Terms and conditions

Published: Jan 15, 2024

1. General application

(1) These General Terms and Conditions (“General Terms and Conditions“) apply to all contractual relationships between QUALIFYZE GMBH (Taunusanlage 8, 60329 Frankfurt am Main, Germany) (“Qualifyze“) and Qualifyze´s clients and potential clients. Qualifyze and our respective (potential) client are also referred to collectively as the “Parties” and each as a “Party“.

(2) Qualifyze’s range of services is only intended for entrepreneurs, i.e. natural or legal persons or partnerships with legal capacity, who are acting in the exercise of their commercial or independent professional activity when concluding the contract (section 14 para. 1 German Civil Code (Bürgerliches Gesetzbuch, “BGB”)). The client´s own terms of business shall not apply, even if we do not expressly object to their validity in individual cases.

(3) Contracts with clients are concluded exclusively in English.

2. Scope of services

(1) Qualifyze enables the client to have suppliers (e.g. from the pharmaceutical, food, cosmetics, and feed sectors, etc.) audited to ensure that these suppliers meet the industry´s quality standards.

(2) In accordance with the respective Framework Subscription Agreement concluded between Qualifyze and the client (“Subscription Agreement”), Qualifyze grants the client access to the Qualifyze Platform with a service plan (“Service Plan“, cf. Annex 1) of the category ESSENTIAL, PLUS, ADVANCED or ENTERPRISE; respectively, the client pays a fee for access to the Qualifyze Platform in accordance with the Service Plan and a credit for a certain number of audits per contract year of the respective Subscription Agreement (“Credit or Credits“).

(3) Qualifyze shall act as a third-party auditor on behalf of the client either for: a) performing a new – shared or exclusive – audit (“New Audit“) of the client´s suppliers (“Auditees“) and preparing a new audit report (“New Audit Report“) for the client, the specific process of which is set out in clause 5; or b) providing the client with an existing audit report from an audit that was already performed (“Existing Audit Report“), the specific process of which is set out in clause 6.

(4) Qualifyze can share any New Audits that are not specifically requested and paid for by the client as an ”Exclusive Audit” (exclusive audits shall be audits specifically requested and paid for by the client as such, in which case Qualifyze shall not be entitled to add the Audit Report to its database or resell it), with other Qualifyze clients on the Qualifyze Platform. Qualifyze will not perform a New Audit if there is an available and valid Existing Audit Report on Qualifyze’s Platform, performed less than 3 years before the date, that meets the requirements of the client.

(5) The audits are conducted by independent, qualified and experienced auditors in accordance with international quality standards (“Auditors“) and Qualifyze ensures the quality, confidentiality, and absence of conflicts of interest of the Auditors. Qualifyze carefully selects its Auditors on the basis of their professional qualifications, experience, and personal suitability. Qualifyze´s Auditors have:

  • successfully completed Qualifyze´s process of auditor qualification and continue to train regularly; and
  • signed a declaration of their personal independence, objectivity, and neutrality and of the confidential treatment of all information and documents obtained during an audit.

If an Auditor becomes unavailable immediately before, during or after an exclusive or shared audit, Qualifyze will – if one of its other Auditors can be used without disproportionate additional expense – appoint another Auditor as substitute.

(6) Qualifyze´s audit reports shall contain a complete, accurate, concise, and clear record of the audit. Unless otherwise agreed, they shall include or refer at least to the following:

  • audit objectives;
  • scope of the audit, in particular, the naming of the Auditee and the processes examined;
  • name of the Auditor/s and the participants from the Auditee;
  • dates and, if applicable, the location where the audit was carried out;
  • audit criteria;
  • audit findings and related supporting evidence;
  • audit conclusions;
  • statement of the extent to which the audit criteria have been met; and
  • any unresolved differences of opinion between the Auditor and the Auditee.

(7) The findings of Qualifyze´s audit reports are based on a sampling process aimed at obtaining the most reliable possible evidence of (non-)compliance with the audit criteria. In addition, there may be other business aspects that were not examined by Qualifyze´s Auditor and which may justify different conclusions. It is the sole responsibility of the client to evaluate the conclusions of the audit report.

(8) If the audit report of an exclusive or shared audit shows the necessity of corrective and/or preventive actions by the Auditee, Qualifyze undertakes to contact the Auditee after a specified period of time in order to obtain information on the status of these actions and to pass it onto the client. Within the scope of a follow-up audit, Qualifyze will verify the completion of these measures and their effectiveness.

3. Conclusion of contracts

(1) If the client declares interest in the performance of New Audits or the acquisition of Existing Audit Reports, Qualifyze will submit a personal offer for a Subscription Agreement to the client. The offer is accepted by signing the Subscription Agreement.

(2) If the client wishes to purchase additional audit reports, Qualifyze will submit a personal offer to the client for an Amendment for additional credits. The offer is accepted by signing the Amendment for additional credits. Once accepted, the Subscription Agreement will be considered amended.

(3) Only Audit Reports for the audit standards specified in Annex 1 will be included in the purchased Service Plan in accordance with the Subscription Agreement. If the client wishes to purchase another type of audit, including exclusive audits, Qualifyze will submit a personal offer to the client for an Amendment for additional credits. The offer is accepted by signing the Amendment for additional credits.

(4) As entrepreneurs the client is not entitled to a right of withdrawal according to §§ 312g, 355 BGB.

4. Credit

(1) For New Audit Reports, Credits are redeemed when the audit date is confirmed. If a confirmed date is cancelled by the Auditee or the New Audit Report cannot be made available to the client due to circumstances that do not lie with the client, that redeemed Credit shall be again made available to the client in accordance with para. 3 below.

(2) For Existing Audit Reports, Credits are redeemed when the Auditee authorization has been granted. If the Auditee declines to share the Existing Audit Report or the Existing Audit Report cannot be made available to the client due to circumstances that do not lie with the client, that Credit shall be again made available to the client in accordance with para. 3 below.

