Product Development. (a) Supplier may develop enhancements it intends to incorporate into the BioGlue Surgical Adhesive during the term of this Agreement that have potential application to the Company Product (“Enhancements”). Unless otherwise agreed by the parties, at least once every six months during the Term, representatives of each of BioForm and Supplier shall hold a meeting in accordance with Sections 4.4 and 8.4 (the “Product Development Meeting”) at which Supplier will present Enhancements for BioForm to consider for application to the Company Product. At such Product Development Meeting, BioForm will also present its marketing plans (pursuant to Section 4.4) for the period and any information or feedback that BioForm reasonably believes may lead to Improvements. Within 30 calendar days following each Product Development Meeting, Supplier shall deliver a notice to BioForm (the “Enhancements Notice”) that shall describe the Enhancements that were presented by Supplier at such Product Development Meeting. Within 30 calendar days following receipt of the Enhancements Notice, BioForm may notify Supplier in writing if BioForm elects that any Enhancement described in the Enhancements Notice shall become an Improvement. If BioForm does provide such notice to Supplier during such 30-calendar day period, then BioForm and Supplier shall agree on a timeline for implementation of the Improvement in new Product Specifications for Company Product. If BioForm does not provide such a notice, said Enhancement shall not be implemented into the Company Product. The Enhancements Notice may also describe any potential Enhancements presented by Supplier at the Product Development Meeting, but BioForm shall not be required to take any action under this Section 8.4 with respect to such potential Enhancements until such time as they are presented by Supplier as Enhancements at a future Product Development Meeting. All Enhancements and potential Enhancement information provided by Supplier shall be considered Supplier Confidential Information. (b) From time to time, each party may request the other party to participate in joint projects to develop Improvements. Neither party is obligated to participate in such projects, and in each **** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. instance, each party’s decision whether to participate will be made in such party’s sole discretion. If both parties mutually agree to participate in such a project (a “Program”), the parties will promptly prepare a mutually agreeable written development agreement specifying the development activities to be performed by and the research and development tasks assigned to each party (the “Development Agreement”). All allocation of Intellectual Property rights with respect to any Program will be set forth in writing in the Development Agreement. (c) In the absence of a Development Agreement, (i) BioForm and Supplier shall retain joint ownership of Intellectual Property rights in which there is joint inventorship by BioForm (or its Affiliates) and Supplier, as determined in accordance with United States patent law, with Supplier’s rights in such joint ownership being subject to the license rights of BioForm under this Agreement, (ii) any Intellectual Property rights related to the Company Products, Enhancements, and Improvements that are created solely by employees or consultants of Supplier during the Term shall be considered to be Intellectual Property rights of Supplier, subject to the license rights of BioForm under this Agreement, and (iii) any Intellectual Property rights related to the Company Products and Improvements that are created solely by employees or consultants of BioForm or any of its Affiliates during the Term shall be considered to be Intellectual Property rights of BioForm. BioForm hereby grants to Supplier a perpetual, royalty free, world-wide, nonexclusive license to Supplier under such Blocking Intellectual Property to make, use, and sell such Intellectual Property outside the Field. “Blocking Intellectual Property” for the purposes of Section 8.4(c)(iii) shall mean Intellectual Property necessary for Supplier to make, use, or sell SA Product.
Appears in 3 contracts
Sources: Exclusive Development, Distribution, and Supply Agreement, Exclusive Development, Distribution, and Supply Agreement (Bioform Medical Inc), Exclusive Development, Distribution, and Supply Agreement (Bioform Medical Inc)
Product Development. 4.1 The PMT shall be responsible for managing R&D Work, Preclinical Work, Clinical Work, Production Work and Regulatory Work as well as related activities performed under the provisions of this Agreement. The chairperson of the PMT shall be chosen by HMRI. Beginning within sixty (a60) Supplier may develop enhancements it intends to incorporate into days after the BioGlue Surgical Adhesive during Effective Date of this Agreement and continuing through the term of this Agreement that have potential application to Agreement, the Company Product (“Enhancements”). Unless PMT will, unless otherwise agreed by the parties:
a) assume responsibility for the Plans as established in Section 4.3;
b) establish, update yearly and seek approval from the Steering Committee for the Plans so long as appropriate which will specify a reasonable level of detail by which ALLIANCE and HMRI will conduct R&D Work, Preclinical Work, Clinical Work, Production Work and Regulatory Work;
c) meet and review progress of R&D Work, Preclinical Work, Clinical Work, Production Work and Regulatory Work at least once quarterly unless ALLIANCE and HMRI otherwise agree, and direct changes or modifications to the Plans as well as budgets therefor;
d) establish a budget for each of the Plans and determine projected additional costs or savings associated with any changes or modifications thereto;
e) present a report with a reasonable level of detail at least every six (6) months during the Term, representatives of each of BioForm and Supplier shall hold a meeting in accordance with Sections 4.4 and 8.4 (the “Product Development Meeting”) at which Supplier will present Enhancements for BioForm to consider for application to the Company Product. At such Product Development MeetingSteering Committee on all activities of the PMT, BioForm will also present its marketing plans (pursuant to Section 4.4) including a budget update, progress by the parties under the current Plans and progress by the PMT on developing Plans for the period next year and associated budgets;
f) approve any information material agreements with any Third Party to be made by either or feedback that BioForm reasonably believes may lead to Improvements. Within 30 calendar days following each Product Development Meeting, Supplier shall deliver a notice to BioForm (the “Enhancements Notice”) that shall describe the Enhancements that were presented by Supplier at such Product Development Meeting. Within 30 calendar days following receipt of the Enhancements Notice, BioForm may notify Supplier in writing if BioForm elects that any Enhancement described in the Enhancements Notice shall become an Improvement. If BioForm does provide such notice to Supplier during such 30-calendar day period, then BioForm and Supplier shall agree on a timeline for implementation of the Improvement in new Product Specifications for Company Product. If BioForm does not provide such a notice, said Enhancement shall not be implemented into the Company Product. The Enhancements Notice may also describe any potential Enhancements presented by Supplier at the Product Development Meeting, but BioForm shall not be required to take any action under this Section 8.4 with respect to such potential Enhancements until such time as they are presented by Supplier as Enhancements at a future Product Development Meeting. All Enhancements and potential Enhancement information provided by Supplier shall be considered Supplier Confidential Information.
(b) From time to time, each party may request the other party to participate in joint projects to develop Improvements. Neither party is obligated to participate in such projects, and in each **** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect both parties hereto related to the omitted portions. instance, each party’s decision whether to participate will be made in such party’s sole discretion. If both parties mutually agree to participate in such a project (a “Program”), the parties will promptly prepare a mutually agreeable written development agreement specifying the development activities to be performed by and the research and development tasks assigned to each party (the “Development Agreement”). All allocation performance of Intellectual Property rights with respect to any Program will be set forth in writing in the Development Agreement.
(c) In the absence of a Development Agreement, (i) BioForm and Supplier shall retain joint ownership of Intellectual Property rights in which there is joint inventorship by BioForm (or its Affiliates) and Supplier, as determined in accordance with United States patent law, with Supplier’s rights in such joint ownership being subject to the license rights of BioForm their obligations under this Agreement, except where the selection of such a Third Party is the unilateral right of either party hereunder; and
g) determine when the regulatory submissions for the United States and Canada are to be transferred to HMRI from ALLIANCE.
4.2 Actions taken by the PMT pursuant to this Agreement as specified in Section 4.1 shall be taken only following unanimous agreement of the parties (iiHMRI and ALLIANCE each having one (1) vote) or at the direction of the Steering Committee.
4.3 Subject to the provisions of this Agreement and approval by the Steering Committee, ALLIANCE agrees to use its reasonable best efforts to execute and complete the Plans as assigned, described and budgeted as set forth in Appendix B and any Intellectual Property rights future Plans authorized pursuant to this Agreement. Subject to the provisions of this Agreement, HMRI agrees to use its reasonable best efforts to execute and complete the Plans as assigned, described and budgeted as set forth in Appendix C and any future Plans authorized pursuant to this Agreement. The PMT and the Steering Committee will exercise the same oversight and control of the Plans of Appendix B and Appendix C as if these Plans had been approved by the Steering Committee hereunder, and said oversight and control will specifically include directing changes and modifications to the Plans. Subject to Section 13.1, HMRI agrees to provide funding to ALLIANCE through June 30, 1997 of at least the amount set forth on Appendix B to develop the Products in the United States and Canada and to make the estimated quarterly payments to ALLIANCE set forth therein, which amounts will be solely applied to Plan Costs and are not refundable. ALLIANCE agrees to utilize the funds for the development of Products in the United States and Canada, and, in the event notice of termination of this Agreement is not given prior to June 30, 1997, any amount of such quarterly payments not previously applied to Plan Costs shall be applied to ALLIANCE's worldwide Plan Costs incurred after June 30, 1997. The parties agree that the Plans may change from time to time but the HMRI financial commitment reflected in Appendix B shall not decrease. If there are any proposed changes of whatever nature to Appendix B (other than the level of financial commitment), and the PMT, or the Steering Committee fail to reach unanimous agreement on said changes in accordance with the procedures set forth herein, then HMRI will have the final decision with respect to said changes. Either party may deliver to the PMT a list of proposed R&D Work, Preclinical Work, Clinical Work, Production Work and Regulatory Work Plans for the following calendar years, a description of each project and an estimated budget for each project. The proposed project description shall include a detailed plan, an itemized estimate of costs and time required, the name of the project leader, where the project will be carried out and the expected benefit. The PMT will review the list of proposed Plans, revise the proposed projects as it sees fit, and devise a R&D Work Plan, Preclinical Work Plan, Clinical Work Plan, Production Work Plan and Regulatory Work Plan from the proposed projects or from projects proposed by the PMT itself. The PMT will establish a budget for each of the Plans. Such Plans and budgets therefor shall be submitted by the PMT to the Steering Committee for approval.
