LICENSE AGREEMENT (EBOPIPRANT)
Exhibit 10.57
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LICENSE AGREEMENT
(EBOPIPRANT)
This License Agreement (the “Agreement”) is entered into as of July 26, 2021 (the “Effective Date”), by and between ObsEva SA, having an address at Xxxxxx xxx Xxxx 00, 0000 Xxxx-Xxx-Xxxxxx, Xxxxxxxxxxx (“ObsEva”) and Organon International GmbH, having an address at Xxxxxxxxxx 00, 0000 Xxxxxxx, Xxxxxxxxxxx (“Organon”). ObsEva and Organon may be referred to herein individually as a “Party” or collectively as the “Parties.”
RECITALS
Whereas, ObsEva Controls (as defined below) certain patents, know-how and other intellectual property rights relating to Licensed Compound and Licensed Products (as such terms are defined below);
Whereas, Organon possesses resources and expertise in the development and commercialization of pharmaceutical products;
Whereas, Organon desires to obtain an exclusive license and sublicense to Develop, Manufacture, Commercialize and otherwise Exploit the Licensed Compounds and Licensed Products in the Field in the Territory (as such terms are defined below) and ObsEva desires to grant to Organon such license and sublicense.
AGREEMENT
Now, Therefore, in consideration of the foregoing premises and the mutual covenants contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Organon and ObsEva hereby agree as follows:
1. | DEFINITIONS |
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[*] = 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.
[*]. For the avoidance of doubt, Net Sales may only occur after the Licensed Product has received Regulatory Approval for the country in which the Net Sales occur.
[*] = 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.
2. | LICENSE GRANTS |
[*] = 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.
3. | GOVERNANCE |
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4. | DEVELOPMENT; REGULATORY |
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[*] = 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.
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5. | COMMERCIALIZATION; MANUFACTURE; SUBCONTRACTING |
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6. | DILIGENCE |
7. | FINANCIAL PROVISIONS |
Non-Sales Milestone Event | Non-Sales Milestone Payment |
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Portion of Aggregate Net Sales of all Licensed Products in the Territory in a Calendar Year | Royalty Rate |
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8. | PAYMENT; RECORDS; AUDITS |
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9. | INTELLECTUAL PROPERTY |
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10. | CONFIDENTIALITY |
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Notwithstanding the foregoing, in the event that a Party is required to make a disclosure of the other Party’s Confidential Information pursuant to Section 10.3(c) or Section 10.3(d), it will, except to the extent prohibited by Applicable Law or judicial or administrative process, give advance notice as promptly as reasonably practicable (and to the extent possible, at least [*] notice) to the other Party of such disclosure and provide a draft of the disclosure to the other Party reasonably in advance of such filing or disclosure to give the other Party a reasonable opportunity to take whatever action available to it under Applicable Law that it deems necessary to protect its Confidential Information (for example, quash such order or to obtain a protective order or confidential treatment requiring that the Confidential Information and documents that are the subject of such order be held in confidence by the applicable court or governmental body or, if disclosed, be used only for the purposes for which the order was issued). The other Party will provide any
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comments as soon as practicable, in no event later than [*] from such notice, and such Party will consider in good faith any timely comments provided by the other Party, but without any obligation to accept such comments. In any event, the Party required to make such disclosure will use efforts to secure confidential treatment of such Confidential Information at least as diligent as such Party would use to protect its own confidential information of a similar nature, but in no event less than reasonable efforts, and the Parties agree to take all reasonable action to avoid disclosure of Confidential Information, and in the event that no protective order or other remedy is obtained, or the disclosing Party waives compliance with the terms of this Agreement, the receiving Party shall furnish only that portion of Confidential Information which the receiving Party is advised by counsel is legally required to be disclosed. Any information disclosed pursuant to any of the foregoing subsections shall remain Confidential Information and subject to the foregoing provisions of this Article 10.
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11. | REPRESENTATIONS, WARRANTIES AND COVENANTS |
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[*] = 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.
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12. | INDEMNIFICATION |
except, in each case (a)-(c), to the extent such Losses arise out of any activities set forth in Section 12.2 for which ObsEva is obligated to indemnify any Organon Indemnitee under Section 12.2.
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except, in each case (a)-(d), to the extent such Losses arise out of any activities set forth in Section 12.1 for which Organon is obligated to indemnify any ObsEva Indemnitee under Section 12.1.
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13. | TERM AND TERMINATION |
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[*] = 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.
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In any event, expiration or termination of this Agreement will not relieve the Parties of any liability that accrued hereunder prior to the effective date of such expiration or termination nor preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement, nor prejudice either Party’s right to obtain performance of any obligation that accrued hereunder prior to the effective date of such expiration or termination (including the rights to receive payments accrued or due prior to the effective date of such termination).