(3) Credits will be:

“Available”: when they have not yet been used by the client within the respective contract year;

“Pending”: when the individual order for the New Audit Report or the Existing Audit Report has been requested      but the audit date has not yet been confirmed or the sharing of the Existing Audit Report has not yet been authorised by the Auditee;

“Redeemed”: when the audit date has been confirmed or the sharing of the Existing Audit Report has been authorised by the Auditee.

(4) If the Credit is not utilised at the end of a contract year, the client may carry over the remaining Credit to the next contract without limitation if the Subscription Agreement is renewed. If the contract is terminated, Credit will be forfeited. The Credit which is carried over into the next contract year must be used within the first 6 (six) months of the new contract year. Otherwise it will be forfeited. If the contract is terminated and one or more reports are not yet available in the Qualifyze Platform, the client will continue to have access until the audit reports are made available.

5. Process for New Audit Reports

(1) After the audit is requested, Qualifyze will contact the respective Auditee and request authorization to perform a New Audit.

(2) As soon as the authorization is received, Qualifyze shall start organising the New Audit, coordinate possible dates with the Auditee and appoint the corresponding Auditor.

(3) The New Audit Report will generally be accessible to the client within a timeframe specified in the respective Subscription Agreement in accordance with the agreed Service Plan from the corresponding audit date on the Qualifyze Platform. In case urgent feedback is required before the Audit Report is uploaded to the Qualifyze Platform or in case of critical observations, some preliminary information can be issued upon request, describing and assessing the most relevant observations found during the audit within 2 (two) weeks from the corresponding audit date.

(4) Once scheduled, Qualifyze is not responsible for any changes the Auditee might impose on the date, facilities and/or products allowed to inspect during the New Audit. Once the audit has been scheduled, the credit will be considered redeemed. If the client cancels the request once the audit has been scheduled, Qualifyze will not make such credit available to the client again.  Notwithstanding the foregoing, if the client cancels a request for a shared audit, provided that the client is not the only client that has requested such a shared audit and there are at least eight (8) weeks remaining before the audit date, the Credit will be made available to the client again.

(5) Qualifyze shall urge the Auditee to submit a Corrective and Preventive Action Plan, (“CAPA-Plan“) as soon as possible. After having approved the proposed corrective actions and timeline, Qualifyze submits CAPA information in the platform according to service plan levels. The client has access to ongoing tracking of the Corrective and Preventive Actions (“CAPAs“) in accordance with the respective Service Plan. Regular follow-ups are performed based on the established timelines as set out in the CAPA-Plan.

(6) After a New Audit is conducted and the New Audit Report is made accessible to the client on the Qualifyze Platform, the New Audit Report shall be added to Qualifyze’s Audit Report database for the purpose of reselling the Audit Report to other clients. Any non-applicable or confidential information is removed from newly created reports.

6. Process for Existing Audit Reports

(1) After the audit report is requested, Qualifyze will contact the respective Auditee and request authorization to share the Existing Audit Report with the client.

(2) As soon as the authorization from the Auditee is received, Qualifyze will prepare a customised Audit Report for the client. If the client cancels the request for the Existing Audit Report once the process has been already initiated by Qualifyze, Qualifyze will not make such a redeemed credit available to the client again.

(3) The Existing Audit Report and CAPA-Plan (if available) will be submitted to the client within 7 (seven) working days from the date of authorization by the Auditee.

(4) Qualifyze is responsible for the ongoing tracking of the CAPAs as of the CAPA-Plan. Regular follow-ups are performed based on the established timelines as set out in the CAPA-Plan.

7. Term and Termination

(1) The Subscription Agreement shall become effective as of the Effective Date of the Subscription Agreement and shall remain in effect for a period of 1 year (“Contract Year”).

(2) The Subscription Agreement shall be renewed automatically for an additional 12 month period each unless either Party terminates the Subscription Agreement with 3 month written notice to the end of the respective Contract Year. The Subscription Agreement cannot otherwise be terminated without cause. The right to extraordinary termination remains unaffected.

8. Payment and invoicing

(1) Our prices are net prices, i.e. plus any value added tax at the statutory rate.

(2) The client shall pay the respective remuneration per Contract Year, which is agreed in the respective Subscription Agreement between the Parties, in one payment at the beginning of the respective Contract Year for access to the Qualifyze Platform in accordance with the Service Plan and the Credit.

(3) The Parties agree that for each Contract Year the respective remuneration will increase by 7%.

(4) The yearly invoice (“Invoice”) shall be issued on the day after the conclusion of the Subscription Agreement or within two weeks after the renewal of the Subscription Agreement. Unless otherwise specified, Qualifyze shall not provide individual invoices for each credit used.

(5) If the client and Qualifyze have concluded an Amendment for Additional Credits in line with clause 3 para. 2 above, Qualifyze will invoice the additional costs for these audits separately.

(6) The remuneration for the provision of an additional audit report according to para. 5 above and the corresponding provisions in the respective Amendment for Additional Credits will become due and payable upon the issuance of the invoice.

(7) The client is obliged to provide complete and truthful information about his billing address (name of the company, legal form, street and house number, P.O Box number, city code, city, country, billing e-mail address) upon conclusion of a Subscription Agreement. If there are any changes to the billing address, the client is obliged to inform Qualifyze about these changes without undue delay. If the client requires the indication of his purchase order number on the invoice, he must provide this number in a timely manner, at least two weeks after conclusion of a Subscription Agreement or Amendment for additional credits.

(8) Unless otherwise agreed, the payment term is 15 days from the receipt of an invoice. Any delay may result in a temporary suspension of the services under this Subscription Agreement.

(9) The client shall only be entitled to set-off or retention rights against our claim for remuneration to the extent that the existence of the counterclaim is not disputed by Qualifyze or has been legally established or results from the same contract under which our service was provided.

