GENERAL TERMS AND CONDITIONS
FOR MANUFACTURING OF WHITE LABEL PRODUCTS
Following General Terms and Conditions for Manufacturing of White Label Products (hereinafter referred to as the „Terms and Conditions“), valid starting 1 March 2019, are subject to change. For the latest version of these Terms and Conditions please see them online on our website.
Please read these Terms and Conditions carefully and make sure that you fully understand them before placing orders for our Products. Please note that by purchasing our Products, you automatically agree to be bound by these Terms and Conditions. If you do not accept these Terms and Conditions, you will not be able to purchase our Products.
When we refer to “FREYHERR”, we mean company FREYHERR d.o.o., Kersnikova 10, 1000 Ljubljana, Slovenia, company registration number: 7196997000. When we refer to “Client”, we mean you, the person purchasing the Products. FREYHERR and Client shall collectively be referred to as “Parties” and each individually as a “Party”.
1.1. Notwithstanding the definitions and explanations in other clauses of these Terms and Conditions, and unless the context otherwise requires, the expressions as set below shall have the following meaning in these Terms and Conditions:
– “Finished Products” means the Products, as prepared by the Client for commercialization purposes, including the secondary packaging.
– “Manufacturing” means the entire production of the Products, as well as its quality control stages.
– “Packaging Materials” means the materials provided by FREYHERR for the purposes of primary packaging of the Raw Material.
– “Products” means all products sold by FREYHERR to the Client, as specified on each Purchase Order and/or corresponding invoice, including the Packaging Materials, as mutually agreed by the Parties.
– “Purchase Order” means the document in any form containing a binding offer by the Client to FREYHERR that specifies the content of each order.
– “Raw Material” means any substance, such as active ingredients and the excipient necessary for the production of the Products, excluding Packaging Material.
2. SUBJECT OF THESE TERMS AND CONDITIONS
2.1. Subject to these Terms and Conditions, FREYHERR undertakes to manufacture, and supply to the Client the Products.
2.2. The Parties specifically agree that with respect to these Terms and Conditions and the Manufacturing of the Products, FREYHERR acts as a 3rd party manufacturer and is only responsible for delivery of Products and obligations as set forth by these Terms and Conditions, whereas the Client acts as the producer with respect to the labeling, marketing and selling of the Products, pertaining to competent authorities, distributors and customers of the Products, and all responsibilities thereof.
2.3. For avoidance of doubt, provision of any type of analytical services is not within the original scope of these Terms and Conditions and is subject to availability and additional terms (i.e., scope and price) mutually agreed between the Parties for each individual case.
3. CLIENT’S OBLIGATIONS AND RESPONSIBILITIES
3.1. It is the responsibility of the Client to have all the necessary legal authorizations and licenses, as well as insurance policies covering quality and legal responsibilities, in order to commercialize the Products. The Client declares that it fully understands and agrees that such Client’s responsibilities defined in this paragraph cannot be in any way directly or indirectly in whole or partially transferred to FREYHERR.
3.2. It is Client’s responsibility to take all necessary steps to become duly registered as the responsible party for commercialization and distribution of the Products and/or Finished Products before competent official authority (e.g. Ministry of Health) of the target destination market, as required by the law in force according to the Products’ legal status.
3.3. Client is responsible for the registration and research of complaints, as well as for the coordination of eventual recall, stock recovery or market withdrawal. The Client undertakes to pay any penalties and costs incurred in connection with such event and, in particular, due to failure to comply with the obligations related to the information stated on the Finished Products.
3.4. As the operator in whose name the Products are commercialized (in the form of Finished Products), the Client expressly assumes the responsibility for providing any information to third parties and to consumers which occur simultaneously with said commercialization, expressly recognizing that all the information provided, altered, modified or removed with or for commercialization is of Client’s exclusive authorship. Client is thus responsible for appropriate labeling and instructions for the use of the Products for the purpose of ensuring safety of the users of the products. Additionally, the Client assumes exclusive liability for all the contributions it has made towards the production of the mentioned Products in the respective production process.
