Terms and conditions

In these General Terms and Conditions “Tjoapack” shall be: Tjoapack Netherlands B.V., with its registered office in (4879 AC) Etten Leur, at Nieuwe Donk 9.

In these General Terms and Conditions “Client” shall be: any natural person or legal entity to whom Tjoapack provides products and services.

These General Terms and Conditions shall apply to all legal relationships whereby Tjoapack acts as (potential) supplier of products and services. These General Terms and Conditions shall apply to every order, offer and agreement between Tjoapack and Client in respect of which Tjoapack shall have declared these General Terms and Conditions applicable, in so far as parties shall not have agreed in writing to depart from these General Terms and Conditions.

1. Purchase Order.   To initiate or schedule Services, Client shall provide a signed Proposal or purchase order and initiation payment (if applicable) in the amount as stated in the Payment Schedule to the Proposal. Purchase orders shall be provided to Tjoapack at Orders@Tjoapack.com and reference the Proposal number.  If a purchase order is issued with conflicting terms and conditions, the General Terms and Conditions herein shall prevail. If Client places an order then the agreement shall be formed only after Tjoapack has accepted and confirmed said order in writing, or proceeds to accepted and confirmed said order in writing, or proceeds to implement same.  If a quotation or offer is accepted by Client then Tjoapack shall have the right to revoke the offer within two days upon receipt.  
2. Pass-Through Expenses. Tjoapack shall charge Client any sourcing and handling fee set forth in the Proposal for all supplies, materials, and services acquired from a third party specifically for or on behalf of Client to satisfactorily complete Services set forth in the Proposal.
3. Invoicing.  Tjoapack shall invoice Client in the amounts and pursuant to the Payment Schedule and Terms set forth in the Proposal.  Invoices subsequent to the initiation payment are due and payable thirty (30) days from receipt of invoice via email.  If any portion of an invoice is reasonably disputed, Client will pay the undisputed amount and the parties will use commercially reasonable efforts to reconcile the disputed amount as soon as practicable.

Should payment of undisputed amounts not be received within thirty (30) days from the invoice receipt date, or Tjoapack determines based on repeated missed or substantially delayed payment history or a material negative change in the credit profile or solvency of Client, Tjoapack reserves the right to change the payment terms by written notice to Client and take one or more of the following actions; (i) following a ten (10) day notice, suspend Services until any overdue payment is made in full, (ii) require all or a portion of payments to be made in advance of the Services, and/or (iii) charge interest on any unpaid undisputed amounts at the rate of 1.5% per month from the due date until actual payment.  In the event of default in payment of undisputed amounts, Client shall be responsible for all collection fees and expenses incurred by Tjoapack, including reasonable attorney’s fees.

All payments to Tjoapack shall be made in Euro by a Tjoapack approved payment facility unless otherwise agreed upon in writing by the Parties.  Tjoapack approved client payment facilities are Client business check, Client wired funds or Client Automated Clearing House (“ACH”) transfers.  In the event of liquidation, (filing for) bankruptcy, admitting Client to statutory debt rescheduling by virtue of the Wet Schuldsanering Natuurlijke Personen [Debt Rescheduling Natural Persons Act], guardianship, attachment or Client’s (provisional) suspension of payment, the claims of Tjoapack on Client shall be immediately due and payable.

1. Taxes and Duties.  Client shall be responsible for all taxes imposed on the sale or use of products or Services by operation of law (such as sales taxes or value-added taxes). The consideration stated under any Proposal is net of any taxes imposed on the amounts payable to Tjoapack hereunder, and any such taxes are additional to Service fees. Client is responsible for payment of any tariffs, duties, or other fees applied to materials purchased by Tjoapack to provide the Services.
2. Amendment.   Additions to or modifications of the Proposal or these General Terms and Conditions must be made in writing and signed by both Parties; however, Client may order additional per-test or hourly Services outside the scope of the Proposal via email approval, which will become part of this Proposal once approved by both Parties via email.  
3. Cancellation or Postponement of Services.  In the event of cancellation of activities set forth in the Proposal, Client shall pay for the cost of Services performed, materials used for the project through the effective date of the cancellation, reasonable project shut down costs, wind-down costs or cancellation fees identified in the Proposal, removal and disposition of Client materials, and Tjoapack’s cost of all materials and Services previously acquired or contracted for and which cannot be cancelled or reallocated.

