EX-10.07 12 ex10-07.htm Execution Version CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***],” HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES...
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***],” HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
THIS SUBLICENSE Agreement (“Agreement”) is entered into on September 26, 2017 (the “Effective Date”) by and between BIOTIME, INC., a California corporation, having its principal place of business at 0000 Xxxxxxxx Xxxxxx, Xxxxx 000, Xxxxxxx, XX 00000 (“BioTime”), and AGEX THERAPEUTICS, INC., a Delaware corporation, having its principal place of business at 0000 Xxxxxxxx Xxxxxx, Xxxxx 000, Xxxxxxx, XX 00000 (“AgeX”).
WHEREAS, AgeX is an Affiliate of BioTime; and
1.1 “Affiliate” means with respect to any Person (including but not limited to BioTime, AgeX or a Third Party) any corporation, limited liability company, limited partnership or other entity in control of, controlled by, or under common control with such Person.
1.2 “AgeX Field” means all uses for the treatment, palliation, diagnosis, or prevention of any disease, disorder or health condition excluding the BioTime Exclusive Field.
1.3 “AgeX Non-Exclusive Field” means products, medical devices, and services for the prevention, treatment, amelioration, diagnosis or monitoring of disorders, degeneration, congenital conditions, or injuries of tendon.
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1.4 “BioTime Exclusive Field” means products, medical devices, and services for the prevention, treatment, amelioration, diagnosis or monitoring of (a) orthopedic indications, meaning [***]; (b) ophthalmological indications, meaning [***]; and (c) medical aesthetics meaning [***].
1.5 “BioTime Non-Exclusive Field” means products, medical devices, and services for the prevention, treatment, amelioration, diagnosis or monitoring of disorders, degeneration, congenital conditions, or injuries of tendon. For the avoidance of doubt, the BioTime Non-Exclusive Field does not include the prevention, treatment, amelioration, diagnosis or monitoring of disorders, degeneration, congenital conditions, or injuries of an orthopedic indication.
1.6 “Cells or Cell Lines” means the cells and cell lines identified in Exhibit A or Exhibit B attached hereto that are covered by (i.e., made or developed using) the Patent Rights or Know-How and/or are provided to AgeX by BioTime.
1.7 “Change of Control” means the occurrence of any of the following: (a) any consolidation or merger of AgeX with or into any Third Party, or any other corporate reorganization involving a Third Party, in which those persons or entities that are stockholders of AgeX immediately prior to such consolidation, merger or reorganization own less than fifty percent (50%) of the surviving entity’s voting power immediately after such consolidation, merger or reorganization; (b) a change in the legal or beneficial ownership of fifty percent (50%) or more of the voting securities of AgeX (whether in a single transaction or series of related transactions) where, immediately after giving effect to such change, the legal or beneficial owner of more than fifty percent (50%) of the voting securities of AgeX is a Third Party; or (c) the sale, transfer, lease, license or other disposition of all or substantially all of AgeX’s assets or business in one or a series of related transactions to a Third Party.
1.8 “Combination Product” means a product that contains a Licensed Product component and at least one other component that has independent research, diagnostic or therapeutic utility, could reasonably be sold separately and has economic value of its own.
1.9 “Commercialization” in respect of a particular product, any and all activities (whether before or after receipt of marketing approval in respect of the product, medical device or service) directed to the marketing, detailing and promotion of the product or medical device after marketing approval for such product has been obtained, and includes marketing, promoting, detailing, distributing, offering to commercially sell and commercially selling the product, medical device or service, importing, exporting or transporting the product or medical device for commercial sale, and regulatory affairs with respect to the foregoing. When used as a verb, “Commercializing” means engaging in Commercialization and “Commercialize” and “Commercialized” shall have corresponding meanings.
1.10 “Commercially Reasonable Efforts” means, with respect to the efforts to be expended by any party and with respect to any objective, the reasonable, diligent, good faith efforts to accomplish such objective as such party would use in its ordinary course of business to accomplish a similar objective under similar circumstances. With respect to any objective relating to the research, development, or exploitation as used herein, “Commercially Reasonable Efforts” means that level, caliber and quality of efforts and resources reasonably and normally used in the Research, Development and Exploitation by biopharmaceutical companies for a product that is of similar market potential and at a similar stage in its Development or product life, taking into account, without limitation, issues of safety, efficacy, product profile, competitiveness in the marketplace, including efforts used by similarly positioned competitors for competing products, regulatory structure involved, optimal timing for market entry, proprietary position, and other relevant scientific, technical, business, marketing, return on investment, financial resources, and other commercial factors. Without limiting the generality of the foregoing, “Commercially Reasonable Efforts, as it applies to the financial matters herein, means adherence to the budgeting and staffing targets and timelines (to the extent adherence to such activities and timelines are controllable by the party responsible for performing such activities).
