Common use of Product Improvements Clause in Contracts

Product Improvements. Intercardia/CPEC grants Xxxxx, the exclusive right in the Territory to bucindolol product improvements (e.g., sustained release formulation, improved or new indications, formulations and strengths), contingent upon Xxxxx reimbursing Intercardia/CPEC for 60% of costs relating to clinical trials and other tests conducted primarily for benefit of the Territory and 1/3 of all other development costs which have a worldwide benefit, including any previous product improvement development costs incurred by Intercardia/CPEC. For example, with respect to costs relating to clinical trials and other tests conducted and incurred primarily for the benefit of the Territory, Xxxxx would reimburse Intercardia/CPEC for 60% of such costs incurred by Intercardia/CPEC, and Intercardia/CPEC would reimburse Xxxxx for 40% of costs incurred by Xxxxx. Where the benefits of the trials and costs are worldwide, Xxxxx would pay 1/3 of such trials and costs incurred by Intercardia/CPEC and Intercardia/CPEC would reimburse Xxxxx for 2/3 of costs incurred by Xxxxx. However, Xxxxx would not reimburse Intercardia/CPEC for any costs where the trials and costs were conducted and incurred exclusively for the benefit of the United States. The overall development of product improvements will be conducted and controlled by Intercardia/CPEC. Xxxxx will reimburse CPEC for one third of previous sustained release development costs (which presently total $418,000.00) upon signing this Agreement, and Xxxxx will pay its share of future costs on a quarterly basis. In case Xxxxx has no interest in an improvement, Intercardia/CPEC shall have no right to market such improved product in the Territory during the term of this Agreement unless hereinafter provided otherwise. [ [ ] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED SEPARATELY WITH THE SEC. ] Intercardia/CPEC and Xxxxx shall mutually agree to any other line extensions to be included under the License Agreement, if any.

Appears in 1 contract

Samples: Agreement (Intercardia Inc)

