Exhibit 10.8
MEIJI SEIKA KAISHA, LTD. INTERNATIONAL HEADQUARTERS, PHARMACEUTICALS

4-16, Kyobashi 2 Chome, Chuo-ku, Tokyo, 104-8002 Japan   TELEPHONE:
+81-3-3273-3426 FAX: +81-3-3281-4058

July 27, 2007
Cornerstone Biopharma Inc.
2000 Regency Parkway
Suite 255
Cary, North Carolina 27511
U.S.A.
Re: License and Supply Agreement
This letter is to confirm the mutual understanding and agreement between Meiji
Seika Kaisha, Ltd. (“Meiji”) and Cornerstone Biopharma Inc. (“Cornerstone”) with
respect to the License and Supply Agreement dated October 12, 2006 regarding
Cefditoren Pivoxil as amended by the Amendment No. 1 dated July 27, 2007 (the
“License Agreement”).
1. Capitalized terms not defined herein shall have the meanings ascribed to them
in the License Agreement.
2. Tedec-Meiji Farma S.A. (“Tedec-Meiji”) shall be added as a production site
for production of 200mg oral tablet form of the Product to be specified in the
Product Registrations of that Product. Cornerstone undertakes to do all
regulatory works and filings required to add Tedec-Meiji as a production site
specified in the Product Registrations of 200mg oral tablet form of the Product
and Meiji shall provide Cornerstone with all information and data required for
such purpose. Meiji shall pay to Cornerstone US$349,000 as reimbursement for
expenses to be incurred by Cornerstone for regulatory works and filings required
to add Tedec-Meiji as a production site. Meiji’s burden for expenses for
regulatory works and filings required to add Tedec-Meiji as a production site
shall be limited to this payment of US$349,000. This payment of US$349,000 shall
be made by way of several installments to be mutually agreed between Meiji and
Cornerstone and shall be completed no later than June 30, 2008.
3. Meiji hereby grants Cornerstone an exclusive right to develop, and apply for
and obtain the Product Registrations for, 400mg oral tablet form of the Product
(“400mg Product”). Tedec-
 
[***] Confidential portions of the exhibit have been omitted and filed
separately with the Securities and Exchange Commission

 

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MEIJI SEIKA KAISHA, LTD. INTERNATIONAL HEADQUARTERS, PHARMACEUTICALS

4-16, Kyobashi 2 Chome, Chuo-ku, Tokyo, 104-8002 Japan   TELEPHONE:
+81-3-3273-3426 FAX: +81-3-3281-4058

Meiji shall be designated as the production site for production of the 400mg
Product to be specified in the Product Registrations of the 400mg Product. All
expenses required to develop
and obtain the Product Registrations for the 400mg Product shall be borne by
Cornerstone. Once the Product Registrations have been obtained for the 400mg
Product, the 400mg Product shall automatically be added to the Product under the
License Agreement.
4. Meiji hereby permits Cornerstone to contact and discuss with the United
States Food and Drug Administration (“FDA”) about the development of once-daily
dosage form of the Product (“Once-Daily Product”) and pediatric form of the
Product (“Pediatric Product”) in the United States. Unless the FDA disapproves
the development plan of the Once-Daily Product and/or the Pediatric Product,
Meiji agrees to grant Cornerstone an exclusive right to develop, and apply for
and obtain the Product Registrations for, the Once-Daily Product and/or the
Pediatric Product in the Territory. Allocation of expenses for such development
and regulatory works in respect of the Once-Daily Product and/or the Pediatric
Product shall be discussed in good faith and agreed between Meiji and
Cornerstone separately. Once the Product Registrations have been obtained for
the Once-Daily Product and/or the Pediatric Product, then the Once-Daily Product
and/or the Pediatric Product shall automatically be added to the Product under
the License Agreement, provided that (a) the running royalty rate applicable to
each of the Once-Daily Product and the Pediatric Product shall be the percentage
of the Net Sales of each of those Products derived from the formula set forth
below and (b) the Launching Date from which the ten (10) year royalty payment
period set forth in Paragraph 2 of Article 5 of the License Agreement commences
in respect of each of the Once-Daily Product and the Pediatric Product shall be
the date of the first commercial sale of each of those Products.
     Running Royalty Rate (%) = [***]
5. Notwithstanding the second paragraph of Paragraph 1 of Article 5 of the
License Agreement, in the event that the 400mg Product, the Once-Daily Product
and/or the Pediatric Product are successfully launched by Cornerstone in the
Territory and an adverse effect on the sales of the Product in the Territory by
a generic Cefditoren is substantially lessened as a result thereof, then
Cornerstone shall continue to pay a reasonable amount out of the License Fee set
 
[***] Confidential portions of the exhibit have been omitted and filed
separately with the Securities and Exchange Commission

 

--------------------------------------------------------------------------------

 

MEIJI SEIKA KAISHA, LTD. INTERNATIONAL HEADQUARTERS, PHARMACEUTICALS

4-16, Kyobashi 2 Chome, Chuo-ku, Tokyo, 104-8002 Japan   TELEPHONE:
+81-3-3273-3426 FAX: +81-3-3281-4058

forth in Paragraph 1 of Article 5 of the License Agreement even if a generic
Cefditoren is launched before the fifth anniversary date of the License
Agreement.
6. It is confirmed by the parties hereto that no rights and licenses are granted
to Cornerstone for the 400mg Product, the Once-Daily Product and the Pediatric
Product outside the Territory and that all rights to research, develop and
commercialize the 400mg Product, the Once-Daily Product and the Pediatric
Product outside the Territory are vested in Meiji. Meiji shall have an unlimited
right to use the results of development and regulatory works conducted for the
400mg Product, the Once-Daily Product and/or the Pediatric Product in the
Territory for the development and commercialization of those Products outside
the Territory.
Please confirm Cornerstone’s agreement to the foregoing by: singing duplicate
copies of this letter and returning one signed copy to us.

                  Yours faithfully,    
 
                Meiji Seika Kaisha, Ltd.    
 
                          /s/ Ryuzo Asada              
 
  Name:   Ryuzo Asada    
 
  Title:   Vice President
International Headquarters
Pharmaceuticals    

ACCEPTED AND AGREED TO:
Cornerstone Biopharma Inc.
          /s/ Craig Collard               
Name: Craig Collard
Title: President and CEO