4.4 HMRI shall pay all Plan Costs, and shall reimburse ALLIANCE for all of its Plan Costs incurred after March 31, 1996. Plan Costs include all out-of- pocket, direct, and indirect expenses ordinary and necessary to the execution of an approved Plan. Out-of-pocket costs, which include payments to third parties for supplies, materials, clinical travel, contracted outside services, etc., shall be documented by records reasonably acceptable to HMRI. Direct and indirect expenses of research and/or development personnel (including, without limitation, scientists, lab technicians, regulatory personnel, clinical support personnel, and the like) shall be expressed in terms of the full-time equivalent ("FTE") rate then in effect for ALLIANCE during the relevant time period. The FTE rate shall be calculated by determining the payroll cost for ALLIANCE's scientific and technical personnel who allocate time among various projects in ALLIANCE's ordinary course of business (including costs for fringe benefits and payroll taxes) and an overhead rate, which includes all costs other than out-of-pocket expenses for ALLIANCE's projects, including LIQUIVENT-Registered Trademark-. During the term of this Agreement, ALLIANCE shall use its standard project costing and accounting system then in effect in computing and tracking its direct and indirect costs. The objective of reimbursing costs in the manner set forth herein is to reimburse Alliance for its actual expenses in carrying out the Plan.
b) By October 1 of each year, the PMT will establish an overall project budget for the upcoming calendar year broken down by major work areas/teams and establish FTE labor and overhead rates to be used as benchmarks to measure performance and accountability. At 6-month intervals, the PMT will add an additional 6-month budget, thus maintaining a rolling 12-month budget.
4.5 Any sums due to ALLIANCE by HMRI pursuant to Articles 4, 8 or 9 shall be billed by ALLIANCE each calendar quarter, substantiated by ALLIANCE with suitable invoices and other reasonable documentation, including documentation based on the actual FTE spending rates for labor and overhead, and paid by HMRI within forty-five (45) days of receipt of such invoices.
4.6 The parties agree to promptly provide each other with copies of records, reports, and regulatory filings showing a reasonable level of detail related to their respective work in the Company ProductsUnited States, EnhancementsJapan, and Improvements that are created solely by employees or consultants each Major European Country conducted under the terms of Supplier during the Term shall be considered to be Intellectual Property rights of Supplierthis Agreement, subject to the license rights of BioForm under this Agreement, and (iii) any Intellectual Property rights related to the Company Products and Improvements that are created solely by employees or consultants of BioForm or any of its Affiliates during the Term shall be considered to be Intellectual Property rights of BioForm. BioForm hereby grants to Supplier a perpetual, royalty free, world-wide, nonexclusive license to Supplier under such Blocking Intellectual Property to make, use, and sell such Intellectual Property outside the Field. “Blocking Intellectual Property” for the purposes of confidentiality obligations described in Section 8.4(c)(iii) shall mean Intellectual Property necessary for Supplier to make, use, or sell SA Product3.5.
Appears in 2 contracts
Sources: License Agreement (Alliance Pharmaceutical Corp), License Agreement (Alliance Pharmaceutical Corp)
Product Development. 2.1.1 As between Akcea and PTC, in the Akcea Territory, Akcea is solely responsible for the Development activities relating to the Products and AKCEA-TTR-LRx in accordance with the terms of the Ionis Pharmaceuticals/Akcea License Agreements, the Strategic Plans and Transition Plans (each as defined therein) and any Regulatory (as defined therein) strategies contemplated under the Ionis Pharmaceuticals/Akcea License Agreements. As between Akcea and PTC, all costs and expenses incurred by or on behalf of Akcea in the performance of such Development activities shall be borne solely by Akcea.
2.1.2 Akcea shall promptly notify PTC (but in any case within [**]) of any Material Changes (as defined in the Ionis Pharmaceuticals/Akcea License Agreements) to the Strategic Plans and any material changes to the Transition Plans that have been approved pursuant to the Ionis Pharmaceuticals/Akcea License Agreements that may affect the Development of the Products in the PTC Territory.
2.1.3 Akcea shall consult with PTC in good faith regarding (a) Supplier may develop enhancements it intends to incorporate into the BioGlue Surgical Adhesive during conduct and implementation of Akcea’s activities under the term of this Agreement that have potential application Strategic Plans and the Transition Plans relating to the Company Product (“Enhancements”). Unless otherwise agreed by the parties, at least once every six months during the Term, representatives of each of BioForm and Supplier shall hold a meeting in accordance with Sections 4.4 and 8.4 (the “Product Development Meeting”) at which Supplier will present Enhancements for BioForm to consider for application to the Company Product. At such Product Development Meeting, BioForm will also present its marketing plans (pursuant to Section 4.4) for the period and any information or feedback that BioForm reasonably believes may lead to Improvements. Within 30 calendar days following each Product Development Meeting, Supplier shall deliver a notice to BioForm (the “Enhancements Notice”) that shall describe the Enhancements that were presented by Supplier at such Product Development Meeting. Within 30 calendar days following receipt of the Enhancements Notice, BioForm may notify Supplier in writing if BioForm elects that any Enhancement described Products in the Enhancements Notice shall become an Improvement. If BioForm does provide such notice to Supplier during such 30-calendar day periodPTC Territory, then BioForm and Supplier shall agree on a timeline for implementation of the Improvement in new Product Specifications for Company Product. If BioForm does not provide such a notice, said Enhancement shall not be implemented into the Company Product. The Enhancements Notice may also describe any potential Enhancements presented by Supplier at the Product Development Meeting, but BioForm shall not be required to take any action under this Section 8.4 with respect to such potential Enhancements until such time as they are presented by Supplier as Enhancements at a future Product Development Meeting. All Enhancements and potential Enhancement information provided by Supplier shall be considered Supplier Confidential Information.
