Common use of By EAGLE; Diligence Clause in Contracts

By EAGLE; Diligence. 8.2.1 EAGLE covenants to XXXXXX that, conditioned upon ROBERT’s fulfillment of its obligations under this Agreement, upon and after the EFFECTIVE DATE, EAGLE shall use commercially reasonable efforts to (i) develop the PRODUCTS and file for MARKETING AUTHORIZATION for the PRODUCTS in the TERRITORY as quickly as practicable after the successful completion of all stability testing and data required for such MARKETING AUTHORIZATION, including completion of all stability procedures, (ii) obtain approval of the MARKETING AUTHORIZATION for the PRODUCTS in the TERRITORY, and (iii) upon receipt of MARKETING AUTHORIZATION of the PRODUCT, use reasonable commercial efforts to commercialize and market the PRODUCT; provided, however, that Eagle shall have no obligation to hire a hospital sales force for the marketing and selling of the PRODUCT. 8.2.2 The PARTIES acknowledge and agree that the DEVELOPMENT COMMITTEE shall, prior to MARKETING AUTHORIZATION for the PRODUCTS (or any REPLACEMENT PRODUCT), formulate an expected business plan (which shall include a detailed budget). If at any time EAGLE’s GROSS PROFIT MARGIN for such PRODUCTS for two consecutive fiscal quarters is less than, or reasonably expected to be less than the gross margin set forth in such business plan by an amount equal to or greater than [*], then EAGLE shall have no obligation to continue to commercialize or market such PRODUCT. 8.2.3 If the marketing of a PRODUCT is discontinued pursuant to Section 8.2.2, the PARTIES shall use their commercially reasonable efforts to sell such PRODUCT to a THIRD PARTY. If the PARTIES are unable to sell such PRODUCT to a THIRD PARTY within [*] in the United States or [*] in countries ex-United States, then XXXXXX shall also have the right to require EAGLE, at ROBERT’S sole election and cost, to use reasonable efforts to provide XXXXXX, to the extent permitted by applicable LAW, with access to and use of the ANDA or 505(b)(2) filing (or other MARKETING AUTHORIZATION) and shall grant to XXXXXX, WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, a perpetual, irrevocable, royalty-free, non-exclusive license, with the right to sublicense, to such PRODUCT, the XXXXXX LICENSED TECHNOLOGY, the ASSIGNED PATENTS, EAGLE PATENT RIGHTS and EAGLE KNOW-HOW solely to the extent necessary to manufacture, or have manufactured solely for sale in the TERRITORY and to develop, register, and sell such PRODUCT solely in the TERRITORY. In the event that any such license is granted, XXXXXX shall pay royalties to EAGLE on the sale of such PRODUCT in the TERRITORY, according to the provisions of Articles 3 and 4, applied mutatis mutandi. As between the PARTIES, EAGLE shall be responsible for all development activities, and for the preparation, filing and maintenance of applications for MARKETING AUTHORIZATION for the finished PRODUCT in the TERRITORY. 8.2.4 In the event that EAGLE materially fails to perform its obligations under Section 8.2.1 in respect of a PRODUCT and fails to cure such default within [*] after ROBERT’s written notice thereof detailing such default (a “DEFAULT”), XXXXXX shall have the right to require EAGLE, at ROBERT’S sole election and cost, on a PRODUCT-by-PRODUCT basis, to use reasonable efforts to provide XXXXXX, to the extent permitted by applicable LAW, with access to and use of the ANDA or 505(b)(2) filing (or other MARKETING AUTHORIZATIONS) in which such DEFAULT occurred, and shall grant to XXXXXX, WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, a perpetual, irrevocable, royalty-free, non-exclusive license, with the right to sublicense, to the PRODUCT, the ASSIGNED PATENTS, the XXXXXX LICENSED TECHNOLOGY, the EAGLE PATENT RIGHTS and the EAGLE KNOW-HOW solely to the extent necessary to manufacture, or have manufactured solely for sale in such country and to develop, register, and sell the PRODUCTS the TERRITORY. In the event that any such license is granted, XXXXXX shall pay royalties to EAGLE on the sale of such PRODUCT in the TERRITORY, according to the provisions of Articles 3 and 4, applied mutatis mutandi.

By EAGLE; Diligence. 8.2.1 EAGLE covenants to XXXXXX SCIDOSE that, conditioned upon ROBERTSCIDOSE’s fulfillment of its obligations under this Agreement, upon and after the EFFECTIVE DATE, EAGLE shall use commercially reasonable commercial efforts to (i) develop the PRODUCTS and file for MARKETING AUTHORIZATION for the PRODUCTS in the TERRITORY as quickly as practicable after the successful completion of all stability testing and data required for such MARKETING AUTHORIZATION, including completion of all stability procedures, (ii) obtain approval of the MARKETING AUTHORIZATION for the PRODUCTS in the TERRITORY, and (iii) upon receipt of MARKETING AUTHORIZATION of the PRODUCT, use reasonable commercial efforts to commercialize and market the PRODUCT; provided, however, that Eagle shall have no obligation to hire a hospital sales force for the marketing and selling of the PRODUCT. 8.2.2 The PARTIES acknowledge and agree that the DEVELOPMENT COMMITTEE shall, prior to MARKETING AUTHORIZATION for the PRODUCTS (or any REPLACEMENT PRODUCT), formulate an expected business plan (which shall include a detailed budget). If at any time EAGLE’s GROSS PROFIT MARGIN for such PRODUCTS for two consecutive fiscal quarters is less than, or reasonably expected to be less than the gross margin set forth in such business plan by an amount equal to or greater than [*], then EAGLE shall have no obligation to continue to commercialize or market such PRODUCT. 8.2.3 If the marketing of a PRODUCT is discontinued pursuant to Section 8.2.2, the PARTIES shall use their commercially reasonable efforts to sell such PRODUCT to a THIRD PARTY. If the PARTIES are unable to sell such PRODUCT to a THIRD PARTY within [*] in the United States or [*] in countries ex-United Statesone hundred twenty (120) days, then XXXXXX SCIDOSE shall also have the right to require EAGLE, at ROBERTSCIDOSE’S sole election and cost, to use reasonable efforts to provide XXXXXXSCIDOSE, to the extent permitted by applicable LAW, with access to and use of the ANDA or 505(b)(2) filing (or other MARKETING AUTHORIZATION) and shall grant to XXXXXXSCIDOSE, WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, a perpetual, irrevocable, royalty-free, non-exclusive license, with the right to sublicense, to such PRODUCT, the XXXXXX SCIDOSE LICENSED TECHNOLOGY, the ASSIGNED PATENTS, EAGLE PATENT RIGHTS and EAGLE KNOW-HOW solely to the extent necessary to manufacture, or have manufactured solely for sale in the TERRITORY and to develop, register, and sell such PRODUCT solely in the TERRITORY. In the event that any such license is granted, XXXXXX SCIDOSE shall pay royalties to EAGLE on the sale of such PRODUCT in the TERRITORY, according to the provisions of Articles 3 and 4, applied mutatis mutandi. As between the PARTIES, EAGLE shall be responsible for all development activities, and for the preparation, filing and maintenance of applications for MARKETING AUTHORIZATION for the finished PRODUCT in the TERRITORY. 8.2.4 In the event that EAGLE materially fails to perform its obligations under Section 8.2.1 in respect of a PRODUCT and fails to cure such default within [*] sixty (60) days after ROBERTSCIDOSE’s written notice thereof detailing such default (a “DEFAULT”), XXXXXX SCIDOSE shall have the right to require EAGLE, at ROBERTSCIDOSE’S sole election and cost, on a PRODUCT-by-PRODUCT basis, to use reasonable efforts to provide XXXXXXSCIDOSE, to the extent permitted by applicable LAW, with access to and use of the ANDA or 505(b)(2) filing (or other MARKETING AUTHORIZATIONS) in which such DEFAULT occurred, and shall grant to XXXXXXSCIDOSE, WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, a perpetual, irrevocable, royalty-free, non-exclusive license, with the right to sublicense, to the PRODUCT, the ASSIGNED PATENTS, the XXXXXX SCIDOSE LICENSED TECHNOLOGY, the EAGLE PATENT RIGHTS and the EAGLE KNOW-HOW solely to the extent necessary to manufacture, or have manufactured solely for sale in such country and to develop, register, and sell the PRODUCTS the TERRITORY. In the event that any such license is granted, XXXXXX SCIDOSE shall pay royalties to EAGLE on the sale of such PRODUCT in the TERRITORY, according to the provisions of Articles 3 and 4, applied mutatis mutandi.

By EAGLE; Diligence. 8.2.1 EAGLE covenants to XXXXXX that, conditioned upon ROBERT’s fulfillment of its obligations under this Agreement, upon and after the EFFECTIVE DATE, EAGLE shall use commercially reasonable efforts to (i) develop the PRODUCTS and file for MARKETING AUTHORIZATION for the PRODUCTS in the TERRITORY United States of America as quickly as practicable after the successful completion of all stability testing and data required for such MARKETING AUTHORIZATION, including completion of all stability procedures, (ii) obtain approval of the MARKETING AUTHORIZATION for the PRODUCTS in the TERRITORYUnited States of America , and (iii) upon receipt of MARKETING AUTHORIZATION of the PRODUCT, use reasonable commercial efforts to commercialize and market the PRODUCT; provided, however, that Eagle shall have no obligation to hire a hospital sales force for the marketing and selling of the PRODUCT. 8.2.2 The PARTIES acknowledge and agree that the DEVELOPMENT COMMITTEE shall, prior to MARKETING AUTHORIZATION for the PRODUCTS (or any REPLACEMENT PRODUCT), formulate an expected business plan (which shall include a detailed budget). If at any time EAGLE’s GROSS PROFIT MARGIN for such PRODUCTS for two consecutive fiscal quarters is less than, or reasonably expected to be less than the gross margin GROSS MARGIN set forth in such business plan by an amount equal to or greater than [*], then EAGLE shall have no obligation to continue to commercialize or market such PRODUCT. 8.2.3 If the marketing of a PRODUCT is discontinued pursuant to Section 8.2.2, the PARTIES shall use their commercially reasonable efforts to sell such PRODUCT to a THIRD PARTY. If the PARTIES are unable to sell such PRODUCT to a THIRD PARTY within [*] in the United States or [*] in countries ex-United States, then XXXXXX shall also have the right to require EAGLE, at ROBERT’S sole election and cost, to use reasonable efforts to provide XXXXXX, to the extent permitted by applicable LAW, with access to and use of the ANDA or 505(b)(2) filing (or other MARKETING AUTHORIZATION) and shall grant to XXXXXX, WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, a perpetual, irrevocable, royalty-free, non-exclusive license, with the right to sublicense, to such PRODUCT, the XXXXXX LICENSED TECHNOLOGY, the ASSIGNED PATENTS, EAGLE PATENT RIGHTS and EAGLE KNOW-HOW solely to the extent necessary to manufacture, or have manufactured solely for sale in the TERRITORY and to develop, register, and sell such PRODUCT solely in the TERRITORY. In the event that any such license is granted, XXXXXX shall pay royalties to EAGLE on the sale of such PRODUCT in the TERRITORY, according to the provisions of Articles 3 and 4, applied mutatis mutandi. As between the PARTIES, EAGLE shall be responsible for all development activities, and for the preparation, filing and maintenance of applications for MARKETING AUTHORIZATION for the finished PRODUCT in the TERRITORY. 8.2.4 In the event that EAGLE materially fails to perform its obligations under Section 8.2.1 in respect of a PRODUCT and fails to cure such default within [*] after ROBERT’s written notice thereof detailing such default (a “DEFAULT”), XXXXXX shall have the right to require EAGLE, at ROBERT’S sole election and cost, on a PRODUCT-by-PRODUCT basis, to use reasonable efforts to provide XXXXXX, to the extent permitted by applicable LAW, with access to and use of the ANDA or 505(b)(2) filing (or other MARKETING AUTHORIZATIONS) in which such DEFAULT occurred, and shall grant to XXXXXX, WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, a perpetual, irrevocable, royalty-free, non-exclusive license, with the right to sublicense, to the PRODUCT, the ASSIGNED PATENTS, the XXXXXX LICENSED TECHNOLOGY, the EAGLE PATENT RIGHTS and the EAGLE KNOW-HOW solely to the extent necessary to manufacture, or have manufactured solely for sale in such country and to develop, register, and sell the PRODUCTS the TERRITORY. In the event that any such license is granted, XXXXXX shall pay royalties to EAGLE on the sale of such PRODUCT in the TERRITORY, according to the provisions of Articles 3 and 4, applied mutatis mtttatis mutandi.

