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2.1 Development Plans. |
2.1.1 Initial Development Plans. The initial Sterile 20 Project Development Plan is attached as Exhibit B (Sterile 20 Project Development Plan) hereto, the initial Sterile 50 Project Development Plan is attached as Exhibit C (Sterile 50 Project Development Plan) hereto, and the initial Lyophilized Low Bioburden Project... |
2.1.2 Amendments to Development Plans. Either Party may propose an amendment to a Development Plan by submitting such proposed amendment in writing to the JGC for review and approval. Upon the approval of the JGC or agreement by the Parties, the applicable Development Plan shall be deemed to be amended by such amendmen... |
2.2 Conduct of Development Programs. |
2.2.1 Sterile 20 Project. Promptly following the Effective Date and in no event later than three (3) months thereafter, CollPlant will initiate activities under the Sterile 20 Project Development Plan to develop sterile CollPlant Collagen that meets or exceeds the applicable specifications set forth on Exhibit E (Speci... |
2.2.2 Sterile 50 Project. If AbbVie provides a written notice to CollPlant prior to the second (2nd) anniversary of the Effective Date requesting that CollPlant initiate activities under the Sterile 50 Project Development Plan, then, upon thirty (30) days following CollPlant's receipt of such written notice, CollPlant ... |
2.2.3 Lyophilized Low Bioburden Project. If AbbVie provides a written notice to CollPlant prior to the second (2nd) anniversary of the Effective Date requesting that CollPlant initiate activities under the Lyophilized Low Bioburden Project Development Plan, then, within ninety (90) days following CollPlant's receipt of... |
2.2.4 Next Generation CollPlant Collagen Feasibility Studies. If AbbVie elects, at its sole discretion, during the Next Generation Studies Option Period, to (a) require CollPlant to continue further development of the CollPlant Collagen developed pursuant to the Sterile 50 Project, then the Parties will promptly agree ... |
2.2.5 CollPlant Responsibility. CollPlant shall have sole responsibility for the conduct of, and shall conduct, the activities under each Development Plan in the Territory and shall do so in accordance with the terms of this Agreement and the applicable Development Plan. Except as set forth in Section 2.2.4 (Next Gener... |
2.2.6 Diligence. CollPlant shall perform the activities allocated to it under each Development Program, and shall use Commercially Reasonable Efforts to achieve the objectives set forth in each Development Plan in accordance with the timelines set forth in the applicable Development Plan, except to the extent that Coll... |
2.2.7 Information and Reports. Within thirty (30) days following the end of each Calendar Quarter until ninety (90) days following the termination of all Development Programs (or such other frequency as mutually agreed by the Parties), CollPlant shall provide to the JGC and AbbVie (a) a detailed, written progress repor... |
2.3 Right of First Negotiation for Option Products. |
2.3.1 Injectable Breast Implant Product Option. In the event that CollPlant develops sufficient information to deliver to APIL the Injectable Breast Implant Product Option Data Package, CollPlant shall deliver to APIL the Injectable Breast Implant Product Option Data Package in order for APIL to consider its right of f... |
2.3.2 Photocurable Dermal Filler Product Option. In the event that CollPlant develops sufficient information to deliver to APIL the Photocurable Dermal Filler Product Option Data Package, CollPlant shall deliver to APIL the Photocurable Dermal Filler Product Option Data Package in order for APIL to consider its right o... |
2.3.3 Israel Innovation Authority Approval. Notwithstanding anything to the contrary in Section 2.3.1 (Injectable Breast Implant Product Option) or Section 2.3.2 (Photocurable Dermal Filler Product Option), the Parties agree and acknowledge that any licenses granted by CollPlant to APIL under the CollPlant Option Produ... |
2.4 No Additional Israel Innovation Authority Financing; Amendments of IIA Terms. During the Term, neither CollPlant nor its Affiliates will seek or obtain any grant or other financing arrangement or commitment from the Israel Innovation Authority or any of its Affiliates without the prior written consent of AbbVie, if... |
2.5 Supply Agreement. Prior to the commencement of the First Stability Study, the Parties will negotiate and enter into a supply agreement on the terms set forth in Schedule 2.5 (Supply Agreement Term Sheet) attached hereto and such other terms to be negotiated and agreed upon by the Parties prior to the commencement o... |
