Transition Service Agreement by and between Amphastar Pharmaceuticals, Inc., and Eli Lilly and Company, dated June 30, 2023
Exhibit 10.3
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS ([***]), HAS BEEN OMITTED BECAUSE
THE INFORMATION (I) IS NOT MATERIAL AND
(II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED
TRANSITION SERVICES AGREEMENT
BETWEEN
ELI LILLY AND COMPANY
AND
AMPHASTAR PHARMACEUTICALS, INC.
DATED AS OF
June 30, 2023
TABLE OF CONTENTS
Page
i
ii
EXHIBITS
Exhibit A1Services
Exhibit A2Excluded Services
Exhibit BNet Economic Benefit
Exhibit CRebates, Chargebacks and Other Financial Matters
Exhibit D Distribution End Date
Exhibit EAdditional Definitions
Exhibit FPrice Mechanics
iii
TRANSITION SERVICES AGREEMENT
THIS TRANSITION SERVICES AGREEMENT (this “Agreement”), dated as of June 30, 2023 (the “Closing Date”), is by and between Eli Lilly and Company, an Indiana corporation (“Lilly”), and Amphastar Pharmaceuticals, Inc., a Delaware corporation (“Recipient”). Each of Lilly and Recipient may be referred to individually as a “Party” and collectively as the “Parties.”
WHEREAS, Lilly and Recipient have entered into that certain Asset Purchase Agreement dated as of April 21, 2023 (the “Asset Purchase Agreement”); and
WHEREAS, following the consummation of the transactions contemplated by the Asset Purchase Agreement, as an accommodation to Recipient, Lilly has agreed to perform (and where applicable, procure the performance of) certain Services (as defined below) for the benefit of Recipient, subject to the terms and conditions contained herein.
NOW, THEREFORE, in consideration of the foregoing, the covenants and agreements set forth herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto agree as follows:
DEFINED TERMS
Capitalized terms used but not defined herein will have the meanings set forth in the Asset Purchase Agreement, as applicable. In addition to those terms defined above and elsewhere in this Agreement, for purposes of this Agreement, the following terms will have the meanings set forth below.
“Confidential Information” means all nonpublic information or materials received or otherwise obtained or observed by or on behalf of a Party or its Affiliates (“Receiving Party”) by or on behalf of the other Party or its Affiliates (“Disclosing Party”) in connection with this Agreement, including technical and non-technical data, know-how, methods, operational information, procedures, and processes, in each case regardless of whether such information is identified as confidential, but excluding any information that is (i) generally available to and known by the public, other than as a result of a breach of this Agreement by the Receiving Party, (ii) the Receiving Party acquires from a Third Party without any duty of confidentiality to the Disclosing Party, (iii) is independently developed or acquired, without reference to or use of the Disclosing Party’s Confidential Information, or (iv) is already known by the Receiving Party at the time of disclosure, without duty of confidentiality to the Disclosing Party.
“Disability” has the meaning set forth in Section 2.19.
“Dispute” has the meaning set forth in Section 12.3.1.
“Distribution End Date” means, with respect to each country in the Supply Territory, the date set forth for such country on Exhibit D (Distribution End Date) hereto, as such date may be modified by the Transition Managers in accordance with Section 2.13.
“Distribution Period” means, with respect to each country in the Supply Territory, the period that commences on the Closing Date and ends on the applicable Distribution End Date for such country.
1
“Entity” means any corporation (including any nonprofit corporation), general partnership, limited partnership, limited liability partnership, joint venture, estate, trust or company (including any limited liability company or joint stock company) or other similar entity.
“Excluded Services” means any services of the nature described in Exhibit A2 (Excluded Services) hereto.
“Good Industry Practice” means the exercise of reasonable skill, care, prudence, efficiency, foresight and timeliness which would be expected from a prudent and experienced Person providing services in the nature of the relevant Services.
“Intellectual Property Rights” means all trademarks, patents, trade dress, service marks, domain names, business names, copyrights (or rights in any of the foregoing, as applicable) and any other intangible property, and all applications and registrations therefor, and all inventions, know-how, trade secrets, and other intellectual property and proprietary rights arising under any jurisdiction.
“Interest Rate” has the meaning set forth in Exhibit E (Additional Definitions) hereto.
“Internal Compliance Codes” means a Party’s internal policies and procedures intended to ensure that a Party complies with applicable Laws and such Party’s internal ethical, medical, and similar standards.
