DEVELOPMENT AGREEMENT
Exhibit 10.1
[***]: CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
This Development Agreement (this “Agreement”) is made and entered into on June 4, 2015 (the “Effective Date”) by and between Tandem Diabetes Care, Inc., a Delaware corporation, having a principal place of business at 00000 Xxxxxxx Xx., Xxx Xxxxx, XX 00000 (“Tandem”) and DexCom, Inc., a Delaware corporation, having a principal place of business at 0000 Xxxxxxxx Xxxxx, Xxx Xxxxx, XX 00000 (“DexCom”).
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A. |
DexCom is in the business of developing and commercializing continuous glucose monitoring systems, and is currently developing the DexCom G5 System (as defined below). |
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B. |
Tandem has developed, and is developing, current and next generations of insulin infusion pump systems. |
The parties therefore agree as follows:
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1.3. |
“DexCom BT CGM Transmitter” means the transmitter component of the DexCom G5 System that is configured to transmit information from a DexCom Sensor via |
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Bluetooth to any receiver adapted to identify, receive, and display such information, and is also controlled from an authenticated receiver, such as the DexCom Receiver, and the DexCom CGM Smartphone App. |
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1.4. |
“DexCom CGM-Enabled Tandem Display Device” means a Tandem Display Device comprising a receiver or other component of the Tandem Insulin Infusion Pump configured to identify, receive, interpret, process and/or display DexCom Sensor Information from a DexCom BT CGM Transmitter and control the DexCom BT CGM Transmitter. A DexCom CGM-Enabled Tandem Display Device will be independently developed by Tandem pursuant to Section 2.1 and is not, and will not be, a component of a DexCom G5 System. |
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1.5. |
DexCom CGM Smartphone App” means the smartphone application component of the DexCom G5 System that identifies, receives, deciphers and displays information transmitted by a DexCom BT CGM Transmitter from a DexCom Sensor, and also enables control of the DexCom BT CGM Transmitter by receiving and transmitting data to the DexCom G5 System, such as configuration settings and calibration values. |
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1.6. |
“DexCom G5 System” means DexCom’s fifth generation continuous glucose monitoring system comprised of the following components, all designed, developed and manufactured by DexCom: a DexCom Sensor, a DexCom BT CGM Transmitter, DexCom Sensor Information, the Communication Protocol, a DexCom Receiver, and the DexCom CGM Smartphone App. |
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1.7. |
“DexCom Receiver” means a component of the DexCom G5 System that identifies, receives, deciphers and displays information transmitted by a DexCom BT CGM Transmitter from a DexCom Sensor, and also enables control of the DexCom Transmitter by receiving and transmitting data to the DexCom G5 System, such as configuration settings and calibration values. |
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1.8. |
“DexCom Sensor” means the component of the DexCom G5 System comprising a continuous glucose monitoring electrode sensor, adapted to (i) penetrate the patient’s skin to come into contact with the patient’s interstitial fluid, (ii) measure interstitial fluid glucose level, and (iii) be operably coupled to a DexCom BT CGM Transmitter to communicate the blood glucose value as measured by the DexCom Sensor to a separate receiver. |
2.
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agreed in writing by both parties or shall be the result of DexCom’s updating of the Specification, which shall be permitted without requiring compliance with Section 10.7. The term “DexCom Sensor Information” shall in no way be construed to include the Raw Data. |
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1.10. |
“Effective Date” is the date set forth in the preamble above. |
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1.11. |
"Integrated System" shall mean a Tandem System that implements the Communication Protocol and is capable, among other things, of receiving and displaying continuous glucose monitoring data generated by the DexCom G5 System. |
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1.12. |
"Intellectual Property Rights" means (collectively): copyright rights (including, without limitation, the exclusive right to use, reproduce, modify, distribute, publicly display and publicly perform the copyrighted work), trademark rights (including, without limitation trade names, trademarks, service marks, and trade dress), patent rights (including, without limitation, the exclusive right to make, have made, import, use, sell and offer to sell), trade secrets, rights of publicity, authors’ and moral rights, goodwill and all other intellectual and industrial property rights as may exist now and/or hereafter come into existence and all renewals, reissues and extensions thereof, regardless of whether such rights arise under the laws of the United States or any other U.S. state or other country or jurisdiction. |
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1.13. |
“Raw Data” means any raw data used by the DexCom G5 System or any other data generated or stored by the DexCom G5 System that is not included in the definition of DexCom Sensor Information. |
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1.15. |
“Tandem Insulin Infusion Pump” means a subcutaneous infusion pump for insulin delivery, either alone or together with other medicaments. |
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1.16. |
“Tandem System” means a subcutaneous infusion system comprised of the following components: a Tandem Insulin Infusion Pump and a Tandem Display Device. |
3.
