Exhibit 10.80
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
COLLABORATION AND LICENSE AGREEMENT
BETWEEN
Metagenomi, Inc.
AND
Ionis Pharmaceuticals, Inc.
Dated November 10, 2022
TABLE OF CONTENTS
Page | ||
Article 1 Overview | 1 | |
1.1. | Drug Discovery Program | 1 |
1.2. | Development and Commercialization | 1 |
1.3. | Co-Development and Co-Commercialization | 1 |
1.4. | Exploratory Research | 2 |
1.5. | Governance | 2 |
1.6. | Purpose | 2 |
Article 2 Collaboration | 2 | |
2.1. | Selection of Collaboration Targets | 2 |
2.2. | Drug Discovery Program | 5 |
2.3. | Exploratory Research Program | 7 |
2.4. | Conduct of Collaboration Activities | 8 |
2.5. | Cost of Collaboration Activities | 8 |
2.6. | Collaboration Program Records and Reports | 9 |
2.7. | Ionis Proprietary Toolbox of Chemical Modifications | 9 |
Article 3 Licenses; Exclusivity | 10 | |
3.1. | License Grants to Ionis | 10 |
3.2. | License Grants to Metagenomi | 11 |
3.3. | Subcontractors | 13 |
3.4. | Technology Transfer | 13 |
3.5. | No Implied Licenses | 14 |
3.6. | Exclusivity | 14 |
Article 4 Governance | 16 | |
4.1. | Joint Steering Committee | 16 |
4.2. | Subcommittees | 17 |
4.3. | Joint Research Committee. | 18 |
4.4. | Alliance Managers | 18 |
4.5. | Additional Participants | 19 |
4.6. | Decision-Making | 19 |
Article 5 Co-Development and Co-Commercialization Options | 20 | |
5.1. | Co-Develop and Co-Commercialization Options | 20 |
5.2. | Development and Commercialization of the Co-Co Products; Opt-Down Right | 21 |
5.3. | Escalation Procedure. | 21 |
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5.4. | Metagenomi Opt-Out | 21 |
Article 6 Development and Commercialization of the Ionis Products | 22 | |
6.1. | Development | 22 |
6.2. | Commercialization | 22 |
Article 7 Regulatory Affairs | 22 | |
7.1. | Regulatory Responsibility | 22 |
7.2. | Right of Reference | 23 |
7.3. | Regulatory Support | 23 |
Article 8 Manufacturing | 24 | |
8.1. | Metagenomi Manufacturing Responsibilities | 24 |
8.2. | Development Supply Agreement | 24 |
8.3. | Commercial Supply Agreement | 25 |
8.4. | Ionis’ Assumption of Manufacturing Responsibilities | 25 |
8.5. | Manufacturing After the Metagenomi Supply Term | 25 |
Article 9 Consideration; Financial Terms | 25 | |
9.1. | Upfront Payment | 25 |
9.2. | [***] | 26 |
9.3. | Option Exercise Fee. | 26 |
9.4. | Ionis Product Milestone Payments | 26 |
9.5. | Ionis Products for [***] Target Populations | 29 |
9.6. | Ionis Product Royalty Payments | 29 |
9.7. | Existing In-License Agreements | 31 |
9.8. | New In-License Agreements | 32 |
9.9. | Payment Obligations Under Certain In-License Agreements | 33 |
9.10. | Metagenomi Product Economics | 33 |
9.11. | Other Payments | 35 |
9.12. | Right to Offset | 35 |
9.13. | Records and Audits | 35 |
9.14. | Currency of Payment; Non-Refundable Payments | 36 |
9.15. | Late Fees | 36 |
9.16. | Currency Restrictions | 37 |
9.17. | Withholding Taxes | 37 |
Article 10 Intellectual Property | 37 | |
10.1. | Ownership of Inventions | 37 |
10.2. | Patent Prosecution | 38 |
10.3. | Patent Enforcement | 40 |
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10.4. | Defense of Claims Brought by Third Parties | 41 |
10.5. | Patent Listing | 41 |
10.6. | Common Ownership Legislation | 42 |
10.7. | Patent Term Extension | 42 |
10.8. | Recording | 42 |
10.9. | Unitary Patent System | 42 |
10.10. | Trademarks | 42 |
10.11. | Common Interest | 43 |
Article 11 Confidentiality | 43 | |
11.1. | Confidential Information | 43 |
11.2. | No Use of Name | 45 |
11.3. | Residual Knowledge | 45 |
11.4. | Public Announcements and Subsequent Disclosures | 46 |
11.5. | Publications | 46 |
Article 12 Representations, Warranties, and Covenants | 47 | |
12.1. | Mutual Representations and Warranties | 47 |
12.2. | Additional Representations of Metagenomi | 47 |
12.3. | Covenants of Metagenomi | 49 |
12.4. | Additional Representations of Ionis | 50 |
12.5. | Covenants of Ionis | 51 |
12.6. | Warranty Disclaimer | 52 |
Article 13 Indemnification; Limitation of Liability; Insurance | 52 | |
13.1. | Indemnification of Metagenomi by Ionis | 52 |
13.2. | Indemnification of Ionis by Metagenomi | 53 |
13.3. | Losses for the Co-Co Products | 53 |
13.4. | Conditions to Indemnification | 54 |
13.5. | Limited Liability | 54 |
13.6. | Insurance Obligations | 54 |
Article 14 Term and Termination | 55 | |
14.1. | Term | 55 |
14.2. | Termination | 55 |
14.3. | Effects of Termination | 56 |
14.4. | Confidential Information | 59 |
14.5. | Surviving Provisions | 59 |
Article 15 Miscellaneous | 60 | |
15.1. | Dispute Resolution | 60 |
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15.2. | Designation of Affiliates | 62 |
15.3. | Patent Disputes | 62 |
15.4. | Injunctive Relief | 63 |
15.5. | Governing Law | 63 |
15.6. | Cumulative Remedies | 63 |
15.7. | Notices | 63 |
15.8. | Amendment; Waiver | 64 |
15.9. | Assignment and Successors | 64 |
15.10. | Rights in Bankruptcy | 64 |
15.11. | Force Majeure | 65 |
15.12. | Interpretation | 66 |
15.13. | Integration | 66 |
15.14. | Severability | 66 |
15.15. | Further Assurances | 67 |
15.16. | Counterparts | 67 |
15.17. | Relationship of the Parties | 67 |
Schedules:
Schedule1.114 | [***] |
Schedule1.146 | Licensed Patent Rights |
Schedule 1.166 | [***] |
Schedule 1.175 | Metagenomi Platform Patent Rights |
Schedule 2.1.1(a) | [***] |
Schedule 2.2 | [***] Drug Discovery Plan |
Schedule 2.3.1 | Exploratory Research Plan |
Schedule 8.2 | Development Supply Agreement Key Terms |
Schedule 11.4 | Press Release(s) |
Schedule 12.2 | Metagenomi Disclosure Schedule |
Schedule 12.4 | Ionis Disclosure Schedule |
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COLLABORATION AND LICENSE AGREEMENT
This COLLABORATION AND LICENSE AGREEMENT (this “Agreement”) is entered into as of November 10, 2022 (the “Effective Date”), by and between Ionis Pharmaceuticals, Inc., a Delaware corporation, having its principal place of business at 2855 Gazelle Court, Carlsbad, CA 92010 (“Ionis”), and Metagenomi, Inc., a Delaware corporation, having its principal place of business at 1545 Park Avenue, Emeryville, CA 94608 (“Metagenomi”). Metagenomi and Ionis are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
WHEREAS, Metagenomi is a biopharmaceutical company that controls certain patent rights, know-how, technology, and expertise with respect to gene editing;
WHEREAS, Ionis is a biopharmaceutical company focused on developing and commercializing pharmaceutical and biopharmaceutical products;
WHEREAS, Metagenomi and Ionis desire to enter into a collaboration to utilize Metagenomi’s and Ionis’ expertise and each Party’s platform to perform research services and other activities focused on the (a) discovery and development of therapeutics, and (b) advancing certain gene editing technologies to enable improved performance, novel mechanisms, and novel delivery strategies; and
WHEREAS, Metagenomi desires to grant to Ionis, and Ionis desires to receive from Metagenomi, an exclusive license under the Licensed Technology to Exploit Licensed Systems and Licensed Products under the terms and conditions set forth herein.