“IT Systems” means Recipient’s IT Systems or Lilly’s IT Systems, as the context requires.
“Liability Cap” has the meaning set forth in Exhibit E (Additional Definitions) hereto.
“Lilly Indemnified Party(ies)” has the meaning set forth in Section 11.4.1.
“Lilly Sold Product” has the meaning set forth in Section 2.8.
“Lilly TSA License” has the meaning set forth in Section 8.2.
“Lilly’s IT Systems” means all communication systems and computer systems used by Lilly (or any of Lilly’s Affiliates) including all hardware and software and elements of the systems that are used (or shared) by Lilly or its Affiliates, but excluding networks generally available to the public.
“Management Representative(s)” has the meaning set forth in Section 12.3.1.
“Marketing Authorization” has the meaning set forth in the Manufacturing Services Agreement.
“Marketing Authorization Transfer Date” means, on a country-by-country basis, the effective date of transfer of the applicable Marketing Authorization(s) as specified in Exhibit C (Marketing Authorization Transfer Plan) to the Manufacturing Services Agreement, with respect to Product for the applicable country, to Recipient or its designated Affiliate.
“Payment Currency” means United States Dollars or U.S. Dollars.
2
“Person” means any individual, Entity or Governmental Authority.
“Proceeding” means any action, suit, litigation, arbitration, proceeding (including any civil, criminal, administrative, investigative or appellate proceeding), prosecution, contest, hearing, inquiry, inquest, audit, examination or investigation that is, has been or may in the future be commenced, brought, conducted or heard at law or in equity or before any Governmental Authority.
“Product” means a powdered formulation (containing glucagon for nasal administration and the related unit dose system for powder) marketed for sale to consumers as of the Closing Date as BAQSIMI® of a SKU set forth on Exhibit M (Product SKUs and Description) to the Manufacturing Services Agreement. For clarity, the Demo Version (as defined in the Asset Purchase Agreement) does not constitute Product.
“Recall Adjustment” has the meaning set forth in Section 3.1.
“Recipient Dependent Element” has the meaning set forth in Section 2.16.1.
“Recipient Indemnified Party(ies)” has the meaning set forth in Section 11.4.2.
“Recipient’s IT Systems” means all communication systems and computer systems used by Recipient (or any of Recipient’s Affiliates) including all hardware, software and websites and elements of the systems that are used (or shared) by Recipient or its Affiliates, but excluding networks generally available to the public.
“Regulatory Services” has the meaning set forth in Section 2.11.1.
“Sales Taxes” has the meaning set forth in Section 6.2.
“Service Charge(s)” means the service charge(s) set forth in respect of each Service or group of Services set forth on any Exhibit (including Exhibit A1 (Services) hereto), for clarity, which may include hourly fees (such as FTE fees), flat fees (such as monthly fixed fee), percentage of Net Sales fees, or out of pocket pass-through of direct costs, as applicable.
“Services” means the transitional services to be provided by Lilly, whether itself or through its Affiliates, under this Agreement (including Exhibit A1 (Services) hereto) including the arrangements set forth on Exhibit A1 hereto, which Exhibit may be modified by mutual agreement of the Transition Managers in accordance with Section 2.13, but in all cases excluding the Excluded Services.
“Services Standard” has the meaning set forth in Section 2.2.
“Subpoena” has the meaning set forth in Section 10.2.1.
“Supply Territory” has the meaning set forth in the Manufacturing Services Agreement.
“Tax” means all taxes, levies, duties, imposts, charges and withholdings of any nature whatsoever together with all penalties, charges and interest relating to any of them or to any failure to file any return required for the purposes of any of them.
3
“Tax Authority” means any taxing or other authority competent to impose any liability in respect of Tax or responsible for the administration or collection of Tax or enforcement of any law in relation to Tax.
“Third Party Agreement” means any Third Party agreement or license, which Lilly or any of its Affiliates is a party to or has the benefit of, and which is required to enable Lilly to deliver, or is otherwise used by Lilly in the delivery of, the Services.
“Third Party Consent” has the meaning set forth in Section 2.4.1.
“Third Party Dependent Element” has the meaning set forth in Section 2.4.2.
“Transition Manager” has the meaning set forth in Section 2.13.