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Product Improvements. Intercardia/CPEC COMPANY grants XxxxxKNOLL, the exclusive right for sales in the Territory to bucindolol product improvements of Licensed Product Improvements (e.g., sustained release formulation, improved or new indicationsindications not included in the Field, formulations and strengths), contingent upon Xxxxx KNOLL reimbursing Intercardia/CPEC COMPANY for sixty (60% %) percent of costs relating to clinical trials and other tests conducted primarily for benefit of the Territory and 1/3 of all other development costs which have a worldwide benefit, including any previous product improvement Licensed Product Improvement development costs incurred by Intercardia/CPECCOMPANY. For example, with respect to costs relating to clinical trials and other tests conducted and incurred primarily for the benefit of the Territory, Xxxxx KNOLL would reimburse Intercardia/CPEC COMPANY for sixty (60% %) percent of such costs incurred by Intercardia/CPECCOMPANY, and Intercardia/CPEC COMPANY would reimburse Xxxxx KNOLL for forty (40% %) percent of costs incurred by XxxxxKNOLL. Where the benefits of the trials and costs are worldwide, Xxxxx KNOLL would pay 1/3 of such trials and costs incurred by Intercardia/CPEC COMPANY and Intercardia/CPEC COMPANY would reimburse Xxxxx KNOLL for 2/3 of costs incurred by XxxxxKNOLL. However, Xxxxx KNOLL would not reimburse Intercardia/CPEC COMPANY for any costs where the trials and costs were conducted and incurred exclusively for the benefit of the United States, Puerto Rico or Japan. The overall development of product improvements Licensed Product Improvements will be conducted and controlled by Intercardia/CPECCOMPANY. Xxxxx will reimburse In December 1996, KNOLL reimbursed CPEC $143,136.67 for one third of previous sustained release development costs (which presently total totaled $418,000.00429,500.00) upon signing this Agreement, and Xxxxx KNOLL will pay its share of future costs on a quarterly basis. In case Xxxxx KNOLL has no interest in an improvementa Licensed Product Improvement, Intercardia/CPEC COMPANY shall have no right to market such improved product in the Territory during the term of this Agreement unless hereinafter provided otherwiseotherwise In case COMPANY has no interest in utilizing a Licensed Product Improvement outside of the Territory, KNOLL shall bear 60% of such development costs and COMPANY shall bear 40% of such development costs and COMPANY shall have no right to market such improved product outside the Territory during the term of this Agreement. COMPANY and KNOLL agree that a sustained release formulation is a Licensed Product Improvement which should be pursued. COMPANY has contracted with Jago Pharma AG, a Swiss corporation ("Jago") for the development of a sustained release formulation utilizing Jago's proprietary Geomatrix technology. COMPANY will xxxxx XXXXX the opportunity to present a proposal regarding the feasibility of utilizing XXXXX'x melt extrusion technology for the development of a sustained release formulation of bucindolol ("Melt/Bucindolol"). As soon as practicable after the COMPANY receives sustained release feasibility information from Jago, the COMPANY and KNOLL shall determine whether to pursue Jago's or XXXXX'x sustained release formulation technology. If XXXXX'x technology is selected, the parties shall agree upon a binding development plan for the KNOLL technology which shall include an agreement as to reimbursement of certain development costs incurred by KNOLL which are directly related to Melt/Bucindolol. If Melt/Bucindolol is selected, KNOLL shall grant COMPANY a license relating to such KNOLL technology in order to permit COMPANY to use, sell, sublicense and otherwise market bucindolol using the KNOLL technology outside the Territory, provided, however, KNOLL shall retain the right to manufacture Melt/Bucindolol for COMPANY and its licensees under a separate supply contract, which shall be on such price and terms as are reasonable and customary for similar supply contracts. All costs and penalties related to [ ] of the [ ] contract and all costs not previously reimbursed by KNOLL to COMPANY shall be allocated and paid by KNOLL and by COMPANY in accordance with the provisions of this Section 4.6. If KNOLL decides not to participate in further development of the Jago technology (beyond the preceding paragraph), and COMPANY decides not to participate in the development of Melt/Bucindolol, KNOLL shall have the right to pursue development of Melt/Bucindolol at its own expense. KNOLL shall accumulate the costs directly associated with the development of Melt/Bucindolol and such development costs shall become a deductible item in calculating the royalties due to COMPANY for sales resulting from Melt/Bucindolol. Such deductions shall be limited to [ ] ([ ]%) percent of the cumulative development costs of Melt/Bucindolol and shall not exceed [ ] ([ ]) percent of the royalty due to COMPANY for Melt/Bucindolol sales, prior to such deduction for any royalty period. For example, if the total development cost of Melt/Bucindolol is $[ ] million, KNOLL will be entitled to recover $[ ] million ([ ]% of $[ ] million) of this cost from future royalties due on sales of Melt/Bucindolol. The maximum which shall be recoverable by KNOLL in any [ ] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED SEPARATELY WITH THE SEC. period (e.g. a quarter) will be limited to [ ] Intercardia([ ]%) percent of the royalty which would have been payable to COMPANY prior to this deduction. For example, if COMPANY's royalty for the first period of Melt/CPEC Bucindolol sales is $[ ] million prior to this deduction, KNOLL will recover $[ ] million of Melt/Bucindolol development costs ([ ]% of $[ ] million) and Xxxxx $[ ] million ($[ ] million less $[ ] million) will be paid to COMPANY, leaving $[ ] million of the $[ ] million due to KNOLL. If COMPANY's royalty for the second period of Melt/Bucindolol sales is $[ ] million prior to this deduction, KNOLL will recover $[ ] million ($[ ] million less the $[ ] million already paid) and COMPANY's royalty will be $[ ] million ($[ ] million less $[ ] million). No deduction for Melt/Bucindolol costs will be made from any royalty from any sales that are not derived from Melt/Bucindolol technology. If KNOLL decides not to participate in further development of the Jago technology, and COMPANY develops a sustained release formulation with Jago, COMPANY shall be entitled to sell directly or through a third party its sustained release formulation in XXXXX'x Territory at such time as the first generic sustained release formulation is approved in an EC member state subject to compliance with Section 2.9. At such time after KNOLL has met its obligations under this Section 4.6, and after KNOLL notifies COMPANY in writing that it does not intend to sell directly or through a third party or to develop a sustained release formulation, XXXXX'x right to sustained release formulations shall terminate and XXXXX'x obligation to reimburse COMPANY for additional sustained release development costs shall terminate. COMPANY and KNOLL shall mutually agree to any other line extensions to be included under the License Agreement, if any.. [ ] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED SEPARATELY WITH THE SEC. 25

