GENERAL TERMS AND CONDITIONS OF OTÉ PHARMA SOL B.V.; UDEN ALGVUK180610

I. SCOPE OF APPLICATION
1. These general terms and conditions apply to all our offers, agreements and their performance.
2. Stipulations varying from these terms and conditions must be agreed in writing, and shall apply only to the specific agreement to which these stipulations directly refer.

1. OFFERS AND ORDERS
   1. Unless otherwise agreed in writing, each offer must be considered to constitute a whole and shall be valid for a period of 30 days or so much longer or shorter as stated in the offer. All our offers are without obligation. They may be withdrawn by us within two working days of receipt of their acceptance.
   2. If an order is placed without a prior offer having been made by us, an agreement will only be concluded when we confirm the order within fourteen days of its receipt or when we actually execute the order.
   3. If the agreement concluded with the other party involves, or also involves, the packaging of the products supplied by the other party, and the other party has submitted samples of the products to be packaged by us, then the products to be supplied by the other party and to be packaged by us must be similar to these samples. If this is not the case, we shall be entitled either to terminate the agreement without being required to pay any compensation to the other party or to charge the resulting additional costs to the other party’s account.
   4. If and when we enter into an agreement with the other party, we shall be entitled, if we deem this necessary, to design and/or order relevant labels. The costs of these labels will be set off against the purchase price. If the agreement is terminated, the other party shall be obliged to purchase the labels and other printed matter still in stock at cost price.

III. PRICES
1. All prices are exclusive of VAT. All prices for deliveries are ex works of our company. They will be based on the factors determining prices at the time of the offer, whatever they may be.
2. We are entitled to increase the stated or agreed prices if said price-determining factors have been subject to an increase after the offer was made or after the agreement was concluded, even if this increase was foreseeable.
3. Specifications of measurements, standards, quality, prices or of whatever nature of our goods or products as provided by us in quotations, brochures, catalogues and/or samples or in any other manner, are approximations only and shall not be binding on us.

1. AMENDMENTS
   1. After conclusion of the agreement, the other party may request for amendments to the agreement in writing. Only amendments that have been requested in this manner and have been accepted by us will be eligible for implementation and settlement. Any additional costs incurred in connection with these amendments will be charged to the other party's account.
2. DELIVERY AND RISK: OBLIGATION TO PURCHASE
   1. In these general terms and conditions the term ‘delivery time(s)’ shall be understood to mean a specific time (expressed in a number of workable working days) within which the contracted work must be completed, or in the case of purchase, the time within which the product must be delivered. The stated delivery times shall never be regarded as strict deadlines. If a delivery time is exceeded, we will be in default only after we have received a written notice of default. We are entitled to make part deliveries, which may be invoiced separately.
   2. The delivery time will commence after the agreement has been concluded, all the information required for the performance of our obligations have been made available to us, all the permits/formalities required for this performance (including the other party’s VAT/tax reference number) have been obtained, concluded or provided by the other party, and payment, if and insofar as required for execution of the order, has been received. The delivery time will be extended by the period during which we have suspended our performance pursuant to these general terms and conditions and/or the law or during which we were prevented to fulfill our obligations due to force majeure as described in Article 13.
   3. Unless otherwise agreed in writing, deliveries will be ex works of our company (Inco terms 1990). The goods will be deemed to have been delivered and the risk with respect to these goods will pass to the other party:
   - as soon as the goods have been placed in a means of conveyance, even when we are taking care of the transport;
   - if the other party refuses, or is deemed to have refused, the cooperation as referred to in subparagraph (b) of the following paragraph;
   - in the case of a call-off arrangement: as soon as the goods have been set apart at our site for the benefit of the other party.
   If and insofar as delivery carriage paid within the European territory of the countries that are part of the EU and EFTA has been agreed, the goods will be ensured by us against normal transportation risks, excluding loss or damage resulting from acts of war and other extraordinary risks.
   4. The other party will undertake to lend us the cooperation necessary for the performance of our obligations. This cooperation will be deemed to have been refused:
   - if we take care of transportation: if the goods were offered for delivery to the other party, but delivery could not be effected;
   - if the other party takes care of transportation: if the goods have not been collected by or on behalf of the other party on the agreed date;
   - if goods were offered for delivery to the other party, but delivery could not be effected, as well as if we or our personnel were denied access to the work site by the other party.
   In these cases the other party will immediately be in default de jure. The day on which this refusal took place will then be considered the date on which the goods were delivered or the work was completed. All the costs incurred by us as a result of such a refusal shall be borne by the other party, without prejudicing any other rights we may have with respect to this failure. Said costs shall also expressly include a reasonable reimbursement of the costs of storage, based on local customary rates.
3. CALL-OFF
   1. If delivery on demand has been agreed, we will deliver the goods no later than 30 working days following the day of call-off, unless otherwise has been agreed in writing.
   2. If call-off periods have been agreed, and the other party fails to place a call in a timely manner, the term referred to in the previous paragraph of this article will be extended by 10 working days.
   3. The other party shall be obliged to make calls. If the other party fails to make the call agreed on, we shall be entitled, after having sent a notice of default to the other party, to store the goods, or to have them stored, at our warehouse or elsewhere at the other party’s expense and risk, or to sell them at the other party’s expense, without prejudicing any other rights we may have with respect to the other party’s failure. By such storage, the goods shall be deemed to have been delivered.