NOW, THEREFORE, the Parties agree as follows:
Overview
The Parties intend to undertake a strategic research collaboration under this Agreement, consisting of drug discovery and exploratory research activities to advance new medicines using gene editing strategies, with the goal of discovering novel medicines for Ionis to Develop and Commercialize on its own or to co-Develop and co-Commercialize with Metagenomi.
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Collaboration
2.1. | Selection of Collaboration Targets. |
2.1.1. | Wave 1 Targets. |
(a) | Initial Wave 1 Target. The first Collaboration Target will be [***], as set forth on Schedule 2.1.1(a) ([***]) (“[***]”). |
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2.1.4. | Encumbrance Check. |
4
2.2. |
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2.2.4. | [***] for Additional Drug Discovery Plans. |
(a) | New [***]. At each JSC meeting during the Target Selection and Substitution Period, Metagenomi will [***]. In addition, [***]. |
(c) | Incremental Development Costs. If, [***]. |
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2.3. | Exploratory Research Program. |
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2.5. | Cost of Collaboration Activities. |
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2.6. | Collaboration Program Records and Reports. |
2.7. | Ionis Proprietary Toolbox of Chemical Modifications. |
2.7.3. | Encumbrance Check. |
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Licenses; Exclusivity
3.1. | License Grants to Ionis. |
3.1.1. | Collaboration Activities License. |
3.1.2. | Exclusive Exploitation License. |
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3.1.3. | Unblocking License. |
3.2. | License Grants to Metagenomi. |
3.2.1. | Metagenomi Activities License. |
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3.2.2. | Unblocking License. |
3.2.3. | Ionis Background Technology License. |
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3.4. | Technology Transfer. |
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3.6. | Exclusivity. |
For clarity, the limitations set forth in this Section 3.6.1 (Exclusivity Obligations) will not apply to any Collaboration Target that is substituted out in accordance with Section 2.1.3 (Target Substitutions).
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(c) | notify the other Party in writing that it [***], in which case, within [***] after the other Party’s receipt of such notice, the Distracted Party and its Affiliates will [***]. |
During the discussion period under Section 3.6.2(a), prior to the time of [***] pursuant to Section 3.6.2(b), or prior to the [***] pursuant to Section 3.6.2(c), as applicable, the Distracted Party and its Affiliates will segregate all activities relating to the Distracting Product from the Exploitation of the Licensed Systems or Licensed Products under this Agreement, including ensuring that (i) no personnel involved in performing Development or Commercialization activities with respect to such Distracting Product have access to non-public plans or information relating to the Development or Commercialization of Licensed Systems or Licensed Products under this Agreement (except that [***]), and (ii) no personnel involved in performing Development or Commercialization activities with respect to Licensed Systems or Licensed Products under this Agreement have access to non-public plans or information relating to the Development or Commercialization of such Distracting Product (except that [***]). The procedures set forth in clauses (i) and (ii) above will be referred to as “Firewall Procedures” for the purposes of this Agreement.
3.6.3. | Change of Control. If there is a Change of Control involving a Party (where such Party is the acquired entity), then: |
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Governance
4.1. | Joint Steering Committee. |
4.1.5. | Specific Responsibilities of the JSC. The responsibilities of the JSC will be to: |
(a) | oversee the overall strategic relationship between the Parties; |
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(g) | review and discuss each Collaboration Program Report, pursuant to Section 2.6.2 (Collaboration Program Reports); |
(h) | review and discuss the Regulatory Strategy for each Licensed Product, as described in Section 7.1 (Regulatory Responsibility); |
(j) | perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties. |
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4.3. | Joint Research Committee. |
4.3.3. | Specific Responsibilities of the JRC. The responsibilities of the JRC will be to: |
(a) | coordinate the Collaboration Activities; |
(d) | perform such other functions as determined by the JSC. |
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4.6. | Decision-Making. |
(a) | Ionis Final Decision-Making Authority. Ionis will have the right to make the final decision regarding [***]. |
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Co-Development and Co-Commercialization Options
5.1. | Co-Development and Co-Commercialization Options. |
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Development and Commercialization of the Ionis Products
6.1. | Development. |
6.2. | Commercialization. |
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7.2. | Right of Reference. |
7.3. | Regulatory Support. |
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Manufacturing
8.1. | Metagenomi Manufacturing Responsibilities. |
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8.4. | [***] Manufacturing Responsibilities. If, (a) [***], or (b) [***], then, in either case, [***]. For clarity, [***]. |
Consideration; Financial Terms
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9.4. | Ionis Product Milestone Payments. |
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Table 9.4.1 – Ionis Product Development Milestones | ||
Ionis Product Development Milestone Event | Ionis Product Development Milestone Payment | |
1. [***] | $[***] | |
2. [***] | $[***] | |
3. [***] | $[***] |
Table 9.4.2 – Ionis Product Regulatory Milestones | ||
Ionis Product Regulatory Milestone Event | Ionis Product Regulatory Milestone Payment | |
1. [***] | $[***] | |
2. [***] | $[***] |
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Table 9.4.3 – Ionis Product Sales Milestones | |||
Ionis Product Sales Milestone Event | Ionis Product Sales Milestone Payment | ||
1. | The first Calendar Year in which the aggregate Net Sales for an Ionis Product exceed $[***] | $[***] | |
2. | The first Calendar Year in which the aggregate Net Sales for an Ionis Product exceed $[***] | $[***] | |
3. | The first Calendar Year in which the aggregate Net Sales for an Ionis Product exceed $[***] | $[***] | |
4. | The first Calendar Year in which the aggregate Net Sales for an Ionis Product exceed $[***] | $[***] |
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9.6. | Ionis Product Royalty Payments. |
Table 9.6.1 – Royalty Rates for Ionis Products | ||
Annual Net Sales of an Ionis Product in the Territory | Royalty Rate as a Percentage of Net Sales | |
Portion of Annual Net Sales of each Ionis Product that is less than or equal to $[***] | [***]% | |
Portion of Annual Net Sales of each Ionis Product that is greater than $[***], and less than or equal to $[***] | [***]% | |
Portion of Annual Net Sales for each Ionis Product that is greater than $[***], and less than or equal to $[***] | [***]% | |
Portion of Annual Net Sales of each Ionis Product that is greater than $[***] | [***]% |
By way of example only, if the Annual Net Sales for an Ionis Product are $[***] for a given Calendar Year, then the Ionis Royalties payable with respect to such Annual Net Sales for such Ionis Product in such Calendar Year, subject to adjustment as set forth in Section 9.6.2 (Adjustment to Ionis Royalties) would be: [***]. For the avoidance of doubt, the obligation to pay Ionis Royalties will be imposed only once with respect to the same unit of an Ionis Product.