(10) Upon request, Qualifyze may invoice in any currency previously agreed upon by the Parties based on the daily ECB exchange rate on the day of invoicing at the time the invoice is generated.

(11) The remuneration will be an all-inclusive price. Other charges such as travel expenses or allowances for the services provided by Qualifyze will not be charged to the client.

9. Performance period and cooperation

(1) Exclusive audits and shared audits shall be performed within the agreed period. However, Qualifyze reserves the right to make subsequent changes to any agreed period, among other things because of the necessary coordination of dates with the Auditee. Clients will be informed immediately of any delays of which we become aware.

(2) The client shall support and assist Qualifyze if and to the extent necessary for the purpose of conducting the audits and preparing the corresponding Audit Reports successfully and satisfactorily. All deadlines agreed with the client presuppose that all necessary information and documents for the proper performance of the services are provided in sufficient anticipation for the correct preparation of the audit.

10. Use of and registration on our website

(1) Qualifyze´s audit list can be found free of charge on www.qualifyze.com and requests for personalized offers for audits or further information can be made by clicking on the search button.

(2) Registration is free of charge at www.qualifyze.com. The information required for registration must be provided completely and truthfully. When registering, users shall enter with e-mail address and choose a password. The e-mail address shall not infringe the rights of third parties or other name and trademark rights or offend common decency. Users are obliged to keep passwords secret and not to disclose it to third parties under any circumstances.

(3) The registration does not entail any obligations whatsoever – apart from agreeing to the present General Terms and Conditions. User accounts can be deleted at any time. A corresponding option can be found in the administration area of the account. The creation of a user account does not create any obligation with regard to the services and products offered by Qualifyze.

11. Warranty and liability

(1) These General Terms and Conditions oblige Qualifyze to perform its activities by qualified personnel to the best of its knowledge. These General Terms and Conditions do not create a partnership, joint venture, or other legal entity between the Parties. Neither Party has the authority to bind the other to any third Party. Insofar as Qualifyze provides mere services, it does not owe any particular success.

(2) If a defect occurs during the performance of a contract for work, the statutory provisions shall apply. A defect shall be deemed to exist if Qualifyze’s performance falls short of what was contractually agreed. Qualifyze cannot guarantee the general usability of audit reports (e.g. acceptance of the audit report or conclusions based on it by third parties) or any other expectations that are not covered by the respective Service Plan. A lack of representativeness of an audit report is generally not a defect either, because audits are carried out on the basis of random samples (cf. clause 2, para. 7).

(3) The statutory liability of Qualifyze and/or its representatives or vicarious agents for damages shall be limited as follows:

  1. Qualifyze’s liability is limited to the amount of damages typically foreseeable at the time of the conclusion of the contract, however, not exceeding a maximum amount of EUR 250,000 (“Maximum Liability Amount”) for the slightly negligent breach of Primary Obligations arising from the contractual obligation. The term “Primary Obligations” refers abstractly to such obligations whose fulfilment is essential to the proper execution of the contract and the compliance on which the respective other party may regularly rely on.
  2. Neither Party shall not be liable for the slightly negligent breach of non-essential obligations arising out of the contractual obligation.
  3. Qualifyze’s liability is excluded for any failure to perform its obligations under the Subscription Agreement, if such failure is related to or caused by a “Force Majeure Event”. A Force Majeure Event is the occurrence of any event or circumstance beyond the reasonable control of a Party, including, but not limited to, war, natural disasters, fire, flood, explosions, earthquakes, atmospheric disasters, exceptional traffic and road situations, strikes, lockouts, civil unrest or pandemic events like SARS-CoV-2. In the event of a Force Majeure Event, the affected Party shall promptly notify the other Party in writing, providing a proof of such Force Majeure Event and try its bests to minimize the possible inconveniences.
  4. Qualifyze´s liability is excluded for any damages resulting from data loss, insofar as these arise from the fact that it is not possible or difficult for the client to retrieve the data due to missing or insufficient data backup.

(4) The aforementioned limitations of liability shall not apply in cases of mandatory statutory liability, in particular in accordance with the German Product Liability Act, in the event of assumption of a guarantee, in the event of damage to life, body or health caused intentionally or with negligence, in the event of intentional breaches of the confidentiality obligation and in the event of other damages based on a grossly negligent breach of duty by Qualifyze or on an intentional or grossly negligent breach of duty by a legal representative or vicarious agent of Qualifyze. The Maximum Liability Amount shall not apply in the event of gross negligence on the part of Qualifyze and/or its representatives or vicarious agents.

(5) Qualifyze is obliged to adequately insure the reasonable liability risks arising from the respective Subscription Agreements.

(6) Qualifyze assumes no liability for the correctness, completeness, topicality, quality, and constant availability of the information provided on www.qualifyze.com. Qualifyze expressly reserves the right to change, supplement or delete parts of www.qualifyze.com or its entire online presence without separate notification or to discontinue publication temporarily or permanently.

(7) Qualifyze’s offer contains links to external websites of third parties on whose content we have no influence. Therefore, we cannot assume any liability for content on these third-party websites. The respective provider or operator of the website is always responsible for the content of the linked pages. The linked pages were checked for possible legal violations at the time of linking. Illegal contents were not recognizable at the time of linking. However, a permanent control of the content of the linked pages is not reasonable without concrete indications of an infringement. We will remove such links immediately if we become aware of any legal infringements. Qualifyze shall: (a) pass through to client any warranty right it receives from a third party provider of SaaS components not authored or manufactured by Qualifyze (“Third Party Components”); and (b) reasonably cooperate with client in enforcing such rights, at client’s expense. QUALIFYZE PROVIDES NO WARRANTIES, EXPRESS OR IMPLIED, WITH REGARD TO THIRD PARTY COMPONENTS, AND QUALIFYZE WILL NOT BE LIABLE FOR ANY FAILURE OR ANY THIRD PARTY COMPONENT TO FUNCTION AS EXPECTED OR INTENDED.