VII. COMPLAINTS
1. The other party shall be responsible for checking the amounts delivered. If the other party does not complain as soon as possible or at least within one working day following the receipt of the delivery, the amounts entered into the consignment notes, delivery notes, invoices or any such documents shall be deemed to be correct.
2. The other party is obliged to inspect the delivered goods upon receipt. Any defects of the delivered goods which are visible immediately on receipt of the goods must immediately be reported and specified by the other party, with a clear description of the complaint, on the consignment note or a similar document. Other complaints must be submitted to us in writing no later than two working days following the receipt of the goods or after the defects could reasonably have been detected. Each time, the complaint must be accompanied by items of evidence (samples, statements of production and package numbers, etc). If the other party fails to complain in a timely manner, or if the goods have been processed wholly or in part, the goods shall be deemed to have been approved and our liability with respect to these goods shall therefore lapse, unless the defect(s) could only be detected upon or as a result of the processing. This will not release the other party from the obligation to complain in a timely manner.
3. Complaints about invoices must be submitted to us in writing within 8 days of the invoice date. If the other party fails to do so, the details on the invoices shall be deemed to have been agreed as correct between the parties.

VIII. PAYMENT
1. Unless otherwise agreed, payment must always be made within 30 days of the invoice date. Setoff is not permitted, unless we have acknowledged the counterclaim wholly and unconditionally.
2. If we have not received payment from the other party within the agreed term of payment, we will be entitled to charge interest on the invoice amount equal to the statutory interest as applicable from the due date plus a % per month or part thereof as from the due date, without prejudice to any other rights we may have in the matter.
3. All legal and other costs incurred by us in order to make the other party perform its obligations shall be borne by the other party. The extrajudicial collection costs shall be calculated in accordance with the collection rate as recommended in collecting business by the Netherlands Bar Association, with a minimum of €750.00, all this without prejudicing our right to claim the higher actual damage or loss.
4. Payments must be made without any deductions at the office of Oté Pharma Sol BV, to a Dutch bank account to be designated by us, or at the office of Oté Pharma Sol GmbH in Germany, or in another manner as indicated by us.
5. Payments made by the other party first are applied to the satisfaction of any interest and costs owed, and then to any claims due and payable on property for which no valid claim for retention of title can be stipulated, and then to the oldest unpaid invoiced claims even if the other party states that payment applies to another or later invoiced claim.
6. We are entitled to require the other party to furnish security. This security must be such that our claim, the interest thereon and related costs are properly covered and that we have easy and unhindered recourse in respect thereof. If the other party refuses to furnish such proper security, we will be entitled to suspend our obligations towards the other party.