For packaging Services which are cancelled or postponed with less than ninety (90) days’ notice before the scheduled production date shall carry additional fees to account for idled facility and personnel resources.  Based upon the timing of Client’s postponement or cancellation, the following fees shall apply:

1. Delivery Schedule.  The scheduled dates for the performance of the Services will be agreed upon following receipt of the fully executed Proposal and will represent Tjoapack’s best estimate of the timing for the various activities to be performed; however, both Parties agree that unforeseen delays may occur.  If such delays occur, both Parties will use good faith efforts to minimize the timing disruption to the scope of work. Client or its designee must provide on time, in the right quantity and within the specifications, any raw materials agreed to be supplied by Client and all dates quoted by Tjoapack for delivery and completion of the Services shall be extended in the event Client-supplied materials are delayed.  Tjoapack shall not be held liable to Client or any third party for any defect or deficiency in Client-supplied materials or resulting from any delay, supply deficiency or supply failure caused by Client or its designee. In the event Client must delay or reschedule Services for any reason, Client shall notify Tjoapack as soon as possible.
2. Safety Information.  Client shall provide all necessary and relevant information available concerning chemical entities and/or biologics provided to Tjoapack, to ensure compliance with quality risk management expectations for cross contamination, safe handling, storage, usage, shipment and disposal. Tjoapack may refuse, without liability, substances that Tjoapack cannot handle safely or which lack, in Tjoapack’s assessment, sufficient information such that Tjoapack can determine that such substances do not pose a risk to health or safety while in Tjoapack’s possession. For extremely hazardous materials requiring containment and/or special engineering controls, a surcharge may be applied. Special storage conditions, applicability of the Opiumwet [Opium Act], and any toxic or explosive nature of the bulk presented for packaging shall be communicated to Tjoapack prior to invitation to quote or order award. Bulk medicines and other materials supplied by Client for packaging shall be shipped to Tjoapack in good order, clearly identified, with clear packing slip affixed, properly sealed and inside hygienic containers.
3. Warranty.  Tjoapack warrants that it operates its facilities in compliance with applicable laws and current Good Manufacturing Practices (“GMP”), Tjoapack’s internal standard operating procedures (“SOPs”) and is registered with the U.S. Food and Drug Administration (“FDA”).  The foregoing warranty is made to Client only and is not transferable.  TJOAPACK MAKES NO WARRANTIES, EXPRESS, IMPLIED OR OTHERWISE, EXCEPT THOSE HEREIN EXPRESSLY PROVIDED.  TJOAPACK SPECIFICALLY DISCLAIMS ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NON-INFRINGEMENT AND ANY WARRANTY, EXPRESS OR IMPLIED, THAT THE ACTUAL SCIENTIFIC OR PHARMACEUTICAL RESULTS OF THE SERVICES HEREUNDER WILL NECESSARILY MEET CLIENT’S DESIRED SCIENTIFIC OR OTHER RESULTS.
4. Inherent Risk of Development. The Parties understand that there are inherent risks associated with development. Tjoapack shall have no liability and Client will pay Tjoapack for Services performed in accordance with the Proposal even if Services fail to meet the specifications or objectives unless such failure is solely attributable to Tjoapack’s failure to follow agreed upon batch records, procedures, protocols, or GMP if applicable.  
5. Liability Limitation.  Tjoapack’s entire liability for performing the Services is limited to the total amount paid by Client to Tjoapack under the Proposal for the activity giving rise to the claim.  NEITHER PARTY SHALL BE LIABLE, WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, FOR ANY PUNITIVE, SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL OR EXEMPLARY DAMAGES (INCLUDING LOST PROFIT OR BUSINESS INTERRUPTION EVEN IF NOTIFIED IN ADVANCE OF SUCH POSSIBILITY) ARISING OUT OF OR PERTAINING TO THE SUBJECT MATTER OF THE PROPOSAL, OR PERFORMANCE OF THE SERVICES.  

In the event of a failed batch or other Services due to Tjoapack’s negligence or failure to follow agreed upon batch records, procedures, or protocols, or GMP if applicable, Tjoapack’s liability will be limited to reperforming the Services at no additional purchase price, including no charge for Tjoapack-supplied materials and testing.  Additionally, Tjoapack will credit Client for any Client-supplied materials lost or damaged due to Tjoapack’s gross negligence, up to the lesser of (i) the replacement cost of such Client-supplied materials, or (ii) fifty thousand euro (€50,000). Tjoapack shall have no liability for loss or damage to Client-supplied materials other than this remedy.  

