Document:

exv10w7

Exhibit 10.7

AMENDMENT NO. 1 TO LICENSE AND SUPPLY AGREEMENT

     This
amendment (the “Amendment”) to that certain License and Supply Agreement dated October
12, 2006 (the “License Agreement”) is made by and between Cornerstone Biopharma Inc., a corporation
organized and existing under the laws of the State of Nevada and having its principal office at
2000 Regency Parkway, Suite 255 Cary, North Carolina, 27511 USA, and 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. Capitalized terms not defined herein
shall have the meanings ascribed to them in the License Agreement.

     The parties have determined to expand the collaboration contemplated by the License Agreement
and accordingly Cornerstone and Meiji hereby agree to modify and amend the License Agreement as
follows:

     1. The text of Article 1(g) shall be deleted and replaced with the following: “(g) The term
“Product” shall mean any pharmaceutical product containing the Compound as an active ingredient in
a finished form suitable for use by ultimate customers as identified by the Product Registrations
(with therapeutic indications indicated therein) existing as of the date of this Agreement, and
shall include any other pharmaceutical product containing the Compound as an active ingredient
and/or any other therapeutic indication of the Product which will hereafter be developed through
collaboration between Licensor and Licensee and agreed to be added to this Agreement between
Licensor and Licensee. In the event that either party desires to develop any new Product and/or any
new therapeutic indication of the Product which does not exist as of the date of this Agreement in
the Territory, such party shall notify the other party of such desire and both parties shall then
discuss in good faith with respect to the possible collaboration for the development of such new
Product and/or therapeutic indication of the Product. Licensee may participate in the development
of such new Product and/or therapeutic indication of the Product in the Territory, provided that
both parties reach agreement on the collaboration for such development including allocation of
works and expenses and any other details for such development by way of a separate written
agreement.”

     2. The text of Article 1(h) shall be deleted and replaced with the following: “(h) The term
“Product Registrations” shall mean the registrations of the Product (with therapeutic indications
indicated therein) granted by the United States Food and Drug Administration existing as of the
date of this Agreement as listed in Annex C attached hereto, and shall include any future
registrations related to the Product which will hereafter be granted by the health authorities in
the Territory as a result of the future development of new Product and/or new therapeutic
indication of the Product through collaboration between Licensor and Licensee as set forth in
Article I (g).”

     3. The text of Article 7.2(e) shall be deleted and replaced with the following: “(e) From the
effective date of this Amendment until July 31, 2008, the payment terms for the API shall be T.T.
remittance to the bank designated by Licensor within thirty (30) days after B/L date or prior to
commencement of manufacture of the Product by Licensee utilizing such API, whichever is earlier;
provided that such payment terms are not applicable to the portion of the API quantity greater than
one (1) API production lot (which is approximately 320kgs potency of

 

API) per shipment or if any preceding order remains unsettled and, in such event, the payment
terms for the said portion of any order or for any order shipped under the said unsettled situation
shall be advance payment by T.T. remittance to the bank designated by Licensor.

     If all payments for the API, until July 31, 2008, are made within thirty (30) days after B/L
date or prior to commencement of manufacture of the Product by Licensee utilizing such API,
whichever is earlier, as of August 1, 2008, Licensor and Licensee shall discuss in good faith to
continue or revise the payment terms thereafter.

     Licensor shall retain the title of ownership to all contents of each shipment of the API until the
payment of the API by Licensee to Licensor is made in full. Should Licensee fail to make any
payment for the API by the due date set forth herein, (i) Licensee shall immediately return to
Licensor or its designee the possession of the API to which the title of ownership is retained by
Licensor in compliance with instructions given by Licensor and (ii) the payment terms for all
subsequent orders for the API shall be advance payment by T.T. remittance to the bank designated by
Licensor.

     4. This Amendment shall be effective as of the date shown below.

     5. This Amendment may be executed in any number of counterparts, each of which shall
constitute one agreement binding on all parties hereto.

IN WITNESS WHEREOF, the parties have caused this Amendment to be executed by their duly authorized
representatives.

	 	 	 	 	 	 	 	 	 
	CORNERSTONE BIOPHARMA INC.	 	 	 	MEIJI SEIKA KAISHA, LTD.

	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Craig Collard
	 	 	 	By:
	 	/s/ Ryuzo Asada
	 

	 	 
	 	 	 	 	 	 
	Name:

	 	Craig Collard
	 	 	 	Name:
	 	Ryuzo Asada
	Title:

	 	President and CEO
	 	 	 	Title:
	 	Vice President
	Date:

	 	July 24, 2007
	 	 	 	Date:
	 	July 27, 2007

2exv10w8

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

 

 

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

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