ARTICLE 3 - GOVERNANCE |
3.1 Joint Governance Committee. Within thirty (30) days after the Effective Date, the Parties shall establish a joint governance committee (the "JGC") to serve as the oversight and decision-making body for the activities to be conducted by the Parties pursuant to this Agreement, as more fully described in this Article ... |
3.2 Responsibilities. The JGC shall perform the following functions, subject to Section 3.5 (Decision-Making): |
(a) review any amendments or updates to a Development Plan proposed by a Party (including timelines and budgets) and decide whether to approve any such amendment to a Development Plan in accordance with Section 2.1.2 (Amendments to Development Plans); |
(b) discuss, oversee and review the progress reports on the Development Program activities submitted by CollPlant in accordance with Section 2.2.7 (Information and Reports); |
(c) provide a forum for discussing any issues or disputes arising from the conduct of the activities under each Development Program with a goal of recommending consensus resolution of the Parties prior to referring such dispute to Executive Officers pursuant to Section 3.5.2 (Escalation to the Executive Officers); |
(d) form subcommittees as the JGC deems necessary, or appropriate, to achieve the objectives and intent of this Agreement (each, a "Subcommittee", and together with the JGC, a "Committee"); |
(e) direct, oversee, review and resolve any reports, recommendations or disputes of any Subcommittee; |
(f) assign responsibilities that may fall within the purview of more than one Subcommittee to a particular Subcommittee; and |
(g) perform such other responsibilities as may be assigned to the JGC pursuant to this Agreement or as may be mutually agreed upon in writing by the Parties from time to time. |
For clarity, the JGC shall not have any authority beyond the specific matters set forth in this Section 3.2 (Responsibilities) unless mutually agreed by the Parties in writing and, further, the JGC's authority shall be subject to the limitations set forth in Section 3.5.3 (Escalation to the Parties; Limitations on Auth... |
3.3 Meetings and Minutes. Each Committee shall meet quarterly, or as otherwise agreed to by the Parties, with the location of such meetings alternating between locations designated by CollPlant and locations designated by AbbVie. The chairperson of the Committee shall be responsible for calling meetings on no less than... |
3.4 Procedural Rules. The JGC shall have the right to adopt such standing rules as shall be necessary and appropriate for its work and the work of each Subcommittee, to the extent that such rules are not inconsistent with this Agreement. A quorum of a Committee shall exist whenever there is present at a meeting at leas... |
3.5 Decision-Making. |
3.5.1 Committee Decision-Making. Except as otherwise provided herein, all decisions of the JGC and of each Subcommittee shall be made by consensus, with all of a Party's voting members collectively having one (1) vote. Decisions of the JGC and each Subcommittee shall be made by unanimous vote. If a Subcommittee is inca... |
3.5.2 Escalation to the Executive Officers. If the JGC cannot agree on a matter within fifteen (15) Business Days (or such other time period as mutually agreed by the Parties) after it has met and attempted to reach such decision, then either Party may, by written notice to the other, refer such issue to the Executive ... |
3.5.3 Escalation to the Parties; Limitations on Authority. If the Executive Officers are unable to resolve the matter within thirty (30) days after the matter is referred to them (or such other time period as mutually agreed by the Parties), then either Party may propose to resolve the matter by an ADR proceeding pursu... |
3.6 Interactions Between a Committee and Internal Teams. The Parties recognize that each Party possesses an internal structure (including various committees, teams and review boards) that will be involved in administering such Party's activities under this Agreement. Nothing contained in this Article 3 - (Governance) s... |
3.7 Expenses. Each Party shall be responsible for all travel and related costs and expenses for its members and other representatives to attend meetings of, and otherwise participate on, a Committee. |
3.8 Authority. Each Party will retain the rights, powers and discretion granted to it under this Agreement and no such rights, powers or discretion will be delegated to or vested in the JGC or any Subcommittee unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties express... |
