Common use of Sale and Purchase of Product Clause in Contracts

Sale and Purchase of Product. (a) BMS (either itself or through its Affiliates) shall supply to the Company, and the Company shall, subject to the terms and conditions of this Agreement, purchase from BMS, one hundred percent (100%) of the Company’s requirements (except for quantities necessary to keep the Company’s back-up supplier qualified) the Product for marketing, distribution, sale and use during the Term, pursuant to Firm Orders submitted by the Company to BMS from time to time in accordance with Section 2.03, at the Purchase Price, and subject to Section 5.02. (b) All quantities of the Product shall be supplied hereunder by BMS in finished dosage form, filled, labeled, branded and packaged for commercial sale or distribution, or as samples, as the case may be, in accordance with the terms and conditions of this Agreement, the Specifications and applicable Laws. BMS shall solely and exclusively supply the Product to the Company, its Affiliates and their respective designees. BMS shall be responsible for the purchase of all raw materials for the manufacture of the Product in accordance with the Product Registrations as necessary to supply the finished Product to the Company under this Agreement. Company shall be responsible for all costs incurred by BMS relating to any Firm Orders placed by Company (including, any raw materials or working inventory purchase by BMS on behalf of Company in connection with Firm Orders). (c) Subject to BMS Regulatory review and approval, and pursuant to applicable law, BMS and the Company shall take any and all actions necessary to change, as expeditiously as possible, the NDC numbers for the Product and to apply new NDC numbers to the Product. Subject to BMS Regulatory review and approval, and pursuant to applicable law, for no more than six (6) months following the Effective Date, the Product manufactured hereunder may continue to be labeled and packaged with the same labels and packaging that are used by BMS in connection with its previous manufacture of the Product for WFHC; provided, however, that the Parties shall use their commercially reasonable efforts to complete the revision of all Product labeling and packaging sooner. Subject to BMS Regulatory review and approval, and pursuant to applicable law, after such time, the Product shall be manufactured with labeling, branding, trade dress and packaging identifying BMS or any Affiliate thereof as the manufacturer of the Product and the Company (or the Company’s designee) as the distributor thereof and the labeling shall reflect the Company’s NDC number. Promptly after the Effective Date, BMS shall provide to the Company samples and copies of all labeling, branding, trade dress and packaging for the Product as of the Effective Date. Within sixty (60) calendar days following the delivery by BMS to the Company of the current labeling and packaging, the Company shall provide to BMS final specifications for the revised labeling, branding, trade dress and packaging of the Product, including all necessary photo-ready art (or its substantial equivalent) reflecting such revisions. (d) Subject to the provisions of Section 2.01 (c), the Company shall control and shall have sole responsibility for, the content and type of all labeling and packaging (and any changes or supplements thereto) for the Product. All such activities related to any changes or supplements to the labeling and packaging shall be conducted at the Company’s sole cost and expense, including any *** in securing any approvals required by the FDA or other applicable regulatory authorities for any such changes or supplements. BMS shall be responsible for obtaining such labels in accordance with the content specified by the Company. Any changes to the labeling and packaging shall be communicated to BMS in writing at least one hundred twenty (120) calendar days (or, if shorter, the period required by applicable Laws or Government Entities) prior to the desired implementation date together with the documentation specifying the content to be included in the labeling and packaging, including all necessary photo-ready art (or its substantial equivalent). BMS shall not be required to implement such changes until its first batch run after the expiration of such one hundred twenty (120) day (or shorter) period. However, BMS shall endeavor to implement the changes as early as practicable. (e) No terms and conditions contained in any Firm Order, acknowledgment, invoice, xxxx of lading, acceptance or other preprinted form issued by either Party shall be effective to the extent they are inconsistent with or modify the terms and conditions contained herein. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Sale and Purchase of Product. (a) During the Term of this Agreement, the Company hereby grants to BMS a royalty-free, non-exclusive and non-transferable right and license to use such assets that are owned or licensed by the Company as are necessary to allow BMS to manufacture and supply the Products exclusively to the Company under this Agreement. Notwithstanding the foregoing, BMS may transfer its right and license under this Section 2.01(a) to an Affiliate of BMS or to a Third Party in accordance with Section 2.06(c). (either itself or through its Affiliatesb) BMS shall supply use commercially reasonable efforts to sell to the Company, and the Company shall, subject to the terms Article XI, Section 2.06(c) and conditions of this AgreementSection 12.02, purchase from BMS, one hundred percent (100%) all of the Company’s 's requirements (except for quantities necessary to keep the Company’s back-up supplier qualified) the each Product for marketing, distribution, sale and use in the Territory during the Term, pursuant to Firm Orders submitted by the Company to BMS from time to time in accordance with Section 2.03, at the Purchase Pricea price determined in accordance with Section 3.01, and subject to the warranties set forth in Section 5.025.02(a). At any time, upon not less than twelve (12) months' prior written notice to BMS, the Company may terminate its obligation to purchase any Product from BMS hereunder and itself (or through an Affiliate or Third Party) commence manufacturing such Product; provided, however, that BMS shall have no obligation to recommence selling any such Product to the Company at any time after the Company has terminated its obligation to purchase any such Product in accordance with this Section 2.01(b). (bc) All quantities of the Product Products supplied hereunder shall be supplied hereunder by BMS in finished dosage form, filled, labeled, branded labeled and packaged for commercial sale or distribution, or distribution as samples, as the case may be, by the Company in accordance with the terms and conditions of this Agreement, the Specifications and applicable Laws. BMS shall solely and exclusively supply the Product Line to the CompanyCompany and its designees, and neither BMS nor its Affiliates and their respective designeesshall have the right to manufacture or supply the Product Line or any Product therein to any other Person. BMS shall be responsible for the purchase of all raw materials for the manufacture of the Product in accordance with the Product Registrations NDAs and other regulatory filings for the Products as necessary to supply the finished Product Products to the Company under this Agreement. Company shall be responsible for all costs incurred by BMS relating to any Firm Orders placed by Company (including, any raw materials or working inventory purchase by BMS on behalf of Company in connection with Firm Orders). (cd) Subject to BMS Regulatory review and approval, and pursuant to applicable law, BMS and the Company shall take any and all actions necessary to change, as expeditiously as possible, the NDC numbers for the Product and to apply new NDC numbers For up to the Product. Subject to BMS Regulatory review and approval, and pursuant to applicable law, for no more than six (6) months later of 180 calendar days following the Effective Date, the each Product manufactured hereunder may shall continue to be labeled and packaged with the same labels and packaging that are used by BMS in connection with its previous manufacture the Products as of the Product for WFHC; provided, however, that the Parties shall use their commercially reasonable efforts to complete the revision of all Product labeling and packaging soonerEffective Date. Subject to BMS Regulatory review and approval, and pursuant to applicable law, after After such time, the each such Product shall be manufactured with labeling, branding, trade dress labeling and packaging identifying BMS or any Affiliate thereof as the manufacturer of the Product Products and the Company (or the Company’s 's designee) as the distributor thereof and the labeling shall reflect the Company’s NDC number. Promptly after the Effective Date, BMS shall provide to the Company samples and copies of all labeling, branding, trade dress and packaging for the Product as of the Effective Datethereof. Within sixty (60) 60 calendar days following the delivery by BMS to the Company of the current labeling and packagingEffective Date, the Company shall provide to BMS final specifications for the revised labeling, branding, trade dress labeling and packaging of the each Product, including all necessary photo-ready art (or its substantial equivalent) reflecting such revisionsmodification. (de) Subject to the provisions of Section 2.01 (c2.01(d), the Company shall control and shall have sole responsibility for, the content and type of all labeling and packaging (and any changes or supplements thereto) for each Product and shall have the Product. All such activities related to responsibility, at the Company's expense, for any changes or supplements to the labeling and packaging shall be conducted at the Company’s sole cost and expensethereto, including any *** in the expense of securing any approvals required by the FDA or other applicable regulatory authorities for any such changes or supplements. BMS shall be responsible for obtaining such labels (and any changes or supplements thereto) in accordance with the content specified by the Company. Any The Company shall use commercially reasonable efforts to communicate any changes to the labeling and packaging shall be communicated to BMS in writing at least one hundred twenty (120) 90-calendar days (or, if shorter, the period required by applicable Laws or Government Entities) prior to the desired implementation date together with the required documentation specifying the content to be included in the labeling and packaging, including all necessary photo-ready art (or its substantial equivalent). BMS shall not be required use its 11 commercially reasonable efforts to implement such changes until as of its first batch run after the expiration Company's desired implementation date, but in no event later than the later of (i) 180-days after the receipt of such request and (ii) the Company's