Common use of Continued Supply Clause in Contracts

Continued Supply. Except in the event of a Required Change or other circumstances requiring the prompt implementation of a proposed Material Change (including where prescribed by law or the requirements of an applicable Regulatory Authority), Miltenyi shall continue to supply Miltenyi Product without the proposed Material Change for [***], using Commercially Reasonable Efforts, to make all appropriate filings and obtain any required amendment or modification of existing regulatory approvals for Autolus Product (unless otherwise agreed, such period not to exceed [***] from the proposed date of implementation of the Material Change as provided in Miltenyi’s change notification pursuant to Section [***].[***].), subject to the Parties reaching agreement, except with respect to any Miltenyi-Requested Change, as to the [***] necessitated by any such continued supply of unchanged Miltenyi Product during such period. If the continued supply of unchanged Miltenyi Product is reasonably estimated by the Parties to exceed a period of [***] from the implementation date of the Material Change notified pursuant to Section [***].[***]., then the Party shall promptly meet to discuss in good faith how to remedy the situation. Notwithstanding the preceding provisions of this subsection (g), in the event that Autolus reasonably determines to reject a proposed Material Change (including a Miltenyi-Requested Change), Miltenyi agrees to continue to supply the applicable Miltenyi Product without such change after expiry of the said [***] period and during the Term of this Agreement or until Autolus has secured an alternate source of supply from a Third Party manufacturer; provided, however, that as a condition precedent to Miltenyi’s continuing obligation to supply unchanged Miltenyi Product after expiry of the said [***] period, this Agreement shall have first been amended, by mutual written agreement between the Parties, as appropriate to reflect the change in circumstances contemplated by this Section [***]. and any [***] (if any) resulting from the manufacture of unchanged Miltenyi Product solely for Autolus, including any applicable adjustments to [***] or other relevant issues. For clarity, in no event shall Miltenyi be required to manufacture, supply or sell a Miltenyi Product to which a Required Change is applicable.

Continued Supply. Except The Parties acknowledge that it may be in the event of a Required Change Parties’ mutual interest and wishes to continue to commercialize the Product for patients in the Collaborator Territory by using Exelixis supplied API, Compound, or other circumstances requiring Product after the prompt implementation of a proposed Material Change (including where prescribed by law or Royalty Term for such Product. If Collaborator desires to Commercialize any Product in the requirements of an applicable Regulatory AuthorityCollaborator Territory after the Royalty Term for such Product as permitted under Section 14.1(b), Miltenyi Collaborator shall continue notify Exelixis up to supply Miltenyi Product without six (6) months prior to the proposed Material Change for [***], using Commercially Reasonable Efforts, to make all appropriate filings and obtain any required amendment or modification of existing regulatory approvals for Autolus Product (unless otherwise agreed, such period not to exceed [***] from the proposed date of implementation expiration of the Material Change as provided in Miltenyi’s change notification pursuant to Section [***].[***].)Royalty Term. Following such notice, subject to the Parties reaching agreement, except with respect shall discuss in good faith to any Miltenyi-Requested Change, as to the [***] necessitated by any such continued supply of unchanged Miltenyi Product during such period. If agree upon commercially reasonable terms and conditions for the continued supply of unchanged Miltenyi such Product is reasonably estimated (in the form then-currently supplied to Collaborator by Exelixis and at the fully-burdened cost of such Product) and the Parties will amend the Commercial Supply Agreement (entered by the Parties on March 6, 2019, as amended) and Commercial Quality Agreement (entered by the Parties on September 25, 2019, as amended) as necessary. Alternatively, Exelixis may elect to exceed grant Collaborator the right to purchase API, Compound, and/or Product from Exelixis’ Third-Party contract manufacturer(s), whether through direct contract, direct purchase orders, or other arrangement agreed by Exelixis and Collaborator, to enable Collaborator to source such Product directly from such contract manufacturer for Commercialization in the Field in the Collaborator Territory. If Exelixis elects to grant Collaborator the right to purchase Product directly from such contract manufacturer, the Parties shall terminate the Commercial Supply Agreement and Commercial Quality Agreement with respect to the applicable Product, and Exelixis shall grant Collaborator a period non-exclusive license under the Exelixis Technology to make or have made the Product in the Collaborator Territory for use in Commercialization of [***] from such Product in the implementation date Collaborator Territory. Thereafter, Collaborator shall be responsible for providing all such Product for its use in the Commercialization of such Product in the Field in the Collaborator Territory. In addition, Exelixis shall grant Collaborator a continued right to use the Product Marks for use in connection with the Commercialization of the Material Change notified pursuant to Section [***].[***]., then the Party shall promptly meet to discuss in good faith how to remedy the situation. Notwithstanding the preceding provisions of this subsection (g), Product in the event that Autolus reasonably determines to reject a proposed Material Change (including a Miltenyi-Requested Change), Miltenyi agrees to continue to supply Field in the applicable Miltenyi Product without such change after expiry of the said [***] period and during the Term of this Agreement or until Autolus has secured an alternate source of supply from a Third Party manufacturer; provided, however, that as a condition precedent to Miltenyi’s continuing obligation to supply unchanged Miltenyi Product after expiry of the said [***] period, this Agreement shall have first been amended, by mutual written agreement between the Parties, as appropriate to reflect the change in circumstances contemplated by this Section [***]. and any [***] (if any) resulting from the manufacture of unchanged Miltenyi Product solely for Autolus, including any applicable adjustments to [***] or other relevant issues. For clarity, in no event shall Miltenyi be required to manufacture, supply or sell a Miltenyi Product to which a Required Change is applicableCollaborator Territory.”