1. BANKRUPTCY ETC.
   1. If the other party does not fulfill properly or on time any of its obligations that may derive from any agreement with us, or if the other party has been declared bankrupt, has been granted a moratorium, or has been placed under guardianship, or its business has been halted or terminated, the other party shall be deemed to be in default de jure and we shall be entitled, at our discretion, without any compensation being required and without prejudice to any other rights to which we are entitled, and without notice of default or judicial intervention, to terminate the agreement wholly or in part, to declare the agreement terminated or suspend execution or further execution of the agreement. In these cases, we shall also be entitled to claim immediate payment of what the other party owes us.
2. RETENTION OF TITLE
   1. The ownership of the goods delivered or to be delivered by us shall not pass by the sole delivery of the goods, but by the fulfillment of the resolutory condition of full payment of what the other party is owing pursuant to the agreement. We will retain title to the goods delivered or to be delivered until the other party has given consideration for the goods delivered or to be delivered by us to the client under the agreement concluded or a similar agreement, as well as for claims on the other party for breach of such agreements, including claims for penalties, interest and costs.
   2. As long as the above-mentioned claims have not been satisfied, the other party shall not be authorized to create a possessory or non-possessory pledge on the goods delivered by us and, at our request, the other party will declare to any third party that wishes to establish such a right thereon that it is not authorized to create such a right. Furthermore, the other party shall refrain from signing any deed in which a right of pledge is created on the goods, as by doing so it will commit embezzlement.
   3. If the other party does not fulfill any obligation under the agreement with respect to the goods sold or work to be performed, we will be entitled, without giving advance notice of default, immediately to recover the goods originally delivered or newly formed. The other party will grant us its unconditional and irrevocable permission to enter those places where the goods are located. As soon as the other party has fulfilled all its payment obligations under these or similar agreements, we will transfer the ownership of the delivered goods to the other party, subject to our right of pledge for other claims that we have on the other party. At our request, the other party will lend us its cooperation with any endeavour deemed desirable or necessary in that context.
3. LIABILITIES AND GUARANTEES
   1. We shall be liable for damage or loss sustained by the other party only if that damage or loss is directly and exclusively attributable to us, with the proviso that any loss or damage sustained shall qualify for compensation only if we have taken out insurance or should reasonably have taken out insurance, in line with usual practice in the business sector. The following limitations shall apply in this respect:
   a. consequential loss (operational breakdown, mooring fees and other expenses, loss of income and the like) will not qualify for compensation, whatever the cause. The other party should take out insurance against such consequential loss.
   b. we will not be liable for any damage caused to property of the other party or third parties as a result of or during the execution of the work.
   c. We will not be liable for damage or loss as a result of intent or gross negligence on the part of auxiliary persons.
   d. the compensation to be paid by us for damage or loss will be moderated if the price to be paid by the other party is small compared to the scope of the damage or loss sustained by the other party.
   2. The other party shall indemnify us against all and any claims for damages by third parties in connection with the use of samples or other things or information submitted by us, and will be liable for all resulting costs.
   3. We guarantee the sound condition of the goods delivered by us and the quality of the raw materials used and/or supplied therefore. We do not accept any liability for defects relating to the nature or quality of the applied raw materials which are the result of government regulations.
   4. Otherwise, in the case of attributable non-performance, untimely performance or improper performance, all our obligations to pay damages shall have been entirely fulfilled by that which the other party has bought or for which an order has been placed, or, at our discretion, to be still delivered or repaired or improved, without prejudice to the above provisions with regard to the guarantees.

XII. INDUSTRIAL AND INTELLECTUAL PROPERTY RIGHTS
1. All our patents, registered and unregistered models, trademarks, copyrights and other intellectual property rights, as well as confidential know-how, will remain our property. Unless expressly and specifically agreed otherwise, the sole delivery of the goods shall not give the other party the right to use these rights and/or know-how for any purpose.
2. All labels, instructions for use, product documentation, specifications, plans, drawings, process information, patterns, models, formulas or other processes (‘specifications’) which have been created, calculated, drawn or designed by us to meet the requirements or instructions of the other party in connection with the delivery of goods, or any information derived there from or otherwise communicated to the Buyer in connection with the delivery of goods will at all times remain our property and must be kept secret in all cases in which we have indicated that these involve confidential information or when it may be clear to the other party from the nature of the information provided that this information is confidential.
3. The other party may not remove or change any indication, notice or other label attached to, or enclosed with, the goods or packaging, relating to the instructions and/or use.

XIII. COMPLIANCE WITH LEGAL REQUIREMENTS
1. The other party will fulfill all obligations required for compliance with all applicable statutory and European requirements and the more detailed instructions provided in this context by us from time to time.
2. Insofar as one or more goods are medical aids, the other party declares that it is familiar with the requirements of the European Union’s medical devices directive (93/42/EEC as most recently amended and as implemented in national law) and with the reporting obligations imposed through this directive on the manufacturers, suppliers, installers and users of these devices.
3. In this respect, the other party declares itself prepared to notify us within ten (10) days about each event that is identified in EU directive 93/42/EEC as an event that should be reported by the other party and/or by us. In case of events which constitute an imminent risk and which must be reported to the competent national authorities ('Authorities’) within seventy-two hours, a notification must immediately be sent to the other party. The other party will ensure that the Goods are properly traceable or will not remove the trace information applied by us so that we can meet the requirements for tracing medical devices.
4. If the other party is located in a jurisdiction in which EU directive 93/42/EEC does not apply, the other party will comply with the provisions applicable to that jurisdiction with regard to medical devices or other provisions with regard to marketing, product and information requirements as well as post-marketing requirements for products the other party bought from us.