Appears in 1 contract

Samples: Marketing and License Agreement (Intercardia Inc)

Product Improvements. Intercardia/CPEC COMPANY grants XxxxxKNOLL, the exclusive right for sales in the Territory to bucindolol product improvements of Licensed Product Improvements (e.g., sustained release formulation, improved or new indicationsindications not included in the Field, formulations and strengths), contingent upon Xxxxx KNOLL reimbursing Intercardia/CPEC COMPANY for sixty (60% %) percent of costs relating to clinical trials and other tests conducted primarily for benefit of the Territory and 1/3 of all other development costs which have a worldwide benefit, including any previous product improvement Licensed Product Improvement development costs incurred by Intercardia/CPECCOMPANY. For example, with respect to costs relating to clinical trials and other tests conducted and incurred primarily for the benefit of the Territory, Xxxxx KNOLL would reimburse Intercardia/CPEC COMPANY for sixty (60% %) percent of such costs incurred by Intercardia/CPECCOMPANY, and Intercardia/CPEC COMPANY would reimburse Xxxxx KNOLL for forty (40% %) percent of costs incurred by XxxxxKNOLL. Where the benefits of the trials and costs are worldwide, Xxxxx KNOLL would pay 1/3 of such trials and costs incurred by Intercardia/CPEC COMPANY and Intercardia/CPEC COMPANY would reimburse Xxxxx KNOLL for 2/3 of costs incurred by XxxxxKNOLL. However, Xxxxx KNOLL would not reimburse Intercardia/CPEC COMPANY for any costs where the trials and costs were conducted and incurred exclusively for the benefit of the United States, Puerto Rico or Japan. The overall development of product improvements Licensed Product Improvements will be conducted and controlled by Intercardia/CPECCOMPANY. Xxxxx will reimburse In December 1996, KNOLL reimbursed CPEC $143,136.67 for one third of previous sustained release development costs (which presently total totaled $418,000.00429,500.00) upon signing this Agreement, and Xxxxx KNOLL will pay its share of future costs on a quarterly basis. In case Xxxxx KNOLL has no interest in an improvementa Licensed Product Improvement, Intercardia/CPEC COMPANY shall have no right to market such improved product in the Territory during the term of this Agreement unless hereinafter provided otherwiseotherwise In case COMPANY has no interest in utilizing a Licensed Product Improvement outside of the Territory, KNOLL shall bear 60% of such development costs and COMPANY shall bear 40% of such development costs and COMPANY shall have no right to market such improved product outside the Territory during the term of this Agreement. COMPANY and KNOLL agree that a sustained release formulation is a Licensed Product Improvement which should be pursued. COMPANY has contracted with Jago Pharma AG, a Swiss corporation ("Jago") for the development of a sustained release formulation utilizing Jago's proprietary Geomatrix technology. COMPANY will xxxxx XXXXX the opportunity to present a proposal regarding the feasibility of utilizing XXXXX'x melt extrusion technology for the development of a sustained release formulation of bucindolol ("Melt/Bucindolol"). As soon as practicable after the COMPANY receives sustained release feasibility information from Jago, the COMPANY and KNOLL shall determine whether to pursue Jago's or XXXXX'x sustained release formulation technology. If XXXXX'x technology is selected, the parties shall agree upon a binding development plan for the KNOLL technology which shall include an agreement as to reimbursement of certain development costs incurred by KNOLL which are directly related to Melt/Bucindolol. If Melt/Bucindolol is selected, KNOLL shall grant COMPANY a license relating