Re: Proposed Development and Supply Agreement between Sirion Therapeutics, Inc.(Sirion) and Plantex USA, Inc. (Plantex) for Diflurprednate

 

 

 

 

 

 

 

 

SIRION

 

By:

 

Effective Date;

Term Sheet Term

 

Project Objective:

(a) Plantex or its affiliates have developed the active pharmaceutical ingredient Diflurprednate (the “API”);

 

 

(b) Sirion, its affiliate and/or licensor intends to obtain approval of a new drug application for Diflurprednate (the “NDA”) from the U.S. Food and Drug Administration (the “FDA”) for sale of an ophthalmic dosage finished product form of Difiurprednate (the “Product”) in the US (the “Territory”); and

 

 

(c) Subject to the foregoing and to the terms and conditions set forth below, Plantex shall maintain a Drug Master File “DMF”) with respect to the API and shall supply the API to Sirion, and Sirion shall purchase the API from Plantex.

 

Drug Master File; API Manufacture:

 

 

 

 

 

 

Product Manufacture:

•    to the extent that Sirion manufactures any Product, Sirion or its affiliate shall, at Sirion’s sole cost and expense, (i) maintain the NDA; (ii) use commercially reasonable efforts to respond promptly to any deficiencies in the NDA and to comply promptly with the comments of applicable governmental regulatory authorities in respect thereof; and (iii) manufacture any Product in compliance with the applicable provisions of the Federal Food, Drug, and Cosmetic Act and all relevant regulations, guidelines, and guidances, including the cGMP.

 

 

•    to the extent its licensor or third-party manufacturer manufactures any Products, Sirion or its affiliate shall, at its sole cost and expense, obtain the agreement of such licensor or manufacturer to (i) maintain the NDA; (ii) use commercially reasonable efforts to respond promptly to any deficiencies in the NDA and to comply promptly with the comments of applicable governmental regulatory authorities in respect thereof; and (iii) manufacture any Products in compliance with the applicable provisions of the Federal Food, Drug, and Cosmetic Act and all relevant regulations, guidelines, and guidances, including the cGMP.

 

Definitive Agreement:

 

Certain Terms:

 

 

(a) Plantex shall cooperate with Sirion and shall, in a commercially timely manner, provide Sirion with all documentation and information relating to the API and/or the DMF reasonably necessary for Sirion or its designee to maintain the NDA.

 

 

(b) During the Term Sheet Term and, if applicable, the Definitive Agreement Term, Sirion, its affiliates and/or third-party manufacturers shall purchase from Plantex all

 

of Sirion’s API requirements, and Plantex shall supply API for the Product to Sirion in such quantities as Sirion shall determine from time to time in accordance with the terms and conditions of this Term Sheet or the Definitive Agreement, as applicable, on an exclusive basis for the Territory, as long as Sirion has filed the NDA no later than [* * *] and as long as Sirion uses its best efforts to have the NDA approved and to launch the Product in the Territory in a timely manner. Sirion (i) will not sell, (ii) will cause its affiliates not to sell and (iii) will use its reasonable efforts to cause its third-party manufacturer(s) not to sell, to any third party, any API supplied by Plantex that is not incorporated into the Products. Plantex reserves the right to sell API to third parties developing, manufacturing, distributing and selling finished pharmaceutical products that are not the Product.

 

 

(c) Sirion shall provide Plantex with a [* * *] forecast on a [* * *] basis of its API requirements. Quantities of API forecasted for the [* * *] of each forecast shall be deemed a firm purchase commitment binding upon Sirion.

 

 

(d) The price at which Sirion, its affiliates or third party manufacturer shall purchase the API from Plantex is [* * *].
[* * *]

 

 

(e) Notwithstanding any other provision in this Term Sheet or the Definitive Agreement, as applicable, during the Term Sheet Term or the Definitive Agreement Term, as applicable, [* * *].

 

 

(f) Beginning [* * *] and during [* * *], as applicable, Sirion shall pay Plantex a royalty of [* * *]. This royalty shall be paid, [* * *].

 

 

For the purpose of this Term Sheet or the Definitive Agreement, as applicable, “net sales” shall mean the aggregate amounts invoiced by or for the benefit of Sirion (and any affiliates) or permitted licensees and distributees respecting the Products sold to independent and unrelated third parties in the Territory, less chargebacks, discounts, credits, allowances, refunds and rebates actually provided, all to the extent attributable to the Product and all as determined in accordance with U.S. generally accepted accounting principles, consistently applied.

 

 

(g) No party shall be liable to the other party for any special,

 

indirect, incidental, consequential damages or lost profits, whether in contract, warranty, negligence, tort, strict liability or otherwise.

 

Marketing and Distribution:

 

Representations and Warranties; Confidentiality and Other Terms:

 

Term and Termination:

 

Expenses: