Supply Agreement. Until the Parties enter into the Supply Agreement, the Parties agree to the following terms, which terms, to the extent applicable, shall be included in the Supply Agreement: 5.1. Pro-Dex will be Monogram’s exclusive manufacturer and supplier for all of the Products. Before providing any manufacturing and supply services to Monogram, Pro-Dex will provide in writing to Monogram: (i) the reference data (from simulated use studies) used to inform the warranty period; (ii) the framework for validating processes for receiving contaminated field units for repairs and servicing; (iii) the price per Product, which, subject to Section 5.3, if Monogram does not agree to, shall be determined by Monogram soliciting bids for that same Product from at least three manufacturing companies that are (a) mutually agreed upon by Monogram and Pro-Dex, (b) ISO 13485 qualified, (c) registered with the FDA, and (d) in compliance with the FDA’s Quality System Regulation (the “Qualified Manufacturers”). The higher of (x) the average of the bids provided by the Qualified Manufacturers and (y) the median of the bids shall be the “Qualified Manufacturer Bid”. After obtaining the Qualified Manufacturer Bid, Pro-Dex will have the right to manufacture and supply that Product at the lesser of (i) one hundred and fifty percent (150%) of the Qualified Manufacturer Bid or (ii) the original bid submitted by Pro-Dex. If Pro-Dex does not elect to manufacture and supply that Product on such terms, Monogram may outsource the manufacturing and supply of that Product to a Qualified Manufacturer selected by Monogram and subject to Pro-Dex’s approval (not to be unreasonably withheld); and (iv) the lead time required by Pro-Dex to deliver the manufactured Products to Monogram, which, if Monogram does not agree to, shall be determined by Monogram soliciting lead time bids for that same Product from at least three Qualified Manufacturers. The higher of (x) the average of the bids provided by the Qualified Manufacturers and (y) the median of the bids shall be the “Qualified Lead Time Bid”. After obtaining the Qualified Lead Time Bid, Pro-Dex will have the right to supply the Products with a lead time equal to the lesser of (i) two hundred percent (200%) of the Qualified Lead Time Bid or (ii) the original bid submitted by Pro-Dex. If Pro-Dex does not elect to manufacture and supply that Product at such lead times, Monogram may outsource the manufacturing and supply of that Product to a Qualified Manufacturer selected by Monogram and subject to Pro-Dex’s approval (not to be unreasonably withheld).
Appears in 1 contract
Sources: Development and Supply Agreement (Monogram Orthopaedics Inc)
Supply Agreement. Until By written notice provided to GSK not later than [… * …] (the “Interim Supply Notice”), XenoPort may request that GSK manufacture and supply (or arrange for the manufacture and supply of) quantities of Product, for commercialization by or on behalf of XenoPort in the Territory, with such supply obligation to commence on the date XenoPort submits to GSK the Interim Supply Notice in accordance with this Section 4.5 and continue until October 30, 2013 (the “Supply Term”), at a supply price and upon terms to be agreed by the Parties enter in a separate supply agreement. Any such supply agreement entered into by the Parties shall be consistent with the terms set forth on Schedule 4.5 attached hereto (the “Supply Agreement”). The Parties shall use Commercially Reasonable Efforts to negotiate and execute the definitive written Supply Agreement promptly following the Termination Effective Date, [… * …] (provided, however, that the Parties shall have entered into an appropriate quality agreement covering responsibilities that will apply to the Product sold to XenoPort pursuant to this Section 4.5, including responsibilities for relevant quality assurance and quality control activities related thereto), [… * …]. If, in accordance with the above, XenoPort requests that GSK provide interim supply of Product, the following shall apply:
(a) XenoPort shall issue firm purchase orders (each, a “Firm Order”) for those quantities of Product to be supplied to XenoPort during the term of the Supply Agreement, which shall be provided to GSK [… * …] XenoPort may issue up to [… * …].
(b) The Firm Orders may be delivered electronically or by other means to such location as GSK shall designate and shall include (i) [… * …]. Product quantities shall be ordered by XenoPort in accordance with agreed minimum quantities and consistent with agreed forecasted demand in effect for such Product, in each case, as set forth on Schedule 4.5B.
(c) If after GSK’s review of XenoPort’s Firm Orders, questions arise based on [… * …] Once all questions relating to [… * …] GSK shall be deemed to have accepted such Firm Order; provided, however, that any delay in resolving such questions may impact the [… * …]. In the event that the Parties are not reasonably able to agree to the following terms, which terms, to the extent applicable, shall be quantities included in any Firm Order, [… * …] GSK shall proceed with supplying those quantities of Product that are agreed to by the Parties (and, therefore, not under review). XenoPort [… * …]
(d) [… * …]
(e) If XenoPort issues the Interim Supply Notice to GSK, then on that same date, XenoPort shall provide to GSK all required artwork to update Labels and/or Labeling (the “Artwork”) for use on Product supplied pursuant to the Supply Agreement:
5.1. Pro-Dex will be Monogram, which shall include, among other things, XenoPort’s exclusive manufacturer and supplier NDC number(s) for all of the Products. Before providing any manufacturing and supply services to Monogram, Pro-Dex will provide in writing to Monogram:
(i) the reference data (from simulated use studies) used to inform the warranty period;
(ii) the framework for validating processes for receiving contaminated field units for repairs and servicing;
(iii) the price per Product, whichand the following terms of this * CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, subject to Section 5.3MARKED BY BRACKETS, if Monogram does not agree toIS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, shall be determined by Monogram soliciting bids for that same Product from at least three manufacturing companies that are (a) mutually agreed upon by Monogram and Pro-Dex, (b) ISO 13485 qualified, (c) registered with the FDA, and (d) in compliance with the FDA’s Quality System Regulation (the “Qualified Manufacturers”). The higher of (x) the average of the bids provided by the Qualified Manufacturers and (y) the median of the bids shall be the “Qualified Manufacturer Bid”. After obtaining the Qualified Manufacturer Bid, Pro-Dex will have the right to manufacture and supply that Product at the lesser of (i) one hundred and fifty percent (150%) of the Qualified Manufacturer Bid or (ii) the original bid submitted by Pro-Dex. If Pro-Dex does not elect to manufacture and supply that Product on such terms, Monogram may outsource the manufacturing and supply of that Product to a Qualified Manufacturer selected by Monogram and subject to Pro-Dex’s approval (not to be unreasonably withheld); and
(iv) the lead time required by Pro-Dex to deliver the manufactured Products to Monogram, which, if Monogram does not agree to, shall be determined by Monogram soliciting lead time bids for that same Product from at least three Qualified Manufacturers. The higher of (x) the average of the bids provided by the Qualified Manufacturers and (y) the median of the bids shall be the “Qualified Lead Time Bid”. After obtaining the Qualified Lead Time Bid, Pro-Dex will have the right to supply the Products with a lead time equal to the lesser of (i) two hundred percent (200%) of the Qualified Lead Time Bid or (ii) the original bid submitted by Pro-Dex. If Pro-Dex does not elect to manufacture and supply that Product at such lead times, Monogram may outsource the manufacturing and supply of that Product to a Qualified Manufacturer selected by Monogram and subject to Pro-Dex’s approval (not to be unreasonably withheld)AS AMENDED.
