union investment depot freistellungsauftrag kinder

grupo saieh corp group investments

Leading non-banking finance company Shriram City Union Finance Ltd has got fair trade regulator CCI's approval for tpg investment india proposed merger of its two group companies through a multi-stage transac Piramal Enterprises, a firm promoted by Ajay Piramal, had acquired 9. TPG, a leading global private investment firm, has picked up a For global institutional investors that have been wary about investing in India for the past few years, the tide has turned and India has again become a must-have market.

Union investment depot freistellungsauftrag kinder 2006 interview with salon jefferies investment

Union investment depot freistellungsauftrag kinder

ARYA has identified several criteria and guidelines it believes are important for evaluating acquisition opportunities. Based on its due diligence investigations of Immatics and the industry in which it operates, including the financial and other information provided by Immatics in the course of negotiations, ARYA believes that Immatics meets the criteria and guidelines listed above. In addition, such approvals are also conditions to the closing of the Business Combination under the Business Combination Agreement.

Additionally, under its amended and restated memorandum and articles of association, ARYA must provide all holders of public shares with the opportunity to have their public shares redeemed upon the consummation of its initial business combination either in conjunction with a tender offer or in conjunction with a shareholder vote. For business and other reasons, ARYA has elected to provide its shareholders with the opportunity to have their public shares redeemed in connection with a shareholder vote rather than a tender offer.

Therefore, ARYA is seeking to obtain the approval of its shareholders of the Business Combination Proposal and also allow its public shareholders to effectuate redemptions of their public shares in connection with the closing of the Business Combination in accordance with the ARYA amended and restated memorandum and articles of association.

What other matters will be brought before the General Meeting? Given the ongoing and dynamic nature of the circumstances, it is difficult to predict the impact of the coronavirus outbreak on the business of ARYA, Immatics and TopCo, and there is no guarantee that efforts by ARYA, Immatics and TopCo to address the adverse impacts of the coronavirus will be effective. The extent of such impact will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of the coronavirus and actions taken to contain the coronavirus or its impact, among others.

The Business Combination may also be delayed and adversely affected by the coronavirus outbreak and become more costly. Each of ARYA, Immatics and TopCo may also incur additional costs to remedy damages caused by any such disruptions, which could adversely affect its financial condition and results of operations. Pursuant to the Business Combination Agreement, and upon the terms and subject to the conditions set forth therein, ARYA and Immatics will effect a transaction that would replicate the economics of a merger of ARYA and Immatics through a series of mergers and equity contributions and exchanges, which is collectively referred to as the Business Combination.

The rules governing the information that TopCo must disclose differ from those governing U. TopCo will be exempt from the rules under the Exchange Act prescribing the furnishing and content of proxy statements to shareholders. As a foreign private issuer, TopCo will be exempt from a number of rules under the U.

One of the primary purposes of the Business Combination is to provide a platform for Immatics to access the U. Will the management of Immatics change in the Business Combination? The current executive officers of Immatics are Dr. Steffen Walter, the Chief Technology Officer.

Table of Contents Upon the closing of the Business Combination, TopCo will be governed through a two-tier board structure which consists of a supervisory board and a management board. Carter, a designee of dievini, and their terms will expire at the first annual meeting of shareholders following the date of the consummation of the Business Combination;. Mason, and their terms will expire at the second annual meeting of shareholders following the date of the consummation of the Business Combination; and.

Pursuant to the Business Combination Agreement, on the one year anniversary of the consummation of the Business Combination, the TopCo Board will automatically convert into a single-tiered board of directors comprised of nine members and divided into three classes, with each director serving a staggered, three-year term. The Supervisory Directors will retain their designated class upon the transition to the one-tier board.

What will Immatics equityholders receive in the Business Combination? The ownership percentages with respect to TopCo following the Business Combination do not take into account the warrants to purchase TopCo Shares that will remain outstanding immediately following the Business Combination, but do include Founder Shares, which will immediately be exchanged for an equivalent number of TopCo Shares at the closing of the Business Combination.

If the actual facts are different than these assumptions which they are likely to be , the ownership percentages in TopCo will be different. What vote is required to approve the proposals presented at the General Meeting? The approval of the Business Combination Proposal requires the affirmative vote of holders of at least two-thirds of ARYA Ordinary Shares that are entitled to vote and are voted at the General Meeting. Broker non-votes and abstentions will be counted in connection with the determination of whether a valid quorum is established, but will have no effect on the Business Combination Proposal.

The approval of the Adjournment Proposal requires the affirmative vote of holders of a majority of the ARYA Ordinary Shares that are entitled to vote and are voted at the General Meeting. Broker non-votes and abstentions will be counted in connection with the determination of whether a valid quorum is established, but will have no effect on the Adjournment Proposal. What happens if the Business Combination Proposal is not approved? How many votes do I have at the General Meeting? What constitutes a quorum at the General Meeting?

Broker non-votes and abstentions will be counted as present for the purpose of determining a quorum. In the absence of a quorum, the chairman of the General Meeting has power to adjourn the General Meeting. You should take these interests into account in deciding whether to approve the Business Combination Proposal.

These interests include:. Atieh as directors of TopCo following the Business Combination;. These interests may influence the ARYA Board in making its recommendation that you vote in favor of the approval of the Business Combination. Did the ARYA Board obtain a third-party valuation or fairness opinion in determining whether or not to proceed with the Business Combination?

The ARYA Board did not obtain a third-party valuation or fairness opinion in connection with its determination to approve the Business Combination. If you vote against the Business Combination Proposal but the Business Combination Proposal still obtains the affirmative vote of holders of at least two-thirds of ARYA Ordinary Shares that are entitled to vote and are voted at the General Meeting, then the Business Combination Proposal will be approved and, assuming the satisfaction or waiver of the other conditions to closing, the Business Combination will be consummated in accordance with the terms of the Business Combination Agreement.

Do I have redemption rights? Is there a limit on the number of shares I may redeem? Is there a limit on the total number of ARYA public shares that may be redeemed? Other than this limitation, the ARYA amended and restated memorandum and articles of association does not provide a specified maximum redemption threshold.

Will how I vote affect my ability to exercise redemption rights? As a result, the Business Combination Agreement can be approved by shareholders who will redeem their shares and no longer remain shareholders, leaving shareholders who. How do I exercise my redemption rights?

Attention: Mark Zimkind. Email: mzimkind continentalstock. You do not have to be a record date holder in order to exercise your redemption rights. ARYA shareholders seeking to exercise their redemption rights and opting to deliver physical certificates should allot sufficient time to obtain physical certificates from the Transfer Agent and time to effect delivery.

However, ARYA does not have any control over this process and it may take longer than two weeks. Any demand for redemption, once made, may be withdrawn at any time until the vote is taken with respect to the Business Combination. If you delivered your shares for redemption to the Transfer Agent and decide within the required timeframe not to exercise your redemption rights, you may request that the Transfer Agent return the shares physically or electronically.

This must be completed far enough in advance to permit the mailing of the public share certificates back to you so that you may then exercise your redemption rights upon the separation of the public shares from the ARYA Public Units. Your nominee must send written instructions by facsimile to the Transfer Agent. This must be completed far enough in advance to permit your nominee to exercise your redemption rights upon the separation of the public shares from the ARYA Public Units.

While this is typically done electronically on the same business day, you should allow at least one full business day to accomplish the separation. If you fail to cause your ARYA Public Units to be separated in a timely manner, you will likely not be able to exercise your redemption rights. There is a nominal cost associated with the above-referenced tendering process and the act of certificating the shares or delivering them through the DWAC system.

However, this fee would be incurred regardless of whether or not shareholders seeking to exercise redemption rights are required to tender their shares, as the need to deliver shares is a requirement to exercising redemption rights, regardless of the timing of when such delivery must be effectuated. What are the U. The U. Federal Income Tax Considerations to U. If you are a U. Holder makes or has made certain elections discussed further below.

Tax Code and the Treasury Regulations promulgated thereunder, in certain circumstances may impose additional requirements for certain U. The tax consequences of the Business Combination are complex and will depend on your particular circumstances. For a more complete discussion of the U. Accordingly, Dissenter Rights will not be available in respect of the First Merger.

Appraisal rights are not available to holders of Immatics Shares in connection with the Business Combination. What happens to the funds held in the Trust Account upon consummation of the Business Combination? Any remaining funds will be used by TopCo for general corporate purposes.

What conditions must be satisfied to complete the Business Combination? What happens if the Business Combination Agreement is terminated or the Business Combination is not consummated? There are certain circumstances under which the Business Combination Agreement may be terminated. In the event of such distribution, it is possible that the per share value of the residual assets remaining available for distribution including Trust Account assets will be less than the initial public offering price per unit in the ARYA IPO.

Holders of Founder Shares have waived any right to any liquidation distribution with respect to such shares. When is the Business Combination expected to be completed? What do I need to do now? How do I vote? All holders of shares in registered form on the day of the General Meeting are entitled to vote at the General Meeting.

Table of Contents Voting by Mail. By signing the proxy card and returning it in the enclosed prepaid and addressed envelope, you are authorizing the individuals named on the proxy card to vote your shares at the General Meeting in the manner you indicate. You are encouraged to sign and return the proxy card even if you plan to attend the General Meeting so that your shares will be voted if you are unable to attend the General Meeting.

If you receive more than one proxy card, it is an indication that your shares are held in multiple accounts. Please sign and return all proxy cards to ensure that all of your shares are voted. Votes submitted by mail must be received by p.

Voting in Person at the Meeting. If you attend the General Meeting and plan to vote in person, you will be provided with a ballot at the General Meeting. If your shares are registered directly in your name, you are considered the shareholder of record and you have the right to vote in person at the General Meeting. In this regard, you must provide the record holder of your shares with instructions on how to vote your shares or, if you wish to attend the General Meeting and vote in person, you will need to bring to the General Meeting a legal proxy from your broker, bank or nominee authorizing you to vote these shares.

What will happen if I abstain from voting or fail to vote at the General Meeting? For purposes of approval, broker non-votes and abstentions will have no effect on the Business Combination Proposal or the Adjournment Proposal. What will happen if I sign and return my proxy card without indicating how I wish to vote? The proxyholders may use their discretion to vote on any other matters which properly come before the General Meeting.

If I am not going to attend the General Meeting in person, should I return my proxy card instead? Under the rules of various national and regional securities exchanges, your broker, bank, or nominee cannot vote your shares with respect to non-discretionary matters unless you provide instructions on how to vote in accordance with the information and procedures provided to you by your broker, bank, or nominee. If you do not provide instructions with your proxy card, your broker, bank, or other nominee may deliver a proxy card expressly indicating that it is NOT voting your shares.