desired implementation date. Each Product shall be sold by the Company under one hundred twenty (120) day (label throughout the Territory. Notwithstanding the foregoing, if at any time the Company desires to sell Products under one or shorter) periodmore labels, the Company shall notify BMS of such desire, which notice shall include a reasonably detailed description of such proposed additional labels and the Company's anticipated annual volume requirements for each SKU which will bear an additional label. However, BMS shall endeavor have the right, but not the obligation, to implement elect, at its sole option, to manufacture such Products with such additional labels. If BMS elects to manufacture such Products with such additional label(s), all additional costs (calculated on a fully burdened cost basis) incurred by BMS in connection with such manufacturing of such Products with such additional labels shall be borne by the changes as early as practicableCompany. If BMS elects not to manufacture the Products with such additional labels, the Company shall have the right to use the Initial Back-Up Supplier to manufacture such Products under such label(s). (ef) No terms and conditions contained in any Firm Order, acknowledgment, invoice, xxxx of bill xx lading, acceptance or other preprinted form issued by either Party shall be effective to the extent they are inconsistent with or modify the terms and conditions contained herein. *** Portions . (g) BMS agrees that if at any time during the Term of this page have been omitted pursuant Agreement it is unable to supply sufficient quantities of a request Product to supply all of the Company's requirements for Confidential Treatment such Product and filed separately with all the Commissionrequirements supplied by BMS for Estrace Tablets for sale in Canada or Estradiol Tablets (or products substantially the same as Estradiol Tablets) for sale in the United States and Canada by the Third Party Purchaser for whom BMS manufactures same, BMS shall allocate the supply of such Product (and products) among the Company, BMS, its Affiliates and any such Third Party Purchaser in good faith on a non-discriminatory and equitable basis.

Sale and Purchase of Product. (a) BMS (either itself or through its Affiliates) shall supply to During the Company, and the Company shall, subject to the terms and conditions term of this Agreement, BMS shall supply to Sano (or to Third Party Manufacturers, if required), at [*****], directly or by such of its Affiliates as it may designate, sufficient quantities of Bulk Materials as may be required by Sano (or such Third Party Manufacturers, if required) to formulate Finished Products sufficient to meet BMS's orders therefor in the Territory. Sano shall use Bulk Materials supplied by BMS to formulate Finished Product, and Sano shall sell to BMS, and BMS shall purchase from Sano, all of BMS, one hundred percent 's requirements for the Finished Product (100%) which shall be deemed to include all of the Company’s requirements (except for quantities necessary to keep the Company’s backof BMS's Affiliates and Sub-up supplier qualifiedDistributors) the Product for marketing, distribution, sale and use during the Term, pursuant to Firm Orders purchase orders submitted by the Company BMS to BMS Sano from time to time in accordance with Section 2.03, at 5.5. BMS will cause all of its Affiliates and Sub-Distributors to purchase their entire requirements of Finished Products from Sano. BMS may place orders for the Purchase Pricerequirements of its Affiliates and Sub-Distributors, and subject either have Sano ship directly to Section 5.02the Affiliates or Sub-Distributors or to BMS for its reshipment to its Affiliates and Sub-Distributors, or BMS's Affiliates and Sub-Distributors may place orders directly with Sano, as the Parties may agree from time to time. *THIS PAGE CONTAINS CONFIDENTIAL MATERIAL THAT HAS BEEN REDACTED. (b) All quantities In consideration of the Product foregoing, during the term of this Agreement and except as otherwise provided herein, the supply of Finished Products by Sano in and for the Territory shall be supplied hereunder by BMS in finished dosage form, filled, labeled, branded and packaged for commercial sale or distribution, or as samples, as exclusively to BMS. During the case may be, in accordance with the terms and conditions term of this Agreement, Sano may supply Finished Products to Third Parties for sales in countries outside the Specifications and applicable LawsTerritory, if any. BMS shall solely and exclusively Thereafter, Sano may supply the Product to the Company, its Affiliates and their respective designees. BMS shall be responsible for the purchase of all raw materials for the manufacture of the Product in accordance with the Product Registrations as necessary to supply the finished Product to the Company under this Agreement. Company shall be responsible for all costs incurred by BMS relating Finished Products to any Firm Orders placed by Company (including, any raw materials or working inventory purchase by BMS on behalf of Company in connection with Firm Orders)third party. (c) Subject Sano shall notify BMS: (i) within 60 days of its receipt of a firm forecast from BMS as provided in the third sentence of Section 5.4, or (ii) immediately upon becoming aware of an event of FORCE MAJEURE under Section 12 or any other event, if Sano cannot supply Finished Products forecasted to be ordered or ordered by BMS. In such event, Sano shall take all reasonable steps