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***],” HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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1.11 “Confidential Information” means all information and know-how and any tangible embodiments thereof provided by or on behalf of one party to the other party either in connection with the discussions and negotiations pertaining to this Agreement or in the course of performing under this Agreement, which may include data, knowledge, practices, processes, ideas, research plans, formulation or manufacturing processes and techniques, scientific, manufacturing, marketing and business plans, and financial and personnel matters relating to the disclosing party or to its present or future products, sales, suppliers, customers, employees, investors or business; provided, that, information or know-how of a party will not be deemed Confidential Information of such party for purposes of this Agreement if such information or know-how: (a) was already known to the receiving party, other than under an obligation of confidentiality or non-use, at the time of disclosure to such receiving party, as can be shown by written records; (b) was generally available or known to parties reasonably skilled in the field to which such information or know-how pertains, or was otherwise part of the public domain, at the time of its disclosure to such receiving party; (c) became generally available or known to parties reasonably skilled in the field to which such information or know-how pertains, or otherwise became part of the public domain, after its disclosure to such receiving party through no fault of the receiving party; (d) was disclosed to such receiving party, other than under an obligation of confidentiality or non-use, by a Third Party who had no obligation to the disclosing party not to disclose such information or know-how to others, as can be shown by written records; or (e) was independently discovered or developed by such receiving party, as can be shown by its written records, without the use or benefit of, or reliance on, Confidential Information belonging to the disclosing party.
1.12 “Control” means, with respect to any Patent(s), possession of the right, whether directly or indirectly, and whether by ownership, license or otherwise, to grant a license, sublicense or other right to or under such Patent(s) as provided for herein.
1.13 “Cover” means that a product or service, when made, used, or sold, or that a method, procedure, process, when practiced, would constitute, but for the license granted to Licensee pursuant to this Agreement, an infringement of any claim or claims included within the Patent Rights.
1.14 “Development” means all activities related to stability testing, process development, formulation, manufacturing scale-up, qualification and validation, quality assurance/quality control, clinical studies, including manufacturing in support thereof, statistical analysis and report writing, the preparation pre-submission and submission of INDs, premarket approvals, 510(k)s, NDAs, BLAs, and other regulatory applications, filings or submissions, regulatory affairs with respect to the foregoing, and all other activities necessary or reasonably useful or otherwise requested or required by the United States Food and Drug Administration, or any successor agency (“FDA”) or a comparable foreign regulatory authority as a condition or in support of obtaining or maintaining a regulatory marketing approval, or an approval for a clinical trial, anywhere in the world. When used as a verb, “Develop” means to engage in Development.
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1.15 “Development Costs” means, subject to the other terms of this Agreement and without duplication, (a) the [***] by or on behalf of AgeX or any of its Affiliates, during the term of and pursuant to this Agreement, that (i) are [***], and (ii) [***] of the sublicense in which the designation was made.
1.16 “Effective Date” has the meaning set forth in the opening paragraph of this Agreement.
1.17 “Exploit” means, to Develop, Manufacture, Commercialize, make, have made, use, offer to sell, sell or import; and “Exploitation” means Developing, Manufacturing, Commercializing, making, having made, using, offering to sell, selling or importing.
1.18 “Know-How” means all compositions of matter, techniques and data and other knowhow and technical information including inventions (whether or not patentable), improvements and developments, practices, methods, concepts, trade secrets, documents, computer data, computer slide illustrations, computer code, apparatus, test data, analytical and quality control data, formulation, manufacturing, patent data or descriptions, development information, drawings, specifications, designs, plans, proposals and technical data .and manuals and all other Confidential Information that is owned or controlled by BioTime as of the Effective Date, and that specifically relates to the subject matter (a) described in or claimed by the Patent Rights, (b) described in or claimed by the abandoned provisional applications including but not limited to: [***] .
1.19 “Licensed Process” means any process or method, the development, use, practice, or sale of which (a) is covered in whole or in part by, or cannot be performed without infringing, a Valid Claim of the Patent Rights in the country in which such Licensed Process is practiced or sold, (b) uses Cells or Cell Line listed in Exhibit A, or (c) otherwise utilizes the Know-How.
1.20 “Licensed Product” means any product, or part thereof or derived therefrom, the development, manufacture, sale, lease, or use of which (a) is covered in whole or in part by, or cannot be performed without infringing, a Valid Claim of the Patent Rights in the country in which any such product or part thereof is developed, made, used, sold or imported by AgeX, (b) uses Cells or Cell Line listed in Exhibit A, or (c) otherwise utilizes the Know-How.
1.21 “Licensed Services” means any service, the development, use, performance, or sale of which is covered in whole or in part by, or cannot be performed without infringing, a Valid Claim of the Patent Rights in the country in which any such service is so developed, used, performed, sold, offered for sale, imported or exported by AgeX or otherwise utilizes the Know-How.
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***],” HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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1.22 “Manufacture” and “Manufacturing” means, in respect of a particular pharmaceutical, bio-pharmaceutical, diagnostic, or prognostic product, and without limitation, all activities related to the production, manufacture, processing, formulation, filling, finishing, packaging, labeling, shipping, handling, holding, storage and warehousing of such product or any intermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial manufacture and analytic development, product characterization, stability testing, quality assurance and quality control.