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Device shall not interfere with the ability of the DexCom BT CGM Transmitter to remain paired and communicate with the DexCom CGM Smartphone App at all times, notwithstanding any pairing with the Tandem System. |
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2.2. |
DexCom Responsibilities. At DexCom’s sole cost, DexCom intends to develop a DexCom G5 System. DexCom shall be solely responsible for all design, development, regulatory and commercialization activities associated with such DexCom G5 System. Upon completion of such development, DexCom will provide Tandem with a communication protocol that permits a DexCom CGM-Enabled Tandem Display Device to identify, receive and display DexCom Sensor Information and to control the DexCom BT CGM Transmitter (the “Communication Protocol”). Upon request, DexCom agrees to provide commercially reasonable assistance in response to questions from Tandem to facilitate Tandem’s implementation of the Communication Protocol. In addition, if reasonably necessary for Tandem to secure regulatory approval for the commercialization of a Tandem System, or a component thereof, DexCom agrees to permit Tandem to reference DexCom’s own regulatory filings for the DexCom G5 System. |
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2.3. |
Costs. Each party shall bear its own costs. |
3. |
Ownership & License |
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3.1. |
Ownership. The parties do not intend for there to be any “joint inventions” under this Agreement and, except as set forth in Section 3.2, this Agreement does not comprise an assignment or license of any intellectual property, trade secrets or confidential information by either party to the other. DexCom (and/or its Affiliates) will own and retain their Intellectual Property Rights. Tandem (and/or its Affiliates) will own and retain their Intellectual Property Rights. |
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3.2. |
License. DexCom hereby grants Tandem a royalty-free, worldwide, non-exclusive license to (i) use the Communication Protocol for the purpose of developing and commercializing a DexCom CGM-Enabled Tandem Display Device, including the right to make, have made, use, sell, offer to sell, have sold and import the DexCom CGM-Enabled Tandem Display Device; and (ii) use the trademarks, trade names and other marketing names used by DexCom for the DexCom G5 System solely in connection with Tandem’s advertising, promotion, marketing and sale of the Tandem System, and in related brochures and other materials, in full accordance with all guidelines and instructions as DexCom may deliver to Tandem from time to time in DexCom’s sole discretion. |
4.
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intercept, propagate, reverse engineer, disassemble, de-encrypt, or derive the source code for the software or bios included in any DexCom G5 System, or any component thereof. Tandem is not granted any right to the Raw Data received or generated by any DexCom G5 System and/or used by it to produce output such as timestamps, measurements or other data, and will not try to derive, de-encrypt or intercept any of such Raw Data. Tandem shall not access or use any information within the DexCom G5 System other than the information contained in the Specification. Tandem shall be prohibited from using the Communication Protocol for any purposes other than as set forth in this Agreement. DexCom shall not access or use any information within the Tandem System other than as set forth in this Agreement. |
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3.4. |
No Other Restrictions. For the avoidance of doubt, except as expressly agreed by the parties in writing, (i) DexCom will not be restricted from distributing, licensing, transferring, or otherwise exploiting the DexCom G5 System or any component thereof, or any Intellectual Property Rights therein, and (ii) Tandem will not be restricted from distributing, licensing, transferring, or otherwise exploiting the Tandem System or any component thereof, or any Tandem Intellectual Property Rights therein. |
4. |
Commercialization |
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4.1. |
DexCom shall have sole discretion to decide whether to complete development of and commercialize the DexCom G5 System and shall be under no obligation to complete such development or commercialization as a result of this Agreement. |
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4.2. |
Tandem shall have sole discretion to decide whether to complete development of and commercialize a version of the Tandem System comprising a DexCom CGM-Enabled Tandem Display Device and shall be under no obligation to complete such development or commercialization as a result of this Agreement. Tandem and DexCom will use commercially reasonable efforts to develop a mutually acceptable written plan to provide training and customer and technical support for any mutual customers prior to Tandem’s submission of any application to regulatory authorities to secure regulatory approval for the commercialization of a DexCom CGM-Enabled Tandem Display Device. |
5.