3.5. Without prejudice to the previous clauses, the Client undertakes to compensate FREYHERR for damages and loss of profit that result from negligent or malicious action by the Client, namely but not limited to, provision of information simultaneously with the commercialization of the Products, including information contained on the label placed by the Client on the packages of the Products, even if within the scope of the laws in force, those damages are attributed to FREYHERR as objective and/or joint liability in relation to third parties. Additionally, the Client undertakes to compensate FREYHERR for damages resulting from the Client’s actions for which FREYHERR may be attributed liability, as well as for damages and loss of profits which FREYHERR may sustain as a result of the denigration of the image and credibility of any of the Products, as well as to FREYHERR’s image, reputation and credibility, and which may, as a result, affect FREYHERR’s position in its respective market. For purposes of the present clause, the Parties expressly recognize that, regardless of the liability before the consumers, in the internal relationship between FREYHERR and the Client, FREYHERR will solely answer for its own actions that contributed towards the production process of the Products.
3.6. Both Parties are obligated to maintain the mutual reputation of each other. Client will not in any way, directly or indirectly, sully, smear or in any other manner cause harm to the reputation and gravity of FREYHERR’s brand and/Products. For the purposes of determining the damages resulting from the denigration of the image and credibility of the Products, FREYHERR and the Client expressly agree that these damages shall include direct and indirect damage including lost profits resulting from e.g. loss of business partnerships and other basis under the condition that FREYHERR will prove the damage incurred in reasonable manner.
3.7. The formulas for the manufacture of the Products are the exclusive property of FREYHERR, and therefore the Client undertakes to keep and treat them in an absolutely confidential manner. The duty of confidentiality remains even after the termination of this contract, and the Client or its civil and criminally responsible officials undertake to cover FREYHERR for all damages arising from any breach of confidentiality obligations.
3.8. Notwithstanding Article 3.7., in case FREYHERR shall use formula provided by the Client, such formula shall be considered as Client’s pre-existing intellectual property and shall remain its exclusive property. In case when development of a new product shall be considered as subject of these Terms and Conditions, such formula shall be considered as Client’s property. In case of mutual development based on FREYHERR’s intellectual property, the new formula shall be considered as the property of FREYHERR. Parties may define intellectual property rights on a case by case basis with regard to a specific formula.
3.9. Client is obliged to immediately notify FREYHERR in case of any administrative or regulatory action conducted against it in relation to the Products, including being subject to inspection procedure or any other official investigation, as well as to inform FREYHERR about the outcome of such action. Client shall refrain from subjecting FREYHERR to any potential scrutiny by official authorities in connection with FREYHERR’s responsibilities which are explicitly excluded according to these Terms and Conditions.
4. OBLIGATIONS AND RESPONSIBILITIES OF FREYHERR
4.1. FREYHERR may collect and maintain the documentation concerning the production and control of each batch manufactured, in individual cases, including the relevant certificates of analysis and manufacturing documentation, such as analysis performed in the manufacturing process or on the Raw Material and the manufacturing batch file, which are available, if existing, to the Client at its request for a period of 1 (one) year after the delivery of the Products related to individual purchase order or for as long as the relevant regulations require.
4.2. FREYHERR may provide stability studies or any other type of analytical services in connection with the Products and / or Finished Products at the request of the Client, subject to availability and additional terms (i.e., scope and price) mutually agreed between the Parties for each individual case.
4.3. FREYHERR may engage third party subcontractors in any country to exercise the rights or perform its obligations under these Terms and Conditions.
4.4. FREYHERR will not be responsible for any lack of Raw Material or Packaging Materials, which has proved to be a failure of its suppliers (temporary disruption of stock, temporary or permanent interruption of the manufacturing process and others). In this case FREYHERR will inform the Client within 15 (fifteen) calendar days about the occurrence of such problems and agree on a joint strategy to resolve the issue.
4.5. In case of complaint, FREYHERR shall exercise best efforts to assist and provide Client with all technical documentation, to investigate promptly any liabilities and to determine the cause of the complaint.
