Pharmacovigilance | Capricor shall be responsible for any safety surveillance related to pharmacovigilance required for the Product in the Territory at its responsibility and expense. The details of the terms related hereto shall be set forth in the Pharmacovigilance Agreement. The global safety database of the Product shall be established at Capricor’s responsibility and expense. |
Supply of Commercial Products | Capricor shall manufacture and supply to NS quantities of commercial Products to satisfy NS’s purchase requirements after packaging as the final product at the Transfer Price. Details regarding the supply of commercial Products shall be determined separately in a supply agreement and a quality agreement. |
Initial Investment | NS shall make a payment to Capricor of 15 million U.S. dollars through a purchase of common shares of Capricor Therapeutics, Inc. pursuant to Article 2 of the Letter of Intent. The purchase price of the common shares shall be at a twenty percent (20%) premium over the sixty (60)-day VWAP preceding the execution date of the SPA. |
Upfront Payment | NS shall make an upfront payment of 20 million U.S. dollars in cash upon the execution of the Agreement. Such payment shall be consideration for the costs and expenses incurred and to be incurred by Capricor in connection with any and all administrative, clinical, process development, CMC, regulatory and commercial development of the Product for the Territory. Timing of the payment of the 20 million U.S. dollars above shall be within 30 days from the date of the invoice to be issued by Capricor after the execution of the Agreement. |
Development Milestones | NS shall pay to Capricor in U.S. dollars the following Development Milestones upon the first achievement of the following particular milestone events with respect to the Products: Timing of such payments shall be within 30 days from the date of the written notice of the respective event after the execution of the Agreement. [***] |
Sales Milestones | Commencing in NS’s fiscal year following achievement of marketing authorization, NS shall pay to Capricor the following Sales Milestones when the annual Net Sales of the commercial Products in the Territory (in total, not on a country by country basis) achieves the following amounts for the first time. The definition of the “Net Sales” shall be set forth in the Agreement. [***] |
Minimum Sales Requirements | NS shall be required to sell a certain minimum number of Commercial Products in the Territory (“Minimum Sales Requirements”) during each calendar year of the Agreement commencing with the year in which the Marketing Authorization is approved and ending upon the termination or expiration of the Agreement. The Minimum Sales Requirements shall be set forth in the Agreement. |
Transfer Price of Commercial Products | During the Agreement Term, NS shall pay to Capricor the amount equivalent to CoG (Cost of Goods) plus a [***]% mark-up for the Products supplied to NS in the Territory as the Transfer Price. |
Supply Price as Share of Revenues | On a country-by-country basis in the Territory, NS shall pay to Capricor on a quarterly basis the amount calculated by the following formula in the Territory during the Agreement Term as a share of revenues from sales of the Products. [***] If any biosimilar of the Product is launched in the Territory, the Parties shall consider reducing the Supply Price above to make performance of the Agreement commercially reasonable to the Parties. |
Withholding Tax | NS shall deduct applicable withholding taxes, if any, from the amount paid to Capricor when NS pays the upfront payment, development milestone payments, sales milestone payments and revenue share, if required. |
Representations and Warranties | Capricor represents and warrants that Capricor has the right to grant NS the rights specified in the “Grant of Rights” and “Trademark” above in the Territory. Capricor shall indemnify and hold NS and NS Indemnified Parties (to be defined in the Agreement) harmless from and against, and in respect of, any and all Third-Party Claims (to be defined in the Agreement) asserted against or incurred by, and any and all expenses payable by NS or any of NS Indemnified Parties that arises out of or relate to actual or alleged infringement of misappropriation alleged by third parties of patents, copyrights, trademarks, or other intellectual property rights by the using or selling of Product (except to the extent arising from NS’s use or sale of the Product in a manner not approved by Capricor). |
Trademarks | During the Agreement Term, the trademarks used for the Products (“Trademarks”) shall be held by Capricor, and Capricor shall grant to NS the right to use such Trademarks in the Territory to the extent necessary to achieve the purposes of the Agreement without any charge to NS. In the Territory, Capricor shall file an application of, register, maintain and manage the Trademarks at Capricor’s responsibility and expense. |
Governing Law | The laws of the State of New York, USA. |