Appears in 1 contract
Sources: Termination and Transition Agreement (Xenoport Inc)
Supply Agreement. Until Unless the Parties enter into agree otherwise, [*] following the Supply AgreementEffective Date, the Parties will negotiate in good faith and enter into a supply agreement (the “Supply Agreement”) consistent with the supply terms and conditions in this Section 5.1 for the supply of the Licensed Antibodies in a [*] drug product format in final form by Agenus to Betta for Development and Commercialization in the Field in the Territory.
(a) The Parties agree that the Supply Agreement should be consistent with the following principle: prior to the following termsManufacturing Technology Transfer Completion pursuant to Section 5.2(b), which terms, Agenus will [*] supply the Licensed Antibodies in a [*] drug product format in final form to Betta for the extent applicable, shall be included Field in the Supply Agreement:
5.1. Pro-Dex will be Monogram’s exclusive manufacturer Territory at [*] of Agenus’ Fully Burdened Manufacturing Costs (or the Fully Burdened Manufacturing Costs of its Affiliate, Sublicensee or Third Party Manufacturer, as applicable), plus all logistics, shipping, and supplier for all of the Products. Before providing any manufacturing and supply services VAT or other applicable transfer taxes, subject to Monogram, Pro-Dex will provide in writing to Monogram:
(i) the reference data (from simulated use studies) used to inform the warranty period;
reasonable forecasting and other typical supply terms and (ii) Betta’s procurement of all import permits and other approvals needed for such Development and Commercialization in the framework Field in the Territory where such supply is intended for validating processes use.
(b) As long as Agenus supplies the Licensed Antibodies to Betta for receiving contaminated field units for repairs Commercialization in the Field in the Territory, no more than once per [*] or more frequently as reasonably required to address any quality issues, and servicing;
upon not less than [*] prior written notice, Agenus will (i) [*] accommodate Betta’s reasonable request to audit Agenus’ third party manufacturer facilities where the Licensed Antibodies supplied hereunder are Manufactured in order to assess compliance with GMP, (ii) accommodate Betta’s reasonable request to audit the parts of Agenus’ facilities that oversee the Manufacture of the Licensed Antibodies by Agenus’ third party manufacturer of the Licensed Antibodies in order to assess compliance with GMP, and (iii) accommodate Betta’s reasonable request to audit Agenus’ books and records directly related to the price per ProductManufacture of such Licensed Antibodies, whichincluding such records provided to Agenus by Agenus’ third party manufacturer of the Licensed Antibodies. Betta will [*] complete such audits within [*], subject during business hours, without unreasonable disruption to Section 5.3the audited party’s normal business operations and in accordance with such party’s security, safety and other rules and requirements. Persons auditing the facilities, books or records shall be required to enter into separate confidentiality agreements, if Monogram does not agree to, expressly covered by this Agreement and shall abide by the safety protocols and standard operating procedures of the audited facility while on site. Any authorized audits of third party facilities shall be determined by Monogram soliciting bids for that same Product from at least three manufacturing companies that are (a) mutually agreed upon by Monogram and Pro-Dex, (b) ISO 13485 qualified, (c) registered with on the FDA, and (d) in compliance with the FDA’s Quality System Regulation (the “Qualified Manufacturers”). The higher of (x) the average of the bids provided by the Qualified Manufacturers and (y) the median of the bids shall be the “Qualified Manufacturer Bid”. After obtaining the Qualified Manufacturer Bid, Pro-Dex will have the right to manufacture and supply that Product at the lesser of (i) one hundred and fifty percent (150%) of the Qualified Manufacturer Bid or (ii) the original bid submitted by Pro-Dex. If Pro-Dex does not elect to manufacture and supply that Product on such terms, Monogram may outsource the manufacturing and supply of that Product to a Qualified Manufacturer selected by Monogram terms and subject to Pro-Dex’s the requirements and approval (not to be unreasonably withheld); and
(iv) of any such third party. For the lead time required by Pro-Dex to deliver the manufactured Products to Monogramavoidance of doubt, which, if Monogram does not agree to, shall be determined by Monogram soliciting lead time bids for that same Product from at least three Qualified Manufacturers. The higher of (x) the average of the bids provided by the Qualified Manufacturers and (y) the median of the bids shall be the “Qualified Lead Time Bid”. After obtaining the Qualified Lead Time Bid, Pro-Dex Agenus will have the satisfied its obligation in Section 5.1(b)(i) above to [*] by asking its third party manufacturer to accommodate an audit by Betta, and in no event will Agenus be required to exercise its own audit right in its agreement with any such third party manufacturer to supply the Products with a lead time equal to the lesser of (i) two hundred percent (200%) of the Qualified Lead Time Bid or (ii) the original bid submitted accommodate an audit request by Pro-Dex. If Pro-Dex does not elect to manufacture and supply that Product at such lead times, Monogram may outsource the manufacturing and supply of that Product to a Qualified Manufacturer selected by Monogram and subject to Pro-Dex’s approval (not to be unreasonably withheld)Betta.