14. | GENERAL PROVISIONS |
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[*] = 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.
The rights and obligations of the Parties under this Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of the Parties specified above, and the name of a Party appearing herein will be deemed to include the name of such Party’s successors and permitted assigns to the extent necessary to carry out the intent of this Section 14.9. Any assignment not in accordance with this Section 14.9 shall be null and void and of no legal force or effect.
If to ObsEva, notices must be addressed to:
ObsEva SA
Chemin des Aulx 12,
1228 Plan-Les-Ouates, Switzerland
Attention: Chief Executive Officer
with a copy to:
ObsEva SA
Chemin des Aulx 12,
1228 Plan-Les-Ouates, Switzerland
Attention: Chief Administrative Officer
If to Organon, notices must be addressed to:
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Organon International GmbH
Xxxxxxxxxx 00,
6006 Lucerne, Switzerland
Attention: [*]
with a copy to:
Organon LLC
00 Xxxxxx Xxxxxx
33rd Floor
Jersey City, NJ (USA) 07302
Attention: SVP, Head of Business Development
Attention: Officer of the Secretary
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{Signature Page Follows}
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In Witness Whereof, the Parties hereto have caused this Agreement to be executed and entered into by their duly authorized representatives as of the Effective Date.
ObsEva SA | Organon International GmbH |
By: /s/ Xxxxx X’Xxxxxxxxx Xxxx: Xxxxx X’Xxxxxxxxx Xxxxx: Chief Executive Officer | By: /s/ Xxxxxx Xxxxxx Xxxx: Xxxxxx Xxxxxx Xxxxx: Managing Officer |
{Signature Page to License Agreement}
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Schedule 1.58
Description of Licensed Compounds
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Schedule 1.60
[*] Patents
[*]
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Schedule 2.3
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Schedule 4.5
Existing Inventory
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Schedule 4.6(a)
Existing INDs
[None]
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Schedule 5.3(a)
Key Terms of Supply Agreements
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Schedule 8.2
ObsEva Bank Account Information
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Schedule 10.8
Joint Press Release
Organon and ObsEva Enter Global License Agreement to Develop and Commercialize Ebopiprant (OBE022), an Investigational Agent Being Evaluated as a First-in-Class Treatment for Preterm Labor
Every year, an estimated 15 million babies are born preterm (before 37 completed weeks of gestation)i ; agent is being studied in an area of significant unmet need
Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange
Jersey City, N.J., Geneva, Switzerland, July 27, 2021 - Organon (NYSE: OGN), a global women’s health company and ObsEva (NASDAQ: OBSV) (SIX: OBSN), a biopharmaceutical company dedicated to improving women’s reproductive health, today announced that the companies have entered into an agreement whereby Organon will license the global development, manufacturing and commercial rights to ebopiprant (OBE022). Ebopiprant is an investigational, orally active, selective prostaglandin F2α (PGF2α) receptor antagonist being evaluated as a potential treatment for preterm labor by reducing inflammation and uterine contractions. If approved, it has potential to be a first-in-class innovation for this common and serious condition with no approved therapies for acute treatment of preterm labor in the United States.
“This development-stage asset is being studied in one of the most crucial unmet needs for women globally. As we build Xxxxxxx’s women’s health research and development portfolio, the agreement strengthens our path to long term growth,” said Xxxxx Xxx, Xxxxxxx’s Chief Executive Officer. “Organon and ObsEva share a commitment to improve the lives of women around the world. Through Organon’s strong development, scientific and medical capabilities, our goal is to change the future for millions of mothers and babies.”
Organon intends to work with the scientific and medical communities and regulatory authorities in major markets, including the United States, to advance the clinical development and registration of ebopiprant.
Xxxxx X’Xxxxxxxxx, CEO of ObsEva, commented, "Organon is the ideal partner for the development and commercialization of ebopiprant and we see this agreement as an important step in advancing this investigational agent. Although preterm birth rates are on the rise, there are currently no other known compounds in development. That is why we are focused on evaluating this agent in an important area of unmet need. Together with the data generated to date, this agreement underscores the value of our program, and we look forward to executing on our shared vision."
Under the terms of the agreement, Organon will gain exclusive worldwide rights to develop and commercialize ebopiprant. ObsEva is entitled to receive tiered double-digit royalties on commercial sales as well as up to $500 million in upfront and milestone payments including $25 million to be paid at signing, up to $90 million in development and regulatory milestones and up to $385 million sales based milestones. Xxxxxxx Xxxxx acted as exclusive financial advisor to ObsEva.