4.6. FREYHERR undertakes to ensure strict confidentiality of all information and technical documentation received from the Client, particularly those relating to the manufacturing processes and products formulations.
4.7. FREYHERR shall only be responsible for the Manufacturing of the Products and shall be liable for those claims and/or damages which are proved to be caused by intent or gross negligence of FREYHERR in the Manufacturing of the Products as provided in these Terms and Conditions.
4.8. The formulations, manufacturing processes and analytical methods for the Products are documented and are the sole property of FREYHERR. However, FREYHERR shall exercise best efforts to respond to all legal and regulatory requests that are under its control and to make available to the Client the necessary clarifications and documentation, so as not to jeopardize or prevent the commercialization of Products either on the national market or in third countries where the Client intends to register or have records of the Products.
4.9. In case FREYHERR will manufacture customized products, FREYHERR shall deliver the Products in the form and substance as instructed by the Client. FREYHERR will not in any way be liable for defects, including latent defects for such product. FREYHERR is not responsible for any other potential adverse characteristics of the Products that occurred after their delivery in accordance with clause 5.2. of these Terms and Conditions.
5. PRICES AND PAYMENTS
5.1. For the supply of the Products pursuant to these Terms and Conditions and the materials needed for such supply, Client shall pay to FREYHERR the prices specified in each invoice issued by FREYHERR on the basis of the valid price list for the Products and mutually agreed terms for each sale of the Products. At any time FREYHERR may change the prices of the Products by providing a new price list with 10 days’ notice. Any such price change shall not apply to purchase orders submitted prior to the effective date of the applicable price change.
5.2. Products shall be delivered Ex Works – EXW (Incoterms 2010) FREYHERR’s facility in Ljubljana or at the production unit in Koper. The place of delivery and the corresponding transfer of risk shall be determined and affirmed on each offer and/or invoice issued by FREYHERR.
5.3. On Client’s request, FREYHERR may arrange the transport of Products to the Client’s designated facility, subject to terms agreed between the Parties. For avoidance of doubt, in accordance with clause 5.2. the risk of loss and/or damage shall pass from FREYHERR to the Client immediately upon the moment FREYHERR makes the Products available at its designated facility or production unit.
5.4. FREYHERR shall issue an invoice corresponding to the Products provided in each order supplied to the Client. The payment of each order must be made with the order confirmation. Client shall make the payment to the business account of FREYHERR, stated on the invoice.
5.5. The price is a definite inclusive global price and it includes the cost of the Products, but is exclusive of VAT and/or other taxes, duties or charges. Any such taxes, duties and charges are at the cost of the Client.
5.6. If the Client fails to pay the invoices on their due dates, FREYHERR has the right stop processing new orders until the due invoices are settled.
5.7. FREYHERR will deliver the Products within 30 (thirty) calendar days from received payment or within time frame as agreed between the parties in relation to individual purchase order. Any requirement of the Client for quicker delivery of orders will be subject to the availability of production capability of FREYHERR and will be negotiated in good faith between the Parties.
5.8. Notwithstanding clauses 3.1. and 3.2. of these Terms and Conditions and subject to prior arrangement regarding scope and price, the Client may engage FREYHERR as a qualified person to conduct a cosmetic safety report on the basis of safety assessment and undertake the execution of registration of Finished Products into the Cosmetic Products Notification Portal (CPNP) in accordance with Regulation (EC) No. 1223/2009 on Client’s behalf. In case of Parties agreeing on the provision of such services, the Client hereby authorizes FREYHERR to execute all underlying actions aimed at achieving such registration. If necessary (i.e. due to request of the competent authorities), the Client shall sign a separate written authorization encompassing the above-mentioned actions to be conducted by FREYHERR. For the purposes of the registration process, the Client is obliged to provide sufficient and correct information in accordance with FREYHERR’s instructions.
6. INTELLECTUAL PROPERTY RIGHTS
6.1. The Client hereby states and confirms that it has all the necessary rights, including intellectual and industrial property rights to enter into these Terms and Conditions and to fully comply with its obligations herein.