ARTICLE 4 - EXCLUSIVITY RIGHTS |
4.1 Grant of Exclusive Rights to AbbVie. Subject to Section 4.6 (CollPlant Right to Sell OTC Skincare Products), CollPlant hereby grants to AbbVie and its Affiliates exclusivity under the CollPlant Technology (even as to CollPlant's and its Affiliates' and their respective licensees'/sublicensees' and distributors' rig... |
4.2 Grant of Evaluation Rights to AbbVie. CollPlant hereby grants to AbbVie and its Affiliates (a) the right under the CollPlant Technology to perform confirmatory work with samples of CollPlant Collagen to determine its suitability for inclusion in Exclusive Products and (b) the right under all Know-How and Patent Rig... |
4.3 Limitations on CollPlant. |
4.3.1 During the Term, other than as set forth in this Agreement or in the Supply Agreement, neither CollPlant nor its Affiliates will, directly or indirectly with a Third Party, Exploit any CollPlant Collagen for use within a product that, if Developed by or on behalf of AbbVie or APIL, would be an Exclusive Product, ... |
4.3.2 Neither CollPlant nor its Affiliates will grant to any Third Party any rights relating to the CollPlant Technology that would conflict with the rights granted to AbbVie hereunder. |
4.4 Covenant Not to Sue. CollPlant shall not, and shall cause each of its Affiliates not to, ever, anywhere in the Territory, institute or prosecute (or in any way aid any Third Party (other than to the extent required by law, regulation, court order or subpoena) in instituting or prosecuting), at law or in equity, any... |
4.5 Grant of Right of Reference to AbbVie. CollPlant hereby grants to AbbVie and its Affiliates and Third Party Transferees (i) a right to use any Know-How related to CollPlant Collagen that is (a) necessary or useful to Exploit an Exclusive Product and (b) Controlled by CollPlant or its Affiliates, solely to support t... |
4.6 CollPlant Right to Sell OTC Skincare Products. Notwithstanding anything to the contrary in this Agreement, CollPlant and its Affiliates and licensees may distribute or sell over the counter topical skincare products through the Amazon.com Professional Beauty channel or a website or digital platform or, for clarity,... |
ARTICLE 5 - GENERAL PROVISIONS RELATING TO ACTIVITIES |
5.1 AbbVie Development and Commercialization. Except as otherwise set forth in this Agreement or in the Supply Agreement, as between the Parties, (a) CollPlant shall be solely responsible for all Development and Manufacturing of the CollPlant Collagen in accordance with the applicable Development Plan for use by AbbVie... |
5.2 AbbVie Diligence Obligations. AbbVie will use Commercially Reasonable Efforts to Develop one Exclusive Product as defined in Sections 1.50.1 and 1.50.2 for commercial launch in one Major Market Country, except to the extent that AbbVie is unable to perform any such activity due to CollPlant's breach of this Agreeme... |
5.3 Compliance. All Development activities to be conducted by a Party under this Agreement shall be conducted in compliance with applicable Laws, including all applicable cGMP requirements, good laboratory practice requirements and good clinical practice requirements, then-current regulatory standards and with the IIA ... |
5.4 Subcontracting. |
5.4.1 AbbVie shall have the right to engage Affiliates or Third Party subcontractors (including by appointing one or more contract sales forces, co-promotion partners or Distributors) to perform any of its activities under this Agreement. |
5.4.2 CollPlant shall have the right to subcontract its Development and Manufacturing activities under this Agreement to any Third Party subcontractor to the extent expressly provided for in a Development Plan or with the approval of AbbVie, not to be unreasonably withheld, conditioned or delayed. |
5.4.3 Any Affiliate or Third Party subcontractor to be engaged by a Party to perform a Party's obligations set forth in this Agreement shall meet the qualifications typically required by such Party for the performance of work similar in scope and complexity to the subcontracted activity. Any Party engaging an Affiliate... |
5.5 Records and Audits. CollPlant shall, and shall require its Affiliates and permitted subcontractors to, maintain materially complete, current and accurate hard and electronic (as applicable) copies of records of all work conducted pursuant to its Development and Manufacturing activities under this Agreement, and all... |
5.6 Cooperation. CollPlant shall support AbbVie during the Term of the Agreement, as may be reasonably necessary, in obtaining Regulatory Approvals for Exclusive Products and in the activities in support thereof, including by providing any necessary documents or other relevant materials in the possession or control of ... |