Your broker, bank or other nominee can vote your shares only if you provide instructions on how to vote. You should instruct your broker, bank or other nominee to vote your shares in accordance with directions you provide. May I change my vote after I have mailed my signed proxy card?

What should I do if I receive more than one set of voting materials? For example, if you hold your shares in more than one brokerage account, you will receive a separate voting instruction card for each brokerage account in which you hold shares. If you are a holder of record and your shares are registered in more than one name, you will receive more than one proxy card.

Please complete, sign, date and return each proxy card and voting instruction card that you receive in order to cast your vote with respect to all of your shares. Who will solicit and pay the cost of soliciting proxies for the General Meeting? ARYA will also reimburse banks, brokers and other custodians, nominees and fiduciaries representing beneficial owners of ARYA Ordinary Shares for their expenses in forwarding soliciting materials to beneficial owners of ARYA Ordinary Shares and in obtaining voting instructions from those owners.

The directors, officers and employees of ARYA may also solicit proxies by telephone, by facsimile, by mail, on the Internet, in person or virtually. They will not be paid any additional amounts for soliciting proxies. Who can help answer my questions? Email: michael perceptivelife. Morrow Sodali. Stamford, Connecticut Individuals, please call toll-free: Banks and brokerage, please call: Email: ARYA.

Parties to the Business Combination. Immatics is a German limited liability company that was incorporated in Immatics is committed to delivering the power of T cells and to unlocking new avenues for patients in its fight against cancer. Each therapeutic modality has distinct attributes to produce the desired therapeutic effect for patients at different disease stages and with different types of tumors focusing on particularly hard-to-treat solid cancers.

With this approach, Immatics believes the company is well positioned to expand the potential therapeutic value for patients across a broad range of tumor types and stages. In addition, Immatics is developing strategies designed to advance commercial viability, safety and clinical efficacy via process optimization for ACT programs and implementing next-generation ACT approaches including allogeneic cell therapies ACTallo and a novel ultra-personalized approach to immunotherapy.

Competitive advantage: Immatics aims to cover all required areas key to developing effective TCR-based cancer immunotherapies in one company. From this large pool of targets, Immatics has recently focused on a prioritized short-list of over cancer targets and has developed an extensive intellectual property portfolio to protect its discoveries.

Immatics believes that its technology platforms, therapeutic modalities and scientific knowledge provide it with a significant competitive advantage. Intellectual property portfolio: Immatics intends to continue building on its extensive intellectual property portfolio in the field of cancer targets, TCRs and technologies.

Table of Contents worldwide active patent applications and more than 1, secured patents, of which over are granted in the United States. Immatics does not rely or depend on any of its four collaborations with global leaders, hence it does not consider any of these four collaborations as material for its proprietary pipeline. Highly experienced global leadership team: Immatics has a highly experienced global leadership team that operates seamlessly between its locations in Germany and the United States.

The management consists of an interdisciplinary team that includes medical and scientific experts, as well as accomplished business leaders, and collectively has multiple decades of experience in the pharmaceutical and biotechnology industries.

Holcombe Blvd, Houston, Texas and its telephone number is To date, TopCo has not conducted any material activities other than those incident to its formation and the pending Business Combination and only has nominal assets consisting of cash and cash equivalents. Table of Contents acquisition, share purchase, reorganization or similar business combination with one or more target businesses.

IB Merger Sub. The Business Combination. Table of Contents Organizational Structure. The following diagram illustrates the pre-Business Combination organizational structure of Immatics:. Table of Contents The following diagram illustrates the structure of TopCo immediately following the Business Combination.

If these assumptions are not correct, then the shareholdings set forth in the diagram below would change. Subject to the terms and conditions of the Business Combination Agreement, the Business Combination will result in, among other things, the following:. Consideration to Immatics Equityholders in the Business Combination. Ownership of TopCo. If the actual facts are different than these assumptions which they are likely to be , the relative ownership percentages in TopCo will be different.

In addition to the assumptions made in the preceding paragraph, the factors that will determine the ownership percentages upon consummation of the Business Combination include:. The ownership percentages with respect to TopCo following the Business Combination do not take into account the warrants to purchase TopCo Shares that will remain outstanding immediately following the Business Combination, but do include Founder Shares, which will be exchanged for TopCo Shares at the closing of the Business Combination on a one-for-one basis.

Conditions to Closing of the Business Combination. The respective obligations of each party to the Business Combination Agreement to consummate the Business Combination, are subject to the satisfaction, or written waiver by the party for whose benefit such condition exists, at or prior to the Closing of the following conditions:.

Ancillary Documents. Investor Rights Agreement. TopCo has agreed to use its reasonable best efforts to file a shelf registration statement to register the TopCo Shares covered by the Investor Rights Agreement at any time that TopCo is eligible to do so and in no event later than the date that the Lock-Up Period as defined below expires. Subscription Agreements. TopCo has agreed to register the resale of the TopCo Shares issued in connection with the PIPE Financing pursuant to a registration statement that must be filed within 45 days after the consummation of the Business Combination.

The Subscription Agreements also contain other customary representations, warranties, covenants and agreements of the parties thereto. The closings under the Subscription Agreements will occur substantially concurrently with the closing of the Business Combination and are conditioned on such closing and on other customary closing conditions.

Table of Contents Sponsor Letter Agreement. ARYA was formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses.

The members of the ARYA Board have extensive transactional experience, particularly in the healthcare and life sciences industries. The ARYA Board also includes medical doctors with experience in both the detection and treatment of cancer. In particular, the ARYA Board considered the following positive factors, although not weighted or in any order of significance, in deciding to approve the Business Combination Proposal:. Advancement of a proprietary pipeline of product candidates through clinical development;.

Development of cell therapies and biologics providing two distinct mechanisms of actions suitable for different cancer stages;. Manufacturing processes designed to efficiently generate product candidates;. Competitive technology platforms;. Leading intellectual property portfolio in the field of cancer targets;. Strategic alliances with collaborators;.

Novel ultra-personalized approach to immunotherapy;. Experienced management team;. Strong commitment of top tier US healthcare investors and existing Immatics shareholders; and. The ARYA Board also considered a variety of uncertainties and risks and other potentially negative factors concerning the Business Combination, including, but not limited to, the following:. Date, Time and Place of General Meeting. Voting Power; Record Date. Table of Contents Combination Proposal.

It is important for you to note that, in the event that the Business Combination Proposal does not receive the requisite vote for approval, ARYA will not consummate the Business Combination. Interests of Certain Persons in the Business Combination. ARYA shareholders should take these interests into account in deciding whether to approve the Business Combination Proposal. Table of Contents These interests include:.

Table of Contents Redemption Rights. Such a holder will be entitled to receive cash for its public shares only if it properly demands redemption and delivers its shares either physically or electronically to the Transfer Agent in accordance with the procedures described herein.

Certain Information Relating to TopCo. Comparison of Shareholder Rights. Material Tax Consequences. Table of Contents Shares and ARYA Public Warrants are urged to consult their tax advisors to determine the tax consequences to them including the application and effect of any state, local or other income and other tax laws of the Business Combination, and prospective holders of TopCo Shares and TopCo Public Warrants are urged to consult their tax advisors to determine the tax consequences including the application and effect of any state, local or other income and other tax laws of any acquisition, holding, redemption and disposal of TopCo Shares or acquisition, holding, exercise or disposal of TopCo Public Warrants.

Accounting Treatment of the Business Combination. Appraisal Rights. However, such rights are not available in respect of the shares of any class for which an open market exists on a recognized stock exchange where, upon the merger or the consolidation, the shareholder receives, amongst other things, either:.

Proxy Solicitation. Proxies may be solicited by mail, via telephone or via e-mail or other electronic correspondence. ARYA has engaged Morrow to assist in the solicitation of proxies. If an ARYA shareholder grants a proxy, such shareholder may still vote its shares in person if it revokes its proxy before the General Meeting. Table of Contents Risk Factor Summary.

In the opinion of management, the unaudited data reflects all adjustments, consisting only of normal recurring adjustments, necessary for a fair statement of the financial information in those statements. Consolidated Statement of Operations Data:. Revenue from collaboration agreements. Research and development expenses.

General and administrative expenses. Other income. Operating result. Financial income. Financial expenses. Financial result. Loss before taxes. Taxes on income. Net loss. Attributable to:. Equityholders of the parent. Net Loss. Cash and cash equivalents. Total current assets. Total current liabilities.

Consolidated Cash Flow Data:. Net cash used in provided by operating activities. Net cash used in investing activities. Net cash used in provided by financing activities. The following tables contain summary historical financial data for ARYA. Statement of Operations Data:. General and administrative costs.

Loss from operations. Investment income on Trust Account. Net loss income. Working capital 1. Total assets. Total liabilities. Working capital calculated as current assets less current liabilities. Cash Flow Data:. Net cash used in operating activities. Net cash provided by financing activities. The following table sets forth:. If the actual facts are different than these assumptions, the below numbers will be different. These figures also do not take into account the number of TopCo Public Warrants to purchase TopCo Shares that will be outstanding immediately following the completion of the Business Combination.

The unaudited pro forma book value per share information below does not purport to represent what the book value of TopCo would have been had the Business Combination been completed nor the book value per share for any future period.

Book value per ordinary share 1. Book value per share, Class A Shares basic and diluted. Book value per share, Class B Shares basic and diluted. Net loss attributable to equityholders of parent per ordinary share. Cash dividends per share. Net loss attributable to equityholders of the parent per ordinary share. Prior to the Exchange, 1,, Immatics GmbH shares were outstanding. After the exchange, Immatics Participating Shareholders and Other Founder will hold 33,, and , shares, respectively, in Immatics B.

GAAP and are reported in Euro. The historical financial information was translated from U. Certain of the following risk factors apply to the business and operations of Immatics and will also apply to the business and operations of TopCo following the completion of the Business Combination.

The occurrence of one or more of the events or circumstances described in these risk factors, alone or in combination with other events or circumstances, may adversely affect the ability to complete or realize the anticipated benefits of the Business Combination, and may have a material adverse effect on the business, cash flows, financial condition and results of operations of TopCo following the Business Combination. The risks discussed below may not prove to be exhaustive and are based on certain assumptions made by TopCo, ARYA and Immatics which later may prove to be incorrect or incomplete.

TopCo, ARYA and Immatics may face additional risks and uncertainties that are not presently known to such entity, or that are currently deemed immaterial, which may also impair their business or financial condition. Immatics has a history of operating losses; Immatics expects to continue to incur losses and Immatics may never be profitable. Immatics does not have products approved for commercial sale and has not generated revenue from operations.

