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Capsugel Ploërmel SAS

CAPSUGEL PLOERMEL SAS (‘CAPSUGEL’) – GENERAL TERMS AND CONDITIONS OF SALE

effective as from April 1, 2016

1.  CAPSUGEL’S ACCEPTANCE OF THE ORDER PLACED BY THE BUYER IS EXPRESSLY LIMITED TO AND MADE CONTINGENT UPON THE ACCEPTANCE BY THE BUYER TO THE CONDITIONS SET FORTH IN THESE GENERAL SALES CONDITIONS (THE “CONDITIONS”). BUYER WILL BE DEEMED TO HAVE AGREED TO THE CONDITIONS SET FORTH HEREIN UNLESS BUYER OBJECTS IN WRITING TO THE CONDITIONS PRIOR TO THE SHIPMENT OF THE PRODUCTS.  CAPSUGEL OBJECTS TO ANY DIFFERENT OR ADDITIONAL TERMS.  THESE CONDITIONS CONTROL OVER ANY CONFLICTING OR ADDITIONAL TERMS AND CONDITIONS INCLUDED IN ANY PURCHASE ORDER OR OTHER CORRESPONDENCE USED BY BUYER IN ORDERING PRODUCTS.  IN THE EVENT, HOWEVER, OF A CONFLICT BETWEEN THESE CONDITIONS AND ANY SPECIAL CONDITIONS OR TERMS SET OUT IN A WRITTEN SUPPLY AGREEMENT OR PURCHASE AGREEMENT EXECUTED BY CAPSUGEL AND BUYER, THEN SUCH SPECIAL CONDITIONS OR TERMS WILL PREVAIL.

2.  Applicable Conditions. These Conditions apply to all sales of all hard capsules, Licaps®, softgels, equipment and spare parts (collectively, the “Products”), by Capsugel to the buyer following receipt of orders made by the buyer and accepted by Capsugel as evidenced by buyer’s receipt of Capsugel’s order confirmation. Changes to any orders are only effective if to Capsugel in writing and thereafter accepted in writing by Capsugel.

3.  Price. The price for the Products and conditions of sales are subject to review from time to time by Capsugel to reflect any changes in the costs of energy, materials and labor and market conditions. Prices invoiced will be those in effect at the time of shipment. Notwithstanding the foregoing, in the event the date of delivery of Products is later than four (4) months from the order date, Capsugel reserves the right to adjust prices in the event raw material prices increases by greater than five percent (5%).

4.  Quantity Variance and Yield. Owing to the specific character of the manufacturing process of Products, Capsugel reserves the right to deliver a quantity of Product ten percent (10%) higher or lower than the quantity ordered. For the manufacturing of Licaps® or softgels, materials supplied by buyer will not be reimbursed unless specifically agreed upon in a separate Commercial Supply Agreement based on an industry accepted manufacturing yield for each product not to exceed 95% of the theoretical yield for any such product.

5.  Delivery Terms. Unless otherwise agreed in writing by Capsugel or set forth herein, Capsugel will deliver the Products CIP (Incoterms 2010) Capsugel’s facility; shipment of the Products is at the buyer’s sole cost and risk. Buyer is responsible for taking out an insurance policy covering loss or damage to the Products or third parties at the time of delivery by Capsugel (the “Delivery Date”). If Capsugel arranges shipment for the buyer, buyer will pay Capsugel for the cost of insurance and freight prepaid by Capsugel. Capsugel shall use reasonable commercial efforts to meet the requested delivery dates for products; time for delivery, however, is not of the essence and Capsugel shall not be liable for any failure to meet any such delivery date.

6.  Title. The Products remain the property of Capsugel until buyer has paid the associated invoices, possibly increased by interest and costs. Until such time as title to the Products has been transferred to the buyer, it is prohibited for the buyer to dispose of, pledge or encumber the Products with any right for the benefit of third parties, except for processing and sale by the buyer in the context of his normal business operations.

