Raw Materials. All Raw Materials, other than the Active Ingredient, to be used in the manufacture of the Patch shall be purchased by [***] at its own expense. LTS shall be responsible for testing and releasing all such Raw Materials in accordance with the Specifications, the Quality Assurance Agreement and all Regulatory Requirements. In the event [***] orders or purchases appropriate quantities of Raw Materials in order to be able to supply the Patches as forecasted in the most current [***] month period in the Rolling Forecast, as defined in Section 2.3, and has paid or has incurred a non-cancelable commitment to pay for such Raw Materials, and (A) [***] (i) cancels such orders pursuant to Section 2.12; (ii) changes the forecasted quantities subject to the terms of this Agreement; or (iii) does not place orders in the amounts forecasted in such [***] month forecast; or (B) the Specifications or the artwork has changed after the Raw Materials have been purchased or ordered, then: (a) such Raw Materials and any works-in-progress may, in a manner to be reasonably agreed between LTS and NeurogesX, be kept in storage by LTS for future production of the Patches hereunder, provided that NeurogesX shall reimburse LTS for all costs and expenses associated with such storage; or ***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. (b) in the event such storage is not practicable or such Raw Materials become obsolete or unusable due to one or more of the events specified under (i) – (iv) above or the Parties do not agree on the manner or compensation for such storage, NeurogesX shall reimburse LTS for all documented out-of-pocket costs and expenses incurred by LTS for such Raw Materials (other than the Active Ingredient) and those reasonable costs and expenses incurred by LTS to produce the works-in-progress, which in each case, cannot be used by LTS for manufacturing Patches and cannot be used by LTS in the manufacture of products for its other clients. NeurogesX may then, at its option upon prior written notice to LTS, take ownership of such Raw Materials and works-in-progress, it being understood that any costs and expenses for transport shall be borne by [***]. If NeurogesX does not exercise such option, LTS will destroy such Raw Materials and works-in-progress, it being understood that NeurogesX shall pay any reasonable costs and expenses for destroying such Raw Materials and works-in- progress.
Appears in 4 contracts
Samples: Commercial Supply and License Agreement, Financing Agreement (NeurogesX Inc), Commercial Supply and License Agreement (NeurogesX Inc)
Raw Materials. All (a) In connection with the Manufacturing Services hereunder, during the Manufacturing Term, J&J or its Affiliates shall use commercially reasonable efforts to (i) acquire, at their sole cost and expense, all Raw MaterialsMaterials required for the Manufacture, other than supply and delivery of the Active IngredientProducts by J&J or its Affiliates as contemplated hereby from approved suppliers set forth on Schedule C and (ii) maintain Inventories of Raw Materials at each Facility in such quantities as the Parties may mutually agree pursuant to the Supply Reviews, to which quantities shall initially be used consistent with the past practice of the Kenvue Business in the manufacture ordinary course of the Patch shall be purchased by [***] at business. Kenvue acknowledges and agrees that in order for J&J to meet its own expense. LTS shall be responsible for testing and releasing all such obligation to supply Products under this Agreement, J&J or its Affiliates must order Raw Materials in accordance with the Specifications, the Quality Assurance Agreement defined lead times and all Regulatory Requirements. In the event [***] orders or purchases appropriate minimum order quantities imposed by approved suppliers of Raw Materials and J&J may order Raw Materials to meet its expected requirements based on the most recent Rolling Forecast in accordance with, and subject to, (i) the longer of such defined lead times or the binding portion of each Rolling Forecast and (ii) such minimum order quantities. Notwithstanding the foregoing, but subject to Section 2.02(c), Section 2.05 and Article 5, (x) in the event of any issues with respect to the supply of any Raw Materials used for the manufacture and delivery of Products, including delays in delivery of Raw Materials, deliveries of Raw Materials that do not conform to applicable specifications or known or reasonably expected shortages or unavailability of Raw Materials, (1) J&J and its Affiliates shall use commercially reasonable efforts to prevent or mitigate any such supply issues with respect