Exhibit 10.58
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
LICENSE AGREEMENT
This License Agreement (the “Agreement”) is dated as of June 10, 2015 (the “Effective Date”) by and between Ares Trading SA, a Swiss corporation with registered offices at Zone Industrielle de l’Ouriettaz, 1108 Aubonne, Switzerland (“Merck Serono”) and Obseva S.A., a Swiss corporation with registered offices at 12, Chemin des Aulx, 1228 Plan-Les-Ouates, Geneva (“Licensee”). Merck Serono and Licensee may be referred to herein as a “Party” or, collectively, as “Parties”.
Witnesseth:
Whereas, Licensee is active in the field of reproductive health and medicine;
Whereas, Merck Serono is engaged, among other activities, in the development of pharmaceutical products; and
Whereas, Merck Serono wishes to license to Licensee, on an exclusive worldwide basis, the right to research, develop, manufacture and commercialize products comprising the Licensed Compounds in the Field (as hereinafter defined); and
Whereas, Licensee wishes to obtain, and Merck Serono is willing to grant a license to the Merck Serono Technology upon the terms and conditions set forth herein; and
Now, Therefore, in consideration of the promises and mutual covenants contained herein, the parties agree to as follows:
The following terms shall have the following respective definitions:
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
Net Sales shall not include credits or allowances actually granted for damaged goods, returns or rejections of previously sold Licensed Products and retroactive price reductions for wastage replacement, indigent patients and similar programs.
For the avoidance of doubt, Net Sales may only occur after the Licensed Product has received Regulatory Approval valid for the country in which the Net Sales occur.
In the event that a Licensed Product is sold in the form of a Combination Product, Net Sales for such Combination Product will be calculated by multiplying actual Net Sales of such Combination Product by the fraction A/(A+B) where A is the invoice price of the Licensed Product containing a Compound as the only active ingredient if sold separately, and B is the invoice price of any other active ingredient(s) or other products, devices, equipment or components in the Combination Product if sold separately. In the event that the Licensed Product or one or more of such active ingredients or other products, devices, equipment or components in the Combination Product are not sold separately, then the Net Sales for such Combination Product shall be determined by the Parties in good faith.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
“Action” has the meaning set forth in Section 5.5 (b).
“Controlling Party” has the meaning set forth in Section 5.6 (c).
“Disputes” has the meaning set forth in Section 10.9.
“Licensee Indemnitees” has the meaning set forth in Section 8.1.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
“Licensee Patents” has the meaning set forth in Section 5.4 (a).
“Losses” has the meaning set forth in Section 8.1.
“Merck Serono Indemnitees” has the meaning set forth in Section 8.2.
“Royalty Term” has the meaning set forth in Section 4.2 (d).
“Term” has the meaning set forth in Section 9.1.
“Upfront Payment” has the meaning set forth in Section 4.1.
For Licensee: [*]
For Merck Serono: [*]
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
Notwithstanding the above obligations of confidentiality and non-use, a Party may disclose information to the extent that such disclosure is reasonably necessary in connection with:
In addition, in connection with any permitted filing by either Party of this Agreement with any Governmental Body, included but not limited to the U.S. Securities and Exchange Commission Agreement, the filing Party shall endeavor to obtain confidential treatment of economic, trade secret information and such other information as may be requested by the other Party, and shall provide the other Party with the proposed confidential treatment request with reasonable time for such other Party to provide comments, and shall include in such confidential treatment request all reasonable comments of the other Party. The filing Party shall, where reasonably practicable, give such advance notice to the other Party of such disclosure requirement as is reasonable under the circumstances and will use its reasonable efforts to cooperate with the other Party in order to secure confidential treatment of such Confidential Information required to be disclosed.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
If to Merck Serono, addressed to:
ARES TRADING SA
Zone Industrielle de l’Ouriettaz
1170 Aubonne
Switzerland
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
Facsimile: [*]
With a copy to:
Merck Serono S.A.
Zone Industrielle de l’Ouriettaz
1170 Aubonne
Switzerland
Attn: Legal Department
Facsimile: [*]
If to Licensee, addressed to:
OBSEVA S.A.
12, Chemin des Aulx
1228 Plan-Les-Ouates, Geneva
Switzerland
Attn: [*]
{Signature page to follow}
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
In Witness Whereof, the parties hereto have caused this Agreement to be executed and delivered in duplicate by their duly authorized representatives with legal and binding effect as of the date first above written.
OBSEVA S.A. By: /s/ Ernest Loumaye Name: Ernest Loumaye Title: CEO | ARES TRADING SA By: /s/ James Singleton Name: James Singleton Title: Authorized Representative |
10.06.2015 By: /s/ Fabien de Ladonchamps Name: Fabien de Ladonchamps Title: Finance Director | By: /s/ Cedric Hyde Name: Cedric Hyde Title: Authorized Representative |
Schedule 1.23
Licensed Compounds
●[*] Thiazolidine Carboxamide Derivatives as Modulators of the Prostaglandin F Receptor
●[*] Thiazolidine Carboxamide Derivatives as Modulators of the Prostaglandin F Receptor
Schedule 1.27
Merck Serono Know-How
[*]
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
Schedule 1.28
Merck Serono Materials
[*]
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
Schedule 1.29
Merck Serono Patents
[*]
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
FIRST AMENDMENT TO THE
LICENSE AGREEMENT
This Amendment N°1 To The License Agreement (“First Amendment”), effective as of July 8, 2016 (“First Amendment Effective Date”), is made and entered into by and between Ares Trading SA, a Swiss corporation with registered offices at Zone Industrielle de l’Ouriettaz, 1170 Aubonne, Switzerland (“Merck Serono”) and Obseva S.A., a Swiss corporation with registered offices at Chemin des Aulx, 12, 1228 Plan-les-Ouates, Geneva, Switzerland (“Licensee”). Merck Serono and Licensee may be referred to herein as the “Party” or, collectively, as the “Parties”.
