SERVICES AGREEMENT
Exhibit 10.15
THIS SERVICES AGREEMENT (“Agreement”), is made and entered into as of February 27th, 2018 (“Effective Date”), by and between:
X. Xxxxxx Healthcare Corporation, a company duly organized under the laws of Delaware, having a place of business at Xxx Xxxxxx Xxxxxxx, Xxxxxxxxx, XX 00000 (“Baxter”); and
2. Regentis Biomaterials Ltd., a company duly organized under the laws of Israel with its principal place of business at 00 Xx’xxxx, Xxxxxxxx Xxxxxxxxxx Xxxx, X.X.Xxx 260, Or-Akiva, 3060000, Israel (“Regentis”).
Each of Baxter and Regentis shall sometimes be referred to as a “Party” and collectively, as the “Parties”.
WHEREAS, Baxter and Teva Medical (Marketing) Ltd. (“Teva”) are parties to a Distribution Agreement dated January 21, 1998 (“Distribution Agreement”) pursuant to which Teva is Xxxxxx’x exclusive agent in Israel for distribution of certain products, including Xxxxxx’x Tisseel products; and
WHEREAS, Baxter, Regentis and Teva entered into a supply agreement dated July 15, 2008, which was amended and restated on January 6, 2009, (the “Supply Agreement”) for supply of Tisseel to Regentis for manufacture of Regentis’s product for animal and human clinical research use and clinical studies (the “Regentis Clinical Product”); and
WHEREAS, Regentis intends to purchase, from Teva, Tisseel for manufacture of Regentis’s product for commercial promotion and sale (the “Regentis Commercial Product”); and
WHEREAS, Regentis wishes to obtain from Xxxxxx, and Xxxxxx wishes to provide, certain services in connection with the supply of Tisseel for the Regentis Commercial Product, and the Parties wish to otherwise agree on certain rights and responsibilities pertaining to such supply.
NOW, THEREFORE, in consideration of the mutual promises and covenants set forth herein the Parties hereby agree as follows:
| 1. | The Supply Agreement will continue to govern the Parties’ rights and responsibilities concerning Xxxxxxx used in the Regentis Clinical Product. This Agreement will govern the Parties’ rights and responsibilities concerning Xxxxxxx used in the manufacture of the Regentis Commercial Product. This Agreement imposes no obligation on Baxter to supply Tisseel to Regentis for the Regentis Commercial Product, via the Distribution Agreement or otherwise. This Agreement imposes no obligation on Regentis to purchase Tisseel from Baxter or Teva for the Regentis Commercial Product. |
| 2. | The term of this Agreement shall commence on the Effective Date and shall remain in full force and effect for five (5) years (the “Initial Term”). Thereafter, this agreement shall renew automatically for further consecutive terms of five (5) years each (the Initial Term collectively with each additional term shall be referred to as the “Term”), unless either Party desires to terminate this agreement by written notice at least two (2) years in advance. Either Party may terminate this Agreement thirty (30) days after written notice to the other Party of a material breach of the Agreement by such other Party, unless such breach is cured within such thirty (30) day period. |
| 3. | The Parties have executed a Quality Agreement dated February 27th, 2018 that is attached as Exhibit A and hereby incorporated by reference into this Agreement. |
| 4. | (a) From time to time as reasonably requested by Regentis and approved by Xxxxxx, Xxxxxx shall provide to Regentis the quality, regulatory, and technical support set forth in the Quality Agreement for the Regentis Commercial Product, up to a maximum aggregate of forty (40) man-hours per calendar year for all such support. In consideration of receipt and availability of such support, Regentis shall pay Baxter $60,000 per year until such time that Regentis receives FDA approval to market the Regentis Commercial Product in the U.S. Thereafter, Regentis shall pay Baxter $200,000 per year during the Term of this Agreement. For the avoidance of doubt, such payments are due regardless of whether Regentis actually requests any support and/or purchases any Tisseel in a particular year. The first such payment shall be due thirty (30) days after the Effective Date, with such payment and corresponding support being pro-rated for the period of the calendar year remaining. Thereafter, such payments are due by January 15 each year except that in the year that Regentis receives FDA approval to market the Regentis Commercial Product in the U.S., Regentis shall pay the $140,000 balance for that year within thirty (30) days after such approval. (b) For any quality, regulatory, or technical support reasonably requested by Xxxxxxxx and approved by Baxter in its sole discretion beyond forty (40) man-hours in any calendar year, Regentis will pay Baxter $2,500 per man-hour. Baxter will issue invoices for any such additional support monthly, and payments are due thirty (30) days from the invoice date. |
