Terms of Business
1. General
1.1 The terms and conditions stated herein are agreed to be those which will apply to a single study or several studies (“Study”) performed for the contracting company (“The Client”) by Pharmaterials Ltd (“Pharmaterials”).
1.2 Pharmaterials shall perform each Study as an independent contractor of The Client and shall have complete and exclusive control over its employees and agents and all technical equipment.
1.3 Pharmaterials' services shall be deemed to be in the nature of consultancy only and, upon completion of the testing and analysis services it provides in connection with any study, Pharmaterials shall provide a report containing its professional conclusion and any relevant recommendations as set forth in the Protocol, (as defined below).
2. Confidentiality
The parties acknowledge that the Confidentiality Agreement between Pharmaterials and the Client (the "Confidentiality Agreement") shall continue to govern their respective obligations to one another with regard to the confidential information each has disclosed to the other and shall continue to disclose to the other in connection with each Study pursuant to these terms and conditions, except as expressly provided herein. The parties' respective obligations with regard to any such confidential information shall survive the termination of a Study in accordance with the terms of the Confidentiality Agreement.
3. Protocol
3.1 Pharmaterials will perform each Study according to the study details in the quotation document (“Protocol(s)”). Should the Client want a more detailed Protocol produced this will be added to the quotation document as a chargeable item. Each Protocol will specify the Study design, information desired, estimated duration of the Study and all other matters pertinent to completion the Study;
3.2 If not otherwise agreed all communications between The Client and Pharmaterials regarding the conduct of the Study shall be addressed to or routed through the Project Manager and The Client's representative.
3.3 The Protocol(s) may be modified (amended) at the discretion of the Project Manager and / or in consultation with The Client. Detailed descriptions of all amendments are committed to a changed order and become valid by signature of The Client. In the event that there is a conflict between a Protocol and these terms and conditions, the terms of the Protocol will take precedence.
3.4 Pharmaterials does not warrant that the Study design and / or the Study results will satisfy the requirements of any regulatory agencies at the time of submission of Study results to such agencies.
4. Orders
Work will only start on a particular Study following receipt of an order number or confirmation of acceptance (“Order”). Orders to Pharmaterials must be issued in writing and shall be confirmed by Pharmaterials in writing.
5. AMENDMENTS / DEVIATIONS
Amendments to Protocols shall be notified to Pharmaterials in writing. Pharmaterials shall make every reasonable effort to implement Orders, but reserve the right to review the price and terms of delivery following amendments to Orders. At the discretion of the Project Manager Pharmaterials reserve the right to make a necessary deviation from the protocol if it is deemed essential for the conduct of the Study.
6. Prices and terms of payment
6.1 The prices for each Study will be agreed in writing. All prices are in UK GBP, net of value added tax and additional costs including, but not limited to consumables costs, packaging, transport, insurance, customs duty. An additional charge shall be made for urgent or express orders. Special prices shall apply for orders carried out in accordance with official rules for special handling materials.
6.2 For Studies with a duration of less than one month, invoices will be issued at the end of the Study. Invoices are payable within 30 days of the invoice date.
6.3 Studies lasting longer than 1 month shall be subject to the following terms of payment, unless otherwise agreed in writing: 30% of Study total within 20 days of confirmation of Order, followed by an agreed monthly payment and a final payment at completion of the Study.
6.4 Accounts payable to The Client by Pharmaterials may be offset only with the prior written consent of Pharmaterials.
6.5 Arrears interest of 12% per annum shall be charged on late payments. Pharmaterials shall not be required to provide further goods or services if The Client is in arrears with any payment due.
7. Cancellation or Termination of Studies
7.1 The Client may cancel any agreed Study prior to onset of that Study subject to the following conditions:
(a) Any Study cancelled by The Client within 4 weeks of the scheduled start date will be charged at 70% of the agreed cost of the first four week duration of the Study. (b) Any Study cancelled by The Client within 2 weeks of the scheduled start date of the Study will be charged at 100% of the agreed cost of the first four week duration of the Study.
7.2 The Client may at any time terminate any Study prior to its completion, by giving written notice to Pharmaterials. In such event, Pharmaterials shall immediately comply with such notice to terminate work on the Study and use its best effort to reduce cost to The Client. For termination for any reason other than a fault of Pharmaterials, The Client shall pay Pharmaterials agreed prices in the Protocol/Order for completed tasks, plus the cost in full of the work scheduled to take place in the 4 week period following termination. Upon such termination, Pharmaterials shall provide The Client with a report including the results of the Study until the termination date in accordance with Pharmaterials standard report format. The Client shall pay the agreed price in the Protocol/Order for the report writing.
