Certain information marked as [***] has been excluded from this exhibit because it is both not material and is the type that the registrant treats as private or confidential PROGRAM PURCHASE AGREEMENT
Exhibit 10.1
Certain information marked as [***] has been excluded from this exhibit because it is both not material and is the type that the registrant treats as private or confidential
THIS PROGRAM PURCHASE AGREEMENT (this “Agreement”), effective as of April 9, 2021 (the “Effective Date”), is made and entered into by and among LES LABORATOIRES SERVIER, a corporation incorporated under the laws of France having a principal place of business at 00 xxx Xxxxxx, 00000 Xxxxxxxx, Xxxxxx (“LLS”) and INSTITUT DE RECHERCHES INTERNATIONALES SERVIER, a corporation incorporated under the laws of France having its principal place of business at 00 xxx Xxxxxx, 00000 Xxxxxxxx, Xxxxxx (“IRIS”) (LLS and IRIS together jointly and severally, “Servier”), and PRECISION BIOSCIENCES, INC., a Delaware corporation with its principal place of business at 000 X Xxxxxxxxx Xx X-000, Xxxxxx, XX 00000, X.X.X. (“Precision”). Precision and Servier may each be referred to herein individually as a “Party” and collectively as the “Parties.”
RECITALS
WHEREAS, the Parties previously entered into that certain Development and Commercial License Agreement, effective February 24, 2016 (as previously amended by that certain Amendment No. 1 to Development and Commercial License Agreement, effective as of February 24, 2017, that certain Amendment No. 2 to Development and Commercial License Agreement, effective as of August 21, 2017, that certain Amendment No. 3 to Development and Commercial License Agreement, effective as of February 5, 2018, that certain Amendment No. 4 to Development and Commercial License Agreement, effective as of May 23, 2018 (“Amendment No. 4”), that certain Amendment No. 5 to Development and Commercial License Agreement, effective as of September 18, 2019, and that certain Amendment No. 6 to the Development and Commercial License Agreement, effective as of October 2, 2020 (the “DCLA”).
WHEREAS, Servier desires to divest the Reversion Program (as defined in Section 1.12).
WHEREAS, Precision desires to re-acquire the rights under the Reversion Program.
WHEREAS, the Parties desire to terminate the DCLA by mutual consent in accordance with Section 14.2.6 of the DCLA as amended by this Agreement, under the terms and conditions set forth herein.
NOW THEREFORE, in consideration of the mutual promises and covenants set forth below and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:
1
1. |
DEFINITIONS |
The following terms as used in this Agreement shall have the meanings set forth in this Article 1. Capitalized terms used in this Agreement without being defined herein shall have the meaning set out in the DCLA.
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1.4. |
“Independently Active Therapeutic Ingredient” means, with respect to a Combination Product, an active therapeutic ingredient having a different Target or mode of action, or which is otherwise treated or designated by the applicable Regulatory Authority as a separate active ingredient, than the applicable Product. |
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[***]
The amounts invoiced by Precision, or any Selling Entity for [***] shall not be included in the computation of Net Sales hereunder and Net Sales shall be the [***]
Further, the following shall not be considered Net Sales: [***]
In the event a Product is co-packaged, co-formulated, sold in conjunction with or otherwise sold in a manner that includes one or more Independently Active Therapeutic Ingredients in addition to a Product (such Product, a “Combination Product”), then Net Sales, for purposes of determining royalty payments on such Combination Product, will be calculated by [***]
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1.6. |
“Other Targets” means [***] |
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1.7. |
[***] |
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1.8. |
“Product” means any of the following: (a) the CAR-T product known as PBCAR0191 Directed to CD19, (b) the CAR-T product known as PBCAR19B Directed to CD19, (c) the CAR-T product known as [***], (d) the CAR-T product known as [***], (e) the CAR-T product known as [***], (f) the CAR-T product known as [***], in each case as described in the applicable Development Plan as of immediately prior to the Effective Date of this Agreement as such product may be further developed thereafter [***] and (g) the first one (1) CAR-T product for which IND Acceptance occurs constituting a Variant (not described in Section 1.8 (a) to (f)) Directed to CD19 or Directed to any Other Target. |