9.6.2. | Adjustments to Ionis Royalties. |
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9.7. | Existing In-License Agreements. |
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9.8. | New In-License Agreements. |
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9.10. | Metagenomi Product Economics. |
Table 9.10.1 – Metagenomi Product Milestones | ||
Metagenomi Product Milestone Event | Metagenomi Product Milestone Payment | |
1. [***] | $[***] | |
2. [***] | $[***] | |
3. [***] | $[***] | |
4. [***] | $[***] |
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9.10.3. | Metagenomi Royalties. |
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9.13. | Records and Audits. |
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10.1. | Ownership of Inventions. |
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10.2. | Patent Prosecution. |
10.2.1. | Ionis-Prosecuted Patent Rights. |
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10.3. | Patent Enforcement. |
10.3.2. | Competitive Infringements. |
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41
10.7. | Patent Term Extension. |
42
Confidentiality
11.1. | Confidential Information. |
43
44
If and whenever any Confidential Information is disclosed in accordance with this Section 11.1.4 (Permitted Disclosures), such disclosure will not cause any such information to cease to be Confidential Information except to the extent that such disclosure results in a public disclosure of such information (other than by breach of this Agreement).
45
11.5. | Publications. |
11.5.1. | Ionis Publications. |
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Representations, Warranties, and Covenants
12.1. | Mutual Representations and Warranties. As of the Effective Date, Metagenomi and Ionis each hereby represents and warrants to the other as follows: |
12.2.1. | [***] Warranty Technology [***] Metagenomi Platform [***]. |
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12.2.7. | To Metagenomi’s Knowledge, no circumstances or grounds exist that would invalidate, [***], the enforceability, validity or scope of any Patent Rights within the Warranty Technology. |
12.2.8. | [***], and no Third Party has any rights, title, or interests in or to, or any license under, any of the Licensed Technology. |
12.2.9. | [***]. |
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12.2.12. | [***]. |
12.3. | Covenants of Metagenomi. Metagenomi covenants to Ionis as follows: |
12.3.1. | Metagenomi and its Affiliates will maintain Control of all Licensed Technology and Licensed Systems owned by Metagenomi or its Affiliates at any time during the Term. |
12.3.2. | Metagenomi and its Affiliates will not [***] with respect to any Licensed Technology which would adversely affect the rights granted to Ionis hereunder. |
12.3.5. | [***]. |
12.3.6. | [***]. |
12.3.8. | Metagenomi will, and will ensure that its Affiliates, comply with Applicable Law in connection with the performance of its and its Affiliates’ activities under this Agreement. |
49
12.3.12. | Neither Metagenomi nor its Affiliates will export, transfer, or sell any Licensed Product to any country or territory except in compliance with Applicable Law. |
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12.5. | Covenants of Ionis. Ionis covenants to Metagenomi as follows: |
12.5.2. | Ionis will, and will ensure that its Affiliates, comply with all Applicable Law in connection with the performance of its and its Affiliates’ activities under this Agreement. |
12.5.6. | Neither Ionis nor its Affiliates will export, transfer, or sell any Licensed Product to any country or territory except in compliance with Applicable Law. |
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12.5.8. | Ionis will not, and will cause its Affiliates not to, use or practice the Licensed Technology, except in accordance with this Agreement. |
Indemnification; Limitation of Liability; Insurance
13.1.2. | the breach by any Ionis Indemnitee of any term of this Agreement; or |
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13.2.3. | the Exploitation of any Licensed System or Licensed Product by or on behalf of any Metagenomi Indemnitee prior to the Effective Date and after termination of this Agreement; |
13.2.4. | the Exploitation of any Metagenomi Product by or on behalf of any Metagenomi Indemnitee; |
13.2.5. | the breach by any Metagenomi Indemnitee of any term of this Agreement; or |
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Term and Termination
14.2. | Termination. This Agreement may be terminated as follows: |
14.2.2. | Termination for Material Breach. |
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14.3.6. | Reversion for Terminated Products other than Combination Products. |
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Miscellaneous
15.1. | Dispute Resolution. |
For Ionis: | Chief Executive Officer (or such other senior executive designated by Ionis for such purpose) |
For Metagenomi: | Chief Executive Officer (or such other senior executive designated by Metagenomi for such purpose) |
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If to Ionis: | Ionis Pharmaceuticals, Inc. |
2855 Gazelle Court
Carlsbad, CA 92010
Attention: Chief Business Officer
Copy to (which copy will not constitute notice):
[***]
Attention: General Counsel
If to Metagenomi: | Metagenomi, Inc. 1545 Park Avenue |
Emeryville CA 94608
Attention: [***]
Attention: [***]
Copy to (which copy will not constitute notice):
Attention: [***]
Copy to [***]
All notices will be deemed effective: (a) if by courier, on the Business Day of delivery as evidenced by the courier’s receipt (or if delivered or sent on a non-Business Day, then on the next Business Day); or (b) if sent by registered or certified airmail, on the Business Day of receipt as evidenced on the return receipt.
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15.10. | Rights in Bankruptcy. |
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(b) | the right to contract directly with any Third Party to complete the contracted work. |
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[Remainder of page intentionally left blank.]
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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives.
