Supply and Manufacturing Sample Clauses

Supply and Manufacturing. (a) Except as set forth on Schedule 4.21(a) of the Disclosure Letter, to the Knowledge of Parent, Product at all times has been manufactured in sufficient quantities and of a sufficient quality to satisfy contractual obligations to supply Product in the Territory without the occurrence of any event causing inventory of Product in the Territory to have become exhausted prior to satisfying such obligations. To the Knowledge of Parent, no event has occurred that has caused or could reasonably be expected to cause Product to be manufactured in a quantity or of a quality insufficient to satisfy production of (i) at least 40,000,000 test strips for calendar year 2021; and (ii) at least 50,000,000 test strips for calendar year 2022. (b) Except as set forth on Schedule 4.21(b) of the Disclosure Letter, to the Knowledge of Parent, (i) no manufacturer (including a contract manufacturer) or producer of Product has (A) been subject to a Regulatory Agency shutdown, restriction or import or export prohibition, or (B) received in the past five (5) years or is currently subject to (1) a FDA Form 483 or (2) other written Regulatory Agency notice of inspectional observations, warning letter, untitled letter or request to make changes to Product that could reasonably be expected to materially adversely impact Product, in either case of sub-clause (1) or (2) with respect to any facility manufacturing or producing Product for import, distribution, sale or lease in the Territory, and (ii) with respect to each such FDA Form 483 received or other written Regulatory Agency notice (if any), all scientific and technical violations or other issues relating to good manufacturing practice requirements documented therein, and any disputes regarding any such violations or issues, have been corrected or otherwise resolved. (c) Except as disclosed in Schedule 4.21(c) of the Disclosure Letter, no Credit Party or any of its Subsidiaries has received any notice, oral or written, from any party to any Manufacturing Agreement containing any indication by or intent or threat of, such party to reduce or cease, in any material respect, the supply of Product in the Territory or the materials (including raw materials), components (including component raw materials and other component materials), equipment, technology (including software, systems, and solutions), or any other element needed to fulfill obligations related to Product in any Manufacturing Agreement through calendar year 2024 (or such ea...

Supply and Manufacturing. (a) To the knowledge of Borrower or any of its Subsidiaries, the testing, manufacturing, production, storage, packaging, labeling and release to the market of each Product has at all times been (i) in compliance in all respects with the final release quality specifications in effect for such Product and (ii) in compliance in all material respects with Requirement of Law. Except as set forth on Schedule 5.22(a) of the Disclosure Letter, to the knowledge of Borrower or any of its Subsidiaries, no manufacturer of Product has received in the past five (5) years a Form 483 or is currently subject to a Form 483 impacting any Product with respect to any facility manufacturing Product and that, with respect to each such Form 483, all scientific and technical violations or other issues relating to good manufacturing practice requirements documented therein, and any disputes regarding any such violations or issues, have been corrected or otherwise resolved. To the knowledge of Borrower, each Product has at all times been manufactured in sufficient quantities and of a sufficient quality to satisfy demand of such Product, without the occurrence of any event causing inventory of such Product to have become exhausted prior to satisfying such demand or any other event in which the manufacture and release to the market of such Product does not satisfy the sales demand for such Product. (b) As of the Effective Date, Schedule 5.22(b) of the Disclosure Letter contains a true, correct and complete list of all manufacturing and supply agreements entered into by any Credit Party or any of its Subsidiaries with third parties for the supply of Product and the active pharmaceutical ingredient incorporated therein in effect as of the Effective Date (the “Manufacturing Agreements”). Borrower has delivered or made available to Lender true, correct and complete copies of each Manufacturing Agreement. After giving effect to consummation of the transactions contemplated by this Agreement, except as described on Schedule 5.22(b) of the Disclosure Letter, each Manufacturing Agreement is a valid and binding obligation of the applicable Credit Party or its Subsidiaries and is in full force and effect, and to the knowledge of each Credit Party or any of its Subsidiaries, is a valid and binding obligations of any other party thereto, and neither the applicable Credit Party or its Subsidiaries or, to the knowledge of each Credit Party or any of its Subsidiaries, any other party thereto is in b...

Supply and Manufacturing. The Parties acknowledge and agree that, as of the Effective Date, LICENSOR is not subject to any obligations with a third- party regarding its current source of Licensed Product, and that LICENSEE shall be permitted to enter into a supply agreement with any third-party manufacturer to secure supply of Licensed Product for LICENSEE directly from such third-party manufacturer. In addition, LICENSOR acknowledges that, upon execution and delivery of the Agreement, LICENSEE shall receive all right, title and interest in LICENSOR’s existing inventory of Licensed Product, whether or not vialed, and all other materials related to the manufacture, formulation and vialing of Licensed Product.