ARTICLE 6 - FINANCIAL TERMS; PAYMENTS |
6.1 Upfront Fee. No later than fifteen (15) Business Days following the Effective Date, (a) AbbVie shall pay CollPlant a one-time, non-refundable, non-creditable upfront payment of Thirteen Million Nine Hundred and Ninety-Nine Thousand Nine Hundred Dollars ($13,999,900.00) and (b) APIL shall pay CollPlant a one-time, n... |
6.2 Option Exercise Fee. |
6.2.1 Injectable Breast Implant Product Option Exercise Fee. If APIL and CollPlant enter into a definitive agreement for the Injectable Breast Implant Product Option, APIL shall pay to CollPlant a one-time, non-refundable, non-creditable payment of Six Million Dollars ($6,000,000) within fifteen (15) Business Days afte... |
6.2.2 Photocurable Dermal Filler Product Option Exercise Fee. If APIL and CollPlant enter into a definitive agreement for the Photocurable Dermal Filler Product Option, APIL shall pay to CollPlant a one-time, non-refundable, non-creditable payment of Four Million Dollars ($4,000,000) within fifteen (15) Business Days a... |
6.3 Contingent Payments. Within fifteen (15) Business Days after the achievement of each trigger event set forth in the table below (each, a "Contingent Payment Trigger Event"), AbbVie shall pay to CollPlant the applicable contingent payment set forth in the table below. |
Contingent Payment Trigger Event |
Successful Conclusion of the First Stability Study* |
If AbbVie elects to have CollPlant perform either the Sterile 50 Work Plan or the LLB Work Plan, then upon the later of: AbbVie's receipt of written notice from CollPlant of the initiation of the applicable stability study under and in accordance with such applicable Work Plan and the initiation of such stability study |
If AbbVie elects to have CollPlant perform either the Sterile 50 Work Plan or the LLB Work Plan, then upon Successful Conclusion of the Stability Study Work Plan under such Work Plan |
* Notwithstanding anything to the contrary in this Agreement, if this Contingent Payment Trigger Event is achieved following the start of the six (6)-month extension period of the Sterile 20 Project under Section 2.2.1 (Sterile 20 Project), then the corresponding Contingent Payment will be reduced as follows: (i) by te... |
6.4 Milestone Payments. |
6.4.1 Exclusive Product Milestones. In partial consideration for the rights granted to AbbVie, within forty-five (45) days after the first achievement of each milestone event set forth in this Section 6.4.1 (Exclusive Product Milestones) (each, an "Exclusive Product Milestone Event") by or on behalf of AbbVie, any of i... |
Exclusive Product Milestone Event |
Dosing of the first patient or first treatment in the first Clinical Trial designed to support the first EU or U.S. application for Regulatory Approval of an Exclusive Product in the EU or U.S., as applicable |
First filing of a Regulatory Approval Application of an Exclusive Product with the applicable Regulatory Authority in any country in the Territory (the "First Application Milestone") |
First Commercial Sale following Regulatory Approval in the first of the following six (6) countries: U.S., UK, Spain, Italy, Germany, and France |
6.4.2 Injectable Breast Implant Product Milestones. If APIL exercises its Injectable Breast Implant Product Option in accordance with Section 2.3.1 (Injectable Breast Implant Product Option), then the definitive license agreement entered into by the Parties under Section 2.3.1 (Injectable Breast Implant Product Option)... |
Injectable Breast Implant Product Milestone Event |
Dosing of the first patient in the first in human Clinical Trial of an Injectable Breast Implant Product |
Dosing of the first patient in the first Pivotal Clinical Trial of an Injectable Breast Implant Product |
First Commercial Sale of the first Injectable Breast Implant Product following Regulatory Approval and Pricing Approval (if applicable) in the first of the following six (6) countries: U.S., UK, Spain, Italy, Germany, and France |
6.4.3 Photocurable Dermal Filler Product Milestones. If APIL exercises its Photocurable Dermal Filler Product Option in accordance with Section 2.3.2 (Photocurable Dermal Filler Product Option), then the definitive license agreement entered into by the Parties under Section 2.3.2 (Photocurable Dermal Filler Product Opt... |
Photocurable Dermal Filler Product Milestone Event |
Dosing of the first patient in the first in human Clinical Trial of a Photocurable Dermal Filler Product |
Dosing of the first patient in the first Pivotal Clinical Trial of a Photocurable Dermal Filler Product |