METAGENOMI, INC. | IONIS PHARMACEUTICALS, INC. | |||
By: | /s/ Brian Thomas | By: | /s/ Brett Monia | |
Name: Brian Thomas | Name: Brett Monia | |||
Title: Chief Executive Officer | Title: Chief Executive Officer |
[Signature Page to Collaboration and License Agreement]
Appendix 1
Definitions
For purposes of this Agreement, whether used in the singular or plural, the following terms will have the meanings set forth below:
1.1. | “AAA” has the meaning set forth in Section 15.1.2 (Arbitration). |
1.2. | “Accounting Standards” means United States Generally Accepted Accounting Principles, as generally and consistently applied throughout a Party’s organization. |
1.3. | “Acquiring Party” has the meaning set forth in Section 9.8.1 (Proposed New In-License Agreement). |
1.4. | “Acquisition Transaction” has the meaning set forth in Section 3.6.2 (Acquisition of Distracting Product). |
1.5. | “Additional Drug Discovery Plan” has the meaning set forth in Section 2.2.2 (Additional Drug Discovery Plans). |
1.6. | “Additional Wave 1 Target” has the meaning set forth in Section 2.1.1(c) (Additional Wave 1 Target Selection). |
1.7. | “Additional Wave 1 Target Notice” has the meaning set forth in Section 2.1.1(c) (Additional Wave 1 Target Selection). |
1.8. | “Additional Wave 1 Target Selection Period” has the meaning set forth in Section 2.1.1(c) (Additional Wave 1 Target Selection). |
1.10. | “Agreement” has the meaning set forth in the Preamble. |
1.11. | “Alliance Manager” has the meaning set forth in Section 4.4 (Alliance Managers). |
1.15. | “Arbitration” has the meaning set forth in Section 15.1.2 (Arbitration). |
1.16. | “Audited Party” has the meaning set forth in Section 9.13.1 (Books and Records). |
1.17. | “Auditing Party” has the meaning set forth in Section 9.13.1 (Books and Records). |
1.18. | “Auditor” has the meaning set forth in Section 9.13.1 (Books and Records). |
1.19. | “Available” means, with respect to a Proposed Target, that such Proposed Target is not an Encumbered Target. |
1.20. | “[***]” has the meaning set forth in Section 2.2.4(a) (New [***]). |
1.22. | “BLA” means a biologics license application that is submitted to the FDA for a Licensed Product, pursuant to 21 C.F.R. § 601.2. |
1.23. | “Business Day” means any day, other than Saturday, Sunday, or any day on which banking institutions in California are authorized or required by Applicable Law to remain closed. |
1.24. | “C.F.R.” means the U.S. Code of Federal Regulations. |
1.28. | “Claim” has the meaning set forth in Section 15.1.1 (Escalation). |
1.29. | “Clinical Trial” means any clinical trial in humans that is designed to generate data in support or maintenance of an IND or MAA. |
1.30. | “CMO” means a contract manufacturing organization. |
1.31. | “[***]” means [***]. |
1.32. | “Co-Co Option” has the meaning set forth in Section 5.1.1 (Option Grant). |
1.33. | “Co-Co Option Notice” has the meaning set forth in Section 5.1.2 (Option Period). |
1.34. | “Co-Co Option Period” has the meaning set forth in Section 5.1.2 (Option Period). |
1.35. | “Co-Co Products” means any Licensed Products that are the subject of a Co-Co Program. |
1.36. | “Co-Co Program” means each Drug Discovery Program for which Metagenomi exercises a Co- Co Option in accordance with Section 5.1 (Co-Development and Co-Commercialization Options). |
1.37. | “Co-Development and Co-Commercialization Agreement” has the meaning set forth in Section 5.2 (Development and Commercialization of the Co-Co Products; Opt-Down Right). |
1.38. | “Collaboration Activities” has the meaning set forth in Section 2.4 (Conduct of Collaboration Activities). |
1.39. | “Collaboration Program” means (a) the Exploratory Research Program and (b) each Drug Discovery Program. |
1.40. | “Collaboration Program Plans” has the meaning set forth in Section 2.4 (Conduct of Collaboration Activities). |
1.41. | “Collaboration Program Report” has the meaning set forth in Section 2.6.2 (Collaboration Program Reports). |
1.44. | “Combination Product” has the meaning set forth in Section 1.190 (Net Sales). |
1.45. | “Commercial Supply Agreement” has the meaning set forth in Section 8.1.1 (Metagenomi Supply Term). |
1.48. | “Common Ownership Legislation” means the legislation on conditions for patentability and novelty, as codified at 35 U.S.C. § 102(c) (Common Ownership Under Joint Research Agreements). |
1.49. | “Competitive Infringement” has the meaning set forth in Section 10.3.1 (Notification). |
1.51. | “Confidentiality Agreement” has the meaning set forth in Section 11.1.2 (Confidential Information of Each Party). |
1.57. | “Development Candidate Report” has the meaning set forth in Section 2.2.6 (Delivery of Development Candidate; Development Candidate Report). |
1.58. | “[***]” has the meaning set forth in Section 9.3 (Option Exercise Fee). |
1.59. | “Development Supply Agreement” has the meaning set forth in Section 8.1.1 (Metagenomi Supply Term). |
1.60. | “Disclosing Party” has the meaning set forth in Section 11.1.1 (General). |
1.61. | “Distracted Party” has the meaning set forth in Section 3.6.2 (Acquisition of Distracting Product). |
1.62. | “Distracting Product” has the meaning set forth in Section 3.6.2 (Acquisition of Distracting Product). |
1.63. | “[***]” means, with respect to a Distracting Product, [***]. |
1.64. | “Drug Discovery Activities” has the meaning set forth in Section 2.2.1 (Initial Drug Discovery Plan). |
1.65. | “Drug Discovery Budget” has the meaning set forth in Section 2.2.1 (Initial Drug Discovery Plan). |
1.66. | “Drug Discovery Plan” has the meaning set forth in Section 2.2.1 (Initial Drug Discovery Plan). |
1.68. | “Drug Discovery Term” has the meaning set forth in Section 2.2.7 (Drug Discovery Term). |
1.69. | “Effective Date” has the meaning set forth in the Preamble. |
1.70. | “EMA” means the European Medicines Agency or any successor agency or authority thereto. |
1.71. | “[***]” has the meaning set forth in Section 3 [***] of the Exploratory Research Plan attached hereto as Schedule 2.3.1 (Exploratory Research Plan). |
1.72. | “Encumbered Proposed Metagenomi Target” has the meaning set forth in Section 2.7.3(a) (Encumbered Targets). |
1.73. | “Encumbered Target” has the meaning set forth in Section 2.1.4(a) (Encumbered Targets). |
1.74. | “Encumbrance” means any and all liens, encumbrances, charges, mortgages, security interests, hypothecations, easements, rights-of-way or encroachments of any nature whatsoever. |
1.75. | “European Union” or “EU” means (a) all countries or territories that are officially part of the European Union, as constituted from time to time, and (b) the United Kingdom. |
1.76. | “Exclusivity Field” means, with respect to a Drug Discovery Program, (a) [***] and (b) [***]. |
1.77. | “Executive Officer” has the meaning set forth in Section 15.1.1 (Escalation). |
1.78. | “Existing Potential Ionis In-License Agreement” has the meaning set forth in Section 9.7.2 (Existing Potential Ionis In-License Agreements). |
