AGREEMENT REGARDING THE OUTSOURCING TO MANUFACTURING LICENSE HOLDER FAGRON STERILE SERVICES (FSS)

QUALITY AGREEMENT

Between the undersigned:

“The applicant”, on the one hand;

And

Fagron Compounding Services NV,
Established at BE-2880 Bornem, Woestijnstraat 53. Represented by Liesa Tack – Qualified Person (QP). Hereinafter referred to as “the contractor”; on the other hand;

The following is agreed:

Article 1 – Subject of the agreement
1.1 The parties enter into a cooperation agreement with the purpose of establishing arrangements, as well as their respective rights and obligations, in order to make magistral preparations (cf. Royal Decree 17/07/2014) available available to the applicant.
1.2 The applicant provides the contractor with anonymised prescription data. On the basis of the anonymised prescription data supplied regarding the magistral preparation, the contractor shall carry out the production of the magistral preparations and deliver them directly to the applicant. The contractor shall invoice the applicant and apply its general terms and conditions of sale (see Commercial Cooperation Agreement).
The following rules shall be applied:
Prior to placing a production order, the applicant shall verify the availability of a commercially authorised equivalent in Belgium that is acceptable to both the prescriber and the patient.
Before making the anonymised prescription data available for further processing, the applicant shall verify that such prescription data are pharmacotherapeutically acceptable for the patient.
1.5 The contractor shall not be responsible for incompatibilities with other medication taken by the patient. Such medication monitoring shall be the sole responsibility of the applicant.
1.6 The applicant shall issue all orders to the contractor only on the basis of a written order, in accordance with the current Belgian regulations, sent to the contractor via email or website. The orders for the products will not include patient data and will contain the following information:
1. the name of the (hospital) pharmacist outsourcing,
2. the address and telephone number of (hospital) pharmacy.
3. the date of application / order,
4. the type of preparation / product,
5. the quantitative and qualitative composition, as well as the volume to be prepared or the number of units.
6. The reference number of the prescription for magistral preparation.
1.7 The preparation is made available to the applicant together with the accompanying batch release certificate of preparation (CoA). This preparation certificate contains at least the following information:
1. the name of the qualified person of the contractor,
2. the address and telephone number of the contractor,
3. the date and lot number of the preparation,
4. the indication of the type of preparation, as well as its qualitative and quantitative composition and pharmaceutical form,
5. the controls carried out with corresponding results,
6. the expiration date,
7. the precautions to be taken for storage and handling of the medicinal product.
This certificate is signed electronically by the Qualified Person upon conformity. The full preparation protocol is archived for 10 years after the actual production took place and can be consulted when performing an audit.
1.8 The contractor acts in full compliance with the guidelines of the Belgian Royal Decree 17/07/2014, “the preparation license”, applicable to manufacturing of magistral / special preparations in Belgium. Should anything change in that circumstance, the applicant will be informed by the contractor.
1.9 The contractor shall not be permitted to change the composition of the preparation or to outsource (partial) processing of the requested preparations to third parties without the written permission of the applicant. If the outsourcing of (partial) processing is necessary in the context of product quality and thus patient safety, this may only take place with a party that possesses the necessary infrastructure and permits. Fagron Compounding Services undertakes to audit this party in accordance with the GMP guidelines, applicable to manufacturing of magistral preparations, and to enter into a quality agreement with this party.
Article 2 – Quality and analyses
2.1 The preparations comply at least with the provisions as included in the Belgian Royal Decree 17/07/2014, “the preparation license”.
2.2 The contractor shall carry out quality control on all batches produced by it by means of direct in process controls and, where applicable, visual or weighing inspections.
2.3 The contractor shall additionally perform an additional quality control on all lots produced by it belonging to category B (with a minimum shelf life exceeding 14 days) of the preparation license by means of sterility tests in accordance with Ph. Eur. 2.6.1 and, if applicable, a test for bacterial endotoxins in accordance with Ph. Eur. 2.6.14 (parenteralia).
2.4 Products will only be delivered after release by the Qualified Person. This also implies that the number of units delivered of a specific batch may deviate from the original number of units ordered as individual units may be withheld from a batch by the Qualified Person for quality reasons. The Qualified Person can also withhold an entire batch.
2.5 The shelf life of the preparations in question is determined based on scientific literature and/or stability studies available within the Fagron group.
2.6 The contractor is responsible for storage, distribution (in accordance with GDP guidelines) and traceability of the magistral preparations to the applicant. The applicant itself is responsible for storage, distribution and traceability of the products at lot level to the patient.
2.7 In the event of a recall of delivered products, the applicant will be notified by the contractor within 24 hours of notification or discovery of non-conformity.
2.8 Complaint Procedure:
1. Upon receipt of a complaint through info@fagronsterile.be or through the representative, a confirmation email will be sent within 1 business day.
2. In the case of a critical complaint where there is a risk to patient safety, it can be reported at any time to +32 471 70 39 33.
3. Complaints should be closed within 45 days and within this time period the complainant will be informed of the final outcome. If complaints are not closed within this timeframe, the complainant will also be contacted and an update will be given regarding the pending complaint.
Article 3 – Responsibilities
The following table identifies the responsibilities of each party to this agreement.

