Common use of Supply of Product Clause in Contracts

Supply of Product. (a) Promptly after the Effective Date, Licensor shall (i) facilitate an introduction between Licensee and Licensor’s contract manufacturer of Product (“CMO”) as of the Effective Date, and (ii) use reasonable efforts to cause such CMO to accept a direct engagement with Licensee for the manufacturing or supply of the Product in finished dosage form. (b) Should such CMO decline to provide approval for a direct engagement with Licensee, Licensor shall use diligent efforts (i) to obtain written approval, in such form and substance as may be satisfactory to Licensee, from such CMO to enable Licensee to place purchase orders for Product from such CMO under Licensor’s current supply agreement with such CMO, as agent or consigning party, for delivery to Licensee or its designee, and (ii) to provide Licensee with the rights and benefits of Licensor’s current supply agreement with such CMO for Product in the Licensee Territory. Licensee shall advance to such CMO all amounts that would be payable under an applicable purchase order. (c) Licensee shall have the right to obtain from Licensor or, at Licensee’s option and subject to the consent of the applicable CMO, any of Licensor’s other CMOs, Product in finished dosage form. Upon Licensee’s request, Licensor shall negotiate with Licensee, or shall use Commercially Reasonable and Diligent Efforts to cause the CMO to negotiate with Licensee at terms to be agreed upon between them, as applicable, a definitive agreement for the supply within the Licensee Territory of Product (the “Licensee Supply Agreement”). The transfer price for Products from Licensor will equal Licensor’s actual out-of-pocket costs to Manufacture or have Manufactured Product for the Licensee Territory, and Licensee shall have the right to audit Licensor’s books and records to verify the transfer price. The transfer price (EXW CMO’s facility (Incoterms 2020)) for Products from a CMO will be fixed and negotiated in good faith by Licensee and such CMO. The Licensee Supply Agreement will include supply for all of Licensee’s clinical and commercial requirements for Product.

Appears in 2 contracts

Sources: License Agreement (Scilex Holding Co), License Agreement (Oramed Pharmaceuticals Inc.)

Supply of Product. (a) Promptly after the Effective Date, Licensor shall (i) facilitate an introduction between Licensee ▇▇▇▇▇, ▇▇▇▇▇▇, and Licensor’s contract manufacturer of Product (“CMO”) as of the Effective DateLicensee, and (ii) use reasonable efforts to cause such CMO each of ▇▇▇▇▇ and ▇▇▇▇▇▇ to accept a direct engagement with Licensee for the manufacturing or supply of the Product in finished dosage form. (b) Should such CMO Oishi and Itochu decline to provide approval for a direct engagement with Licensee, Licensor shall use diligent efforts (i) to obtain written approval, in such form and substance as may be satisfactory to Licensee, from such CMO each of Oishi and Itochu to enable Licensee to place purchase orders for Product from such CMO Oishi and/or Itochu under Licensor’s current supply agreement with such CMOthe Supply Agreement, as agent or consigning party, for delivery to Licensee or its designee, and (ii) to provide Licensee with the rights and benefits of Licensor’s current supply agreement with such CMO the Supply Agreement for Product in the Licensee Territory. Licensee shall advance to such CMO Oishi and Itochu all amounts that would be payable under an applicable purchase order. (c) Licensee shall have the right to obtain from Licensor or, at Licensee’s option and subject to the consent of the applicable CMOcontract manufacturer, any of Licensor’s other CMOs, contract manufacturers of Product (each a “CMO”) Product in finished dosage form. Upon Licensee’s request, Licensor shall negotiate with Licensee, or shall use Commercially Reasonable and Diligent Efforts to cause the CMO to negotiate with Licensee at terms to be agreed upon between them, as applicable, a definitive agreement for the supply within the Licensee Territory of Product (the “Licensee Supply Agreement”). The transfer price for Products from Licensor will equal Licensor’s actual out-of-pocket costs to Manufacture or have Manufactured Product for the Licensee Territory, and Licensee shall have the right to audit Licensor’s books and records to verify the transfer price. The transfer price (EXW CMO’s facility (Incoterms 2020)) for Products from a CMO will be fixed and negotiated in good faith by Licensee and such CMO. The Licensee Supply Agreement will include supply for all of Licensee’s clinical and commercial requirements for Product.