1.79. | “Existing Potential Metagenomi In-License Agreement” has the meaning set forth in Section 9.7.1 (Effective Date Licensed Technology; Existing Metagenomi In-License Agreements). |
1.82. | “Exploratory Research Activities” has the meaning set forth in Section 2.3.1 (Exploratory Research Plan). |
1.83. | “Exploratory Research Budget” has the meaning set forth in Section 2.3.1 (Exploratory Research Plan). |
1.84. | “Exploratory Research Plan” has the meaning set forth in Section 2.3.1 (Exploratory Research Plan). |
1.85. | “Exploratory Research Program” has the meaning set forth in Section 2.3.1 (Exploratory Research Plan). |
1.86. | “Exploratory Research Term” has the meaning set forth in Section 2.3.3 (Exploratory Research Term). |
1.87. | “FDA” means the United States Food and Drug Administration and any successor agency or authority thereto. |
1.88. | “FD&C Act” means the United States Food, Drug, and Cosmetic Act, as amended, and the rules and regulations promulgated thereunder, as may be in effect from time to time. |
1.89. | “Field” means, with respect to a given Drug Discovery Program, [***]. |
1.90. | “Firewall Procedures” has the meaning set forth in Section 3.6.2 (Acquisition of Distracting Product). |
1.92. | “[***]” means, with respect to an Ionis Program and an Ionis Product Development Milestone Event, [***]. |
1.93. | “Force Majeure” has the meaning set forth in Section 15.11 (Force Majeure). |
1.94. | “FTE” has the meaning set forth in Section 1.95 (FTE Rate). |
1.96. | “Gene Editing” means [***]. |
1.98. | “Guide RNA” means any single- or double-stranded polynucleotide (including any analogue, variant, or mimic thereof) used for genome sequence site-specific targeting of a Gene Editing protein. |
1.99. | “[***]” has the meaning set forth in Section 2.2.4(c) (Incremental Development Costs). |
1.100. | “[***]” has the meaning set forth in Section 2.2.4(c) (Incremental Development Costs). |
1.102. | “Indemnitee” has the meaning set forth in Section 13.4 (Conditions to Indemnification). |
1.103. | “Infringement” has the meaning set forth in Section 10.3.1 (Notification). |
1.104. | “[***]” has the meaning set forth in Section 2.2.4(c) (Incremental Development Costs). |
1.105. | “Initiation” means, with respect to any Clinical Trial, the date on which the first subject in such trial receives his or her initial dose in such Clinical Trial. |
1.106. | “Insolvency Event” has the meaning set forth in Section 14.2.3 (Termination for Insolvency). |
1.107. | “Intellectual Property Rights” means any Know-How, Patent Rights, Trademarks, copyrights, trade secrets, and any other intellectual property rights however denominated throughout the world. |
1.109. | “Ionis” has the meaning set forth in the Preamble. |
1.110. | “Ionis Background Technology” has the meaning set forth in Section 2.7.1 (Option Grant). |
1.111. | “Ionis Collaboration Know-How” has the meaning set forth in Section 10.1.2(b) (Ionis Collaboration Technology). |
1.112. | “Ionis Collaboration Patent Rights” has the meaning set forth in Section 10.1.2(b) (Ionis Collaboration Technology). |
1.113. | “Ionis Collaboration Technology” has the meaning set forth in Section 10.1.2(b) (Ionis Collaboration Technology). |
1.114. | “Ionis [***]” means [***]. |
1.116. | “Ionis Indemnitees” has the meaning set forth in Section 13.2 (Indemnification of Ionis by Metagenomi). |
1.118. | “Ionis IP Option” has the meaning set forth in Section 2.7.1 (Option Grant). |
1.119. | “Ionis IP Option Effective Date” has the meaning set forth in Section 2.7.3(b) (Effects if a Proposed Metagenomi Target is not an Encumbered Proposed Metagenomi Target). |
1.122. | “Ionis Licensed Patent Rights” means any Patent Rights Controlled by Ionis or any of its Affiliates that Cover any Ionis Licensed Know-How. |
1.123. | “Ionis Licensed Technology” means Ionis Licensed Know-How and Ionis Licensed Patent Rights. |
1.124. | “Ionis Product Development Milestone Event” has the meaning set forth in Section 9.4.1 (Ionis Product Development Milestone Payments). |
1.125. | “Ionis Product Development Milestone Payment” has the meaning set forth in Section 9.4.1 (Ionis Product Development Milestone Payments). |
1.126. | “Ionis Product Regulatory Milestone Event” has the meaning set forth in Section 9.4.2 (Ionis Product Regulatory Milestone Payments). |
1.127. | “Ionis Product Regulatory Milestone Payment” has the meaning set forth in Section 9.4.2 (Ionis Product Regulatory Milestone Payments). |
1.128. | “Ionis Product Sales Milestone Event” has the meaning set forth in Section 9.4.3 (Ionis Product Sales Milestone Payment). |
1.129. | “Ionis Product Sales Milestone Payment” has the meaning set forth in Section 9.4.3 (Ionis Product Sales Milestone Payment). |
1.130. | “Ionis Products” means any Licensed Products that are the subject of an Ionis Program. |
1.132. | “Ionis Proprietary Toolbox of Chemical Modifications” means [***] that is Covered by an Ionis Toolbox Patent. |
1.133. | “Ionis-Prosecuted Patent Rights” has the meaning set forth in Section 10.2.1(a). |
1.134. | “Ionis Records” has the meaning set forth in Section 9.13.1 (Books and Records). |
1.135. | “Ionis Royalties” has the meaning set forth in Section 9.6.1 (Ionis Royalty Rates). |
1.136. | “Ionis Royalty Rates” has the meaning set forth in Section 9.6.1 (Ionis Royalty Rates). |
1.137. | “Ionis Royalty Report” has the meaning set forth in Section 9.6.4 (Ionis Royalty Reports). |
1.138. | “Ionis Toolbox Patent” means any Patent Right Controlled by Ionis as of the Effective Date or during the Collaboration Term that [***]. |
1.139. | “Joint Collaboration Know-How” has the meaning set forth in Section 10.1.2(c) (Joint Collaboration Technology). |
1.140. | “Joint Collaboration Patent Rights” has the meaning set forth in Section 10.1.2(c) (Joint Collaboration Technology). |
1.141. | “Joint Collaboration Technology” has the meaning set forth in Section 10.1.2(c) (Joint Collaboration Technology). |
1.142. | “Joint Research Committee” or “JRC” has the meaning set forth in Section 4.3.1 (Formation and Purpose of the JRC). |
1.143. | “Joint Steering Committee” or “JSC” has the meaning set forth in Section 4.1.1 (Formation and Purpose of the JSC). |
1.149. | “Licensed Technology” means all Licensed Know-How and Licensed Patent Rights and Metagenomi’s interest in the Joint Collaboration Technology. |
1.150. | “Licensee” has the meaning set forth in Section 15.10.1. |
1.151. | “Licensing Party” has the meaning set forth in Section 15.10.1. |
1.152. | “Losses” has the meaning set forth in Section 13.1 (Indemnification of Metagenomi by Ionis). |
1.154. | “Major European Markets” means each of France, Germany, Spain, Italy, and the United Kingdom. |
1.155. | “Major Market” means each of Japan, the Major European Markets, and the US. |
1.157. | “Manufacturing Know-How” has the meaning set forth in Section 8.5 (Manufacturing After the Metagenomi Supply Term). |
1.158. | “Manufacturing Technology Transfer” has the meaning set forth in Section 8.5 (Manufacturing After the Metagenomi Supply Term). |