(b) From time any Material Change (as defined in the Ionis Pharmaceutical/Akcea License Agreements) prior to time, each party may request the other party to participate in joint projects to develop Improvementstheir implementation. Neither party is obligated to participate in If any such projects, and in each **** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect activities are solely related to the omitted portions. instanceDevelopment of the Products in the PTC Territory, each party’s decision whether to participate then the Parties will be made in such party’s sole discretion. If both parties mutually agree to participate a budget for such activities, and the costs of such activities under such mutually agreed budget will be borne by PTC.
2.1.4 Akcea shall invite PTC to appoint a representative to attend, and such PTC representative shall be permitted to attend, any portions of any JSC or other Subcommittee meetings that are held pursuant to the Ionis Pharmaceuticals/Akcea License Agreements that relate to the Development of any of the Products in the PTC Territory.
2.1.5 PTC will conduct any Phase 4 Clinical Trials that are required or requested in writing by a Regulatory Authority in a country in the PTC Territory as a condition of, or in connection with, obtaining or maintaining Regulatory Approval in such a project country (a “Program”)whether such Phase 4 Clinical Trial is commenced prior to or after receipt of such Regulatory Approval) or as otherwise determined by PTC to conduct. As between Akcea and PTC, the parties will promptly prepare a mutually agreeable written development agreement specifying the development activities to be performed all costs and expenses incurred by and the research and development tasks assigned to each party (the “Development Agreement”). All allocation or on behalf of Intellectual Property rights with respect to any Program will be set forth in writing PTC in the Development Agreement.
(c) In the absence performance of a Development Agreement, (i) BioForm and Supplier any such Phase 4 Clinical Trials shall retain joint ownership of Intellectual Property rights in which there is joint inventorship by BioForm (or its Affiliates) and Supplier, as determined in accordance with United States patent law, with Supplier’s rights in such joint ownership being subject to the license rights of BioForm under this Agreement, (ii) any Intellectual Property rights related to the Company Products, Enhancements, and Improvements that are created be borne solely by employees or consultants of Supplier during the Term shall be considered to be Intellectual Property rights of Supplier, subject to the license rights of BioForm under this Agreement, and (iii) any Intellectual Property rights related to the Company Products and Improvements that are created solely by employees or consultants of BioForm or any of its Affiliates during the Term shall be considered to be Intellectual Property rights of BioForm. BioForm hereby grants to Supplier a perpetual, royalty free, world-wide, nonexclusive license to Supplier under such Blocking Intellectual Property to make, use, and sell such Intellectual Property outside the Field. “Blocking Intellectual Property” for the purposes of Section 8.4(c)(iii) shall mean Intellectual Property necessary for Supplier to make, use, or sell SA ProductPTC.
Appears in 1 contract
Sources: Collaboration and License Agreement (PTC Therapeutics, Inc.)
Product Development. (a) Supplier may develop enhancements it intends From the date hereof to incorporate into the BioGlue Surgical Adhesive Closing Date, the Buyer and Seller agree to negotiate in good faith and reasonably cooperate in preparing, supplementing and finalizing (A) the Product Development and Distribution Agreement, (B) an Indemnity Reinsurance Agreement between the Buyer and MetLife USA or an appropriate Affiliate of MetLife USA (the “Reinsurance Agreement”), providing for the Buyer to cede to MetLife USA or an appropriate Affiliate of MetLife USA, and for MetLife USA or such Affiliate to indemnify the Buyer, on a coinsurance basis, for an agreed upon percentage of the contractual liabilities of the Buyer with respect to the Buyer Products (as defined below) issued during the term of this the Product Development and Distribution Agreement that have potential application to the Company Product (“Enhancements”). Unless otherwise agreed and payable by the parties, at least once every six months during Buyer after the Term, representatives commencement of each the offering of BioForm and Supplier shall hold a meeting the Buyer Products in accordance with Sections 4.4 the Product Development and 8.4 Distribution Agreement, and (C) an Administration Agreement between the same parties (the “Product Development MeetingAdministration Agreement”) at ), under which Supplier MetLife USA or an appropriate Affiliate of MetLife USA will present Enhancements for BioForm agree to consider for application to administer the Company Product. At such Product Development Meeting, BioForm will also present its marketing plans (pursuant to Section 4.4) for Buyer Products during the period and any information or feedback that BioForm reasonably believes may lead to Improvements. Within 30 calendar days following each Product Development Meeting, Supplier shall deliver a notice to BioForm (the “Enhancements Notice”) that shall describe the Enhancements that were presented by Supplier at such Product Development Meeting. Within 30 calendar days following receipt term of the Enhancements NoticeIndemnity Reinsurance Agreement, BioForm may notify Supplier in writing if BioForm elects that any Enhancement described each case on terms to be negotiated and agreed upon in good faith by the Enhancements Notice Buyer and MetLife USA substantially consistent with the term sheet attached as Exhibit D. The Parties shall become an Improvement. If BioForm does provide such notice to Supplier during such 30-calendar day period, then BioForm and Supplier shall agree on a timeline for implementation of the Improvement in new Product Specifications for Company Product. If BioForm does not provide such a notice, said Enhancement shall not be implemented enter into the Company Product. The Enhancements Notice may also describe any potential Enhancements presented by Supplier at the Product Development Meetingand Distribution Agreement, but BioForm shall not be required to take any action under this Section 8.4 with respect to the Reinsurance Agreement and the Administration Agreement on the Closing Date, it being understood that none of such potential Enhancements until such time as they are presented by Supplier as Enhancements at a future Product Development Meeting. All Enhancements and potential Enhancement information provided by Supplier agreements shall be considered Supplier Confidential Informationentered into unless all of them are entered into.