Appears in 2 contracts

Sources: Licensing Agreement (Scilex Holding Co), Lidocaine License Agreement (Oramed Pharmaceuticals Inc.)

Supply of Product. (a) Promptly after 3.1. Subject to the Effective Dateterms and conditions of this Agreement, Licensor ABI shall (i) facilitate an introduction between Licensee and Licensor’s contract manufacturer of supply Bulk Product (“CMO”) as of the Effective Dateto NCPC for formulation, testing, and (iiupon government approval) use reasonable efforts sale in the Territory. Bulk Product shall be supplied in response to cause such CMO issuance by NCPC of written purchase orders delivered to accept a direct engagement ABI specifying the quantity to be supplied, along with Licensee any special instructions/requests regarding supply and/or delivery. In addition to Bulk Product, ABI shall supply other product or ingredients reasonably requested by NCPC, subject to agreement by the Parties regarding price and other terms and conditions, and subject to availability. ABI shall have no responsibility for formulating or manufacturing lozenges, nor for obtaining any required regulatory approvals, nor for packaging, distribution, promotion, pricing, or marketing of lozenges in the manufacturing or supply Territory, all of which shall be completed by NCPC with the Product in finished dosage formassistance of ABI. (b) Should 3.2. ABI agrees to allow NCPC right of reference to ABI's US FDA Drug Master File for HBL IFN-[alpha] and to do such CMO decline other acts as are reasonably necessary, and within ABI's control, to provide facilitate approval of HBL IFN-[alpha]-containing lozenges in the Territory for a direct engagement use in the Licensed Indication, and ABI also hereby agrees to consult with LicenseeNCPC at NCPC's request concerning regulatory affairs, Licensor shall use diligent efforts (i) to obtain written review documents to be submitted to governmental agencies for approval, in and to take such form and substance other actions as may be satisfactory necessary from time to Licensee, from such CMO time to enable Licensee to place purchase orders facilitate approval of Licensed Product for Product from such CMO under Licensor’s current supply agreement with such CMO, as agent or consigning party, for delivery to Licensee or its designee, sale and (ii) use in the Territory. ABI also agrees to provide Licensee with the rights and benefits of Licensor’s clinical data from its past, current supply agreement with such CMO for Product in the Licensee Territory. Licensee shall advance to such CMO all amounts or future studies, that would be payable under an applicable purchase order. (c) Licensee shall have the right to obtain from Licensor or, at Licensee’s option and subject relevant to the consent testing, use or sale of Licensed Products in the Territory. ABI further agrees to provide sufficient Bulk Product for preliminary studies and ***Indicates that a portion of the applicable CMOtext has been omitted and filed separately with the Commission. clinical trials as may be appropriate and necessary to support testing and application for approval and commercialization of Licensed Products. ABI shall reasonably provide to NCPC other support or assistance requested by NCPC and within ABI's capabilities with respect to regulatory and clinical activities, any of Licensor’s other CMOs, Product in finished dosage form. Upon Licensee’s request, Licensor shall negotiate with Licensee, or shall use Commercially Reasonable and Diligent Efforts to cause the CMO to negotiate with Licensee at terms to be agreed upon between them, as applicable, on a definitive agreement for the supply within the Licensee Territory of Product (the “Licensee Supply Agreement”). The transfer price for Products from Licensor will equal Licensor’s actual out-of-pocket costs to Manufacture or have Manufactured Product for the Licensee Territory, and Licensee shall have the right to audit Licensor’s books and records to verify the transfer price. The transfer price (EXW CMO’s facility (Incoterms 2020)) for Products from a CMO will be fixed and negotiated in good faith by Licensee and such CMO. The Licensee Supply Agreement will include supply for all of Licensee’s clinical and commercial requirements for Productfully reimbursed basis.

