Immulab Terms & Conditions of Sale (Export & IH)
Any order placed by the purchaser will be taken to be an order incorporating these terms and conditions even if any inconsistencies are introduced in the purchaser’s order or acceptance, unless expressly agreed by Immulab Pty Ltd (ABN 77 623 052 095) (Immulab) in writing. When placing orders, the purchaser must include its purchase order number and include a full product code number and description. The purchaser must also specify a delivery address and an invoicing address. No order will be binding upon Immulab until it is accepted by Immulab.
Immulab will use its commercially reasonable efforts to supply the goods in accordance with the purchaser’s accepted orders. Notwithstanding any other terms and conditions, Immulab is not be liable for any loss or damage which the purchaser may suffer or incur as a result of Immulab’s failure to supply the goods in accordance with the purchaser’s accepted orders.
2. Prices and Quotations
Prices for the goods are as quoted by Immulab to the purchaser. Quotations are valid for 30 days, unless otherwise agreed in writing. Unless the price (including any applicable freight or service fee) quoted by Immulab is expressly stated to be inclusive of any applicable goods and services tax (GST), all goods will be charged at the prices ruling at the date of delivery plus any applicable GST which must be paid to Immulab by the purchaser when payment for the goods is due. Immulab will issue tax invoices and adjustment notes which comply with GST legislation. These documents will show the GST exclusive price, the amount of GST and a total including GST.
Payment must be made in cash or by direct debit to Immulab’s nominated bank account (or in another method agreed by Immulab in writing) prior to delivery, unless otherwise agreed in writing by Immulab. Without prejudice to any other rights or remedies of Immulab, if any payment is not made on the due date, the purchaser will be in default and, without limiting any other rights of Immulab, the purchaser must pay to Immulab, by way of liquidated damages, interest at the rate of 1% per month, calculated from the due date for payment until payment is made in full.
4. Claims for wrongful delivery
Any claim by the purchaser for short or wrongful delivery of the goods must be notified to Immulab in writing within 2 days of delivery of the goods. The claim should include the docket number and date of receipt. Any claim which the purchaser does not notify within that time (time being of the essence) will be taken to have been absolutely waived.
5. Quantity and Inspection
Purchases of goods must be in the minimum quantities advised by Immulab to the purchaser in writing. The purchaser must notify Immulab immediately of any defect in the goods of which it becomes aware after delivery and will take all reasonable steps to mitigate loss (if any) arising as a consequence of the defect.
No returns or credit adjustments will be allowed by Immulab unless:
- there is a fault in manufacture of the goods;
- the goods have been recalled by Immulab;
- prior agreement of Immulab has been given to return the goods; and
- the following have been satisfied :
- a returned goods authorisation number supplied by Immulab has been written on the outside of goods being returned;
- the goods are still in their original and unopened containers and the labels have not been removed or defaced;
- packing requirements given by Immulab for the return, the mode of transport and transport company have been followed; and
- the returned goods have been inspected by Immulab’s Quality Assurance department upon receipt for compliance with the return conditions.
Immulab warrants that the goods supplied with comply with the specifications for those goods. Immulab warrants to replace or allow a full credit (at Immulab’s discretion) for all goods manufactured or supplied by it which Immulab, in its discretion, determines are defective in materials or workmanship under normal use and service, up to the expiry date of the goods, provided that the goods have been stored In accordance with Immulab’s instructions. To obtain the benefit of this warranty, the purchaser must notify Immulab in writing immediately on becoming aware of the alleged defect and before the expiry date of the goods. The benefits conferred by this warranty are in addition to all other rights and remedies which the purchaser has under any statute.
8. Implied terms
All conditions and warranties expressed or implied by statute, the common law, equity, trade, custom or usage or otherwise are expressly excluded to the maximum extent permitted by law.
9. Liability and Indemnity
So far as the law permits, the liability of Immulab for a breach of a condition or warranty that cannot be excluded is limited, at Immulab’s option, to:
- the replacement of the goods;
- the supply of equivalent goods;
- a full credit in respect of the goods; or
- the cost of replacing the goods or of acquiring equivalent goods.
The purchaser will indemnify and keep indemnified Immulab and its officers, employees and agents (“Immulab Indemnified”) from and against any loss, damage (whether direct or indirect), liability, cost (including legal costs), expense, change or diminution in value of any kind, incurred by the Immulab Indemnified or arising directly or indirectly from or in respect of (i) the goods, their repacking, uses or effects, or (ii) any claim, suit, demand, action or proceeding (including for infringement of third party trademarks or trade names) by any person against any of the Immulab Indemnified in respect of the goods supplied by Immulab.
10. Indirect Loss
So far as the law permits, Immulab is not liable in any way for any indirect or consequential loss or loss of profit including, without limitation, any loss by reason of delay, defective or faulty material s or workmanship, negligence or any act or matter or thing done, permitted or omitted by Immulab.
11. Delivery, Risk and Property
- Immulab will pack the goods suitable for delivery to the destination designated by the purchaser and agreed by Immulab. Immulab will sell the goods ex works, Immulab’s premises (Melbourne 3000), unless otherwise agreed in writing.