1.23 “Net Sales” means the invoiced amount on sales by AgeX or its Affiliates or Sublicensees of Licensed Products, Licensed Services or Licensed Processes less (to the extent applicable and appropriately documented) (i) sales, tariff and import duties, use and other taxes directly imposed with reference to particular sales, (ii) discounts, rebates, and similar credits and charge backs actually allowed and taken (regardless of whether taken or paid at the time of sale or paid or credited to the buyer at a subsequent date), and (iii) amounts allowed or credited on returns; provided, any such allowed deductions shall be listed on the invoice for the applicable Licensed Product, Licensed Process or Licensed Service or otherwise documented in the ordinary course of business. In the case of Combination Products, Net Sales means the total invoice amount earned on sales of Combination Products by AgeX or its Affiliates to any third person or entity, less, to the extent applicable, the deductions set forth above, multiplied by a proration factor that is determined as follows:
a) If all components of the Combination Product were sold separately during the same or immediately preceding calendar quarter, the proration factor shall be determined by the formula [***]; or
b) if all components of the Combination Product were not sold separately during the same or immediately preceding calendar quarter, the proration factor shall be determined by the formula [***].
1.24 “Patent Rights” means the patents and patent applications identified on Exhibit C attached hereto, and any divisional, continuation or continuation-in-part of those applications, but only to the extent the claims in said applications are directed to subject matter specifically described in the patents and patent applications identified on Exhibit C, as well as any patents issued on these patent applications, and any reissues, reexaminations, extensions and substitutions (or the equivalent) thereof and any foreign counterparts to those patents and patent applications. The parties agree that Exhibit C may be revised from time to time after the Effective Date to reflect changes thereto.
1.25 “Person” means any individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.
1.26 “Research” means performance of scientific experiments to answer questions not answerable or easily answerable through the published scientific literature, pre-clinical and other non-clinical testing, test method development, and toxicology, formulation, and process development work.
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***],” HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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1.27 “Sublicensee” means a Person, other than an Affiliate, that is granted a sublicense by a Party under the license grants hereunder.
1.28 “Sublicensing Consideration” has the means the royalties payable pursuant to Section 2.3(d).
1.29 “Territory” means worldwide, where patent coverage applies.
1.30 “Third Party” means any Person other than AgeX, BioTime, or their respective Affiliates.
1.31 “Valid Claim” means (a) a claim of any issued and unexpired United States or foreign patent included in the Patent Rights which has not lapsed or become abandoned or been declared invalid or unenforceable by a court of competent jurisdiction or an administrative agency from which no appeal can be or has been taken within the time allowed from such appeal and which has not been disclaimed or determined to be invalid or unenforceable through reissue, disclaimer· or otherwise, or (b) to the extent rights are granted by a governmental patent authority thereunder (i.e., to the extent that the owner would be able to enforce a right to a patent royalty thereunder under applicable patent law), a claim of a pending patent application included in the Patent Rights..
ARTICLE 2. LICENSE GRANT AND RELATED OBLIGATIONS
2.2 BioTime shall, and hereby does, grant AgeX, subject to the terms and conditions of Section 2.1, and subject the rights granted to ACT, Third Parties or any Affiliates, a license to any new Licensed Patents created after the Effective Date that cover Licensed Products, Licensed Processes, and Licensed Services, in the AgeX Field and the AgeX Non-Exclusive Field in the Territory, to (a) Research, Develop, Exploit, make, have made, use, sell, have sold, offer for sale, have offered for sale, import, have imported, export and have exported Licensed Products, (b) Research, Develop, Exploit, use, practice, sell, have sold, offer for sale, have offered for sale, import, have imported, export and have exported Licensed Processes, (c) develop, use, perform, sell, have sold, offer for sale, have offered for sale, import, have imported, export and have exported Licensed Services, and (d) Research using Cells or Cell Lines listed in Exhibit B, from the Effective Date for a period of ten (10) years.
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a) The terms of any such sublicense or further rights of reference shall be in accordance with the terms and conditions of this Agreement and the ACT Licenses. With regard to all Sublicenses granted by AgeX pursuant to the rights granted to it by BioTime under this Agreement, (i) AgeX may not grant to any Sublicensee any right to maintain BioTime Licensed Patents, defend claims brought by Third Parties, or commence any legal action against any Third Party for infringement of BioTime Licensed Patents and (ii) AgeX shall notify BioTime of AgeX’s intent to enter into a sublicense and shall (1) provide BioTime with a draft of the proposed sublicense not later than [***] days before such sublicense is executed and BioTime shall have the right to provide a copy of such draft to ACT, (2) to allow BioTime and ACT to comment on the terms of the sublicense if BioTime or ACT chooses to comment, and (3) provide BioTime with a fully executed copy of all sublicense agreements within [***] days after execution and BioTime shall have the right to provide a copy thereof to ACT;;
b) Notwithstanding the grant of any such sublicense or further rights of reference hereunder, AgeX shall remain solely responsible to BioTime for the performance of its obligations under the terms hereof and for any breach of such obligations, whether such breach shall be caused by AgeX or any Sublicensee; and
c) For the avoidance of doubt it is hereby acknowledged that the appointment by AgeX of any distributor for a Licensed Product, Licensed Process or Licensed Service the extent permitted herein, or of any Third Party to assist in the Development of a Licensed Product, Licensed Process or Licensed Service shall not be deemed to constitute the appointment of a Sublicensee or the sublicense by AgeX of any rights hereunder.