12. Copyright and rights of use, confidentiality

(1) Qualifyze´s trademarks, patents, inventions, trade secrets, copyrights, software, symbols, designs, illustrations, drawings, diagrams, logos, and other intellectual property, including but not limited to the company and product information presented on www.qualifyze.com, are protected by trademark, patent, copyright and other intellectual property laws and regulations. They may not be reproduced or otherwise used or made available to third parties without our written consent. Unauthorized use of our intellectual property will be considered a severe infringement and contract breach.

(2) The use of the audit reports, including any test results, calculations, descriptions, and other related documents that are or have been prepared in connection with the audit shall be subject to the following provisions:

The audit reports provided to the client are confidential information, which is also subject to copyright protection; they are only intended for use by the client´s company and must be kept secret and confidential from third parties;

Qualifyze is the sole and exclusive owner of the audit reports. Qualifyze grants the client a simple, non-transferable, and non-sublicensable right of use of the audit report ordered, subject to full payment of the remuneration owed for it, to use the audit report exclusively for its own (internal) purposes, and to make it available only for these own purposes to authorities, courts or third parties (including affiliated companies as defined by sections 15 ff. of the German Stock Corporation Act (Aktiengesetz,“AktG”)), insofar as these third parties are themselves bound by law or contract to maintain confidentiality (e.g. consultants, certification bodies). The use includes both the permanent storage and duplication of the audit report on any number of the internal equipment as well as the making of individual paper copies for internal use;

The client is not permitted to use audit reports or parts thereof for purposes other than internal company purposes. In particular, the client is not permitted to copy audit reports or parts thereof, to make them publicly accessible or to make them available to third parties for their own use or to allow access to them;

Qualifyze is entitled to provide the audit reports with a technical access restriction (e.g. password) to protect them from improper use. It is not permissible to overcome or circumvent this security measure. Any access passwords must be kept secret and protected from access by third parties;

The client may not remove any references to the owners of the copyrights of the audit reports. 

(3) Any use that goes beyond the use permitted in this clause 12 requires Qualifyze´s prior express consent in text form unless it is permitted by law.

(4) “Confidential Information” under these General Terms and Conditions and/or any  Subscription Agreement shall mean all information about a Party and/or its Affiliated Companies and/or its respective representatives (“Disclosing Party“), as well as their respective businesses and affairs,  which was or is obtained either verbally or in writing or electronically or in any other form at any time (before, on or after the signing of the respective Subscription Agreement and irrespective of who provided such information and how such information was provided) by the respective other Party and/or its Affiliated Companies and/or its representatives (“Receiving Party“).

Confidential Information received by the Parties can be disclosed by the Parties to their Affiliated Companies, under these General Terms and Conditions and the respective Subscription Agreement, provided that such Affiliated Companies are aware of and comply with the confidentiality obligations contained in these General Terms and Conditions and the respective Subscription Agreement and protect it against unauthorized access by third parties. All employees, officers, directors, representatives, attorneys, consultants and agents, of the client and employees, officers, directors, representatives, attorneys, consultants and agents of any of the client´s affiliated companies that are in contact with the audit reports or are disclosed any Confidential Information must be bound by confidentiality obligations at least as strict as the ones applying to the client and for equivalent timeframes.  

Affiliated Company” or “Affiliated Companies” shall mean any company directly or indirectly owning or controlling any Party, or any company under the same direct or indirect ownership or control as any Party, or any company directly or indirectly owned or controlled by any Party. Ownership or control shall exist through the direct or indirect ownership or control of more than 50% of the nominal value of the issued equity share capital or of more than 50% of the shares entitling the holders to vote for the appointment of directors or persons performing similar functions. Ownership or control shall also exist when there is power to direct or cause the direction of the management or policies of the company by any means.

(5) The confidentiality obligations under these General Terms and Conditions and/or any Subscription Agreement include, in particular, the following Confidential Information:

  1. The contents of the Subscription Agreement;
  2. The Parties and/or their Affiliated Companies’ operations, activities, business and finances;
  3. The Parties and/or their Affiliated Companies’ suppliers, customers, account records, budgets and ledgers;
  4. Any information designated in writing or orally or electronically by the Parties and/or their Affiliated Companies marked as “confidential”;
  5. Any information about Auditors;
  6. Any information about Auditees;
  7. The content of the Audit Report.

(6) Confidential Information also includes trade secrets which have an economic value, are protected by appropriate confidentiality measures and where there is a legitimate interest in keeping them confidential (“Trade Secret“). Any information or materials that constitute a Trade Secret and are labelled as such may be disclosed under these General Terms and Conditions and/or any Subscription Agreement by a Disclosing Party only if prior to such disclosure the potential recipient has been advised of the intent of the Disclosing Party to reveal a Trade Secret under these General Terms and Conditions and/or any Subscription Agreement, and the recipient has given its written consent to receive such Trade Secret under these General Terms and Conditions and/or any Subscription Agreement.

With respect to any Trade Secrets permissibly disclosed under these General Terms and Conditions and/or any Subscription Agreement, the recipient shall use the highest level of protection that it uses for its own Trade Secrets, but in any case no less than a reasonable degree of care, to prevent any unauthorized use, disclosure, dissemination or publication thereof, or other more stringent protections as may be agreed in writing by the Disclosing Party and recipient.

(7) The Audit Report is for internal use of the client and its Affiliated Companies, as long as the Affiliated Companies are bound to confidentiality obligations as strict as the ones set forth in these General Terms and Conditions and/or any Subscription Agreement and for equivalent timeframes.

The client is permitted to disclose the Audit Report to the authorities when requested and when bound by law or judicial or government order. If the client has a genuine interest and needs to share the Audit Report with other parties (e.g., its customers) prior written authorization from Qualifyze and the corresponding Auditee is required. In this case, the sharing is free of charge.