(b) From time to timeOn and after the date of this Agreement, each party may request until the other party to participate in joint projects to develop Improvements. Neither party is obligated to participate in such projectseffective date of the Product Development and Distribution Agreement, the Buyer and its Affiliates shall not develop, and in each **** Certain information on this page has been omitted and filed separately with will suspend the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. instancedevelopment, each party’s decision whether to participate will be made in such party’s sole discretion. If both parties mutually agree to participate in such a project (a “Program”), the parties will promptly prepare a mutually agreeable written development agreement specifying the development activities to be performed by and the research and development tasks assigned to each party (the “Development Agreement”). All allocation of Intellectual Property rights with respect to any Program will be set forth in writing in the Development Agreementfixed indexed annuities.
(c) In From the absence date of a Development this Agreement, the Buyer shall and the Seller shall cause MetLife USA to, or shall cause their respective appropriate Affiliate, to use commercially reasonable efforts to jointly develop and agree to a fixed indexed annuity product design, including product specifications and all materials customarily included for the Buyer’s internal approval procedures for such products (i) BioForm and Supplier shall retain joint ownership of Intellectual Property rights in the “Buyer Products”), which there is joint inventorship are to be offered by BioForm (or Buyer through its Affiliates) and Supplier, as determined retail sales force in accordance with United States patent lawthe Product Development and Distribution Agreement. After product design and specifications have been agreed upon, Seller shall cause MetLife USA to, or shall cause their respective Affiliate to, draft the contract forms and prepare all filing materials necessary or appropriate to make the filings with Supplier’s rights Governmental Authorities described in Section 7.17(d) and Buyer shall have the right to pre-approve all such joint ownership being subject filings. Each of the parties will bear its own expense of drafting such forms and preparing such filing materials.
(d) Provided that the Seller fulfills its obligations under clauses (a) and (c) above, as applicable and Buyer has approved such filings, the Buyer shall transmit to the license rights of BioForm under this Agreement, (ii) any Intellectual Property rights related appropriate Governmental Entities and file all filings required to obtain approvals to issue the Company Products, Enhancements, Buyer Products in all U.S. jurisdictions in which the Buyer and Improvements that are created solely by employees or consultants of Supplier during the Term shall be considered to be Intellectual Property rights of Supplier, subject to the license rights of BioForm under this Agreement, and (iii) any Intellectual Property rights related to the Company Products and Improvements that are created solely by employees or consultants of BioForm or any of its Affiliates during are authorized to issue fixed indexed annuity contracts and where the Term parties have mutually-agreed to make such filings; provided that the Buyer shall be considered use commercially reasonable efforts to make all such required filings not later than the later of August 1, 2016 and the date that is thirty (30) days after MetLife USA or its appropriate Affiliate has provided to Buyer the materials required by second to last sentence of Section 7.17(c). The Seller shall cause MetLife USA and MetLife USA’s appropriate Affiliates to use commercial best efforts to assist the Buyer and its Affiliates with respect to making such filings and obtaining such approvals.
(e) Subject to the terms and conditions of this Agreement, the Buyer shall use its commercially reasonable efforts to take, or cause to be Intellectual Property rights of BioForm. BioForm hereby grants to Supplier a perpetual, royalty free, world-wide, nonexclusive license to Supplier under such Blocking Intellectual Property to make, usetaken, and sell such Intellectual Property outside the Field. “Blocking Intellectual Property” for the purposes of Section 8.4(c)(iii) shall mean Intellectual Property necessary for Supplier to make, usedo, or cause to be done, all things necessary, proper or advisable to enable and permit the Buyer’s and its Affiliates’ retail sales force to market and sell SA ProductMetLife Products pursuant to the Distribution Agreement and the Buyer Products pursuant to the Product Development and Distribution Agreement, including without limitation removing any limitations thereto contained in its errors and omissions insurance or other liability insurance coverage.
(f) From the date of this Agreement until the end of the sixth month following the Closing Date, the Buyer shall and the Seller shall cause MetLife USA to, or shall cause their respective appropriate Affiliate, to explore in good faith the possibility of entering into agreements to designate specified variable annuity contracts with one or more living benefit riders as Buyer Products subject to the Product Development and Distribution Agreement or a similar agreement, and subject to reinsurance and administrative arrangements similar to those described in this Section 7.17 with respect to Buyer Products. MetLife USA shall have a right of first refusal to develop and provide variable annuity products with living benefits (other than guaranteed accumulation benefits) to be issued by Buyer’s retail sales force, and to provide related reinsurance and administration.
(g) In connection with their distribution of ML USA variable annuity products, Buyer and its affiliates shall retain sole discretion to modify their business and compensation practices to comply with Law, including any requirements relating to the U.S. Department of Labor’s “investment advice” regulation and related fiduciary duties under ERISA and Section 4975 of the Internal Revenue Code. If Buyer or its Affiliates make any such change that affects the distribution of the ML USA variable annuity products, the Parties shall in good faith explore alternatives relating to the continued offer of such products through the Buyer's retail sales force.
