What comes next for this: SUPPLY AGREEMENT This Supply Agreement (the "Agreement") is made as of this ____ day of March, 2018 (the "Effective Date"), by and between Cutanea Life Sciences, Inc., a corporation duly organized and existing under the laws of the State of Delaware with its principal place of business at 1500 Liberty Ridge Drive, Suite 3000, Wayne, PA 19087 hereinafter referred to as "CUTANEA"), and Ferrer Internacional, S.A., a Spanish corporation with its principal place of business at Av. Diagonal, 549, 5t h floor, 08029 Barcelona (Spain) (hereinafter indistinctly referred to as "Ferrer" and/or "Supplier"). CUTANEA and Ferrer taken together hereinafter are referred to as "PARTIES". WITNESSETH: WHEREAS, CUTANEA is engaged in the distribution, promotion and sale of certain pharmaceutical, OTC and medical device products and in particular desires that Ferrer manufacture (directly and/or through a third party) and supply CUTANEA with the "Products" (as defined below); and WHEREAS, Ferrer and Medimetriks Pharmaceuticals, Inc. (hereinafter "Medimetriks") entered into a License and Supply Agreement dated March 10, 2014, as amended, (hereinafter referred as "LSA") pursuant to which among other things, Ferrer granted Medimetriks exclusive commercialization and distribution rights to the Product (as defined in the LSA) throughout the Territory (as defined in the LSA); and WHEREAS, with Ferrer's consent, CUTANEA has acquired and assumed the rights, duties and obligations of Medimetriks under the LSA; and WHEREAS, Ferrer desires to manufacture (directly and/or through a third party) and supply CUTANEA with such Products; NOW, THEREFORE, in consideration of the mutual covenants hereinafter expressed, the Parties, intending to be legally bound hereby, agree as follows: 1. DEFINITIONS 1.1 Act "Act" means the Federal Food, Drug and Cosmetic Act, as amended, and regulations promulgated hereunder. 1.2 Business Day "Business Day" means any day other than a Saturday, Sunday or other day on which banks in Philadelphia, Pennsylvania and/ or Barcelona, Spain are permitted or required to close by any applicable law. ___ = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
1.3 Confidential Information "Confidential Information" means, other than information described in Section 9.1.2, all business and technical information, including third party information, in whatever form or manner presented, which is: (a) disclosed by or on behalf of a party (the "Disclosing Party") to the other party (the "Receiving Party") or learned or observed by the Receiving Party before or during the term of this Agreement; and (b) disclosed during any discussions and proceedings relating to any of the foregoing information, whether disclosed in oral, electronic, visual, written or any other form. "Confidential Information" shall include all information of the Disclosing Party that the Disclosing Party would consider confidential or proprietary under the circumstances. The fact that the Disclosing Party may have marked or identified as confidential or proprietary any specific information shall be indicative that such Disclosing Party believes such information to be confidential or proprietary, but the failure to so mark information shall not determine that such information is or is not considered confidential information by such Disclosing Party. 1.4 FDA "FDA" means the United States Food and Drug Administration, or any successor entity thereto. 1.5 Forecasted Needs "Forecasted Needs" means CUTANEA's estimate of Products (including in trade/sample form) to be ordered from Supplier for the upcoming rolling ___ period. 1.6 Governmental or Regulatory Authority "Governmental or Regulatory Authority" means governments, regulatory authorities, governmental departments, agencies, agents, commissions, bureaus, officials, courts, bodies, boards, tribunals or dispute settlement panels or other law, rule or regulation-making organizations or entities (a) having or purporting to have jurisdiction on behalf of any nation, territory or state or any other geographic or political subdivision of any of them, or (b) exercising, or entitled or purporting to exercise any administrative, executive, judicial, legislative, policy, regulatory or taxing authority or power. 1.7 Manufacture "Manufacture" means all the activities relating to production of the Products including packaging and shipment preparation, quality control and release of Products. All the references contained in this Agreement regarding manufacturing activities shall be deemed rendered by Supplier, even if performed by its designee (whether in the form of a subcontractor, agent or otherwise). In consequence, all Manufacturing activities with respect to the Products to be Manufactured hereunder by Supplier shall be carried out by Supplier (or its designee) at the notified facility and utilizing equipment in the manner set forth in the Specifications, except to the extent that Supplier receives CUTANEA's advance written permission to alter the location or specified usage of the equipment that may be required under the Specifications or the NDA, as applicable. 3 ___ = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