Appears in 1 contract
Supply Agreement. Until Within [* * *] after the Parties meeting referenced in Section 8.1, Durect shall notify Zogenix in writing if Durect elects to supply Zogenix’s Phase III Clinical Trial and commercial requirements for Product or Product Formulation, as applicable, in the Territory. If Durect so elects to supply, Durect and Zogenix shall each use Commercially Reasonable Efforts to enter into a supply agreement (the “Supply Agreement”) and associated technical agreement governing QA (“Technical Agreement”) providing for the supply by Durect (by itself or through a Third Party manufacturer reasonably acceptable to Zogenix) of all of Zogenix’s and its Affiliates’ and Sublicensees’ commercial requirements (including Phase IV Clinical Trials) of Product or Product Formulation, as applicable, in the Territory. Each Party shall use Commercially Reasonable Efforts to enter into the Supply Agreement, the Parties agree Agreement no later than [* * *] prior to the following termsinitiation of the first Phase III Clinical Trial. Product or Product Formulation, which terms, to the extent as applicable, supplied shall be included meet the specifications provided for in the Supply Agreement:
5.1. Pro-Dex will Agreement and associated Technical Agreement to be Monogram’s exclusive manufacturer and supplier for all executed by each of the ProductsParties hereto. Before providing any Under the Supply Agreement, Zogenix shall pay Durect a transfer price for the Product or Product Formulation, as applicable, equal to Durect’s fully burdened manufacturing and supply services Cost, such term to Monogrambe defined in the Supply Agreement [* * *], Pro-Dex will provide in writing to Monogram:
(i) the reference data (from simulated use studies) used to inform the warranty period;
(ii) the framework for validating processes for receiving contaminated field units for repairs and servicing;
(iii) the price per Productproduce Product or Product Formulation, whichas applicable, subject to Section 5.3, if Monogram does not agree to, shall be determined by Monogram soliciting bids for that same Product from at least three manufacturing companies that are (a) mutually agreed upon by Monogram and Pro-Dex, (b) ISO 13485 qualified, (c) registered with the FDA, and (d) in compliance with the FDA’s Quality System Regulation (the “Qualified Manufacturers”plus [* * *]). The higher Supply Agreement shall also contain provisions for back-up sources of (x) supply and other customary terms and conditions for such type of agreements. Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the average of the bids provided by the Qualified Manufacturers and (y) the median of the bids shall be the “Qualified Manufacturer Bid”. After obtaining the Qualified Manufacturer Bid, Pro-Dex will have the right to manufacture and supply that Product at the lesser of (i) one hundred and fifty percent (150%) of the Qualified Manufacturer Bid or (ii) the original bid submitted by Pro-Dex. If Pro-Dex does not elect to manufacture and supply that Product on such terms, Monogram may outsource the manufacturing and supply of that Product to a Qualified Manufacturer selected by Monogram and information subject to Pro-Dex’s approval (not to be unreasonably withheld); and
(iv) the lead time required by Pro-Dex to deliver confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the manufactured Products to Monogram, which, if Monogram does not agree to, shall be determined by Monogram soliciting lead time bids for that same Product from at least three Qualified Manufacturers. The higher of (x) the average of the bids provided by the Qualified Manufacturers Securities and (y) the median of the bids shall be the “Qualified Lead Time Bid”. After obtaining the Qualified Lead Time Bid, Pro-Dex will have the right to supply the Products with a lead time equal to the lesser of (i) two hundred percent (200%) of the Qualified Lead Time Bid or (ii) the original bid submitted by Pro-Dex. If Pro-Dex does not elect to manufacture and supply that Product at such lead times, Monogram may outsource the manufacturing and supply of that Product to a Qualified Manufacturer selected by Monogram and subject to Pro-Dex’s approval (not to be unreasonably withheld)Exchange Commission.
Appears in 1 contract
Supply Agreement. Until (a) Within * after the Parties Effective Date of this Agreement, the parties shall enter into a supply agreement (“Supply Agreement”) on reasonable and customary terms with respect to the preclinical, clinical and commercial supply arrangements contemplated in Section 8.1 for such Products and Program Carriers, including without limitation provisions for quality assurance and quality control, and in any event consistent with terms summarized in this Section 8.2.
(b) Emisphere shall utilize a qualified Third Party subcontractor to perform its manufacturing obligations with respect to Products and the Program Carrier; provided that each subcontractor and subcontract agreement (and any material changes thereto) that does not solely relate to or provide services with respect to the Program Carrier will be subject to Genta’s prior approval, not to be unreasonably withheld, and that the terms of each subcontract agreement shall be reasonably consistent with all of the requirements and limitations imposed upon Emisphere under the Supply Agreement. To the extent the Emisphere wishes to itself manufacture the Products or Program Carriers (as opposed to using a subcontractor), then the parties will negotiate in good faith the terms of such a proposed arrangement, including without limitation as to price and quality assurance. * denotes material omitted pursuant to a Confidential Treatment Request and filed separately with the Securities and Exchange Commission.
(c) Supply prices under the Supply Agreement for Program Carrier or finished Product supplied by Emisphere will not exceed *. Genta shall supply the Gallium Salt to Emisphere free of charge, including shipping costs, for all Products to be manufactured by Emisphere.
(d) The Supply Agreement will contain terms and conditions typically included in supply agreements for similar products at similar volumes and similar stages of development. Without limiting the generality of the foregoing, the Parties agree to the following terms, which terms, to the extent applicable, shall be included in parties intend that the Supply Agreement:
5.1. Pro-Dex Agreement will be Monogram’s exclusive manufacturer and supplier for all of include the Products. Before providing any manufacturing and supply services to Monogram, Pro-Dex will provide in writing to Monogramfollowing:
(i) Provisions that require Genta, on a monthly basis, to provide Emisphere with a written * rolling forecast of its anticipated Product (or, as applicable, Program Carrier) demand (each a “Forecast”). It is anticipated that the reference data quantities set forth in the first * of each Forecast will be treated as firm purchase orders, and that otherwise, each Forecast will be non-binding. It is also anticipated that Emisphere will generally be obligated to accept all purchase orders for Products (from simulated or, as applicable, Program Carrier) issued by Genta, except those that specify a delivery date less than * after the purchase order date. Lastly, and notwithstanding the foregoing, it is anticipated that Emisphere will not be obligated, but will agree to use studiescommercially reasonable efforts, to manufacture and supply, or have manufactured and supplied, Genta with quantities of Product or Program Carrier (as applicable) used in excess of * of the most recent estimate provided to inform Emisphere in a Forecast. The Supply Agreement will contain similar forecasting mechanisms and delivery obligations of Genta with respect to Gallium Salt API required for the warranty period;manufacture of Product pursuant to the Supply Agreement.
(ii) Provisions providing Genta with the framework right to reject any delivery of Product or Program Compound that does not conform to the applicable specifications (as established by mutual written agreement of the parties) by giving written notice to Emisphere of such rejection within 30 days after receipt of such delivery (or for validating processes defects not reasonably discoverable upon delivery, within 30 days after their initial discovery by Genta), along with mechanisms for receiving contaminated field units resolving disputes as to Product or Program Compound conformity through the use of a mutually acceptable Third Party laboratory. Provisions will also be included that require any Gallium Salt API provided by Genta to conform to applicable specifications, and that provide for repairs testing of such material for conformance with such specifications as well as for mechanisms for acceptance and servicing;rejection of such materials by Emisphere or its contract manufacturer.
(iii) Provisions permitting Genta, its Affiliates and Sublicensees manufacture or have manufactured finished Product and the price per Product, which, subject to Section 5.3, if Monogram does not agree to, shall be determined Program Carrier in the event of certain material performance failures by Monogram soliciting bids for that same Product from at least three manufacturing companies that are (a) mutually agreed upon by Monogram and Pro-Dex, (b) ISO 13485 qualified, (c) registered with the FDA, and (d) in compliance with the FDA’s Quality System Regulation (the “Qualified Manufacturers”). The higher of (x) the average of the bids provided by the Qualified Manufacturers and (y) the median of the bids shall be the “Qualified Manufacturer Bid”. After obtaining the Qualified Manufacturer Bid, Pro-Dex will have the right to manufacture and supply that Product at the lesser of (i) one hundred and fifty percent (150%) of the Qualified Manufacturer Bid or (ii) the original bid submitted by Pro-Dex. If Pro-Dex does not elect to manufacture and supply that Product on such terms, Monogram may outsource the manufacturing and supply of that Product to a Qualified Manufacturer selected by Monogram and subject to Pro-Dex’s approval (not to be unreasonably withheld); andEmisphere.
