Manufacturing. (a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time.
(b) The Supplier shall not change any process, material, component, packaging or manufacturing location without the Purchaser’s express prior written approval.
Manufacturing. Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Aquaculture Program that relate to the Intrexon Materials, including through the use of a suitable Third Party contract manufacturer. To the extent that Intrexon so elects, Intrexon may request that AquaBounty and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials or bulk quantities of other components of AquaBounty Products, then Intrexon shall provide to AquaBounty or a contract manufacturer selected by AquaBounty and approved by Intrexon (such approval not to be unreasonably withheld) all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials or bulk qualities of other components of AquaBounty Products for use in the Field and (b) reasonably necessary to enable AquaBounty or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of AquaBounty Products. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to AquaBounty or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any AquaBounty Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit AquaBounty to switch manufacturers.
Manufacturing. (a) Ikaria shall be solely responsible for the Manufacture of Products for Development or for Commercialization in the Field in the Territory, which Ikaria may conduct itself or through Affiliates or Licensees.
(b) BioLineRx Ltd. shall have the option (either directly or through an Affiliate), exercisable in its sole discretion no later than [**] months prior to the date on which Ikaria intends to file for Regulatory Approval in the U.S., to Manufacture Product pursuant to the terms of a supply agreement to be negotiated in good faith by the Parties, provided that (i) BioLineRx may exercise the foregoing option only to the extent that it has the demonstrated ability to manufacture the Product, including compliance with cGMP and all applicable laws and regulations, including those of the FDA and EMEA, (ii) BioLineRx shall bear all expenses required to establish and qualify the BioLineRx manufacturing site, including the costs of scale-up batches, process validation batches and stability batches, (iii) BioLineRx shall not be entitled to assign such option or to utilize subcontract manufacturing, and (iv) neither Party shall have any obligation to enter into such agreement unless all of the terms and conditions thereof are acceptable to both Parties. If BioLineRx Ltd. exercises such option and the Parties enter into a supply agreement, (x) Ikaria shall be required to purchase no less than twenty percent (20%) of its requirements for the Product from BioLineRx, and (y) the per unit price for the Product shall be the [**], provided that the price shall not exceed [**] percent ([**]%) of the Net Sales price per unit of Product; provided, further, that if BioLineRx at any time shall fail to supply Product on time or such supply is otherwise disrupted, the minimum purchase requirement set forth in the preceding clause (x) shall no longer apply. Any clinical supply provided to Ikaria by BioLineRx would be provided at cost.
(c) The Parties will discuss the most efficient structure for the Manufacture and supply of Product for Development and Commercialization purposes. If the Parties determine that coordination in Manufacturing is appropriate, the Parties will establish a Joint Manufacturing Committee (the “Joint Manufacturing Committee” or “JMC”) to coordinate Manufacturing efforts. If established, the JMC would be comprised of [**] representatives of Ikaria and [**] representatives of BioLineRx, to oversee the Manufacturing of Products. Each Party would make its i...
Manufacturing. (a) Subject to Section 4.3.4(b) below, Gen-Probe shall have the right to manufacture or to have manufactured and supply Chiron with Chiron's requirements for each Nonexclusive Future Clinical Diagnostic Assay to be conducted by the Clinical Diagnostic Instruments in the Territory for use in the Clinical Diagnostic Field, provided that Gen-Probe is able to meet Chiron's reasonable requirements as to timing and quantity of Nonexclusive Future Clinical Diagnostic Assays, meeting the warranty requirements of Section 6.6, at a cost equal to or better than that available from other manufacturers. If Gen-Probe elects to manufacture or to have manufactured the Nonexclusive Future Clinical Diagnostic Assay, pursuant to the preceding sentence, Gen-Probe shall be obligated to supply Chiron with its requirements of such Nonexclusive Future Clinical Diagnostic Assay in accordance with Article 6.
(b) With respect to each Nonexclusive Future Clinical Diagnostic Assay which Gen-Probe declines to manufacture or, if Gen-Probe elects to manufacture, with respect to each Nonexclusive Future Clinical Diagnostic Assay which Gen-Probe fails to supply Chiron within forty-five (45) days of the requested delivery date with Chiron's monthly requirements for a Nonexclusive Future Clinical Diagnostic Assay as most recently forecasted and ordered in accordance with Section 6.3 below, for any three (3) months in any nine-month period then Chiron shall have the right, at its option, to manufacture (or to have manufactured) its requirements of such Nonexclusive Future Clinical Diagnostic Assay to be conducted by the Clinical Diagnostic Instruments in the Territory for use in the Clinical Diagnostic Field; provided, however, that to the extent Gen-Probe is able to meet Chiron's requirements for Rare Reagents in accordance with this Agreement, Gen-Probe shall retain the exclusive right to manufacture (or to have manufactured) and the obligation to supply Chiron with its requirements of the Rare Reagents for use in such Nonexclusive Future Clinical Diagnostic Assay in accordance with Article 6 below. If Gen-Probe declines to manufacture as described above, Gen-Probe promptly shall provide reasonable technical assistance, with the cost to be shared equally by the parties, as necessary to enable Chiron to exercise its rights to manufacture (or have manufactured) such Nonexclusive Future Clinical Diagnostic Assay. If Gen-Probe elects to manufacture but fails to supply Chiron as described above,...
Manufacturing. (a) Within sixty (60) days after the Effective Date, Cephalon (or its designee) and FBIO shall negotiate in good faith to enter into a manufacturing and supply agreement (the “Manufacturing and Supply Agreement”), pursuant to which Cephalon shall, subject to the terms of the Manufacturing and Supply Agreement, (i) Manufacture and supply (or have Manufactured and supplied) to FBIO *, active pharmaceutical ingredient (“API”) and drug product for Licensed Compounds or Licensed Products, and (ii) conduct the Manufacturing development activities for Licensed Compounds or Licensed Products, in each case (for clauses (i) and (ii)) as requested by FBIO and in the Territory for an initial period to be agreed to by the Parties, unless earlier terminated as provided therein (the “Initial Supply Term”). Notwithstanding the foregoing, the Manufacturing and Supply Agreement shall in no way restrict FBIO from contracting with Third Parties to Manufacture and supply (or have Manufactured and supplied) to FBIO API and drug product for Licensed Compounds or Licensed Products and conduct Manufacturing development activities for Licensed Compounds or Licensed Products.
(b) From and after the Initial Supply Term, (i) FBIO, at its own cost and expense, shall be responsible for all Manufacturing development, establishment of Manufacturing sources and supply chains, and Manufacture and supply of the Licensed Compounds and Licensed Products in the Field and in the Territory, subject to the provisions of this Section 3.3(b), (ii) FBIO shall use Commercially Reasonable Efforts to execute and to perform, or cause to be performed through its Affiliates and Sublicensees, the Manufacturing activities assigned to it in this Agreement and by Cephalon, and (iii) FBIO shall be solely responsible, at its cost and expense, for Manufacturing and supplying the worldwide requirements for the Development and Commercialization of the Licensed Compounds and Licensed Products in and for the Field and the Territory in accordance with Good Manufacturing Practice and all applicable Laws and standards. * Confidential material redacted and filed separately with the Commission.
Manufacturing. 3.11.1 Subject to section 3.11.4, NovaDel shall manufacture and supply Licensee with Licensed Product on commercially reasonable terms for clinical development of the Licensed Product pursuant to a manufacturing agreement (the "Manufacturing Agreement") to be entered into following execution of this Agreement.
3.11.2 Subject to section 3.11.4, following receipt of Regulatory Approval, NovaDel shall manufacture and supply Licensee with Licensed Product on commercially reasonable terms pursuant to the Manufacturing Agreement.
3.11.3 NovaDel agrees that, at all times during the performance of the Development Activities, it will act in accordance with GMP and all applicable laws, rules and regulations.
3.11.4 The manufacturing agreement will provide among other things that in the event that Licensee enters into a Sublicense for a Licensed Product and such Sublicensee desires to obtain rights to manufacture such Licensed Product, then NovaDel will not unreasonably withhold its consent to transfer the manufacturing rights to such Sublicensee, provided that measures are incorporated into the sublicensing agreement to continue to safeguard the confidentiality of NovaDel Know-how and technology with respect to the Licensed Product as set forth in section 3.11.5
3.11.5 It is the intent of the Parties that NovaDel be the exclusive manufacturer of the Licensed Product pursuant to the terms of the Manufacturing Agreement; provided, however, that in the event that NovaDel is unable or unwilling to provide clinical or commercial supply of Licensed Product within a reasonable period of time upon commercially reasonable terms, then Licensee shall be entitled to seek alternate manufacturing source. In such event, Licensee shall use commercially reasonable efforts to ensure that any such alternate manufacturing source agree (a) to maintain in strictest confidence all information relating to the manufacture of the Licensed Product and the Licensed Technology, (b) not to file any intellectual property protection relating to inventions that may arise from the manufacture of the Licensed Product and Licensed Technology, and (c) that any intellectual property that does arise out of the manufacture of the Licensed Product and Licensed Technology belong to NovaDel.
Manufacturing. Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Fibroblast Program that relate to the Intrexon Materials. To the extent that Intrexon so elects, Intrexon may request that Fibrocell and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials, bulk drug product or bulk quantities of other components of Fibrocell Products, then Intrexon shall provide to Fibrocell or a contract manufacturer selected by Fibrocell and approved by Intrexon all Information Controlled by Intrexon that is related to the manufacturing of such Intrexon Materials, bulk drug product or bulk qualities of other components of Fibrocell Products, for use in the Field and is reasonably necessary to enable Fibrocell or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials, bulk drug product or bulk quantities of other components of Fibrocell Products, in each case as manufactured by Intrexon. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to Fibrocell or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any Fibrocell Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit Fibrocell to switch manufacturers. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.
Manufacturing. Bellicum shall have the right to manufacture or have manufactured such quantities of any Dimerizer as it may require in order to develop and commercialize any Licensed Product pursuant to the terms of this Agreement. Bellicum will notify ARIAD in writing of its intent to manufacture (or have manufactured by a Third Party) any Dimerizer at least […***…] prior to commencement of manufacture by itself or through a Third Party. Upon ARIAD’s request at any time, the Parties will negotiate in good faith a supply agreement under which ARIAD will provide […***…] rolling […***…] forecasts of its anticipated need for such Dimerizer (of which an agreed number of months will be binding) provided that, under such supply agreement, either (a) Bellicum will use commercially reasonable efforts to supply all quantities of Dimerizer ordered by ARIAD and will supply such Dimerizer to ARIAD and ARIAD’s licensees on at a price equal to fully burdened manufacturing costs plus […***…] percent ([…***…]%); or (b) if a Third Party manufactures such Dimerizer for Bellicum, then Bellicum shall (i) procure for ARIAD and its Affiliates and licensees the right to purchase such Dimerizers from the Third Party on terms no less favorable than those granted to Bellicum, giving ARIAD and its Affiliates and licensees equal priority with respect to quantity or lead time for delivery of such Dimerizers as given to Bellicum, its Affiliates and its Sublicensees, and (ii) grant to such Third Party all licenses to Patent Rights and Technology Controlled by Bellicum (without Bellicum incurring additional expense or obligations to Third Party licensors of Bellicum) as may be required in order for the Third Party to supply ARIAD and ARIAD’s licensees with such Dimerizers. In addition, the supply agreement will provide that, if Bellicum or its Third Party manufacturer fails to supply Dimerizer as required thereby, Bellicum or its Third Party manufacturer will transfer to ARIAD or its designee all technology necessary to manufacture such Dimerizer and will grant all necessary licenses to ARIAD or its designee on a royalty fee basis.
Manufacturing. The Parties acknowledge and agree that it is their current mutual intention that they will consider in due course entering into a written agreement (with a KO Affiliate or a KO Distributor identified by KO) on mutually acceptable terms to provide for the manufacture of certain Products in the Territory. This Section 1.5 shall not be deemed to be an agreement by the Parties for such manufacture and the Parties shall not have any obligations with respect thereto unless and until a written agreement has been duly executed.
Manufacturing. 4.1 Lilly will manufacture final Product(s). Emisphere will manufacture at least [***] % of the Carrier needed for Product sales. Lilly will pay Emisphere the latter's [***] on all Carrier used for sales of Products less than or equal to the sales schedule set forth in the relevant Appendix to the Option Agreement. Above the Product sales level specified in the relevant Appendix of the Option Agreement, Lilly will pay Emisphere's direct manufacturing costs (calculated according to the [***] . Lilly will be permitted to manufacture up to [***] % of the Carrier needed to manufacture the Products. If Lilly can find a Carrier source that can offer a supply price that is at least [***] % lower than Emisphere's supply price (including Lilly, with supply price in such case being [***] [***] , all determined in accordance with GAAP principles), Lilly may use such supplier for up to [***] % of the Carrier needed to manufacture the Product. So long as Lilly uses it as a supplier of Carrier, Emisphere will hold at minimum [***] [***] of Carrier inventory per year to be determined at the appropriate time. Emisphere's manufacturing operations will meet any required regulatory agency's specifications for registration, as set forth in the [***] .
4.2 Lilly shall be permitted to produce Carrier for its use in clinical trials, but only until Emisphere is able to supply the Carrier pursuant to the terms of Section 4.1.
4.3 Lilly reserves the right to audit the facility of Emisphere as specified in the [***] , including its processes, records, and other facets of the operation as may be necessary to assure that all applicable FDA or similar government regulations have been met. Emisphere shall permit duly authorized representatives of Lilly to audit all research, development and manufacturing areas and operations as they apply to Emisphere projects or Carriers for Lilly at reasonable times with a prior appointment. The right to audit will also apply to Carrier used in trials to support product registration. These audits will be conducted to assure compliance with all pertinent acts, regulations, and guidelines promulgated by the FDA and other regulatory authorities. Such audits will be permitted during normal business hours and will be performed with a minimum of disruption. Lilly shall furnish to Emisphere copies of all reports prepared as a result of these audits. Lilly agrees to notify Emisphere within [***] of any concerns that it may have regarding Carrier(s). Lilly wil...
