Common use of Term Description Clause in Contracts

Term Description. Stage Supplied Amgen will supply Novartis with Franchise Product 1 in [*] form in accordance with the provisions of the Supply Agreement. The Parties shall determine whether to supply Franchise Product 1 in [*] form based on whether [*]. Additionally, Amgen will supply Novartis with placebo of Franchise Product 1. Specifications Amgen will Manufacture and supply one distinct Franchise Product 1 fulfilling one set of specifications. However, the Franchise Product 1 specifications may need to be revised in accordance with requests from the local health authorities (including with respect to testing methods) on a country-by-country basis. Novartis will not agree to commitments with a local health authority with respect thereto without the prior written consent of Amgen. Remaining Shelf Life The minimum shelf life remaining upon delivery for use in a particular country shall be equal to [*]% of the then current approved shelf life of the Franchise Product 1 in such country (provided that the then current approved shelf life in such country is a minimum of [*] months). If the then current approved shelf life of the Franchise Product 1 in such country is less than [*] months, the Parties shall, through a governance body established under the Supply Agreement, negotiate in good faith a new minimum shelf life taking into account Governmental Authority requirements and existing tender constraints. IncoTerm Franchise Product 1 will be supplied to Novartis [*] (Incoterms 2010 ICC). Risk and title to the Franchise Product 1 shall transfer at [*]. Cost Franchise Product 1 will be supplied to Novartis at [*] (such terms to be defined in the Supply Agreement in a manner substantially similar as defined in that certain [*] effective as of [*]. In addition thereto, Amgen will be entitled to charge Novartis certain support costs directly related to the Manufacture or supply of Franchise Product 1 for the Territory that are not included in [*] (“Support Costs”) ([*]). The mechanism for discussing, tracking and charging for Support Costs to be more fully detailed in the Supply Agreement. The Supply Agreement shall [*] to be defined in the Supply Agreement. Site of Manufacture Amgen has sole discretion to determine which Amgen site will be utilized for Manufacturing drug substance and drug product for the Franchise Product 1, [*]. [*]. [*]. At any time, Amgen can use a Third Party CMO, [*], provided that [*]. Audit Right Novartis will have the right to inspect Amgen’s sites utilized for Manufacturing, [*] storage, testing, shipping or receiving of the Franchise Product 1 [*] per twelve (12) month period, as well as more often in case of quality issue. Amgen Ref. No. 2015641252 SCHEDULE

Appears in 1 contract

Sources: Exclusive License and Collaboration Agreement (Amgen Inc)

Term Description. Stage Supplied Amgen Variation Management The Supply Agreement will supply Novartis with Franchise Product 1 include provisions relating to variation management, including notification requirements, whether or not such variation is required by Governmental Authorities, or requires Governmental Authority approval. Indemnification Each Party (the “Indemnifying Party”) will indemnify the other Party for losses for any claim brought by a Third Party against the other Party to the extent such losses result from (i) the gross negligence or willful misconduct of the Indemnifying Party in [*] form in accordance with performing under the provisions Supply Agreement or the Quality Agreement or (ii) the breach by the Indemnifying Party of its obligations under the Supply Agreement. The Parties shall determine whether Amgen will indemnify Novartis for losses for any claim brought by a Third Party against Novartis to supply the extent such losses result from any manufacturing defect at the time of delivery of Franchise Product 1 to Novartis (including failure of product to be manufactured in [*] form based on whether [*]. Additionallyaccordance with cGMP), except in the case that the Amgen will supply reasonably requests Novartis to take prompt mitigating actions (including conducting a recall) with placebo of respect to such Franchise Product 1. Specifications , in which case (1) Amgen will Manufacture shall be responsible for the costs related to such mitigation actions and supply one distinct (2) Novartis shall be responsible for losses with respect to such Franchise Product 1 fulfilling one set of specificationsfor which Novartis declines to take such requested actions to the extent that such losses result from Novartis’ refusal to implement such requested actions. However, the Franchise Product 1 specifications may need to be revised in accordance with requests from the local health authorities (including with respect to testing methods) on a country-by-country basis. Distribution Novartis will not agree require its distributors to commitments with a local health authority with respect thereto without the prior written consent of Amgen. Remaining Shelf Life The minimum shelf life remaining upon delivery for use have appropriate controls in a particular country shall be equal place to [*]% of the then current approved shelf life of manage the Franchise Product 1 in such country (provided that the then current approved shelf life in such country is a minimum of [*] months)accordance with product labeled conditions. If the then current approved shelf life of the Miscellaneous The Supply Agreement would contain other customary provisions including, without limitation, provisions regarding financial audit rights, confidentiality, warranties, and termination. Franchise Product 1 in such country is less than [*] months, the Parties shall, through a governance body established under the Supply Agreement, negotiate in good faith a new minimum shelf life taking into account Governmental Authority requirements 2 and existing tender constraints. IncoTerm Franchise Product 1 will be supplied to Novartis [*] (Incoterms 2010 ICC). Risk 3 The terms and title to the Franchise Product 1 conditions set out in this Commercial Supply Schedule shall transfer at [*]. Cost Franchise Product 1 will be supplied to Novartis at [*] (such terms to be defined in only serve as a basis for the Supply Agreement in a manner substantially similar as defined in that certain [*] effective as of [*]. In addition thereto, Amgen will be entitled to charge Novartis certain support costs directly related to the Manufacture or supply of Franchise Product 1 for the Territory that are not included in [*] (“Support Costs”) ([*]). The mechanism for discussing, tracking and charging for Support Costs to be more fully detailed in the Supply Agreement. The Supply Agreement shall [*] to be defined in the Supply Agreement. Site of Manufacture Amgen has sole discretion to determine which Amgen site will be utilized for Manufacturing drug substance and drug product for the Franchise Product 1, [*]. [*]. [*]. At any time, Amgen can use a Third Party CMO, [*], provided that [*]. Audit Right Novartis will have the right to inspect Amgen’s sites utilized The Supply Agreements for Manufacturing, [*] storage, testing, shipping or receiving of the Franchise Product 1 [*] per twelve (12) month period2 and the Franchise Product 3, as well as more often if any, shall include terms and conditions substantially similar to those set out in case of quality issuethis Commercial Supply Schedule. Amgen Ref. No. 2015641252 SCHEDULESCHEDULE Amgen Ref. No. 2015641252 SCHEDULE Amgen Ref. No. 2015641252 SCHEDULE Out-of-Pocket Development Expenses, with respect to a Licensed Product, include direct out-of-pocket costs that are attributable to the Development of the Licensed Product including:

Appears in 1 contract

Sources: Exclusive License and Collaboration Agreement (Amgen Inc)

Term Description. Stage Supplied Amgen will supply Novartis Commencement of Out-of-Court Transaction Upon the election of Panda Holdings I, the Company and all, and not less than all, of the Lenders under the Credit Agreement, the Company shall consummate the Out-of-Court Transaction. Upon such election, the Company and the Requisite Lenders shall revise the Restructuring Support Agreement, this Restructuring Term Sheet and any applicable definitive documentation to reflect the terms of such Out- of-Court Transaction. This Summary of Proposed Material Terms and Conditions (this “DIP Term Sheet”) outlines certain material terms of a potential Superpriority Senior Secured Debtor-in-Possession Credit Facility proposed to be provided by the DIP Lenders (as defined below) to Panda Temple Power, LLC (“Panda”) and its affiliated debtors and debtors-in-possession in connection with Franchise Product 1 their voluntary pre-arranged chapter 11 cases subject to, among other conditions, the negotiation and execution of definitive documentation in [*] form and substance acceptable to the DIP Agent, the DIP Lenders and the Debtors, satisfactory completion of credit and underwriting approval, satisfactory completion of due diligence and the satisfaction of the other conditions set forth herein and in accordance any definitive documentation. No DIP Lender (as defined below) is under any obligation to make a loan or make any commitment to lend and this DIP Term Sheet does not constitute a commitment, a contract to provide a commitment or any agreement by the DIP Lenders to provide any financing. This DIP Term Sheet does not attempt to describe all of the terms, conditions and requirements that would pertain to the financing described herein, but rather is intended to outline certain basic items around which the DIP Lenders currently believe a financing could be structured. In addition, the pricing and all other terms included herein are based on market conditions on the date hereof and are subject to change in all respects. This DIP Term Sheet is confidential and is delivered to you with the provisions understanding that neither it nor its substance shall be disclosed to any third party. This DIP Term Sheet shall be governed by Rule 408 of the Supply Agreement. The Parties shall determine whether to supply Franchise Product 1 in [*] form based on whether [*]. Additionally, Amgen will supply Novartis with placebo Federal Rules of Franchise Product 1. Specifications Amgen will Manufacture Evidence and supply one distinct Franchise Product 1 fulfilling one set any and all similar and applicable rules and statutory provisions governing the non-admissibility of specifications. However, the Franchise Product 1 specifications may need to be revised in accordance with requests from the local health authorities (including with respect to testing methods) on a country-by-country basis. Novartis will not agree to commitments with a local health authority with respect thereto without the prior written consent of Amgen. Remaining Shelf Life The minimum shelf life remaining upon delivery for use in a particular country shall be equal to [*]% of the then current approved shelf life of the Franchise Product 1 in such country (provided that the then current approved shelf life in such country is a minimum of [*] months). If the then current approved shelf life of the Franchise Product 1 in such country is less than [*] months, the Parties shall, through a governance body established under the Supply Agreement, negotiate in good faith a new minimum shelf life taking into account Governmental Authority requirements and existing tender constraints. IncoTerm Franchise Product 1 will be supplied to Novartis [*] (Incoterms 2010 ICC). Risk and title to the Franchise Product 1 shall transfer at [*]. Cost Franchise Product 1 will be supplied to Novartis at [*] (such terms to be defined in the Supply Agreement in a manner substantially similar as defined in that certain [*] effective as of [*]. In addition thereto, Amgen will be entitled to charge Novartis certain support costs directly related to the Manufacture or supply of Franchise Product 1 for the Territory that are not included in [*] (“Support Costs”) ([*]). The mechanism for discussing, tracking and charging for Support Costs to be more fully detailed in the Supply Agreement. The Supply Agreement shall [*] to be defined in the Supply Agreement. Site of Manufacture Amgen has sole discretion to determine which Amgen site will be utilized for Manufacturing drug substance and drug product for the Franchise Product 1, [*]. [*]. [*]. At any time, Amgen can use a Third Party CMO, [*], provided that [*]. Audit Right Novartis will have the right to inspect Amgen’s sites utilized for Manufacturing, [*] storage, testing, shipping or receiving of the Franchise Product 1 [*] per twelve (12) month period, as well as more often in case of quality issue. Amgen Ref. No. 2015641252 SCHEDULEsettlement discussions.

Appears in 1 contract

Sources: Restructuring Support Agreement