Qualifyze is entitled to add the Audit Report to its database and to resell it provided that all of client’s Confidential information is removed from the Audit Report prior to it being added to the Qualifyze’s database.

(8) The Parties are obliged to take all necessary and appropriate measures to avoid the non-authorized disclosure of Confidential Information vis-à-vis third parties and/or the unauthorized access of Confidential Information by third parties.

(9) The Parties undertake to exercise the same degree of care and protection they take to preserve their own Confidential Information. Neither Party makes any representation or warranty as to the accuracy or completeness of its Confidential Information. The disclosing Party will not be liable for any use of its Confidential Information, or by any error or omission concerning its Confidential Information.

(10) Upon written request from the Disclosing Party, the Receiving Party will, within 30 business days, return to the Disclosing Party all documents and other materials in the Receiving Party’s possession containing Confidential Information of the Disclosing Party. The Disclosing Party might, at its sole discretion, request the Receiving Party to destroy all documents and other materials in the Receiving Party’s possession containing Confidential Information of the Disclosing Party. 

Notwithstanding the foregoing, (a) the Receiving Party may retain one copy of all documents and other materials containing Confidential Information of the Disclosing Party for archival, compliance and legal purposes, and (b) the Receiving Party shall not be required to destroy any securely stored computer files that contain Confidential Information of the Disclosing Party created during automatic system back-ups and/or archiving systems, provided that the Confidential Information so retained remains subject to the confidentiality obligations set forth in these General Terms and Conditions and/or any Subscription Agreement.

(11) No confidentiality obligations shall apply to information, materials and documents which:

  1. are already known or in the possession of the Receiving Party prior to their receipt;
  2. are legally received by the Receiving Party from a third party without any confidentiality obligations;
  3. are in the public domain or enter the public domain through no wrongful act of the Receiving Party;
  4. can be proven by the Receiving Party to have been developed independently of Confidential Information received from the Disclosing Party;
  5. are required to be disclosed by any applicable law, regulation, legal processes, government authority or courts, subject to prior notice to the Disclosing Party to the extent reasonably possible; or
  6. are approved in writing by the Disclosing Party not to be treated as confidential.

If and when requested, the Receiving Party has to furnish evidence of facts constituting one of the afore mentioned exemptions.

(12) The confidentiality obligations pursuant to these General Terms and Conditions and/or any Subscription Agreement and/or any Amendment for Additional Credits, shall survive and continue for a period of 7 years after the expiration or termination of the respective Subscription Agreement.

(13) The client shall take all reasonable and appropriate measures to safeguard confidential information against theft, loss, leak and unauthorized disclosure to third parties. In the event of any breach or violation of the confidentiality obligations attributable to the client leading to Qualifyze’s liability towards the auditee, Qualifyze shall have the right to seek full recourse against the client, including the recovery of all indemnification amounts paid by Qualifyze to the auditee, as well as legal fees and any other associated costs. (14) The client shall notify Qualifyze immediately in case of theft, loss, leak or unauthorized disclosure of any confidential information and provide all necessary assistance to Qualifyze to mitigate the potential damages provoked by said theft, loss, leak or unauthorized disclosure.

(15) The Parties agree that, during the term of this agreement none of them will make any public statements which materially disparage the other party. Notwithstanding the foregoing, nothing in this clause shall prohibit any person from making truthful statements when required by law, order of a court or other body having jurisdiction.

13. Data protection

(1) The signatories and the contact persons are informed that their personal data will be processed by Qualifyze GmbH as controller of the data. Qualifyze shall observe any applicable data protection regulation, in particular the provisions of the General Data Protection Regulation UE 2016/679 (Datenschutz Grundverordnung, “DSGVO”) and the Telecommunications and Telemedia Data Protection Act (Gesetzes zur Regelung des Datenschutzes und des Schutzes der Privatsphäre in der Telekommunikation und bei TelemedienTTDSG”). The legal basis for the processing is the performance of the contract.  The data may be transferred to the Affiliates of Qualifyze for administrative purposes only, as well as Auditees and appointed traders within or outside the European Union.

(2) The data subject may exercise the rights to access, rectification or erasure of the data, restriction of processing and portability, as well as withdraw the consent, without affecting the lawfulness of the processing based on consent before its withdrawal, by sending a written request to the Data Controller, whose contact details may be find in section 1. They may also lodge a complaint with a supervisory authority. The data will be stored for the duration of the contractual relationship and even after the termination until the appropriate legal actions for this purpose expire. 

(3) For further information on the treatment of personal data by Qualifyze see www.qualifyze.com/data-privacy/.

14. Governing law

(1) These General Terms and Conditions and any contract entered into by the client and Qualifyze are subject to the law of the Federal Republic of Germany, without regard to its conflict of laws rules and principles. The provisions of the UN Convention on Contracts for the International Sale of Goods (CISG) will not apply to these General Terms and Conditions nor to any contract entered into by the client and Qualifyze.

(2) The Parties agree that they shall in good faith work towards implementation of this General Terms and Conditions and any dispute arising out of or in relation to this General Terms and Conditions shall be first attempted to be resolved amicably by mutual negotiations or mediation, failing which such dispute shall be referred to the courts at Qualifyze´s registered office in Frankfurt am Main (Germany). In such a case, the courts located in Frankfurt am Main, shall have exclusive jurisdiction for the disputes arising from or in connection with these General Terms and Conditions and any contract entered into by the client and Qualifyze, including those concerning its existence, validity, performance, expiration or termination. However, at the sole discretion and option of Qualifyze, Qualifyze shall also be entitled to assert claims against the client at its general place of jurisdiction.

15. Compliance

(1) Both Parties represent and warrant compliance with applicable laws and  regulations on human rights and labour practices, as well as anti-bribery, anti-corruption, anti-money laundering, antitrust and fair competition and other national and international laws applicable to their respective activity and that no investigation, action, suit or proceeding by or before any court, or governmental agency, authority or body, or any arbitrator, involving any of the Parties with respect to applicable local anti-bribery, anti-corruption or anti-money laundering laws or regulations is pending or, (to the best of its knowledge), threatened.