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1.9. |
“Product Partnering Transaction” means a transaction pursuant to which Precision or any of its Affiliates grants to a Third Party (such Third Party, a “Product Partner”) [***] |
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1.11. |
“Reimbursement Approval” means with respect to a particular Product and a particular country or regulatory jurisdiction, any pricing and reimbursement approvals by the applicable Regulatory Authority or other Governmental Authority in such country or regulatory jurisdiction that are necessary for a sale or transfer of such Product to any applicable Regulatory Authority or other Governmental Authority, or for a sale or |
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transfer of such Product to be reimbursable or credited by, charged to or otherwise paid for by, in whole or in part, any applicable Regulatory Authority or other Government Authority in such country or regulatory jurisdiction at the relevant time. |
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1.13. |
“Royalty Term” shall have the meaning set forth in Section 3.7. |
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1.15. |
“Selling Entity” has the meaning set forth in Section 1.2. |
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1.16. |
“Third Party License Agreement” means any agreement (including any settlement agreement) entered into after the Effective Date with a Third Party, whereby royalties are to be paid to such Third Party based on the grant of rights under Patent Rights Controlled by such Third Party in a country or countries, which Patent Rights are Necessary to Commercialize the Product. For purposes of this definition, “Necessary to Commercialize” means, with respect to a particular Product and Patent Rights Controlled by a Third Party in a particular country or countries, [***]. In the event Servier in good faith disputes the determination by Precision that such Patent Rights are Necessary to Commercialize, such dispute shall be resolved in accordance with Section 8.4. |
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1.17. |
“Upfront Fee” has the meaning set forth in Section 3.1. |
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1.18. |
“Waiver Fee” has the meaning set forth in Section 3.2. |
The following new sub-section is hereby added to Section 14.2 of the DCLA (Early Termination):
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14.2.6 |
By Mutual Consent. This Agreement may be terminated by the mutual written consent of the Parties. |
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2.1. |
The Parties hereby terminate the DCLA, as amended by this Agreement, by mutual consent in accordance with Section 14.2.6 of the DCLA and under the terms and conditions set forth herein. |
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2.2. |
All licenses and options to license granted to either Party under the DCLA, including all sublicenses thereunder, are hereby immediately terminated. |
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2.3. |
Except with respect to the surviving obligations set forth in Article 5 of this Agreement, each of the Parties is hereby released from its obligations under the DCLA, including with respect to the Reversion Program. |
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2.4. |
Within [***] following the Effective Date of this Agreement, Servier shall, at the request of Precision, (i) deliver to Precision (and if delivery is not feasible, certify the destruction of) any and all tangible Confidential Information of Precision in Servier’s possession, (ii) remove Confidential Information of Precision relating to the manufacturing and Regulatory Filings for the Product known as PBCAR19B from all databases and systems, without regard for whether such removal is practicable, and (iii) to the extent practicable, remove any other Confidential Information of Precision from all databases and systems and in those instances where removal is not practicable, segregate or otherwise indicate that such Confidential Information is restricted. Servier represents and warrants that it has no Confidential Information of Precision in its lab notebooks. Servier shall have the right to retain one (1) copy of Precision’s Confidential Information described in sub-part (iii) above in its archives solely for the purpose of maintaining compliance with its obligations hereunder. |
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2.6. |