Appears in 1 contract

Sources: License Agreement (Amarillo Biosciences Inc)

Supply of Product. Licensor shall supply the Finished Product to Licensee in accordance with the terms of this Agreement, and all other terms (save for those agreed by the Parties) whether express or implied, shall be excluded from any contract for Finished Product. Licensor shall (subject to clause 13), during the Term, manufacture and deliver such quantities of Finished Product which are ordered by Licensee in writing from time to time within ninety (90) days from the date of Licensee's Binding Purchase Order pursuant to clause 13. Subject to the foregoing, Licensor shall confirm in writing each purchase order within ten (10) business days from the receipt of the same. Without prejudice to any rights or remedies available to Licensee under law or this Agreement, Licensor agrees to promptly notify Licensee after becoming aware of any actual or anticipated delay in any delivery of Finished Product. As part of the Supply Price, Licensor shall package and label Finished Product manufactured by Licensor according to clause 14 above for distribution by Licensor shall include the Trademark. As part of the Supply Price, Licensor shall package and label Products in compliance with the instructions provided by Licensee, provided that Licensor shall have no obligation to implement new packaging or labelling requirements communicated by Licensee with a lead time of less than nine (9) months. Any inventory of obsolete packaging and labelling material ordered by Licensee shall be fully paid for by the Licensee if not possible to use. If permitted by local rules and regulations in a country in which Finished Product shall be distributed, Licensor shall be identified as the developer/manufacturer/licensor of the Finished Product distributed in such country. The packaging of the Finished Product, approved by Licensor using supporting documentation provided by Licensee, shall be: (a) Promptly after sufficient to protect the Effective DateFinished Product during shipment, Licensor shall (i) facilitate an introduction between Licensee and Licensor’s contract manufacturer of Product (“CMO”) as of the Effective Date, and (ii) use reasonable efforts to cause such CMO to accept a direct engagement with Licensee for the manufacturing or supply of the Product in finished dosage form. (b) Should compliant with environmental regulations or other relevant rules or regulations; and (c) contain the proper labelling as instructed by Licensee pursuant to this Agreement. Licensee shall repackage any Finished Product units. Product traceability shall always be assured. cGMP and cGDP shall be applied and documented for the Product from Licensee. The integrity of the sealed immediate container has to be assured whatever action undertaken by the Licensee. Licensor shall use reasonable endeavours to supply the Finished Product and to meet the delivery date, but time of delivery shall not be of the essence and Licensor shall have no liability to Licensee if, notwithstanding such CMO decline endeavours, there is any delay in delivery. All Finished Product delivered by Licensor shall be delivered DAT Arlanda, Stockholm, shipment point LOD Israel and/or Istanbul Turkey. (Delivered At Terminal per Inco terms 2010, made part of this Agreement by reference). Licensee shall use its reasonable endeavours to provide approval collect the Finished Product in a prompt manner. Warehouse or storage costs incurred by Licensor due to Finished Product being left at the point of delivery for an extended period of time on Licensee’s instructions, or as a direct engagement result of an act or omission of Licensee, shall be borne by Licensee. Risk in the Finished Product shall pass to Licensee upon delivery. The title to any consignment of the Finished Product shall not pass to Licensee until Licensor has received payment in full. During such time as title in the Finished Product remains with Licensor, Licensee shall: 14.1.1 store or otherwise keep the Finished Product in such a way as clearly to indicate at all times that the Finished Product are owned by Licensor and shall not remove, obscure or delete any m▇▇▇ placed on the Finished Product by Licensor which may enable the Finished Product to be identified; and 14.1.2 have the power to deal with or use the Finished Product (and other goods in which the Finished Product are incorporated) as fiduciary bailee of Licensor in the normal course of its business and to dispose of the Finished Product or such goods by way of bona fide sale at full market value. In order to secure the availability and timely delivery of the Finished Product to Licensee, Licensor shall use diligent efforts (i) undertakes to obtain written approvalkeep at all times, at its sole costs, expense and responsibility, in such form and substance as may be satisfactory to Licensee, from such CMO to enable Licensee to place purchase orders for Product from such CMO under Licensor’s current supply agreement with such CMO, as agent or consigning party, for delivery to Licensee or its designee, and (ii) to provide Licensee with the rights and benefits premises a sufficient safety stock of Licensor’s current supply agreement with such CMO for Product in the Licensee Territory. Licensee shall advance to such CMO all amounts that would be payable under an applicable purchase order. (c) Licensee shall have the right to obtain from Licensor or, at