Product Manufacturing. The manufacture (including compounding) of the Company’s products, whether by or on behalf of the Company or any of its subsidiaries (“Company Products”), is being conducted in compliance with all applicable Healthcare Laws, except where such failure to comply would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. For the past three years, neither the Company nor any of its subsidiaries has had any product or manufacturing site or compounding pharmacy (whether Company-owned or that of a contract manufacturer for the Company’s products) subject to a Governmental Authority shutdown or import or export prohibition, nor received any United States Food and Drug Administration (“FDA”) Form-483 or other Governmental Authority notice of inspectional observations, “warning letters,” “untitled letters,” requests to make changes to the Company Products, processes or operations, or written notice from the FDA or other Governmental Authority alleging or asserting noncompliance with any applicable Healthcare Laws, in each case except as would not, whether individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. To the Company’s knowledge, neither the FDA nor any other Governmental Authority is considering such action, except where such an action could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
Product Manufacturing. The manufacture of the Company’s products by or, to the knowledge of the Company, on behalf of the Company is being conducted in compliance in all material respects with the Federal Food, Drug, and Cosmetic Act, including, without limitation, the FDA’s Quality System Regulation at 21 CFR Part 820, and, to the extent applicable, the respective counterparts thereof promulgated by governmental authorities in the United Kingdom and the European Union. Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company has not had any manufacturing site (whether Company-owned or, to the knowledge of the Company, that of a third-party manufacturer for the Company’s products) subject to a governmental authority (including FDA) shutdown or import or export prohibition.
Product Manufacturing. The manufacture of the Company’s products by or on behalf of the Company is being conducted in compliance in all material respects with the Federal Food, Drug, and Cosmetic Act, including, without limitation, the FDA’s Quality System Regulation at 21 CFR Part 820 (collectively, “FDCA”). The Company is not aware of any manufacturing site (whether Company-owned or that of a third-party manufacturer for the Company’s products) that performs manufacturing activity for the Company subject to a governmental authority (including the FDA) shutdown or import or export prohibition.
Product Manufacturing. The manufacture of the Company’s products by or, to the knowledge of the Company, on behalf of the Company is being conducted in compliance in all material respects with the Federal Food, Drug, and Cosmetic Act, including, without limitation, the FDA’s Quality System Regulation at 21 CFR Part 820 (collectively, “FDCA”), and, to the extent applicable, the respective counterparts thereof promulgated by governmental authorities in the United Kingdom and the European Union. Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company has not had any manufacturing site (whether Company-owned or, to the knowledge of the Company, that of a third-party manufacturer for the Company’s products) subject to a governmental authority (including FDA) shutdown or import or export prohibition.
Product Manufacturing. The manufacture of the Company’s products by or, to the knowledge of the Company, on behalf of the Company, to the extent applicable, is being conducted in compliance with the FDCA, including, without limitation, the FDA’s Quality System Regulation set forth at 21 CFR Part 820, and the respective counterparts thereof promulgated by governmental authorities in the United Kingdom and the European Union, except where failures to so comply, whether individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect. The Company has not had any manufacturing site (whether Company-owned or, to the knowledge of the Company, that of a third-party manufacturer for the Company’s products) subject to a governmental authority (including FDA) shutdown or import or export prohibition.
Product Manufacturing. With respect to each product of the Transferred Business, Ciba and/or its Subsidiaries (i) have obtained all applicable Permits (other than as set forth on Schedule 3.01(n)) necessary for the manufacture, distribution, sale and marketing of such products, except for such Permits the lack of which would not reasonably be expected to have a Material Adverse Effect, and (ii) are in material compliance with the terms and conditions of all such Permits in each jurisdiction in which such products are manufactured, distributed, sold or marketed. All products of the Transferred Business have been manufactured in full compliance with applicable product specifications.
Product Manufacturing. The manufacture of the Company’s products by or, to the knowledge of the Company, on behalf of the Company, is not subject to the FDA’s Quality System Regulation set forth at 21 CFR Part 820, or any similar legal requirement promulgated by governmental authorities in the United Kingdom and the European Union, except where failures to so comply, whether individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect. The Company has not had any manufacturing site (whether Company-owned or, to the knowledge of the Company, that of a third-party manufacturer for the Company’s products) subject to a governmental authority (including FDA) shutdown or import or export prohibition.
Product Manufacturing. Argent hereby acknowledges and agrees that TEAMM’s duties and obligations hereunder are dependent upon TEAMM’s ability to obtain and maintain an adequate supply of the Products from Mikart. Accordingly, Argent shall cooperate with TEAMM to ensure that a long-term supply agreement is executed between TEAMM and Mikart with respect to the Products (“Mikart Supply Agreement”).
Product Manufacturing. The manufacture of the Company’s products, whether by or on behalf of the Company or any of its subsidiaries, is to the Company’s knowledge being conducted in compliance in all material respects with all applicable Health Care Laws, including, without limitation, the FDA’s current good manufacturing practice regulations for products prepared for clinical trials or sold in the United States, and the respective counterparts thereof promulgated by governmental authorities in countries outside the United States. Except as would not reasonably be expected to be material to the Company, neither the Company nor any of its subsidiaries has had any product or manufacturing site (whether Company-owned or that of a contract manufacturer for the Company’s products) subject to a governmental authority (including FDA) shutdown or import or export prohibition, nor received any FDA Form-483 or other governmental authority notice of inspectional observations, “warning letters,” “untitled letters,” requests to make changes to the Company’s products, processes or operations, or similar correspondence or notice from the FDA or other governmental authority alleging or asserting material noncompliance with any applicable Health Care Laws. To the Company’s knowledge, neither the FDA nor any other governmental authority is considering such action.
Product Manufacturing. 7.1 In the interest of the competitive position of the Products emerging from the cooperation, an economic, safe and reliable source of manufacture must be identified. After the start of Phase I clinical trials, the PDP Group will initiate the cooperative identification and development of suitable manufacturing technology to provide the best reasonable conditions for manufacturing the Product(s). Regulatory provisions which apply to biologicals may have an impact on the final manufacturing arrangements. For example, it may be required that Ciba-Geigy obtain and maintain the ELA for the Product(s) in the U.S.A. to assume and maintain its governmental marketing approval for the U.S.A. in accordance with this Agreement. If so, Ciba-Geigy may be required to satisfy FDA requirements for ownership and/or control over the means of manufacture in order to obtain and maintain such ELA. In that event, Ciba-Geigy shall hold ownership and/or control over such means of manufacture. The parties shall negotiate in good faith to reach mutually agreeable terms to permit Ciba-Geigy to comply with its regulatory responsibilities.
7.2 In accordance with Amex 4 (Process Development and Production), Tanox will produce Product(s) required for pre-clinical and Phase I and Phase II clinical development, subject to reimbursement of Tanox's manufacturing costs (as defined in the third and fourth sentence of Paragraph 7.4) by Ciba-Geigy. Production of Product(s) for Phase III clinical trials and subsequent commercial production will be subject to the respective manufacturing rights of the parties agreed under this Paragraph 7.