“Transition Period” has the meaning set forth in Section 5.1, as may be extended, on a Service-by-Service basis, in accordance with Section 5.2.
“Transition Steering Committee” or “TSC” has the meaning set forth in Section 2.14.
“TSA Product Intellectual Property Rights” means all Intellectual Property Rights primarily related to the Product, excluding all trademarks, trade dress, service marks, domain names, business names, or other sources of indicia or origin, that are generated in connection with activities under this Agreement by either Party, solely or jointly with others.
“VAT” means value-added Tax.
“Withholding Agent” has the meaning set forth in Section 7.2.
SERVICES
4
5
6
Recipient (such Product, “Lilly Sold Product”), subject to the terms of this Section 2.8 and Section 9.3.2.
7
8
9
(including all Exhibits hereto). The Transition Managers will (a) review, consider for modification, and if so agreed, modify any Exhibits hereto, in writing (including by electronic transmission such as email), during the term of this Agreement and (b) serve as the primary contact points for the resolution of any issues or potential disputes that may arise during the performance of this Agreement, with the intent of averting the escalation of such issues or potential disputes. The Transition Managers will meet at least monthly during the term of this Agreement in person or virtually in order to discuss the quality of the Services and the status of the transition and to manage open issues. These meetings may take place in person, by telephone, via a web-based meeting service, or otherwise as agreed by the Parties. For the avoidance of doubt, pursuant to the terms of this Agreement including its Exhibits, the Transition Managers may, on behalf of the respective Parties, agree in writing (including by electronic transmission such as email) in accordance with Section 2.13 to the provision and receipt of additional or extended Services for a Service Charge that may be different from the corresponding Service Charge set forth on Exhibit A1 (Services) hereto for the applicable Services during the applicable Transition Period. The Transition Managers may have additional responsibilities as mutually agreed to by the Parties.
10
11
part of the Services required under this Agreement is rendered invalid as a result of such Disability, then Lilly will, upon written request from Recipient, and at Recipient’s expense, use commercially reasonable efforts to repeat that part of the Services affected by the Disability as soon as reasonably practicable in light of the existence of such Disability.
Recalls
IT SYSTEMS
TERM
12
may be different from the corresponding Service Charge set forth on Exhibit A1 hereto for the applicable Services during the applicable Transition Period. If Lilly agrees (pursuant to this Section 5.2) to provide such Service for any extended Transition Period, then such Service will remain a Service and be subject in all respects to the provisions of this Agreement during the extended Transition Period, and the extended Transition Period will be deemed the Transition Period for purposes of this Agreement.
CONSIDERATION AND PAYMENT
13
day basis) monthly Service Charge for such partial calendar month (for clarity, which proration will be based on the actual number of business days in the calendar month for which Lilly was providing the applicable Service relative to the total number of business days in such calendar month).
14
will make its personnel available upon reasonable advance notice and during normal business hours to answer such questions as Recipient may reasonably ask for such purpose.
WITHHOLDING AND VAT
15
OWNERSHIP OF ASSETS; INTELLECTUAL PROPERTY
16
TERMINATION
17
reason in accordance with the terms hereof, the Parties will cooperate in the orderly termination of the relevant Service(s) hereunder, including Section 9.3.1 and Section 9.3.2:
CONFIDENTIALITY
18
LIMITATION OF LIABILITY; INDEMNIFICATION
19
remedies under applicable Law, including claims for damages or indemnification for the losses incurred by reason of such breach of this Agreement.
20
OTHER PROVISIONS
21
22
| 12.9.1. if to Lilly: |
| Eli Lilly and Company |
| Lilly Corporate Center |
| Indianapolis, IN 46285 |
| Attention: Vice President, Corporate Business Development |
| |
| with a copy (which shall not constitute notice) to: |
| |
| Eli Lilly and Company |
| Lilly Corporate Center |
| Indianapolis, IN 46285 |
| Attention: General Counsel |
| |
| with a copy (which shall not constitute notice) to: |
| |
| Kirkland & Ellis LLP |
| 601 Lexington Avenue |
| New York, NY 10022 |
| Attention: [***] |
| [***] |
| [***] |
| |
| |
| 12.9.2. if to Recipient: |
| Amphastar Pharmaceuticals, Inc. |
| 11570 Sixth Street |
| Rancho Cucamonga, CA 91730 |
| Attention: Jacob Liawatidewi |
| EVP Corporate Administration Center |
| Email: [***] |
| |
| |
| with a copy (which shall not constitute notice) to: |
| |
| Wilson Sonsini Goodrich & Rosati |
| One Market Plaza |
| Spear Tower, Suite 3300 |
| San Francisco, CA 94105 |
| Attention:[***] |
| [***] |
| Email: [***] |
| [***] |
Notice so given will (in the case of notice so given by mail) be deemed to be given when received and (in the case of notice so given by courier or hand delivery) on the date of actual transmission or (as the case may be) personal delivery.