Licensee’s option and subject to the consent of the applicable CMO, any of Licensor’s other CMOs, Product in finished dosage form. Upon Licensee’s request, Licensor shall negotiate with Licensee, or shall use Commercially Reasonable and Diligent Efforts to cause the CMO to negotiate with Licensee at terms to be agreed upon between them, as applicable, a definitive agreement for the supply within the Licensee Territory of Finished Product (the “Licensee Supply AgreementSafety Stock”). The transfer price Such Safety Stock shall correspond to at least one (1) month of Licensee’s average monthly orders for Products from Finished Product over the previous twelve (12) calendar months to be assessed and updated at the end of each calendar quarter Safety stock will be kept as bulk product by Licensor. Licensor will equal Licensor’s actual out-of-pocket costs to Manufacture or have Manufactured may not deliver Finished Product which is not manufactured at an approved facility and may not change the manufacturing site and/or the regulatory commitments (which are defined in the Marketing Authorisation documentation and shall include without limitation manufacturing method and specification) for the Finished Product without obtaining prior written approval therefore from the Competent Authority. Licensee's right to possession of the Finished Product shall terminate immediately upon the any of the events listed in clause 24 affecting Licensee, or if Licensee Territoryencumbers any of the Finished Product. Licensee grants Licensor, its agents and employees an irrevocable licence at any time to enter any premises where the Finished Product are or may be stored in order to inspect them, or, where Licensee's right to possession has terminated, to recover them. Where Licensor is unable to determine whether any Finished Product are the Finished Product in respect of which Licensee's right to possession has terminated, Licensee shall be deemed to have sold all Finished Product of the right kind sold by Licensor to audit Licensee in the order in which they were invoiced to Licensee. During the Term Licensee or any Competent Authority shall be entitled upon prior written notice to visit, inspect and carry out audits relating to the Finished Product at Licensor’s books and records 's facilities, to verify the transfer pricecompliance with this Agreement. The transfer price With regards to Licensee such visits shall be arranged during normal working hours within three (EXW CMO’s facility (Incoterms 2020)3) for Products weeks from a CMO will be fixed and negotiated the date of notice. For purposes of such audits, the Parties undertake to co-operate in good faith with each other and provide the other Party with such information and documentation relating to the Finished Product and the manufacture thereof, which it may reasonably request. Product shipped to Licensee cannot be returned to Licensor at any time. All costs for expired Products shall be covered by Licensee. Licensor shall only provide Licensee with batches of Product that have previously been released and such CMOapproved. A Certificate of Analysis (CoA) of each specific batch, intended for Licensee Territories can on special request be sent before shipment of a specific order. Licensee has to approve the certificate via fax or email within two business days. A CoA shall specify Product, batch number, and tests performed in accordance with the specifications submitted to the competent authorities within the Territory. Further it shall contain the name and address of Licensor - manufacturing site and number of Manufacturing Authorisation Licence or Certificate of GMP Compliance of a Licensor’s third Party Manufacturer. A CoA shall specify Product, batch number, and tests performed in accordance with the specifications submitted to the competent authorities within the Territory. Further it shall contain the name and address of Licensor - manufacturing site and number of Manufacturing Authorisation Licence or Certificate of GMP Compliance of a Licensor. Batch Release Certificate, signed by Licensor QP. The Batch Release Certificate shall be accompanied with a declaration of having no deviations in the manufacturing and control or a list of cleared and closed deviations All sites involved in the manufacture including packaging and quality control of the batch should be listed with name and address. The name and address must correspond to the information provided on the Manufacturing Authorisation/Establishment Licence. Each shipper box shall include a temperature logger. On the Packing list, it shall be indicated the location of temperature loggers and information on required transportation conditions of the Product. Licensor 's QP shall collaborate with Licensee Supply Agreement 's QP and shall provide Licensee 's QP with for local Product release, relevant GMP information related to the Products and required by Licensee´s for the release of the Products in the Territory.. Final judgement on which information to provide shall be solely based on GMP and on the Licensor´s QP judgement. Such information will include supply for all of be provided within reasonable time. Without derogating from the aforesaid, Licensor's QP shall provide Licensee’s clinical 's QP with general information on Licensor's quality assurance system, Licensor's quality policy and commercial requirements for Productthe manufacturing process's compliance with GMP requirements.