Whereas, the Parties entered into a License Agreement on 10 June 2015 (“License Agreement”) concerning Merck Serono’s proprietary compounds known as [*];
Whereas, [*], is not claimed by and not specifically disclosed in the Merck Serono Patents listed on Schedule 1.29 of the License Agreement;
Whereas, Licensee wishes and Merck Serono agrees to seek patent protection for [*] and Licensee instructed Clark and Elbing LLP, a law firm with registered offices at 101 Federal Street Fl, 1500 Boston, MA02110, US (“C&E”) to prepare and file two new US patent applications covering [*] which were agreed upon by the Parties and of which the abstracts are attached hereto as Exhibit A;
Whereas, the two patent applications were filed on 4 January 2016 and the U.S. Patent Application No.: [*] under attorney docket [*] contains only Merck Serono Know-How and compounds and the U.S. Patent Application No.: [*] under attorney docket [*] contains both, Merck Serono Know-How and Licensee Know-How;
WHEREAS, the Parties agree that the patent application [*] shall be a Merck Serono Patent according to Section 5.3 of the License Agreement and that the patent application [*] shall be a Licensee Patent according to Section 5.4(a) of the License Agreement; and
Whereas, the Parties therefore wish to amend the License Agreement as set forth herein.
Now, Therefore, in consideration of the mutual covenants contained herein, and for other good and valuable consideration, the Parties hereto, intending to be legally bound, hereby agree as follows:
Capitalized terms used but not otherwise defined herein shall have the meanings ascribed to such terms in the License Agreement.
I.Modification of Schedule 1.29. The following patent application shall be added to the Merck Serono Patents in Schedule 1.29 of the License Agreement:
[*]
II.Reimbursement. According to Section 5.4(b) of the License Agreement Merck Serono shall reimburse Licensee $8’989.75 for patent expenses incurred by Licensee in the preparation and filing of the patent application [*] and Merck shall bear all further costs and expenses of filing, prosecution and maintaining this patent application in the Territory.
For the avoidance of doubt and in accordance with Section 5.4(a) of the License Agreement, Licensee shall solely bear all costs and expenses of filing, prosecution and maintaining the patent application [*] in the Territory.
III.Patent Maintenance. Contrary to what is provided by Section 5.4(b) of the License Agreement, Merck Serono agrees that the filing, prosecution, and maintenance of patent application [*] shall be under the responsibility of Licensee, provided that (i) Licensee coordinates all responses to office actions, country selection, filing strategy, enforcement activities and any other matter related to patent application [*] with the Merck Patent
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
Department in Darmstadt (hereinafter “Merck Patent GmbH”) and (ii) Merck Serono via Merck Patent GmbH shall reimburse Licensee for all reasonable costs and out-of-pocket expenses related to the filing, prosecution, and maintenance of patent application [*] after approval by a Merck Patent GmbH patent attorney, it being specified that such approval shall not unreasonably be withheld. Invoices can only be processed if they are addressed to Merck Patent GmbH.
For the coordination activities described in the preceding paragraph:
(a)Merck Patent GmbH’s contact person is [*], it being specified that Merck Patent GmbH shall be allowed to change such contact person provided that (i) it informs Licensee in a written notice prior to such change and (ii) the newly appointed contact person shall have the same skills and competences as the previous contact person; and
(b)Licensee shall inform Merck Patent GmbH about the coordination activities and Merck shall participate in the coordination activities, both in a timely manner (in particular in view of any relevant process timelines); in the event Merck Patent GmbH fails to do so, it is understood by the Parties that Licensee shall have the right to proceed further in such relevant process.
For the avoidance of doubt, Licensee is solely responsible for filing, prosecution, maintaining and enforcement of the patent application [*] in the Territory.
IV.Effectiveness. This First Amendment shall become effective as of the First Amendment Effective Date.
V.Counterparts; Fax; Signatures. This First Amendment may be executed in two (2) counterparts, including by facsimile or PDF, each of which, when signed and executed, shall be deemed to be an original and both of which together shall constitute the one and same document.
VI.Full Force and Effect. Except as set forth in this First Amendment, the License Agreement shall remain unchanged. This First Amendment, including its Exhibit A, shall be incorporated into and deemed part of the License Agreement from the First Amendment Effective Date on, and any future reference to the License Agreement shall include the terms and conditions of this First Amendment.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
In Witness Whereof, the Parties have caused this First Amendment to be executed by their duly authorized representatives.
OBSEVA S.A. By: /s/ Ernest Loumaye Name: Ernest Loumaye Title: CEO | ARES TRADING SA By: /s/ Cedric Hyde Name: Cedric Hyde Title: Authorized Representative |
By: /s/ Fabien de Ladonchamps Name: Fabien de Ladonchamps Title: VP Finance | By: /s/ Sebastien Boutte Name: Sebastien Boutte Title: Authorized Representative |
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
EXHIBIT A
[*]
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.