Master Alliance Provisions Guide (MAPGuide)

Moderna – Lonza, COVID-19 mRNA Vaccine & Therapies, Manufacturing & Process Development Agreement

  • Business model | Payment Structures

2. Statements Of Work – Process And Product Development; Process Or Product Manufacture; Flow-Down provisions; Quality Agreement

2.2. Modification of Statement of Work. Should MODERNA want to change a Statement of Work or to include additional Services to be provided by LONZA, including any changes to the Specifications, Process or Test Methods for the Products, MODERNA may propose to LONZA (including via the JSC or JMT) an amendment to such Statement of Work with the desired changes or additional Services (each a “Change Order”). LONZA will provide MODERNA with a Change Order containing a description of the required modifications to the relevant Statement of Work, and any proposed changes to the pricing or other fees as well as impact on timelines as a result of such modifications, and will use diligent efforts to do so within [***] of receiving such notice from MODERNA. LONZA may also propose a Change Order to MODERNA, and MODERNA will use diligent efforts to answer to such proposal within [***] of receiving such proposal. If the proposed Change Order is not acceptable to the receiving Party, the Parties will promptly negotiate in good faith a Change Order that is mutually acceptable. LONZA shall continue to work under this Agreement (including under the existing Statement of Work) during any such negotiations. LONZA shall use commercially reasonable efforts to accommodate any of MODERNA’s requested changes, provided if a change is required by any Regulatory Authority on or after the Commencement Date for a Product, such change shall be included in a Change Order. The modified Statement of Work shall be binding on the Parties only if it is signed by both Parties. Thereafter such modified version of the Statement of Work will be deemed to have replaced the prior version of the Statement of Work. Notwithstanding the foregoing, if a modified version of the Statement of Work is not agreed to by both Parties, the existing Statement of Work shall remain in effect, unless terminated by MODERNA in accordance with this Agreement or the existing Statement of Work.

9. Financial Terms

9.1 Pricing. [***].

9.2 Payments. MODERNA will make payments to LONZA in the amounts and on the dates set forth in the relevant Statement of Work upon receipt of an invoice from LONZA.

9.3 Invoices and Pricing. LONZA will charge for the Services in accordance with the price schedule in the relevant Statement of Work. LONZA will invoice MODERNA according to the schedule set forth in the relevant Statement of Work. LONZA will deliver invoices electronically by email, which shall be considered to be an original invoice. Invoices shall be e-mailed to [***], and/or to such other e-mail address(es) as MODERNA may stipulate from time to time. LONZA will not deliver a paper invoice. Payment of each invoice is due within [***] after MODERNA’s receipt of such invoice. Unless otherwise provided in the relevant Statement of Work, all pricing excludes taxes and costs relating to shipping, validation and regulatory filings. The price shall be invoiced to MODERNA in U.S. Dollars or such other currency as agreed upon in the relevant Statement of Work.

9.7 Cost Improvements. Promptly after a Product has been launched, LONZA will in good faith continuously seek to improve and reduce direct material costs, direct operating labor costs and indirect expenses attributable to the manufacture of the Product throughout the term of this Agreement and, at the request of MODERNA, provide MODERNA written evidence demonstrating the efforts and activities undertaken by LONZA in furtherance thereof. LONZA and MODERNA agree to periodically, but not less than [***], review the cost of materials, labor, expenses and other matters that influence the price MODERNA pays for the Product and determine whether any price decreases may be appropriate. Upon the request of MODERNA, LONZA will provide to MODERNA reasonable evidence of any and all improvements as they are achieved and of the availability of any potential improvements hereunder. LONZA agrees to reflect and incorporate into this Agreement achieved price reductions realized by LONZA after the effective date of such price change. MODERNA and LONZA will set specific key performance indicators defining timing and percent reduction for the manufacture of the Product (“KPIs”) once a Product has been launched. KPIs may include, but are not limited to, manufacturing operations (including inventory reductions, process improvement, and lead-times), sourcing, international operations and logistics, and business practices. Progress of these goals will be reviewed periodically, but in any case no less than [***]. All savings achieved through these cost improvements by LONZA will be [***].