First Commercial Sale of the first Photocurable Dermal Filler Product following Regulatory Approval and Pricing Approval (if applicable) in the first of the following six (6) countries: U.S., UK, Spain, Italy, Germany, and France |
6.5 Royalties. |
6.5.1 Royalties for Exclusive Products. Commencing upon the First Commercial Sale of an Exclusive Product in a country in the Territory, on an Exclusive Product-by-Exclusive Product and country-by-country basis, AbbVie shall pay to CollPlant royalties at the rate of eight percent (8%) of annual Net Sales of each Exclus... |
6.5.2 Royalties for Injectable Breast Implant Products. If APIL enters into negotiations regarding the Injectable Breast Implant Product Option in accordance with Section 2.3.1 (Injectable Breast Implant Product Option), then, unless otherwise mutually agreed upon by APIL and CollPlant in writing, the definitive licens... |
6.5.3 Royalties for Photocurable Dermal Filler Products. If APIL enters into negotiations regarding the Photocurable Dermal Filler Product Option in accordance with Section 2.3.2 (Photocurable Dermal Filler Product Option), then, unless otherwise mutually agreed upon by APIL and CollPlant in writing, the definitive lic... |
6.6 Royalty Term. On a country-by-country and product-by-product basis, royalty payments with respect to the Net Sales of an Exclusive Product or, if payable under a definitive license agreement pursuant to Section 2.3.1 (Injectable Breast Implant Product Option) or Section 2.3.2 (Photocurable Dermal Filler Product Opt... |
6.7 Royalty Adjustments. Notwithstanding Section 6.5 (Royalties) but subject to Section 6.7.4 (Mechanics of Adjustments to Royalties): |
6.7.1 Valid Claim Expiration. From and after the date on which an Exclusive Product is sold in a particular country and is not covered by a Valid Claim within a CollPlant Patent for such product, that would be infringed by AbbVie's manufacture, use, or sale of such product in such country, the royalty rate for such Exc... |
6.7.2 Trigger Products. |
(a) Exclusive Products. On an Exclusive Product-by-Exclusive Product and country-by-country basis, if, in any Calendar Quarter following the first commercial sale of an EP Trigger Product with respect to an Exclusive Product and a country, the Net Sales of such Exclusive Product in such country is lower than or equal t... |
(b) Option Products. If CollPlant and APIL enter into a definitive license agreement pursuant to Section 2.3.1 (Injectable Breast Implant Product Option) or Section 2.3.2 (Photocurable Dermal Filler Product Option), unless otherwise agreed upon by the parties thereto in writing, such definitive license agreement will p... |
6.7.3 Stacking. If AbbVie, any of its Affiliates or any Third Party Transferee obtains a license from a Third Party under any Patent Right (a) that covers any Exclusive Product or the development, manufacture, use, import, offer for sale, sale or Exploitation of any Exclusive Product or (b) where, in AbbVie's reasonabl... |
6.7.4 Mechanics of Adjustments to Royalties. Any reductions set forth in Section 6.7 (Royalty Adjustments) shall be applied to the royalty rate payable to CollPlant under Section 6.5.1 (Royalties for Exclusive Products) in the order in which the event triggering such reduction occurs; provided that the adjustments made... |
6.8 Reports; Payment of Royalty. During the Term, following the First Commercial Sale of any Exclusive Product in any country in the Territory, AbbVie shall furnish to CollPlant a written report within ninety (90) days after the end of each Calendar Quarter showing, on an Exclusive Product-by-Exclusive Product and coun... |
6.9 Financial Records. AbbVie shall, and shall cause its Affiliates and shall contractually require its and their Third Party Transferees to, keep full, clear and accurate records pertaining to Net Sales for a minimum period of three (3) years (or such longer period as required by applicable Law) after the relevant pay... |
6.10 Audit; Audit Dispute. |
6.10.1 Audit. At the request of CollPlant, AbbVie shall, and shall cause its Affiliates to, permit an independent public accounting firm of nationally recognized standing designated by CollPlant and reasonably acceptable to AbbVie, at reasonable times during normal business hours and upon reasonable notice of not less ... |
6.10.2 Audit Dispute. In the event of a dispute with respect to any audit under Section 6.10.1 (Audit), CollPlant and AbbVie shall work in good faith to resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within thirty (30) days, the dispute shall be submitt... |
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