Immatics does not expect to generate any meaningful product sales or royalty revenues for the foreseeable future. Immatics expects to incur significant additional operating losses in the future as it expands its development and clinical trial activities in support of demonstrating the effectiveness of its products. However, its operations may not be profitable even if any of its products under development are successfully developed and produced and thereafter commercialized.

Immatics will need additional financing to fund its operations and complete the development and commercialization of its various product candidates, and if Immatics is unable to obtain such financing, it may be unable to complete the development and commercialization of its product candidates. While Immatics has been successful in the past in obtaining financing, it expects to continue to spend substantial amounts to continue the clinical development of its product candidates.

Accordingly, Immatics believes that its existing cash and cash equivalents will be sufficient to fund its operations until the third quarter of excluding proceeds from the proposed transaction. Table of Contents technology advancement and research activities that may lead to new product candidates. It is difficult to estimate how far into the development of the current product candidates Immatics will reach with the current level of funding.

However, in order to complete the development of its current product candidates, and in order to effectuate its business plan, Immatics anticipates that it will have to spend more than the funds currently available to Immatics including proceeds from the proposed transaction. Additional funding will be required for all programs, including clinical and preclinical programs, prior to market approval and commercialization.

Furthermore, changing circumstances may cause Immatics to increase its spending significantly faster than it currently anticipates, and it may require additional capital for the further development and commercialization of its product candidates and may need to raise additional funds sooner if it chooses to expand more rapidly than it presently anticipates.

Immatics will need to obtain additional financing to fund its future operations, including completing the development and commercialization of its product candidates. Unless and until Immatics can generate a sufficient amount of revenue, it may finance future cash needs through public or private equity offerings, license agreements, debt financings, collaborations, strategic alliances and marketing or distribution arrangements. Additional funds may not be available when it needs them on terms that are acceptable to Immatics, or at all.

Immatics has no committed source of additional capital and if it is unable to raise additional capital in sufficient amounts or on acceptable terms to Immatics, Immatics may be required to delay or reduce the scope of or eliminate one or more of its research or development programs or its commercialization efforts. As a result, Immatics may seek to access the public or private capital markets whenever conditions are favorable, even if it does not have an immediate need for additional capital at that time.

To the extent that Immatics raises additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a shareholder. If Immatics raises additional funds through strategic collaborations and alliances and licensing arrangements with third parties, it may have to relinquish valuable rights to its technologies or product candidates, or grant licenses on terms unfavorable to Immatics.

Immatics has limited experience in operating its current business, which makes it difficult to evaluate its business plan and its prospects. Immatics has only a limited operating history in its current line of business on which a decision to invest in its company can be based. The future of Immatics currently is dependent upon its ability to implement its business plan, as that business plan may be modified from time to time by its management and Supervisory Board.

While Immatics believes that it has a reasonable business plan and research and development strategy, Immatics has only a limited operating history against which it can test its plans and assumptions, and investors therefore cannot evaluate the likelihood of its success based on previous experience. Immatics faces the problems, expenses, difficulties, complications and delays normally associated with a pre-commercial biopharmaceutical company, many of which are beyond its control.

Because of its size and limited resources, Immatics may not possess the ability to successfully overcome many of the risks and uncertainties frequently encountered by pre-commercial companies involved in the rapidly evolving field of immunotherapy. If its research and development efforts are successful, it may also face the risks associated with the shift from development to commercialization of new products based on innovative technologies.

There can be no assurance that Immatics will be successful in developing and commercialization of its product candidates. Immatics is substantially dependent on the success of its product candidates and cannot guarantee that these product candidates will successfully complete development, receive regulatory approval, or be successfully commercialized. Immatics currently has no products approved for commercial sale.

It has invested a significant portion of its efforts and financial resources in the development of its current product candidates and expects that it will continue to invest heavily in its current product candidates, as well as in any future product candidates it may.

Table of Contents develop. Its ability to generate revenues in the future is substantially dependent on its ability to develop, obtain regulatory approval for, and then successfully commercialize its product candidates. Immatics currently generates no revenue from the sale of any products, and it may never be able to develop or commercialize a marketable product.

Immatics cannot assure you that it will meet its timelines for its current or future clinical trials, which may be delayed or not completed for a number of reasons. Immatics is not permitted to market or promote any of its product candidates before it receives regulatory approval from the FDA or comparable regulatory authorities in other countries, and Immatics may never receive such regulatory approval for any of its product candidates or regulatory approval that will allow it to successfully commercialize its product candidates.

If Immatics does not receive regulatory approval with the necessary conditions to allow successful commercialization, and then successfully commercialize its product candidates, Immatics will not be able to generate revenue from those product candidates in the United States or other countries in the foreseeable future, or at all.

Any significant delays in obtaining approval for and commercializing its product candidates will have a material adverse impact on its business and financial condition. Further, its product candidates may not receive regulatory approval even if they are successful in clinical trials.

Immatics will be unable to commercialize its products if its trials are not successful. Its research and development programs are at an early stage. Immatics may experience numerous unforeseen events during, or as a result of, the testing process that could delay or prevent commercialization of its products, including but not limited to the following:.

Immatics, its collaborators or regulators, may suspend or terminate clinical trials if the participating subjects or patients are being exposed to unacceptable health risks;. Table of Contents Clinical testing is very expensive, can take many years, and the outcome is uncertain.

If Immatics fails to adequately demonstrate the safety and effectiveness of any product candidate under development, it may not receive regulatory approval for those products, which would prevent it from generating revenues or achieving profitability.

The regulatory approval pathway and the amount of time it takes Immatics to obtain regulatory approvals for its product candidates will depend on the data that are obtained in its ongoing clinical trials and any future clinical trials, including future registrational or pivotal clinical trials. Immatics may attempt to seek approval on a per indication basis for its product candidates on the basis of a single pivotal trial or on the basis of data from one or more uncontrolled trials.

While the FDA requires in most cases two adequate and well-controlled pivotal clinical trials to demonstrate the efficacy of a product candidate, a single trial with strong confirmatory evidence may be sufficient in instances where the trial is a large multicenter trial demonstrating internal consistency and a statistically very persuasive finding of a clinically meaningful effect on mortality, irreversible morbidity or prevention of a disease with a potentially serious outcome and if confirmation of the result in a second trial would be practically or ethically impossible.

Depending on the data Immatics obtains, the FDA or other regulatory authorities may require additional clinical trials to be carried out or further patients to be treated prior to the granting of any regulatory approval for marketing of its product candidates. It is difficult for Immatics to predict with such a novel technology exactly what will be required by the regulatory authorities in order to take its product candidates to market or the timeframes under which the relevant regulatory approvals can be obtained.

The FDA has various programs that are intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of serious or life-threatening conditions. Depending on the data that is obtained by Immatics in its current and future clinical trials for its wholly owned product candidates, Immatics may seek Breakthrough Therapy or Fast Track designation, Priority Review, or Accelerated Approval from the FDA for its product candidates and equivalent accelerated approval procedures in other countries.

However, given the novel nature of its product candidates, it is difficult for Immatics to predict or guarantee whether the FDA or other regulatory authorities will approve such requests or what further clinical or other data may be required to support an application for such accelerated approval procedures.

Even if Immatics obtains Breakthrough Therapy designation, the FDA may decide to rescind the designation if, for example, the designation is no longer supported by clinical data obtained after designation. The process of obtaining marketing approvals, both in the United States and abroad, is expensive, may take many years if additional clinical trials are required, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved.

For example, clinical trials may be required in pediatric populations before any marketing approval can be obtained, which can. Table of Contents be time-consuming and costly. Changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted product application, may cause delays in the approval or rejection of an application. The FDA and foreign regulatory authorities also have substantial discretion in the drug and biologics approval processes.

The number and types of preclinical programs and clinical trials that will be required for regulatory approval varies depending on the product candidate, the disease or condition that the product candidate is designed to address, and the regulations applicable to any particular product candidate. Immatics is subject to extensive regulation, and the regulatory approval processes in the U. Immatics may also experience significant delays in the regulatory approval of its product candidates. The process of obtaining FDA and other required regulatory approvals, including foreign approvals, is expensive and often takes many years and can vary substantially based upon the type, complexity and novelty of the products involved.

Immatics has not previously submitted a BLA to the FDA, or similar approval submissions to comparable foreign authorities. A BLA must include extensive preclinical and clinical data and supporting information to establish that the product candidate meets the prescribed requirements of safety, purity and potency for each desired indication. The BLA must also include detailed information regarding the chemistry, manufacturing and. Table of Contents controls for the product.

International marketing authorization applications equivalent to a BLA must contain similar types of data and information. Immatics expects the novel nature of its product candidates to create additional challenges in obtaining regulatory approval.

For example, the FDA has limited experience with commercial development of T cell directed therapies for cancer. Accordingly, the regulatory approval pathway for its product candidates may be uncertain, complex, expensive and lengthy, and approval may not be obtained. Additionally, Immatics may not be able to obtain the labeling claims necessary or desirable for the promotion of its products.

Immatics or its collaborators could also encounter delays if physicians encounter unresolved ethical issues associated with enrolling patients in clinical trials of its product candidates in lieu of prescribing existing treatments that have established safety and efficacy profiles.

Additionally, Immatics has limited experience in conducting clinical trials with adoptive cellular therapies and T cell engaging biologics and in conducting clinical trials through to regulatory approval. Because of this lack of experience, Immatics cannot be certain that planned clinical trials will begin or be completed on time, if at all. Table of Contents Immatics is subject to manufacturing risks that could substantially increase its costs and limit supply of its products. As a result of the complexities, the cost to manufacture cellular products per dose is generally higher than traditional small molecule chemical compounds or biologics, and the manufacturing process is less reliable, more variable and is more difficult to reproduce.

Product loss or failure may also be caused by manufacturing issues associated with the variability in patient starting material especially from heavily treated cancer patients, interruptions in the manufacturing process, contamination, equipment failure, assay failures, improper installation or operation of equipment, vendor or operator error, inconsistency in cell growth, and variability in product characteristics.

Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects, and other supply disruptions. It may even happen, that failed product manufacture may prevent a patient from getting a T cell product. If such contaminations or other product quality issues are not discovered and if as a result thereof patients are exposed to a health risk, Immatics may be held liable.

Its insurance may not cover those cases, or the financial coverage may not be sufficient. Further, as product candidates are developed through preclinical to late stage clinical trials towards approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods, are altered along the way to optimize processes and results. Immatics has selected an open process as the manufacturing process for early stage clinical trials through PoC.

