AMENDMENT NO. 1 TO AMENDED AND RESTATED DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

Tandem and DexCom have previously entered into that certain Amended and Restated Development and Commercialization Agreement, effective January 4, 2013 (as amended, the “Agreement”), pursuant to which the parties agreed to collaborate on development and commercialization of an Integrated System; and

The parties desire to amend the Agreement as set forth herein.  

The Agreement is hereby amended as follows:

The heading for Section 3.3 is hereby amended and restated in its entirety to read:  “Intellectual Property License; Marketing Fund.”

Section 3.3.2 is hereby amended and restated in its entirety as set forth below:

The parties mutually acknowledge and agree that they have been informed of the regulatory plan to seek and maintain regulatory approval of the Integrated System in the United States, but as of the date hereof have not developed a written Regulatory Plan as contemplated by Section 4.1 of the Agreement.

The parties mutually agree that Section 7.2.2 is amended and restated in its entirety as follows: “Tandem and DexCom agree to establish a process by which Tandem will deliver the Integrated System and DexCom will deliver Sensors and Transmitters to a customer. [***].”

In satisfaction of the provisions of Section 7.4, the parties hereby mutually agree that they have each previously reviewed and approved the warranties provided in the user manual accompanying the Integrated Device as included in the initial Regulatory Approval. The warranties actually included in such user manual shall supercede any warranties provided in Exhibit E of the Agreement, and Exhibit E is hereby deleted and removed, and shall be of no further force or effect.

In accordance with the provisions of Section 7.5.1, the parties hereby confirm that they have mutually agreed to use “t:slim G4” as the primary brand name for the Integrated System.” Dexcom further acknowledges that it has previously reviewed and approved the final configuration of the Integrated System and packaging as contemplated by the initial Regulatory Approval for the product, and hereby: (i) confirms that the Integrated System and packaging thereof as included in the initial Regulatory Approval satisfied the requirements of second sentence of Section 7.5.1(a); and (ii) waives the requirements under Section 7.5.1(a) to display a DexCom trademark as contemplated thereby.  

The last sentence of Section 7.5.2 is hereby amended and restated in its entirety as follows:  “Any newly created Marketing Materials will be presented to a DexCom designated representative at least once each calendar quarter for review to confirm compliance with this section.”

The parties confirm that they previously mutually agreed to a Commercial Launch Date of September 24, 2015 as contemplated by Section 7.6.1.

The parties mutually agree that Section 7.6.4 is amended and restated in its entirety as follows:  “Tandem and DexCom agree to establish a process by which Tandem will promptly deliver to DexCom information regarding customers that are shipped an Integrated System on a direct basis to facilitate DexCom’s supply of Sensors and Transmitters to such customer. Customers that receive an Integrated System through an authorized third party distributor are expected to also receive supplies of Sensors and Transmitters through the same distributor, and information for those customers will not be provided by Tandem to Dexcom. Further details of this process will be mutually agreed by the parties.”

The last two sentences of Section 7.10.1 and Exhibit F to the Agreement are hereby deleted and removed and shall be of no further force or effect.

The following sentence is hereby added at the end of Section 7.7.1:  “Promptly following FDA Approval of the Integrated System, DexCom shall provide Tandem with Sensors and Transmitters [***] to be used for training as follows: 

The following is hereby added as a new Section 7.7.5:  “7.7.5.  DexCom, [***], shall make its patient care team reasonably available to provide additional training regarding the Sensors and Transmitters to Integrated System customers requiring additional assistance.”

Exhibit G of the Agreement is removed and deleted, and of no further force and effect, and Section 11.1.1 of the Agreement is hereby amended and restated in its entirety as follows: “On or before the Commercial Launch Date, the parties shall enter into a form of Quality Agreement related to the Integrated System and Sensors and Transmitters. The Quality Agreement may be amended from time to time by mutual written agreement of the parties.”

This Amendment No. 1 may be executed in two or more counterparts, each of which shall be deemed an original but all of which together shall be considered one and the same agreement, it being understood that all parties need not sign the same counterpart. The exchange of copies of this Amendment No. 1 and of signature pages by facsimile transmission or by email transmission in portable document format, or similar format, shall constitute effective execution and delivery of such instrument(s) as to the parties and may be used in lieu of the original Amendment No. 1 for all purposes.

Except as provided herein, all other terms, conditions and provisions of the Agreement shall remain in full force and effect.

This Amendment No. 1 and the Agreement, including all documents referred to herein and attached hereto, constitutes the entire agreement of the parties on the subject matter hereof and supersedes all prior representations, understandings and agreements between the parties with respect to such subject matter.