necessary to minimize production delays to license and thereafter maintain at least one third-party manufacturer that is reasonably acceptable to BMS Regulatory review and approvalas a source for the manufacture of Finished Products other than Sano itself, for Sano's resale to BMS, and Sano may license other third-party manufacturers, as Sano deems necessary or advisable in its judgment and as BMS may reasonably accept, for the manufacture of Finished Product for Sano's resale to BMS (all third-party manufacturers so licensed by Sano shall be referred to individually as a "Third-Party Manufacturer" and collectively as "Third-Party Manufacturers"). Sano shall provide such technical assistance to reasonably enable any Third-Party Manufacturer to manufacture the Finished Products pursuant to applicable lawthe specifications in this Agreement. This right shall be without prejudice to any other rights or remedies which BMS may have at law or in equity due to such inability to supply. In the event that any such inability to supply results in significant delays in the availability of the quantities of Finished Product ordered by BMS, BMS and shall be relieved of the Company shall take following obligations: (1) to launch the Product in any and all actions necessary to changecountry as soon as commercially practicable, as expeditiously as possible, the NDC numbers for the Product and provided in Section 3.6(a); (2) to apply new NDC numbers to the Product. Subject to BMS Regulatory review and approval, and pursuant to applicable law, for no more than six (6) months following the Effective Date, the Product manufactured hereunder may continue to be labeled and packaged with the same labels and packaging that are used by BMS in connection with its previous manufacture of the Product for WFHC; provided, however, that the Parties shall use their commercially reasonable efforts to complete market Product in the revision Territory as provided in Section 3.6(a) and (b); (3) to actively switch prescriptions from BuSpar. to the Product in the Territory, as provided in Section 3.7(a); and (4) to satisfy the Minimum Purchase Requirements, as provided in Section 5.8(c). If such delays are for a period of 120 days or less, then when Sano is again able to supply BMS with the quantities of Finished Product ordered by BMS by the requested delivery dates, the foregoing obligations of BMS shall be reinstated, subject to adjustment to BMS's obligations to account for such delays. If such delays are for a period of more than 120 days, then when Sano is again able to supply BMS with the quantities of Finished Product ordered by BMS by the requested delivery dates, the Parties shall conduct good faith discussions to determine if it is commercially reasonable to reinstate any or all Product labeling and packaging soonerof the foregoing obligations at that time, based on considerations such as intervening changes in market conditions. Subject In the event that the Parties, despite good faith discussions, cannot reach an agreement on the foregoing, then the Parties shall submit such matter to BMS Regulatory review and approval, and arbitration pursuant to applicable law, after such time, the Product shall be manufactured with labeling, branding, trade dress and packaging identifying BMS or any Affiliate thereof as the manufacturer of the Product and the Company (or the Company’s designee) as the distributor thereof and the labeling shall reflect the Company’s NDC number. Promptly after the Effective Date, BMS shall provide to the Company samples and copies of all labeling, branding, trade dress and packaging for the Product as of the Effective Date. Within sixty (60) calendar days following the delivery by BMS to the Company of the current labeling and packaging, the Company shall provide to BMS final specifications for the revised labeling, branding, trade dress and packaging of the Product, including all necessary photo-ready art (or its substantial equivalent) reflecting such revisionsSection 13.15. (d) Subject BMS shall notify Sano immediately upon becoming aware of an event of FORCE MAJEURE under Section 12 or any other event, if BMS cannot supply Bulk Materials in sufficient quantities to the provisions of Section 2.01 (c)enable Sano to formulate and supply Finished Product forecasted to be ordered or ordered by BMS. In such event, the Company BMS shall control take all reasonable steps necessary to minimize production delays to license and shall have sole responsibility for, the content and type of all labeling and packaging (and any changes or supplements thereto) thereafter maintain at least one third-party manufacturer that is reasonably acceptable to Sano as a source for the Product. All such activities related manufacture of Bulk Materials other than BMS itself, for BMS's delivery to any changes Sano at no charge, and BMS may license other third-party manufacturers, as BMS deems necessary or supplements advisable in its judgment and as Sano may reasonably accept, for the manufacture of Bulk Materials for BMS's delivery to the labeling and packaging shall be conducted at the Company’s sole cost and expense, including any *** in securing any approvals required by the FDA or other applicable regulatory authorities for any such changes or supplementsSano. BMS shall be responsible for obtaining provide such labels in accordance with technical assistance to reasonably enable any such third-party manufacturer to manufacture the content specified by the Company. Any changes Bulk Materials