| 5. | In connection with the support services provided by Baxter under this Agreement, including the Quality Agreement, Baxter may disclose confidential and/or proprietary information to Regentis (“Confidential Information”). Absent Xxxxxx’x written consent Regentis shall not disclose Confidential Information to third parties. Regentis may use Confidential Information as necessary to secure and maintain regulatory approval for the Regentis Commercial Product, including, notwithstanding the preceding sentence, disclosing Confidential Information to an appropriate regulatory body; provided that: (i) Regentis may not use Confidential Information for any other purpose; and (ii) if such use/disclosure would make any Confidential Information publicly available, Regentis must first obtain Xxxxxx’x written consent. |
| 6. | Baxter shall have no liability to Regentis whatsoever in connection with Xxxxxxxx’s purchase of Tisseel from Teva, for third party claims or otherwise. Xxxxxx’x sole liability to Regentis under this Agreement and the Quality Agreement shall be the re-performance of any service improperly rendered. IN NO EVENT XXXX XXXXXX BE LIABLE TO REGENTIS FOR LOST PROFITS OR FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES ARISING FROM OR IN CONNECTION WITH THIS AGREEMENT. |
| 7. | Regentis shall defend, indemnify, and hold harmless Baxter, its successors, assigns, affiliates, directors, officers, agents, and employees (collectively, “Indemnitees”) from and against any and all liabilities, losses, damages, and expenses (including attorneys’ fees) resulting from claims, demands, costs or judgments allegedly or actually arising out of or relating to Regentis’s purchase and use of Tisseel and/or the purchase, possession manufacture, packaging, distribution use, testing, sale, offer for sale, or other distribution of the Regentis Commercial Product. |
2
| 8. | If at any time during the Term, Xxxxxxxx decides in good faith to commence negotiations with any third party for the acquisition of all or substantially all of Regentis’s stock or assets, Regentis shall provide a written notice to Baxter at least ten (10) business days in advance of commencing such negotiations. |
| 9. | This Agreement together with the Quality Agreement constitutes the entire agreement between the Parties relating to the subject matter herein, and all prior proposals, discussions and writings by and between the Parties relating to the subject matter herein are superseded hereby. None of the terms of this Agreement shall be deemed to be waived by either Party or amended unless such waiver or amendment is written and signed by both Parties. |
| 10. | In the event any portion of this Agreement is declared void or invalid by a court or tribunal of competent jurisdiction, such provision shall be modified or severed from this Agreement, and the remaining provisions shall remain in effect unless the effect of such severance would be to alter substantially this Agreement or the obligations of the Parties, in which case this Agreement may be immediately terminated. |
| 11. | This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, without reference to any rules of conflict of laws. This Agreement shall not be construed against the party preparing it but shall be construed as if the parties jointly prepared it. |
| 12. | This Agreement shall not be assignable without the prior written consent of the other Party, which consent shall not be unreasonably withheld, except that Baxter may assign the Agreement in connection with a transfer of the business to which this Agreement pertains or to a parent corporation or affiliate under common ownership. |
| 13. | All notices to either Party hereunder shall be in writing and shall be deemed to have been duly given if delivered personally to such Party or sent to such Party by email or by facsimile transmission with confirmation of receipt or by registered or certified mail, postage prepaid to the addresses listed above |
Communication between Parties shall be to the following:
| To Baxter | To Regentis: | ||
| Xxxxxxx Xxxx | Xxxxxxxx Xxxxxx | ||
| Senior Director, US Market Development | President & CEO | ||
| Xxxxxx Healthcare Inc. | Regentis Biomaterials, Ltd | ||
| Tel: 000 000 0000 | Tel: 000 000 00000 | ||
| email: Xxxxxxx.xxxx@xxxxxx.xxx | email: xxxxxxx@xxxxxxxx.xx.xx |
Or to such other individuals as the Parties provide notice of.
3
| 14. | This Agreement may be executed by the Parties hereto in separate counterparts, each of which when so executed and delivered shall be deemed an original and all of which counterparts taken together shall constitute but one and the same instrument. |
IN WITNESS WHEREOF, the Parties have signed this Agreement as of the Effective Date,
| Regentis Biomaterials Ltd. | Xxxxxx Healthcare Corporation | |||
| By: | /s/ Xxxxxxxx Xxxxxx | By: | Xxx Xxxxx | |
| Name: | Xxxxxxxx Xxxxxx, Ph.D. | Name: | Xxx Xxxxx | |
| Title: | President & CEO | Title: | President, Advanced Surgery | |
| Date: | February 27th, 2018 | Date: | 3/1/18 | |
4
Exhibit A
Quality Agreement
5
Baxter
QUALITY AGREEMENT
This Quality Agreement this “Agreement” is by and between Regentis Biomaterials Ltd., hereafter referred to as “Regentis”, and Xxxxxx Healthcare Corporation, hereafter referred to as “Baxter”, either of which may be referred to as a “Party” or together as “Parties.”