Appears in 1 contract
Sources: Purchase Agreement (Metlife Inc)
Product Development. 2.1.1 As between Akcea and PTC, in the Akcea Territory, Akcea is solely responsible for the Development activities relating to the Products and AKCEA-TTR-LRx in accordance with the terms of the Ionis Pharmaceuticals/Akcea License Agreements, the Strategic Plans and Transition Plans (each as defined therein) and any Regulatory (as defined therein) strategies contemplated under the Ionis Pharmaceuticals/Akcea License Agreements. As between Akcea and PTC, all costs and expenses incurred by or on behalf of Akcea in the performance of such Development activities shall be borne solely by Akcea.
2.1.2 Akcea shall promptly notify PTC (but in any case within [***]) of any Material Changes (as defined in the Ionis Pharmaceuticals/Akcea License Agreements) to the Strategic Plans and any material changes to the Transition Plans that have been approved pursuant to the Ionis Pharmaceuticals/Akcea License Agreements that may affect the Development of the Products in the PTC Territory.
2.1.3 Akcea shall consult with PTC in good faith regarding (a) Supplier may develop enhancements it intends to incorporate into the BioGlue Surgical Adhesive during conduct and implementation of Akcea’s activities under the term of this Agreement that have potential application Strategic Plans and the Transition Plans relating to the Company Product (“Enhancements”). Unless otherwise agreed by the parties, at least once every six months during the Term, representatives of each of BioForm and Supplier shall hold a meeting in accordance with Sections 4.4 and 8.4 (the “Product Development Meeting”) at which Supplier will present Enhancements for BioForm to consider for application to the Company Product. At such Product Development Meeting, BioForm will also present its marketing plans (pursuant to Section 4.4) for the period and any information or feedback that BioForm reasonably believes may lead to Improvements. Within 30 calendar days following each Product Development Meeting, Supplier shall deliver a notice to BioForm (the “Enhancements Notice”) that shall describe the Enhancements that were presented by Supplier at such Product Development Meeting. Within 30 calendar days following receipt of the Enhancements Notice, BioForm may notify Supplier in writing if BioForm elects that any Enhancement described Products in the Enhancements Notice shall become an Improvement. If BioForm does provide such notice to Supplier during such 30-calendar day periodPTC Territory, then BioForm and Supplier shall agree on a timeline for implementation of the Improvement in new Product Specifications for Company Product. If BioForm does not provide such a notice, said Enhancement shall not be implemented into the Company Product. The Enhancements Notice may also describe any potential Enhancements presented by Supplier at the Product Development Meeting, but BioForm shall not be required to take any action under this Section 8.4 with respect to such potential Enhancements until such time as they are presented by Supplier as Enhancements at a future Product Development Meeting. All Enhancements and potential Enhancement information provided by Supplier shall be considered Supplier Confidential Information.
(b) From time any Material Change (as defined in the Ionis Pharmaceutical/Akcea License Agreements) prior to time, each party may request the other party to participate in joint projects to develop Improvementstheir implementation. Neither party is obligated to participate in If any such projects, and in each **** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect activities are solely related to the omitted portions. instanceDevelopment of the Products in the PTC Territory, each party’s decision whether to participate then the Parties will be made in such party’s sole discretion. If both parties mutually agree to participate a budget for such activities, and the costs of such activities under such mutually agreed budget will be borne by PTC.
2.1.4 Akcea shall invite PTC to appoint a representative to attend, and such PTC representative shall be permitted to attend, any portions of any JSC or other Subcommittee meetings that are held pursuant to the Ionis Pharmaceuticals/Akcea License Agreements that relate to the Development of any of the Products in the PTC Territory.
2.1.5 PTC will conduct any Phase 4 Clinical Trials that are required or requested in writing by a Regulatory Authority in a country in the PTC Territory as a condition of, or in connection with, obtaining or maintaining Regulatory Approval in such a project country (a “Program”)whether such Phase 4 Clinical Trial is commenced prior to or after receipt of such Regulatory Approval) or as otherwise determined by PTC to conduct. As between Akcea and PTC, the parties will promptly prepare a mutually agreeable written development agreement specifying the development activities to be performed all costs and expenses incurred by and the research and development tasks assigned to each party (the “Development Agreement”). All allocation or on behalf of Intellectual Property rights with respect to any Program will be set forth in writing PTC in the Development Agreement.
(c) In the absence performance of a Development Agreement, (i) BioForm and Supplier any such Phase 4 Clinical Trials shall retain joint ownership of Intellectual Property rights in which there is joint inventorship by BioForm (or its Affiliates) and Supplier, as determined in accordance with United States patent law, with Supplier’s rights in such joint ownership being subject to the license rights of BioForm under this Agreement, (ii) any Intellectual Property rights related to the Company Products, Enhancements, and Improvements that are created be borne solely by employees or consultants of Supplier during the Term shall be considered to be Intellectual Property rights of Supplier, subject to the license rights of BioForm under this Agreement, and (iii) any Intellectual Property rights related to the Company Products and Improvements that are created solely by employees or consultants of BioForm or any of its Affiliates during the Term shall be considered to be Intellectual Property rights of BioFormPTC. BioForm hereby grants to Supplier a perpetual, royalty free, world-wide, nonexclusive license to Supplier under such Blocking Intellectual Property to make, use, and sell such Intellectual Property outside the Field. “Blocking Intellectual Property” for the purposes of Section 8.4(c)(iii) shall mean Intellectual Property necessary for Supplier to make, use, or sell SA Product.ActiveUS 169009360v.1
Appears in 1 contract
Sources: Collaboration and License Agreement (Akcea Therapeutics, Inc.)