pursuant to the labeling and packaging specifications in this Agreement. This right shall be communicated without prejudice to BMS any other rights or remedies which Sano may have at law or in writing at least one hundred twenty (120) calendar days (or, if shorter, the period required by applicable Laws or Government Entities) prior equity due to the desired implementation date together with the documentation specifying the content such inability to be included in the labeling and packaging, including all necessary photo-ready art (or its substantial equivalent). BMS shall not be required to implement such changes until its first batch run after the expiration of such one hundred twenty (120) day (or shorter) period. However, BMS shall endeavor to implement the changes as early as practicablesupply. (e) No terms and conditions contained in any Firm Order, acknowledgment, invoice, xxxx of lading, acceptance or other preprinted form issued by either Party shall be effective to the extent they are inconsistent with or modify the terms and conditions contained herein. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Sale and Purchase of Product. (a) BMS (either itself or through its Affiliates) shall supply to During the Company, and the Company shall, subject to the terms and conditions term of this Agreement, BMS shall supply to Sano (or to Third Party Manufacturers, if required), [*****], directly or by such of its Affiliates as it may designate, sufficient quantities of Bulk Materials as may be required by Sano (or such Third Party Manufacturers, if required) to formulate Finished Products sufficient to meet BMS's orders therefor in the Territory. Sano shall use Bulk Materials supplied by BMS to formulate Finished Product, and Sano shall sell to BMS, and BMS shall purchase from Sano, all of BMS, one hundred percent 's requirements for the Finished Product (100%) which shall be deemed to include all of the Company’s requirements (except for quantities necessary to keep the Company’s backof BMS's Affiliates and Sub-up supplier qualifiedDistributors) the Product for marketing, distribution, sale and use during the Term, pursuant to Firm Orders purchase orders submitted by the Company BMS to BMS Sano from time to time in accordance with Section 2.03, at 5.5. BMS will cause all of its Affiliates and Sub-Distributors to purchase their entire requirements of Finished Products from Sano. BMS may place orders for the Purchase Pricerequirements of its Affiliates and Sub-Distributors, and subject either have Sano ship directly to Section 5.02the Affiliates or Sub-Distributors or to BMS for its reshipment to its Affiliates and Sub-Distributors, or BMS's Affiliates and Sub-Distributors may place orders directly with Sano, as the Parties may agree from time to time. (b) All quantities In consideration of the Product foregoing, during the term of this Agreement and except as otherwise provided herein, the supply of Finished Products by Sano in and for the Territory shall be supplied hereunder by BMS in finished dosage form, filled, labeled, branded and packaged for commercial sale or distribution, or as samples, as exclusively to BMS. During the case may be, in accordance with the terms and conditions term of this Agreement, Sano may supply Finished Products to Third Parties for sales in countries outside the Specifications and applicable LawsTerritory, if any. BMS shall solely and exclusively Thereafter, Sano may supply the Product to the Company, its Affiliates and their respective designees. BMS shall be responsible for the purchase of all raw materials for the manufacture of the Product in accordance with the Product Registrations as necessary to supply the finished Product to the Company under this Agreement. Company shall be responsible for all costs incurred by BMS relating Finished Products to any Firm Orders placed by Company (including, any raw materials or working inventory purchase by BMS on behalf of Company in connection with Firm Orders)third party. (c) Subject Sano shall notify BMS: (i) within 60 days of its receipt of a firm forecast from BMS as provided in the third sentence of Section 5.4, or (ii) immediately upon becoming aware of an event of FORCE MAJEURE under Section 12 or any other event, if Sano cannot supply Finished Products forecasted to be ordered or ordered by BMS. In such event, Sano shall take all reasonable steps necessary to minimize production delays to license and thereafter maintain at least one third-party manufacturer that is reasonably acceptable to BMS Regulatory review and approvalas a source for the manufacture of Finished Products other than Sano itself, for Sano's resale to BMS, and Sano may license other third-party manufacturers, as Sano deems necessary or advisable in its judgment and as BMS may reasonably accept, for the manufacture of Finished Product for Sano's resale to BMS (all third-party manufacturers so licensed by Sano shall be referred to individually as a "Third-Party Manufacturer" and collectively as "Third-Party Manufacturers"). Sano shall provide such technical assistance to reasonably enable any Third-Party Manufacturer to manufacture the Finished Products pursuant to applicable lawthe specifications in this Agreement. This right shall be without prejudice to any other rights or remedies which BMS may have at law or in equity due to such inability to supply. In the event that any such inability to supply results in significant delays in the availability of the quantities of Finished Product ordered by