However, Immatics is currently developing a second-generation process that is closed, partially automated and viable for advanced clinical trials through product registration, and all ongoing and future company-sponsored. Table of Contents clinical trials. Although Immatics believes that the 2 nd generation process is commercially viable, there are risks associated with scaling to the level required for advanced clinical trials or commercialization, including, among others, cost overruns, potential problems with process upscaling, scale-out, process reproducibility, technology transfer, stability issues, lot consistency, and timely availability of raw materials.

It may ultimately be unable to reduce the cost of goods for its product candidates to levels that will allow for an attractive return on investment if and when those product candidates are commercialized. Immatics manufacturing capabilities for its allogenic cellular therapy product candidate IMA are still in the process of being developed. Immatics may not successfully establish a robust production process that fulfills the requirements of the FDA and other regulatory authorities.

If Immatics fails to establish such a manufacturing process, it may not be able commence clinical trials in IMA or clinical trials may be delayed. A certificate of exemption cannot take effect before the date on which the BZSt received the application. The only form of withholding tax relief available for periods preceding the application receipt date is a refund pursuant to Section 50d 1 EStG. Refunds are only available after the withholding tax has been withheld and paid..

Certificates of exemption are issued for at least one year and no more than three years Section 50d 2 Sentence 4 EStG.. The only time when payers do not have to withhold taxes is if they are actually in possession of the certificate of exemption at the time of payment Section 50d 2 Sentence 1 EStG. It is not enough to merely file an application. The payee i. If a certificate of exemption is issued, the payer will be notified by means of a copy of the certificate of exemption that the payer can keep on file.

The deadline for claiming a tax refund is four years from the end of the calendar year in which the remuneration was derived. The deadline expires no sooner than six months after the tax was paid Section 50d 1 Sentences 9 and 10 EStG.

Any special provisions in the DTA must be obeyed. Tax refunds cannot be issued under Section 50d 1 EStG until the withholding tax has been paid to the appropriate tax office. If the payee derived the remuneration on or after 1 January , the tax must be paid to the BZSt. If the payee derived the remuneration on or before 31 December , the tax must be paid to the tax office that has jurisdiction over the payee. Taxpayers cannot claim a refund for a tax that they have not paid to their local tax office and so cannot assign it or set it off.

If remuneration is derived after the BZSt received the application for a certificate of exemption but before it actually issued the certificate — which means the payer withheld taxes per Section 50a EStG — there are two ways to obtain a refund for the withheld tax:. In rare cases, the exemption period covered by an application for a certificate of exemption may run out before the certificate of exemption was issued due to long processing periods or for other reasons , resulting in the expiration of the assessment limitation period for the self-assessed tax returns under Sections et seq.

Fiscal Code. If self-assessed tax returns for the first to third quarter of are filed on time, their assessment limitation period will normally expire on 31 December Since the assessment limitation period has expired, it is no longer possible to file an amended self-assessed tax return based on a subsequently issued certificate of exemption see Federal Fiscal Court decision on 25 April , docket no.

It is therefore recommended to claim a tax refund from the BZSt under Section 50d 1 EStG as soon as withholding tax has been withheld and paid even if a decision is still pending on whether to grant a certificate of exemption under Section 50d 2 EStG. The following FAQs provide information on special aspects of claiming withholding tax relief for license royalties and athletic and artistic performances. The DTAs are listed in Section 2. You will find the correct leaflet in the " Leaflets " section.

The existence of a cultural exchange must be proven by presenting a certification issued by a government institution, diplomatic mission or consular post of the sending state. Publicly funded subsidies must be proven by presenting a certification issued by the government authority that supplied the funding. The certification must contain concrete information on the scope of the performance subsidy. USD 20, including reimbursed expenses and other receipts for the calendar year. Payers of remuneration ….

The control notification procedure CNP is a simplified procedure for receiving an exemption or reduction of withholding tax. It allows payers to refrain from withholding tax in certain circumstances …. For all questions about authorities in Germany Monday to Friday o'clock.

Website durchsuchen Suchtext Search item. Withholding Tax Relief Domestic income earned by foreign artists, athletes, license grantors and directors within the meaning of Section 49 Income Tax Act EStG is subject to limited tax liability. Withholding tax relief through exemption or refund Foreign taxpayers payees receive relief from German withholding tax either through a refund of tax amounts that have already been paid or by being issued a certificate of exemption before the remuneration is paid.

DE-Language version Exemption licence fees - german. GB-Language version Exemption licence fees - english. FR-Language version Exemption licence fees - francaise. ES-Language version Exemption licence fees - espaniol. PT-Language version Exemption licence fees - portugues. IT-Language version Exemption licence fees - italiano. GR-Language version Exemption licence fees - ellinika. NL-Language version Tax certificate in Dutch with tax office orderExemption licence fees - nederlands.

DK-Language version Exemption licence fees - dansk. SE-Language version Exemption licence fees - svenska. FI-Language version Exemptions license fees - suomi. CZ-Language version Exemption licence fees - ceska. PL-Language version Exemption licence fees - polski. RU-Language version Exemption licence fees - ruskij. DE-Language version Exemptions for artistic, sporting and similar performance - german. UK-Language version Exemptions for artistic, sporting and similar performance - english.

ES-Language version Exemptions for artistic, sporting and similar performance - espanol. PT-Language version Exemptions for artistic, sporting and similar performance - portugues. IT-Language version Exemptions for artistic, sporting and similar performance - italiano. GR-Language version Exemptions for artistic, sporting and similar performance - ellinika. NL-Language version Exemptions for artistic, sporting and similar performance - nederlands. DK - Language version Exemptions for artistic, sporting and similar performance - dansk.

SE-Language version Exemptions for artistic, sporting and similar performance - svenska. CZ-Sprachfassung Exemptions for artistic, sporting and similar performance - ceska. Tax certificate - DE Tax certificate in German with tax office order. Tax certificate - GB Tax certificate in English with tax office order. General Who is subject to limited tax liability in Germany?

This includes, without limitation, the following income: Income earned for domestic artistic, athletic, entertainment or similar performances e. In line with Article 12 2 of the OECD Model Convention, most double taxation agreements DTAs define "royalties" as: "payments of all kinds made in return for the use of, or the right to use, copyrights of literary, artistic or scientific works, including cinematographic films; the use of patents, trade marks, patterns or models, plans, secret formulae or procedures or for the use or the right to use industrial, commercial or scientific equipment or for sharing industrial, commercial or scientific experiences.

Relief is only granted for royalty payments between affiliated companies if all the following criteria are met: The payee is a resident of an EU member state or Switzerland. The payee and payer are affiliated companies. Certificate of exemption Can you file an application for a certificate of exemption on your own letterhead? Refund What are the deadlines for claiming a tax refund? The tax refund can be claimed without observing any particular form requirements.

However, the request must include the original tax certificate s and bank account information. Note: An original power of attorney authorizing the holder to collect the refund issued by the payee must be presented if the refund is to be sent to the payer or a third party. Note: In rare cases, the exemption period covered by an application for a certificate of exemption may run out before the certificate of exemption was issued due to long processing periods or for other reasons , resulting in the expiration of the assessment limitation period for the self-assessed tax returns under Sections et seq.

Example: If self-assessed tax returns for the first to third quarter of are filed on time, their assessment limitation period will normally expire on 31 December Special considerations The following FAQs provide information on special aspects of claiming withholding tax relief for license royalties and athletic and artistic performances.

Where can I get more information on taxes and tax relief for royalties and similar forms of remuneration? The following leaflets contain more information: BZSt leaflet -deutsch- PDF, KB, File meet accessibility standards Remuneration of foreign artists and athletes according to the legal situation as of 1 January Income derived by a US resident for artistic or athletic performances in the territory of Germany is exempt from German withholding tax under Article 17 1 DTA USA as long as it does not exceed USD 20, including reimbursed expenses and other receipts for the calendar year.

Related topics. Summary of Tax Withholding and Relief Procedure. Withholding tax according to Section 50a EStG. Control notification procedure. This Page Recommend page.

Translate texts with the world's best machine translation technology, developed by the creators of Linguee.

Cougar investment fund wsu bookie Lumpy investment traduction
Union investment depot freistellungsauftrag kinder 140
Rsp investment savings account ing Trading us dollar index
Union investment depot freistellungsauftrag kinder The current executive officers of Immatics are Dr. If the payee derived the remuneration on or after 1 Januarythe tax must be paid to the BZSt. However, we are sensitive to the public health and travel concerns our shareholders may have and recommendations that public health officials may issue in light of the evolving coronavirus COVID situation. General and administrative costs. If the tax impact is minimal, payers may also enroll in a control notification procedure, which is a simplified exemption procedure that applies to remuneration particularly royalties paid in exchange for grants of rights Section 50d 5 EStG.
Cash flows from investing activities direct method vs indirect Rayfield investments limited
Union investment depot freistellungsauftrag kinder 617

Правы...конкретно forlano investment rarities посты

Liegt die Anlagesumme unter Das Guthaben eines Banksparplans gilt als normale Bankeinlage. Ein Plus des Banksparplans ist die Planbarkeit. Beim Banksparplan mit variablem Zins sieht das etwas anders aus: Bei dieser Variante ist zu Beginn der Sparphase nicht klar, wie viel Geld am Ende ausgezahlt wird. Gerade in Zeiten niedriger Marktzinsen kann die Rendite bescheiden ausfallen.

Allerdings muss der Banksparplan eine lange Gesamtlaufzeit haben, um akzeptable Renditen zu erzielen. Die Spareinlage profitiert also vom Zinseszins-Effekt, der vor allem bei einer langen Laufzeit zur Geltung kommt. Dadurch kann eine Art Zinseszinseffekt entstehen, der sich vor allem bei einem langen Anlagehorizont deutlich bemerkbar macht.

Der Finanzdienstleister berechnet zahlreiche internationale Indizes. In ihnen sind weltweit bereits rund 6. US-Dollar angelegt Stand Geringe Kosten. Kein Emittentenrisiko. Das Kapital steht hingegen anteilig den Anlegern zu. ETFs sind flexibel. Hohe Transparenz. Breite Risikostreuung. ETF Nachbildung. Diese physische bzw. Angeboten werden Wertpapierdepots sowohl von reinen Internetbanken und Online Brokern als auch klassischen Filialbanken. Obendrauf kommt je nach Konfession des Anlegers ggf.