to the applicable Raw Materials, including using commercially reasonable efforts to implement as soon as reasonably practicable any applicable Existing BCP, (2) J&J shall promptly notify Kenvue of any supply issues that are not promptly resolved pursuant to the preceding clause (1), and (3) without limiting the Parties’ respective roles and responsibilities set forth in Section 2.02(c), each Party shall reasonably cooperate with the other Party in connection with resolving any issues with respect to the supply of any Raw Materials, including any performance or operational issues with suppliers of Raw Materials, as soon as reasonably practicable and (y) in the event that any Raw Materials used for the manufacture of a Product are or become unavailable, subject to the preceding clause (x), neither J&J nor any of its Affiliates shall be (1) responsible for procuring replacements or substitutes for such Raw Materials which J&J and its Affiliates are not able to supply procure using commercially reasonable efforts or (2) liable for any incremental costs associated with the Patches as forecasted in the most current [***] month period in the Rolling Forecast, as defined in Section 2.3, and has paid procurement of any such replacements or has incurred a non-cancelable commitment to pay substitutes for such Raw Materials, and (A) [***] (i) cancels such orders pursuant to Section 2.12; (ii) changes the forecasted quantities subject to the terms of this Agreement; or (iii) does not place orders in the amounts forecasted in such [***] month forecast; or (B) the Specifications or the artwork has changed after the Raw Materials have been purchased or ordered, then:
(a) such Raw Materials and any works-in-progress may, in a manner to be reasonably agreed between LTS and NeurogesX, be kept in storage by LTS for future production of the Patches hereunder, provided that NeurogesX shall reimburse LTS for all costs and expenses associated with such storage; or ***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
(b) in the event such storage is not practicable J&J shall be liable for excess or such obsolete Raw Materials become if such excess or obsolescence is caused by orders of Raw Materials that were not in accordance with applicable lead times pursuant to this Section 2.02. Kenvue shall have no liability for excess or obsolete Raw Materials purchased by J&J unless the excess or unusable due to one or more of the events specified under obsolescence (i) – (iv) above is caused by a change to, or cancellation of, a Binding Purchase Order or the Parties do not agree on the manner or compensation for such storagebinding portion of a Rolling Forecast, NeurogesX shall reimburse LTS for all documented out-of-pocket costs and expenses incurred by LTS for such (ii) is in connection with Raw Materials ordered in accordance with applicable lead times pursuant to this Section 2.02 or (other than iii) is caused by a change to the Active IngredientSpecifications of a Product that was approved in accordance with this Agreement. Notwithstanding anything to the contrary contained herein, J&J shall not be liable for any actions taken by J&J or its Affiliates in connection with acquiring or ordering Raw Materials or the management of suppliers of Raw Materials at the direction of Kenvue, including any excess or obsolete Raw Materials resulting therefrom. J&J will promptly invoice Kenvue for any amounts due by Kenvue to J&J pursuant to this Section 2.02(b). Any such invoice shall be issued and paid in accordance with Section 3.01(f).
(c) Xxxxxx and those J&J each agrees to comply with the following roles and responsibilities with respect to transacting with, and management of, approved suppliers of Raw Materials:
(i) With respect to all suppliers of Raw Materials, J&J shall be responsible for managing ordinary course logistics and operations matters with respect to all approved suppliers of Raw Materials, including using commercially reasonable costs efforts to resolve any ordinary course performance or operational issues;
(ii) With respect to suppliers of Raw Materials designated as “J&J pure buy” on Schedule C, J&J shall also be responsible for (x) managing contractual matters with such supplier, (y) using commercially reasonable efforts to resolve any performance or operational issues arising outside of the ordinary course and expenses incurred by LTS (z) in the case of any such suppliers under purchase orders only or with which there is no contract or agreement, using commercially reasonable efforts to produce resolve any performance or operational issues;