d) Consideration
i. AgeX will pay to BioTime [***] of all Net Sales of a Licensed Product, Licensed Process or Licensed Service by Sublicensees until the royalty payments to ACT by BioTime total [***]Dollars (U.S.) ($[***]).:After the consideration in Section 2.2(d)(i) is fully paid, AgeX will pay to BioTime a [***] Royalty on Net Sales of a Licensed Product, Licensed Process or Licensed Service by Sublicensees. If AgeX is obligated to pay royalties to one or more BioTime Affiliates for the use of other patent rights with respect to the use, manufacture or sale of a Licensed Product, Licensed Process or Licensed Service and as a result the royalties payable under this Article plus the royalties payable to BioTime and its Affiliates in the aggregate would exceed [***]of Net Sales, the royalty due under this Article shall be reduced such that the total amount of royalties payable to BioTime and its Affiliates is [***], with the allocation of such royalties among BioTime and its Affiliates to be made in accordance with their instructions.
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***],” HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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ii. Sublicensing Consideration. AgeX shall pay to BioTime [***] of any Sublicensing Consideration, including, but not limited to, upfront payments and milestones, and will include non-cash exchanges or considerations. Sublicensing Consideration does not include [***]. If AgeX is obligated to pay Sublicensing Consideration to one or more BioTime Affiliates for the use of patent rights with respect to the use, manufacture or sale of a Licensed Product, Licensed Process or Licensed Service and as a result the Sublicensing Consideration payable under this Section plus the Sublicensing Consideration payable to BioTime and its Affiliates would exceed [***] of the Sublicensing Consideration, the Sublicensing Consideration due under this Section may be reduced such that the total amount of Sublicensing Consideration payable to BioTime and its Affiliates is [***], with the allocation of such Sublicensing Consideration among BioTime and its Affiliates to be made in accordance with their instructions
iii. Development Funding. Consideration received from a Sublicensee of AgeX that is explicitly designated in the sublicense agreement to cover Development Costs will not be considered Sublicensing Considering subject to Section 2.2(d) (iii). Any Sublicensing Considering actually received by AgeX that was designated as Development Costs that were not actually incurred by AgeX as Development Costs in respect to Development of a Licensed Product, Licensed Service or Licensed Process, will become Sublicensing Consideration if not returned upon completion or termination of the project for which the consideration was so designated.
This Agreement shall be in full force and effect from the Effective Date until the later of (i) July 10, 2028 or (ii) the end of the term of the last-to-expire of the Patent Rights licensed under this Agreement unless otherwise terminated by operation of law or pursuant to the terms of this Agreement.
ARTICLE 4. OBLIGATIONS, FEES & ROYALTIES
As additional consideration of the license granted to AgeX from BioTime in Article 2 of this Agreement, AgeX shall pay to BioTime a royalty equal to [***] of the Net Sales received by AgeX and its Affiliates for all Licensed Products, Licensed Process or Licensed Service sold, performed, or leased by AgeX or any Affiliate. The obligation of AgeX to pay royalties on Net Sales by AgeX and its Affiliates (but not on Net Sales received by Sublicensees) shall terminate (a) with respect to Net Sales arising in any country concurrently with the expiration or termination of the last applicable Valid Claim within the Patent Rights in such country in which the Licensed Product, Licensed Process or Licensed Service is, (as applicable), performed, sold, leased, or manufactured, or in which the Patent Rights are licensed, and (b) in any and all cases when royalty payments to ACT by BioTime total [***] (U.S.) ($[***]). If AgeX is obligated to pay royalties to one or more BioTime Affiliates for the use of other patent rights with respect to the use, manufacture or sale of a Licensed Product, Licensed Process or Licensed Service and as a result the royalties payable under this Article plus the royalties payable to BioTime and its Affiliates in the aggregate would exceed [***] of Net Sales, the royalty due under this Article shall be reduced such that the total amount of royalties payable to BioTime and its Affiliates is [***] with the allocation of such royalties among BioTime and its Affiliates to be made in accordance with their instructions.