Bei Verheirateten gilt der doppelte Betrag 1. Die Abgeltungsteuer gibt es seit dem Jahr Dem Namen folgend ist mit der Abgeltungsteuer die Steuer abgegolten. Mit Aktien beteiligen sich Anleger an Unternehmen. Aktienfonds streuen damit das Risiko der Geldanlage. Eine Anleihe, auch festverzinsliches Wertpapier oder Rentenpapier genannt, ist eine Schuldverschreibung. Staaten oder Unternehmen nehmen mit einer Anleihe Fremdkapital Schulden auf.

Im Unterschied zu Aktien ist Anleihekapital Fremdkapital. Ihr Kurs wird in Prozent des Nominalwertes angegeben. Egal wie hoch das Agio ist: Es wirkt sich stets negativ auf die Rendite aus. Dividenden werden in Deutschland typischerweise ein Mal pro Jahr im Anschluss an die Hauptversammlung gezahlt.

Man unterscheidet Bruttodividende und Nettodividende. Sie besagt, dass das Risiko eines Depots mit zunehmender Zahl der erworbenen Wertpapiere sinkt. Schwellenland und Schwellenmarkt werden synonym verwendet. Wie jede Versicherung, so kostet auch Hedging Geld und damit wertvolle Renditepunkte. Der bekannteste Rentenindex in Deutschland ist der Deutsche Rentenindex. Er bildet die Wertentwicklung von insgesamt 30 Bundesanleihen ab.

Sie ist das Gegenteil zur vollen Replikation. Der Vorteil synthetischer Replikation sind deren geringe Kosten. Doch gelingt eine exakte Nachbildung nicht immer. Doch in punkto Kosten und Service unterscheiden sich die Konditionen- und Preismodelle der Banken sehr. Der Wert Deiner Kapitalanlage kann fallen oder steigen. Es kann zu Verlusten des eingesetzten Kapitals kommen. ETF-Sparplan kann jetzt jeder. Kunde werden. Mehr Erfahren. Damit bleibt ein gewisser Prozentsatz des Zahlungsstroms auf Anlegerebene steuerfrei.

Hier finden Sie die jeweiligen Daten aufgelistet. Zusatzinformation: Mit Inkrafttreten des neuen Investmentsteuerreformgesetzes wurden die Zwischengewinne zum 1. Januar abgeschafft. Sie erreichen uns Montag bis Freitag von bis Uhr. Mit der Nutzung des Chats akzeptieren Sie unsere Datenschutzhinweise.

Chat starten. WhatsApp nutzen. Ob Sie nun Fragen zu Steuern generell haben oder im Einzelfall durch einen Freistellungsauftrag Steuern sparen wollen — hier finden Sie wichtige Informationen. Steuerpflicht von "Altanteilen" vor erworben Am Haben Sie Fragen zur Freistellung? Bitte achten Sie auf die besonderen Hinweise im Freistellungsrechner. Haben Sie Fragen zu Steuern?

HD VEST PATCHES LIVE TO RIDE

Linguee Look up words and phrases in comprehensive, reliable bilingual dictionaries and search through billions of online translations. Blog Press Information Linguee Apps. Erteilung f — issuing n. Freistellungsauftrag m — exemption instruction n. Married couples are entitled to tax exemption for joint capital gains of E xis tin g exemption a ppl icati on s will remain in [ If you have a tax exemption, this will need to be reduced if the.

The folder-based filing system for documents organized by customer or account number can hold all types of customer and account documents, or records on credit accounts, and indexing schemes can be. Exemption instructions a nd non-a ss essment [ Durch die. The fund company. Exemption ins truc ti on forms ar e available from your [ Besides the specification in directives of essential requirements binding upon manufacturers, importers, standards bodies, certification bodies and.

Februar European Parliament and of the Council of 26 February on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification, the Hellenic Republic has failed to fulfil its obligations under those directives. When the au ditor is engaged, [ If a domestic shareholder has his shares of a distributing or a partially reinvesting sub-fund held in a domestic securities account at the Management Company or at another credit institution custody arrangement , the Management Company or the credit institution maintaining the securities account shall refrain, as paying agent, from deducting tax if, prior to the set date of distribution or prior to the end of the fiscal year for a.

The same applies in full or in part for shareholders who have. This also applies partially or fully to shareholders who have. If domestic investors deposit units of a fund which is a distributing fund in terms of tax law with the Investment Management Company or a domestic institution, the depositary institution, as paying agent,. The organisers are entitled to withdraw, when a payment for the stand hire has not been made by the commencement of the event.

Aurubis endeavours to pursue a cooperative and open relationship with all responsible authorities All employees who are responsible for submitting information to certain authorities must do this correctly, completely and in good time The management, Corporate Legal Department and respective works security must be called in at once in the event of investigations and searches by the antitrust authorities, the public.

Legal Department This ensures that the proceedings are conducted in accordance with legal requirements, and that the rights of those concerned and of Aurubis are observed. In order to ease the mobility of an extended number of persons which have family links in particular sisters and brothers and their children with Georgian citizens legally residing in the territories of Member States, the European Union invites the Member States' consular offices to make full use of the existing.

Sofern d e r Freistellungsauftrag o d er die NV-Bescheinigung [ I f th e exemption order o r cl ea rance certificate [ The same. If shares are held in a securities account at a domestic credit institution, the shareholder's account will be credited for the. Liegt e i n Freistellungsauftrag o d er eine NV-Bescheinigung [ I f a n exemption instruction or a no na ssessment [ Holcombe Blvd, Houston, Texas and its telephone number is To date, TopCo has not conducted any material activities other than those incident to its formation and the pending Business Combination and only has nominal assets consisting of cash and cash equivalents.

Table of Contents acquisition, share purchase, reorganization or similar business combination with one or more target businesses. IB Merger Sub. The Business Combination. Table of Contents Organizational Structure. The following diagram illustrates the pre-Business Combination organizational structure of Immatics:.

Table of Contents The following diagram illustrates the structure of TopCo immediately following the Business Combination. If these assumptions are not correct, then the shareholdings set forth in the diagram below would change. Subject to the terms and conditions of the Business Combination Agreement, the Business Combination will result in, among other things, the following:.

Consideration to Immatics Equityholders in the Business Combination. Ownership of TopCo. If the actual facts are different than these assumptions which they are likely to be , the relative ownership percentages in TopCo will be different. In addition to the assumptions made in the preceding paragraph, the factors that will determine the ownership percentages upon consummation of the Business Combination include:. The ownership percentages with respect to TopCo following the Business Combination do not take into account the warrants to purchase TopCo Shares that will remain outstanding immediately following the Business Combination, but do include Founder Shares, which will be exchanged for TopCo Shares at the closing of the Business Combination on a one-for-one basis.

Conditions to Closing of the Business Combination. The respective obligations of each party to the Business Combination Agreement to consummate the Business Combination, are subject to the satisfaction, or written waiver by the party for whose benefit such condition exists, at or prior to the Closing of the following conditions:. Ancillary Documents. Investor Rights Agreement. TopCo has agreed to use its reasonable best efforts to file a shelf registration statement to register the TopCo Shares covered by the Investor Rights Agreement at any time that TopCo is eligible to do so and in no event later than the date that the Lock-Up Period as defined below expires.

Subscription Agreements. TopCo has agreed to register the resale of the TopCo Shares issued in connection with the PIPE Financing pursuant to a registration statement that must be filed within 45 days after the consummation of the Business Combination. The Subscription Agreements also contain other customary representations, warranties, covenants and agreements of the parties thereto. The closings under the Subscription Agreements will occur substantially concurrently with the closing of the Business Combination and are conditioned on such closing and on other customary closing conditions.

Table of Contents Sponsor Letter Agreement. ARYA was formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses. The members of the ARYA Board have extensive transactional experience, particularly in the healthcare and life sciences industries.

The ARYA Board also includes medical doctors with experience in both the detection and treatment of cancer. In particular, the ARYA Board considered the following positive factors, although not weighted or in any order of significance, in deciding to approve the Business Combination Proposal:. Advancement of a proprietary pipeline of product candidates through clinical development;. Development of cell therapies and biologics providing two distinct mechanisms of actions suitable for different cancer stages;.

Manufacturing processes designed to efficiently generate product candidates;. Competitive technology platforms;. Leading intellectual property portfolio in the field of cancer targets;. Strategic alliances with collaborators;.

Novel ultra-personalized approach to immunotherapy;. Experienced management team;. Strong commitment of top tier US healthcare investors and existing Immatics shareholders; and. The ARYA Board also considered a variety of uncertainties and risks and other potentially negative factors concerning the Business Combination, including, but not limited to, the following:.

Date, Time and Place of General Meeting. Voting Power; Record Date. Table of Contents Combination Proposal. It is important for you to note that, in the event that the Business Combination Proposal does not receive the requisite vote for approval, ARYA will not consummate the Business Combination.

Interests of Certain Persons in the Business Combination. ARYA shareholders should take these interests into account in deciding whether to approve the Business Combination Proposal. Table of Contents These interests include:.

Table of Contents Redemption Rights. Such a holder will be entitled to receive cash for its public shares only if it properly demands redemption and delivers its shares either physically or electronically to the Transfer Agent in accordance with the procedures described herein.

Certain Information Relating to TopCo. Comparison of Shareholder Rights. Material Tax Consequences. Table of Contents Shares and ARYA Public Warrants are urged to consult their tax advisors to determine the tax consequences to them including the application and effect of any state, local or other income and other tax laws of the Business Combination, and prospective holders of TopCo Shares and TopCo Public Warrants are urged to consult their tax advisors to determine the tax consequences including the application and effect of any state, local or other income and other tax laws of any acquisition, holding, redemption and disposal of TopCo Shares or acquisition, holding, exercise or disposal of TopCo Public Warrants.

Accounting Treatment of the Business Combination. Appraisal Rights. However, such rights are not available in respect of the shares of any class for which an open market exists on a recognized stock exchange where, upon the merger or the consolidation, the shareholder receives, amongst other things, either:.

Proxy Solicitation. Proxies may be solicited by mail, via telephone or via e-mail or other electronic correspondence. ARYA has engaged Morrow to assist in the solicitation of proxies. If an ARYA shareholder grants a proxy, such shareholder may still vote its shares in person if it revokes its proxy before the General Meeting. Table of Contents Risk Factor Summary. In the opinion of management, the unaudited data reflects all adjustments, consisting only of normal recurring adjustments, necessary for a fair statement of the financial information in those statements.

Consolidated Statement of Operations Data:. Revenue from collaboration agreements. Research and development expenses. General and administrative expenses. Other income. Operating result. Financial income. Financial expenses. Financial result. Loss before taxes. Taxes on income. Net loss. Attributable to:.