1. Indemnification.  

a. Tjoapack shall defend, indemnify and hold harmless Client, its directors, officers, employees, agents and representatives from any product liability or third party claims, proceedings or investigations including, without limitation, all Losses (as defined below), to the extent arising out of Tjoapack’s gross negligence or willful misconduct in the performance of the Services.

b. Client shall defend, indemnify and hold harmless Tjoapack, its directors, officers, employees, agents and representatives from any products liability or other third party claims, proceedings or investigations arising out of or in connection with the Services performed hereunder including, without limitation, judgments or amounts paid in settlement of claims, proceedings or investigations, and all expenses, fees or costs in connection therewith (collectively, “Loss”), provided that such Loss is not subject to indemnification by Tjoapack under Section 12(a) hereof.

1. Proprietary Information and Technology.  Client will own all raw data and deliverables arising out of the Services.  Client confidential information and pre-existing intellectual property of Client shall remain the sole property of Client. Any patent or other intellectual property rights directly resulting from the Services or included as a deliverable in the Proposal will be assigned to Client.  Client shall indemnify Tjoapack against any liability for infringement of any patent or other intellectual property rights arising from Client-directed Services or Client-supplied information or materials in the performance of the Services.

Tjoapack shall retain ownership of any processes, techniques, improvements, know-how, trade secrets, discoveries and other intellectual property developed by Tjoapack independent of the Services and the Proposal (all of which shall be referred to herein as “Tjoapack Proprietary Technology”). The Parties acknowledge and agree that Tjoapack may develop improvements to Tjoapack Proprietary Technology in the course of fulfilling its obligations under this Proposal, which improvements are a result of Tjoapack’s expertise and are of general applicability to Tjoapack’s business of providing services for a variety of organizations other than Client. Tjoapack shall own all auxiliary resources such as tools, plates, tooling, moulds and other machine or production components purchased by Tjoapack for the purpose of performing the agreement concluded with Client, whether or not Tjoapack has passed on the costs thereof in whole or in part to Client.

1. Nondisclosure.  For a period of ten (10) years from the termination or expiration of the Proposal, except to fulfil its obligations hereunder, and except as required to the extent required by law, regulation, judicial requirement, or regulatory agency,

1. Tjoapack will not itself use, or provide or disclose to any third party, any information, data, or documents which were identified by Client as confidential at the time of disclosure to Tjoapack or which were specifically developed or generated by Tjoapack for Client, and any information of Client which a reasonable person would expect to be proprietary or confidential to Client; and
2. Client shall not provide or disclose to any third party, any information or documents which are identified by Tjoapack as confidential at the time of disclosure to Client, including information observed during a site visit or audit, pricing of services, or information contained within this Proposal, and any information of Tjoapack or its third party clients which a reasonable person would expect to be proprietary or confidential to Tjoapack or its third party clients.

The above confidentiality obligation shall not apply or shall cease to apply to any information which the receiving Party can demonstrate by documentary proof:

1. is already in the possession of the receiving Party at the time it is disclosed by the disclosing Party;
2. is in the public domain at the time it is disclosed by the disclosing Party;
3. enters the public domain through sources independent of the receiving Party and through no fault of the receiving Party;
4. is lawfully obtained by the receiving Party without any confidentiality restrictions from a third party who has a right to disclose such information to the receiving Party; or
5. has been at any time developed by the receiving Party independently of disclosure from the disclosing Party.

1. Audits by Client Representatives. During regular business hours and mutually agreed upon times, Client may review the records of Tjoapack relating to the Services performed and pass-through expenses incurred to assure compliance with all provisions of the Proposal.  Such review must be completed in not more than one (1) business day with one (1) auditor and shall be offered to Client once every three (3) calendar years.  Subsequent reviews during the same calendar year, or such reviews that cannot be completed in one business day will be at Client’s sole cost and expense, at Tjoapack’s then current rates.  

Client’s rights in this Section shall be subject to compliance with Tjoapack’s reasonable measures for purposes of confidentiality, safety, and security, and will be further subject to Client’s compliance with Tjoapack’s premises rules that are generally applicable to all persons at Tjoapack’s facilities.  Should Client utilize one or more third party(ies) in exercising its rights in this paragraph, Client certifies that such party(ies) shall be subject to an obligation of confidentiality consistent with the obligations of confidentiality required of Client hereunder and such third party(ies) shall be subject to any and all conditions upon Client’s rights that are set forth in this Section.  

1. Inspections by Governmental or Regulatory Authority.  Tjoapack shall be responsible for handling and responding to any FDA or other governmental body inspections or inquiries received by Client or Tjoapack regarding the Services.  Tjoapack shall support and allow audits and inspections by the FDA or other applicable regulatory authorities.  In cases where Tjoapack is required to provide significant Client or product-specific support to such inspections or inquiries, or allow audits or inspections by regulatory agencies other than the FDA, Client agrees to pay Tjoapack for the time required, at Tjoapack’s then current regulatory support rate.  