7.  Specifications. With respect to empty capsules, Capsugel warrants that at the date of delivery the empty capsules will comply with the quality standards set forth in Capsugel’ s general specifications in the Capsugel Technical Reference. With respect to filled Licaps® capsules and softgels, Capsugel warrants that at the date of delivery the filled Licaps® capsules and softgels will meet the specifications set forth in the Formula Agreement (or equivalent document or agreement). The ideal storage conditions are a relative humidity of 50% and a temperature of 20°C. Capsugel recommends that the Products be stored in the closed containers in which they are dispatched in areas where the ambient temperature is 15°C to 25°C and the relative humidity 35% to 65%. The storage of the bulk Licaps® capsules and softgels should be limited to 60 days after receipt. Capsugel shall not be liable for any defective or non-conforming Products if the above storage conditions are not followed. responsibility of CAPSUGEL cannot be engaged if those conditions are not respectedWith respect to equipment and spare parts, Capsugel warrants that at the date of delivery the equipment and/or spare parts shall conform to the specifications stated in the operating manual for the equipment subject, where applicable, to accepted variations within industry standards, and shall be equal in quality to similar equipment and parts. EXCEPT AS EXPRESSLY SET FORTH IN THIS PARAGRAPH, CAPSUGEL GIVES NO WARRANTIES, GUARANTEES, CONDITIONS OR REPRESENTATIONS, WHETHER EXPRESS OR IMPLIED, AND CAPSUGEL HEREBY DISCLAIMS ALL EXPRESS OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION, THOSE OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.  The Products are sold on the condition that buyer or any other user shall be responsible for all intellectual property decisions concerning the finished product and buyer shall carry out its own independent tests to determine the suitability of the Products for its purpose and that all risks arising out of the use of the Products are assumed by the buyer and the user, since the conditions of use are beyond Capsugel’s control.

8.  Trademarks. Whether empty capsules, filled Licaps® capsules or softgels with the color combinations, text or logo specified by the buyer are free to be used for marketing as such or with any products is beyond Capsugel’s knowledge, control and responsibility. No warranty, guaranty or representation is given by Capsugel as to the absence of any trademark, patent or other intellectual property right or concerning compliance with regulatory requirements. No statement made by Capsugel shall be construed to be a recommendation or approval to infringe any patent or trademark or as an opinion regarding non-infringement of any patent or trademark or other intellectual property. Buyer is not permitted to use Capsugel’s trademarks without Capsugel’s express written consent.

9.  Force Majeure. Either party shall be excused from the performance of its obligations in the event such performance is prevented by conditions constituting force majeure (including but not limited to acts of God, regulation or law of any government, war, civil commotion, strike or other labor disturbance, epidemic, failure of production facilities by fire, earthquake or storms, or non-availability of raw materials), and such excuse shall continue so long as such conditions continue.

10.  Buyer Representations and Warranties. Buyer represents and warrants that (a) it will comply with all present and future laws; (b) the Products will not be used in the production, encapsulation, packaging or marketing of any product which is in violation of any federal, state or local law or with any person or entity on any applicable government sanction, restricted party or denial list without a license or otherwise in violation of applicable law or regulation; (c) it is responsible for communicating with any governmental authority concerning Products, including without limitation with respect to the registration, classification or notification of Products, or the use, packaging, labeling, distribution, marketing, labeling, promotion, sale or disposal of the same or any adverse events related to Products (for the avoidance of doubt, Capsugel may interact with governmental authorities for the purpose of fulfilling its obligations hereunder); (d) storing and handling Products in appropriate conditions following its delivery; (e) determining that the specifications for Product to permit its sale in each country in the world and (f) it is not, and will not, in connection with any Product, do business with or sell directly or indirectly to the Government of Iran, the Iranian Military or Iranian military or law enforcement purchasers or importers, Iran’s petroleum sector or Iran’s development of weapons of mass destruction, Iranian Specially Designated Nationals, or entities considered by the U.S. to be supporters of terrorism or proliferators of weapons of mass destruction (which entities can be identified by accessing the U.S. Office of Foreign Asset Control “Blocked Persons and Specifically Designated Nationals List” https://sdnsearch.ofac.treas.gov/); and it is aware of and, hereby confirms its compliance with, all applicable economic sanctions, including, without limitation, any applicable U.S. economic sanctions. Buyer shall conduct all such activities at all times in compliance with applicable laws. The parties acknowledge and agree that Capsugel has no control, role, or other form of influence in Buyer’s use, packaging, labeling, distribution, marketing, promotion, sale and disposal of Products, nor does it control or influence over any payments or transfers of value that may be made by buyer to health care professionals, health care institutions, or any other customer or third party. Buyer is responsible for participation and compliance in all government health care programs and any rebate liability, mandatory pricing, or reporting obligations resulting therefrom. 

11.  Defective Products. Any complaints in relation to visible defects in the Products must- on pain of nullity - be notified in writing to the Customer Services Department of Capsugel within 10 days after the Products were delivered to the buyer. Any complaints in relation to hidden defects in the Products must- on pain of nullity - be notified in writing to the Customer Services Department of Capsugel within 90 days from the delivery date. Products may not be returned without the prior examination of a representative sample and without Capsugel’s express, prior, written authorisation. The buyer is always responsible for the risks of any return. Buyer’s sole and exclusive remedy, and Capsugel’s sole and exclusive liability, for defective Products, or for its breach of these Conditions shall be, at Capsugel’s discretion, (i) replacement of the Products with buyer providing raw materials free of charge; or (ii) refund of the purchase price of the Products in relation to which the non-conformance or breach has occurred. 

