Common use of Product Characteristics Clause in Contracts

Product Characteristics. (a) Xxxxxx shall not be obligated to accept from SuperGen any Finished Product with less than the greater of (i) seventy-five percent (75%) of approved shelf life for such Finished Product or (ii) thirteen (13) months of remaining shelf life. (b) SuperGen shall provide Xxxxxx with a certificate of analysis with respect to the shipment of the Finished Product to Xxxxxx. Full batch documentation, including batch production records, and manufacturing and analytical records shall be available for review by Xxxxxx on site at the manufacturing facility used by SuperGen (or by SuperGen's Third Party manufacturer(s)), during regular business hours and upon reasonable advance written notice from Xxxxxx. (c) Xxxxxx shall notify SuperGen in writing of any defect or shortage in the CONFIDENTIAL TREATMENT REQUESTED quantity of any shipment of Finished Product no later than ten (10) business days following receipt of the Finished Product. In the event of any such defect or shortage, SuperGen shall, at SuperGen's choice, replace the defective Finished Product or make up the shortage if replacement stock is available in the next shipment of Finished Product, but in any case no later than twenty (20) days or, if no such replacement stock is available, as soon as reasonably practical after receiving such notice, at no additional cost to Xxxxxx. (d) With respect to all SuperGen Third Party manufacturers of the Compound, the Product, and the Finished Product, SuperGen shall provide Xxxxxx with a continuing FDA guarantee in the format as set forth in 21 C.F.R. Section.7.13(A)(j).

Appears in 2 contracts

Samples: Sales, Distribution, and Development Agreement (Abbott Laboratories), Sales, Distribution, and Development Agreement (Supergen Inc)

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Product Characteristics. (a) Xxxxxx shall not be obligated to accept from SuperGen any Finished Product with less than the greater of (i) seventy-five percent (75%) of approved shelf life for such Finished Product or (ii) thirteen (13) months of remaining shelf life. (b) SuperGen shall provide Xxxxxx with a certificate of analysis with respect to the shipment of the Finished Product to Xxxxxx. Full batch documentation, including batch production records, and manufacturing and analytical records shall be available for review by Xxxxxx on site at the manufacturing facility used by SuperGen (or by SuperGen's Third Party manufacturer(s)), during regular business hours and upon reasonable advance written notice from Xxxxxx. (c) Xxxxxx shall notify SuperGen in writing of any defect or shortage in the 38 <PAGE> CONFIDENTIAL TREATMENT REQUESTED quantity of any shipment of Finished Product no later than ten (10) business days following receipt of the Finished Product. In the event of any such defect or shortage, SuperGen shall, at SuperGen's choice, replace the defective Finished Product or make up the shortage if replacement stock is available in the next shipment of Finished Product, but in any case no later than twenty (20) days or, if no such replacement stock is available, as soon as reasonably practical after receiving such notice, at no additional cost to Xxxxxx. (d) With respect to all SuperGen Third Party manufacturers of the Compound, the Product, and the Finished Product, SuperGen shall provide Xxxxxx with a continuing FDA guarantee in the format as set forth in 21 C.F.R. Section.7.13(A)(j).. ARTICLE 9:

Appears in 1 contract

Samples: Sales, Distribution, and Development Agreement

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Product Characteristics. (a) Xxxxxx shall not be obligated to accept from SuperGen any Finished Product with less than the greater of (i) seventy-five percent (75%) of approved shelf life for such Finished Product or (ii) thirteen (13) months of remaining shelf life[__________________________]. (b) SuperGen shall provide Xxxxxx with a certificate of analysis with respect to the shipment of the Finished Product to Xxxxxx. Full batch documentation, including batch production records, and manufacturing and analytical records shall be available for review by Xxxxxx on site at the manufacturing facility used by SuperGen (or by SuperGen's Third Party manufacturer(s)), during regular business hours and upon reasonable advance written notice from Xxxxxx. (c) Xxxxxx shall notify SuperGen in writing of any defect or shortage in the CONFIDENTIAL TREATMENT REQUESTED quantity of any shipment of Finished Product no later than ten (10) business days [_______________] following receipt of the Finished Product. In the event of any such defect or shortage, SuperGen shall, at SuperGen's choice, replace the defective Finished Product or make up the shortage if replacement stock is available in the next shipment of Finished Product, but in any case no later than twenty (20) days [__________________________] or, if no such replacement stock is available, as soon as reasonably practical after receiving such notice, at no additional cost to Xxxxxx. (d) With respect to all SuperGen Third Party manufacturers of the Compound, the Product, and the Finished Product, SuperGen shall provide Xxxxxx with a continuing FDA guarantee in the format as set forth in 21 C.F.R. Section.7.13(A)(jSection 7.13(A)(j).

Appears in 1 contract

Samples: Sales Contracts (Abbott Laboratories)

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