(iii) With respect to suppliers of Raw Materials designated as “Kenvue-directed buy” on Schedule C, Kenvue shall be responsible for (x) managing contractual matters with such supplier and (y) resolving any performance or operational issues arising outside of the works-in-progressordinary course (for the avoidance of doubt, which in each case, including any purchase orders pursuant to a contract or agreement between Kenvue and such suppliers);
(iv) With respect to all suppliers of Raw Materials, each Party shall reasonably cooperate with the other Party in connection with resolving any performance or operational issues related to suppliers of Raw Materials as soon as reasonably practicable and, except as set forth in any Existing BCP, Kenvue shall be responsible for the establishment of any alternative suppliers of Raw Materials; and
(v) If and to the extent that, as of the Effective Date, J&J is a party to a contract or agreement with a supplier designated as “J&J pure buy” on Schedule C, (x) J&J shall use commercially reasonable efforts to maintain such existing contract or agreement (including by any extensions or renewals thereof) during any relevant Product Term until such time as Kenvue has entered into a contract or agreement with such supplier; provided that if J&J determines, in its reasonable discretion, that such existing contract or agreement cannot reasonably be maintained, extended or renewed by J&J on comparable terms, as applicable, the Parties shall cooperate in good faith and use commercially reasonable efforts to address the continued supply of applicable Raw Materials as promptly as practicable, including by establishing an alternative supplier if mutually agreed; and (y) Kenvue shall use commercially reasonable efforts to negotiate and enter into an agreement or contract for the supply of Raw Materials by such supplier or an alternative supplier thereto as promptly as practicable following the Effective Date. Any incremental costs incurred by J&J under an extension or renewal of such an existing contract or in connection with effecting such extension or renewal and any costs of establishing any alternative supplier of Raw Materials shall be borne by Kenvue; provided that, with respect to (1) the extension or renewal of any contract or agreement or (2) the establishment of any alternative supplier of Raw Materials, in each case, that will be used by LTS to supply Raw Materials for manufacturing Patches both Products and cannot be used by LTS in the manufacture of products for J&J’s other customers and representatives (including the J&J Business), the incremental costs of such extension or renewal or costs of establishing such alternative supplier, as applicable, shall be allocated as mutually agreed by the Parties. The Parties will review and update Schedule C as the Parties may mutually agree in the Supply Reviews.
(d) Except where J&J has failed to place orders permitted under the applicable supply agreements for sufficient Raw Materials from approved suppliers in accordance with the binding portion of applicable Forecasts and the defined lead times imposed by such suppliers, J&J and its other clientsAffiliates shall have no liability for any delays in Manufacturing Services or the delivery of Product attributable to (x) delays in the delivery of Raw Materials or (y) the delivery of Raw Materials that do not conform to applicable specifications, in each case, by the suppliers thereof. NeurogesX may thenIn the event of any such delayed or non-conforming delivery, J&J shall use commercially reasonable efforts to minimize any delays in Manufacturing Services or delivery of Product resulting from such delayed or non-conforming delivery of Raw Materials. In the event that J&J is party to an agreement with the applicable supplier and Kenvue incurs Damages in connection with or as a result of such delayed or non-conforming delivery, Kenvue shall have the right of subrogation and J&J shall, at its option upon prior written notice Kenvue’s cost and expense, use commercially reasonable efforts to LTStake such actions as Kenvue may reasonably request to facilitate a claim against such supplier for such Damages. For the avoidance of doubt, purchase orders pursuant to a contract or agreement between Kenvue and the applicable supplier of Raw Materials shall not constitute a separate agreement between J&J and such supplier and Kenvue shall pursue any claims against such supplier directly pursuant to such contract or agreement; provided that J&J shall, at Kenvue’s cost and expense, use commercially reasonable efforts to take ownership such actions as reasonably necessary to facilitate a claim against such supplier for Damages arising in connection with such purchase order.