1.8 Product(s) "Product(s)" means product(s) as listed from time to time in Schedule A Manufactured by the Supplier (directly or through a third person) to meet the Specifications (as hereinafter defined); except as otherwise set forth on Schedule A, the Product will be ready for re-sale by CUTANEA to its customers in finished, final packaged form bearing CUTANEA's labels, it being understood that, after generic competition of the Product enters the market in the United States of America including Puerto Rico and the U.S. Virgin Islands, CUTANEA will be permitted to place orders for Product under a generic label. The term "Generic" shall be interpreted as defined under Section 1.17 of the LSA. 1.9 Specifications "Specifications" means, with respect to the Products, the critical quality standards that include test attributes, analytical procedures, and appropriate acceptance criteria and Manufacturing procedures for which such Product should conform to be considered acceptable for its intended use and conform to quality standards approved by Governmental and Regulatory Authorities and as provided in the NDA for the Products, and required for the Manufacture and supply of such Product(s). 1.10 Supply Price "Supply Price" means the price to be charged to CUTANEA from time to time by Supplier for Products Manufactured and supplied hereunder, as set forth in Schedule A. 2. PRODUCT MANUFACTURE AND SUPPLY 2.1 Manufacture and Purchase. Subject to the terms and conditions of this Agreement, Supplier agrees that it will, on a non-exclusive basis (but exclusive for supply of the Product in the United States of America including Puerto Rico and the U.S. Virgin Islands), Manufacture (directly or through a designee) for and provide and supply to CUTANEA, and CUTANEA agrees that it will purchase exclusively from Supplier, all of its requirements of the Products as follows: Supplier shall supply Products in accordance with the Specifications and in sufficient quantity to meet CUTANEA's Forecasted Needs for the length of this Agreement. All deviations from the Specifications must be approved by CUTANEA, in writing, prior to Supplier Manufacturing the Product. 2.2 Raw Materials and Components. As between Supplier and CUTANEA, Supplier shall be responsible for the supply of all raw materials and components necessary for the Manufacture of Products at no additional cost to CUTANEA. Supplier (or its designee) shall order the initial components for each Product as soon as CUTANEA provides Supplier (or its designee) with the relevant artwork for the Product. 4 ___ = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
2.3 Quality Tests and Checks. In order to assure the conformity of the Products to the Specifications, the Supplier shall deliver or cause to be delivered to CUTANEA, at the time of shipment, a certificate of analysis and compliance or other batch documentation upon reasonable request (such as, deviations, investigations, batch records) with respect to each batch of Product supplied hereunder in the form required by the Quality Agreement. 2.4 Forecasting and Other Obligations. 2.4.1 As soon as practicable following execution of this Agreement, but in any event within ten (10) Business Days, CUTANEA agrees to provide Supplier with a best estimate, non-binding (except for the first six months) forecast of its Forecasted Needs for Products (including in trade/sample form) for the upcoming rolling 18-month period (the "Forecast"). Thereafter, CUTANEA will update this rolling ___ Forecast quarterly. 2.4.2 With regards to the FDA Fees, CUTANEA shall maintain the NDA for the Products and pay, from time to time, all required FDA filing and related Product fees. 2.4.3 CUTANEA shall notify Supplier within one Business Day, after it receives any materially adverse contact or communication from any Governmental or Regulatory Authority that relates to any Product. Supplier shall notify CUTANEA as soon as reasonably possible after it receives any materially adverse contact or communication from any Governmental or Regulatory Authority that relates to any Product and may reasonably be expected to affect patient safety. For matters that would not reasonably be expected to affect patient safety, Supplier shall notify CUTANEA of such communications in its discretion. 2.4.4 CUTANEA shall provide Supplier with copies of all communications received from or sent to any Governmental or Regulatory Authority with respect to any Product within three business days after receipt or sending of the communication, as the case may be (subject to confidentiality and privilege restrictions, if any). CUTANEA shall consult with Supplier regarding the response to any inquiry or observation from a Governmental or Regulatory Authority relating to a Product. CUTANEA shall consider all reasonable requests and comments by Supplier with respect to all contacts and communications with a Governmental or Regulatory Authority. 2.5 Purchase Orders. 2.5.1 CUTANEA agrees to purchase from Supplier all Products Manufactured for CUTANEA in accordance with valid CUTANEA Purchase Orders pursuant to the terms of this Agreement and provided that such Products meet the Specifications approved by CUTANEA. 5 ___ = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