XIV. STORAGE OF GOODS
1. From the moment the other party has accepted the goods delivered by us until the time at which the other party supplies its customers with these goods, the other party shall be liable for any faulty manipulation resulting in damage caused to or by the goods.
2. The enclosed spaces which the other party uses for the storage and processing of the goods must:
• be properly designed and large enough to facilitate storage, cleaning, maintenance and other necessary actions;
• provide sufficient protection against any circumstances that may negatively affect the quality and/or sterile condition of the goods, such as light, temperature, humidity, particles suspended in the air, and contamination by microbes;
• provide proper separation of the goods, more particularly, there should be properly separated zones available for defective goods, recalled goods, and waste;
• not be used for actions that may cause impurities or other actions that may contaminate the goods.
3. The other party will implement the following systems:
• a documented pest control system involving regular inspections and the placing of bait and/or spraying of insecticide and that has been designed to prevent contamination of materials and goods;
• a registration system for complaints from end users to facilitate the reporting of complaints about the products to us; and
• a recall system that can trace the goods on the basis of a reference, the batch or lot number, or the amount. The other party will implement adequate systems that are able to retrieve all the complaints lodged by the Buyer's customers. This system must enable the other party to report such complaints to us.
4. The other party must ensure that an effective stock rotation system is applied with respect to our products, preferably a system based on the first in/first out principle for sterile goods or for goods that have a best-before or expiry date.

1. LABELING AND MARKETING
   1. We will provide the other party with advertising material approved by us and marketing information, claims and statements about the products. When advertising and marketing the goods, the other party will not use any other information, statements or claims than those provided in our marketing materials. If the other party wants to use other statements, claims or information to advertise and market the goods, the other party will submit these statements, claims and/or this information to us in advance and will not use them until and only if we give permission to do so.
   2. The other party may not remove or change any indication, notice or other label attached to, or enclosed with, the goods or packaging, relating to the instructions and/or use.
   3. The other party shall defend, hold harmless and indemnify us against any losses, liabilities or claims, including but nor limited to damage or loss caused by withdrawal or forced withdrawal of the product from the market, resulting from the other party’s use of information, claims and statements in advertising and marketing materials other than those approved by us.

XVI. OEM LABELING
1. As a manufacturer within the meaning of the EU medical devices directive (93/42/EEG as most recently amended and as implemented in national law), the other party is aware that it is liable for private-label goods that are supplied by us but are marketed under the other party’s name and label and in packaging specified by the other party (‘OEM goods’).
2. As far as these private-label goods are concerned, the other party will not be entitled to identify us in any way whatsoever as the manufacturer of the goods, unless explicitly agreed otherwise. The other party shall defend, hold harmless and indemnify us against any losses, liabilities or claims based on the argument that we are the manufacturer of the private-label goods.

XVII. FORCE MAJEURE
1. Breaches may not be attributed to us if our suppliers, subcontractors and/or carriers are in default and/or fail to perform, nor in the case of fire, industrial actions or lockouts, riots or uprising, war, government measures, including bans on import, export or transit, frost and any other circumstances of such a nature that the obligations under the agreement can no longer be construed as binding on us. In case of failure as referred to in this Article, this failure will be considered a justification for termination of the agreement.

XVIII. RIGHT OF RETENTION
1. We shall have the right to retain all things that we have in our possession of or on behalf of the other party until the other party has fulfilled all its obligations to which the things concerned have a direct or sufficient relation to justify refusal of delivery. If the things that fall under this right are removed from our control, we shall be entitled to claim these things as if we were the owner thereof.

XIX. INDEMNIFICATION
1. We shall never be further liable to third parties for any damage or loss resulting from the execution of the agreement to which the present terms and conditions apply than we would be to the other party. The other party shall indemnify us against any further liability and, where possible, the other party will demand that a stipulation will be included in its agreements with third parties exonerating us from further liability. The other party shall fully indemnify us against any claims for damages by third parties based on violation of intellectual property rights, use of drawings, data, materials or parts, or caused by application of working methods that have been made available to us by or on behalf of the other party or have been prescribed by, or on behalf of, the other party for the execution of the agreement.

1. JOINT AND SEVERAL LIABILITY
   1. If two or more persons or legal entities enter into an agreement, they shall be jointly and severally liable for the full compliance with the obligations under that agreement.

XXI. APPLICABLE LAW AND DISPUTES
1. All our offers, agreements and their performance are exclusively governed by Dutch law. Application of the Vienna Sales Convention (Treaty Series 1981, 184; 1986, 61) is, however, expressly excluded.
2. Any disputes arising from our offers and/or agreements will be settled by the competent court in the legal district where we have our head office, without prejudice to the competence of the sub district court in matters coming under its jurisdiction.
3. In case of differences in interpretation of the Dutch and English texts of these general terms and conditions, the Dutch text will prevail.