6.2. FREYHERR commits itself to fully respect Client’s intellectual and industrial property rights, namely but not limited to, the trademarks and distinctive signs Client will use/register in relation with the Finished Products, and not to act in any way that could harm any of such rights.
6.3. The brands considering technology and/or pharmaceutical forms identified in connection with the Products are of the exclusive property of FREYHERR, thus Client does not have any rights in relation to FREYHERR and its related brands.
6.4. The Client shall include its own marketing collateral details of the Products and/or Finished Products subject to such Products being clearly marked as being proprietary to Client. The Client shall not in any way relate to FREYHERR, its trademarks, logos or text unless explicitly approved by FREYHERR in written manner and in advance. Any usage of FREYHERR trademarks shall be considered as material breach of these Terms and Conditions. The Client shall be fully liable to the FREYHERR for any kind of unauthorized use of the FREYHERR’s trademarks and for any kind of damages resulting from such Client’s action. In the event of such unauthorized use of FREYHERR’s trademarks, FREYHERR shall also be entitled to claim payment of contractual penalty for such breach of EUR 30,000.00 (thirty thousand Euros) for each breach and the Client undertakes to pay the penalty to the FREYHERR within 8 days of the FREYHER’s written request.
7. FORCE MAJEURE
7.1. The failure or delay of either of the Parties to perform any obligation under these Terms and Conditions solely by reason of acts of government, riots, wars, embargos, strikes, lockouts, accidents, port congestions or other causes beyond its control shall not be deemed to be a breach of these Terms and Conditions.
7.2. Nevertheless, this provision will apply provided that the Party affected by the force majeure event promptly notifies the other Party in writing of the nature and extent of the event causing its failure or delay in performance.
8.1. The Parties undertake to keep all information disclosed in the course of their business relationship, including the existence and content of these Terms and Conditions (hereinafter referred to as “Confidential Information”) strictly secret and confidential. Furthermore, no Party shall make any use thereof, except for the purpose of these Terms and Conditions, nor disclose the same to any person other than to responsible employees of any Party engaged in the activities provided in these Terms and Conditions and to governmental authorities if so required by law or necessary to secure the issuance by such authorities of documents as prerequisite to the lawful engagement in the activities object of these Terms and Conditions. This secrecy and non-disclosure obligation shall not be applied to information which any Party can demonstrate:
(i) was already known by the receiving Party prior to the time of its disclosure hereunder; or
(ii) is or becomes generally available to the public through no act or omission of the receiving Party; or
(iii) is rightfully received by the receiving Party from a third party not under any obligation of confidentiality regarding the disclosing Party.
8.2. These Terms and Conditions shall be deemed to apply equally to the representatives and employees of each Party in case these should become aware of Confidential Information.
9. GOVERNING LAW
These Terms and Conditions shall be interpreted and governed by the laws of the Republic of Slovenia.
10.1. If any dispute, controversy or difference arises out of or in connection with these Terms and Conditions, the Parties hereto shall use their best efforts to settle such dispute, controversy or difference amicably.
10.2. If an amicable solution cannot be reached, any dispute, controversy or difference will be settled by the Slovenian courts.
The failure by any Party to insist upon the strict adherence to any specification or lesser provision of these Terms and Conditions on any occasion shall not be considered a waiver of any right hereunder, nor shall it deprive the Party of the right thereafter to insist upon the strict adherence to that provision or any other provision of these Terms and Conditions.
12.1. In the event that a provision of these Terms and Conditions is ruled to be void or unenforceable, these Terms and Conditions shall exist without this provision and the Parties shall use all reasonable efforts to replace it by a valid and enforceable provision which corresponds as far as possible to the economic purpose of the provision to be replaced.
In these Terms and Conditions, unless the contrary intention appears: (a) the words “including” and “include” mean “including, but not limited to”; (b) the singular includes the plural and vice versa; (c) a reference to a person or entity (including FREYHERR or the Client) includes a reference to the person’s executors, administrators, successors, substitutes and assigns; and (d) headings are for reference only and do not form part of these Terms and Conditions.
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