The Parties hereby acknowledge and agree that Section 2.6 of the DCLA was removed from the DCLA pursuant to Amendment No. 4, therefore the license set forth in Section 2.6.1 of the DCLA has never been entered into between the Parties and Precision has no right to request in writing to enter into an agreement pursuant to which Precision may use Isolex Platform Technology in connection with Products. |
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result of activities in connection with the DCLA) to make, have made, use, sell, offer for sale, import and otherwise Develop and Commercialize Products (or any other engineered human T Cells with Chimeric Antigen Receptors Directed to CD19 or any Other Targets) in the Field in the Territory and (ii) make such assignments as necessary to accomplish the intended effect of Section 14.3.1(a) of the DCLA. |
3. |
PAYMENTS |
Phase I Success for the Licensed Product Candidate PBCAR0191 |
$ [***] |
Additional milestone payment upon Phase I Success for the Licensed Product Candidate PBCAR0191 |
$ [***] |
First Gene Editing Event for the Licensed Product Candidate Directed to [***] |
$ [***] |
First Gene Editing Event for the Licensed Product Candidate Directed to [***] |
$ [***] |
Total Waiver Fee |
$ 18,750,000 |
REGULATORY AND COMMERCIAL MILESTONES for the first Product Directed to CD19 |
|
[***] |
$ [***] |
[***] |
$ [***] |
[***] |
$ [***] |
[***] |
$ [***] |
[***] |
$ [***] |
[***] |
$ [***] |
[***] |
$ [***] |
Sub-total |
$ [***] |
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SALES MILESTONE PAYMENTS for the first Product Directed to CD19 |
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$[***] of global Net Sales of the first Product Directed to CD19 to achieve such sales level in a Calendar Year |
$ [***] |
$[***] of global Net Sales of the first Product Directed to CD19 to achieve such sales level in a Calendar Year |
$ [***] |
$[***] of global Net Sales of the first Product Directed to CD19 to achieve such sales level in a Calendar Year |
$ [***] |
Sub-total |
$ [***] |
For clarity, the maximum total milestones payable for all Products Directed to CD19 shall be $[***], regardless of whether such milestones are achieved by one or both of the Products Directed to CD19.
REGULATORY AND COMMERCIAL MILESTONES for each Product Directed to Other Targets |
|
[***] |
$ [***] |
[***] |
$ [***] |
[***] |
$ [***] |
[***] |
$ [***] |
[***] |
$ [***] |
[***] |
$ [***] |
Sub-total |
$ [***] |
SALES MILESTONE PAYMENTS for each Product Directed to Other Targets |
|
$[***] of global Net Sales of the Product in a Calendar Year |
$ [***] |
$[***] of global Net Sales of the Product in a Calendar Year |
$ [***] |
$[***] of global Net Sales of the Product in a Calendar Year |
$ [***] |
Sub-total |
$ [***] |
For clarity, the maximum total milestones payable for all Products Directed to Other Targets shall be $[***]
Each milestone payment set forth in this Section 3.3 shall be payable by Precision upon the first achievement of the applicable milestone, and Precision shall provide notice to Servier of such achievement within [***] following such achievement. Following Servier’s receipt of a notice described in the immediately preceding sentence, Servier shall provide Precision with a corresponding invoice and Precision shall pay to Servier the applicable milestone payment described above within [***] after receipt of such invoice.
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case solely the payment obligations set forth in Section 3.5 shall apply with respect to the scope of such Product Partnering Transaction), pay to Servier non-creditable, non-refundable royalty payments at the following royalty rates on the applicable portion of cumulative Calendar Year global Net Sales of the applicable Product: |
ROYALTIES |
|
For each Product Directed to [***] |
[***]% |
For each Product Directed to [***] |
[***]% |
For each Product Directed to [***] |
[***]% |
For each Product Directed to [***] |
[***]% |
REGULATORY MILESTONE any Product Directed to CD19 |
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[***] |
$ [***] |
For clarity, the above payment for a Product Directed to CD19 shall be payable one time upon the first achievement of such milestone by any Product Directed to CD19, in accordance with the invoice procedures set forth in Section 3.3, even if Precision has entered into a Product Partnering Transaction for such Product prior to the achievement of such milestone, but such milestone shall not be payable under this Section 3.5 if it has already been paid by Precision under Section 3.3.