to such KNOLL technology in order to permit COMPANY to use, sell, sublicense and otherwise market bucindolol using the KNOLL technology outside the Territory, provided, however, KNOLL shall retain the right to manufacture Melt/Bucindolol for COMPANY and its licensees under a separate supply contract, which shall be on such price and terms as are reasonable and customary for similar supply contracts. All costs and penalties related to [ ] of the [ ] contract and all costs not previously reimbursed by * KNOLL to COMPANY shall be allocated and paid by KNOLL and by COMPANY in accordance with the provisions of this Section 4.6. If KNOLL decides not to participate in further development of the Jago technology (beyond the preceding paragraph), and COMPANY decides not to participate in the development of Melt/Bucindolol, KNOLL shall have the right to pursue development of Melt/Bucindolol at its own expense. KNOLL shall accumulate the costs directly associated with the development of Melt/Bucindolol and such development costs shall become a deductible item in calculating the royalties due to COMPANY for sales resulting from Melt/Bucindolol. Such deductions shall be [ ] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED SEPARATELY WITH THE SEC. limited to [ ] Intercardia([ ]%) percent of the cumulative development costs of * Melt/CPEC Bucindolol and Xxxxx shall not exceed [ ] ([ ]%) percent of the royalty due to * COMPANY for Melt/Bucindolol sales, prior to such deduction for any royalty period. For example, if the total development cost of Melt/Bucindolol is $[ ] * million, KNOLL will be entitled to recover $[ ] million ([ ]% of $[ ] million) * of this cost from future royalties due on sales of Melt/Bucindolol. The maximum which shall be recoverable by KNOLL in any period (e.g. a quarter) will be limited to [ ] ([ ]%) percent of the royalty which would have been payable to * COMPANY prior to this deduction. For example, if COMPANY's royalty for the first period of Melt/Bucindolol sales is $[ ] million prior to this deduction, KNOLL * will recover $[ ] million of Melt/Bucindolol development costs ([ ]% of $[ ] * million) and $[ ] million ($[ ] million less $[ ] million) will be paid to * COMPANY, leaving $[ ] million of the $[ ] million due to KNOLL. If COMPANY's * royalty for the second period of Melt/Bucindolol sales is $[ ] million prior to * this deduction, KNOLL will recover $[ ] million ($[ ] million less the $[ ] * million already paid) and COMPANY's royalty will be $[ ] million ($[ ] million * less $[ ] million). No deduction for Melt/Bucindolol costs will be made from * any royalty from any sales that are not derived from Melt/Bucindolol technology. [ ] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED SEPARATELY WITH THE SEC. If KNOLL decides not to participate in further development of the Jago technology, and COMPANY develops a sustained release formulation with Jago, COMPANY shall be entitled to sell directly or through a third party its sustained release formulation in XXXXX'x Territory at such time as the first generic sustained release formulation is approved in an EC member state subject to compliance with Section 2.9. At such time after KNOLL has met its obligations under this Section 4.6, and after KNOLL notifies COMPANY in writing that it does not intend to sell directly or through a third party or to develop a sustained release formulation, XXXXX'x right to sustained release formulations shall terminate and XXXXX'x obligation to reimburse COMPANY for additional sustained release development costs shall terminate. COMPANY and KNOLL shall mutually agree to any other line extensions to be included under the License Agreement, if any.