Product Development. (a) Supplier may develop enhancements it intends to incorporate into The parties shall, within 30 days after the BioGlue Surgical Adhesive during the term date of this Agreement that have potential application to the Company Product (“Enhancements”). Unless otherwise agreed by the partiesAgreement, at least once every six months during the Term, representatives of each of BioForm and Supplier shall hold form a meeting in accordance with Sections 4.4 and 8.4 (the “multi-functional Product Development Meeting”) at Committee which Supplier will present Enhancements identify mutually agreed-upon new product opportunities and prioritize the application of resources for BioForm to consider for application to endoscopy-related product improvements and/or the Company Product. At such Product Development Meeting, BioForm will also present its marketing plans (pursuant to Section 4.4) for the period and any information or feedback that BioForm reasonably believes may lead to Improvements. Within 30 calendar days following each Product Development Meeting, Supplier shall deliver a notice to BioForm (the “Enhancements Notice”) that shall describe the Enhancements that were presented by Supplier at such Product Development Meeting. Within 30 calendar days following receipt development of the Enhancements Notice, BioForm may notify Supplier in writing if BioForm elects that any Enhancement described in the Enhancements Notice shall become an Improvement. If BioForm does provide such notice to Supplier during such 30next-calendar day period, then BioForm and Supplier shall agree on a timeline for implementation of the Improvement in new Product Specifications for Company Product. If BioForm does not provide such a notice, said Enhancement shall not be implemented into the Company Product. The Enhancements Notice may also describe any potential Enhancements presented by Supplier at the Product Development Meeting, but BioForm shall not be required to take any action under this Section 8.4 with respect to such potential Enhancements until such time as they are presented by Supplier as Enhancements at a future Product Development Meeting. All Enhancements and potential Enhancement information provided by Supplier shall be considered Supplier Confidential Informationgeneration endoscopy-related products.
(b) From time OAI and the Company shall exchange ideas and plans for a "Total GI Endoscopy" suite (including but not limited to timeendo-therapy products, each party may request the other party to participate in joint projects to develop Improvements. Neither party is obligated to participate in such projectsendoscopes, and in washers/disinfectors) with components which will interact with each **** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. instance, each party’s decision whether to participate will be made in such party’s sole discretion. If both parties mutually agree to participate in such a project (a “Program”), the parties will promptly prepare a mutually agreeable written development agreement specifying the development activities to be performed by other and the research and development tasks assigned to each party (the “Development Agreement”). All allocation of Intellectual Property rights with respect to any Program will be set forth in writing in the Development AgreementEndoWorks(TM) computer system.
(c) In The Company agrees to evaluate and use commercially reasonable efforts to incorporate OAI's reasonably conceptualized and documented design changes and/or enhancements to the absence Products ("OAI Enhancements"). Any increase or reduction in the Company's manufacturing costs (labor and materials) resulting from OAI Enhancements shall be reflected in reasonable price adjustments. Any engineering/design costs and delivery dates for OAI Enhancements shall be quoted to OAI for its approval and payment. Any related tooling purchased by OAI for the Company's use in implementing OAI Enhancements shall be owned by OAI and shall be used exclusively for the benefit of OAI. Any and all Intellectual Property relating to OAI Enhancements shall be owned by OAI and the Company shall receive a Development Agreementnon-exclusive license to use such OAI Enhancements on the Products for the balance of the Agreement Term (on a royalty-free basis) and for a period of nine months thereafter, PROVIDED that (i) BioForm use of such license shall not cause the Company to compete with OAI or any OAI Affiliate during the Agreement Term and Supplier shall retain joint ownership of Intellectual Property rights in which there is joint inventorship by BioForm (or its Affiliates) and Supplier, as determined in accordance with United States patent law, with Supplier’s rights in such joint ownership being subject to the license rights of BioForm under this Agreement, (ii) any Intellectual Property rights related to the Company Products, Enhancements, and Improvements that are created solely by employees or consultants remits a mutually agreed-upon royalty (based on the enhanced value of Supplier the affected product(s)) to OAI during the aforementioned nine-month post-Agreement grace period. (The license during the Agreement Term may be granted on a worldwide basis depending on OAI's evaluation of its impact on OAI's Affiliates.) The Company shall not use the OAI Enhancements for itself or for any other party for any purpose other than the performance of its obligations hereunder. Product design changes and/or enhancements conceived jointly by OAI and the Company shall be considered to be Intellectual Property rights of Supplier, subject to the license rights of BioForm under this Agreement, owned by OAI and (iii) any Intellectual Property rights related to the Company Products and Improvements that are created solely by employees or consultants of BioForm or any of its Affiliates during the Term jointly.