Proceeds with respect to a Product Partnering Transaction with respect to a Product Directed to [***] |
[***]% of any Proceeds, which Proceeds [***] |
Proceeds with respect to a Product Partnering Transaction with respect to a Product Directed to [***] |
[***]% of any Proceeds, which Proceeds [***] |
Proceeds with respect to a Product Partnering Transaction with respect to a Product Directed to [***] |
[***]% of any Proceeds, which Proceeds [***] |
Proceeds with respect to a Product Partnering Transaction with respect to a Product Directed to [***] |
[***]% of any Proceeds, which Proceeds [***] |
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3.6. |
Diligence obligation. Should Precision enter into a Product Partnering Transaction with respect to a Product Directed to CD19 or a Product Directed to any Other Target, [***]. |
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with respect to such Product in such other country and (ii) Proceeds payments pursuant to Section 3.5 with respect to a Product Partnering Transaction for such Product with respect to such other country shall expire ten (10) years after the First Commercial Sale of such Product in such other country (all of the foregoing, as applicable with respect to a particular Product, the “Royalty Term”). |
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3.10. |
Royalty Payment Timing; Royalty Reports. Within [***] following the end of each Calendar Quarter during which (a) royalty payments accrue pursuant to Section 3.4 with respect to a particular Product or (b) Proceeds payments accrue pursuant to Section 3.5 with respect to a Product Partnering Transaction with respect to a particular Product, Precision shall provide Servier with a Sales Report and any other information reasonably required by Servier for the purpose of calculating royalties, Proceeds payments and sales milestone payments due under this Agreement. Any royalty payments and Proceeds payments due to Servier will be paid on the date of delivery of such Sales Report. In the event that either Party determines that the calculation of Net Sales for a Calendar Quarter deviates from the amounts previously reported to Servier for any reason (such as, on account of additional amounts collected or Product returns), Precision and Servier shall reasonably cooperate to reconcile any such deviations to the extent necessary under applicable legal or financial reporting requirements. |
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written notice to Precision, but no more frequently than once per year. No accounting period of Precision shall be subject to audit more than one time by Servier, unless after an accounting period has been audited by Servier, Precision restates its financial results for such accounting period, in which event Servier may conduct a second audit of such accounting period in accordance with this Section 3.11. Adjustments (including remittances of underpayments or overpayments disclosed by such audit) shall be made by the Parties to reflect the results of such audit, which adjustments shall be paid (plus interest as set forth in Section 3.13) promptly following receipt of an invoice therefor. Servier shall bear the full cost and expense of such audit unless such audit discloses an underpayment by Precision of [***] or more of the amounts due under this Agreement for the audited period, in which case Precision shall bear and reimburse Servier for the full cost and expense of such audit. |
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3.14. |
Reporting. All financial reporting hereunder shall be, if applicable, on the basis of U.S. GAAP, consistently applied. |
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3.15. |
Currency; Exchange Rate. All payments to be made under this Agreement shall be made in USD by bank wire transfer in immediately available funds to a bank account designated by written notice from Servier. With respect to sales not denominated in USD, Precision shall convert each applicable quarterly sales in foreign currency into |
10
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USD by using the then current and reasonable standard exchange rate methodology applied by Precision in its worldwide accounting practices, consistent with U.S. GAAP, consistently applied. Based on the resulting sales in USD, the then applicable royalties shall be calculated. The initial wire transfer instructions for Servier are set forth on Schedule 2. |
4. |
Right of First negotiation |
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4.2. |
[***] |
|
4.3. |
[***] |
|
4.4. |
[***] |
5. |
AMENDMENT TO SECTION 14.3.4 of the dcla |
Section 14.3.4 of the DCLA is hereby amended as follows:
|
14.3.4 |
Survival. The following Articles and Sections of this Agreement, as well as remedies for breach of this Agreement, shall survive expiration or termination of this Agreement for any reason: ARTICLE I (solely to the extent required to enforce any other surviving rights or obligations of the Parties), Section 4.5, Section 9.1, Section 12.1, Section 12.2, Section 12.4.2, Section 12.4.5, ARTICLE XIII and Section 14.3.4. |
Without limiting the foregoing, survival of Section 12.1 of the DCLA additionally means that all information disclosed by Precision to Servier under this Agreement shall be treated as Confidential Information of Precision under the provisions of Section 12.1 of the DCLA for the term of this Agreement. For the avoidance of doubt, Section 13.4.1 of the DCLA shall apply to activities
11
arising out of this Agreement as if fully set forth herein, provided that the reference to Article XII in Section 13.4.1 of the DCLA shall be replaced by Section 12.1, Section 12.2, Section 12.4.2, and Section 12.4.5.
