Transfer by Sublicensor. At any time during the Term of the Agreement, upon reasonable request by Sublicensee (through the Alliance Managers), Sublicensor shall provide to Sublicensee copies of written documentation pertaining to manufacturing technologies, but only to the extent that such documentation is necessary for Sublicensee (i) to conduct its pre-clinical and clinical development activities or (ii) to make arrangements for supply of Compound, formulated Compound (interim product) (if any) and/or Product for Sublicensee’s use in Phase III clinical trials, and commercialization of Product in the Field in the Sublicensee Territory. Manufacturing technologies shall include methods of synthesis, manufacturing, testing, analysis and formulation of intermediates, Compound, formulated Compound (interim product) (if any) or Product, as well as the following items, to the extent controlled by Sublicensor: (a) Methods for testing compliance with the specifications for intermediates, Compound, and additional test methods for stability studies for the intermediates, Compound; (b) Test Methods for the specifications for formulated Compound (interim product) (if any) or Product, and additional test methods for stability studies for them; (c) Manufacturing method (including in-process test methods) of Compound, formulated Compound (interim product) (if any) and finished Product; (d) Specifications or other information regarding intermediates, Compound, formulated Compound (interim product) (if any) or Product, or starting materials, intermediates, reagents, therefor (which shall be provided to Sublicensee by Sublicensor or its Affiliates or, to the extent practicable, through Third Party Manufactures or Third Party suppliers of such starting materials, intermediates, or reagents); and (e) any other matters related to manufacturing or storage to be agreed on by Manufacturing Steering Team. In addition, Sublicensor or its Affiliates shall, upon Sublicensee’s reasonable request, provide up to sixty (60) hours of hands-on training at Sublicensor’s or its Third Party Manufacturer's facility by qualified Sublicensor or its Third Party Manufacturers’ technicians without charge, and thereafter, upon Sublicensor’s agreement to provide additional hours of hands-on training at Sublicensor’s or its Third Party Manufacturer's facility, Sublicensor shall provide up to fifty (50) additional hours of such training for which Sublicensee shall pay Sublicensor’s qualified technicians at a rate to be agreed, based on industry standard, by the Parties, negotiating in good faith. Upon the request for training, the Parties shall jointly approve a plan for training including timing, objectives, and activities. Sublicensor shall use reasonable commercial efforts to ensure the training is completed in accordance with the objectives and timing formulated by the Parties. Upon Sublicensee’s reasonable request, Sublicensor also shall use good faith efforts to facilitate an interaction between Sublicensee and Sublicensor’s Third Party Manufacturers or other Third Party suppliers which have supplied or are now supplying starting materials to Sublicensor, its other licensees or its Third Party Manufacturers, to aid Sublicensee in obtaining information regarding intermediates, Compound, formulated Compound (interim product) (if any) or Product or starting materials, intermediates, and reagents therefor.
Appears in 2 contracts
Samples: Sublicense Agreement (Keryx Biopharmaceuticals Inc), Sublicense Agreement (Keryx Biopharmaceuticals Inc)
Transfer by Sublicensor. At any time during the Term of the Agreement, upon reasonable request by Sublicensee (through the Alliance Managers), Sublicensor shall provide to Sublicensee copies of written documentation pertaining to manufacturing technologies, but only to the extent that such documentation is necessary for Sublicensee (i) to conduct its pre-clinical and clinical development activities or (ii) to make arrangements for supply of Compound, formulated Compound (interim product) (if any) and/or Product for Sublicensee’s use in Phase III clinical trials, and commercialization of Product in the Field in the Sublicensee Territory. Manufacturing technologies shall include methods of synthesis, manufacturing, testing, analysis and formulation of intermediates, Compound, formulated Compound (interim product) (if any) or Product, as well as the following items, to the extent controlled by Sublicensor:
(a) Methods for testing compliance with the specifications for intermediates, Compound, and additional test methods for stability studies for the intermediates, Compound;
(b) Test Methods for the specifications for formulated Compound (interim product) (if any) or Product, and additional test methods for stability studies for them;
(c) Manufacturing method (including in-process test methods) of Compound, formulated Compound (interim product) (if any) and finished Product;
(d) Specifications or other information regarding intermediates, Compound, formulated Compound (interim product) (if any) or Product, or starting materials, intermediates, reagents, therefor (which shall be provided to Sublicensee by Sublicensor or its Affiliates or, to the extent practicable, through Third Party Manufactures or Third Party suppliers of such starting materials, intermediates, or reagents); and