1.160. | “Metagenomi” has the meaning set forth in the Preamble. |
1.161. | “Metagenomi Activities” has the meaning set forth in Section 3.2.1(a) (Metagenomi Activities License Grant). |
1.162. | “Metagenomi Collaboration Cost Reports” has the meaning set forth in Section 2.5.1 (Reimbursement by Ionis). |
1.163. | “Metagenomi Collaboration Know-How” has the meaning set forth in Section 10.1.2(a) (Metagenomi Collaboration Technology). |
1.164. | “Metagenomi Collaboration Patent Rights” has the meaning set forth in Section 10.1.2(a) (Metagenomi Collaboration Technology). |
1.165. | “Metagenomi Collaboration Technology” has the meaning set forth in Section 10.1.2(a) (Metagenomi Collaboration Technology). |
1.166. | “Metagenomi [***]” means [***]. |
1.167. | “Metagenomi Drug Discovery Costs” has the meaning set forth in Section 2.5.1 (Reimbursement by Ionis). |
1.168. | “Metagenomi Exploratory Research Costs” has the meaning set forth in Section 2.5.1 (Reimbursement by Ionis). |
1.169. | “Metagenomi Field” means all therapeutic, prophylactic, palliative, analgesic, and diagnostic uses in humans through the use of the Metagenomi Platform. |
1.171. | “Metagenomi Indemnitees” has the meaning set forth in Section 13.1 (Indemnification of Metagenomi by Ionis). |
1.173. | “Metagenomi Platform” means [***]. |
1.174. | “Metagenomi Platform Know-How” means any Know-How within Metagenomi Platform as of the Effective Date or during the Term. |
1.176. | “Metagenomi Platform Technology” means the Metagenomi Platform Patent Rights and the Metagenomi Platform Know-How. |
1.178. | “Metagenomi Product Milestone Event” has the meaning set forth in Section 9.10.1 (Metagenomi Product Milestone Payments). |
1.179. | “Metagenomi Product Milestone Payment” has the meaning set forth in Section 9.10.1 (Metagenomi Product Milestone Payments). |
1.180. | “Metagenomi-Prosecuted Patent Rights” has the meaning set forth in Section 10.2.2 (Metagenomi-Prosecuted Patent Rights). |
1.181. | “Metagenomi Records” has the meaning set forth in Section 9.13.1 (Books and Records). |
1.182. | “Metagenomi Royalties” has the meaning set forth in Section 9.10.3(a) (Metagenomi Royalty Rates) |
1.183. | “Metagenomi Royalty Rate” has the meaning set forth in Section 9.10.3(a) (Metagenomi Royalty Rates) |
1.184. | “Metagenomi Royalty Report” has the meaning set forth in Section 9.10.4 (Metagenomi Royalty Reports). |
1.186. | “Metagenomi Supply Term” has the meaning set forth in Section 8.1.1 (Metagenomi Supply Term). |
1.187. | “Metagenomi System” means a Gene Editing protein and a Guide RNA that is designed to modulate a Metagenomi Target. |
1.188. | “Metagenomi Target” means each target for which Metagenomi exercises an Ionis IP Option pursuant to Section 2.7 (Ionis Proprietary Toolbox of Chemical Modifications). |
1.189. | “MG Manufactured Components” has the meaning set forth in Section 8.1.1 (Metagenomi Supply Term). |
(b) | amounts repaid or credited by reason of rejection, returns or recalls of goods, rebates or bona fide price reductions determined by the Selling Party in good faith; |
(d) | refunds or clawbacks of a portion of payments previously paid by the Selling Party for not achieving a predetermined metric or term in an outcome-based contracts; |
(g) | an allowance for transportation costs, distribution expenses, special packaging, insurance charges, and storage and warehousing costs. |
Net Sales (including any deductions) will be calculated using the Selling Party’s internal audited systems used to report such sales as adjusted for any of the items above not taken into account in such systems, fairly applied and as employed on a consistent basis throughout such Selling Party’s operations. To the extent any accrued amounts used in the calculation of Net Sales are estimates, such estimates will be trued-up to actuals (including that, for any estimates of deductions that are later decreased, the difference will be added back to Net Sales). In no event will any particular amount identified above be deducted more than once in calculating Net Sales (i.e., no “double counting” of deductions).
In the case of any sale or other disposal of a product between or among such Party or its Affiliates or Sublicensees for resale, Net Sales will be calculated only on the value charged or invoiced on the first arm’s-length sale thereafter to a Third Party (other than a Sublicensee). In the case of any sale that is not invoiced or is delivered before invoice, Net Sales will be calculated at the time all the revenue recognition criteria under such Party’s Accounting Standards are met. In the case of any sale or other disposal for value, such as barter or counter-trade, of any Licensed Product or Metagenomi Product (as applicable), or part thereof, other than in an arm’s-length transaction exclusively for money, Net Sales will be calculated on the value of the non-cash consideration received or the fair market price (if higher) of such Licensed Product(s) or Metagenomi Product(s) (as applicable) in the country of sale or disposal. Notwithstanding the foregoing, the following will not be included in Net Sales: (1) sales between or among a Party and its Affiliates or Sublicensees (but Net Sales will include sales to the first Third Party (other than a Sublicensee) by a Party or its Affiliates or Sublicensees); and (2) any named patient sales or any sale or other distribution at cost or less than cost for use in any Clinical Trial, for bona fide charitable purposes, test marketing program, or for compassionate use.
Solely for purposes of calculating Net Sales, if the Selling Party sells a Licensed Product or Metagenomi Product (as applicable) in the form of a combination product containing a Licensed System or Metagenomi System (as applicable) and one or more other therapeutically or prophylactically active ingredients or delivery devices that is not a Licensed System or Metagenomi System (as applicable) (“Other Product”) (whether combined in a single formulation or package, as applicable, or formulated separately but packaged under a single label approved by a Regulatory Authority and sold together for a single price) (such combination product, a “Combination Product”), Net Sales of such Combination Product for the purpose of determining the payments due to the other Party pursuant to this Agreement will be calculated by [***]. If the gross selling price of a Licensed Product or Metagenomi Product (as applicable) containing such Licensed System or Metagenomi System (as applicable) in such country when sold separately in finished form (i.e., without the other active ingredients or delivery device) can be determined but the gross selling price of the Other Product in such country cannot be determined, then Net Sales in such country for purposes of determining royalty payments will be calculated by [***]. If such separate sales are not made in a country, then Net Sales will be calculated by [***].