(e) In the event that J&J is unable to meet, or anticipates it will be unable to meet, in whole or in part, the required product quantities for Kenvue, as set forth in any Forecast, and J&J’s other customers and representatives (including of the J&J Business) as a result of a shortage of any Raw Materials, J&J shall promptly notify Kenvue of such inability, its cause, its expected duration and any proposed remedial measures, and J&J shall allocate Raw Materials as follows:
(i) first, pro rata to the production of Lifesaving or Life Prolonging Products for Kenvue and worksJ&J’s other customers and representatives (including of the J&J Business); and
(ii) second, pro rata to the production of products (including Products) other than Lifesaving or Life Prolonging Products for Kenvue and J&J’s other customers and representatives (including of the J&J Business); provided that the Parties shall determine in good faith and mutually agree upon such pro rata allocation based on the quantity of each such product (x) produced by J&J in the preceding twelve (12) calendar months and (y) forecasted by the most recent Rolling Forecast and then-in-progress, it being understood that any costs applicable forecasts of J&J’s other customers and expenses for transport shall be borne by [***]. If NeurogesX does not exercise such option, LTS will destroy such Raw Materials and works-in-progress, it being understood that NeurogesX shall pay any reasonable costs and expenses for destroying such Raw Materials and works-in- progressrepresentatives (including of the J&J Business).
Appears in 2 contracts
Samples: Transition Manufacturing Agreement (Kenvue Inc.), Transition Manufacturing Agreement (Kenvue Inc.)
Raw Materials. All 1.2.1 Cerus shall arrange, at its own expense, for the supply and delivery to Porex of [ * ] (in conformance with the specifications set forth on Exhibits A-1 and B-1), [ * ] for production of Plasma Disks (collectively, the “Raw Materials”) as set forth in the Porex Raw Material Projections (as hereinafter defined). Porex shall timely inspect such Raw Materials. If such Raw Materials fail to meet the specifications for such Raw Materials set forth in Exhibits A-3, A-4, A-5 and B-2, Porex shall have the right to reject such Raw Materials. If Porex does not deliver such written notice to Cerus within the [ * ] business day period from inspection of such Raw Materials, other than Porex shall be deemed to have accepted the Active IngredientRaw Materials. On or before September 15th (with respect to the first half of the applicable calendar year) and June 15th (with respect to the second half of the applicable calendar year), Porex and Cerus shall meet in person or telephonically (each, a “Raw Materials Planning Meeting”) to discuss Porex’s anticipated: (i) requirements for Raw Materials needed to manufacture the quantity of Components forecasted by Xxxxx for the upcoming Purchase Order Period (as defined in Section 1.3); and (ii) the required delivery dates of such Raw Materials needed to meet Xxxxx’ projected delivery schedule for the upcoming Purchase Order Period. Within [ * ] business days after receipt of Cerus’ Short Term Forecast as provided in Section 1.3, Porex shall provide Cerus with a good faith forecast of the additional Raw Materials, if any, needed by Porex, taking into account its current inventory of Raw Materials, to manufacture the forecasted quantity of Components for the upcoming Purchase Order Period; and (ii) the latest date by which such Raw Materials must be received by Porex to meet Xxxxx’ projected delivery schedule, in each case as set forth in the applicable Purchase Order (the “Porex Raw Material Projections”). Such obligation by Xxxxx to supply and deliver Raw Materials as provided in the Porex Raw Material Projections shall hereinafter be referred to as the “Raw Material Obligation”.
1.2.2 Porex shall be solely responsible for obtaining the [ * ] (in conformance with the specifications set forth on Exhibit B-2) used for production of the Plasma Disks. Porex shall also be responsible for ordering and purchasing packaging material meeting the Specifications.
1.2.3 In the event Raw Materials are supplied to Porex in excess of the Raw Materials consumed in the manufacture of the Patch Product, Porex shall be purchased by [***] at its own expense. LTS shall be responsible for testing notify Cerus and releasing all use such Raw Materials in accordance with fulfillment of the Specifications, the Quality Assurance Agreement and all Regulatory Requirementssubsequent order. In the event [***] orders or purchases appropriate quantities Porex requires Raw Materials in excess of Raw Materials in order to be able to supply the Patches as forecasted specified in the most current [***] month period Porex Raw Material Projections as a result of Porex’s failure to comply with the procedures applicable to the production of Components as set forth on Exhibit C, Porex shall bear all additional costs for obtaining such additional materials from Cerus or its designated supplier at a price equal to Cerus’ cost.