(iv) Provisions specifying that any failure to perform, or delay in performance, by Emisphere under the lead Supply Agreement that arises from Genta’s failure to supply Gallium Salt API as required to make Product within the time required by Pro-Dex to deliver under the manufactured Products to Monogram, which, if Monogram does not agree toSupply Agreement, shall not be determined deemed to be a breach by Monogram soliciting lead time bids for that same Product from at least three Qualified Manufacturers. The higher of (x) the average Emisphere of the bids provided by the Qualified Manufacturers and (y) the median of the bids shall be the “Qualified Lead Time Bid”. After obtaining the Qualified Lead Time Bid, Pro-Dex will have the right to supply the Products with a lead time equal to the lesser of (i) two hundred percent (200%) of the Qualified Lead Time Bid or (ii) the original bid submitted by Pro-Dex. If Pro-Dex does not elect to manufacture and supply that Product at such lead times, Monogram may outsource the manufacturing and supply of that Product to a Qualified Manufacturer selected by Monogram and subject to Pro-Dex’s approval (not to be unreasonably withheld)Supply Agreement.
Appears in 1 contract
Sources: Development and License Agreement (Emisphere Technologies Inc)
Supply Agreement. Until Section 4.1 (Supply Agreements) of the Agreement is hereby deleted in its entirety and replaced as follows:
(a) By [***], the Parties will negotiate in good faith and enter into a supply agreement for the Manufacture and supply of clinical quantities of Licensed Products by Lyra to Lian for use solely in connection with Clinical Trials and other Development of Licensed Products in the Field in the Territory (the “Clinical Supply Agreement”).
(b) Following Lyra’s receipt of Regulatory Approval for the use of the Licensed Product for CRS in the U.S., the Parties will negotiate in good faith and enter into either an addendum to the Clinical Supply Agreement or a standalone supply agreement for the Manufacture and supply of the Licensed Products to Lian to support any expanded access program, compassionate use program (including named patient program or single patient program), or other program for the supply of the Licensed Product in the Field in any Region before receipt of Regulatory Approval for Commercialization of the Licensed Product (“Pre-Approval Commercial Programs”) in such Region to the extent permitted by and in accordance with applicable Laws, including any such program in the Hainan Boao Lecheng International Medical Tourism Pilot Zone, Hong Kong and Guangdong-Hong Kong-Macao Great Bay Area (the “EAP Supply Agreement”). Such Licensed Product will be in the same labeled, finished form, formulation, and dosage strength(s) that Lyra is, at such time, Manufacturing or having Manufactured for commercial use in the U.S and if such Licensed Product is sold at or below cost such supply shall be at a price equal to [***] and if such Licensed Product is sold above cost such supply shall be at a price equal to [***]. For clarity, any quantities of Licensed Products ordered by Lian but failed to be supplied or caused to be supplied by Lyra under the EAP Supply Agreement in a given Calendar Year shall not be included in determining whether a Supply Failure has occurred for such Calendar Year.
(c) No later than [***] prior to the date Lian anticipates its First Commercial Sale of the Licensed Product in the Territory, the Parties will negotiate in good faith and enter into a supply agreement for the Manufacture and supply of commercial quantities of Licensed Products by Lyra to Lian for the commercial sale and distribution of Licensed Product in the Field in the Territory (the “Commercial Supply Agreement” and, together with the Clinical Supply Agreement and the EAP Supply Agreement, the Parties agree to “Supply Agreements”). Unless otherwise agreed or required by applicable Laws, the following termsSupply Agreements will specify that Lyra will (or will cause its Affiliates to) Manufacture and supply, which termsand Lian will purchase from Lyra, to all of Lian’s, its Affiliates’ and Sublicensees’ requirements for the extent Licensed Products for the Development, or Commercialization (as applicable, shall be included ) in the Supply Agreement:
5.1. Pro-Dex will be Monogram’s exclusive manufacturer Field in the Territory in their finished form and supplier for all of the Products. Before providing any manufacturing and supply services at a price equal to Monogram, Pro-Dex will provide in writing to Monogram:
(i) the reference data (from simulated use studies) used to inform the warranty period;
(ii) the framework for validating processes for receiving contaminated field units for repairs and servicing;
(iii) the price per Product, which, subject to Section 5.3, if Monogram does not agree to, shall be determined by Monogram soliciting bids for that same Product from at least three manufacturing companies that are (a) mutually agreed upon by Monogram under the Clinical Supply Agreement, [***] and Pro-Dex, (b) ISO 13485 qualifiedunder the Commercial Supply Agreement, (c) registered with the FDA, and (d) in compliance with the FDA’s Quality System Regulation (the “Qualified Manufacturers”). The higher of (x) the average of the bids [***]; provided by the Qualified Manufacturers and (y) the median of the bids shall be the “Qualified Manufacturer Bid”. After obtaining the Qualified Manufacturer Bid, Pro-Dex will have the right to manufacture and supply that Product at the lesser of (i) one hundred and fifty percent (150%) of the Qualified Manufacturer Bid or (ii) the original bid submitted by Pro-Dex. If Pro-Dex does not elect to manufacture and supply that Product on such terms, Monogram may outsource the manufacturing and supply of that Product to a Qualified Manufacturer selected by Monogram and subject to Pro-Dex’s approval (not to be unreasonably withheld); and
(iv) the lead time required by Pro-Dex to deliver the manufactured Products to Monogram, which, if Monogram does not agree to, shall be determined by Monogram soliciting lead time bids for that same Product from at least three Qualified Manufacturers. The higher of (x) the average of the bids provided by the Qualified Manufacturers and (y) the median of the bids shall be the “Qualified Lead Time Bid”. After obtaining the Qualified Lead Time Bid, Pro-Dex will have the right to supply the Products with a lead time equal to the lesser of (i) two hundred percent (200%) of the Qualified Lead Time Bid or (ii) the original bid submitted by Pro-Dex. If Pro-Dex does not elect to manufacture and supply that Product at such lead times, Monogram may outsource the manufacturing and supply of that Product to a Qualified Manufacturer selected by Monogram and subject to Pro-Dex’s approval (not to be unreasonably withheld)[***].
Appears in 1 contract
Sources: License and Collaboration Agreement (Lyra Therapeutics, Inc.)