By EAGLE; Diligence. 8.2.1 EAGLE covenants to XXXXXX SCIDOSE that, conditioned upon ROBERTSCIDOSE’s fulfillment of its obligations under this Agreement, upon and after the EFFECTIVE DATE, EAGLE shall use commercially reasonable commercial efforts to (i) develop the PRODUCTS and file for MARKETING AUTHORIZATION for the PRODUCTS in the TERRITORY as quickly as practicable after the successful completion of all stability testing and data required for such MARKETING AUTHORIZATION, including completion of all stability procedures, (ii) obtain approval of the MARKETING AUTHORIZATION for the PRODUCTS in the TERRITORY, and (iii) upon receipt of MARKETING AUTHORIZATION of the a PRODUCT, use reasonable commercial efforts to commercialize and market the such PRODUCT; provided, however, that Eagle shall have no obligation to hire a hospital sales force for the marketing and selling of the PRODUCTArgatroban or [*]. 8.2.2 The PARTIES acknowledge and agree that the DEVELOPMENT COMMITTEE shall, prior to MARKETING AUTHORIZATION for the PRODUCTS Argatroban or [*] (or any 505(b)(2) REPLACEMENT PRODUCT), formulate an expected business plan (which shall include a detailed budget). If at any time EAGLE’s GROSS PROFIT MARGIN for such PRODUCTS for two consecutive fiscal quarters is less than, or reasonably expected to be less than the gross margin set forth in such business plan by an amount equal to or greater than [*], then EAGLE shall have no obligation to continue to commercialize or market such PRODUCT. 8.2.3 If at any time EAGLE’s GROSS PROFIT MARGIN for the THIRD AND FOURTH PRODUCT (or applicable strength thereof or any REPLACEMENT PRODUCT related thereto) for two consecutive fiscal quarters is less than, or reasonably expected to be less than, [*], then EAGLE shall have no obligation to continue to commercialize or market such PRODUCT. 8.2.4 If the marketing of a PRODUCT is discontinued pursuant to Section 8.2.28.2.2 or 8.2.3, the PARTIES shall use their commercially reasonable efforts to sell such PRODUCT to a THIRD PARTY. If the PARTIES are unable to sell such PRODUCT to a THIRD PARTY within [*] in the United States or [*] in countries ex-United Statesone hundred twenty (120) days, then XXXXXX SCIDOSE shall also have the right to require EAGLE, at ROBERTSCIDOSE’S sole election and cost, to use reasonable efforts to provide XXXXXXSCIDOSE, to the extent permitted by applicable LAW, with access to and use of the ANDA or 505(b)(2) filing (or other MARKETING AUTHORIZATION) and shall grant to XXXXXXSCIDOSE, WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, a perpetual, irrevocable, royalty-free, non-exclusive license, with the right to sublicense, to such PRODUCT, the XXXXXX SCIDOSE LICENSED TECHNOLOGY, the ASSIGNED PATENTS, EAGLE PATENT RIGHTS and EAGLE KNOW-HOW solely to the extent necessary to manufacture, or have manufactured solely for sale in the TERRITORY and to develop, register, and sell such PRODUCT solely in the TERRITORY. In the event that any such license is granted, XXXXXX SCIDOSE shall pay royalties to EAGLE on the sale of such PRODUCT in the TERRITORY, according to the provisions of Articles 3 and 4, applied mutatis mutandi. As between the PARTIES, EAGLE shall be responsible for all development activities, and for the preparation, filing and maintenance of applications for MARKETING AUTHORIZATION for the finished PRODUCT in the TERRITORY. 8.2.4 8.2.5 In the event that EAGLE materially fails to perform its obligations under Section 8.2.1 in respect of a any PRODUCT and fails to cure such default within [*] sixty (60) days after ROBERTSCIDOSE’s written notice thereof detailing such default (a “DEFAULT”), XXXXXX SCIDOSE shall have the right to require EAGLE, at ROBERTSCIDOSE’S sole election and cost, on a PRODUCT-by-PRODUCT basis, to use reasonable efforts to provide XXXXXXSCIDOSE, to the extent permitted by applicable LAW, with access to and use of the ANDA or 505(b)(2) filing (or other MARKETING AUTHORIZATIONS) in which such DEFAULT occurred, and shall grant to XXXXXXSCIDOSE, WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, a perpetual, irrevocable, royalty-free, non-exclusive license, with the right to sublicense, to the PRODUCT, the ASSIGNED PATENTS, the XXXXXX SCIDOSE LICENSED TECHNOLOGY, the EAGLE PATENT RIGHTS and the EAGLE KNOW-HOW solely to the extent necessary to manufacture, or have manufactured solely for sale in such country and to develop, register, and sell the PRODUCTS the TERRITORY. In the event that any such license is granted, XXXXXX SCIDOSE shall pay royalties to EAGLE on the sale of such PRODUCT in the TERRITORY, according to the provisions of Articles 3 and 4, applied mutatis mutandi.

