DEVELOPMENT AGREEMENT
Exhibit 10.5
[***]: 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 G6 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 G6 System that is configured to transmit information from a DexCom Sensor via 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 |
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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 G6 System. |
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1.5. |
DexCom CGM Smartphone App” means the smartphone application component of the DexCom G6 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 G6 System, such as configuration settings and calibration values. |
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1.6. |
“DexCom G6 System” means DexCom’s sixth 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 G6 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 G6 System, such as configuration settings and calibration values. |
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1.8. |
“DexCom Sensor” means the component of the DexCom G6 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. |
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1.9. |
“DexCom Sensor Information” consists of a DexCom BT CGM Transmitter interface spec that specifies contents of the transmitter broadcast message and the available control functions (the “Specification”). The transmitter broadcast message will contains items such as estimated glucose value, device display time stamp information, the trend arrow and calibration confidence intervals as stored in the DexCom BT CGM Transmitter. The control functions provide the commands required to start session, stop session and calibrate. Any additional sensor information to be shared must be 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. |
2.
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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 G6 System or any other data generated or stored by the DexCom G6 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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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 G6 System. |
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(c) |
Costs. Each party shall bear its own costs. |
III. |
Ownership & License |
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(a) |
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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(b) |
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 G6 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. |
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(c) |
Limitations on Use. Tandem agrees not to distribute, license, sublicense or otherwise transfer the Communication Protocol to any third party. Tandem shall have no right under this Agreement to in any way distribute the Communication Protocol, or to intercept, propagate, reverse engineer, disassemble, de-encrypt, or derive the source code for the software or bios included in any DexCom G6 System, or any component thereof. Tandem is not granted any right to the Raw Data received or generated by any DexCom G6 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 G6 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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(d) |
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, |
4.
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transferring, or otherwise exploiting the DexCom G6 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. |
IV. |
Commercialization |
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(a) |
DexCom shall have sole discretion to decide whether to complete development of and commercialize the DexCom G6 System and shall be under no obligation to complete such development or commercialization as a result of this Agreement. |
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(b) |
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. |
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(d) |
Tandem hereby acknowledges that DexCom may discontinue its support of the DexCom G6 System [***]. DexCom agrees to[***]. Tandem further acknowledges that DexCom has no obligation to[***]. |
5.
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A. |
was already known to the Receiving Party, other than under an obligation of confidentiality, at the time of disclosure; |
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B. |
was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving party; |
6.
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(c) |
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. |
7.
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[***] 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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(e) |
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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(f) |
Notwithstanding the foregoing, an Indemnitor under this Section 7 has no obligation for any Losses to the extent resulting from (i)[***], or (ii)[***]. |
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(c) |
Effect of Termination. |
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B. |
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. |
8.
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 ANTICIPATED SALES OR ON ACCOUNT OF EXPENDITURES, INVENTORY, INVESTMENTS, LEASES OR COMMITMENTS IN CONNECTION WITH THE BUSINESS OR GOODWILL OF TANDEM OR DEXCOM.
9.
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obligations on behalf of or in the name of any other party or to bind any other party to any contract, agreement or undertaking with any third party. |
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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 |
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0000 Xxxxxxxx Xxxxx |
10.
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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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(j) |
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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(k) |
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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(l) |
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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(m) |
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 G5 Development Agreement between the parties entered into concurrently with this Agreement. |
[Signature Page Follows]
11.
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. |
Tandem Diabetes Care, Inc. |
By: /s/ Xxxxx Xxx for Xxxx Xxxxx |
By: /s/ Xxx X. Xxxxxxxxxxxx |
Xxxx Xxxxx |
Print Name: Xxx X. Xxxxxxxxxxxx |
Title: Senior Vice President |
Title: President & Chief Executive Officer |
and Chief Financial Officer |
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Date: June 4, 2015 |
Date: June 4, 2015 |