Supply Agreement. Until Within [***] after the Parties enter into Effective Date (or such other period as agreed by the Supply AgreementParties), the Parties shall agree on a clinical supply agreement between the Parties pursuant to which MTEM would supply [***] as elected by Takeda, for the Phase I Program and (with MTEM’s written approval) thereafter until the completion of the Technology Transfer, which supply agreement shall also include as Co-Development Costs any mutually agreed Manufacturing process development and supply chain development activities for the applicable Licensed Product (or ▇▇▇▇ ▇▇▇-▇ Fusion Protein) beyond the activities conducted pursuant to the following terms, which terms, [***] with GMP and shall be provided for up to [***] (and if needed prior to the extent applicableTechnology Transfer, shall such additional quantities as are reasonably requested by Takeda and can be included in the Supply Agreement:
5.1. Pro-Dex will be Monogram’s exclusive manufacturer and supplier for all of the Products. Before providing any manufacturing and supply services to Monogram, Pro-Dex will provide in writing to Monogram:
(i) the reference data (from simulated use studies) used to inform the warranty period;
(ii) the framework for validating processes for receiving contaminated field units for repairs and servicing;
(iii) the price per Product, which, subject to Section 5.3, if Monogram does not agree to, shall be determined supplied by Monogram soliciting bids for that same Product from at least three manufacturing companies that are (a) mutually agreed upon by Monogram and Pro-Dex, (b) ISO 13485 qualified, (c) registered with the FDA, and (d) in compliance with the FDA’s Quality System Regulation (the “Qualified Manufacturers”MTEM through Commercially Reasonable Efforts). The higher If no Supply Agreement for the supply of (x) [***] is in place within the average time period specified above, then MTEM shall supply [***] on the terms set forth herein. If Takeda initiates the Technology Transfer from MTEM and no Supply Agreement for the supply of the bids provided by the Qualified Manufacturers and (y) the median of the bids [***] is in place, MTEM shall be the “Qualified Manufacturer Bid”. After obtaining the Qualified Manufacturer Bid, Pro-Dex will have the right to manufacture and supply that Product at the lesser of complete (i) one hundred and fifty percent (150%) of the Qualified Manufacturer Bid or (iihave completed) the original bid submitted by ProManufacture of any work-Dex. If Proin-Dex does not elect to manufacture process Licensed Products or Components thereof and supply that Product on all such terms, Monogram may outsource the manufacturing and supply of that Product to a Qualified Manufacturer selected by Monogram and subject to Pro-Dex’s approval (not to be unreasonably withheld); and
(iv) the lead time required by Pro-Dex to deliver the manufactured Products to Monogram, which, if Monogram does not agree to, costs shall be determined by Monogram soliciting lead time bids for that same Product from at least three Qualified Manufacturersdeemed Co-Development Costs. The higher of (x) Joint Manufacturing Committee shall propose to the average of Parties, from time to time, amendments to the bids provided by the Qualified Manufacturers and (y) the median of the bids Supply Agreement as needed to meet Manufacturing objectives, but for clarity, such amendments shall be effective only if and when the “Qualified Lead Time Bid”. After obtaining the Qualified Lead Time Bid, Pro-Dex will have the right to supply the Products with a lead time equal to the lesser of (i) two hundred percent (200%) of the Qualified Lead Time Bid or (ii) the original bid submitted by Pro-Dex. If Pro-Dex does not elect to manufacture and supply that Product at Parties duly execute such lead times, Monogram may outsource the manufacturing and supply of that Product to a Qualified Manufacturer selected by Monogram and subject to Pro-Dex’s approval (not to be unreasonably withheld)an amendment.
Appears in 1 contract
Sources: Development Collaboration and Exclusive License Agreement (Molecular Templates, Inc.)
Supply Agreement. Until Reasonably in advance of the Parties enter into the Supply AgreementCommercialization of any Licensed Product, the Parties agree shall negotiate in good faith and enter into a mutually acceptable supply agreement (such initial agreement, as amended or extended, together with any subsequent agreements covering subject matter substantially similar thereto, a “Supply Agreement”) that will incorporate a related quality agreement and will set forth the terms and conditions by which SomaLogic shall manufacture and supply SOMAmer Reagents, either itself or through a Third Party contract manufacturer agreed by the Parties, to manufacture SOMAmer Reagents as reasonably required by Illumina (and Illumina’s Affiliates and Sublicensees) solely for use in the research, development or Commercialization of the Licensed Products, in each case in accordance with the terms and conditions set forth in this Section 8.11. Each such Supply Agreement shall include, at a minimum, the following terms, which terms, to the extent applicable, shall be included in the Supply Agreement:
5.1. Pro-Dex will be Monogram’s exclusive manufacturer terms and supplier for all of the Products. Before providing any manufacturing and supply services to Monogram, Pro-Dex will provide in writing to Monogramconditions:
(i) specification of a manufacturing site, to be agreed by the reference data (from simulated use studies) used to inform the warranty periodParties;
(ii) the framework materials described on Exhibit F that include a summary of the required SOMAmer Reagents (as may be subsequently updated in the Supply Agreement) shall be supplied to Illumina at cost plus )***%***); provided that the total amount paid by Illumina for validating processes such materials described in Exhibit F shall not exceed (***$***) in total per sample (including all calibration ▇▇▇▇▇); and provided further that such amount shall decrease by at least (***%***) over each two (2)-Fiscal Year period starting on January 1, 2024 until the total amount paid by Illumina for receiving contaminated field units for repairs and servicingsuch SOMAmer Reagents does not exceed (***$***) in total per sample (including all calibration ▇▇▇▇▇) at which point SomaLogic shall pass on to Illumina any further cost reductions that are achieved by SomaLogic;
(iii) the price per Product, which, subject to Section 5.3, if Monogram does not agree to, SomaLogic shall be determined by Monogram soliciting bids for that same Product from at least three manufacturing companies that are (a) mutually agreed upon by Monogram enable and Pro-Dex, (b) ISO 13485 qualified, (c) registered with the FDA, and (d) in compliance with the FDA’s Quality System Regulation validate a primary Third Party contract manufacturer of SOMAmer Reagents (the “Qualified ManufacturersSecondary Manufacturer”). The higher of (x) solely for use in the average research, development or Commercialization of the bids provided by Licensed Products and, as a backup supplier in the Qualified Manufacturers and (y) event the median Secondary Manufacturer is unable or unwilling to supply SOMAmer Reagents as required under the Supply Agreement, an additional Third Party contract manufacturer of SOMAmer Reagents solely for use in the research, development or Commercialization of the bids shall be the Licensed Products (“Qualified Manufacturer BidTertiary Manufacturer”. After obtaining the Qualified Manufacturer Bid, Pro-Dex will have the right to manufacture and supply that Product at the lesser of (i) one hundred and fifty percent (150%) of the Qualified Manufacturer Bid or (ii) the original bid submitted by Pro-Dex. If Pro-Dex does not elect to manufacture and supply that Product on such terms, Monogram may outsource the manufacturing and supply of that Product to a Qualified Manufacturer selected by Monogram and subject to Pro-Dex’s approval (not to be unreasonably withheld); and
(iv) the lead time required by Pro-Dex to deliver the manufactured Products to Monogramfor quality assurance purposes, which, if Monogram does not agree to, shall be determined by Monogram soliciting lead time bids for that same Product from at least three Qualified Manufacturers. The higher of (x) the average of the bids provided by the Qualified Manufacturers in connection with and (y) the median of the bids shall be the “Qualified Lead Time Bid”. After obtaining the Qualified Lead Time Bid, Pro-Dex will have the right to supply the Products with a lead time equal in addition to the lesser Supply Agreement, SomaLogic shall execute quality assurance agreements with each of (i) two hundred percent (200%) of Illumina, the Qualified Lead Time Bid or (ii) Secondary Manufacturer and the original bid submitted by Pro-Dex. If Pro-Dex does not elect Tertiary Manufacturer, in each case with terms and conditions reasonably satisfactory to manufacture and supply that Product at such lead times, Monogram may outsource the manufacturing and supply of that Product to a Qualified Manufacturer selected by Monogram and subject to Pro-Dex’s approval (not to be unreasonably withheld)Illumina.