12.  Liability and Indemnity. In no event shall Capsugel or its affiliates be liable to buyer or its affiliates for any incidental, indirect, punitive, exemplary, special or consequential damages of any kind however caused (including fault or negligence) arising out of or in connection with any purchase order related to the subject matter hereunder, including without limitation, loss of profits, goodwill or business interruption. Capsugel’s aggregate liability arising out of or in connection with any purchase order related to the subject matter hereunder shall be limited to the aggregate fees received by Capsugel under the purchase order creating such liability. Further, buyer agrees to unconditionally indemnify, defend and hold harmless Capsugel and its officers, directors, employees, agents, consultants, successors and assigns from and against any losses, damages (including statutory damages), liabilities, obligations, (including without limitation incidental, consequential, special or indirect damages (including loss of revenue, diminution in value or any damages based on any type of multiple)), deficiencies, actions, judgments, suits, interest, awards, penalties, forfeitures, fines, levies, disbursements, costs or expenses of whatever kind, including reasonable attorneys' fees and expenses (“Claim”) that may be imposed on, incurred by, appropriated from or asserted against Capsugel in any way relating to or arising out of (a) the violation of any third party’s trade secrets, trademarks, copyright, patent or other proprietary rights related to the subject matter hereunder; (b) any misrepresentations, omissions or breach of any warranty of buyer herein; (c) the gross negligence or willful misconduct of buyer or (d) the manufacture, packaging, sale, marketing, labeling, promotion, use, distribution or disposal of the finished product; except, in each case, to the extent such Claims are attributable to the gross negligence or willful misconduct of Capsugel.

13.  Confidentiality. Buyer acknowledges that Capsugel’s information relating to empty capsules, equipment and capsule filling that Capsugel shares with buyer is confidential and proprietary to Capsugel, and buyer agrees to maintain the confidentiality of any such information disclosed by Capsugel for a period of ten (10) years from the date of disclosure and to use such information only for the purpose of filling Capsugel capsules. With respect to filled Licaps® capsules, the Formula Agreement (or equivalent agreement or document) may also contain Capsugel’s confidential information, in particular the combination of ingredients (e.g., excipients) and processes used to formulate the filled Licaps® capsules product. As such, buyer agrees not to share this formulation with a third party or purchase this formulation from a third party. Buyer will safeguard and protect Capsugel’s confidential and proprietary information in the same manner it protects its own similar information, and in no event utilizing less than reasonable industry practices.

14.  Intellectual Property. All rights and title to inventions and intellectual property conceived and reduced to practice by Capsugel in the course of performing its obligations hereunder shall belong to Capsugel. For purposes of clarity, the term “inventions” shall encompass, without limitation, any new process, systems, equipment, or any improvement thereon, and components and/or intermediate substances, whether patentable or not, made by Capsugel in connection with or related to the Products.

15.  Payment. All Products shipped and invoiced shall be payable to Capsugel within thirty (30) days from the date of invoice. Capsugel reserves the right to invoice buyer for the Products on or after the date Products are available for delivery to buyer (the “Sale Date”); provided however that Capsugel shall be responsible for taking out an insurance policy covering loss or damage to the Products from the Sale Date to, but not including, the Delivery Date. Payment shall be made in the currency shown on the invoice. Capsugel reserves the right to charge buyer for warehousing products held for buyer beyond the agreed upon delivery date and shall issue a separate and additional invoice for such warehousing to buyer. Should the buyer fail to timely pay any invoice, interest shall accrue on all past due amounts at a rate of three times the French legal interest in force, from the date when payment becomes due to the date payment is made. A fixed amount of €40 as a compensation for recovery costs will automatically be due. If recovery costs are higher than this fixed amount, Capsugel can claim a complementary compensation for all remaining reasonable recovery costs, based on documentary evidence.

16.  Severability. If any provision or part of a provision in these Terms and Conditions or the sales agreement to which these Terms and Conditions apply is null and void or unenforceable, the remaining provisions of these Terms and Conditions or the sales agreements to which the Terms and Conditions apply shall remain in force undiminished. If the case arises, the parties shall in good faith agree on a provision that approaches as closely as possible the intended legal effect of the provision or part thereof that has been declared null and void or unenforceable.

17.  Governing Law. These Conditions shall be governed solely by the laws of France, without reference to its conflicts of law provisions, and shall be subject to the exclusive jurisdiction of French Courts and the parties hereby waive all defenses and objections to the jurisdiction of such courts and such venue, including that of inconvenient forum. The parties agree that the United Nations Convention for the International Sale of Goods is expressly waived and excluded from having applicability to the order these Conditions relate to.


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