Supply and Manufacturing a. Except as set forth on Schedule 4.21(a) of the Disclosure Letter, to the Knowledge of such Credit Party, Product at all times during the past five (5) years has been manufactured in sufficient quantities and of a sufficient quality to satisfy demand of Product in the Territory, without the occurrence of any event or any series of related events causing inventory of Product to have become exhausted prior to satisfying such demand. To the Knowledge of such Credit Party, no event or circumstance (or series of related events or circumstances) has occurred that has caused or could reasonably be expected to cause inventory of Product to become exhausted in any calendar year prior to satisfying the sales demand (if any) of Product in the Territory in such calendar year. b. Except as set forth on Schedule 4.21(b) of the Disclosure Letter, to the Knowledge of such Credit Party, no event or circumstance (or series of related events or circumstances) has occurred or, in the reasonable business judgment of Borrower, is reasonably likely to occur, that would cause or could reasonably be expected to cause Product (A) to not be manufactured in any calendar year in sufficient quantities to satisfy or exceed the greater of (i) the net sales amount for such calendar year set forth in the Product Revenue Forecast and (ii) the expected needs of patients with the disease or condition for which Product was designated as an Orphan Drug for such calendar year, as reasonably determined by a Responsible Officer of the Borrower in good faith (provided such calendar year occurs during the full term of Orphan Drug exclusive approval granted under 21 C.F.R. § 316.34); or (B) to not be manufactured in a manner that supports Orphan Drug designation under EU Law or Japanese Law, as applicable. c. Except as set forth on Schedule 4.21(c) of the Disclosure Letter, to the Knowledge of such Credit Party, (i) no manufacturer (including a contract manufacturer) or producer of Product has been during the last five (5) years or is currently subject to a material Regulatory Agency shutdown, restriction or import or export prohibition, (ii) no manufacturer (including a contract manufacturer) or producer of Product has received in the past five (5) years or is currently subject to (1) a FDA Form 483 or (2) other written Regulatory Agency notice of inspectional observations, Warning Letter, Untitled Letter or request to make changes to Product that could reasonably be expected to impact Product, in...

Supply and Manufacturing. CORIXA will grant INNEXUS reasonable access at reasonable times to its facilities or contractors, and in any event no more frequently than one time per calendar year, for production of intermediates involved in the modification of monoclonal antibodies using SAT Technology. CORIXA will, as it determines in its sole discretion and to the extent possible without violating existing obligations to third parties, provide pertinent information regarding supply contracts and potential contractors.

Supply and Manufacturing. 5.1 At the direction of the Development Committee, MoliChem shall manage the planning, agreements and operations concerning the supply and manufacture of the Products for the Development Program; provided however, all manufacturing specifications shall be established by the Development Committee. 5.2 At the direction of the Development Committee, MoliChem shall also manage all matters concerning the supply and manufacture of any Product for the Commercialization Program, in accordance with the specifications established by the Development Committee. 5.3 Although MoliChem shall manage the manufacture of the Products, qualified personnel of InterMune shall participate and collaborate in the supply and manufacture of the Products according to the plan set forth by the Development Committee and for so long as MoliChem continues to manage the manufacture of the Products, InterMune shall have a right to audit the manufacture of Moli1901 in accordance with generally accepted audit procedures for similar manufacturing processes. 5.4 In the event MoliChem is unwilling or unable to manufacture any Product, it may request that the Development Committee take responsibility for the manufacture of such Product. All costs of manufacturing shall be borne by InterMoli. 5.5 Notwithstanding any other provision of this Agreement to the contrary, in the event MoliChem has taken any action with respect to manufacturing any Product that materially jeopardizes the commercialization of such Product and InterMune can produce evidence that such MoliChem actions have materially jeopardized the commercialization of any Product, and MoliChem has failed to cure such action within ninety (90) days after receiving notice from InterMune that such actions have materially jeopardized the commercialization of the Product, then all rights to control the manufacturing with respect to such Product shall thereafter be directed by InterMune.

Supply and Manufacturing. (a) To the Knowledge of Borrower, the Product has at all times been manufactured in sufficient quantities and of a sufficient quality to satisfy demand of the Product, without the occurrence of any event causing inventory of the Product to have become exhausted prior to satisfying such demand or any other event in which the manufacture and release to the market of the Product does not satisfy the sales demand for the Product. (b) Except as disclosed in the Exchange Act Documents or set forth on Schedule 4.21(b) of the Disclosure Letter, to the Knowledge of Borrower, no manufacturer of the Product has received in the past five (5) years a Form 483 or is currently subject to a Form 483 impacting the Product with respect to any facility manufacturing the Product and that, with respect to each such Form 483, all scientific and technical violations or other issues relating to good manufacturing practice requirements documented therein, and any disputes regarding any such violations or issues, have been corrected or otherwise resolved.

Supply and Manufacturing. Roche shall be fully responsible for all supply and manufacturing of Product. Trimeris shall have no say with regard to Roche’s supply and manufacturing efforts. Trimeris shall have no say with regard to Roche’s handling, maintenance or divestiture of its Boulder, Colorado manufacturing facility, and Trimeris has no financial or decision making rights with regard to such manufacturing facility.

Supply and Manufacturing. To the Knowledge of Seller, the development, testing, manufacturing, production, storage, packaging, labeling and release to the market of Product is (i) in compliance with the final release quality specifications in effect for the Product and (ii) in compliance in all material respects with Applicable Law. To the Knowledge of Seller, no manufacturer of Product has received or is currently subject to a Form 483, with respect to the manufacture of Product. To the Knowledge of Seller, as of the date hereof, the Seller reasonably expects to have, as of the date of the launch of the Product, sufficient quantities of Product and of a sufficient quality to satisfy Seller’s then-estimated demand for Product in the U.S.

Supply and Manufacturing. (a) To the knowledge of the Credit Parties, the Products have at all times been manufactured in sufficient quantities and of a sufficient quality to satisfy demand of the Products, without the occurrence of any event causing inventory of the Products to have become exhausted prior to satisfying such demand or any other event in which the manufacture and release to the market of the Products does not satisfy the sales demand for the Products and which has resulted in, or could reasonably be expected to result in, a Material Adverse Effect. (b) To the knowledge of the Credit Parties, no manufacturer of any Product is currently subject to a Form 483 that prevents the manufacturing, testing, and release of such Product and that, with respect to any such Form 483, all scientific and technical violations or other issues relating to good manufacturing practice requirements documented therein, and any disputes regarding any such violations or issues, have been corrected or otherwise resolved.