Appears in 1 contract

Sources: Supply and Exclusive License Agreement (Oasmia Pharmaceutical AB)

Supply of Product. 13.1 Licensor shall supply the Finished Product to Licensee in accordance with the terms of this Agreement, and all other terms (save for those agreed by the Parties) whether express or implied, shall be excluded from any contract for Finished Product. 13.2 Licensor shall (subject to Clause 12.3), during the Term, manufacture and deliver such quantities of Finished Product which are ordered by Licensee in writing from time to time within sixty (60) days from the date of Licensee's Binding Purchase Order pursuant to Clause 12.1. Subject to the foregoing, Licensor shall confirm in writing each purchase order within five (5) business days from the receipt of the same. 13.3 As part of the Supply Price, Licensor shall package and label Finished Product manufactured by Licensor according to Clause 13.1 above for distribution by Licensee. As part of the Supply Price, Licensor shall package and label Products in compliance with the instructions provided by Licensee, provided that Licensor shall have no obligation to implement new packaging or labelling requirements communicated by Licensee with a lead time of less than two (2) months. If permitted by rules and regulations in the Territory, Licensor shall be identified as the developer/manufacturer/licensor of the Finished Product distributed in the Territory. The packaging of the Finished Product, approved by Licensee using supporting documentation provided by Licensee, shall be: (a) Promptly after sufficient to protect the Effective DateFinished Product during shipment, (b) compliant with environmental regulations or other relevant rules or regulations; and (c) contain the proper labelling as instructed by Licensee pursuant to this Agreement. Licensee may repackage any Finished Product units. 13.4 Licensor shall use reasonable endeavours to supply the Finished Product and to meet the delivery date. Without prejudice to any rights or remedies available to Licensee under law or this Agreement, Licensor shall (i) facilitate an introduction between agrees to promptly notify Licensee and Licensor’s contract manufacturer after becoming aware of Product (“CMO”) as any actual or anticipated delay in any delivery of Finished Product. In the Effective Date, and (ii) use reasonable efforts to cause such CMO to accept a direct engagement with Licensee for event that Licensor could not fulfil the manufacturing or supply delivery of the Product in finished dosage formwithin three (3) months after the lead time pursuant to Clause 12.1, then the Licensee shall be entitled to demand Licensor for a compensation which is limited to ten percent (10%) of the value of the delayed Finished Product. 13.5 All Finished Product delivered by Licensor shall be delivered CIP Arlanda Sweden - Narita Japan (bper Incoterms 2000, made part of this Agreement by reference) Should or to any other destination specified by Licensee from time to time within the Territory. 13.6 Licensee shall use its reasonable endeavours to collect the Finished Product in a prompt manner. Warehouse or storage costs incurred by Licensor due to Finished Product being left at the point of delivery for an extended period of time on Licensee’s instructions, or as a result of an act or omission of Licensee, shall be borne by Licensee. 13.7 Risk in the Finished Product shall pass to Licensee upon delivery. 13.8 The title to any consignment of the Finished Product shall not pass to Licensee until Licensor has received payment in full of the price. 13.9 During such CMO decline time as title in the Finished Product remains with Licensor, Licensee shall: 13.9.1 store or otherwise keep the Finished Product in such a way as clearly to provide approval for a direct engagement indicate at all times that the Finished Product are owned by Licensor and shall not remove, obscure or delete any m▇▇▇ placed on the Finished Product by Licensor which may enable the Finished Product to be identified; and 13.9.2 have the power to deal with or use the Finished Product (and other goods in which the Finished Product are incorporated) as fiduciary bailee of Licensor in the normal course of its business and to dispose of the Finished Product or such goods by way of bona fide sale at full market value. 