7.3 Either Pharmaterials or The Client may terminate a Study in the event of breach of a material obligation of the other if such breach remains uncured after 30 days notice. The termination of a Study shall not relieve Pharmaterials or The Client of its obligations to the other in respect of confidentiality of information, consents for advertising purposes and publications, indemnification and compensation for services performed.
8. Study Performance
8.1 Pharmaterials will use its best efforts according to the present state of science and technology to provide facilities, all technical equipment and staff needed to complete the Study as described in the Protocol (as amended if appropriate) and in accordance these terms and conditions. Pharmaterials may employ external consultants and laboratory or field capacity for specific needs of the Study. Pharmaterials will be responsible for the work of its external resources in the same way as for its own work.
8.2 Pharmaterials reserves the right to subcontract services to third parties. Pharmaterials shall use only organisations with similar standards of quality and confidentiality requirements.
8.3 All external consultants, sources of external capacity and third parties with which Pharmaterials contracts shall be subject to restrictions on confidentiality and non-use which are no less restrictive than those contained in the Confidentiality Agreement. Pharmaterials shall be responsible for assuring that any external consultants, sources of external capacity and third parties with which Pharmaterials contracts comply with these terms and conditions.
9. Study Materials
The Client will provide Pharmaterials free of charge with sufficient amounts of all compounds, materials or other substances with which the Study shall be performed (“Materials”), as well as the necessary information and data to enable Pharmaterials an appropriate handling of the Materials, in particular but not limited to the identification, stability, storage and safety requirements of the Materials. The Client shall update all such information and data provided to Pharmaterials as such information becomes available to The Client. If delays in the agreed commencement or performance of the Study occur because of The Client's inability to supply Pharmaterials with Materials or information required to begin or perform the Study, Pharmaterials may reallocate resources being held for performance of the Study without incurring liability to The Client. A fee will be charged for rescheduling work and charges for cancellation (see above) will also apply.
10. Reports
Pharmaterials will prepare the results of all Studies in a Pharmaterials standard report format, containing its professional conclusion and any relevant recommendations, unless otherwise specified in the Protocol. Pharmaterials will provide a draft report on completion of the Study. On receipt of The Client's approval or two weeks after dispatch of the draft report, whichever is sooner, Pharmaterials will provide one original and one copy of the final report. Additional copies of reports and interim reports not specified in the Protocol and / or copies of or original raw data will be provided at The Client's request and expense. Pharmaterials will not publish any report or data prepared by Pharmaterials for The Client without prior written consent of The Client. This consent shall not be unreasonably withheld. Neither Pharmaterials nor The Client shall use the name of the other party or the names of any of its staff for any advertising, promotional or other public purposes without the prior written consent of such party.
11. Retention of data and materials
11.1 Pharmaterials will retain raw data or copies or originals of the Protocol, amendments to the Protocol and the final report for 5 years. Upon expiration of such 5 year period The Client will be asked and shall direct whether to destroy such data or material, to retain for a standard storage fee or to transfer to any address specified by The Client at The Client's expense.
11.2 Pharmaterials will return unused Client materials to the Client at the Client’s expense.
12. Patents and Inventions
12.1 All data, information, reports and any and all related documentation, which are developed, generated or derived, directly or indirectly, by Pharmaterials (or by any subcontractor or agent of Pharmaterials) for The Client during the course of each Study (the "Data"), and all inventions, discoveries, formulae, procedures, know-how and any other intellectual property, and any improvements thereto, whether patentable or not, which result or evolve directly, during the course of the Study or as a result of the services performed hereunder by Pharmaterials (or by any subcontractor or agent of Pharmaterials) (together with any Data relating thereto, the "Inventions"), shall be and remain the sole and exclusive property of The Client so far as they relate to the Materials or the product to which the Study relates (the “Product”); provided, however, that any Inventions made, developed or discovered solely by Pharmaterials (or by any subcontractor or agent of Pharmaterials) that constitutes an invention, improvement or other intellectual property relating generally (i.e., not solely to the Study or the Product) to drug delivery technology, formulation, analysis or manufacturing process of pharmaceutical products (together with any Data relating thereto, "Pharmaterials Inventions"), shall be and remain the property of Pharmaterials, and Pharmaterials hereby grants to The Client a perpetual, irrevocable, worldwide, royalty-free, exclusive license (with the right to sublicense) to develop, use, manufacture and sell such Pharmaterials Inventions in connection with the development, use, manufacture and sale of the Product, provided, further that the foregoing license shall not be exclusive with respect to a Product that is a non-patented (or non-patent pending) compound. Except as specifically set forth herein, neither Pharmaterials nor its employees or agents shall have or acquire any right, title or interest in Inventions. If related to the Product, Pharmaterials shall promptly disclose in writing to The Client any Inventions. If related to the Product and to the extent not Pharmaterials Inventions, Pharmaterials shall assign any and all rights in any Inventions to The Client and shall assist The Client, at no cost to Pharmaterials, in perfecting its rights in such Inventions.