Each Party shall notify the other regarding any such inquiries and provide the other Party copies of any pertinent correspondence from such authorities related to the product or Services covered in the Proposal.  Tjoapack shall provide to Client and any governmental body any information reasonably requested by Client and/or such governmental body concerning any governmental inspection related to the Services or Client’s products (with all information provided to Client being subject to the confidentiality provisions herein and with Tjoapack being able to redact any information provided to Client to remove third party confidential information that does not relate to Client’s Services or products).  Client agrees to fully cooperate with and assist Tjoapack in fulfilling its obligations pursuant to this Section.

1. Insurance. At all times while the Proposal is in effect and for three (3) years thereafter, Tjoapack and Client shall each:
   1. Maintain insurance which covers general liability (including but not limited to property damage, personal injury, and bodily injury), Products/Professional liability, and contractual liability, each at limits not less than €1,000,000 per occurrence/€2,000,000 in the aggregate (which limits may be met by a combination of categorical and umbrella coverage);
   2. Maintain Workers’ Compensation, if required by applicable laws, and Employer’s Liability coverage with a limit of not less than €500,000; and
   3. Provide, within thirty (30) days of the other Party’s request, Certificates of Insurance verifying insurance limits agreed upon.

Tjoapack and Client shall each obtain all the insurance policies described in clauses 17(a) and (b) from insurers having A.M. Best ratings of A-, VIII or higher.  

Tjoapack shall have no liability for loss or damage to Client materials while in process, in transit or while being stored at Tjoapack’s facilities.  Client may, at its own cost and expense, obtain insurance, including transit coverage, covering losses to Client’s property while it is at Tjoapack’s facilities or in transit to or from Tjoapack’s facilities.

1. Documentation and Retention of Documentation. Unless otherwise specified in the Proposal, raw data, certificates, batch records, source documents and reports (collectively, “Documentation”) will be in Tjoapack’s standard format.

Documentation shall be retained by Tjoapack pursuant to the quality agreement, or longer if required by applicable law, with the exception of Documentation that supports validations, which will be maintained for the duration of the utilization of the method or process validated.   If specifically requested by Client, longer term storage may be arranged at Client’s expense.  Otherwise, Documentation may be destroyed following the retention period.  Hard copies of Documentation may be destroyed by Tjoapack at any time as long as copies are retained in electronic format.

During the above-described retention periods, Documentation shall be available for inspection by Client, its authorized agents and authorized government agencies. Controlled and versioned documents such as Tjoapack’s SOPs are not Documentation, and may be viewed but not copied.

1. Retention of Materials. Sample retains shall be held by Tjoapack pursuant to Tjoapack’s SOPs or the applicable quality agreement, or for longer periods of time if required by applicable law(s) or the Proposal.  Prior arrangements must be made for alternate disposition at Client’s expense.
2. Delivery/Shipment.  Displayed or supplied samples or models shall be merely indicative, without the deliverable product being required to match same.  All product(s) and deliverables shall be delivered EX WORKS (Incoterms 2020) Tjoapack’s facility. Tjoapack is not a distributor of Client’s products and Client is responsible for shipment of packaged products from Tjoapack’s facility.  In the case of scheduled product, prior to pick-up by the carrier Client must provide Tjoapack with reasonable evidence (e.g. a copy of the current DEA registration for the destination, when applicable) that the destination for the product is authorized to receive the product. Notwithstanding anything to the contrary in the Proposal, Client acknowledges and agrees that Tjoapack shall have no obligation to release product or deliverables for shipment to any destination for which Client has not provided adequate evidence of authorization as required in this Section.  Title and risk of loss of packaged product shall transfer to Client upon Tjoapack’s Quality Department approval of batch disposition documentation and notification to Client that product is available for shipment or disposition. Client shall be responsible for any damage to or loss of work in progress or final product 1) during shipment external to Tjoapack, or 2) while such work in progress or final product is in the custody of Client or a third party (such as for additional testing). Client shall make arrangements for its shipper to pick up product or deliverables within thirty (30) days of release by Tjoapack.  Storage beyond thirty (30) days shall be invoiced to Client at Tjoapack’s standard rates or subject to a separate mutually-agreeable proposal.