If a license agreement or collaboration agreement that is negotiated in an arm’s length transaction with an Sublicensee includes a definition of “Net Sales” that differs in any material respect from the definition contained in this Section 1.190 (Net Sales), then the Parties will discuss such material differences and will use reasonable efforts to negotiate in good faith any reasonable modifications to this Section 1.190 (Net Sales) that are necessary to avoid any ambiguity in the calculation of the royalty payment due to a Party under this Agreement for sales of Licensed Products or Metagenomi Products by such Sublicensee.
1.191. | “[***]” means [***]. |
1.192. | “New In-License Agreement” has the meaning set forth in Section 9.8.2 (Acceptance of a Proposed New In-License Agreement). |
1.193. | “New Ionis In-License Agreement” has the meaning set forth in Section 9.8.2 (Acceptance of a Proposed New In-License Agreement). |
1.194. | “New Metagenomi In-License Agreement” has the meaning set forth in Section 9.8.2 (Acceptance of a Proposed New In-License Agreement). |
1.195. | “Non-Withholding Party” has the meaning set forth in Section 9.17 (Withholding Taxes). |
1.196. | “Opt-Down Right” has the meaning set forth in Section 5.2 (Development and Commercialization of the Co-Co Products; Opt-Down Right). |
1.197. | “Opt-Out Date” has the meaning set forth in Section 5.4 (Metagenomi Opt-Out). |
1.198. | “Opt-Out Period” has the meaning set forth in Section 5.4 (Metagenomi Opt-Out). |
1.199. | “Opt-Out Right” has the meaning set forth in Section 5.4 (Metagenomi Opt-Out). |
1.200. | “Option Exercise Fee” has the meaning set forth in Section 9.3 (Option Exercise Fee). |
1.201. | “Option Exercise Notice” has the meaning set forth in Section 2.7.2 (Option Exercise). |
1.202. | “Option Package” has the meaning set forth in Section 5.1.2 (Option Period). |
1.203. | “Option Term” has the meaning set forth in Section 2.7.2 (Option Exercise). |
1.204. | “Other Product” has the meaning set forth in Section 1.190 (Net Sales). |
1.206. | “Party” has the meaning set forth in the Preamble. |
1.207. | “Party Vote” has the meaning set forth in Section 4.6.1 (Committee Decisions). |
1.209. | “Payments” has the meaning set forth in Section 9.17 (Withholding Taxes). |
1.213. | “Pre-Existing Ionis Restriction” has the meaning set forth in Section 2.7.3(a) (Encumbered Targets). |
1.214. | “Pre-Existing Restriction” has the meaning set forth in Section 2.1.4(a) (Encumbered Targets). |
1.219. | “Proposed Metagenomi Target” has the meaning set forth in Section 2.7.2 (Option Exercise). |
1.220. | “Proposed Metagenomi Target Notice” has the meaning set forth in Section 2.7.2 (Option Exercise). |
1.221. | “[***]” has the meaning set forth in Section 2.2.4(c) (Incremental Development Costs). |
1.222. | “Proposed New In-License Agreement” has the meaning set forth in Section 9.8.1 (Proposed New In-License Agreements). |
1.223. | “Proposed New Ionis In-License Agreement” has the meaning set forth in Section 9.8.1 (Proposed New In-License Agreements). |
1.224. | “Proposed New Metagenomi In-License Agreement” has the meaning set forth in Section 9.8.1 (Proposed New In-License Agreements). |
1.225. | “Proposed Replacement Target” has the meaning set forth in Section 2.1.3(d) (Substitution Procedure). |
1.226. | “Proposed Target” means any (a) Additional Wave 1 Target, (b) Wave 2 Target, or (c) Proposed Replacement Target. |
1.227. |
1.229. | “Quarterly Reimbursement Payments” has the meaning set forth in Section 2.5.1 (Reimbursement by Ionis). |
1.230. | “Receiving Party” has the meaning set forth in Section 11.1.1 (General). |
1.234. | “Regulatory Strategy” has the meaning set forth in Section 7.1 (Regulatory Responsibility). |
1.236. | “Reimbursement Cap” has the meaning has the meaning set forth in Section 2.5.1 (Reimbursement by Ionis). |
1.237. | “Replacement Target Notice” has the meaning set forth in Section 2.1.3(d) (Substitution Procedure). |
1.238. | “Requested CMO” has the meaning set forth in Section 8.1.2 (Requested CMO). |
1.239. | “Requested CMO Contract” has the meaning set forth in Section 8.1.2 (Requested CMO). |
1.240. | “Residual Knowledge” has the meaning set forth in Section 11.3 (Residual Knowledge). |
1.241. | “Reversion IP In-License Agreement” has the meaning set forth in Section 14.3.6(b) (Third Party Reversion IP). |
1.242. | “Reversion License” has the meaning set forth in Section 14.3.6(a) (Reversion License Grant). |
1.245. | “Second Wave 1 Target” has the meaning set forth in Section 2.1.1(b) (Second Wave 1 Target). |
1.246. | “Selling Party” has the meaning set forth in Section 1.190 (Net Sales). |
1.247. | “Subcommittee” has the meaning set forth in Section 4.2 (Subcommittees). |
1.250. | “Supply Price” has the meaning set forth in Section 8.1.1 (Metagenomi Supply Term). |
1.251. | “Target Selection and Substitution Period” has the meaning set forth in Section 2.1.4(b) (Expiration of Pre-Existing Restrictions). |
1.252. | “Target Substitution Period” has the meaning set forth in Section 2.1.3(a) (Discretionary Substitutions). |
1.253. | “Technological Infeasibility” has the meaning set forth in Section 2.1.3(b) (Substitutions for Technological Infeasibility). |
1.254. | “Term” has the meaning set forth in Section 14.1 (Term). |
1.255. | “Terminated Combination Products” has the meaning set forth in Section 14.3.7 (Reversion for Certain Combination Products). |
1.258. | “Territory” means all countries of the world and all territories and possessions thereof. |
1.259. | “Third Party” means any Person other than a Party or an Affiliate of a Party. |
1.260. | “Third Party Claims” has the meaning set forth in Section 13.1 (Indemnification of Metagenomi by Ionis). |
1.261. | “Third Party Distributor” means any Third Party that distributes (but does not Develop or Manufacture) a Licensed Product directly to customers. |
1.262. | “Third Party Expert” has the meaning set forth in Section 15.1.3(a). |
1.263. | “Third Party Infringement Claim” has the meaning set forth in Section 10.4 (Defense of Claims Brought by Third Parties). |
1.264. | “Third Party IP” has the meaning set forth in Section 9.6.2(c) (Third Party Payments). |
1.265. | “Third Party Payment” has the meaning set forth in Section 9.6.2(c) (Third Party Payments). |
1.267. | “[***]” has the meaning set forth in Section 2.1.1(a) (Initial Wave 1 Target). |
1.268. | “[***] Target Population” has the meaning set forth in Section 9.5 (Ionis Products for [***] Target Populations). |
1.269. | “Unblocking Field” means [***]. |
1.270. | “United States” or “U.S.” means the United States of America and all of its districts, territories and possessions. |
1.271. | “Upfront Payment” has the meaning set forth in Section 9.1 (Upfront Payment). |
1.275. | “Wave 2 Target” has the meaning set forth in Section 2.1.2 (Wave 2 Target Options). |
1.276. | “Wave 2 Target Notice” has the meaning set forth in Section 2.1.2 (Wave 2 Target Options). |
1.277. | “[***]” has the meaning set forth in Section 9.2 ([***]). |
1.278. | “Wave 2 Target Selection Period” has the meaning set forth in Section 2.1.2 (Wave 2 Target Options). |
1.279. | “Withholding Party” has the meaning set forth in Section 9.17 (Withholding Taxes). |
Schedule 1.114
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Schedule 1.146
Licensed Patent Rights
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Schedule 1.166
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Schedule 1.175
Metagenomi Platform Patent Rights
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Schedule 2.1.1(a)
[***]
“[***]” is the [***].