12.2 Pharmaterials warrants and covenants that, to Pharmaterials' actual knowledge, the performance of Pharmaterials' services hereunder will not infringe or misappropriate any intellectual property right of any third party, except to the extent such services are provided in accordance with any specifications provided by The Client or other written instructions given by The Client.
13. Indemnities
13.1 In the event of a material or technical error by Pharmaterials in the performance of the Study which renders the Study invalid, Pharmaterials' sole obligation to The Client shall be for Pharmaterials, at its option, to either repeat the Study at Pharmaterials cost, subject to The Client's provision to Pharmaterials of any active pharmaceutical ingredient (API) or other necessary Materials or to refund The Client the contract price paid. In no event will Pharmaterials be liable to The Client for any indirect or consequential losses (including lost profits or revenues), cost of replacement of API or damage on account of such error. Pharmaterials shall indemnify The Client, its stockholders, directors, officers, employees and agents and keep it indemnified on demand against all liabilities, losses, claims, damages, costs (including cost of enforcement) and expenses from any claims by Pharmaterials employees or others arising out of Pharmaterials' negligent acts giving rise to any personal injury, death or property damage occurring during the conduct of the Study. Except for Pharmaterials' wilful acts, Pharmaterials will not be liable to indemnify The Client against any loss of expense resulting from any claim arising out of The Client's or The Client's monitor's use of the Study or its marketing of any substance which is subject of the Study.
13.2 The Client shall indemnify Pharmaterials, its stockholders, directors, officers, employees and agents and keep it indemnified on demand against all liabilities, losses, claims, damages, costs (including cost of enforcement) and expenses arising from or in connection with (a) any claim for personal injury, death or property damages arising out of a failure to warn Pharmaterials of any dangerous property of the Materials or any other item supplied to Pharmaterials by The Client, (b)he Client's use of the Study or its use or marketing of any substance tested by Pharmaterials, or (c) patent infringement relating to any Materials provided to Pharmaterials by The Client or Pharmaterials' services provided hereunder, to the extent that such infringement does not arise as a result of a breach of any representation or warranty of Pharmaterials hereunder.
14. Force Majeure
Either Pharmaterials or The Client shall be excused from performing its obligations under a Study if its performance is delayed or prevented by any event beyond its reasonable control, including but not limited to fire, explosion, weather, decease, war, insurrection, civil strife, riot, government action, or power failure, provided that such performance shall be excused only to the extent of and during such disability. Any time specified for completion of performance in the Protocol falling due to during or subsequent to the occurrence of any of such events shall be automatically extended for a period of time equal to the period of such disability. Pharmaterials will promptly notify The Client if, by reason of any events referred to herein, Pharmaterials is unable to meet any such time for performance specified in the Protocol. If any part of the Study is invalid as result of such disability, Pharmaterials will, upon written request of The Client but at The Client's or The Client's monitor's sole cost and expense, repeat that part of the Study affected by the disability.
15. Visits
The Client's or The Client's monitor's representative(s) may visit Pharmaterials at reasonable times and with reasonable frequency during normal business hours to observe the progress of the Study. Pharmaterials will assist The Client in scheduling such visits.
16. Assignment
The rights and obligations of Pharmaterials and The Client pursuant to any Study shall not be assigned in whole or in part by either party without the prior written consent of the other, which consent shall not be unreasonably withheld or delayed. Any attempt to assign such obligations without such consent shall be void and of no effect; provided that no such consent shall be required in connection with any assignment to an associated company of either party.
17. Proper Law
These terms and conditions shall be construed and enforced in accordance with the English Law and the parties agree that the English Courts shall have exclusive jurisdiction in respect of any disputes hereunder.
18. Modification
These terms and conditions shall not be waived, released, discharged, changed or modified in any manner except by an instrument signed by the duly authorised officers of each of Pharmaterials or The Client, which document shall make specific reference to these terms and conditions and shall express the plan or intention to modify same. |