13.10 In order to secure the availability and timely delivery of the Finished Product to Licensee, Licensor shall use diligent efforts (i) agrees to obtain written approvalundertake to keep at all times, at its sole costs, expense and responsibility, in such form and substance as may be satisfactory to Licensee, from such CMO to enable Licensee to place purchase orders for Product from such CMO under Licensor’s current supply agreement with such CMO, as agent or consigning party, for delivery to Licensee or its designee, and (ii) to provide Licensee with the rights and benefits premises a sufficient safety stock of Licensor’s current supply agreement with such CMO for Product in the Licensee Territory. Licensee shall advance to such CMO all amounts that would be payable under an applicable purchase order. (c) Licensee shall have the right to obtain from Licensor or, at Licensee’s option and subject to the consent of the applicable CMO, any of Licensor’s other CMOs, Product in finished dosage form. Upon Licensee’s request, Licensor shall negotiate with Licensee, or shall use Commercially Reasonable and Diligent Efforts to cause the CMO to negotiate with Licensee at terms to be agreed upon between them, as applicable, a definitive agreement for the supply within the Licensee Territory of Finished Product (the “Licensee Supply AgreementSafety Stock)) designated to Licensee. The transfer price Such Safety Stock shall correspond to at least three (3) months of Licensee’s average monthly orders for Products from Licensor will equal Finished Product over the previous twelve (12) calendar months to be assessed and updated at the end of each calendar quarter, and shall be rotated with Licensor’s actual out-of-pocket regular inventory of Finished Product to maintain shelf life. For the avoidance of doubt, the Parties expressly agree that the costs to Manufacture or have Manufactured and expenses incurred by Licensor as result of keeping such Safety Stock shall be deemed already included in the Supply Price. 13.11 Licensor shall not deliver Finished Product which is not manufactured at an approved facility and shall not change the manufacturing site and/or the regulatory commitments (which are defined in the Marketing Authorisation documentation and shall include without limitation manufacturing method and specification) for the Finished Product without obtaining prior written approval therefore from Licensee Territoryand the Competent Authority. 13.12 During the Term and the time which Licensee uses its stock of Finished Product delivered by Licensor, Licensor shall provide Licensee, and Licensee shall have at Licensee’s request also the Competent Authority, with letter(s) of authorisation as well as any documentation relating to the Finished Product required by Licensee, or such authorities, for Marketing Authorisation. 13.13 Licensee's right to audit possession of the Finished Product shall terminate immediately upon the any of the events listed in Clause 24.2(b) affecting Licensee, or if Licensee encumbers any of the Finished Product. 13.14 Licensee grants Licensor’s books , its agents and records employees an irrevocable right at any time to enter any premises where the Finished Product are or may be stored in order to inspect them, or, where Licensor's right to possession has terminated, to recover them. 13.15 During the Term Licensee or any Competent Authority shall be entitled upon prior written notice to visit, inspect and carry out audits relating to the Finished Product at Licensor's facilities, to verify the transfer pricecompliance with this Agreement. The transfer price With regard to Licensor such visits shall be arranged during normal working hours within four (EXW CMO’s facility (Incoterms 2020)4) for Products weeks from a CMO will be fixed and negotiated the date of notice. For purposes of such audits, the Parties undertake to co-operate in good faith by Licensee with each other and provide the other party with such CMO. The Licensee Supply Agreement will include supply for all of Licensee’s clinical information and commercial requirements for Productdocumentation relating to the Finished Product and the manufacture thereof, which it may reasonably request.