- If Immulab agrees to arrange delivery on behalf of the purchaser then the cost of freight and insurance arranged by Immulab will be to the purchaser’s account, and Immulab will be acting as the purchaser’s agent and will be entitled to charge a handling fee. The purchaser indemnifies and keeps indemnified Immulab against all actions, claims, demands, losses, damages, costs and expenses for which Immulab may become liable which relate directly or indirectly to Immulab’s acting as the purchaser’s agent under this clause.
- The purchaser is deemed to have accepted the goods when a packed consignment is loaded for delivery at Immulab’s premises. Risk in the goods passes to the purchaser upon such loading. Property and ownership of the goods passes to the purchaser upon payment
- Any time quoted for delivery is an estimate only. The purchaser is not relieved of any obligation to accept or pay for goods because of any delay in delivery.
- If Immulab determines that it is or may be unable to deliver within a reasonable time or at all the order may be cancelled by Immulab. If the order is cancelled, the purchaser will have no claim against Immulab for any damage, loss, cost or expense.
12. Literature and suitability of goods
- Literature provided by Immulab to the purchaser in conjunction with the supply of goods (including information brochures, product information, consumer medical information, data information sheets and instruction sheets) contain information concerning the limitations of the goods and the manner in which, and the purposes for which, the goods a1-e suitable for use. That literature must be read and considered carefully by the purchaser.
- The purchaser acknowledges that it alone is responsible for determining the fitness of Immulab’s goods for the purpose for which the purchaser intends to use them.
- The purchaser should be aware the goods are considered as unregistered therapeutic goods outside Australia and have undergone little or no evaluation of quality, safety or efficacy by regulatory authorities outside Australia.
- The purchaser acknowledges that it alone is responsible for obtaining any necessary approvals for importation of the goods and for obtaining any necessary approvals for the purchaser’s intended use of the goods.
- Responsibility for prescribing therapeutic goods rests solely with the treating health professional. The purchaser will be responsible for ensuring that the patient or the patient’s legal guardian is in a position to make an informed decision regarding treatment. Informed consent should be in writing unless there are good reasons to the contrary. Informed consent should be freely given and in line with good medical practice.
13. Safety Reporting
- Safety reporting for the goods will be in accordance with the International Conference on Harmonisation (ICH) Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting E2D guidelines. (i) Adverse events (AEs) / adverse drug reactions (ADRs) include any events associated with the goods from any source, and any events associated with product technical complaints/quality defect or falsified medicinal products. AEs/ADRs also include the following, whether or not an associated AE has occurred: product exposure during pregnancy (including maternal/paternal exposure) irrespective of pregnancy outcome, neonatal exposure via breast milk, lack of efficacy, overdose, maladministration/medication error, misuse/abuse, off label use, occupational exposure, and suspected transmission of an infectious agent. (ii) Minimum criteria for a valid AE/ADR includes: an identifiable patient (e.g. patient initials, gender, date of birth), an identifiable reporter (e.g. healthcare professional), at least one AE/ADR, and the suspect goods.
- The Purchaser must report all information for AEs/ADRs (including those that do not meet minimum criteria) associated with the Product(s) to Immulab within 1 working day of first becoming aware of the AE/ADR, by Email: firstname.lastname@example.org or Facsimile : +61 3 9389 1454, using the Adverse Event Report Forms set out in Schedule 1. All AE/ADR information exchanged between the purchaser and Immulab must be in the English language only.
- The purchaser must follow up with the reporter/ healthcare professional for all AEs/ADRs once, and serious AEs/ADRs three (3) times, to attempt to obtain further information. Immulab may request the purchaser to ask specific questions of the reporter / healthcare professional upon follow up. All follow up information received by the purchaser must be forwarded onto Immulab according to the process for initial information, as described above.
- Failure by Immulab not to insist on strict performance of any term, warranty or condition of the contract will not be taken as a waiver of it or any rights Immulab may have.
- The purchaser acknowledges that neither Immulab nor any person purporting to act on its behalf has made any representation or given any promise or undertaking which is not expressly set out in writing, whether as to the fitness of goods for any particular purpose or any other matter.
- The relationship between the parties is that of independent parties and will not be deemed to be that of principal/agent, joint venture, partnership or otherwise. The purchaser is not authorised to act on behalf of Immulab purporting to bind Immulab. The purchaser acts as an independent contractor buying for itself and selling in its own name and at its own risk.
- Any notice to be given by the purchaser to Immulab must be sent by prepaid mail to Immulab’s registered address. No notice will be taken to have been given until it is actually received at Immulab’s address.
- These terms and the supply of goods are governed by and will be construed in accordance with the laws of Victoria, Australia (to the exclusion of the provisions of the United Nations Convention of Contracts for the International Sale of Goods). The purchaser submits to the non-exclusive jurisdiction of the courts of Victoria, Australia.
Schedule 1 – Adverse Event Report Forms