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***],” HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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ARTICLE 5. COMMERCIAL DILIGENCE & MILESTONES
6.1 During the course of this Agreement, BioTime and AgeX may provide each other with Confidential Information. Confidential Information may be disclosed in oral, visual or written form, and includes such information that is designated in writing as such by the discloser at the time of disclosure, orally disclosed information that is designated in writing as confidential within 30 days after such oral disclosure, or information which, under all of the given circumstances ought reasonably be treated as Confidential Information of the disclosing party. BioTime and AgeX each intend to maintain the confidential or trade secret status of their Confidential Information. Each shall exercise reasonable care to protect the Confidential Information of the other from disclosure to third parties; no such disclosure shall be made without the other’s written permission. Upon termination or expiration of this Agreement, BioTime and/or AgeX shall comply with the other’s written request to return all Confidential Information that is in written or tangible form. Except as expressly provided herein, neither BioTime nor AgeX is granted any license to use the other’s Confidential Information. The obligations of BioTime and AgeX under this Article 6, shall survive any expiration or termination of this Agreement. Notwithstanding the preceding provisions of this Section 6.1, until such time as this Agreement is terminated: (a) Know How and the content of any patent application relating to or included in Patent Rights shall be deemed to be the AgeX’s Confidential Information rather than BioTime’s Confidential Information; (b) AgeX shall have the right to disclose Know How and the content of patent applications related to or included in Patent Rights to third parties without restriction under this Agreement; and (c) AgeX shall not have any obligation to BioTime to treat Know How or the content of any patent application related to or included in Patent Rights as BioTime’s Confidential Information.
6.2 The parties agree that the specific terms (but not the overall existence) of this Agreement shall be considered Confidential Information; provided, however, that the parties may disclose the terms of this Agreement to investors or potential investors, potential business partners, potential co-developers, manufactures, marketers, or distributors of any Licensed Product, Licensed Process, or Licensed Service, and in any prospectus, offering, memorandum, or other document or filing required by applicable securities laws or other applicable law or regulation. The parties may also disclose Confidential Information that is required to be disclosed to comply with applicable law or court order, provided that the recipient gives reasonable prior written notice of the required disclosure to the discloser and reasonably cooperates with the discloser’s efforts to prevent such disclosure.
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ARTICLE 7. QUARTERLY & ANNUAL REPORTS
7.1 AgeX shall maintain complete and accurate records of Licensed Products, Licensed Services and Licensed Processes that are sold, performed, or, leased by AgeX or its Affiliate under this Agreement, and all Sublicense Revenue received by AgeX and its Affiliates. AgeX shall keep, and shall cause its Affiliates to keep, full, true and accurate books of account containing all particulars that may be necessary for the purpose of showing the amounts payable to BioTime hereunder and AgeX’s compliance with the terms and conditions of this Agreement. Said books of account shall be kept at AgeX’s principal place of business or at such other location as may be agreed upon by the parties. Said books and the supporting data shall be open upon reasonable advance notice (and no more frequently than once per calendar year) for three (3) years following the end of the calendar year to which they pertain, to the inspection of BioTime or its agents for the purpose of verifying AgeX’s royalty statement or compliance in other respects with this Agreement. If any such audit determines that the reported payments to BioTime were less than [***] of the actual amount due to BioTime for the period in question, AgeX shall bear the cost of such audit (without limiting BioTime’s other remedies with respect thereto).
7.2 After the first commercial sale of a Licensed Product, Licensed Service or Licensed Process by AgeX or any Affiliate, within thirty (30) days after March 31, June 30, September 30 and December 31, of each year, shall deliver to BioTime a true and accurate report of all Net Sales and License Revenue during the preceding three-month period under this Agreement as shall be pertinent to a royalty accounting hereunder. Each such report shall include at least the following:
a) number(s) and type(s) of Licensed Products, Licensed Processes and Licensed Services sold, leased, or performed by AgeX and/or its Affiliates;
b) total xxxxxxxx and payments received for Licensed Products, Licensed Processes and Licensed Services performed, sold, or leased by AgeX and its Affiliates; and
c) deductions applicable as provided in Section 1.25;
7.3 each such report submitted, AgeX shall pay to BioTime the royalties and other payments due and payable under this Agreement. If no royalties or other payments shall be due, AgeX shall so report.
7.4 AgeX’s reporting obligations hereunder shall terminate when AgeX’s obligation to pay royalties and sublicensi
ARTICLE 8. PAYMENTS, RECORDS AND AUDITS
BioTime, Inc.
0000 Xxxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxx, XX 00000
Attention: Accounts Payable
Email: xx@xxxxxxxxxx.xxx
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***],” HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***],” HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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ARTICLE 9. PATENT PROSECUTION, MAINTENANCE, AND DEFENSE
9.1 Prosecution, Maintenance, and Defense. BioTime will, as allowed under the ACT Licenses, (i) use Commercially Reasonable Efforts to prosecute and maintain the Patent Rights, and (ii) control all prosecution, filing, and defense of the Patent Rights, provided that BioTime will use Commercially Reasonable Efforts to provide AgeX copies of documents prepared by or received from patent counsel related to the prosecution and/or maintenance of the Patent Rights to AgeX for review and comment prior to filing to the extent practicable under the circumstances.