By EAGLE; Diligence. 8.2.1 EAGLE covenants to XXXXXX that, conditioned upon ROBERT’s fulfillment of its obligations under this Agreement, upon and after the EFFECTIVE DATE, EAGLE shall use commercially reasonable efforts to (i) develop the PRODUCTS and file for MARKETING AUTHORIZATION for the PRODUCTS in the TERRITORY as quickly as practicable after the successful completion of all stability testing and data required for such MARKETING AUTHORIZATION, including completion of all stability procedures, (ii) obtain approval of the MARKETING AUTHORIZATION for the PRODUCTS in the TERRITORY, and (iii) upon receipt of MARKETING AUTHORIZATION of the PRODUCT, use reasonable commercial efforts to commercialize and market the PRODUCT; provided, however, that Eagle shall have no obligation to hire a hospital sales force for the marketing and selling of the PRODUCT. 8.2.2 The PARTIES acknowledge and agree that the DEVELOPMENT COMMITTEE shall, prior to MARKETING AUTHORIZATION for the PRODUCTS (or any REPLACEMENT PRODUCT), formulate an expected business plan (which shall include a detailed budget). If at any time EAGLE’s GROSS PROFIT MARGIN for such PRODUCTS for two consecutive fiscal quarters is less than, or reasonably expected to be less than the gross margin set forth in such business plan by an amount equal [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. to or greater than [*], then EAGLE shall have no obligation to continue to commercialize or market such PRODUCT. 8.2.3 If the marketing of a PRODUCT is discontinued pursuant to Section 8.2.2, the PARTIES shall use their commercially reasonable efforts to sell such PRODUCT to a THIRD PARTY. If the PARTIES are unable to sell such PRODUCT to a THIRD PARTY within [*] in the United States or [*] in countries ex-United States, then XXXXXX shall also have the right to require EAGLE, at ROBERT’S sole election and cost, to use reasonable efforts to provide XXXXXX, to the extent permitted by applicable LAW, with access to and use of the ANDA or 505(b)(2) filing (or other MARKETING AUTHORIZATION) and shall grant to XXXXXX, WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, a perpetual, irrevocable, royalty-free, non-exclusive license, with the right to sublicense, to such PRODUCT, the XXXXXX LICENSED TECHNOLOGY, the ASSIGNED PATENTS, EAGLE PATENT RIGHTS and EAGLE KNOW-HOW solely to the extent necessary to manufacture, or have manufactured solely for sale in the TERRITORY and to develop, register, and sell such PRODUCT solely in the TERRITORY. In the event that any such license is granted, XXXXXX shall pay royalties to EAGLE on the sale of such PRODUCT in the TERRITORY, according to the provisions of Articles 3 and 4, applied mutatis mutandi. As between the PARTIES, EAGLE shall be responsible for all development activities, and for the preparation, filing and maintenance of applications for MARKETING AUTHORIZATION for the finished PRODUCT in the TERRITORY. 8.2.4 In the event that EAGLE materially fails to perform its obligations under Section 8.2.1 in respect of a PRODUCT and fails to cure such default within [*] after ROBERT’s written notice thereof detailing such default (a “DEFAULT”), XXXXXX shall have the right to require EAGLE, at ROBERT’S sole election and cost, on a PRODUCT-by-PRODUCT basis, to use reasonable efforts to provide XXXXXX, to the extent permitted by applicable LAW, with access to and use of the ANDA or 505(b)(2) filing (or other MARKETING AUTHORIZATIONS) in which such DEFAULT occurred, and shall grant to XXXXXX, WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, a perpetual, irrevocable, royalty-free, non-exclusive license, with the right to sublicense, to the PRODUCT, the ASSIGNED PATENTS, the XXXXXX LICENSED TECHNOLOGY, the EAGLE PATENT RIGHTS and the EAGLE KNOW-HOW solely to the extent necessary to manufacture, or have manufactured solely for sale in such country and to develop, register, and sell the PRODUCTS the TERRITORY. In the event that any such license is granted, XXXXXX shall pay royalties to EAGLE on the sale of [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. such PRODUCT in the TERRITORY, according to the provisions of Articles 3 and 4, applied mutatis mutandi.