About Ebopiprant
In November 2020, ObsEva announced positive results from PROLONG, the Phase 2a proof-of-concept, randomized, double-blind, placebo-controlled trial of ebopiprant in preterm labor. In this study, 113 women with spontaneous preterm labor (gestational age between 24 and 34 weeks) were randomized and treated with atosiban (ex-U.S. standard of care) plus ebopiprant or atosiban plus placebo for 7 days. There were 83
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(73%) women with xxxxxxxxx pregnancies and 30 (27%) with twin pregnancies. One hundred and forty-one neonates were born.
In the PROLONG study, ebopiprant reduced delivery in xxxxxxxxx pregnancies at 48 hours after the start of dosing by 55% compared to atosiban alone. Overall, 7/56 (12.5%) of women receiving ebopiprant delivered within 48 hours of starting treatment compared to 12/55 (21.8%) receiving placebo (OR 90% CI: 0.52 (0.22, 1.23)). In xxxxxxxxx pregnancies, 5/40 (12.5%) of women receiving ebopiprant delivered within 48 hours compared to 11/41 (26.8%) receiving placebo (OR 90% CI: 0.39 (0.15, 1.04)). A modest effect on delivery at 7 days was seen in the singletons.
The incidence of maternal, fetal and neonatal adverse events were comparable between subjects in the ebopiprant group and the placebo group.
Ebopiprant (OBE022) was licensed from Merck KGaA, Darmstadt, Germany, in 2015.
About ObsEva
ObsEva is a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on new therapies for the treatment of uterine fibroids, endometriosis, and preterm labor. ObsEva is listed on the Nasdaq Global Select Market and is traded under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is traded under the ticker symbol “OBSN”. For more information, please visit xxx.XxxXxx.xxx.
About Organon
Organon is a global healthcare company formed through a spinoff from Merck, known as MSD outside of the United States and Canada, to focus on improving the health of women throughout their lives. Here for her health, the company has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the reproductive health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon’s products produce strong cash flows that will support investments in future growth opportunities in women’s health, including business development like recently acquired Alydia Health, a medical device company focused on postpartum hemorrhage. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets.
Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 9,000 employees with its headquarters located in Jersey City, New Jersey. For more information, visit xxxx://xxx.xxxxxxx.xxx and connect with us on LinkedIn and Instagram.
Forward-Looking Statement of Organon & Co.
Except for historical information herein, this news release of Organon & Co. (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about ebopiprant as a potential treatment for preterm labor, Xxxxxxx’s and ObsEva’s ability to improve the lives of women, Xxxxxxx’s ability to advance the clinical development of ebopiprant, and the potential benefits of the license. Forward-looking statements may be identified by words such as “potential,” “expects,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will” or words of similar meaning. These
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statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including the impact of the recent global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Xxxxxxx’s ability to accurately predict its future financial results and performance; Organon’s ability to accurately predict future market conditions; manufacturing difficulties or delays; dependence on the effectiveness of Organon’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
Xxxxxxx does not undertake any obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Xxxxxxx’s filings with the Securities and Exchange Commission (“SEC”), including its registration statement on Form 10, available at the SEC’s Internet site (xxx.xxx.xxx).
Cautionary Note Regarding Forward Looking Statements of ObsEva SA
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of and commercialization plans for ObsEva’s product candidates, expectations regarding regulatory and development milestones, including the potential timing of regulatory submissions to the EMA and FDA and ObsEva’s ability to obtain and maintain regulatory approvals for its product candidates, and the results of interactions with regulatory authorities. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials and clinical development, including the risk that the results of earlier clinical trials may not be predictive of the results of later stage clinical trials, related interactions with regulators, ObsEva’s reliance on third parties over which it may not always have full control, the impact of the ongoing novel coronavirus outbreak, and other risks and uncertainties that are described in the Risk Factors section of ObsEva’s Annual Report on Form 20-F for the year ended December 31, 2020 filed with Securities and Exchange Commission (SEC) on March 5, 2021 and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva’s website at xxxx://xxx.XxxXxx.xxx. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
Media Contacts Organon: | Xxxxxxx Xxxx (614) 314-8094 | Investor Contacts: | Xxxxxxxx Xxxxxxx (201) 275-2711 |
[*] = 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.
| Xxxx Xxxxxx (732) 675-8448 | | Xxxxxx Xxxxxx (267) 000-0000 |
CEO Office Contact Obseva: | Xxxxxx Xxxxxx +41 22 552 0000 Xxxxxx.Xxxxxx@xxxxxx.xx | Investor Contacts: | Xxxxx Xxxxxxx +1(617) 435 0000 xxxxxxxx@xxxxxxxxxxxxxxx.xxx |
[*] = 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 11.1(z)
CMO Agreements
[*]
[*] = 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.