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***],” HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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9.5 New Patents, Inventions, and Discoveries.
a) AgeX shall have the right to file and prosecute new patent applications (and to obtain new patents) covering Licensed Products, Licensed Processes, and Licensed Services, and any other subject matter, with respect to any Know How and any other technology, invention, or discovery made by AgeX or any of its Affiliates using Patent Rights and Know How. AgeX shall, and hereby does, grant BioTime an exclusive license to the new patents in the BioTime Exclusive Field and a nonexclusive license in the BioTime Non-Exclusive Field developed from the Effective Date for a period of [***].
b) AgeX and BioTime shall jointly file and prosecute new applications covering Licensed Products, Licensed Processes, and Licensed Services, and any other subject matter, with respect to any Know-How and any other technology, invention, or discovery made jointly by AgeX and BioTime using Patent Rights and/or Know-How. The Parties will share in the costs for filing, and prosecuting any jointly owned inventions relating to Licensed Products, Licensed Processes, and Licensed Services and any other subject matter, with respect to any Know-How and any other technology, invention, or discovery using Patent Rights and/or Know-How.
(a) BioTime shall be entitled to terminate this Agreement on written notice to AgeX;
(b) AgeX shall provide [***] prior written notice of such Patent Challenge and provide BioTime all materials, information, opinions, and analyses to be used to support such challenge;
(c) AgeX shall promptly reimburse all costs and expenses (including attorneys’ fees) incurred by or on behalf of BioTime with respect to any defense against such Patent Challenge; and
(d) all amounts due or payable under ARTICLE 4 will be doubled with respect to any payments due or triggered during the pendency of any Patent Challenge. If the outcome of such Patent Challenge is a determination against the party or parties making, causing, or enabling such Patent Challenge (the “Challenging Party”), such payments shall remain at such doubled amount for the remainder of the Term. If the outcome of such Patent Challenge is a determination in favor of the Challenging Party, AgeX will have no right to recoup any amounts paid under this Agreement before or during the pendency of such Patent Challenge.
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***],” HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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AgeX shall permanently and legibly xxxx all AgeX Products made, used, sold, or otherwise disposed of by AgeX, any Affiliate thereof, , or their containers, (i) in accordance with patent notice appropriate under Xxxxx 00, Xxxxxx Xxxxxx Code or any similar law in any foreign jurisdiction and (ii) with any other notice of patent rights reasonably necessary, in any country where AgeX Products are sold, to (a) enable Patent Rights (to the extent, in each case, relating to AgeX Products) to be enforced to their full extent or (ii) ensure the availability of all potential legal or equitable remedies with respect to any infringement of any Patent Rights (to the extent, in each case, relating to AgeX Products) by any Third Party.
ARTICLE 11. TERMINATION BY BIOTIME
11.1 BioTime may terminate this Agreement and the rights, privileges and license granted hereunder by written notice upon a breach or default of this Agreement by AgeX, as follows:
a) non-payment of any amounts due which is not cured within [***] of receipt of written notice of such non-payment wherein said notice is delivered by registered mail; or
b) breach of any obligation which is not cured within [***] of a written request to remedy such breach wherein said request is delivered by registered mail, or if the breach cannot be cured within said [***] period, failure of AgeX within said [***] period to proceed with reasonable promptness thereafter to cure the breach.
11.2 Such termination under 11.1(a) or 11.1(b) shall become automatically effective unless AgeX shall have cured any such material breach or default prior to the expiration of the applicable cure period.
11.3 AgeX shall have the right to terminate this Agreement at any time on [***] prior notice to BioTime, and upon payment of all amounts due BioTime through the effective date of the termination.
11.4 Upon termination of this Agreement for any reason, nothing herein shall be construed to release either party from any obligation that matured prior to the effective date of such termination; and Article 6, Article 9, Article 12, and any other Sections or provisions which by their nature are intended to survive termination, shall survive any such termination.
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***],” HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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ARTICLE 12. DISPOSITION OF LICENSED PRODUCTS ON HAND
Upon expiration or termination of this Agreement by either party, AgeX shall provide BioTime with a written inventory of all AgeX Products in process of manufacture, in use or in stock. AgeX may dispose of any such AgeX Products within the [***] period following such expiration or termination, provided, however, that AgeX shall pay royalties and render reports to BioTime thereon in the manner specified herein.
ARTICLE 13. WARRANTY BY BIOTIME
13.2 EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, BIOTIME, ITS DIRECTORS, OFFICERS, AGENTS, SHAREHOLDERS, EMPLOYEES, AND AFFILIATES MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANT ABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF PATENT RIGHTS CLAIMS, ISSUED OR PENDING, AND THE ABSENCE OF LATENT OR OTHER DEFECTS, WHETHER OR NOT DISCOVERABLE. NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION MADE OR WARRANTY GIVEN BY BIOTIME THAT THE PRACTICE BY AGEX OF THE LICENSE GRANTED HEREUNDER SHALL NOT INFRINGE THE PATENT RIGHTS OF ANY THIRD PARTY. IN NO EVENT SHALL BIOTIME, ITS DIRECTORS, OFFICERS, AGENTS, SHAREHOLDERS, EMPLOYEES AND AFFILIATES BE LIABLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING ECONOMIC DAMAGE OR INJURY TO PROPERTY AND LOST PROFITS, REGARDLESS OF WHETHER BIOTIME SHALL BE ADVISED, SHALL HAVE OTHER REASON TO KNOW, OR IN FACT SHALL KNOW OF THE POSSIBILITY OF SUCH DAMAGES.