Appears in 1 contract
Supply Agreement. Until Within [***], the Parties will negotiate in good faith and enter into a supply agreement for the Manufacture and supply of the Licensed Products by Company to Licensee for Development and Commercialization in the Field in the Territory (the “Supply Agreement”). Unless otherwise agreed or required by applicable Laws, the Supply Agreement will specify that (a) Company will (or will cause its Affiliates to) Manufacture and supply, and Licensee will exclusively purchase from Company, all of Licensee’s, its Affiliates’ and Sublicensees’ needs for the Licensed Products for the Development and Commercialization in the Field in the Territory in their finished form and at a price equal to [***]; provided, however, that such price may not be greater than [***]; (b) such Licensed Products will be compliant with all requirements of the applicable Regulatory Authority(ies) and applicable Laws; (c) such Licensed Products supplied by Company to Licensee for a given vial will come from the drug substance Manufactured by or on behalf of Company; and (d) other customary supply terms, including [***]. Notwithstanding the foregoing, the Supply Agreement will further specify that if Company, its Affiliated Entities or sublicensees identifies, secures or engages a CMO for the Manufacture and supply of the Licensed Products and the Fully Burdened Manufacturing Cost for such CMO to Manufacture and supply the Licensed Products is lower than the price charged by Company to Manufacture and supply Licensed Products under the Supply Agreement, the Parties agree to the following termsthen (x) Company will inform Company of such CMO, which termsand (y), to the extent applicableat Company’s election, shall be included in the Supply Agreement:
5.1. Pro-Dex Company will be Monogram’s exclusive manufacturer and supplier for all of the Products. Before providing any manufacturing and supply services to Monogram, Pro-Dex will provide in writing to Monogram:
either (i) the reference data (from simulated use studies) used to inform the warranty period;
(ii) the framework for validating processes for receiving contaminated field units for repairs and servicing;
(iii) reduce the price per Product, which, subject to Section 5.3, if Monogram does not agree to, shall be determined by Monogram soliciting bids for that same Product from at least three manufacturing companies that are (a) mutually agreed upon by Monogram and Pro-Dex, (b) ISO 13485 qualified, (c) registered with the FDA, and (d) in compliance with the FDA’s Quality System Regulation (the “Qualified Manufacturers”). The higher of (x) the average of the bids provided by the Qualified Manufacturers and (y) the median of the bids shall be the “Qualified Manufacturer Bid”. After obtaining the Qualified Manufacturer Bid, Pro-Dex will have the right to manufacture Manufacture and supply that Product at Licensed Products under the lesser of (i) one hundred and fifty percent (150%) of the Qualified Manufacturer Bid Supply Agreement to match such CMO’s Fully Burdened Manufacturing Cost, or (ii) use Commercially Reasonable Efforts to provide, or cause such CMO to provide, an opportunity to engage such CMO for the original bid submitted by Pro-Dex. If Pro-Dex does not elect to manufacture and supply that Product on such terms, Monogram may outsource the manufacturing Manufacture and supply of that Product Licensed Products to a Qualified Manufacturer selected by Monogram and subject to Pro-Dex’s approval (not Licensee on substantially the same terms as those provided or proposed to be unreasonably withheldprovided to Company, its Affiliated Entities or sublicensees (in which case the exclusivity obligations described in the foregoing clause (a) will not apply with respect to such CMO); and
(iv) provided, if Licensee fails to secure such Manufacture and supply from such CMO, then Company will use Commercially Reasonable Efforts to purchase the lead time required by Pro-Dex to deliver the manufactured applicable Manufacturing services from such CMO and will supply such Licensed Products to Monogram, which, if Monogram does not agree to, shall be determined by Monogram soliciting lead time bids for that Licensee on substantially the same Product from at least three Qualified Manufacturers. The higher of (x) the average of the bids terms as those provided by the Qualified Manufacturers and (y) the median of the bids shall be the “Qualified Lead Time Bid”. After obtaining the Qualified Lead Time Bidsuch CMO to Company, Pro-Dex will have the right to supply the Products with a lead time equal to the lesser of (i) two hundred percent (200%) of the Qualified Lead Time Bid its Affiliated Entities or (ii) the original bid submitted by Pro-Dex. If Pro-Dex does not elect to manufacture and supply that Product at such lead timessublicensees, Monogram may outsource the manufacturing and supply of that Product to a Qualified Manufacturer selected by Monogram and subject to Pro-Dex’s approval (not to be unreasonably withheld)as applicable.
Appears in 1 contract
Supply Agreement. Until Within ten (10) days after the Parties enter into the Supply AgreementEffective Date, the Parties agree to the following terms, which terms, to the extent applicable, shall be included in the Supply Agreement:
5.1. Pro-Dex will be Monogram’s exclusive manufacturer and supplier for all of the Products. Before providing any enter into a separate manufacturing and supply services agreement in the form attached hereto as Exhibit C (the “Supply Agreement”) pursuant to Monogram, Pro-Dex will provide in writing to Monogram:
(i) the reference data (from simulated use studies) used to inform the warranty period;
(ii) the framework for validating processes for receiving contaminated field units for repairs and servicing;
(iii) the price per Product, which, subject to Section 5.3a satisfactory audit by Servier, if Monogram does not agree to, shall be determined CTI (or an Affiliate) by Monogram soliciting bids for that same Product from at least three manufacturing companies that are (a) mutually agreed upon itself or through any Third Party contract manufacturer approved by Monogram and Pro-Dex, (b) ISO 13485 qualified, (c) registered with the FDA, and (d) in compliance with the FDA’s Quality System Regulation Servier (the “Qualified ManufacturersCMOs”)) shall supply to Servier, Servier’s requirements for Licensed Product (subject to Section 9.6) for all countries in the Servier Territory. The higher Parties acknowledge that CTI is in the process of (x) validation of a new supplier for Drug Product, which has been approved in principle by Servier. Notwithstanding the average of the bids provided by the Qualified Manufacturers and (y) the median of the bids shall be the “Qualified Manufacturer Bid”. After obtaining the Qualified Manufacturer Bidforegoing, Pro-Dex Servier will have the right to manufacture perform a quality review with the current and supply that Product at prospective sources to verify their ability to meet global quality standards. The Supply Agreement shall comply with the lesser terms and conditions of this Agreement and will also provide that:
9.2.1 CTI (ior an Affiliate) one hundred and fifty percent (150%by itself or through CMO(s) of shall maintain a qualified site or sites for the Qualified Manufacturer Bid Manufacture **. The qualified site(s) is or (ii) the original bid submitted by Pro-Dex. If Pro-Dex does not elect are intended to manufacture and supply that Product on such terms, Monogram may outsource the manufacturing and provide a secure adequate global supply of that Product ** based upon current sales projections. Servier may use alternate site(s) for the Manufacture ** solely for the Servier ex-EU Territory and ** for the Servier Territory, and at its sole cost and expense, or otherwise in case of supply failure pursuant to a Qualified Manufacturer selected by Monogram the Supply Agreement (the “Alternate Site Option”). Unless otherwise agreed, responsibility for oversight and subject to Pro-Dex’s approval (not to be unreasonably withheldmanagement of such alternate site(s); and
(iv) the lead time required by Pro-Dex to deliver the manufactured Products to Monogram, which, if Monogram does not agree toas well as any and all associated costs, shall be determined borne solely by Monogram soliciting lead time bids Servier. CTI shall have audit rights with respect to any such alternate site(s) in accordance with Section 9.8. Servier may order that additional ** be held in reserve by Servier for that same Product from its safety stock requirements at least three Qualified Manufacturersits sole cost and expense.