2.5.2 During the term of this Agreement, CUTANEA will order Product(s) by issuing firm Purchase Orders not less than ___ business days before the requested delivery date(s) of such Product(s), and Supplier shall provide approval of the Purchase Order by the Supplier within five (5) business days following the Purchase Order reception, such approval signifying Supplier's commitment to deliver such Product(s) on the requested deliver date(s), it being understood that Supplier must accept a Purchase Order for delivery of Product not less than ___ business days before the requested delivery date when included in the first ___ of the Forecasted Needs. Each purchase order shall set forth the Product for which the purchase order is being issued, the quantity being ordered (in trade/sample form), the Supply Price for the Product(s) being ordered and the requested delivery date for the Product being ordered, and the locations to which such quantities shall be delivered. 2.5.3 Within ten (10) Business Days following this Agreement becoming effective and thereafter on or before the last day of each calendar quarter, CUTANEA shall provide Supplier with specific data as to its Forecasted Needs for such Product (including in trade/sample form) for the following rolling ___. Supplier will use commercially reasonable efforts to deliver Product to CUTANEA with minimum expiry dating remaining of ___% of the approved shelf-life. 2.5.4 CUTANEA's purchase orders shall designate the desired quantities of Products, delivery dates and destinations. Supplier shall fill and ship all orders of Products in accordance with CUTANEA's reasonable written instructions. CUTANEA'S purchase order may specify up to three (3) shipping destinations per batch of Product but will be in full pallet quantities. Additional destinations can be accommodated only upon CUTANEA payment of a shipping preparation fee to be negotiated by Supplier and CUTANEA. 2.6 Acceptance / Rejection of Products. 2.6.1 All Products shall be submitted to inspection and evaluation by or on behalf of CUTANEA to determine whether or not said Products meet the Specifications. CUTANEA will provide in good faith written acceptance of a batch of Product or written notification of any deficiencies within two (2) Business Days after receipt of the Certificate of Analysis for the Product batch. Written acceptance of a batch of the applicable Product is required as a condition to the delivery of Product to Cutanea's designated shipping agent in accordance with Section 3. If for any reason Supplier does not receive any such notification within such two (2) Business Day period, Supplier will promptly notify CUTANEA of such fact and CUTANEA will as soon as practicable and, in any event within another two (2) Business Days thereafter provide such written notice to Supplier and be responsible for any storage or similar charges that Supplier may incur for not delivering such Product. The lack of reception of such written acceptance within the second two (2) Business Day period shall be deemed as the batch is accepted. If, once the Product is delivered, CUTANEA determines that there is any deficiency with respect to any Product, CUTANEA will notify Ferrer of such claim within fifteen (15) Business Days of delivery of the Products. Each such notice of rejection to Supplier shall specify in reasonable detail the ways in which the Product batch failed to meet Specifications. CUTANEA shall grant to Supplier (or its designee) the right to inspect or test said Product batch and dispute CUTANEA rejection according to the provisions provided in this Section 2.6. In the event that Supplier disagrees with CUTANEA's defective Product claim, the issue shall be submitted to a mutually agreed upon independent third party laboratory, whose decision shall be final and binding upon the Parties. The costs arising from the laboratory's intervention and the costs of the replaced Products (including return and destruction costs of the defective Products) shall be borne by the Party whose results were mistaken. As to any such Product batch which is determined to fail the Specifications ("Rejected Product"), CUTANEA shall have no obligation to pay for such Rejected Product and Supplier shall replace such Rejected Product as soon as possible and no later than ninety (90) days thereafter. 6 ___ = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.