(2) In addition to the foregoing, the Parties warrant to conduct their activities in accordance with the notions and principles of ethics, honesty and good faith, avoiding direct and/or through third parties, involvement in illegal commercial activities, that includes conducting commercial activities subject to trade sanctions laws (the U.S. Department of the Treasury’s Office of Foreign Assets Control sanctions regulations  – “OFAC”, the U.S. Export Administration Regulations, the UK Export Control Act of 2002, and the E.U. sanctions regulations).

(3) The client shall immediately notify Qualifyze in the event of a breach of this clause and any breach of the aforementioned clauses would be considered a material breach and may lead to the termination of the Subscription Agreement.

(4) In the case where the sub-contractor or business partner of the client, if any, would not comply with any of the laws mentioned in the clauses 15(1) and 15(2), or would breach the applicable regulations or commit any offence, Qualifyze could never be held responsible and the client shall hold Qualifyze harmless of all the consequences of this breach or offence, whether financial or extra-financial.

(5) If the client knows or suspects that any of Qualifyze may have violated any of the law or regulations mentioned in the clauses 15(1) and 15(2), Qualifyze encourages the client to report this to Qualifze through the available whistleblowing channel: https://www.qualifyze.com/whistleblowing-channel/.

Qualifyze undertakes to process the report within the principle of confidentiality, and investigate it, maintaining the objectivity and reliability.

(6) In addition to the foregoing, both Parties guarantee that its Representatives will conduct themselves with utmost fairness, objectivity, neutrality and impartiality. The Parties expressly undertake to refrain from any conduct that could compromise the impartiality of their Representatives. Furthermore, both Parties, along with their Representatives, shall not accept, solicit or offer any form of payment, gift, or benefit, whether directly or indirectly or monetary or otherwise, beyond the explicitly agreed-upon terms outlined in this Subscription Agreement. In the event that either Party becomes aware of any breach or threatened breach of the obligations set forth in this paragraph, they shall promptly, and without undue delay, inform the other party in writing of any such breach or threatened breach.

16. Miscellaneous

(1) No Party may assign any rights or claims under these General Terms and Conditions and/or any Subscription Agreement without the prior written consent of the other Party (within the meaning of section 126 b BGB). This will not apply to assignments to Affiliated Companies of the assigning Party or successors of the Parties.

(2) In case of discrepancies among different contracts signed by the Parties, the following order of precedence shall apply for interpretation and enforcement:

  1. CDAs (Confidential Disclosure Agreements).
  2. Subscription Agreements.
  3. GTC.
  4. Quality Agreements.

(3) The failure or delay by either Party in exercising or enforcing any right, remedy or power under these General Terms and Conditions and/or any Subscription Agreement shall not constitute or operate as a waiver of that right, remedy or power. The single or partial exercise or enforcement of any right, remedy or power under these General Terms and Conditions and/or any Subscription Agreement shall not preclude or restrict any further exercise or enforcement of that right, remedy or power, or the exercise or enforcement of any other right, remedy or power under these General Terms and Conditions and/or any Subscription Agreement.

(4) Each Party represents and warrants to the other Party that it has the legal power and authority to enter into and perform under these General Terms and Conditions and/or any respective Subscription Agreement.

(5) Each of the Parties agrees that the electronic signatures used in execution of these General Terms and Conditions and/or any Subscription Agreement, any subsequent amendments shall constitute an original for all purposes. The Parties also agree that exchanging scanned copies of these General Terms and Conditions and/or any Subscription Agreement, any subsequent amendments containing traditional handwritten/wet ink signatures via email is legally binding and has the same legal effect as exchanging hard copies.

(6) English language terms used in these General Terms and Conditions and all contracts between the Parties describe German legal concepts only and shall not be interpreted by reference to any meaning attributed to them in any jurisdiction other than Germany.

Annex 1

Service Plan

 

ESSENTIAL

PLUS

ADVANCED

ENTERPRISE

SERVICE

 

 

 

 

Audit Organisation

✔️

✔️

✔️

✔️

Audit Execution

✔️

✔️

✔️

✔️

Your audit requirements included in agenda

✔️

✔️

✔️

✔️

Comprehensive Audit Report

✔️

✔️

✔️

✔️

Comment on draft report

 

✔️

✔️

✔️

Audit report delivery time

Within 10weeks

Within 8 weeks

Within 6 weeks

Within 4 weeks

Preliminary audit report (upon request)

 

 

✔️

✔️

Basic CAPA (status display in the platform only)

✔️

✔️

✔️

✔️

Advanced CAPA (complete CAPA document including adequacy review)

 

✔️

✔️

✔️

Audit pre-alignment with quality office and/or auditor (upon request)

 

 

✔️

✔️

Audit post-alignment with quality officer and/or auditor (upon request)

 

 

✔️

✔️

CAPA review support (updates, follow ups, add comments, assessment, etc)

 

 

 

✔️

New audit reports versions (new products added to existing report)

 

 

 

✔️

TYPE OF AUDITS

 

 

 

 

API, excipients, FDF, GDP, Packaging, GMP Labs

✔️

✔️

✔️

✔️

Fast track audits *

 

 

15% of your audits

30% of your audits

Pharmacovigilance, Medical Devices, GLP, GCLP *

 

 

5% of your audits

15% of your audits

Sustainability/ESG audits (Social & Environmental Compliance)

 

 

15%of your audits

 

20%of your audits

SUPPORT

 

 

 

 

Dedicated Sales Account Executive Manager

✔️

✔️

✔️

✔️

Dedicated Customer Success Manager

 

✔️

✔️

✔️

Dedicated Quality Account Manager

 

 

✔️

✔️

Direct contact to legal and accounting department

 