13.3 AgeX agrees to maintain insurance or self-insurance that is reasonably adequate to fulfill any potential obligation to the indemnified parties. AgeX shall continue to maintain such insurance or self-insurance during the term of this Agreement and after the expiration or termination of this Agreement for a period of five (5) years.
13.4 Limitations. Nothing in this Agreement shall be construed as:
a) a warranty or representation by BioTime as to the validity or scope of any Patent Rights.
b) a warranty or representation by BioTime that anything made, used, sold or otherwise disposed of pursuant to any license granted under this Agreement is or will be free from infringement of intellectual property rights of third parties.
c) an obligation by BioTime to bring or prosecute actions or suits against third parties for patent infringement, except as may expressly be provided in ARTICLE 14 hereof.
d) conferring by implication, estoppel or otherwise any license or rights under any patents of BioTime other than Patent Rights.
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***],” HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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15.2 Evidence of Insurance and Notice of Changes. AgeX will provide BioTime with written evidence of such insurance upon request of BioTime. AgeX will provide BioTime with written notice of at least [***] prior to the cancellation, non-renewal, or material change in such insurance.
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***],” HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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No waiver by either party hereto of any breach or default of any of the covenants or agreements herein set forth shall be deemed a waiver as to any subsequent and/or similar breach or default.
Neither this Agreement, nor any rights or obligations hereunder, are assignable or otherwise transferable, in whole or in part (including by operation of law, merger, or other business combination), by AgeX without the prior written consent of BioTime. The failure of AgeX to comply with the terms of this paragraph shall be grounds for termination of the Agreement by BioTime under Section _. Any permitted assignee of either Party shall, as a condition to such assignment, assume all obligations of its assignor arising under this Agreement following such assignment. Any purported assignment by a party of this Agreement, or any of such party’s rights or obligations hereunder, in violation of this Article 17 shall be void. In the event of any assignment of this Agreement by a party requiring the other party’s consent under this ARTICLE 17, the assigning Party shall pay the other Party [***] upon the consummation of such assignment. In the event that written consent is provided by BioTime for the assignment of this Agreement in connection with, (a) assignment of this Agreement by AgeX pursuant to this ARTICLE 17, or (b) any sale by AgeX of all or substantially all of a portion of its assets or business constituting a particular AgeX Product line or business unit engaged in the Research, Development or Commercialization of any AgeX Product, AgeX will pay BioTime a non-refundable fee of [***]. A Change of Control will not be deemed an assignment.
ARTICLE 18. INDEMNIFICATION; LIMITATION OF LIABILITY
(a) any default by AgeX of its obligations under this Agreement;
(b) any breach by AgeX of any of its representations and warranties set forth in this Agreement; and
(c) any negligent act or omission of AgeX in connection with the performance of its obligations under this Agreement;
Notwithstanding the foregoing, AgeX shall not be required to indemnify BioTime, its Affiliates, and their respective officers, directors, employees and agents for any Claim to the extent such Claim are attributable to any of the matters as to which BioTime has an obligation to indemnify AgeX or for which the negligence, willful misconduct, or violation of any law by any Person other than AgeX an AgeX Indemnified Party contributed to the death or injury that is the subject of the Claim.
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***],” HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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18.2 Indemnity by BioTime. BioTime shall indemnify, defend and hold harmless AgeX, its subsidiaries and their respective officers, directors, employees and agents, from and against any and all costs, claims, damages and expenses (including reasonable attorneys’ fees and other expenses of legal proceedings) (collectively, “Claims”), in connection with any and all suits, actions, investigations, claims or demands of Third Parties arising from or occurring as a result of death or injury of any person caused or resulting from the use of any BioTime Product. Notwithstanding the foregoing, BioTime shall not be required to indemnify AgeX, its Affiliates, and their respective officers, directors, employees and agents for any Claims to the extent such Claims are attributable to any of the matters as to which AgeX has an obligation to indemnify BioTime or for which AgeX’s negligence or willful misconduct contributed to the Claim.
18.3 Indemnification Procedures.
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Any payment, notice or other communication required or permitted to be given to either party hereto shall be in writing and shall be deemed to have been properly given and effective: (a) on the date of delivery if delivered in person during recipient’s normal business hours; or (b) on the date of attempted delivery if delivered by courier, express mail service or first-class mail, registered or certified. Such notice shall be sent or delivered to the respective addresses given below, or to such other address as either party shall designate by written notice given to the other party as follows:
In the case of AgeX:
AgeX Therapeutics, Inc.