6. |
press release; Disclosures of terms of agreement |
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7. |
TERM AND termination |
|
7.1. |
Term. This Agreement shall become effective as of the Effective Date and shall be perpetual, irrevocable and non-terminable. Neither Party shall have any right to cancel, revoke or terminate this Agreement or any license or right granted by either Party to the other Party in or pursuant to this Agreement. |
8. |
MISCELLANEOUS |
|
8.2. |
Headings; Rules of Construction. Headings are inserted for convenience and shall not affect the meaning or interpretation of this Agreement. Each Party agrees that this Agreement shall be interpreted without regard to any presumption or rule requiring construction against the Party causing this Agreement to be drafted. Except as otherwise explicitly specified to the contrary in this Agreement, (a) the words “hereof,” “herein,” “hereby,” “hereunder” and words of similar import shall refer to this Agreement as a whole and not to any particular section or subsection of this Agreement and reference to a particular section of this Agreement shall include all subsections thereof, (b) references to a section, exhibit or schedule means a section of, or exhibit or schedule to, this Agreement unless such reference appears in amended text of the DCLA or refers specifically to a section of the DCLA, (c) definitions shall be equally applicable to both the singular and plural forms of the terms defined, and references to the masculine, feminine or neuter gender shall include each other gender, (d) the words “include,” “includes” and “including” shall be deemed to be followed by the words “without limitation,” (e) references to a rule, statute or regulation (including CPR rules and procedures) include all rules and regulations thereunder and any successor statute, rule or regulation, in each case as amended or otherwise modified from time to time, (f) |
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references to a particular Governmental Authority include any successor agency or body to such Governmental Authority and (g) references to “days” means calendar days, unless specified as Business Days. |
If to Precision: |
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|
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Precision BioSciences, Inc. |
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000 Xxxx Xxxxxxxxx Xxxxxx, Xxxxx X-000 |
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Xxxxxx, XX 00000 |
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Facsimile: (000) 000-0000 |
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|
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Attention: Xxxxx Xxxxxx, Senior Vice President, Business Development and Alliance Management |
|
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with a copy (which copy shall not constitute legal notice to Precision) to: |
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|
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Smith, Anderson, Blount, Dorsett, Xxxxxxxx & Xxxxxxxx, LLP |
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000 Xxxxxxxxxxxx Xxxxxx, Xxxxx 0000 |
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Xxxxxxx, XX 00000 |
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Facsimile: (000) 000-0000 |
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Attention: Xxxx X. Xxxxxxx, Esq. |
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If to Servier: |
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|
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Head of Alliance Management |
|
Les Laboratoires Servier |
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Institut de Recherches Internationales Servier |
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00 xxx Xxxxxx |
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00000 Xxxxxxxx, Xxxxxx |
|
Email: [***] |
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Attention: Alliance Management Director |
|
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with a copy (which copy shall not constitute legal notice to Servier) to: |
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|
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Contracts Department Director |
|
Les Laboratoires Servier |
|
Institut de Recherches Internationales Servier |
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00 xxx Xxxxxx |
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00000 Xxxxxxxx, Xxxxxx |
|
Email: [***] |
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Attention: Xxxxxxxx Xxxxxxxxx |
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8.4. |
Dispute Resolution. In the event of a dispute arising out of or in connection with this Agreement, the Parties shall endeavor to solve the problem amicably and promptly by negotiation between Executive Officers of the respective Parties, in each case who have authority to settle the dispute, claim or controversy. If a Party provides written notice to the other Party regarding any such dispute and such dispute is not resolved through such negotiation procedures within [***] after receipt of such written notice by the other Party, any and all disputes arising out of or in connection with this Agreement shall be finally settled by confidential arbitration in accordance with the rules of arbitration of the International Chamber of Commerce by one or more arbitrators appointed in accordance with said rules. Arbitration proceedings shall be held in New York, New York, USA. The language shall be in English. |