 

 

✔️

PLATFORM

 

 

 

 

Auditor CV visibility pre-audit

 

✔️

✔️

✔️

Request / Audit Quick Dashboard

 

 

✔️

✔️

# of users

1*

5*

20*

unlimited

Unlimited Access to your archive of audit reports

 

 

✔️

✔️

Data Analytics for supplier Insights

 

 

 

✔️

Data Analytics of CAPA management

 

 

 

✔️

Access to my Audits via API

 

 

 

✔️

Manage your own audits (Audit Management)

 

 

 

✔️

CONTRACT TERMS

 

 

 

 

Legal documents

QF standard

QF standard

QF standard

Individual

Billing terms (15 days standard)

15 days

Up to 30 days

Up to 45 days

Individual

Flexible QMS activities (QTA negotiation, audits)

 

 

✔️

✔️

Priority on CDA management (when requested by customer)

 

 

✔️

✔️

 

Published: Jan 15, 2024

Qualifyze GmbH, located at Taunusanlage 8, 60329 Frankfurt am Main, Germany (hereinafter “Qualifyze”), provides access to the feature Supplier Intelligence (hereinafter “SI”) of the Qualifyze online Platform (“Qualifyze Platform”) to individuals who register on the Qualifyze Platform and accept this General Terms and Conditions for SI (hereinafter “SI GTC”).
Unless stated otherwise, the use of SI is entirely free of charge and subject to acceptance of the SI GTC. IF YOU DO NOT AGREE WITH THE SI GTC, DO NOT CLICK ON ACCEPT.

1. General application

(1) These SI GTC apply to users registered in the Qualifyze Platform that wish to use SI (hereinafter “Users or User”).
(2) The validity of this SI GTC is exclusive and shall be deemed applicable from the moment the User makes first use of the SI and accepts this SI GTC. Any User’s own terms and conditions that supplement or deviate from these SI GTC shall only become part of the agreement between the Parties if Qualifyze expressly accepts them in writing with the signature of a legal representative. The same applies to any other terms and conditions described in offers, confirmation emails or other User’s documents.
(3) While SI is accessible to any individual, it is hereby notified that Qualifyze’s range of services is only intended for entrepreneurs, i.e. natural or legal persons or partnerships with legal capacity, who are acting in the exercise of their commercial or independent professional activity when accepting the SI GTC (section 14 para. 1 German Civil Code (Bürgerliches Gesetzbuch, “BGB”)).
(4) SI GTC are accepted and drafted exclusively in English. Contracts and General Terms and Conditions drafted in other languages shall be merely for information purposes.
(5) Unless stated otherwise, the use of SI is entirely free of charge.

2. Scope of services

(1) Qualifyze grants Users access to SI in the Qualifyze Platform, that integrates customers, suppliers, and auditors, making it easier than ever before to manage audits across multiple sites. Users will be able to manage and execute all audit-related actions in one place, by monitoring Users audits in real-time and receiving notifications the User needs to know when needed.

(2) User shall be able to manage every step of its own audits, in one place, including CAPA follow ups, Auditor CVs, reminders, analytics, real-time audit status updates, audit report repository.

(3) Through SI, Users shall be able to access certain de-identified data of suppliers worldwide. Including but not limited to: number of reports available, number of observations, number of minor observations, number of major observations, number of critical observations, number of open CAPAs and closed CAPAs (hereinafter the “Data”). The User can select the Data to be displayed per country, audit type or organizations.  For the avoidance of any doubt, the Data will in no case be linked to an identifiable supplier. Qualifyze reserves the right to not provide certain Data of certain countries, audit types or organizations if the number of existing reports is not large enough to ensure Data de-identification.

(4) Qualifyze hereby grants Users a nonexclusive access license to use the SI as necessary for User’s internal business purposes, provided Users complies with the restrictions in these SI GTC, or Qualifyze General Terms and Conditions (“QF General Terms and Conditions”), including but not limited to confidential and non-disclosure obligations.

3. Use of and registration on our website

(1) Registration and use of the SI is free of charge at www.qualifyze.com. The information required for registration must be provided completely and truthfully. When registering, Users shall enter with e-mail address and choose a password. The e-mail address shall not infringe the rights of third parties or other name and trademark rights or offend common decency.
(2) The registration does not entail any obligations whatsoever – apart from agreeing to the SI GTC and QF General Terms and Conditions. User accounts can be deleted at any time. A corresponding option can be found in the administration area of the account. The creation of a user account does not create any obligation with regard to the services and products offered by Qualifyze and shall not grant the User access to SI if the User does not accept the SI GTC.
(3) Users are obliged to keep passwords secret and not to disclose it to third parties under any circumstances. User shall be responsible for managing and controlling the access rights of its authorized users.
(4) Users are responsible for any activity carried out by their own accounts while using the SI. Qualifyze reserves the right to suspend or terminate any account if there is a reasonable belief that any of the Users has violated the SI GTC, QF General Terms and Conditions or engaged in any unauthorized or prohibited activities.
(5) Qualifyze reserves the right to interrupt or temporarily suspend the services, in whole or in part, to perform maintenance, updates, or any other actions necessary to ensure the operation and security of SI or ww.qualifyze.com. Qualifyze shall make reasonable efforts to schedule a routine maintenance during off-peak hours to minimize disruption to the Users. Qualifyze shall not be liable for any loss, damage or inconvenience caused by such interruptions.