(e) any other matters related to manufacturing or storage to be agreed on by Manufacturing Steering Teamthe parties. In addition, Sublicensor or its Affiliates shall, upon Sublicensee’s reasonable request, provide up to sixty (60) hours of hands-on training at Sublicensor’s or its Third Party Manufacturer's ’s facility by qualified Sublicensor or its Third Party Manufacturers’ technicians without charge, and thereafter, upon Sublicensor’s agreement to provide additional hours of hands-on training at Sublicensor’s or its Third Party Manufacturer's ’s facility, Sublicensor shall provide up to fifty (50) additional hours of such training for which Sublicensee shall pay Sublicensor’s qualified technicians at a rate to be agreed, based on industry standard, by the Parties, negotiating in good faith. Upon the request for training, the Parties shall jointly approve a plan for training including timing, objectives, and activities. Sublicensor shall use reasonable commercial efforts to ensure the training is completed in accordance with the objectives and timing formulated by the Parties. Upon Sublicensee’s reasonable request, Sublicensor also shall use good faith efforts to facilitate an interaction between Sublicensee and Sublicensor’s Third Party Manufacturers or other Third Party suppliers which have supplied or are now supplying starting materials to Sublicensor, its other licensees or its Third Party Manufacturers, to aid Sublicensee in obtaining information regarding intermediates, Compound, formulated Compound (interim product) (if any) or Product or starting materials, intermediates, and reagents therefor.
Appears in 1 contract
Samples: Sublicense Agreement (Keryx Biopharmaceuticals Inc)
Transfer by Sublicensor. At any time during the Term of the Agreement, upon reasonable request by Sublicensee (through the Alliance Managers), Sublicensor shall provide to Sublicensee copies of written documentation pertaining to manufacturing technologies, but only to the extent that such documentation is necessary for Sublicensee (i) to conduct its pre-clinical and clinical development activities or (ii) to make arrangements for supply of Compound, formulated Compound (interim product) (if any) and/or Product for Sublicensee’s use in Phase III clinical trials, and commercialization of Product in the Field in the Sublicensee Territory. Manufacturing technologies shall include methods of synthesis, manufacturing, testing, analysis and formulation of intermediates, Compound, formulated Compound (interim product) (if any) or Product, as well as the following items, to the extent controlled by Sublicensor:
(a) Methods for testing compliance with the specifications for intermediates, Compound, and additional test methods for stability studies for the intermediates, Compound;
(b) Test Methods for the specifications for formulated Compound (interim product) (if any) or Product, and additional test methods for stability studies for them;
(c) Manufacturing method (including in-process test methods) of Compound, formulated Compound (interim product) (if any) and finished Product;
(d) Specifications or other information regarding intermediates, Compound, formulated Compound (interim product) (if any) or Product, or starting materials, intermediates, reagents, therefor (which shall be provided to Sublicensee by Sublicensor or its Affiliates or, to the extent practicable, through Third Party Manufactures or Third Party suppliers of such starting materials, intermediates, or reagents); and
(e) any other matters related to manufacturing or storage to be agreed on by Manufacturing Steering Teamthe parties. In addition, Sublicensor or its Affiliates shall, upon Sublicensee’s reasonable request, provide up to sixty (60) hours of hands-on training at Sublicensor’s or its Third Party Manufacturer's facility by qualified Sublicensor or its Third Party Manufacturers’ technicians without charge, and thereafter, upon Sublicensor’s agreement to provide additional hours of hands-on training at Sublicensor’s or its Third Party Manufacturer's facility, Sublicensor shall provide up to fifty (50) additional hours of such training for which Sublicensee shall pay Sublicensor’s qualified technicians at a rate to be agreed, based on industry standard, by the Parties, negotiating in good faith. Upon the request for training, the Parties shall jointly approve a plan for training including timing, objectives, and activities. Sublicensor shall use reasonable commercial efforts to ensure the training is completed in accordance with the objectives and timing formulated by the Parties. Upon Sublicensee’s reasonable request, Sublicensor also shall use good faith efforts to facilitate an interaction between Sublicensee and Sublicensor’s Third Party Manufacturers or other Third Party suppliers which have supplied or are now supplying starting materials to Sublicensor, its other licensees or its Third Party Manufacturers, to aid Sublicensee in obtaining information regarding intermediates, Compound, formulated Compound (interim product) (if any) or Product or starting materials, intermediates, and reagents therefor.
Appears in 1 contract
Samples: Sublicense Agreement (Keryx Biopharmaceuticals Inc)