1.2.4 Cerus and Porex will work together to achieve the rates and yields as described in the Rolling Forecast, as defined in Section 2.3Exhibit G . Porex shall provide monthly inventories of, and has paid or has incurred shall track the Raw Material usage for, each lot of Raw Material supplied by Cerus and shall provide Cerus with a non-cancelable commitment to pay report (“Raw Material Report”) at the depletion of each Raw Material lot. Such Raw Material Report shall contain the Porex lot numbers and the quantity of wafers manufactured for such Raw Materialseach lot of [ * ] supplied by Cerus, and (A) [***the Porex lot number and quantity of disks manufactured for each lot of [ * ] (i) cancels such orders pursuant supplied by Cerus. The Raw Material Report will also identify when [ * ] set forth in Exhibit G. The Parties shall collectively review the Raw Material Report and discuss the root cause, financial responsibility, and what actions, if any, shall be taken to Section 2.12; (ii) changes [ * ]. Notwithstanding the forecasted quantities subject to foregoing, [ * ] will not exceed [ * ] without the terms prior written consent of this Agreement; or (iii) does not place orders Cerus, which consent will be conditioned upon a discussion regarding the root cause, disposition and the financial responsibility for scrap rates in the amounts forecasted in such [***] month forecast; or (B) the Specifications or the artwork has changed after excess of [ * ].
1.2.5 The process flow charts from receipt of the Raw Materials have been purchased or ordered, then:
(a) such Raw Materials and any works-in-progress may, in a manner to be reasonably agreed between LTS and NeurogesX, be kept in storage by LTS for future production shipment of the Patches hereunderComponents are attached hereto as Exhibit C, provided that NeurogesX shall reimburse LTS for all costs and expenses associated with such storage; or ***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect subject to the omitted portions.
(b) in the event such storage is not practicable or such Raw Materials become obsolete or unusable due to one or more change by mutual written agreement of the events specified under (i) – (iv) above or the Parties do not agree on the manner or compensation for such storage, NeurogesX shall reimburse LTS for all documented out-of-pocket costs and expenses incurred by LTS for such Raw Materials (other than the Active Ingredient) and those reasonable costs and expenses incurred by LTS to produce the works-in-progress, which in each case, cannot be used by LTS for manufacturing Patches and cannot be used by LTS in the manufacture of products for its other clients. NeurogesX may then, at its option upon prior written notice to LTS, take ownership of such Raw Materials and works-in-progress, it being understood that any costs and expenses for transport shall be borne by [***]. If NeurogesX does not exercise such option, LTS will destroy such Raw Materials and works-in-progress, it being understood that NeurogesX shall pay any reasonable costs and expenses for destroying such Raw Materials and works-in- progressParties.
Appears in 1 contract
Raw Materials. All 1.2.1 Cerus shall arrange, at its own expense, for the supply and delivery to Porex of [ * ] (in conformance with the specifications set forth on Exhibits A-1 and B-1), [ * ] for production of Plasma Disks (collectively, the “Raw Materials”) as set forth in the Porex Raw Material Projections (as hereinafter defined). Porex shall timely inspect such Raw Materials. If such Raw Materials fail to meet the specifications for such Raw Materials set forth in Exhibits X-0, X-0, X-0 and B-2, Porex shall have the right to reject such Raw Materials. If Porex does not deliver such written notice to Cerus within the [ * ] business day period from inspection of such Raw Materials, other than Porex shall be deemed to have accepted the Active IngredientRaw Materials. On or before September 15th (with respect to the first half of the applicable calendar year) and June 15th (with respect to the second half of the applicable calendar year), Porex and Cerus shall meet in person or telephonically (each, a “Raw Materials Planning Meeting”) to discuss Porex’s anticipated: (i) requirements for Raw Materials needed to manufacture the quantity of Components forecasted by Cerus for the upcoming Purchase Order Period (as defined in Section 1.3); and (ii) the required delivery dates of such Raw Materials needed to meet Cerus’ projected delivery schedule for the upcoming Purchase Order Period. Within [ * ] business days after receipt of Cerus’ Short Term Forecast as provided in Section 1.3, Porex shall provide Cerus with a good faith forecast of the additional Raw Materials, if any, needed by Porex, taking into account its current inventory of Raw Materials, to manufacture the forecasted quantity of Components for the upcoming Purchase Order Period; and (ii) the latest date by which such Raw Materials must be received by Porex to meet Cerus’ projected delivery schedule, in each case as set forth in the applicable Purchase Order (the “Porex Raw Material Projections”). Such obligation by Cerus to supply and deliver Raw Materials as provided in the Porex Raw Material Projections shall hereinafter be referred to as the “Raw Material Obligation”.