Whereas. Baxter and Regentis have entered into a Services Agreement with an Effective Date of February 27th, 2018 (the “Services Agreement”) regarding certain services that Baxter will provide to Regentis in connection with Regentis’s purchase of Xxxxxx’x TISSEEL product (the “Product”) from Xxxxxx’x Israeli distributor, Teva Medical (Marketing) Ltd. (“Teva”), for manufacture of Regentis’s product for commercial promotion and sale; and
Whereas, the Parties wish to define the quality support that Baxter will provide to Regentis under the Services Agreement in this Quality Agreement.
| 1. | Quality Control/Assurance: |
| a. | Conformance to Specifications: All Product that Baxter supplies to Teva shall meet the Baxter Product Specifications. |
| b. | Compliance to Regulations: In connection with the manufacture and sale of TISSEEL, Baxter shall comply with both applicable EU and FDA regulations (as per 21 CFR211 and 21 CFR 600-680), |
| c. | Verification of Product Specifications: Regentis may inspect the Product for integrity and confirm adherence to the Baxter Product Specifications and Certificate of Analysis. If the Product fails to conform to the Baxter Product Specifications, Regentis may pursue available remedies, if any, from Teva. Regentis will have no right to any remedy from Baxter. |
| d. | Batch Documentation: Baxter will provide to Teva, with each released Product batch, a Certificate of Analysis (the “COA”) and a Certificate of Conformance (the “COC”) for the Product. |
| e. | Testing Methodology: Upon Regentis’s request, Baxter may provide the appropriate testing methodology used to establish the relevant specifications in the COA (e.g. total protein, clottable protein, etc.) so that Regentis shall be able to internally validate the COA,; provided, however, at the time of Regentis’ request, Baxter shall review the testing methodology for the Product to determine if any of the requested testing methodology is proprietary in nature. If such testing methodology is deemed by Baxter, in its sole discretion, to be proprietary, Baxter will, at that time, determine what information may be provided to Regentis. The Parties reserve the right to determine alternatives to the testing procedure (e.g. utilization of appropriate third-party testing services, licensing agreements, and the like.) |
| f. | Change Control: Regentis may request, up to three (3) times per year, identification of any changes made to TISSEEL or its manufacturing process since the last request which required submission or notification to various regulatory authorities regarding the Sealer Protein component of TISSEEL. Such request may be sent to the Contacts identified in Section 6 below. |
| 2. | Regulatory
Activities: Baxter will notify Teva of any recalls or withdrawals of Product sold
to Teva.
In accordance with, and subject to the limitations set forth in, the Services Agreement, Baxter will provide reasonable assistance to Regentis to support and address quality issues and/or regulatory filings when requested by Regentis.
Regentis will not be permitted to audit Baxter, but Baxter will assist Regentis by providing certifications or regulatory inspection results (i.e. Memo) to satisfy such regulatory requests, when requested by such regulatory authority. |
Page
1|2
Confidential
| 3. | Terms of Agreement: |
This Agreement shall become effective and binding upon approval of both Parties. Approval shall be documented via signatures from authorized representatives of both Parties.
This Agreement shall become effective on the Services Agreement Effective Date and shall remain in effect for as long as the Services Agreement is in effect.
Any modification or amendment of this Agreement or waiver of any of the terms thereof requires written confirmation by both Parties. Should individual provisions of this Agreement be or become invalid, the remaining provisions will not be affected in their validity.
| 4. | Assignment |
Regentis shall not assign any or all of its rights or obligations under this Agreement without Xxxxxx’x prior written consent, which shall not unreasonably be withheld.
| 5. | Other Agreements |
This Agreement shall be incorporated within and constitute a part of the Services Agreement. In the event of a conflict between this Agreement and the Services Agreement, this Agreement will prevail for matters of quality and the Services Agreement, will control for all business, legal and financial issues. Regentis’s sole and exclusive remedies for any breach by Baxter of this Quality Agreement are (i) the re-performance of any service improperly performed, or (ii) termination of this Quality Agreement. Under no circumstances xxxx Xxxxxx be liable to Regentis for any money damages for breach of this Quality Agreement.
This Agreement shall be binding upon and inure to the benefit of the Parties, their successors and permitted assigns.
| 6. | Contact List |
| BAXTER | Regentis | |
| Primary Contact | Xxx Xxxxxxxxx | Xxxxx Xxxxxx-Xxxxxx, Ph.D. |
| VP, Quality | V.P. of Operations | |
| Ph: [ ] | Ph: [ ] | |
| [ ] | [ ] | |
| Secondary Contact | Xxxxx Xxxxxxxxx | Xxxx Xxxxxx |
| Quality Technical Consultant | QA Specialist | |
| Ph: [ ] | Ph [ ] | |
| [ ] | [ ] |
| 7. | Accepted and Agreed |
| Manufacturer Approval | Purchaser Approval |
| XXXXXX Healthcare Corporation | Regentis |
| Name: Xxx Xxxxx | Name: Xxxxxxxx Xxxxxx, Ph.D |
| Signature: /s/ Xxx Xxxxx | Signature: /s/ Xxxxxxxx Xxxxxx, Ph.D |
| Title: President Advanced Surgery | Title: President & CEO |
| Date: 3/1/2018 | Date: February 27th, 2018 |
Page
2|2
Confidential