Appears in 1 contract

Sources: Development, Supply and Exclusive License Agreement (Oasmia Pharmaceutical AB)

Supply of Product. (a) Promptly after 2.1 Manufacturer guarantees that it will inspect all merchandise prior to shipment from the Effective Date, Licensor shall (i) facilitate an introduction between Licensee and Licensor’s contract manufacturer of Product (“CMO”) as of the Effective DateNew York, and (ii) use reasonable efforts to cause that such CMO to accept a direct engagement with Licensee for the manufacturing or supply of the Product merchandise will be in finished dosage form. (b) Should such CMO decline to provide approval for a direct engagement with Licensee, Licensor shall use diligent efforts (i) to obtain written approval, in such form and substance as may be satisfactory to Licensee, from such CMO to enable Licensee to place purchase orders for Product from such CMO under Licensor’s current supply agreement with such CMO, as agent or consigning party, for delivery to Licensee or its designee, and (ii) to provide Licensee with the rights and benefits of Licensor’s current supply agreement with such CMO for Product in the Licensee Territoryfirst class condition. Licensee shall advance to such CMO all amounts that would be payable under an applicable purchase order. (c) Licensee Distributor shall have the right to obtain from Licensor orinspect merchandise upon delivery in . All merchandise will be shipped FOB, at Licensee’s option New York. 2.2 Manufacturer shall obtain, arrange and subject advance payment for expenses relating to the consent packaging, loading and shipping and carriage from Manufacturer’s facility of the applicable CMOProducts and any licenses, any customs formalities, tariffs, duties, taxes and other charges payable upon export, certain of Licensorwhich expenses shall be invoiced to Distributor pursuant to Section 3.2 hereof. Distributor shall have the option to designate a carrier of choice. Title to and risk of loss of the Products shall pass to Distributor upon loading of the Products at the Manufacturer’s other CMOs, Product in finished dosage form. Upon Licensee’s request, Licensor shall negotiate with Licensee, or shall use Commercially Reasonable and Diligent Efforts to cause the CMO to negotiate with Licensee at terms to be agreed upon between them, as applicable, a definitive agreement for the supply within the Licensee Territory of Product (the “Licensee Supply Agreement”). The transfer price for Products from Licensor will equal Licensor’s actual out-of-pocket costs to Manufacture or have Manufactured Product for the Licensee Territoryfacility, and Licensee Distributor shall thereafter be responsible for all costs and expenses relating to the Products, including, without limitation, the cost of carriage, insurance, unpacking and unloading the Products and any licenses, customs formalities, tariffs, duties, taxes and other charges payable upon import. 2.3 Manufacturer shall have the right to: (a) (i) refuse to audit Licensor’s books accept any order from Distributor, (ii) cancel any order previously accepted by Manufacturer, and records (iii) refuse or delay the shipment of Products, in each case immediately upon the breach by Distributor of any material provision of this Agreement or immediately upon the failure of Distributor to verify meet any payment schedules or credit or other financial requirements which may, from time to time, be established by Manufacturer; (b) allocate its inventory of Products from time to time and in such manner as it may determine in its sole discretion; and (c) at any time, effect changes in, or discontinue the transfer pricemanufacture or sale of, any Product without incurring any liability to Distributor. The transfer price In the event Manufacturer effects changes in any Product which shall cause such Product to be incompatible with any other Product with which it was compatible prior to such change, Manufacturer shall provide Distributor with written notice thirty (EXW CMO’s facility 30) days prior to the date on which the prior version of the changed Product shall no longer be available. In the event Manufacturer discontinues the sale of any Product, the Manufacturer shall provide Distributor with written notice thirty (Incoterms 2020)30) days prior to the date on which such discontinuation is effective 2.4 Distributor hereby grants to Manufacturer a security interest in all Products sold to Distributor and any proceeds thereof (including accounts receivable) as security for all its payment obligations for Products from a CMO will be fixed purchased and negotiated in good faith not paid for by Licensee Distributor under this Agreement. Upon the request of Manufacturer, Distributor shall execute any document or instrument necessary or appropriate to confirm or perfect such security interest and Manufacturer is hereby authorized to execute any such CMO. The Licensee Supply Agreement will include supply for all of Licenseedocument or instrument on Distributor’s clinical and commercial requirements for Productbehalf.

Appears in 1 contract

Sources: International Distributors Agreement