9.2.2 Based upon Servier’s forecasted need, CTI will schedule and coordinate the Manufacture of a full batch or batches of approximately ** unlabeled vials (per batch), and arrange storage at the vendor’s facility at Servier’s expense if needed. The higher of (x) the average Servier will be required to place orders with CTI and be responsible for cancellation fees and immediate reimbursement of the bids provided by the Qualified Manufacturers and (y) the median cost of the bids batch in accordance with the Supply Agreement. Servier may request, and CTI will make reasonable efforts to supply, partial batches from its commercial supply chain to minimize excess Servier inventory and carrying cost.
9.2.3 In case of a worldwide shortage ** available to CTI (other than the Servier safety stock, which shall be allocated solely to Servier), the “Qualified Lead Time Bid”. After obtaining the Qualified Lead Time Bid**, Pro-Dex will have the right to supply the Products with a lead time equal to the lesser of (i) two hundred percent (200%) if any, shall be allocated between Servier and CTI ** of the Qualified Lead Time Bid or (ii) Licensed Product over the original bid submitted by Pro** period preceding the shortage.
9.2.4 Servier shall place an initial purchase order for **, including any country-Dexspecific **. ** covering the respective **. Such purchase orders in aggregate **. If Pro-Dex does ** are not elect to manufacture available at the time of purchase order, CTI shall supply such product **, and supply that Product at within ** if **. CTI shall invoice Servier for each such lead times, Monogram may outsource ** order and such invoice shall be payable within ** after the manufacturing and supply of that Product to a Qualified Manufacturer selected invoice date by Monogram and subject to Pro-Dex’s approval (not to be unreasonably withheld)Servier.
Appears in 1 contract
Sources: Exclusive License and Collaboration Agreement (Cti Biopharma Corp)
Supply Agreement. Until Within [***] following the Parties enter into the Supply AgreementEffective Date, the Parties agree to will negotiate in good faith and execute a commercial supply agreement for the following terms, which terms, to Licensed Product in its current formulation (the extent applicable, shall be included in the “Supply Agreement:
5.1. Pro-Dex will be Monogram’s exclusive manufacturer ”), and supplier for all of the Products. Before providing any manufacturing and supply services accompanying quality agreement pursuant to Monogram, Pro-Dex will provide in writing to Monogram:
(i) the reference data (from simulated use studies) used to inform the warranty period;
(ii) the framework for validating processes for receiving contaminated field units for repairs and servicing;
(iii) the price per Product, which, subject to Section 5.3, if Monogram does not agree to, shall be determined by Monogram soliciting bids for that same Product from at least three manufacturing companies that are which (a) mutually agreed upon Eidos will supply to Bayer Licensed Product manufactured by Monogram or on behalf of Eidos and Pro-Dex, (b) ISO 13485 qualifiedBayer shall purchase such Licensed Product from Eidos, for the sole purpose of Exploitation of Licensed Product in the Field in the Licensed Territory. The Supply Agreement shall, at a minimum, reflect the supply terms set forth on Schedule 6.1 hereto, including for clarity, terms with respect to [***]. Furthermore, Bayer acknowledges that Eidos is a party to (ca) registered [***] and (b) [***] pursuant to which [***] manufactures and supplies the Licensed Product, and accordingly, except as otherwise agreed in Schedule 6.1, the Supply Agreement shall be in form and substance substantially consistent with the FDA[***]. Bayer shall use Commercially Reasonable Efforts to [***]. Notwithstanding the foregoing, Bayer cannot refuse to [***]. Eidos shall use Commercially Reasonable Efforts to facilitate Bayer’s entering into such a supply agreement with [***] and [***]. Bayer shall not be restricted from obtaining supply from any other qualified contract manufacturers, including contract manufacturers that Eidos may appoint from time to time during the Term, with respect to Licensed Products or components thereof and from directly ordering Licensed Products or components thereof from such other contract manufacturers; provided, that [***]. Each Party shall inform the other Party through the JSC and its Sub-Committees reasonably in advance about any plan to establish a supply relationship with any new contract manufacturer for Licensed Products or components thereof, and (d) upon such information the Parties shall in compliance good faith discuss and coordinate entering into a joint supply agreement with such contract manufacturer. In the FDA’s Quality System Regulation (the “Qualified Manufacturers”). The higher event of (x) the average a supply shortfall of the bids provided by the Qualified Manufacturers and (y) the median of the bids shall be the “Qualified Manufacturer Bid”. After obtaining the Qualified Manufacturer Bid, Pro-Dex will have the right to manufacture and supply a contract manufacturer that Product is at the lesser time of (i) one hundred such shortfall used by both Parties, the Parties shall, through the JSC and fifty percent (150%) of the Qualified Manufacturer Bid or (ii) the original bid submitted by Proits Sub-Dex. If Pro-Dex does not elect to manufacture and supply that Product on such termsCommittees, Monogram may outsource the manufacturing and supply of that Product to a Qualified Manufacturer selected by Monogram and subject to Pro-Dex’s approval (not to be unreasonably withheld); and
(iv) the lead time required by Pro-Dex to deliver the manufactured Products to Monogram, which, if Monogram does not agree to, shall be determined by Monogram soliciting lead time bids for that same Product from at least three Qualified Manufacturers. The higher of (x) the average of the bids provided by the Qualified Manufacturers and (y) the median of the bids shall be the “Qualified Lead Time Bid”. After obtaining the Qualified Lead Time Bid, Pro-Dex will have the right to supply the Products with a lead time equal to the lesser of (i) two hundred percent (200%) of the Qualified Lead Time Bid or (ii) the original bid submitted by Pro-Dex. If Pro-Dex does not elect to manufacture and supply that Product at such lead times, Monogram may outsource the manufacturing and supply of that Product to a Qualified Manufacturer selected by Monogram and subject to Pro-Dex’s approval (not to be unreasonably withheld)[***].