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8.5. |
Governing Law. Any dispute, claim or controversy arising under or related to this Agreement, including the construction, validity and performance of this Agreement, shall be governed in all respects by the substantive laws of the state of New York, excluding its provisions regarding conflicts of law. |
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8.6. |
Rights in Bankruptcy. All rights, powers and remedies of the Non-Debtor Party provided herein are in addition to and not in substitution for any and all other rights, powers and remedies now or hereafter existing at law or in equity (including under the Bankruptcy Laws) in the event of the commencement of a case under the Bankruptcy Laws by or against the Debtor Party. The Non-Debtor Party, in addition to the rights, power and remedies expressly provided herein, shall be entitled to exercise all other such rights and powers and resort to all other such remedies as may now or hereafter exist at law or in equity (including under the Bankruptcy Laws) in such event. |
|
8.7. |
Severability. Whenever possible, each term and provision of this Agreement shall be interpreted in such manner as to be valid and effective under applicable Laws, but, if any term or provision of this Agreement is held to be invalid or unenforceable under applicable Laws, such term or provision shall be invalid and ineffective only to the extent of such invalidity or unenforceability, without invalidating or making unenforceable the remainder of this Agreement. In the event of such invalidity or unenforceability, the Parties shall use reasonable efforts to seek and agree on an alternative valid and enforceable provision that preserves the original purpose and intent of the Agreement. |
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8.8. |
Independent Contractors. It is understood that the Parties are independent contractors and engage in the operation of their own respective businesses, and neither Party hereto is to be considered the agent or partner of the other Party for any purpose whatsoever. Neither Party has any authority to enter into any contracts or assume any obligations for the other Party or make any representations or warranties on behalf of the other Party. |
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8.9. |
Entire Agreement. This Agreement and the surviving provisions of the DCLA constitute the entire agreement between the Parties and shall cancel and supersede any and all prior and contemporaneous negotiations, correspondence, understandings and agreements, whether oral or written, between the Parties respecting the subject matter hereof, including the Confidentiality Agreement and that certain non-binding term sheet exchanged by the Parties prior to the Effective Date. To the extent there is a conflict |
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between this Agreement and the surviving provisions of the DCLA, this Agreement shall prevail. |
|
8.10. |
Further Assurances. The Parties shall do and cause to be done, and shall cause their respective Affiliates to do and cause to be done, all such acts, matters, and things, and shall execute and deliver, and shall cause their respective Affiliates to execute and deliver, all such additional documents, instruments, conveyances, and assurances, and take such further actions, as may be required to carry out the provisions hereof and give effect to the transaction contemplated herein. |
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8.12. |
Compliance with Laws. Each Party will comply with all applicable Laws in performing its obligations and exercising its rights hereunder. |
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8.13. |
Counterparts. This Agreement may be executed in more than one counterpart, each of which shall be deemed an original, but all of such counterparts taken together shall constitute one and the same agreement. This Agreement may be executed and delivered electronically or by facsimile and upon such delivery such electronic or facsimile signature will be deemed to have the same effect as if the original signature had been delivered to the other Party. |
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IN WITNESS WHEREOF, the Parties have caused this Program Purchase Agreement to be executed by their duly authorized representatives.
For Precision BioSciences, Inc. |
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For Les Laboratoires Servier |
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By: |
/s/ Xxxxxxx Xxxx |
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By: |
/s/ Xxxx Falcand |
Name: |
Xxxx XXXX |
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Name: |
Xxxx FALCAND |
Title: |
CEO |
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Title: |
Proxy |
For Institut de Recherches Internationales Servier |
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By: |
/s/ Xxxxxx Xxxxxxxx |
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Name: |
Xxxxxx XXXXXXXX |
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Title: |
Executive Vice President R&D |
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EXECUTION VERSION
CT0090683 - Confidential
SCHEDULE 1 – REVERSION PROGRAM (Section 1.12(a), (b) and (c))
[***]
EXECUTION VERSION
CT0090683 - Confidential
SCHEDULE 2 - WIRE TRANSFER INSTRUCTION
[***]
EXECUTION VERSION
CT0090683 - Confidential
SCHEDULE 3 – APPROVED PARAGRAPHS AND QUOTATION
[***]
EXECUTION VERSION
CT0090683 - Confidential
SCHEDULE 4 – ARBITRATION PROCEDURES FOR PROCEEDS ALLOCATION
[***]