Schedule 2.2
[***] Drug Discovery Plan
Attached.
Schedule 2.2
[***] Drug Discovery Plan
[***]
Schedule 2.3.1
Exploratory Research Plan
Attached.
Schedule 2.3.1
Exploratory Research Plan
[***]
Schedule 8.2
Development Supply Agreement Key Terms
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Press Release(s)
Attached.
Ionis partners with Metagenomi to add gene editing to its broad technology platform
− | Collaboration with a leader in gene editing systems is Ionis’ latest move to expand and diversify its technology |
− | CRISPR-Cas gene editing is a natural extension of Ionis’ innovative approach to delivering potentially transformative therapies |
− | Ionis to hold webcast Nov. 14 at 8 a.m. Eastern Time |
CARLSBAD, Calif. and EMERYVILLE, Calif. Nov. 14, 2022 – Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) and Metagenomi today announced that the companies have entered a collaboration that will leverage Ionis’ extensive expertise in RNA-targeted therapeutics and Metagenomi’s versatile next-generation gene editing systems to pursue a mix of validated and novel genetic targets that have potential to expand therapeutic options for patients. The companies will jointly conduct research aimed initially at delivering investigational medicines for up to four genetic targets. Ionis has the right to add four more targets upon achievement of pre-determined development milestones.
“Ionis was founded over 30 years ago to discover and develop novel, highly personalized medicines using our powerful RNA-targeting technology platform. This partnership with Metagenomi supports Ionis’ strategic objective to advance our technology and expand our capabilities to deliver precision genetic medicines.
Together, we can broaden the application of gene editing by leveraging Ionis’ vast experience in nucleic acid therapeutics to optimize and extend the reach of gene editing for liver targets and to new tissues,” said Ionis Chief Executive Officer Brett P. Monia, Ph.D. “This alliance brings our two companies closer to delivering next-generation therapies with the potential to revolutionize the treatment of diseases.”
“Gene editing has the potential to transform chronic therapies into potentially curative treatments for patients who currently have limited options,” said Brian C. Thomas,
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EMBARGOED UNTIL MONDAY, NOVEMBER 14 AT 6:05 A.M. EASTERN TIME
Ph.D., chief executive officer and founder of Metagenomi. “This collaboration is a strategic step to combine Metagenomi’s leading gene editing toolbox of diverse, specific and highly efficient nucleases, with Ionis’ pioneering expertise of RNA-targeted therapeutics, to catalyze the next wave of in vivo gene editing applications. We continue to follow our strategy of partnering with the most experienced teams in the genetic medicines field that will allow us to transform the lives of patients.”
Under the terms of the agreement, Ionis will pay $80 million upfront to Metagenomi plus the potential for future milestone payments and royalties. Wells Fargo Securities acted as financial advisor to Ionis on the transaction.
Webcast
Ionis will conduct a webcast on Nov. 14 at 8 a.m. Eastern Time to discuss this announcement and related activities. Interested parties may access the webcast [here]. A webcast replay will be available for a limited time at the same address.
CRISPR Gene Editing
“CRISPR (clustered regularly interspaced short palindromic repeats) gene editing is a technology that modifies the sequence of DNA in cells utilizing a specific RNA-guided nuclease (Cas enzyme). Gene editing enzymes act as molecular word processors to correct the genetic code at the precise spot where it is malfunctioning.”
About Ionis Pharmaceuticals, Inc.
For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with its novel antisense technology. Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading cardiovascular and neurological franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision of becoming a leading, fully integrated biotechnology company.
To learn more about Ionis, visit www.ionispharma.com and follow us on Twitter @ionispharma.
About Metagenomi
Metagenomi is a gene editing company committed to developing potentially curative therapeutics by leveraging a proprietary toolbox of next-generation gene editing systems to accurately edit DNA where current technologies cannot. Our metagenomics- powered discovery platform and analytical expertise reveal novel cellular machinery sourced from otherwise unknown organisms. We adapt and forge these naturally
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evolved systems into powerful gene editing systems that are ultra-small, extremely efficient, highly specific and have a decreased risk of immune response. These systems fuel our pipeline of novel medicines and can be leveraged by partners. Our goal is to revolutionize gene editing for the benefit of patients around the world. For more information, please visit https://metagenomi.co/.
Ionis’ Forward-looking Statements
This press release includes forward-looking statements regarding Ionis’ business and the therapeutic and commercial potential of Ionis’ technologies and products in development. Any statement describing Ionis’ goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including but not limited to, those related to our commercial products and the medicines in our pipeline, and particularly those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such medicines. Ionis’ forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements.
Although Ionis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Ionis. As a result, you are cautioned not to rely on these forward-looking statements.
These and other risks concerning Ionis’ programs are described in additional detail in Ionis’ annual report on Form 10-K for the year ended Dec. 31, 2021, and the most recent Form 10-Q quarterly filing, which are on file with the Securities and Exchange Commission. Copies of these and other documents are available from the Company.
In this press release, unless the context requires otherwise, “Ionis,” “Company,” “we,” “our,” and “us” refers to Ionis Pharmaceuticals and its subsidiaries.
Ionis Pharmaceuticals® is a trademark of Ionis Pharmaceuticals, Inc.
Ionis Investor Contact: info@ionisph.com, 760-603-2331
Ionis Media Contact: corporatecommunications@ionisph.com, 760-603-4679
Metagenomi Investor Contact: Simon Harnest, simon@metagenomi.co
+1 (917) 403-1051
Metagenomi Media Contact: Ashlye Hodge, ashlye@metagenomi.co
+1 (510) 734-4409
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Schedule 12.2
Metagenomi Disclosure Schedule
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Schedule 12.4
Ionis Disclosure Schedule
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