1.2.2 Porex shall be solely responsible for obtaining the [ * ] (in conformance with the specifications set forth on Exhibit B-2) used for production of the Plasma Disks. Porex shall also be responsible for ordering and purchasing packaging material meeting the Specifications.
1.2.3 In the event Raw Materials are supplied to Porex in excess of the Raw Materials consumed in the manufacture of the Patch Product, Porex shall be purchased by [***] at its own expense. LTS shall be responsible for testing notify Cerus and releasing all use such Raw Materials in accordance with fulfillment of the Specifications, the Quality Assurance Agreement and all Regulatory Requirementssubsequent order. In the event [***] orders or purchases appropriate quantities Porex requires Raw Materials in excess of Raw Materials in order to be able to supply the Patches as forecasted specified in the most current [***] month period Porex Raw Material Projections as a result of Porex’s failure to comply with the procedures applicable to the production of Components as set forth on Exhibit C, Porex shall bear all additional costs for obtaining such additional materials from Cerus or its designated supplier at a price equal to Cerus’ cost.
1.2.4 Cerus and Porex will work together to achieve the rates and yields as described in the Rolling Forecast, as defined in Section 2.3Exhibit G . Porex shall provide monthly inventories of, and has paid or has incurred shall track the Raw Material usage for, each lot of Raw Material supplied by Cerus and shall provide Cerus with a non-cancelable commitment to pay report (“Raw Material Report”) at the depletion of each Raw Material lot. Such Raw Material Report shall contain the Porex lot numbers and the quantity of wafers manufactured for such Raw Materialseach lot of [ * ] supplied by Cerus, and (A) [***the Porex lot number and quantity of disks manufactured for each lot of [ * ] (i) cancels such orders pursuant supplied by Cerus. The Raw Material Report will also identify when [ * ] set forth in Exhibit G. The Parties shall collectively review the Raw Material Report and discuss the root cause, financial responsibility, and what actions, if any, shall be taken to Section 2.12; (ii) changes [ * ]. Notwithstanding the forecasted quantities subject to foregoing, [ * ] will not exceed [ * ] without the terms prior written consent of this Agreement; or (iii) does not place orders Cerus, which consent will be conditioned upon a discussion regarding the root cause, disposition and the financial responsibility for scrap rates in the amounts forecasted in such [***] month forecast; or (B) the Specifications or the artwork has changed after excess of [ * ].
1.2.5 The process flow charts from receipt of the Raw Materials have been purchased or ordered, then:
(a) such Raw Materials and any works-in-progress may, in a manner to be reasonably agreed between LTS and NeurogesX, be kept in storage by LTS for future production shipment of the Patches hereunderComponents are attached hereto as Exhibit C, provided that NeurogesX shall reimburse LTS for all costs and expenses associated with such storage; or ***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect subject to the omitted portions.
(b) in the event such storage is not practicable or such Raw Materials become obsolete or unusable due to one or more change by mutual written agreement of the events specified under (i) – (iv) above or the Parties do not agree on the manner or compensation for such storage, NeurogesX shall reimburse LTS for all documented out-of-pocket costs and expenses incurred by LTS for such Raw Materials (other than the Active Ingredient) and those reasonable costs and expenses incurred by LTS to produce the works-in-progress, which in each case, cannot be used by LTS for manufacturing Patches and cannot be used by LTS in the manufacture of products for its other clients. NeurogesX may then, at its option upon prior written notice to LTS, take ownership of such Raw Materials and works-in-progress, it being understood that any costs and expenses for transport shall be borne by [***]. If NeurogesX does not exercise such option, LTS will destroy such Raw Materials and works-in-progress, it being understood that NeurogesX shall pay any reasonable costs and expenses for destroying such Raw Materials and works-in- progressParties.
Appears in 1 contract