Amendment No. 1 (hereinafter the “Amendment No. 1”) to the Technology Transfer, Clinical Supply Agreement dated October 23, 2012, (hereinafter the “Agreement”)
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Exhibit 10.12
Amendment No. 1
(hereinafter the “Amendment No. 1”)
to the Technology Transfer, Clinical Supply Agreement
dated October 23, 2012,
(hereinafter the “Agreement”)
between
000 Xxxxxxxxx Xxxxx
Xxxxx 000
Xxxxxxx Xxxxxx, XX XXX 00000
(hereinafter called “VERSARTIS”)
and
Boehringer Ingelheim RCV GmbH & Co KG
[*]
(hereinafter called “BI RCV”).
Preamble
Whereas, the Agreement has been concluded between VERSARTIS and BI RCV regarding the manufacture of VRS-317.
Whereas, the Parties intend on continuing their good relationship and are now desirous to perform additional cGMP fill and finish and drug substance services under the
1.
Agreement, but the Services anticipated under the Agreement did so far only cover the certain manufacture of VRS-317 as bulk drug substance.
Therefore, the Parties agree that hereby (i) BI RCV shall provide such additional cGMP fill and finish work as described in this Amendment No. 1; and (ii) the Appendices 1 through 8 of the Agreement shall be updated to reflect these additional cGMP fill and finish and additional bulk drug substance services.
| 1. | The Parties agree that Appendix 2 (“Project Plan (BI Services and Prices)”) as attached to the Agreement shall be updated and be replaced in its entirety by Exhibit B to this Amendment No. 1 (“Project Plan (BI Services and Prices)”), which shall become the new Appendix 2 to the Agreement. |
| 2. | The Parties agree that the fill & finish and additional drug substance services set forth in Appendix 2 are considered part of the Services and firmly ordered. The Parties shall agree on the timelines for the cGMP manufacture of drug product set forth in such Appendix 2 in good faith after signature of this Amendment No. 1. VERSARTIS acknowledges and agrees that the manufacture of drug product according to Appendix 2 is under the condition precedent that sufficient drug substance is available at BI RCV. |
| 3. | Equally, the Parties agree that Appendices 1, 3, 4, 5, 6 and 8 as attached to Agreement shall be updated and be replaced in their entirety by Exhibits A, C, D, E, F and H to this Amendment No. 1, which shall become the new Appendices 1, 3, 4, 5, 6 and 8, respectively. |
| 4. | The Quality Agreement (QA, Exhibit G), as updated November 20, 2013 shall replace the existing Appendix 7 in its entirety. |
| 5. | This Amendment No. 1 shall take effect as of October 1, 2013 (“Effective Date”) and as far as not amended herein, the Agreement remains in full force and effect and - for the avoidance of doubt - all terms and conditions, as far as not amended herein, shall apply to the manufacture of Product in the form of drug product accordingly. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
2.
Xxxxxx, 00 Jan, 2014
Boehringer Ingelheim RCV GmbH & Co KG
| i.V. | ppa. | |||
| [*] |
[*] | |||
| [*] |
[*] | |||
Redwood Shores, CA, 14 Dec, 2013
| /s/ Xxxxxxx Xxxxxxx |
| Xx. Xxxxxxx Xxxxxxx |
| CEO |
List of Exhibits:
| Exhibit A: | [*] and Versartis Deliverables (incl. Requirements for Versartis Deliverables) and assumptions | |
| Exhibit B: | Project Plan (BI Services and Prices) | |
| Exhibit C: | Project Timeline | |
| Exhibit D: | Payment Schedule | |
| Exhibit E: | [*] agreed by the Parties (to be attached upon agreement of the Parties) | |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
3.
| Exhibit F: | Members of the Project Team, Steering Committee and Chief Executive Officers | |
| Exhibit G: | Quality Agreement (to be added) | |
| Exhibit H: | Testing of [*] from Versartis | |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
4.
Exhibit A:
[*] and Versartis Deliverables (incl. Requirements for Versartis Deliverables) and assumptions
[*]
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
5.
Exhibit B: Project Plan (BI Services and Prices)
Remark: “(done)” means work completed by BI RCV, invoiced to Versartis
| Price |
Activities / Services included |
Price [Euro] | BI RCV deliverables | |||||
| [*] |
• [*] |
[* | ] | • [*] | ||||
[*]
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
6.
Exhibit C: Project Plan and Timeline
[*]
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
7.
Exhibit D: Payment schedule
[*]
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
8.
Exhibit E: [*] agreed by the Parties (to be attached upon agreement of the Parties)
[*]
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
9.
Exhibit F: Members of the Project Team, Steering Committee and Chief Executive Officers
| Project Manager BI RCV |
Versartis | |||
| [*] | [*] | |||
| Project Team BI RCV |
Versartis | |||
| [*] | [*] | |||
| Steering Committee BI RCV |
Steering Committee Versartis | |||
| [*] | [*] | |||
Further participants from BI RCV in SCs: [*].
Further participants from Versartis in SCs: [*]
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
10.
Exhibit G: Quality Agreement
Quality agreement to be attached.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
11.
Exhibit H: Testing of [*] from Versartis
| Method |
Specification | |
| [*] | [*] |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
12.