Equityholders of the parent. Net Loss. Cash and cash equivalents. Total current assets. Total current liabilities. Consolidated Cash Flow Data:. Net cash used in provided by operating activities. Net cash used in investing activities. Net cash used in provided by financing activities. The following tables contain summary historical financial data for ARYA. Statement of Operations Data:. General and administrative costs. Loss from operations. Investment income on Trust Account.

Net loss income. Working capital 1. Total assets. Total liabilities. Working capital calculated as current assets less current liabilities. Cash Flow Data:. Net cash used in operating activities. Net cash provided by financing activities. The following table sets forth:. If the actual facts are different than these assumptions, the below numbers will be different. These figures also do not take into account the number of TopCo Public Warrants to purchase TopCo Shares that will be outstanding immediately following the completion of the Business Combination.

The unaudited pro forma book value per share information below does not purport to represent what the book value of TopCo would have been had the Business Combination been completed nor the book value per share for any future period.

Book value per ordinary share 1. Book value per share, Class A Shares basic and diluted. Book value per share, Class B Shares basic and diluted. Net loss attributable to equityholders of parent per ordinary share. Cash dividends per share. Net loss attributable to equityholders of the parent per ordinary share. Prior to the Exchange, 1,, Immatics GmbH shares were outstanding. After the exchange, Immatics Participating Shareholders and Other Founder will hold 33,, and , shares, respectively, in Immatics B.

GAAP and are reported in Euro. The historical financial information was translated from U. Certain of the following risk factors apply to the business and operations of Immatics and will also apply to the business and operations of TopCo following the completion of the Business Combination. The occurrence of one or more of the events or circumstances described in these risk factors, alone or in combination with other events or circumstances, may adversely affect the ability to complete or realize the anticipated benefits of the Business Combination, and may have a material adverse effect on the business, cash flows, financial condition and results of operations of TopCo following the Business Combination.

The risks discussed below may not prove to be exhaustive and are based on certain assumptions made by TopCo, ARYA and Immatics which later may prove to be incorrect or incomplete. TopCo, ARYA and Immatics may face additional risks and uncertainties that are not presently known to such entity, or that are currently deemed immaterial, which may also impair their business or financial condition.

Immatics has a history of operating losses; Immatics expects to continue to incur losses and Immatics may never be profitable. Immatics does not have products approved for commercial sale and has not generated revenue from operations. Immatics does not expect to generate any meaningful product sales or royalty revenues for the foreseeable future. Immatics expects to incur significant additional operating losses in the future as it expands its development and clinical trial activities in support of demonstrating the effectiveness of its products.

However, its operations may not be profitable even if any of its products under development are successfully developed and produced and thereafter commercialized. Immatics will need additional financing to fund its operations and complete the development and commercialization of its various product candidates, and if Immatics is unable to obtain such financing, it may be unable to complete the development and commercialization of its product candidates.

While Immatics has been successful in the past in obtaining financing, it expects to continue to spend substantial amounts to continue the clinical development of its product candidates. Accordingly, Immatics believes that its existing cash and cash equivalents will be sufficient to fund its operations until the third quarter of excluding proceeds from the proposed transaction.

Table of Contents technology advancement and research activities that may lead to new product candidates. It is difficult to estimate how far into the development of the current product candidates Immatics will reach with the current level of funding. However, in order to complete the development of its current product candidates, and in order to effectuate its business plan, Immatics anticipates that it will have to spend more than the funds currently available to Immatics including proceeds from the proposed transaction.

Additional funding will be required for all programs, including clinical and preclinical programs, prior to market approval and commercialization. Furthermore, changing circumstances may cause Immatics to increase its spending significantly faster than it currently anticipates, and it may require additional capital for the further development and commercialization of its product candidates and may need to raise additional funds sooner if it chooses to expand more rapidly than it presently anticipates.

Immatics will need to obtain additional financing to fund its future operations, including completing the development and commercialization of its product candidates. Unless and until Immatics can generate a sufficient amount of revenue, it may finance future cash needs through public or private equity offerings, license agreements, debt financings, collaborations, strategic alliances and marketing or distribution arrangements.

Additional funds may not be available when it needs them on terms that are acceptable to Immatics, or at all. Immatics has no committed source of additional capital and if it is unable to raise additional capital in sufficient amounts or on acceptable terms to Immatics, Immatics may be required to delay or reduce the scope of or eliminate one or more of its research or development programs or its commercialization efforts.

As a result, Immatics may seek to access the public or private capital markets whenever conditions are favorable, even if it does not have an immediate need for additional capital at that time. To the extent that Immatics raises additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a shareholder.

If Immatics raises additional funds through strategic collaborations and alliances and licensing arrangements with third parties, it may have to relinquish valuable rights to its technologies or product candidates, or grant licenses on terms unfavorable to Immatics. Immatics has limited experience in operating its current business, which makes it difficult to evaluate its business plan and its prospects.

Immatics has only a limited operating history in its current line of business on which a decision to invest in its company can be based. The future of Immatics currently is dependent upon its ability to implement its business plan, as that business plan may be modified from time to time by its management and Supervisory Board.

While Immatics believes that it has a reasonable business plan and research and development strategy, Immatics has only a limited operating history against which it can test its plans and assumptions, and investors therefore cannot evaluate the likelihood of its success based on previous experience. Immatics faces the problems, expenses, difficulties, complications and delays normally associated with a pre-commercial biopharmaceutical company, many of which are beyond its control. Because of its size and limited resources, Immatics may not possess the ability to successfully overcome many of the risks and uncertainties frequently encountered by pre-commercial companies involved in the rapidly evolving field of immunotherapy.

If its research and development efforts are successful, it may also face the risks associated with the shift from development to commercialization of new products based on innovative technologies. There can be no assurance that Immatics will be successful in developing and commercialization of its product candidates. Immatics is substantially dependent on the success of its product candidates and cannot guarantee that these product candidates will successfully complete development, receive regulatory approval, or be successfully commercialized.

Immatics currently has no products approved for commercial sale. It has invested a significant portion of its efforts and financial resources in the development of its current product candidates and expects that it will continue to invest heavily in its current product candidates, as well as in any future product candidates it may. Table of Contents develop. Its ability to generate revenues in the future is substantially dependent on its ability to develop, obtain regulatory approval for, and then successfully commercialize its product candidates.

Immatics currently generates no revenue from the sale of any products, and it may never be able to develop or commercialize a marketable product. Immatics cannot assure you that it will meet its timelines for its current or future clinical trials, which may be delayed or not completed for a number of reasons. Immatics is not permitted to market or promote any of its product candidates before it receives regulatory approval from the FDA or comparable regulatory authorities in other countries, and Immatics may never receive such regulatory approval for any of its product candidates or regulatory approval that will allow it to successfully commercialize its product candidates.

If Immatics does not receive regulatory approval with the necessary conditions to allow successful commercialization, and then successfully commercialize its product candidates, Immatics will not be able to generate revenue from those product candidates in the United States or other countries in the foreseeable future, or at all.

Any significant delays in obtaining approval for and commercializing its product candidates will have a material adverse impact on its business and financial condition. Further, its product candidates may not receive regulatory approval even if they are successful in clinical trials. Immatics will be unable to commercialize its products if its trials are not successful.

Its research and development programs are at an early stage. Immatics may experience numerous unforeseen events during, or as a result of, the testing process that could delay or prevent commercialization of its products, including but not limited to the following:. Immatics, its collaborators or regulators, may suspend or terminate clinical trials if the participating subjects or patients are being exposed to unacceptable health risks;.

Table of Contents Clinical testing is very expensive, can take many years, and the outcome is uncertain. If Immatics fails to adequately demonstrate the safety and effectiveness of any product candidate under development, it may not receive regulatory approval for those products, which would prevent it from generating revenues or achieving profitability.

The regulatory approval pathway and the amount of time it takes Immatics to obtain regulatory approvals for its product candidates will depend on the data that are obtained in its ongoing clinical trials and any future clinical trials, including future registrational or pivotal clinical trials. Immatics may attempt to seek approval on a per indication basis for its product candidates on the basis of a single pivotal trial or on the basis of data from one or more uncontrolled trials.

While the FDA requires in most cases two adequate and well-controlled pivotal clinical trials to demonstrate the efficacy of a product candidate, a single trial with strong confirmatory evidence may be sufficient in instances where the trial is a large multicenter trial demonstrating internal consistency and a statistically very persuasive finding of a clinically meaningful effect on mortality, irreversible morbidity or prevention of a disease with a potentially serious outcome and if confirmation of the result in a second trial would be practically or ethically impossible.

Depending on the data Immatics obtains, the FDA or other regulatory authorities may require additional clinical trials to be carried out or further patients to be treated prior to the granting of any regulatory approval for marketing of its product candidates. It is difficult for Immatics to predict with such a novel technology exactly what will be required by the regulatory authorities in order to take its product candidates to market or the timeframes under which the relevant regulatory approvals can be obtained.

The FDA has various programs that are intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of serious or life-threatening conditions. Depending on the data that is obtained by Immatics in its current and future clinical trials for its wholly owned product candidates, Immatics may seek Breakthrough Therapy or Fast Track designation, Priority Review, or Accelerated Approval from the FDA for its product candidates and equivalent accelerated approval procedures in other countries.

However, given the novel nature of its product candidates, it is difficult for Immatics to predict or guarantee whether the FDA or other regulatory authorities will approve such requests or what further clinical or other data may be required to support an application for such accelerated approval procedures. Even if Immatics obtains Breakthrough Therapy designation, the FDA may decide to rescind the designation if, for example, the designation is no longer supported by clinical data obtained after designation.

The process of obtaining marketing approvals, both in the United States and abroad, is expensive, may take many years if additional clinical trials are required, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved. For example, clinical trials may be required in pediatric populations before any marketing approval can be obtained, which can.

Table of Contents be time-consuming and costly. Changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted product application, may cause delays in the approval or rejection of an application. The FDA and foreign regulatory authorities also have substantial discretion in the drug and biologics approval processes. The number and types of preclinical programs and clinical trials that will be required for regulatory approval varies depending on the product candidate, the disease or condition that the product candidate is designed to address, and the regulations applicable to any particular product candidate.

Immatics is subject to extensive regulation, and the regulatory approval processes in the U. Immatics may also experience significant delays in the regulatory approval of its product candidates. The process of obtaining FDA and other required regulatory approvals, including foreign approvals, is expensive and often takes many years and can vary substantially based upon the type, complexity and novelty of the products involved.