Appears in 1 contract
Sources: Exclusive License Agreement (BridgeBio Pharma, Inc.)
Supply Agreement. Until the
(a) The Parties will work expeditiously and in good faith to negotiate and enter into a non- exclusive supply agreement (the "Supply Agreement") within 60 days following the Effective Date, the Parties agree to which agreement will include at a minimum the following termsterms (together with such other terms as are customary in commercially analogous supply agreements, which terms, including with respect to the extent applicable, shall be included in the Supply Agreement:
5.1. Pro-Dex will be Monogram’s exclusive manufacturer and supplier for all insurance requirements of the Products. Before providing any manufacturing and supply services to Monogram, Pro-Dex will provide in writing to Monogram:each Party):
(i) the reference data Company Parties shall purchase from the Partner, and the Partner shall sell to the Company Parties (from simulated use studiesA) an agreed upon percentage of the Company Parties' total annual inventory requirements of Branded CBW Cannabis Products, to a maximum of up to 50% of such annual inventory requirements, and (B) an agreed upon percentage of the Company Parties' total annual inventory requirements of Cannabis Products used as inputs by the Company Parties for the creation and development of Branded Company Cannabis Products ("Input Cannabis Products"), to inform a maximum of up to 50% of such annual inventory requirements, subject in each case to mutually agreed adjustments for the warranty periodpurposes of ensuring that the Company Parties and their franchisees have sufficiently diverse product inventories and are not exposed to unreasonable supply risk;
(ii) the framework for validating processes for receiving contaminated field units for repairs Company Parties will ensure that all Cannabis Products sold by the Partner to the Company Parties will be stocked on the highest-visibility shelf space available at retail locations operated by the Company Parties and servicingtheir franchisees, and will not be subject to any slotting, promotional, advertising or similar stocking or display fees or charges in connection therewith;
(iii) the price per Product, which, subject to compliance with Applicable Law, including the obtaining by each Party of all necessary licenses and approvals:
(A) the Partner Parties will sell Branded CBW Cannabis Products and Unbranded Cannabis Products to Spirit Leaf at wholesale prices, and the Parties agree that such wholesale prices may be higher than then current market prices for similar Cannabis Products if the Parties determine that revenue-sharing between them is best accomplished by the Partner Parties earning a portion of their revenue allocation through the direct sale of Branded CBW Cannabis Products and Unbranded Cannabis Products to Spirit Leaf;
(B) Spirit Leaf may sell Branded CBW Cannabis Products and Unbranded Cannabis Products, or create and sell Branded Company Cannabis Products using Unbranded Cannabis Products, either directly (including through one or more public or private intermediaries, procuring agents, institutional purchasers or other similar entities) or through its franchisees; and
(C) unless the Parties have determined to effect their revenue-sharing agreement through the sales contemplated in Section 5.32.3(a)(iii)(A), the Partner will be entitled to earn and be paid a fee or be provided some other mutually agreeable financial benefit or accommodation to ensure that it is put in a substantially similar financial position as if Monogram does not agree toit had elected to earn and be paid a revenue-sharing allocation, shall be determined by Monogram soliciting bids for that same Product from at least three manufacturing companies that are (a) mutually as agreed upon by Monogram the Parties in the Supply Agreement and Pro-Dexas contemplated in Section 2.3(a)(iii)(A), (b) ISO 13485 qualified, (c) registered with the FDA, and (d) in compliance with the FDA’s Quality System Regulation (the “Qualified Manufacturers”). The higher of (x) the average it being understood that such benefit or accommodation may include a portion of the bids provided franchise or royalty fees (or similar fees) charged by the Qualified Manufacturers and (y) the median of the bids shall be the “Qualified Manufacturer Bid”. After obtaining the Qualified Manufacturer Bid, Pro-Dex will have the right Spirit Leaf to manufacture and supply that Product at the lesser of (i) one hundred and fifty percent (150%) of the Qualified Manufacturer Bid its franchisees or (ii) the original bid submitted by Pro-Dex. If Pro-Dex does not elect to manufacture and supply that Product on such terms, Monogram may outsource the manufacturing and supply of that Product to a Qualified Manufacturer selected by Monogram and subject to Pro-Dex’s approval (not to be unreasonably withheld); andsome other mutually agreeable fee or payment.
(iv) the lead time required by ProParties will, through each Party's Relationship Manager, on an annual basis, or as more frequently as the Parties may jointly determine, discuss and analyze the suitability, terms and effectiveness of the profit-Dex sharing framework set out in Section 2.3(a)(iii) relative to deliver the manufactured Products to Monogrameach Party's objectives and concerns, whichand make such adjustments, if Monogram does not agree toany, shall be determined to such profit-sharing framework as the Parties may jointly agree;
(v) independently market, promote and advertise the other Party and its business by Monogram soliciting lead time bids for that same Product from at least three Qualified Manufacturers. The higher of producing professional quality content including text, pictures and video content (x"Promotional Content") relating to the average promotion of the bids provided other Party and its business, subject to each Party's branding requirements;
(vi) distribute Promotional Content through their respective retail outlets (including corporate-owned and franchised locations) and media networks, including magazines, trade-shows, newsletters, websites, franchisee communications and social media;
(vii) use Promotional Content in furtherance of increasing brand visibility and awareness of each Party's business and products, including through active and continuous product placement, endorsements, cross-promotions and "mentions", directly or indirectly, through the Parties respective networks, including social media networks; and
(viii) jointly develop Promotional Content for the purpose of creating media campaigns oriented to mass-media channels.
(b) The Parties acknowledge that the entering into of the Supply Agreement is a material condition of this Agreement and a material inducement to the entering into of this Agreement.
(c) Until the Supply Agreement is entered into, the Parties agree that they shall work in good faith to give effect to the purpose and spirit of this Section 2.3.
(d) Upon execution and delivery thereof by the Qualified Manufacturers and Parties, the Supply Agreement will supersede the terms of this Section 2.3 in all respects.
(ye) the median of the bids shall be the “Qualified Lead Time Bid”. After obtaining the Qualified Lead Time BidFor greater certainty, Pro-Dex will have the right to supply the Products with a lead time equal to the lesser of (i) two hundred percent (200%) of the Qualified Lead Time Bid or (ii) the original bid submitted by Pro-Dex. If Pro-Dex does not elect to manufacture and supply that Product at such lead times, Monogram may outsource the manufacturing and supply of that Product any reference in this Section 2.3 to a Qualified Manufacturer selected by Monogram franchisee of a Company Party will be deemed to refer to a franchisee of Spirit Leaf and subject to Pro-Dex’s approval (not to be unreasonably withheld)a franchisee of Watch It!.
Appears in 1 contract
Sources: Strategic Alliance Agreement