Appears in 1 contract

Samples: Marketing and License Agreement (Intercardia Inc)

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Product Improvements. Intercardia/CPEC grants XxxxxKnoll, the exclusive right in the Territory to bucindolol product improvements (e.g., sustained release formulation, improved or new indications, formulations and strengths), contingent upon Xxxxx Knoll reimbursing Intercardia/CPEC for 60% of costs relating to clinical trials and other tests conducted primarily for benefit of the Territory and 1/3 of all other development costs which have a worldwide benefit, including any previous product improvement development costs incurred by Intercardia/CPEC. For example, with respect to costs relating to clinical trials and other tests conducted and incurred primarily for the benefit of the Territory, Xxxxx Knoll would reimburse Intercardia/CPEC for 60% of such costs incurred by Intercardia/CPEC, and Intercardia/CPEC would reimburse Xxxxx Knoll for 40% of costs incurred by XxxxxKnoll. Where the benefits of the trials and costs are worldwide, Xxxxx Knoll would pay 1/3 of such trials and costs incurred by Intercardia/CPEC and Intercardia/CPEC would reimburse Xxxxx Knoll for 2/3 of costs incurred by XxxxxKnoll. However, Xxxxx Knoll would not reimburse Intercardia/CPEC for any costs where the trials and costs were conducted and incurred exclusively for the benefit of the United States. The overall development of product improvements will be conducted and controlled by Intercardia/CPEC. Xxxxx Knoll will reimburse CPEC for one third of previous sustained release development costs (which presently total $418,000.00) upon signing this Agreement, and Xxxxx Knoll will pay its share of future costs on a quarterly basis. In case Xxxxx Knoll has no interest in an improvement, Intercardia/CPEC shall have no right to market such improved product in the Territory during the term of this Agreement unless hereinafter provided otherwise. Intercardia/CPEC and Knoll agree that a sustained release formulation is a product improvement which should be pursued. Intercardia/CPEC has contracted with Jago Pharma AG, a Swiss corporation ("Jago") for the development of a sustained release formulation utilizing Jago's proprietary Geomatrix technology. Intercardia/CPEC will xxxxx Xxxxx the opportunity to present a proposal regarding the feasibility of utilizing Xxxxx'x melt extrusion technology for the development of a sustained release formulation. By the end of [ ], Intercardia/CPEC and Knoll shall determine whether to pursue Jago's or Xxxxx'x sustained release formulation technology. If Xxxxx'x technology is selected, the parties shall agree upon a binding development plan for the Knoll technology which shall include an agreement as to reimbursement of certain development costs incurred by Knoll which are directly related to bucindolol. If the Knoll melt extrusion technology is selected, Knoll shall xxxxx Intercardia/CPEC a license relating to such Knoll technology in order to permit Intercardia to use, sell, sublicense and otherwise market bucindolol using the Knoll technology outside of Xxxxx'x territory, provided, however, Knoll shall retain the right to manufacture bucindolol for Intercardia/CPEC and its licensees under a separate supply contract. All costs and penalties related to [ ] of the [ ] contract and all costs not previously reimbursed by Knoll to Intercardia/CPEC, shall be allocated and paid by Knoll and by Intercardia/CPEC in accordance with the provisions of the prior paragraph. If Knoll decides not to particpate in further developement of the Jago technology (beyond the preceding paragraph), and Intercardia/CPEC decide not to participate in the development of bucindolol utilizing Xxxxx'x melt extrusion technology ("Melt/Bucindolol"), Knoll shall have the right to pursue developement of Melt/Bucindolol at its own expense. Knoll shall accumulate the costs directly associated with the development of Melt/Bucindolol and such developement costs shall become a deductible item in calculating the royalties due to CPEC for sales resulting from Melt/Bucindolol. Such deductions shall be limited to [ ]% ([ ] percent) of the cumulative development costs of Melt/Bucindolol and shall not exceed [ ]% ([ ] percent) of the royalty due to CPEC for Melt/Bucindolol sales, prior to such deduction for any royalty period. For example, if the total development cost of Melt/Bucindolol is $[ ] million, Knoll will be entitled to recover $[ ] million ([ ]% of $[ ] million) of this cost from future royalties due on sales of Melt/Bucindolol. The maximum which shall be recoverable by Knoll in any period (e.g. a quarter) will be limited to [ ]% of the royalty which would have been payable to CPEC prior to this deduction. For example, if CPEC's royalty for the first period of Melt/Bucindolol sales is $[ ] million prior to this deduction, Knoll will recover $[ ] million of Melt/Bucindolol development costs ([ ]% of $[ ] million) and $[ ] million ($[ ] million less $[ ] million) will be paid to CPEC, leaving $[ ] million of the $[ ] million due to Knoll. If CPEC's royalty for the second period of Melt/Bucindolol sales is $[ ] million prior to this deduction, Knoll will recover $[ ] million ($[ ] million less the $[ ] million already paid) and CPEC's royalty will be $[ ] million ($[ ] million less $[ ] million). No deduction for Melt/Bucindolol costs will be made from any royalty from any sales that are not derived from Melt/Bucindolol technology. If Knoll decides not to participate in furhter development of the Jago technology, and Intercardia/CPEC develops a sustatined release formulation with Jago, Intercardia/CPEC shall be entitled to sell directly or through a third party its sustained release formualation in Xxxxx'x Territory at such time as the first generic sustained relase formulation is approved in an EC member state. At such time after Knoll has met its obligations under the second paragraph of this Section 5, and after Knoll notifies Intercardia/CPEC in writing that it does not intend to sell directly or through a third party or to develop a sustained release formulation, Xxxxx'x right to sustained release formulations shall terminate and Xxxxx'x oblgiation to reimburse Intercardia/CPEC for additional sustatined release developoment costs shall terminate. [ ] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED SEPARATELY WITH THE SEC. ] Intercardia/CPEC and Xxxxx Knoll shall mutually agree to any other line extensions to be included under the License Agreement, if any.

Appears in 1 contract

Samples: Agreement (Intercardia Inc)

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