This Label License is a legal agreement between You (either an individual or a single entity) and TopoTarget USA, Inc. ("TopoTarget") for the Totect® individual patient treatment kit, which contains ten vials of 500 mg Dexrazoxane, ten vials of Totect® diluent, and instructions for their use ("Product").

Using the Product indicates your acknowledgment that You have read this Agreement and agree to its terms. This Agreement also contains the conditions and limitations on the license grant and your responsibilities and requirements associated with this Agreement.

1.1 You or the legal entity by whom you are employed ("You") have entered into a Conditional Sales and License Agreement or a Limited License with TopoTarget, the terms of which agreements may be reviewed at www.topotarget.com.

1.2 You have obtained the Product from TopoTarget or its authorized agent.

1.3 You may use the Product solely for the treatment of a single patient on your premises for the treatment of extravasation resulting from intravenous anthracycline chemotherapy in accordance with the Totect® Label ("Licensed Use"). You may not use the Product or any portion thereof, for any use other than the Licensed Use. The Limited Use includes a non-exclusive, single use license, without the right to sublicense, under U.S. Patent No. 6,727,253 B2, which license expires upon the completion of the Licensed Use or destruction, or repossession by TopoTarget of the Product.

1.4 The term of this Label License Agreement shall continue for the period of the Licensed Use of the Product, unless earlier terminated.

1.5 This Agreement does not permit You to use the Product to conduct research, including without limitation for clinical research involving human subjects.

1.6 The Product is protected by intellectual property laws and treaties. Except for the limited rights of use granted herein, all right, title and interest to Product, including patent, copyright, and trademark rights in and to the Product, the accompanying printed materials, and any copies of the Product are owned by TopoTarget.

2.1 The non-exclusive, limited license for the Licensed Use of Product under U.S. Patent No. 6,727,253 B2 contained herein is conditioned on Your agreement that You will not or will not authorize or otherwise cause others to:

(a) sell, rent, lease, reproduce, transmit, or distribute the Product or any component thereof to any person, individual or corporation, other than Your employee or a physician with privileges at Your  hospital, wherein that physician has an immediate need for the Totect® Emergency Treatment Kit and wherein that physician agrees to abide by the terms of this agreement or, in the instance of where You are a buyer’s agent, you have been provided written evidence by TopoTarget or Your customer that Your customer has entered into a Limited License with TopoTarget to use the Product,

(b) reverse engineer the Product,

(c) save any unused portion of a Product remaining after a Licensed Use,

(d) use any portion of Product remaining after a Licensed Use to treat any patient other than the patient initially treated under such Licensed Use,

(e) acquire the Product or dexrazoxane for the treatment of extravasation resulting from intravenous anthracycline chemotherapy under U.S. Patent No. 6,727,253 B2 from any source other than  TopoTarget or its authorized agent or

(f)  use the Product, whether or not obtained from TopoTarget or its licensed distributors, for any treatment other than the treatment of extravasation resulting from intravenous anthracycline chemotherapy under U.S. Patent No. 6,727,253 B2;

failure to comply with any one or more of 2.1(a), (b), (c), (d), (e) or (f) is outside of the license granted by Articles 1 and 2, hereof and constitutes infringement of U.S. Patent No. 6,727,253 B2.

2.2 Any unused Product after a Licensed Use must be properly disposed of or destroyed.

3.1 TopoTarget warrants that all Product, at the time of shipment, shall be manufactured in accordance with the IND or NDA, as applicable, and cGMPs. This warranty only applies to Product that has been purchased from TopoTarget or its authorized agents. Except for the express warranties in the limited warranty set forth above, TopoTarget makes no other warranties of any kind and disclaims all other warranties, whether oral or written express or implied including the implied warranties of merchantability and fitness for particular purpose.

3.2 The entire risk arising out of the use, results, and performance of the product is assumed by you.

3.3 Your exclusive remedy and the limit of the liability of TopoTarget or any of its authorized agents for any and all losses, injury, or damages resulting from the use or handling of the product (including claims based in contract, negligence, product liability, strict liability, tort, or otherwise) shall be the price paid by you for the product, or at the election of TopoTarget, the replacement of the product. In no event shall TopoTarget or its authorized agents be liable for any incidental, consequential, special, or punitive damages.

3.4 TopoTarget shall not be responsible for claims by a third party against You, and You agree to indemnify and hold TopoTarget harmless against any and all such claims.

3.5 In any event, the maximum aggregate liability of TopoTarget and its authorized agent to You shall not exceed the purchase price paid by You for the Product.

4.1 This Agreement shall be governed by and interpreted in accordance with the laws of the State of Delaware, United States of America. The parties hereby consent to submit to personal jurisdiction and venue exclusively in the Federal and state courts of the State of Delaware, United States of America.

4.2 Your rights in this Agreement may not be transferred to anyone else without the written consent of TopoTarget. If your rights are transferred with TopoTarget’s consent or by operation of law, this Agreement is binding on the person or entity receiving the transferred rights.

4.3 You agree that in the event of a breach or threatened breach of this Agreement, TopoTarget will suffer irreparable harm and will be entitled to specific performance, and preliminary and/or permanent injunctive relief to enforce this Agreement without the need to post bond and that such relief shall be in addition to, and not in lieu of, any monetary damages or other relief a court of competent jurisdiction, whether at law or equity, may award.

4.4 Without prejudice to any other rights, this Agreement shall terminate if You fail to comply with any term of this Agreement. In such event, You must destroy all copies of the Product and all of its component parts in your possession.

4.5 All warranties and indemnifications, and any limitations thereof, as set forth and described in Section 3, shall survive termination of this Agreement.

4.6 If any provision of this Agreement is declared invalid, illegal, or unenforceable by a Court of competent jurisdiction, such provision shall, as to that jurisdiction, be ineffective only to the extent of such invalidity, illegality, or unenforceability, and shall not in any manner affect the remaining provisions hereof in such jurisdiction or render any other provision of this Agreement invalid, illegal, or unenforceable in any other jurisdiction.

4.7 This Agreement contains the entire agreement between the parties, supersedes any other agreement or discussions, oral and written, concerning the subject matter hereof, and may not be modified or amended except by a written amendment signed by both parties.

5.1 All notices shall be deemed duly given if you complete the form below, accept the Terms and Conditions set forth herein and submit same via the "Submit" button at the bottom of the form.