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4.4. |
Tandem hereby acknowledges that DexCom may discontinue its support of the DexCom G5 System [***]. DexCom agrees to [***]. Tandem further acknowledges that DexCom has no obligation to [***]. |
6.
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6.1.1. |
was already known to the Receiving Party, other than under an obligation of confidentiality, at the time of disclosure; |
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6.1.2. |
was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving party; |
7.
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expenses (including without limitation, reasonable attorneys’ fees and litigation costs) (collectively, “Losses”) payable to third parties in connection with such claims, suits and proceedings, to the extent arising from or occurring as a result of: (i) DexCom’s breach of the [***], (ii) the [***], or (iii) physical injury (including death) and/or property damage [***], excluding [***]. |
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7.3. |
If the manufacture or use of the Integrated System results in a claim, suit or proceeding in which DexCom and Tandem are both entitled to indemnification by the other party pursuant to Sections 7.1 and 7.2, then the parties will discuss in good faith their cooperation in connection with such matter, and shall discuss in good faith an equitable allocation of each party’s indemnification obligations under this Section 7. |
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7.4. |
If the manufacture or use of the Integrated System results in a third-party claim, suit, allegation, action or proceeding against Tandem or DexCom alleging infringement of a claim of a patent or alleges infringement or misappropriation of some other intellectual property right of such third party and neither DexCom nor Tandem is entitled to indemnification pursuant to Sections 7.1 and 7.2 (an "Integrated System Infringement Action"), such party will promptly notify the other party in writing. The parties will [***]and [***] of any Integrated System Infringement Action. The parties will [***] concerning any Integrated System Infringement Action and, in the [***] that the [***], the parties [***]. |
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7.5. |
Any party seeking indemnification hereunder (the “Indemnitee”) will promptly notify the indemnifying party (the “Indemnitor”) of any claim, loss, or expense likely to lead to a claim for indemnification, along with all material related information. The Indemnitor will [***], except that [***]. The Indemnitee may [***]. The Indemnitee will [***]. The Indemnitee may [***]. In addition, the Indemnitee may [***]. |
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7.6. |
Notwithstanding the foregoing, an Indemnitor under this Section 7 has no obligation for any Losses to the extent resulting from (i) [***], or (ii) [***]. |
8.
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additional one (1) year periods, unless either party notifies the other at least ninety (90) days prior to the expiration of the then current term (the total period during which this Agreement is effective being the “Term”). |
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8.3. |
Effect of Termination. |
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8.3.2. |
Survival. In addition, Articles 1, 3.1, 3.3, 3.4, 4.4, 5, 6, 7, 8, 9 and 10 will survive expiration or termination of this Agreement. Further, Section 3.2 will survive expiration or termination of this Agreement to the extent reasonably necessary for Tandem to satisfy ongoing warranty obligations and to provide ongoing service and support to any customer who originally acquired a DexCom CGM-Enabled Tandem Display Device during the Term of this Agreement. |
EXCEPT WITH RESPECT TO A BREACH OF AN OBLIGATION UNDER SECTION 6 OR 10.7, OR CLAIMS REQUIRING INDEMNIFICATION PURSUANT TO SECTIONS 7.1, 7.2, 7.3 OR 7.4, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER OR ANY OTHER ENTITY FOR COSTS OF PROCUREMENT OF SUBSTITUTE GOODS, LOST PROFITS, OR ANY OTHER SPECIAL, CONSEQUENTIAL, OR INCIDENTAL DAMAGES, HOWEVER CAUSED AND UNDER ANY THEORY OF LIABILITY ARISING OUT OF THIS AGREEMENT WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE. THESE LIMITATIONS SHALL APPLY WHETHER OR NOT THE BREACHING PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY PROVIDED HEREIN.
IF EITHER PARTY TERMINATES THIS AGREEMENT IN ACCORDANCE WITH ANY OF ITS PROVISIONS, NEITHER PARTY SHALL BE LIABLE TO THE OTHER, BECAUSE OF SUCH TERMINATION, FOR COMPENSATION, REIMBURSEMENT OR DAMAGES ON ACCOUNT OF THE LOSS OF PROSPECTIVE PROFITS OR
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ANTICIPATED SALES OR ON ACCOUNT OF EXPENDITURES, INVENTORY, INVESTMENTS, LEASES OR COMMITMENTS IN CONNECTION WITH THE BUSINESS OR GOODWILL OF TANDEM OR DEXCOM.