0000 Xxxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxx, XX 00000 Attention: Xxxxxxx X. Xxxx, Ph.D., CEO Email: xxxxx@xxxxxxxxxx.xxx
In the case of BioTime:
BioTime, Inc.
0000 Xxxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxx, XX 00000
Attention: Xxxxxx Xxxxxxx, CO-CEO
Email: xxxxxxxx@xxxxxxxxxx.xxx
and
BioTime, Inc.
0000 Xxxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxx, XX 00000
Attention: General Counsel
Email: xxxxx@xxxxxxxxxx.xxx
ARTICLE 20. REGULATORY COMPLIANCE
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This Agreement shall be governed by and construed in accordance with the laws of the State of California, without giving effect to any conflict of laws principles or rules.
ARTICLE 22. RELATIONSHIP OF PARTIES
In assuming and performing the obligations of this Agreement, AgeX and BioTime are each acting as independent parties and neither shall be considered or represent itself as a joint venture, partner, agent or employee of the other.
23.2 By BioTime. BioTime may not use AgeX’s name in connection with BioTime’s publicity related to their respective intellectual property and commercialization achievements without prior written consent.
ARTICLE 24. DISPUTE RESOLUTION
24.2 Arbitration. In the event that the Parties have been unable to reach accord using the procedures set forth in Section 13.1 and only if such is the case, either Party may seek final resolution of the matter through binding arbitration, and only through binding arbitration. The failure of a Party to comply with the provisions of Section 13.2 with respect to any controversy or claim shall constitute an absolute bar to the institution of any proceedings, by arbitration or otherwise, with respect to such controversy or claim. Any such arbitration shall be held in San Francisco, California in the English language before a panel of three (3) arbitrators in accordance with the then existing Rules of Arbitration of the American Arbitration Association (the “AAA”) and judgment upon the award rendered by the arbitrators may be entered or enforced in any court having jurisdiction thereof. In any arbitration proceeding hereunder, each Party shall select one arbitrator and the arbitrators selected by the Parties shall then select a third arbitrator, who shall have at least fifteen (15) years’ experience in pharmaceutical patent licensing. The arbitrators shall permit the Parties to have discovery to the extent permitted by the rules of the AAA. The decision of the arbitrators shall be final and binding on the Parties and shall be accompanied by a written opinion of the arbitrators explaining the arbitrators’ rationale for their decision. The intent of the Parties is that except for the entering of an arbitration order in a court of competent jurisdiction, disputes shall be resolved finally in arbitration as provided above, without appeal, and without recourse to litigation in the courts.
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ARTICLE 25. GENERAL PROVISIONS
25.1 The headings of the several sections are inserted for convenience of reference only and are not intended to be a part of or to affect the meaning or interpretation of this Agreement.
25.2 This Agreement shall not be binding upon the parties until it has been signed herein below by or on behalf of each party, and as of the Effective Date.
25.3 No amendment or modification of this Agreement shall be valid or binding upon the parties unless made in writing and signed by both parties.
25.4 This Agreement embodies the entire understanding of the parties, and supersede all previous communications, representations or understandings, either oral or written, between the parties relating to the subject matter thereof.
25.5 The provisions of this Agreement are severable, and in the event that any provision of this Agreement shall be determined to be invalid or unenforceable under any controlling body of the law, such invalidity or unenforceability shall not in any way affect the validity or enforceability of the remaining provisions hereof.
25.6 This Agreement may be signed in counterparts, each of which when taken together shall constitute one fully executed document. Each individual executing this Agreement on behalf of a legal Person does hereby represent and warrant to each other person so signing that he or she has been duly authorized to execute this Agreement on behalf of such Person.
25.7 In the event of any litigation, arbitration, judicial reference or other legal proceeding involving the parties to this Agreement to enforce any provision of this Agreement, to enforce any remedy available upon default under this Agreement, or seeking a declaration of the rights of either party under this Agreement, the prevailing party shall be entitled to recover from the other such attorneys’ fees and costs as may be reasonably incurred, including the costs of reasonable investigation, preparation and professional or expert consultation incurred by reason of such litigation, arbitration, judicial reference, or other legal proceeding.
[Signature page follows]
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AGEX THERAPEUTICS, INC. | BIOTIME, INC. | |||
By | /s/ Xxxxxxx X. Xxxx | By | /s/ Xxxxxx X. Xxxxxxx | |
(Signature) | (Signature) | |||
Name: | Xxxxxxx X. Xxxx | Name: | Xxxxxx X. Xxxxxxx | |
Title: | Chief Executive Officer | Title: | Co-Chief Executive Officer |
[Signature page of the ACT Sublicense Agreement]
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EXHIBIT A
Cells or Cell Lines
ACT No. | Cell Line | |
[***] | [***] |
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***],” HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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EXHIBIT B
ACT No. | Cell Line | |
[***] | [***] |
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***],” HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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EXHIBIT C
Patent Rights
[***]
[***]
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY “[***],” HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.