BMS, BMS and shall be relieved of the Company shall take following obligations: (1) to launch the Product in any and all actions necessary to changecountry as soon as commercially practicable, as expeditiously as possible, the NDC numbers for the Product and provided in Section 3.6(a); (2) to apply new NDC numbers to the Product. Subject to BMS Regulatory review and approval, and pursuant to applicable law, for no more than six (6) months following the Effective Date, the Product manufactured hereunder may continue to be labeled and packaged with the same labels and packaging that are used by BMS in connection with its previous manufacture of the Product for WFHC; provided, however, that the Parties shall use their commercially reasonable efforts to complete market Product in the revision Territory as provided in Section 3.6(a) and (b); (3) to actively switch prescriptions from BuSpar. to the Product in the Territory, as provided in Section 3.7(a); and (4) to satisfy the Minimum Purchase Requirements, as provided in Section 5.8(c). If such delays are for a period of 120 days or less, then when Sano is again able to supply BMS with the quantities of Finished Product ordered by BMS by the requested delivery dates, the foregoing obligations of BMS shall be reinstated, subject to adjustment to BMS's obligations to account for such delays. If such delays are for a period of more than 120 days, then when Sano is again able to supply BMS with the quantities of Finished Product ordered by BMS by the requested delivery dates, the Parties shall conduct good faith discussions to determine if it is commercially reasonable to reinstate any or all Product labeling and packaging soonerof the foregoing obligations at that time, based on considerations such as intervening changes in market conditions. Subject In the event that the Parties, despite good faith discussions, cannot reach an agreement on the foregoing, then the Parties shall submit such matter to BMS Regulatory review and approval, and arbitration pursuant to applicable law, after such time, the Product shall be manufactured with labeling, branding, trade dress and packaging identifying BMS or any Affiliate thereof as the manufacturer of the Product and the Company (or the Company’s designee) as the distributor thereof and the labeling shall reflect the Company’s NDC number. Promptly after the Effective Date, BMS shall provide to the Company samples and copies of all labeling, branding, trade dress and packaging for the Product as of the Effective Date. Within sixty (60) calendar days following the delivery by BMS to the Company of the current labeling and packaging, the Company shall provide to BMS final specifications for the revised labeling, branding, trade dress and packaging of the Product, including all necessary photo-ready art (or its substantial equivalent) reflecting such revisionsSection 13.15. (d) Subject BMS shall notify Sano immediately upon becoming aware of an event of FORCE MAJEURE under Section 12 or any other event, if BMS cannot supply Bulk Materials in sufficient quantities to the provisions of Section 2.01 (c)enable Sano to formulate and supply Finished Product forecasted to be ordered or ordered by BMS. In such event, the Company BMS shall control take all reasonable steps necessary to minimize production delays to license and shall have sole responsibility for, the content and type of all labeling and packaging (and any changes or supplements thereto) thereafter maintain at least one third-party manufacturer that is reasonably acceptable to Sano as a source for the Product. All such activities related manufacture of Bulk Materials other than BMS itself, for BMS's delivery to any changes Sano at no charge, and BMS may license other third-party manufacturers, as BMS deems necessary or supplements advisable in its judgment and as Sano may reasonably accept, for the manufacture of Bulk Materials for BMS's delivery to the labeling and packaging shall be conducted at the Company’s sole cost and expense, including any *** in securing any approvals required by the FDA or other applicable regulatory authorities for any such changes or supplementsSano. BMS shall be responsible for obtaining provide such labels in accordance with technical assistance to reasonably enable any such third-party manufacturer to manufacture the content specified by the Company. Any changes Bulk Materials pursuant to the labeling and packaging specifications in this Agreement. This right shall be communicated without prejudice to BMS any other rights or remedies which Sano may have at law or in writing at least one hundred twenty (120) calendar days (or, if shorter, the period required by applicable Laws or Government Entities) prior equity due to the desired implementation date together with the documentation specifying the content such inability to be included in the labeling and packaging, including all necessary photo-ready art (or its substantial equivalent). BMS shall not be required to implement such changes until its first batch run after the expiration of such one hundred twenty (120) day (or shorter) period. However, BMS shall endeavor to implement the changes as early as practicablesupply. (e) No terms and conditions contained in any Firm Order, acknowledgment, invoice, xxxx of lading, acceptance or other preprinted form issued by either Party shall be effective to the extent they are inconsistent with or modify the terms and conditions contained herein. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.