Client must be the importer and exporter of record or utilize its own customs broker for any materials being imported and shipped to or from Tjoapack.  Client is responsible for ensuring appropriate documentation is in place for all material exported to another country.  Any importation or exportation of the product or materials, including responsibility for obtaining applicable permits, shall be Client’s responsibility and expense. Client agrees that Tjoapack’s preparation of or signature on distribution papers or other documentation is based on Tjoapack’s reliance on Client’s representations regarding such papers and, to the extent that Tjoapack prepares or signs any distribution papers or other documentation, it will do so as the express authorized agent of Client.

1. Delivery Acceptance.   Client shall give written notice to Tjoapack within thirty (30) days from the date product is made available for shipment, if the product(s) fails to conform to the agreed upon specifications or terms of the Proposal.  In the absence of such notice, the product(s) or deliverable(s) shall be deemed accepted by Client.
2. Termination. Client may terminate the Proposal on sixty (60) days' written notice to Tjoapack. In the event of a clinical failure or market withdrawal, either Party may terminate the Proposal effective immediately. Upon termination, Client shall pay the fees set forth in Section 6.  Tjoapack may terminate this Proposal for Client’s material breach with sixty (60) days’ written notice if Client does not cure the breach within such notice period.

Miscellaneous

1. Dispute Resolution.  In the event of a dispute regarding payment or the performance of Services (“Dispute”), the Parties shall endeavor to negotiate in good faith an agreeable solution.  If after ten (10) business days following receipt of a Party’s written notification of a Dispute such Dispute has not been resolved, the Dispute shall be brought to the attention of the senior management of each Party and such senior manager or his/her designee will negotiate in good faith to define and implement a final resolution.  The intent of this Section is to encourage the Parties to work together to resolve any Dispute without having to rely on arbitration or any other legal proceeding.  However, nothing in this Section shall prevent or inhibit either Party to institute any other action to resolve such Dispute(s).
2. Force Majeure.  Tjoapack shall not be liable for any failure to meet its obligations under the Proposal due to any cause beyond Tjoapack’s reasonable control, including, without limitation, acts of public enemy, acts of any governmental authority, including governmental laws, ordinances, rules and regulations whether or not valid, acts of God, including hurricanes, floods, epidemics or pandemics and severe weather, quarantine restrictions, strikes or lockouts, labor disputes or shortages, embargoes, war, riot, malicious acts or damage, accidents, interruption of supplies, equipment malfunction or failure of electrical supply or other utilities.
3. Entire Agreement.  The Proposal and these General Terms and Conditions constitute the entire agreement with respect to the Services to be provided under the Proposal.  
4. Choice of Law.  The Proposal shall be interpreted and construed in accordance with the laws of the Netherlands, without the application of its choice of law provisions to the contrary.
5. Assignment.  No assignment by either Party of this Proposal or any of its rights or obligations hereunder shall be effective unless and until the assignee executes and delivers to the non-assigning Party in writing that it will be bound by all the obligations of the assigning Party hereunder.  No assignment shall relieve the assignor of any of its obligations which accrued prior to the date of the assignment.
6. No Solicitation of Employees.  Tjoapack and Client agree that neither Party will, during the term of the Proposal and for one (1) year thereafter, directly or indirectly recruit a current or former employee of the other Party who has performed any work in connection with the Proposal.  However, newspaper, internet or other general advertisements to fill job openings shall be deemed not to be “recruitment” hereunder.  Any exceptions to this provision must be in writing and signed by an authorized representative of each Party.
7. Master Services Agreement.   In the event Tjoapack and Client execute a Master Services Agreement (including a commercial supply agreement) which covers the Services, the terms and conditions of such Master Services Agreement shall supersede the terms and conditions set forth herein, unless otherwise stated in the Master Services Agreement.
8. Survival.  Paragraphs 2 through 24, 26, 28, 29 and 30 of these General Terms and Conditions shall survive the expiration, cancellation, or termination of the Proposal, as well as any other terms which by their nature are intended to survive its expiration or termination.
9. Severability.  If any provision of this Proposal or its exhibits is held to be illegal, invalid or unenforceable, such provision will be fully severable, this Proposal will be construed and enforced as if such provision had never comprised a part hereof, and in lieu of such provision, there will be automatically added as a part of this Proposal a legal, valid and enforceable provision as similar to the terms to such illegal, invalid or unenforceable provision as may be possible and reasonably acceptable to Tjoapack and Client.
10. No Other Relationship; No Third Party Rights.  Tjoapack and Client are independent contractors and nothing contained herein shall be deemed to create any joint venture, partnership, or agency relationship between them. Unless explicitly stated in the Proposal, this Proposal does not create any rights or obligations in any person other than Tjoapack and Client.

TJOAPACK NETHERLANDS B.V.