(d) OAI's audit rights set forth in Section 3.2 shall be considered apply to be Intellectual Property rights of BioForm. BioForm hereby grants to Supplier a perpetual, royalty free, world-wide, nonexclusive license to Supplier under such Blocking Intellectual Property to make, use, and sell such Intellectual Property outside the Field. “Blocking Intellectual Property” for the purposes of this Section 8.4(c)(iii) shall mean Intellectual Property necessary for Supplier to make, use, or sell SA Productas well.
Appears in 1 contract
Product Development. (a) Supplier may A. AERT agrees to provide WBM exclusive colors and profiles of ChoiceDek® Premium Products for WBM to sell to Lowe’s in the Lowe’s territory, and such exclusive colors and profiles are listed in Exhibit B. WBM shall have first right of refusal for an exclusive for ChoiceDek® Products for sale to Lowe’s on any new colors and profiles of decking products that AERT might develop enhancements it intends to incorporate into the BioGlue Surgical Adhesive during the term of this Agreement; provided that, at such time, WBM is not in breach of this Agreement. WBM is obligated to respond in writing to such offers from AERT within sixty (60) days of receipt of product design specifications, cost estimates, and prototypes. WBM’s failure to so notify AERT within such sixty (60) day period shall be deemed WBM’s refusal thereof and AERT shall be entitled to sell such products to any person or entity.
B. To help ensure timely deliveries of ChoiceDek® Products to WBM, AERT shall produce a reasonable inventory of finished ChoiceDek® Products at its producing locations (reference the “Reload Agreement that have potential application to the Company Product (“Enhancements”attached hereto as Exhibit A). Unless otherwise Said production will be based upon a mutually [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. agreed upon strategic inventory plan which will be implemented and finalized by the parties, at least once every six months during the Term, representatives [**] of each of BioForm calendar year for the following year. ChoiceDek® Products will be maintained by AERT based upon a production schedule mutually agreed upon by AERT and Supplier shall hold a meeting WBM, taking into consideration WBM’s minimum purchase requirements established in accordance with Sections 4.4 and 8.4 (the “Product Development Meeting”) at which Supplier will present Enhancements for BioForm to consider for application to the Company Productprovisions of this Agreement. At such Product Development Meeting, BioForm will also present its marketing plans (pursuant to Section 4.4) for the period and any information or feedback that BioForm reasonably believes may lead to Improvements. Within 30 calendar days following each Product Development Meeting, Supplier shall deliver a notice to BioForm (the “Enhancements Notice”) that shall describe the Enhancements that were presented by Supplier at such Product Development Meeting. Within 30 calendar days following receipt of the Enhancements Notice, BioForm may notify Supplier in writing if BioForm elects that any Enhancement described in the Enhancements Notice shall become an Improvement. If BioForm does provide such notice to Supplier during such 30-calendar day period, then BioForm and Supplier shall agree on a timeline for implementation of the Improvement in new Product Specifications for Company Product. If BioForm does not provide such a notice, said Enhancement shall not be implemented into the Company Product. The Enhancements Notice may also describe any potential Enhancements presented by Supplier at the Product Development Meeting, but BioForm shall not be required to take any action under this Section 8.4 with respect to such potential Enhancements until such time as they are presented by Supplier as Enhancements at a future Product Development Meeting. All Enhancements and potential Enhancement information provided by Supplier Such inventories shall be considered Supplier Confidential Informationshipped in good condition and not weathered. Further, AERT will rotate inventories so that no high volume ChoiceDek® Products item remains in inventory longer than three (3) months.
(b) From time to time, each party may request the other party to participate in joint projects to develop Improvements. Neither party is obligated to participate in such projects, and in each **** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. instance, each party’s decision whether to participate will be made in such party’s sole discretion. If both parties mutually agree to participate in such a project (a “Program”), the parties will promptly prepare a mutually agreeable written development agreement specifying the development activities to be performed by and the research and development tasks assigned to each party (the “Development Agreement”). All allocation of Intellectual Property rights with respect to any Program will be set forth in writing in the Development Agreement.
(c) In the absence of a Development Agreement, (i) BioForm and Supplier shall retain joint ownership of Intellectual Property rights in which there is joint inventorship by BioForm (or its Affiliates) and Supplier, as determined in accordance with United States patent law, with Supplier’s rights in such joint ownership being subject to the license rights of BioForm under this Agreement, (ii) any Intellectual Property rights related to the Company Products, Enhancements, and Improvements that are created solely by employees or consultants of Supplier during the Term shall be considered to be Intellectual Property rights of Supplier, subject to the license rights of BioForm under this Agreement, and (iii) any Intellectual Property rights related to the Company Products and Improvements that are created solely by employees or consultants of BioForm or any of its Affiliates during the Term shall be considered to be Intellectual Property rights of BioForm. BioForm hereby grants to Supplier a perpetual, royalty free, world-wide, nonexclusive license to Supplier under such Blocking Intellectual Property to make, use, and sell such Intellectual Property outside the Field. “Blocking Intellectual Property” for the purposes of Section 8.4(c)(iii) shall mean Intellectual Property necessary for Supplier to make, use, or sell SA Product.
Appears in 1 contract
Sources: Wood Plastic Composite Decking Agreement (Advanced Environmental Recycling Technologies Inc)