Continued Supply. Except 4.3.2.1 Microgenics shall ensure the continued worldwide supply of the Assay in quantities at least sufficient to meet each applicable Binding Forecast. Without limiting the foregoing, Microgenics agrees to maintain a safety stock of rare reagents sufficient to meet each applicable Binding Forecast for the Assay. Microgenics shall provide Achaogen at least [***] ([***]) months (or [***]) prior written notice of any possible shortfall in meeting each applicable Binding Forecast or other commercial demand for the Assay, and the Parties shall promptly meet and discuss all reasonable commercial resolutions if Microgenics is unable to assure supply as needed to meet each applicable Binding Forecast pursuant to the terms set forth in Section 4.3.2.2. 4.3.2.2 In addition, in order to ensure security of supply of the Assay, within [***] of Microgenics’ receipt of the first Regulatory Approval for the Assay in any country in the event Territory, Microgenics shall designate [***] (the “Back-up Supplier”) which such Back-up Supplier shall be and remain qualified as a manufacturer of the Assay for the supply of the Assay for sale in the Territory. Microgenics shall [***] ensure that the Back-up Supplier can supply the Assay for sale in the Territory within [***] days. Microgenics will develop a Required Change or other circumstances requiring manufacturing transition plan that will highlight [***] needed to complete the prompt implementation transition to the back-up supplier. This plan will be presented to the JSC prior to first commercial launch of a proposed Material Change (including where prescribed by law or the requirements of an applicable Regulatory Authority)Assay. 4.3.2.3 If, Miltenyi shall continue to supply Miltenyi Product without the proposed Material Change for any reason, [***], using Commercially Reasonable Effortsboth Microgenics and the Back-up Supplier (as applicable) are unable to supply the Assay in quantities sufficient to meet the quantities of the Assay either (a) as set forth in each applicable Binding Forecast or (b) based on such other measure of commercial demand as agreed to by the Parties in writing, in either case, during any given [***] ([***]) month period for a given country in the Territory, then Microgenics hereby grants Achaogen or its designee a Shortfall License, which license shall survive until [***] ([***]) months following the date that either Microgenics or the Back-up Supplier (as applicable) is in a position again to fulfill such demand (as such positioning is demonstrated [***]) (the “Supply Resumption Date”). The Shortfall License shall expire automatically [***] ([***]) months after the Supply Resumption Date; provided, however, that (a) Achaogen shall be entitled to use, sell, offer for sale, and import any assay that are in inventory prior to the expiration of the Shortfall License (even if such activity occurs after expiration of the Shortfall License). Additionally, [***], Microgenics shall (i) make all appropriate filings and obtain any required amendment or modification its personnel available for a reasonable period of existing regulatory approvals for Autolus Product time (unless otherwise agreed, such period not to exceed [***] from the proposed date of implementation of the Material Change as provided in Miltenyi’s change notification pursuant to Section ([***].[***].), subject ) months) to the Parties reaching agreement, except effect a successful technology transfer with respect to any Miltenyi-Requested Changethe manufacture and commercialization of such Assay under the terms of this paragraph, (ii) provide Achaogen with copies of the physical embodiment of all processes, protocols, procedures, methods, tests and other intellectual property rights licensed to Achaogen under the Shortfall License, as applicable, related to Assay (including the [***] necessitated by any such continued supply of unchanged Miltenyi Product during such period. If the continued supply of unchanged Miltenyi Product is reasonably estimated by the Parties to exceed a period of [***] from the implementation date of the Material Change notified pursuant to Section [***].[***]., then the Party shall promptly meet to discuss in good faith how to remedy the situation. Notwithstanding the preceding provisions of this subsection (gmanufacture thereof), in the event that Autolus reasonably determines to reject a proposed Material Change (including a Miltenyi-Requested Change), Miltenyi agrees to continue to iii) supply the applicable Miltenyi Product without such change after expiry of the said [***] period and during the Term of this Agreement or until Autolus has secured an alternate source of supply from a Third Party manufacturer; provided, however, that as a condition precedent to Miltenyi’s continuing obligation to supply unchanged Miltenyi Product after expiry of the said [***] period, this Agreement shall have first been amended, by mutual written agreement between the Parties, as appropriate to reflect the change in circumstances contemplated by this Section [***]. and any [***] (if anyincluding [***]) resulting from the manufacture of unchanged Miltenyi Product solely for Autolus, including any applicable adjustments reasonably required to perform [***] or other relevant issues. For clarity, in no event shall Miltenyi as may be required by the applicable Regulatory Authorities, and upon request by Achaogen, [***], provide Achaogen (and/or its designee) with [***] related to manufacturethe Assay, supply or and (iv) promptly assist Achaogen (and/or its designee) in obtaining all necessary Regulatory Approvals and/or modifying and/or transferring existing Regulatory Approvals to enable Achaogen (and/or its designee) to develop, make, have made, use, market, distribute, import, sell a Miltenyi Product to which a Required Change is applicableand offer for sale the Assay ([***]).