivoxil (RCF)

	 	Page 10 of 14
	 

	 	Date of issue October 29, 1999
	 
	 	 
	SPECIFICATIONS AND TEST METHOD

	 	Original doc. No.
	 

	 	     40-23-023-CFB0000-00-V01

[***]

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

36

 

[1207]-0945-V3

MEIJI SEIKA KAISHA, LTD.

	 	 	 
	Bulk Cefditoren Pivoxil (RCF)

	 	Page 11 of 14
	 

	 	Date of issue October 29, 1999
	 
	 	 
	SPECIFICATIONS AND TEST METHOD

	 	Original doc. No.
	 

	 	     40-23-023-CFB0000-00-V01

[***]

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

37

 

[1207]-0945-V3

MEIJI SEIKA KAISHA, LTD.

	 	 	 
	Bulk Cefditoren Pivoxil (RCF)

	 	Page 12 of 14
	 

	 	Date of issue October 29, 1999
	 
	 	 
	SPECIFICATIONS AND TEST METHOD

	 	Original doc. No.
	 

	 	     40-23-023-CFB0000-00-V01

[***]

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

38

 

[1207]-0945-V3

MEIJI SEIKA KAISHA, LTD.

	 	 	 
	Bulk Cefditoren Pivoxil (RCF)

	 	Page 13 of 14
	 

	 	Date of issue October 29, 1999
	 
	 	 
	SPECIFICATIONS AND TEST METHOD

	 	Original doc. No.
	 

	 	     40-23-023-CFB0000-00-V01

[***]

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

39

 

[1207]-0945-V3

MEIJI SEIKA KAISHA, LTD.

	 	 	 
	Bulk Cefditoren Pivoxil (RCF)

	 	Page 14 of 14
	 

	 	Date of issue October 29, 1999
	 
	 	 
	SPECIFICATIONS AND TEST METHOD

	 	Original doc. No.
	 

	 	     40-23-023-CFB0000-00-V01

[***]

 

[***] Confidential portions of the exhibit have been omitted and filed separately with the
Securities and Exchange Commission.

40

 

Annex B

List of Patents

	 	 	 	 	 	 	 	 	 
	Application No.	 	Filed	 	Patent No.	 	Date of Patent
	(1)36124

	 	April 7, 1987
	 	 	4839350	 	 	June 13, 1989
	(2) 19172

	 	February 26, 1987
	 	 	4918068	 	 	April 17, 1990
	(3)09/051318

	 	October 14, 1996
	 	 	5958915	 	 	September 28, 1999
	(4) 09/269109

	 	Septembers, 1999
	 	 	6294669	 	 	September 25, 2001
	(5) 09/854462

	 	May 15, 2001
	 	 	6441162	 	 	August 27, 2002
	(6) 09/446380

	 	February 18, 2000
	 	 	6288223	 	 	September 11, 2001

41

 

Annex C

Product Registrations

NDA# 021-222 SPECTRACEF (Cefditoren Pivoxil) 200mg Tablet Oral

42

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