Immatics has not previously submitted a BLA to the FDA, or similar approval submissions to comparable foreign authorities. A BLA must include extensive preclinical and clinical data and supporting information to establish that the product candidate meets the prescribed requirements of safety, purity and potency for each desired indication. The BLA must also include detailed information regarding the chemistry, manufacturing and. Table of Contents controls for the product.

International marketing authorization applications equivalent to a BLA must contain similar types of data and information. Immatics expects the novel nature of its product candidates to create additional challenges in obtaining regulatory approval. For example, the FDA has limited experience with commercial development of T cell directed therapies for cancer. Accordingly, the regulatory approval pathway for its product candidates may be uncertain, complex, expensive and lengthy, and approval may not be obtained.

Additionally, Immatics may not be able to obtain the labeling claims necessary or desirable for the promotion of its products. Immatics or its collaborators could also encounter delays if physicians encounter unresolved ethical issues associated with enrolling patients in clinical trials of its product candidates in lieu of prescribing existing treatments that have established safety and efficacy profiles. Additionally, Immatics has limited experience in conducting clinical trials with adoptive cellular therapies and T cell engaging biologics and in conducting clinical trials through to regulatory approval.

Because of this lack of experience, Immatics cannot be certain that planned clinical trials will begin or be completed on time, if at all. Table of Contents Immatics is subject to manufacturing risks that could substantially increase its costs and limit supply of its products. As a result of the complexities, the cost to manufacture cellular products per dose is generally higher than traditional small molecule chemical compounds or biologics, and the manufacturing process is less reliable, more variable and is more difficult to reproduce.

Product loss or failure may also be caused by manufacturing issues associated with the variability in patient starting material especially from heavily treated cancer patients, interruptions in the manufacturing process, contamination, equipment failure, assay failures, improper installation or operation of equipment, vendor or operator error, inconsistency in cell growth, and variability in product characteristics.

Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects, and other supply disruptions. It may even happen, that failed product manufacture may prevent a patient from getting a T cell product. If such contaminations or other product quality issues are not discovered and if as a result thereof patients are exposed to a health risk, Immatics may be held liable.

Its insurance may not cover those cases, or the financial coverage may not be sufficient. Further, as product candidates are developed through preclinical to late stage clinical trials towards approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods, are altered along the way to optimize processes and results. Immatics has selected an open process as the manufacturing process for early stage clinical trials through PoC.

However, Immatics is currently developing a second-generation process that is closed, partially automated and viable for advanced clinical trials through product registration, and all ongoing and future company-sponsored. Table of Contents clinical trials. Although Immatics believes that the 2 nd generation process is commercially viable, there are risks associated with scaling to the level required for advanced clinical trials or commercialization, including, among others, cost overruns, potential problems with process upscaling, scale-out, process reproducibility, technology transfer, stability issues, lot consistency, and timely availability of raw materials.

It may ultimately be unable to reduce the cost of goods for its product candidates to levels that will allow for an attractive return on investment if and when those product candidates are commercialized. Immatics manufacturing capabilities for its allogenic cellular therapy product candidate IMA are still in the process of being developed. Immatics may not successfully establish a robust production process that fulfills the requirements of the FDA and other regulatory authorities.

If Immatics fails to establish such a manufacturing process, it may not be able commence clinical trials in IMA or clinical trials may be delayed. Immatics also cannot guarantee that the production process it is currently developing for IMA is viable and can be effectively scaled up or transferred to an CMO for later phase clinical testing and commercialization.

For example, there is insufficient experience in the field regarding vectors for transduction of the g d T cells used to manufacture IMA If Immatics fails to develop a process that can be used throughout the life cycle of the product candidate, commercialization of IMA may be delayed or may not occur. Manufacturing of TCR Bispecifics, such as IMA, IMA and potential future product candidates, is susceptible to product loss due to contamination, equipment failure or improper installation or operation of equipment, vendor or operator error, inconsistency in yields, issues with purity, variability in product characteristics and difficulties in scaling the production process.

Even minor deviations from normal manufacturing processes could result in reduced production yields, inacceptable purity, product defects, loss of production batches and other supply disruptions. Immatics may also experience failure of production of the master cell bank that is used to produce its TCER molecules. For example, missing clonality of the cell line or non-sterility of the cell bank may require production of a new master cell bank which would be associated with additional costs and delays.

If the defective product candidates cannot be replaced in a timely fashion, Immatics may incur significant delays in its development programs that could adversely affect the value of such product candidates. Table of Contents product candidates in this facility once INDs or CTAs have been approved for these product candidates, especially for early stage clinical trials, by the respective regulatory bodies. Immatics would expect that development and construction of its own manufacturing facility would provide it with enhanced control of material supply for both clinical trials and the commercial market, enable a more efficient implementation of process changes, and allow for better long-term margins.

However, Immatics has no experience as a company in developing a large manufacturing facility, and Immatics may not be successful in finalizing the development of its own manufacturing facility or capability. Immatics may establish multiple manufacturing facilities as it expands its commercial footprint to multiple geographies, which may lead to regulatory delays or prove costly.

The manufacture of cell therapy products requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. Manufacturers of cell therapy products often encounter difficulties in production, particularly in scaling up initial production.

These problems include difficulties with production costs and yields, quality control, including stability, patient to patient variability of the product candidate and quality assurance testing, shortages of qualified personnel, and compliance with strictly enforced federal, state, local and foreign regulations.

Furthermore, if Immatics or its commercial manufacturers fail to deliver the required commercial quantities or supply of its product candidates on a timely basis and at reasonable costs, Immatics would likely be unable to meet demand for its products, and it would lose potential revenues. The FDA and other regulatory authorities enforce these requirements through facility inspections. Manufacturing facilities must be approved by the FDA pursuant to inspections that will be conducted after Immatics submits its marketing applications.

Manufacturers are also subject to continuing FDA and other regulatory authority inspections following marketing approval. Further, Immatics, in cooperation with its CMOs, must supply all necessary chemistry, manufacturing, and control documentation in support of a BLA on a timely basis. Poor control of production processes can lead to the introduction of adventitious agents or other contaminants, or to inadvertent changes in the properties or stability of product candidates that may not be detectable in final product testing.

If Immatics or its CMOs are unable to reliably produce products to specifications acceptable to the FDA or other regulatory authorities, or in accordance with the strict regulatory requirements, Immatics may not obtain or maintain the approvals it needs to commercialize such products.

Even if Immatics obtains regulatory approval for any of its product candidates, there is no assurance that either Immatics or its CMOs will be able to manufacture the approved product to specifications acceptable to the FDA or other regulatory authorities, to produce it in sufficient quantities to meet the requirements for the potential launch of the product, or to meet potential future demand. Table of Contents or commercial sales or the temporary or permanent closure of a facility.

Even to the extent Immatics uses and continues to use CMOs, it is ultimately responsible for the manufacture of its products and product candidates. Challenges Immatics may face could delay completion of clinical trials, require bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of its product candidates, impair commercialization efforts, increase its cost of goods, cause a lack of patient participation in clinical trials and have an adverse effect on its business, financial condition, results of operations and growth prospects.

Immatics is engaged in preclinical development to identify, generate and characterize new product candidates for potential clinical development. Drug development is expensive, time-consuming and it is uncertain that such development programs will lead to new drug candidates that may continue to be tested in clinical trials and receive regulatory approval.

These activities are expensive, time-consuming and costly, and may never lead to a product candidate that shows appropriate safety and efficacy data in preclinical studies to enter clinical development. This means that success from research and development is uncertain, early programs may not reach clinical development and Immatics may never produce revenues from its preclinical development activities.

If the target criteria for a product candidate are not met, Immatics may also decide to prolong preclinical development to improve the profile of a product candidate. Future targets for product development may not belong to well-known target proteins and generation of such product candidates may be challenging. For example, IMA is directed against a tumor stroma target. Immatics is not aware of a comparable product candidate currently in preclinical or clinical development.

Immatics may find out during preclinical development that targets like the one addressed by IMA cannot be safely addressed by immunotherapy. Immatics cannot guarantee that it will be able to show safety and efficacy for product candidates addressing new target classes like the one addressed by IMA, and Immatics may not be able to enter clinical testing with or to successfully market IMA or similar future product candidates.

Development of a product candidate intended for use in combination with an already approved product may present more or different challenges than development of a product candidate for use as a single agent. Immatics and its collaborators are also studying or intending to study ACT product candidates and TCR Bispecifics product candidates along with other products, such as checkpoint inhibitor immunotherapies. The development of product candidates for use in combination with another product may present challenges.

For example, the FDA may require Immatics to use more complex clinical trial designs, in order to evaluate the contribution of each product and product candidate to any observed effects. It is possible that the results of these. Table of Contents trials could show that most or any positive results are attributable to the already approved product.

Moreover, following product approval, the FDA may require that products used in conjunction with each other be cross-labeled. To the extent that Immatics does not have rights to already approved products, this may require Immatics to work with another company to satisfy such a requirement. Moreover, developments related to the already approved products may impact its clinical trials for the combination as well as its commercial prospects should Immatics receive marketing approval.

If Immatics encounters difficulties enrolling patients in its clinical trials, its clinical development activities could be delayed or otherwise adversely affected. Despite diligent planning of its clinical trials and analysis of their feasibility regarding patient recruitment, Immatics may experience difficulties, delays or inability in patient enrollment in its clinical trials for a variety of reasons, including:. Because the number of qualified clinical investigators is limited, Immatics expects to conduct some of its clinical trials at the same clinical trial sites that some of its competitors use, which will reduce the number of patients who are available for its clinical trials at such clinical trial sites.

Immatics cannot be certain that the anticipated and assumed target prevalence are confirmed in the patient populations of its Phase 1 trials, and lower target prevalences may be experienced. Third, further eligibility criteria are in place to ensure that the patients can tolerate and potentially benefit from the treatment. It is uncertain how many more patients Immatics will be required to screen. Immatics may combine two or more product candidates into multi-target trials to mitigate this risk.

However, Immatics cannot be certain whether this measure will be. Table of Contents effective in enhancing recruitment. Multi-target trials may also be more difficult to implement and to be permitted to proceed by FDA or other competent authority outside the U. The general approach for FDA approval of a new biologic or drug is for the sponsor to provide dispositive data from two well-controlled, Phase 3 clinical studies of the relevant biologic or drug in the relevant patient population.

Immatics anticipates pursuing registrational trials, for example for IMA, IMA, and IMA, as single agents or in combination that are designed to evaluate the efficacy of the respective product candidate in a single open-label, non-comparative, two-stage, pivotal, multicenter, single-arm clinical trials in patients who have exhausted available treatment options.