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Tandem: |
Tandem Diabetes Care |
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00000 Xxxxxxx Xx. |
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Xxx Xxxxx, XX 00000 |
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Attn: Chief Executive Officer |
10.
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10.7. |
Standstill. Except as permitted by the last sentence of this Section 10.7, during the Term of this Agreement and for a period of twelve (12) months thereafter, without the prior written consent of the Board of Directors of Tandem, DexCom and its officers, directors and Affiliates, will not directly or indirectly in any manner: (i) acquire, announce an intention to acquire, or agree to acquire, directly or indirectly, alone or in concert with others, by purchase, gift or otherwise, any direct or indirect beneficial ownership (within the meaning of Rule 13d-3 under the Securities Exchange Act of 1934 (the “Exchange Act”)) or interest in any securities or direct or indirect rights, warrants or options to acquire, or securities convertible into or exchangeable for, any securities of Tandem (ii) make, or in any way participate in, directly or indirectly, alone or in concert with others, any “solicitation” of “proxies” to vote (as such terms are used in the proxy rules of the SEC promulgated pursuant to Section 14 of the Exchange Act) any securities of Tandem with respect to any business combination, restructuring, recapitalization or similar transaction; (iii) form, join or in any way participate in a “group” within the meaning of Section 13(d)(3) of the Exchange Act with respect to any voting securities of Tandem; (iv) acquire, announce an intention to acquire, or agree to acquire, directly or indirectly, alone or in concert with others, by purchase, exchange or otherwise, (a) any of the assets, tangible or intangible, of Tandem or (b) direct or indirect rights, warrants or options to acquire any assets of Tandem, other than in the ordinary course of business; (v) enter into any arrangement or understanding with, or otherwise assist or encourage, others to do any of the actions restricted or prohibited under clauses (i), (ii), (iii) or (iv) of this Section 10.7; (vi) otherwise act in concert with others, to seek to offer to Tandem or any of its stockholders any business combination, restructuring, recapitalization or similar transaction to or with Tandem, or (vii) take any action to control the management, Board of Directors or policies of Tandem. Notwithstanding the above, cumulative acquisitions by DexCom, including any Affiliate of DexCom, of less than one percent (1%) of Tandem's outstanding common shares shall not be deemed a breach of this provision. |
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10.8. |
Modifications. No amendment or modification of any provision of this Agreement will be effective unless in writing signed by all parties hereto. No provision of this |
11.
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Agreement will be varied, contradicted or explained by any oral agreement, course of dealing or performance or any other matter not set forth in an agreement in writing and signed by all parties. |
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10.10. |
Governing Law. This Agreement and any dispute arising from the performance or breach hereof will be governed by and construed and enforced in accordance with, the laws of the State of Delaware without regard for conflicts of laws principles. |
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10.11. |
Counterparts. This Agreement may be executed in two or more counterparts, each of which will be deemed an original, and all of which together, will constitute one and the same instrument. |
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10.12. |
Headings. Headings used herein are for convenience only and will not in any way affect the construction of or be taken into consideration in interpreting this Agreement. |
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10.13. |
Entire Agreement. This Agreement, including the Attachments attached hereto, constitutes the entire agreement with respect to the subject matter hereof, and supersedes all prior or contemporaneous understandings or agreements, whether written or oral, between DexCom and Tandem with respect to such subject matter. For the avoidance of doubt, DexCom and Tandem acknowledge and agree that this Agreement does not terminate, amend or otherwise modify either (i) the Amended and Restated Development and Commercialization Agreement between the parties dated as of January 4, 2013 or (ii) the G6 Development Agreement between the parties entered into concurrently with this Agreement. |
[Signature Page Follows]
12.
Exhibit 10.1
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be signed by duly authorized officers or representatives as of the date first above written.
DexCom, Inc. By: /s/ Xxxxx Xxx for Xxxx Xxxxx Title: Senior Vice President and Chief Financial Officer Date: June 4, 2015
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Tandem Diabetes Care, Inc. By: /s/Xxx X. Xxxxxxxxxxxx Print Name: Xxx X. Xxxxxxxxxxxx Title: President and CEO Date: June 4, 2015 |