4. Warranty and liability

(1) Qualifyze does not warrant that the Software will perform without error or that it will run without immaterial interruption. Qualifyze gives no warranty regarding, and will have no responsibility or liability for, any loss arising out of: (a) a modification of SI made by anyone other than Qualifyze, unless Qualifyze approves such modification in writing; or (b) use of the SI in combination with any operating system not authorized by Qualifyze or with hardware or software that is unsuitable.
(2) Qualifyze’s offer contains links to external websites of third parties on whose content Qualifyze has no influence. Therefore, Qualifyze cannot assume any liability for content on these third-party websites. The respective provider or operator of the website is always responsible for the content of the linked pages. The linked pages were checked for possible legal violations at the time of linking. Illegal contents were not recognizable at the time of linking. However, a permanent control of the content of the linked pages is not reasonable without concrete indications of an infringement. We will remove such links immediately if we become aware of any legal infringements. Qualifyze shall: (a) pass through to Client any warranty right it receives from a third party provider of SaaS components not authored or manufactured by Qualifyze (“Third Party Components”); and (b) reasonably cooperate with Client in enforcing such rights, at Client’s expense. QUALIFYZE PROVIDES NO WARRANTIES, EXPRESS OR IMPLIED, WITH REGARD TO THIRD PARTY COMPONENTS, AND QUALIFYZE WILL NOT BE LIABLE FOR ANY FAILURE OR ANY THIRD PARTY COMPONENT TO FUNCTION AS EXPECTED OR INTENDED.
(3) Qualifyze assumes no liability for the correctness, completeness, topicality, quality, and constant availability of the information provided on www.qualifyze.com or SI. Qualifyze expressly reserves the right to change, supplement or delete parts of www.qualifyze.com or its entire online presence without separate notification or to discontinue publication temporarily or permanently.
(4) As a service provider, Qualifyze is responsible for its own content on this website according to the general law § 7 Abs.1 Telemediengesetz (TMG). However, Qualifyze not obliged to monitor transmitted or stored third-party information or to investigate circumstances which indicate an illegal activity according to §§ 8 to 10 TMG. Obligations to remove or block the use of information according to general laws remain unaffected. Liability in this regard, however, is only possible from the time of knowledge of a specific infringement. If Qualifyze becomes aware of any such infringements, Qualifyze will immediately remove such content.
(5) EXCEPT FOR THE EXPRESS WARRANTIES SPECIFIED IN THESE SI GTC, QUALIFYZE MAKES NO WARRANTIES, EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS OR ANY IMPLIED WARRANTY ARISING FROM STATUTE, COURSE OF DEALING, COURSE OF PERFORMANCE, OR USAGE OF TRADE.
(6) QUALIFYZE HEREBY DISCLAIMS ANY RESPONSIBILITY OR LIABILITY FOR ANY MISUSE, MISINTERPRETATION, OR ANY EFFECTS RESULTING FROM THE UTILIZATION OF THE INFORMATION OBTAINED THROUGH SI. IT IS THE USER’S RESPONSIBILITY TO EXERCISE DUE DILIGENCE AND VERIFY THE ACCURACY OF THE INFORMATION.
(7) QUALIFYZE DISCLAIMS ANY LIABILITY ARISING FROM THE USE OF SI, IN CASES WHERE THE LAW DOES NOT PERMIT SUCH DISCLAIMER, the maximum liability of Qualifyze and/or its representatives or vicarious agents for damages shall be limited to the amount of damages typically foreseeable at the time of the acceptance of the SI GTC, not exceeding a maximum of EUR 100 (“Maximum Liability Amount”).

5. Incorporation of Qualifyze General Terms and Conditions

These SI GTC are subject to QF General Terms and Conditions, valid at the time of acceptance by the Users, which can be found at https://www.qualifyze.com/terms-conditions, including but not limited to Confidentiality, Data Protection, copyright and rights of use and compliance with the laws. 

6. Governing law

(1) These SI GTC are subject to the law of the Federal Republic of Germany, without regard to its conflict of laws rules and principles. The provisions of the UN Convention on Contracts for the International Sale of Goods (CISG) will not apply to these SI GTC nor to any contract entered into by the Users and Qualifyze.

(2) The courts at Qualifyze´s registered office in Frankfurt am Main (Germany) shall have exclusive jurisdiction for all disputes arising from or in connection with these SI GTC and any contract entered into by the Users and Qualifyze, including those concerning its existence, validity, performance, expiration or termination. However, at the sole discretion and option of Qualifyze, Qualifyze shall also be entitled to assert claims against the Client at its general place of jurisdiction.

7. Miscellaneous

(1) No Party may assign any rights or claims under these SI GTC without the prior written consent of the other Party (within the meaning of section 126 b BGB). This will not apply to assignments to Affiliated Companies of the assigning Party or successors of the Parties.

(2) The failure or delay by Qualifyze in exercising or enforcing any right, remedy or power under these SI GTC shall not constitute or operate as a waiver of that right, remedy or power. The single or partial exercise or enforcement of any right, remedy or power under these SI GTC shall not preclude or restrict any further exercise or enforcement of that right, remedy or power, or the exercise or enforcement of any other right, remedy or power under these SI GTC.

(3) Each Party represents and warrants to the other Party that it has the legal power and authority to enter into and perform under these SI GTC.

(4) English language terms used in these General Terms and Conditions and all contracts between the Parties describe German legal concepts only and shall not be interpreted by reference to any meaning attributed to them in any jurisdiction other than Germany.

(5) By accepting these SI GTC, you represent and warrant that you have full power and authority to enter into this SI GTC on behalf of yourself, the User, or the company you represent, and to bind them to these SI GTC. If you are accepting these SI GTC on behalf of a company or legal entity, you further represent and warrant that you have obtained all necessary authorizations and approvals from the appropriate individuals or governing bodies within that legal entity to accept these SI GTC on its behalf. If you do not have the necessary authority or if you do not agree with these SI GTC, you must not accept this agreement and may not use the services.

(6) In the event of any conflict or contradiction between the terms and conditions set forth in this document and the terms of any other Subscription Agreement or terms and conditions entered into between User and Qualifyze, the SI GTC shall prevail, unless expressly agreed otherwise in writing and mutually by the Parties. In the case where a specifically written and signed Subscription Agreement includes a provision regarding precedence over the SI GTC, such provision shall prevail.