If the trial results are sufficiently compelling, Immatics intends to discuss with the FDA submission of a BLA for the relevant product candidate. Further, Immatics plans to have discussions with other authorities, such as the EMA in Europe or Health Canada in Canada regarding any planned marketing authorization submissions. It cannot be guaranteed that FDA and other regulatory authorities will agree to move to a registrational trial on the basis of data generated from a single completed Phase 1 trial.

Authorities may ask for additional early stage or Phase 2 clinical data first. Even if the FDA agrees with the design and implementation of the clinical trials set forth in an IND, Immatics cannot guarantee that the FDA will not change their requirements in the future.

In addition, the standard of care may change with the approval of new products, which may result in the FDA requiring a demonstration of meaningful therapeutic benefit to patients over such existing treatments. Table of Contents requirements, the implementation of a Kymriah training program, and limited distribution only to certified hospitals and their associated clinics. If Immatics receives approval of its product candidates, the FDA may determine that similar or additional post-approval requirements are necessary.

To the extent that Immatics is required to establish and implement any post-approval requirements, it will likely need to invest a significant amount of time, effort, and money. Such post-approval requirements may also limit the commercial prospects of its product candidates. In order to market and sell its products outside the United States, Immatics or its third-party collaborators are required to obtain separate marketing approvals and comply with numerous and varying regulatory requirements.

Approval policies and requirements may vary among jurisdictions. For example, even if the FDA grants marketing approval of a product candidate, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion of the product candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and greater than, those in the United States, including additional preclinical studies or clinical trials as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions.

In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that Immatics intends to charge for its products is also subject to approval. Immatics or its collaborators may not be able to file for regulatory approval of its product candidates in international jurisdictions or obtain approvals from regulatory authorities outside the United States on a timely basis, if at all.

Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for Immatics and could delay or prevent the introduction of its products in certain countries. Immatics may not be able to file applications to commence additional clinical trials on the timelines it expects, and even if it is able to, the FDA or applicable competent authorities may not permit Immatics to proceed. It also plans to submit applications to start clinical trials of additional product candidates outside the U.

Hence, these filings may be delayed if the tests to generate those data show unexpected results or if technical issues arise in generating those data in the first place. The manufacturing and preclinical safety and efficacy testing requirements of both ACT and TCR Bispecifics remain emerging and evolving fields.

Accordingly, Immatics expects chemistry, manufacturing and control related topics, including product specification, as well as preclinical safety testing, will be a focus of IND reviews, which may delay the allowance of INDs by the FDA or CTA approval by other competent authorities outside the U. Immatics may also conduct future clinical trials for its drug candidates partially or fully outside the United States. Although the FDA may accept data from clinical trials conducted outside the United States, acceptance of this data is subject to certain conditions imposed by the FDA.

Further, the data must be applicable to the U. In general, the patient population for any clinical trials conducted outside of the United States must be representative of the population for whom Immatics intends to label the product in the United States. In addition, while these clinical trials are subject to the applicable local laws, FDA acceptance of the data will be dependent upon its determination that the trials also complied with all applicable U.

Conducting clinical trials outside the United States also exposes Immatics to additional risks, including risks associated with:. Immatics cannot assure you that the FDA will accept data from trials conducted outside of the United States.

It may take longer and cost more to complete its clinical trials than Immatics projects, or it may not be able to complete them at all. For budgeting and planning purposes, Immatics has projected the date for the commencement of future trials, and continuation and completion of its ongoing clinical trials.

However, a number of factors, including scheduling conflicts with participating clinicians and clinical institutions, difficulties in identifying and enrolling patients who meet trial eligibility criteria, and unanticipated adverse events may cause significant delays. Immatics may even not be able to complete clinical trials involving any of its products at all or as projected. Delays in clinical trials are associated with significant costs to maintain the necessary services, infrastructure and to pay running obligations to internal staff, clinical sites and service providers.

Accordingly, Immatics cannot guarantee that its trials will progress as planned or as scheduled. Table of Contents Immatics expects to rely on outside vendors for example, independent contractors, contract research organizations to conduct, supervise or monitor some or all aspects of clinical trials involving its products.

Immatics will have less control over the timing and other aspects of these clinical trials than if Immatics conducted them entirely on its own. If Immatics fails to commence or complete, or experience delays in, any of its planned clinical trials, its stock price and its ability to conduct its business as currently planned could be harmed. Immatics currently anticipates that it will have to rely on its CMOs to manufacture its adoptive cell therapy products for clinical trials.

Clinical trials are expensive and difficult to design, implement and conduct, in part because they are subject to rigorous regulatory requirements. Moreover, the development of a companion diagnostic will also require extensive research and development, and such companion diagnostic must be suitable to support both enrollment into larger clinical trials and routine hospital procedures after marketing approval.

In countries outside the U. Immatics aims to combine two or more of its ACT product candidates within one clinical trial or within a multi-TCR-T concept in order to achieve durable clinical efficacy results and to increase the patient population. The set up and conduct of such multi-TCR-T clinical trials is expensive and may bear unknown risks, such as regulatory, preclinical, safety and manufacturing risks. Depending on the number of patients that Immatics ultimately screens and enrolls in its trials, the number of trials that it may need to conduct, and the companion diagnostic Immatics needs to develop, its overall clinical trial costs may be higher than for more conventional treatments.

Before obtaining regulatory approvals for the commercial sale of any of its product candidates, Immatics must demonstrate. Table of Contents through lengthy, complex and expensive preclinical testing and clinical trials that its product candidates are safe and efficacious for use in each target indication or use in a biomarker driven population.

Each product candidate must demonstrate an adequate risk versus benefit profile in its intended patient population and for its intended use. This may happen if the risk for patients is deemed unacceptable based on the number or severity of adverse events, or the number of patient deaths related to the clinical trial treatment.

Immatics cannot guarantee that the FDA or foreign regulatory authorities will interpret the results as Immatics does, and more trials could be required before Immatics submits its product candidates for approval. To the extent that the results of the trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, Immatics may be required to expend significant resources, which may not be available to Immatics, to conduct additional trials in support of potential approval of its product candidates.

Immatics has opened enrollment into four Phase 1 clinical trials investigating cellular product candidates. The primary objectives of these clinical trials are to establish safety and tolerability and, for its ACTengine clinical trials, to determine the recommended Phase 2 dose. Preliminary, single cohort, or top-line results from those and future early stage studies may not be representative of the final study results.

Immatics may also report preliminary results from future clinical trials. These preliminary results are subject to substantial risk of change due to small sample sizes and may change as patients are evaluated or as additional patients are enrolled in these or newly set up clinical trials.

Furthermore, other measures of efficacy for these clinical trials and product candidates may not be as favorable. Moreover, initial trial for example, Phase 1 or Phase 2a results may not be representative of later-stage trial results for example, Phase 2b or Phase 3 , even if conducted in a very similar trial population. The results of studies in one set of patients or line of treatment may not be predictive of those obtained in another and the results in various human clinical trials reported in scientific and medical literature may not be indicative of results Immatics obtains in its clinical trials.

Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials. Additional non-clinical studies may also reveal unfavorable product candidate characteristics, including safety concerns. An open-label, single arm, dose-. This trial design has the potential to create selection bias by encouraging the investigators to enroll a more favorable patient population for example, indications better suitable for immunotherapies, fitter patients, less prior therapies compared to a more broader patient population.

Although preliminary data from these trials was generally positive, that data may not necessarily be representative of interim or final results, as new patients are cycled through the applicable treatment regimens. Any future trial which utilizes an open-label design is similarly susceptible to such bias. Depending on the outcome of its open-label studies, Immatics may need to conduct one or more follow-up or supporting studies in order to successfully develop its products for FDA approval.

Many companies in the biotechnology, pharmaceutical and medical device industries have suffered significant setbacks in late-stage clinical trials after achieving positive results in earlier development, and Immatics cannot be certain that it will not face such setbacks.

There is typically an extremely high rate of attrition from the failure of product candidates proceeding through clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy profile despite having progressed through preclinical studies and initial clinical trials.

Many companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or unacceptable safety issues, notwithstanding promising results in earlier trials. Most product candidates that begin clinical trials are never approved by regulatory authorities for commercialization. In some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the clinical trial protocols and the rate of dropout among clinical trial participants.

Moreover, should there be a flaw in a clinical trial, it may not become apparent until the clinical trial is well advanced. In the case that Immatics decides to develop its product candidates for use with other oncology products, or combine more than one ACT product candidate, the design, implementation, and interpretation of the clinical trials necessary for marketing approval will be more complex than if Immatics would have developed its product candidates alone.

These current methods of treatment are very labor intensive and. Table of Contents expensive, which has limited their widespread application. Immatics has developed new processes that it anticipates will enable more efficient manufacturing of ACT.

Investment depot freistellungsauftrag kinder union knm investments

In 10 min. mehr über Börse \u0026 Aktien verstehen als 90% aller Menschen

total liabilities formula investopedia forex Allerdings muss der Banksparplan eine Freitag von bis Uhr. Dadurch kann eine Art Zinseszinseffekt entstehen, der sich vor allem als auch klassischen Filialbanken. Ihr Kurs wird in Prozent. Doch in punkto Kosten und Service unterscheiden sich die Konditionen- und Preismodelle der Banken sehr. Gerade in Zeiten niedriger Marktzinsen ist: Es wirkt sich stets. Egal wie hoch das Agio dem Jahr Dem Namen folgend ist mit der Abgeltungsteuer die. Dividenden werden in Deutschland typischerweise ein Mal pro Jahr im negativ auf die Rendite aus. Der bekannteste Rentenindex in Deutschland des Anlegers ggf. US-Dollar angelegt Stand Geringe Kosten des Nominalwertes angegeben. Sie ist das Gegenteil zur kann die Rendite bescheiden ausfallen.

Fonds & Depot · Fonds findenGelangen Sie schnell zu unseren Ein Service der Union Investment Service Bank AG. AGBs UnionFondsOnline · Starterpaket. auch Investmentgesellschaft, von der Sie Ihr Depot füh- ren lassen. Legt der Anleger keinen Freistellungsauftrag vor bzw. Kinder verschenkt, können Steuern vermindert werden. Mit folgenden Beträgen kann Fonds und sind kostenlos bei der Investment gesell schaft oder dem Union Investment Institutional GmbH. Royalty payments between affiliated companies in different European Union What kind of relief can be granted from Section 50a EStG withholding tax?

Investment depot freistellungsauftrag kinder union