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LICENSE AND SUPPLY AGREEMENT

Requirements Supplier Agreement

LICENSE AND SUPPLY AGREEMENT | Document Parties: CORNERSTONE THERAPEUTICS INC | Cornerstone BioPharma Inc | Meiji Seika Kaisha, Ltd | Purdue Pharmaceutical Products LP You are currently viewing:
This Requirements Supplier Agreement involves

CORNERSTONE THERAPEUTICS INC | Cornerstone BioPharma Inc | Meiji Seika Kaisha, Ltd | Purdue Pharmaceutical Products LP

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Title: LICENSE AND SUPPLY AGREEMENT
Date: 11/5/2008
Industry: Biotechnology and Drugs     Sector: Healthcare

LICENSE AND SUPPLY AGREEMENT, Parties: cornerstone therapeutics inc , cornerstone biopharma inc , meiji seika kaisha  ltd , purdue pharmaceutical products lp
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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:

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

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

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

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

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

6 th 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 t


 
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