	APPLICANT	CONTRACTOR
Review and verification of completeness of written assignment	X	X
Possible grouping of issued orders for manufacturing	X
Specifications protocol and drafting of it		X
Specifications of analysis method		X
Labelling of the preparation: lot, date of manufacturing, expiration date, qualitative and quantitative composition and information for proper storage and handling of the medicine		X
Other labelling: patient, prescriber, posology, …	X
Manufacturing of the magistral preparations in accordance with the written order		X
Quality control of manufactured magistral preparations		X
Release, delivery of certificate of analysis and full product responsibility of manufactured magistral preparations		X
Storage and distribution of magistral preparations to be distributed until receipt at the applicant’s facility		X
Storage and distribution of magistral preparations to be distributed upon receipt at the applicant’s facility	X
Traceability of distributed magistral preparations until receipt at the applicant’s facility		X
Traceability of distributed magistral preparations upon receipt by the applicant	X
Receipt, handling, follow-up of complaints	X	X
Receipt, handling, operational execution, follow-up and storage of recalled products (recalls) as far as finished magistral preparations are concerned	X	X

Article 4 – Delivery reliability.
The contractor guarantees the applicant to respect the predetermined delivery time (defined in the commercial agreement), barring circumstances beyond the contractor’s control.
Article 5 – Provisions relating to the right of audit.
Fagron Compounding Services is inspected on a regular basis by the FAMHP (Belgian Federal Agency for Medicinal and Healthcare products). The applicant shall have the right, in consultation with the contractor, to conduct an audit in the context of the work related to this agreement: including with regard to compliance with specifications and guidelines in the manufacture and analysis of the relevant magistral preparations.
Article 6 – Confidentiality.
Neither party shall make any communication regarding the contents of this agreement or any further agreements arising therefrom without the prior written consent of the other party. This is equally true where it concerns the performance of the agreement and the parties’ names are in the public eye.
Article 7 – Exclusivity
This agreement does not imply a commitment to exclusivity of the applicant vis-à-vis the contractor.
Article 8 – Deviations and/or additional agreements
Deviations from this contract and/or additional agreements must be included in an annex to this contract and will only be implemented after mutual and written consent.
Article 9 – Dates.
This agreement shall enter into force as of the date of signature of this Quality Agreement by the applicant . This agreement can be terminated immediately by operation of law and without prior notice in case of breach of one of the provisions of this agreement or its annexes.
This agreement will be governed and interpreted in accordance the Belgian law. The courts having jurisdiction over any dispute between the parties arising out of or in connection with this agreement shall be determined by the Service Agreement.
The agreement is valid for the applicant given the responsible functions already signed upon approval of the mastered document FSSBE-FORM-0073.


COMMERCIAL AGREEMENTS

Between the undersigned:

“The applicant”, on the one hand;

And

Fagron Compounding Services NV,
Established at BE-2880 Bornem, Woestijnstraat 53. Represented by Michel Forier – Business Leader. Hereinafter referred to as “the contractor”; on the other hand;

The following is agreed:

Article 1 – Subject matter of the agreement
1.1 The parties enter into a cooperation agreement with the aim of establishing commercial arrangements for the provision of magistral preparations to the applicant.
1.2 The applicant prefers to communicate verbally and in writing in English.
1.3 The applicant shall submit its anonymised prescription data to the contractor. Based on this prescription data, the contractor shall produce the magistral preparations and deliver them directly to the applicant. The contractor shall invoice the applicant and apply its general terms and conditions of sale.
1.4. Orders are placed via the website (fagronsterile.be) or by email (via info@fagronsterile.be). The applicant will receive a personal login to place orders via the website.
1.5. The quality of the products and the responsibilities of both parties are laid down in the FSS – Quality Agreement.
Article 2 – Fees and costs
2.1. For each standard shipment (transport) of finished magistral preparations from the contractor to the applicant, a transport surcharge of €17,50 (*) will be charged if the total order value is less than €1,000 excluding VAT.
2.2. An urgency fee (express delivery, see below) applies to any order that must be delivered on the same day or at the weekend (express delivery, see below).
2.3. The contractor will charge the costs in accordance with the applicable legislation.
2.4. The rates (*) displayed on the ordering platform are valid. By placing an order via the platform, the applicant agrees to the proposed rate. For formulas without a price (€0.00 / price on request) or formulas that are not yet included in the ordering platform, the price will be calculated manually upon explicit request and communicated to the applicant. Once the applicant has agreed to the price, the order will be accepted. Depending on factors such as changes in raw material prices, the rates may be adjusted periodically on the ordering platform. These amounts are exclusive of 6% VAT.
Standard lead time
– Active reference in stock: order placed on a working day before 3 p.m. = delivery on the next working day (exception: no deliveries on Wednesdays)
– Active reference, not in stock as standard: production date in consultation with the applicant within a maximum of 10 working days
– Reference that is not actively produced: production date in consultation with the applicant within a maximum of 20 working days
Express delivery
An urgency fee applies to express deliveries (same day or weekend). This urgency fee depends on the distance and storage conditions. This additional fee will be submitted for approval in advance.
Delivery within a time window
Delivery takes place according to the standard delivery time (8 a.m. to 5 p.m.). A time window can be scheduled on the planned delivery day. This entails an additional cost of €17,50 (*) if the total order value is less than €1,000 excluding VAT.
Cancellation of scheduled production
The cancellation of a pre-scheduled production is only possible on the day of the order, before 12 PM.
If this time window cannot be met and cancellation does take place, the costs incurred due to the destruction of the materials will be charged.
(*) Prices are subject to annual adjustment.
Article 3 – Confidentiality
Neither party shall make any statements about the content of this agreement or any further agreements arising from it without the prior written consent of the other party.
This is equally true where it concerns the performance of the agreement and the parties’ names are in the public eye.
Article 4 – Exclusivity
This agreement does not imply any obligation of exclusivity on the part of the applicant towards the contractor.
Article 5 – Deviations
Deviations from this agreement, in accordance with the applicable legislation, may only occur after mutual and written consent.
Article 6 – Agreements in the event of loan
In the event that the registered medicines required to make the preparations are supplied by the applicant, the following provisions shall apply.
6.1. Once the request for production has been accepted by the contractor, the applicant must send the required registered medicines to the contractor in accordance with the guidelines on Good Distribution Practices. The applicant shall take the initiative to transport these registered medicines and shall therefore bear responsibility for this. The applicant may also call on the contractor for this, who works together with a GDP transporter for this purpose.
In the case of medicines subject to narcotics legislation, the accompanying narcotics voucher must be delivered together with the goods. This must be done in accordance with Belgian legislation on the movement of narcotic medicines.
6.2. The registered medicines may be sent directly from the manufacturer of this medicine to the contractor and stored correctly at the contractor’s premises, pending preparation, in a clearly defined location for each applicant. Upon arrival, the contractor shall check the correct quantity, batch number and expiry date, transport conditions (temperature) and the correct medicine, but cannot be held responsible for any other non-conformity of this delivery. The registered medicines remain the property of the applicant at all times.
6.3. The applicant shall ensure that the registered medicines are adequately insured against damage resulting from the risks of fire, lightning, explosion, spacecraft crashes, electrical damage, storm, hail, water damage, flooding and business interruption resulting from a risk covered above.
The contractor and the applicant mutually waive any recourse under the above-mentioned insurance, except in cases of wilful misconduct. This mutual waiver of recourse shall be included in the applicant’s insurance policy. Article 7 – Dates
This agreement shall enter into force on the date of its signing and shall remain in force for a period of one year, which shall be tacitly renewed on an annual basis, subject to immediate termination by operation of law and without prior notice of default in the event of a breach of any of the provisions of this agreement or its annexes.
The applicant may terminate the contract at any time without additional costs, subject to two months’ notice. Notice of termination must be communicated by registered letter.
This agreement shall be governed by and interpreted in accordance with Belgian law.
The courts of the district of Ghent shall have exclusive jurisdiction over any dispute between the parties arising from or related to this agreement.