23
Agreement and shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expiration. Notwithstanding anything to the contrary in this Agreement, the Parties’ respective obligations under Section 2.8.3 (with respect to Lilly Sold Product), Section 2.10 (Distribution Activities) (to the extent of any surviving obligations to process customer order and distribute finished Product), Section 2.15 (Data Privacy), Section 2.19 (Force Majeure), Section 3.1 (Recalls), Section 6.5 (Interest on Late Payments), Section 9.3 (Rights and Duties of Parties Upon Termination or Expiration), Article VII (Withholding and VAT), Article VIII (Ownership of Assets; Intellectual Property), Article X (Confidentiality), Article XI (Limitation of Liability; Indemnification) and Article XII (Other Provisions) and under the heading “Pharmacovigilance and Global Patient Safety” of Exhibit A1 (Services) hereto, and Recipient’s obligations under Section 2.11 (Regulatory) and Section 2.12.2 (Recipient’s Covenants) and under the headings “Commercial Operations,” “Sales and Marketing” and “Medical Affairs” of Exhibit A1 (Services) hereto will survive the expiration or termination of this Agreement. Section 6.1.1, Section 6.2 (Sales Taxes), Section 6.3 (Statement of Services Charges and Reimbursable Costs) and Section 6.4 (Payments) and Section 2 of Exhibit B (Net Economic Benefit) hereto will survive to the extent of any unpaid amounts due thereunder or any payments made or other activities conducted in accordance with the surviving provisions hereof.
[The remainder of this page is intentionally blank.]
24
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed by their respective duly authorized officers as of the Closing Date.
ELI LILLY AND COMPANY | |||
| By: | /s/ Michael B. Mason | |
| | Name: Michael B. Mason | |
| | Title: Executive Vice President and President, Lilly Diabetes and Obesity | |
AMPHASTAR PHARMACEUTICALS, INC. | |||
| By: | /s/ Bill Peters | |
| | Name: Bill Peters | |
| | Title: Authorized Signatory | |
[Signature Page to Manufacturing Services Agreement]
Exhibit A1
Services
Service Charge:
The Monthly Fee is [***] Percent ([***]%) of the Net Sales (as defined in Exhibit B (Net Economic Benefit) to the Transition Services Agreement) for each calendar month during the term of the Transition Services Agreement, which Monthly Fee (with respect to the applicable calendar month) will include the applicable Services as provided in this Exhibit below as subject to the Monthly Fee, unless otherwise agreed by the Parties in writing.
For Services included within the Monthly Fee, no additional amounts will be due unless, and except to the extent that, for any Services, Recipient agrees to and shall be responsible for other Service Charge(s) as specifically set forth below for the applicable Service(s); provided that, for Services that are subject to a cap on the number of hours included in the Monthly Fee, any Services in excess of the applicable cap set forth below will be charged as FTE Fees at the applicable rate set forth below.
For Services not included within the Monthly Fee, the applicable Service Charges are specified below in this Exhibit.
The FTE Fees, unless otherwise specified in this Exhibit or agreed by the Parties in writing, shall be billed at $[***] U.S. Dollars per FTE hour. With respect to any Services relating to [***], the FTE Fees shall be billed at $[***] U.S. Dollars per FTE hour with a monthly cap of [***] hours for the aggregate of applicable Services. [***].
1
Excluded Services
[***]
2
Excluded Services
Exhibit B
Net Economic benefit
[***]
1
Net Economic Benefit
Exhibit C
Rebates, Chargebacks and Other Financial Matters
[***]
2
Rebates, Chargebacks and Other Financial Matters
Exhibit D
Distribtution End Date
[***]
1
Distribution End Date
Exhibit E
Additional Definitions
[***]
1
Additional Definitions
Exhibit F
Price Mechanics
[***]
1
Price Mechanics